chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 73 years old male patient who experienced felt a little bit different the next day, a headache off and on since then, on the right side of his head, the right side of his mouth feels sensitive and painful and his right upper jaw and back right molar have been aching and painful, while he received vaccine INFLUENZA VACCINE. The patient's past medical history included Cardiac failure with in 2006, and a quadruple bypass surgery, and now has a defibrillator and pacemaker. The patient's past vaccination(s) included flu shots in the past and never had a reaction. The patient's past medical treatment(s) and family history were not provided. Concomitant medication was not reported. On 24-Sep-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a non-serious felt a little bit different the next day (feeling abnormal) following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious a headache off and on since then, on the right side of his head (headache) following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious the right side of his mouth feels sensitive and painful (oral pain) following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious his right upper jaw and back right molar have been aching and painful (pain in jaw) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.) Final diagnosis was his right upper jaw and back right molar have been aching and painful, the right side of his mouth feels sensitive and painful, a headache off and on since then, on the right side of his head and felt a little bit different the next day. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for a headache off and on since then, on the right side of his head, as Unknown for the right side of his mouth feels sensitive and painful, as Unknown for his right upper jaw and back right molar have been aching and painful and as Unknown for felt a little bit different the next day. List of documents held by sender: none.
Patient seen in ER 11-NOV-2006 14:45. Mother reported itching on left thigh 10-NOV-2006. 11-NOV-2006 noticed redness and swelling and warmth left thigh. Treated with Benadryl 25 mg PO every 6 hours until symptoms gone. Prenisone 5 mg and ice to area.
3/23/21 started fever:temp max 102.9 on and off through 3/24/21 3/24/21: temp max: 100.5 Used Tylenol Extra strength Fevers now resolved  Below Lt arm injection site 3in x 1in size, site slightly warm, red, swollen, itching, rash,  Called PCP and recommended benadryl
Developed a large lump under skin at left arm pit.  Fever. Dizziness and drowsiness.
3 months after vaccine, started having pain in feet and it slowly travelled up my legs and continued up through all of my body. It felt like my body was burning from the inside out. Eventually it spread through my body. Went to urgent care and doctor feared that I may have blood clots in my legs and was sent to the ER. Had an Ultrasound done on my legs to check for blood clots, none were found. Then they did a CT Angio Chest combination test and was diagnosed with Tachycardia. Was only sent home with cyclobenzaprine medication for muscle spasms. Was in extreme pain before this medication, but then felt worse after taking cyclobenzaprine. Hospital called later in the day to follow up with me. I told them that the medicine was making me feel worse, they came to find out that I was sent home with somebody else's discharge papers and prescription. Afterwards I went to see my own primary doctor and had blood work done. My pain became so bad I was barely able to function without pain. Was referred to a Rheumatologist. At Rheumatologist was given 15mg. of prednisone to take daily. Was diagnosed Rheumatoid Arthritis, Gout and Polymyalgia Rheumatica. Was given vitamin D3, calcium, nystatin, and B12. Went back 1 week later and there hadn't been any changes in my bloodwork or pain levels, doctor increased prednisone from 15 mg to 20 mg. Pain finally did start to ease up over the next couple of months. My heart rate was still high, so my doctor prescribed diltiazem extended release but it didn't help. My calcium levels have been too high, after bloodwork my doctor want's to remove my Palate Thyroid.
Possible cellulitis to site of Varicella (left arm).  Possible transmission of chicken pox to sibling.
Patient woke the next day with an uncharacteristic migraine headache that was intractable for 7 days.
Patient's mom came to report patient's conditions. Patient has bad diarrhea, vomiting and fever.
Sharp and strong pain on my chest, left side one week later of my second vaccination. When to urgent care around September 12., 2021 They took chest x-rays . Doctor said my heart looked find and that maybe was the muscle covering my heart. I was sent to a cardiologist who did a Treadmill Stress Test and  Myocardial Perfusion Imaging Procedure. Everything came out ok. My mammogram came ok too. But  I continue having this sharp pain on my heart. For this reason I did not do the booster.
Progressive Limbic Encephalitis; inattention; short term memory loss; apraxia; slow cognitive speeds; Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LIMBIC ENCEPHALITIS (Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis), CONDITION AGGRAVATED (Progressive Limbic Encephalitis), ATTENTION DEFICIT HYPERACTIVITY DISORDER (inattention), AMNESIA (short term memory loss), APRAXIA (apraxia) and COGNITIVE DISORDER (slow cognitive speeds) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MZ0A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Limbic encephalitis in September 2020.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced LIMBIC ENCEPHALITIS (Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis) (seriousness criteria hospitalization and medically significant), ATTENTION DEFICIT HYPERACTIVITY DISORDER (inattention) (seriousness criteria hospitalization and medically significant), AMNESIA (short term memory loss) (seriousness criteria hospitalization and medically significant), APRAXIA (apraxia) (seriousness criteria hospitalization and medically significant) and COGNITIVE DISORDER (slow cognitive speeds) (seriousness criteria hospitalization and medically significant). On 22-Mar-2021, the patient experienced CONDITION AGGRAVATED (Progressive Limbic Encephalitis) (seriousness criterion hospitalization). At the time of the report, LIMBIC ENCEPHALITIS (Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis), CONDITION AGGRAVATED (Progressive Limbic Encephalitis), ATTENTION DEFICIT HYPERACTIVITY DISORDER (inattention), AMNESIA (short term memory loss), APRAXIA (apraxia) and COGNITIVE DISORDER (slow cognitive speeds) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with Plasma Pherisis x7 exchanges plus IV methylprednisolone followed by Prednisone taper.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
administered a dose of ACTHIB reconstituted with sterile water instead of provided 0.4% Sodium chloride, with no reported adverse event; Initial information received on 06-Jun-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 3 years old male patient who experienced administered a dose of acthib reconstituted with sterile water instead of provided 0.4% sodium chloride, with no reported adverse event while receiving vaccine hib (prp/t) vaccine (Act-Hib).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine polysacch (Pneumococcal Polysaccharide Vaccine).  On 27-May-2022, the patient received a dose of suspect hib (prp/t) vaccine at a dose of 0.5ml with lot UJ740AA via unknown route in unknown administration site for Immunization.  On 27-May-2022 the patient developed a non-serious administered a dose of acthib reconstituted with sterile water instead of provided 0.4% sodium chloride, with no reported adverse event (wrong technique in product usage process) following the administration of hib (prp/t) vaccine. This situation is reported as a medication error due to reconstituting with alternate diluent.   Action taken: not applicable.  Outcome: 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 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.; Sender's Comments:  US-SA-2022SA213837:
I had the shot late afternoon on Saturday and woke up Sunday morning with a major ringing and  I would guess 90% loss of hearing in my left ear, to day is Friday and I still am unable to hear anything in my left ear I saw my Docter on Monday and she indicated my ear was a little swollen and gave me a prescription for Methylprednisolone 4 MG and after two days on it I still am unable to hear anything in the left ear
Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). On 18-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Vaccine expires 6/30/2019. NDC # 19515-909-41. Produced by ID biomedical corporation Part of GlaxoSmithKline. Patient developed erythema, warmth and tenderness around the injection site the day after administration. Symptoms were rapidly progressive. Similar to the year before. Was treated with antibiotics last year and again for this current reaction that was concerning for cellulitis.
Mild fever becoming severe at night. 102.3 degrees F at 4:30 AM. Lightheadedness, nausea, body aches, dry cough.   Mild chest pain, soreness. Symptoms are flu like. Sinus congestion and headaches continue through the morning along with the cough.
Ache in right arm and shoulder beginning the day after the flu shot to present (almost 2 months). Range of motion is limited: cannot move right arm over left shoulder or behind right side of the back. Difficult to put on shirt. Cannot lay on right side in bed. Doctor assigned physical therapy exercises as of 12/12/2017.
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL3246), on 06Feb2021 as dose 2, single (Lot number: EL3246) and in Oct2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESCITALOPRAM (LEXAPRO), start date: Feb2022; DEXTROAMPHETAMINE SUFATE, start date: Jun2021; TOPIRAMATE, start date: Jun2021; TRAZODONE, start date: Mar2022, stop date: Jul2022; CETIRIZINE HCL, start date: Apr2022; TYLENOL; ADVIL [IBUPROFEN]; ADULT MULTIVITAMIN; VITAMIN D NOS; start date: Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: labs: Unknown Results; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Anti viral drug PAXLOVID was taken from 30Jul2022 to 03Aug2022 for the treatment of COVID 19.  No follow-up attempts are possible. No further information is expected.
Individual called LHD to report adverse reactions to  vaccine including, SOB, dizziness, weakness, vomitting, headache and chills lasting 8 - 10 hours.
17AUG95 t104 & vomiting; parent took pt to ER late 17AUG95-ER reports pt had ear infect & temp was D/T shots, ear infect & teething; was issued ATB po & IM & Phenergan supp, APAP for temp
mostly debilitated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: ASTHENIA (non-serious), outcome "unknown", described as "mostly debilitated".  Additional information: It was reported that in Apr2021, the patient supported in a mission advocated by getting the covid vaccine. Since then the patient had been mostly debilitated.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine administered at 9am, later noticed itch and fine rash (not hives) on both forearms, more on left than right. At 12 noon took diphenhydramine 25mg tablet and now at 2:30p itch resolved. 10/3 rash persists but no antihistamine needed.
Have some inflammation issues going on right now; This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting for itself. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunization. Patient medical history included rheumatoid arthritis and Ehlers-Danlos syndrome. Concomitant medications were not reported. It was stated that he was getting his second dose tomorrow and he just find that his first dose well not expecting anything unusual with his second dose. On an unspecified date patient reported that  he has some inflammation issues going on right now. His doctor would like to put him on steroids and they were wondering how long after he get his second dose tomorrow. Should they wait for starting the course of steroids. The outcome of then event was unknown.  No follow-up attempts are needed; No further is information expected
Information has been received from a registered nurse concerning a 22 year old female who was vaccinated with first and second doses of MMR II in May 2005 and on 04 May 2006 (lot# 649759/0383R), respectively. On 14 Aug 2006 a measles titer was taken and the result was negative, the patient did not seroconvert for measles. There was no product quality complaint involved. Additional information has been requested.
Felt like the flu. Chills, severe muscle aches, everywhere,  for about 6 hours. Very sore arm
Site of injection warm to touch, swelling and redness streaking down arm, was given Benadryl and Tylenol.
Information has been received from a nurse referring to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On 02-AUG-2016, the patients might have received improperly stored and then expired doses of ROTATEQ (lot # K022995, expiration date 22-JUL-2016, dose not reported) orally. On 08-JUL-2016, the vaccine was improperly stored at 49.1 degree Fahrenheit for 1 hour 7 minutes. There was no previous excursion. Data logger was involved. No adverse effects were reported. The nurse had requested stability data for ROTATEQ for the excursion that occurred prior to expiration. Additional information has been requested.
Medical Assistant when she was inputting the vaccine information in the patient chart she realized that she gave the 11 yr old patient the Men B instead of the Tdap. She informed the provider and the practice manager, the provider called the mother to informed her of the incident.Patient is doing well with no reaction to the vaccine.
torticollis- pain and stiffness of trapezius on left side of neck, same side as vaccine (left deltoid)
arm swollen and red and unable to move it; arm swollen and red and unable to move it; arm swollen and red and unable to move it; inflammation; This is a spontaneous report from a contactable Pharmacist. A patient of unknown age and gender received pneumococcal 13-val conj vac (DIPHT CRM197 PROTEIN) (PREVNAR 13) on unknown date at single dose via unknown route of administration for immunization. Medical history and concomitant medications were not reported. Reporter wanted to know whether these were common side effects and any management recommendations: arm swollen and red and unable to move it. Reporter was just glad to know that it was being recorded and expected to happen and did not realize that sometimes it occurred 7-14 days after injection. Reporter given this shot for a lot of patients and this was the very first time reporter had this complaint. Patient was advised to get Benadryl, Tylenol and ibuprofen for inflammation, and ice. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3248), via an unspecified route of administration on 11Mar2021 09:00 (at the age of 52-years old) at 1st dose, single dose in the left arm for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications (reported as no other medications in two weeks) The patient was not pregnant at the time of vaccination and had no COVID prior vaccination. The patient also had no other vaccines in four weeks. On an unspecified date, the patient experienced fatigue. The patient received no treatment for this event. The patient has not tested for COVID post-vaccination. The patient was vaccinated at a workplace clinic. Outcome of the event was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Sore arm at injection site starting 5:00am 08Jan2022  Headache starting 12:00pm 08Jan2022  Fever starting 12:00pm 08Jan2022
Fever, chills, body aches, fatigue, muscle weakness, and injection site pain, redness and tenderness.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose VAQTA. Subsequently the patient experienced an unspecified allergic reaction to the vaccine. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
shingles; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient had one shot 4 weeks before day of reporting. In 2021, patient had shingles. The patient enquired did this normal. The follow up was not required.
PRES. Patient developed posterior headache lasting approximately 7 days with facial paresthesia.
I26.99 ACUTE PULMONARY EMBOLISM 4/6/2023 SEPSIS UNSPECIFIED ORGANISM J96.10 CHRONIC RESPIRATORY FAILURE 4/6/2023 SEPSIS UNSPECIFIED ORGANISM J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/14/2023 SEPSIS UNSPECIFIED ORGANISM R09.02 HYPOXEMIA 3/21/2023 SEPSIS UNSPECIFIED ORGANISM
Right side hearing loss; Dizziness; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Right side hearing loss) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced DEAFNESS (Right side hearing loss) (seriousness criterion medically significant), DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DEAFNESS (Right side hearing loss), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Magnetic resonance imaging: normal (normal) normal.         Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient developed rash at the injection site. The rash grow in size  every day and now its about 6 in by 4 in size. She applied aloe Vera cream and hydro-cortisone cream.
She received covid vaccine of Pfizer on 9/16/2021 started to experience, burning throughout the body in certain area, headache, ringing of the ears,teeth pain eye pain, dizziness, took Tylenol to help with side effects, hasn't take any other medication that she takes on daily to to medical history but still are having side effect have not gone to see doctor as of 9/20/2021