chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a patient's parent via Sanofi Pasteur MDS refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb vaccine (manufacturer unknown) (dose, lot# and route of administration were not reported). On an unknown date, the patient collapsed and suffered from getting the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) shot. The patient was taken to emergency room (ER) and got asthma which she did not have prior to the vaccination. The outcome of the events was not reported. Relatedness between asthma and quadrivalent human polyomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) was not reported. Additional information is not expected because the reporter contact details were not provided.
Fainted 5 minutes after vaccine given. Came to combative, very pale and took 30 minutes to feel "ok".
Case number PHEH2012US023628, is an initial spontaneous report received from a nurse on 27 Nov 2012 and a follow up report from the nurse received on 17 Dec 2012. This report refers to a male child. He was vaccinated with a 0.5 ml dose of MENVEO (batch number: not reported) intramuscularly into the left deltoid region on 01 Dec 2011. It was reported that he was vaccinated with a second dose of 0.5 ml MENVEO (batch number: A12011) intramuscularly into the right deltoid region on 27 Nov 2012. After vaccine administration, it was realized that the patient had already received vaccine previously. In the follow up, it was confirmed that the patient had no adverse event between the 1st and 2nd dose of the suspect drug. Follow up report from the nurse received on 17 Dec 2012: The patient details, dose and administration route (region) of suspect drug and information related to the patient's condition were updated.
Patient received a Pfizer vaccine at another clinic on 03/05/2021 and the Moderna vaccine on 03/18/2021 from this facility.
Shortness of breath, dizziness, acute headache, dull to acute chest pains, and rapid heart rate onset while sedentary on the evening of 5/2. Episode repeated prompting visit to ER. Episode recurred during drive to ER. Released with instructions to get heart monitor fitting within 5 days. Symptoms recurred the following evening prompting return visit to ER. Symptoms recurred twice during drive to ER. Released with instructions to get heart monitor fitting within 24 hours. Shortness of breath and lightheadedness have continued at times.
11/12/2022 I experienced extreme vertigo around 8:00PM. I have tinnitus and just before the vertigo, it became abnormally loud. By around 11:00PM, the vertigo was so bad and the pounding in my ears was very scary. I had never experienced anything like that. This continued through the night into the morning. When I would wake up, the room was spinning. I called the doctor and was told to go to the urgent care or hospital. All day long the vertigo continued, and I was unable to do much. When I went to urgent care, they did an EKG, did not say the results, and said it could be a sign of a stroke, so I needed to go to the emergency department. I went to the emergency department. I had a negative COVID test. A CT was done that evening. I stayed in observation room overnight. I was given meclizine for the vertigo. I was also given ZOFRAN for nausea because I had become nauseated. The next morning around 9:00, I had an MRI. The results of the CT and MRI ruled out a stroke. I had an EKG that was normal. They also did blood work which showed I had low potassium. Later that day the physical therapist assessed me and believed it was a benign positional vertigo position which a Neurologist confirmed later that afternoon. He did an Epley maneuver. I was discharged a few hours later with physical therapy prescribed to continue treating the vertigo. I just finished physical therapy. I am still experiencing dizziness and reduced hearing in my left ear. I was advised to follow up with an ENT. I have that appointment next week. I have a follow up appointment with a Neurologist in February. I still have not fully recovered. I still experience dizziness and my balance is off.
Got a metallic taste in the mouth; Flush; Felt sick; Muscle cramping; Severe fatigue; Aching; Not been able to walk more than a few blocks or exercise since; Flu-like symptoms; Not been able to walk more than a few blocks or exercise/muscles go into cramps doing small things like stairs or an incline on the street or even just house cleaning getting up and down; Get out of breath; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 03Mar2021 at 10:00 (at the age of 52-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on 24Mar2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included drug allergy to cephalosporin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. It was reported that the patient was in good health while receiving both the first and second doses of the vaccine. The patient was walking and jogging 6 miles a day. The minute the patient received the vaccines, she got a metallic taste in the mouth, flush and then felt sick for an hour. This went away both the times, however, the patient had muscle cramping and severe fatigue and aching since the first dose and had not been able to walk more than a few blocks or exercise since. It had now been 3.5 months of waiting for the flu-like symptoms to go away. The patient's muscles went into cramps doing small things like stairs or an incline on the street or even just house cleaning while getting up and down and the patient got out of breath. The patient had been to the doctor and could not find the cause. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metallic taste, flush and felt sick were resolved on an unknown date in 2021. The clinical outcome of the events muscle cramping, severe fatigue, aching, and not been able to walk more than a few blocks or exercise since, flu-like symptoms, muscles go into cramps doing small things like stairs or an incline on the street or even just house cleaning getting up and down and get out of breath were not resolved at the time of this report.
Information has been received from a certified medical assistant concerning a 36-year-old female with no pertinent medical history or allergies who may have been vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) as a child who now has a negative mumps titer. There was no concomitant medication. The patient does not remember if she received measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The patient sought medical attention via an office visit. On 19-SEP-2007, the patient had titers drawn in order to volunteer at a hospital. A product quality complaint was not involved. Additional information has been requested.
Influenza nasal mist administerd to pregnant teen on 11-30-15. On 12-1-15, reported runny nose and slight sore throat.
Pt was in observation area and developed substernal chest pain. No sweating, no nausea, no neck, jaw or arm pain.
I developed what is known as the ?COVID arm? rash about 12 days after my first dose of Moderna. I had one smaller rash at the exact injection site and another much larger rash a few inches below that. Both rashes were red, itchy, slightly painful, and warm to the touch. I am treating it with Benadryl, which has helped relieve the itchiness.
2nd dose I began having muscle aches  around 10pm (about 10 hours post 2nd dose) then I woke up in the night at 1am ( about 13 hours post injection) with a fever of 101.4, muscle aches (my legs, arms, neck, and back), chills, and sinus dryness.  This was controlled 3 hours later by tylenol. For the next 36 hours post symptom onset my sinuses were still affected, my muscles felt very weak and the glands in my neck felt swollen. Everything has resolved except the swollen glands in my neck and my sinsuses being dry and painful.
4/6/22 I started hyperventilating, had trouble getting my breath. An ambulance was called, and I was taken to the hospital and was admitted. I was diagnosed with AFIB. I was treated for that. A cardioversion was done while I was in the hospital. After 18 hours, I went back out of rhythm again.  Then I had a pacemaker placed and was given medicines. The medications I was prescribed amiodarone, baby aspirin, ENTRESTO, FARXIGA, LASIX, metoprolol, XARELTO. I added vitamin C to the other vitamins and supplements I was already on. I was taken off the lovastatin and put back on. I have my pacemaker checked and have had my AFIB in control. I went back to the hospital the first of June, 2022 for a procedure, an ablation, they could not do and found a blood clot. Now, they are treating the blood clot with medication.
Information has been received from a registered nurse concerning a child who was vaccinated with MMR II. Subsequently the pt developed a seizure and lost cognitive ability. Unspecified medical attention was sought. Upon internal review, the convulsions and cognitive disorder were considered to be other medical events. The registered nurse also reported that another child developed seizures (WAES0209USA01885). Additional info has been requested.
Gave pt. flu injection, removed needle from lt. arm. No needle on end of syringe, looked on floor, near vicinity - no needle seen. Marked site on arm, sent pt. to Urgent Care for x-ray.
Wednesday throughout the day I was not feeling well. I was feeling the frequent urge to urinate but was not urinating. I went into acute pain at 06:00PM, went to Clinic in agony. They treated for back spasms and they gave me the Depo shot (steroids) and Toradol shot which neither relieved the pain. They prescribed Baclofen. I was also vomiting Wednesday night. Thursday I was feeling a lot better. Friday, I woke up in unbearable pain. I couldn't stop vomiting and tried taking medication to stop the pain. I called 911 and the EMT took me to the hospital. They brought me in the nurse tapped my kidney and she immediately knew it was kidney related. They did a urinalysis and they found I had a kidney infection and did CT scan as well and found I had a kidney stone. So I had both the kidney infection and stone. I was in extreme pain and was in the ER for 12 hours. They were deciding for surgery or a stent to relieve pain, neither was done. Pain has not come back, but there is still discomfort.
Vaccine adjuvant without active component; Received vaccine adjuvant without active component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 477X5, expiry date 27-MAY-2024) for prophylaxis.   On 20-APR-2023, the patient received the 1st dose of Shingrix. On 20-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine adjuvant without active component) and inappropriate dose of vaccine administered (Verbatim: Received vaccine adjuvant without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The reporter reported that the patient received Shingrix vaccine adjuvant without active component. The reporter did consent to follow up. The reporter gave by error Shingrix adjuvant portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with US2023058300 and US2023AMR058824 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023058300:Same reporter/Other patient US-GSK-US2023AMR058824:Same reporter/Batch case
VACCINE WAS INDICAITED DUE ON GRITS, AFTER VACCINE WAS GIVEN I REALIZED THAT MAXIUM AGE HAS EXCEEDED AND SHOULD NOT HAVE BEEN GIVEN.NO ADVERSE EVENTS WERE NOTED WHEN PT. LEFT OFFICE.
HAD COVID 1/22/22.     ADMITTD 3-22-22 THRU 3-28-22  MEDICAL CENTER AND WAS COVID NEGATIVE AT  PER PCR ON 3-22-22.  HE WAS ADMITTED FROM NURSING HOME WITH PNEUMONIA AND INITALLY ON 100 PERCENT nrb BUT WEANED TO 6 LITERS N/C.  hIS CXR WAS NOW CLEAN WITH NO PNEUMONIA. AND WAS TRANSFERRED TO A DIFFERENT NURSING HOME WHERE DECEASD ON 4-19-22
6/13 68-year-old female with past medical history of right nephrectomy secondary to stones and infection, hypertension, CAD with recent NSTEMI status post PCI in May 2022 presented from nephrology office yesterday complaining of dyspnea, air hunger, productive cough with greenish-yellow sputum.
Dementia was on a slow progression over the past 12 years. Since the injection, the progression has accelerated dramatically with a loss of reality. Saying she is doing things that she is not or saying that she has done something that never occurred.
Pain, swelling, raised rash, continued swelling and spreading of rash still as of the time of this report-10-22-2015, 10:40 am.
exposed to relative w/chicken pox;had 1 dasy mild fever, not ill-recv 5 pox;
Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: HEADACHE (non-serious), outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional Information: Getting a second covid shot. Took an aspirin last night. Inquiring if it would affect the vaccine. Clarified aspirin was not related to the first covid vaccine, called just had a headache. The patient had headache after getting the first vaccine.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hemorrhage stroke; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (Hemorrhage stroke) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGIC STROKE (Hemorrhage stroke) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGIC STROKE (Hemorrhage stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.  Company comment: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected serious AESI of Haemorrhagic stroke in an unknown timeframe with the unspecified dose of mRNA-1273 vaccine. The outcome was reported as unknown, however the event was reported by the patient. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected serious AESI of Haemorrhagic stroke in an unknown timeframe with the unspecified dose of mRNA-1273 vaccine. The outcome was reported as unknown, however the event was reported by the patient. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
No adverse event; Moderna temp excursion - administered 3 doses past beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Beyond use date was reported as 02-Jul-2023. No other temp excursions experienced by this product. No particulates or discoloration noted. Moderna product was transported and maintained between 36 to 46 Fahrenheit. Treatment information was not provided.  This case contains information about patient 2nd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732784 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732784:Master case (Patient 3 administered on 7/7/2023  )
I had congestion, a runny nose, sore throat and chills. I completed an at home COVID-19 test and was positive. I called my doctor and did a telehealth visit and he gave me a prescription for PAXLOVID which I took. I started to feel better within 2 days of taking the medication. I think that I was having some allergy symptoms around the same time. 10 days later I tested negative. 2 days after that I began to have rebound symptoms. I retested and was positive. The symptoms lasted about 2 days and then got better. I am not sure whether I have recovered as the current symptoms I am having are similar.
pt recvd vax; 2-3 hrs later became limp;no tx rendered;
Cried up to five hours on day vaccines given, somewhat consolable. No treatment given as we were notified 1 month after event.
Change in level of alertness. Per vaccinator assistant (relative of client)- Not acting her normal .  Per client- tired/ unable to concentrate, feels flush and pale. VD 9:40AM HR99, O2 99%, BP 116/60, BS 175.  VS bp 109/66, hr 93, r14 Cincinnati- Negative. Went home with family. Instruct to contact PCP, and if unchanged to go to ED.
received her 2nd dose of the COVID-19 vaccine and her symptoms got worse; Gastrointestinal symptoms; Bloating of the stomach; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (received her 2nd dose of the COVID-19 vaccine and her symptoms got worse), ABDOMINAL DISCOMFORT (Gastrointestinal symptoms) and ABDOMINAL DISTENSION (Bloating of the stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (received her 2nd dose of the COVID-19 vaccine and her symptoms got worse), ABDOMINAL DISCOMFORT (Gastrointestinal symptoms) and ABDOMINAL DISTENSION (Bloating of the stomach). At the time of the report, CONDITION AGGRAVATED (received her 2nd dose of the COVID-19 vaccine and her symptoms got worse), ABDOMINAL DISCOMFORT (Gastrointestinal symptoms) and ABDOMINAL DISTENSION (Bloating of the stomach) outcome was unknown.            Concomitant medications were not provided. No Treatment information was provided.   This case was linked to MOD-2021-287626 (Patient Link).
This case was reported by a physician and described the occurrence of a lump at the injection site in a 7-month-old male subject who was vaccinated with PEDIARIX. On 11 April 2008 the subject received 3rd dose of PEDIARIX at 0.5ml in the right thigh. On 14 April 2008, 3 days after vaccination with PEDIARIX, the subject experienced a lump at the injection site. The child's parents noted the lump and reported it to the physician. The lump was described as soft, mobile and the size of a grape. There was no redness. No treatment had been required as of the time of reporting. No reactions were noted following the first two administrations of PEDIARIX. At the time of reporting the event was unresolved.
received Pentacel but not the Hib portion, patient is being recalled to receive Hib separate (with no reported adverse event); Initial information received on 11-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant and unknown gender patient who received Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but not the HIB portion, patient is being recalled to receive HIB separate (with no reported adverse event).  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 10-Aug-2023, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but not the HIB portion suspension for injection with unknown batch number, strength & expiry date via unknown route in unknown administration site for Routine immunization with no reported adverse event (single component of a two-component product administered) (latency: same day).  Information on the batch number was requested.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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.