chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician, via a GSK sales representative, that described the occurrence of swelling at the injection site in an unspecified number of 4-year-old subjects of unspecified genders who were vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date(s) the subjects received the 5th dose of INFANRIX (.5 ml, unknown). At an unspecified time after vaccination with INFANRIX, the subjects experienced swelling at the injection site and injection site redness. A physician reported to a GSK sales representative that she has noticed an increase in injection site swelling and redness in 4-year-olds vaccinated with INFANRIX. The representative reported that the events were primarily occurring in an unspecified number of 4-year-old subjects, but the children of other ages were possibly involved. No other patient specific identifiers were provided for the vaccination subjects. The physician inquired if the formulation of INFANRIX had changed, since she had been using the vaccine for a long period of time and this was a new development. A product complaint was lodged for this report, but no lot number was provided. At the time of reporting the outcome of the events was unspecified. The GSK sales representative noted that there was a pertussis outbreak in the reporting region, but did not know if any of the subjects vaccinated with INFANRIX had been exposed to or diagnosed with pertussis.
Severe Fatigue, Severe nausea and vommitting, severe muscle aches and pains, fever-like symptoms
felt hot, flushed, lightheaded, tight feeling around jaw and chin within 2 minutes of giving vaccine; reported feeling very nervous before getting vaccine, due to prior anaphylaxis with different type of COVID vaccine, felt sx were more likely 2/2 anxiety. after discussion of risks/benefits, given pt's history of anaphylaxis and her understandable anxiety about current vaccine and post-injection symptoms, gave 50mg PO diphenhydramine and 125mg IM Solu-Medrol. at no point did she have sensation of face, tongue, or throat swelling; shortness of breath; nausea or vomiting; syncope or pre-syncope; chest pain; skin changes such as hives. HR 80s, SpO2 98-99% on room air, and BP 160s/90s throughout time pt was symptomatic. pt felt much better after 30 minutes of observation, ambulated comfortably without dizziness or pre-syncope. after 50 minutes of observation pt felt comfortable going home with family member driving. pt was unsure whether she had epi-pen in her car or purse, so she was sent with epi-pen and family member was instructed in administration of epi-pen with trainer device. pt was escorted out without incident.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 08-OCT-2012, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Started with slight sore throat. Had chills and fever during night.  c/o head and neck pain this a.m. along with ear pain, sore throat, nausea, and occasional cough.
Headaches started after 5th shot. He was getting 4-5 per day in the bitemporl area. Treated with Motrin and told to follow up with his primary care physician.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T024284, expiration date: 15-JUL-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Patient reported: "The injection site is still a tad red but there's a very definite bump under the skin. I had pretty significant nausea and distance on day 2, the nausea has gotten better but the diarrhea has remained. I also have had a pretty extreme increase in my restless legs, like just sitting for half an hour and my legs are pins and needles and need to move. I've gotten a couple headaches as well." EDD: 6/1/23 Type 1 DM Hypothyroid
About 3 hours after receiving the vaccine I started to have a headache that would go from the base of head on the right side, up the right side of my head to the back of my right eye. This lasted for 5 days. I had tried tylenol, ibuprofen, and advil with no relief. On day 4 I woke up with and additional symptom of nausea. I went to Urgent care where they tested me for Covid which came back negative and suggested this was side effects from the vaccine. The nausea lasted until the 7th day post vaccine.
Information has been received from a healthcare worker from a physician's office concerning a 17 year old female with no medical history and allergic to SULFAMETHOXAZOLE (+) TRIMETHOPRIM (BACTRIM) who on 28-MAR-1996 was vaccinated with a first dose of VARICELLA (Lot# 660495/0431X) and experienced no adverse side effects. On 19-AUG-2008 the patient was vaccinated with a second dose of GARDASIL on the left arm and with a dose of FLUMIST. On 20-AUG-2008, an angioedema developed on her upper right arm where the VARICELLA was administered. At the time of reporting, the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
patient was administered with 0.25 (half dose) of MENACTRA, no AE; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old female patient who was administered with 0.25 (half dose) of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6827BA and expiration date:18-Feb-2022) , via intramuscular route in the right deltoid for prophylactic vaccination on an unknown date (underdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B ; HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and INFLUENZA VACCINE (INFLUENZA VACCINE) for prophylactic vaccination.  On It was an actual medication error case due to vaccine underdose (Same day latency).  No adverse event reported at the time of reporting.  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.
Arthralgia, Fever, chills Narrative: chills, low grade fever, and most intense joint pain of employee's life
3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine". The reporter knew 3 people that have been diagnosed with Sarcoidosis after having the Pfizer Covid-19 vaccine. The reporter wanted to know have there been any other such reports of these side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Started as I walked, I would drift to the left. If I started on the right side of the aisle and walked down it, I would be on the left side by the time I reached the end. It became more noticeable, so I visited the doctor and told her what was going on. She was confused as I was. Then I started with other symptoms such as walking difficulties. My legs were very weak, and I couldn't walk very far without stopping for a rest. Now when I go shopping, I have to stop for frequent rest. My walking difficulties and the weakness in my legs is so pronounced that I needed to get a handicap sticker. I went back to the doctor and told her I had other problems. I was developing incontinence, lately visual disturbances blurry vision (I recently had cataract surgery and glasses aren't enough anymore). Headaches, a lot of them, and them being the worst in the morning then getting better during the day. Tired frequently. Often, I experience nausea. I went back to the doctor and brought the list of symptoms I was experiencing, and she wasn't sure, but she said she would speak with a neurologist. She called me a couple days later and he was recommending an MRI of my brain. So, she set that up and I had the MRI and it showed something. In my fourth ventricle in my brain, my fourth ventricle was producing too much spinal fluid. I went to see a neurologist at the hospital, and he wanted me to see a neurosurgeon who I'm seeing on April 12, 2022. I'm probably going to have a shunt in my brain, which they attach to a tube that runs into my abdomen that will drain the excess fluid. Right now, the fluid is crushing my brain against the side of my skull. I also fall a lot to the left. I don't become dizzy or anything, I will just be walking along and fall to the left. Neurologist noted that there was no cure, but they are able to treat it.
Beginning the day after my vaccine I had a fever, and stomach upset. Starting on Thursday I had severe abdominal pain, that has now lasted 6 days. I went to hospital where they treated me at the ED for acute gastritis.
ATE CHOCOLATE 45 MINUTES BEFORE TAKING VIVOTIF; This spontaneous case report was received from a consumer (PVX2019-051) on 07-Jan-2019. The report describes an 18-year-old male consumer who "ate chocolate 45 minutes before taking Vivotif". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer ate a little piece of chocolate 45 minutes before taking a dose of Vivotif on 05-Jan-2018. The last dose was on 07-Jan-2018.  The action taken with Vivotif with respect to the event "ate chocolate 45 minutes before taking Vivotif" was not applicable.  The clinical outcome of the event "ate chocolate 45 minutes before taking Vivotif" was unknown.  Company's Comment: The causality of the event "ate chocolate 45 minutes before taking Vivotif" was considered as not applicable; Sender's Comments: Company's Comment: The causality of the event "ate chocolate 45 minutes before taking Vivotif" was considered as not applicable
Experienced severe pain at the injection site; This is a spontaneous report from contactable physician via a Pfizer Sales Representative. An elderly female patient (68 or 70 year old) received on an unknown date a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization. Medical history and concomitant medications were not reported. The patient experienced severe pain at the injection site that asked for almost a week after administration with vaccine. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
pt recv vax @ approx 2PM 24NOV98 & 6PM had some wheezing, rapid heart beat & felt weak;
CONTINUING PALPITATIONS, SHORTNESS OF BREATH, FATIGUE, AND DIZZINESS.. .  JUST ABOUT THE SAME TIME, i HAD A NEW HEART DEVICE IMPLANT.  A-FIB SUSEQUENTLY DIAGNOSED.    MY CARDIOLOGIST DOES NOT THINK THERE IS A CONNECTION. I WANT TO BRING THIS TO YOUR ATTENTION BECAUSE THERE MAY BE A CHANCE THAT OLDER PERSONS ALREADY PRESENTING WITH CARDIOMYOPATHY MIGHT BE SUSCEPTIBLE TO THESE SYMPTOMS WHILE NOT HAVING THE SAME LEVEL OF INFLAMATION AS IS  BEING NOTICED IN YOUNG ADULTS.   INDIVIDUALS AT MY AGE TEND TO HAVE SO MANY COMORBIDITIES UNTIL THEY MAY BE UNLIKELY TO NOTICE NEW SYMPTOMS.
I received a flu vaccine on November 17 at Employee Health and noticed that the injection site was high on my left shoulder near my joint. That evening I could hardly move my arm and since then have had shoulder pain and muscle soreness.
Mild rash on forearms approximately 10 minutes after injection. Subsided/cleared 10 minutes later.   Issue potentially occurred with first dose but difficult to determine based on resident skin color. Gave low dose (6.25mg diphenhydramine) 30 minutes prior to the dose on 2/26 in the event there was a adverse reaction with 1st dose.
headache; fatigue; chills; fever; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Oct2021 09:00 (Lot number: FF8841) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: FLU VACCINE VII, administration date 20Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 13Jan2021, when the patient was 26 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 03Feb2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 07Oct2021 21:00, outcome "recovered" (Oct2021), described as "headache"; FATIGUE (non-serious) with onset 07Oct2021 21:00, outcome "recovered" (Oct2021), described as "fatigue"; CHILLS (non-serious) with onset 07Oct2021 21:00, outcome "recovered" (Oct2021), described as "chills"; PYREXIA (non-serious) with onset 07Oct2021 21:00, outcome "recovered" (Oct2021), described as "fever"; MYALGIA (non-serious) with onset 07Oct2021 21:00, outcome "recovered" (Oct2021), described as "muscle aches". Therapeutic measures were not taken as a result of headache, fatigue, chills, pyrexia, myalgia.  Additional information : Patient did not met any seriousness criteria. The most recent COVID-19 vaccine was administered at workplace clinic. Other vaccine was administered in four weeks. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient was not tested positive for COVID-19.   No follow-up attempts are possible. No further information is expected.
Frequent episodes of unresponsiveness while awake. Stiffening, vomiting, arching of back, jerking occurred twice, one at ER. Given ATIVAN. First occurred on 1/16/13 around 10:30 AM.
This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 11th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
ACHE; WEAK; FEELS TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ustekinumab. On an unspecified date, the subject experienced ache, weak, and feels tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feels tired, weak and ache was not reported. This report was non-serious.  Version (2) created to amend previously reported information on 18/Mar/2021. Upon review the following information was amended: Labeling of event (weak) updated to labeled from unlabeled
Patient reported loss of vision, and tinnitis. She felt hot, sweaty, and nauseous. I had her remove her hat and sweatshirt and she had a drink of water. My intern called EMS to assess the patient. After sitting down for a few minutes, her vision did improve. Blood pressure with a wrist cuff was 110/72. No symptoms of anaphylaxis or difficulty breathing. EMS arrived after a few minutes, they assessed her vitals she reported doing better. Patient denied being taken to the hospital for further assessment.
Today I was diagnosed with Covid 19.; Today I was diagnosed with Covid 19.; I am devastated; This is a spontaneous report received from a contactable consumer or other non hcp.   A 56-years-old male patient received bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date,at the age of 56 years old,as Dose number unknown,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced he was diagnosed with covid 19 on an unspecified date and devastated on an unspecified date.The outcome of the events was unknown.Patient wanted to know what are the Short Term & Long Term effects after Covid 19 disappears.  Follow-up (01Sep2021): This is a follow-up spontaneous report received from a contactable consumer.Forwarded as an Adverse Event and Medical Inquiry on 01Sep2021 Reporter provided verification of contact address on 31Aug2021.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Severe left lower pain; painful diarrhea for 12 hours; Dose 1 and dose 2 not Pfizer; Dose 1 and dose 2 not Pfizer; booster dose; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 11:15 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Lot Number: Unknown. Unable to locate or read the details), administration date: 12Feb2021, for COVID-19 immunization; Moderna (Dose Number: 1, Lot Number: Unknown. Unable to locate or read the details), administration date: 22Jan2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Dose 1 and dose 2 not Pfizer"; IMMUNISATION (medically significant) with onset 06Dec2021, outcome "unknown", described as "booster dose"; PAIN (medically significant) with onset 06Dec2021 18:00, outcome "not recovered", described as "Severe left lower pain"; DIARRHOEA (medically significant) with onset 06Dec2021 18:00, outcome "not recovered", described as "painful diarrhea for 12 hours". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) negative, notes: Nasal Swab. Unspecified therapeutic measures were not taken as a result of pain, diarrhoea.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Off label use, Interchange of vaccine products, Immunisation, Pain, Diarrhoea. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
the adult patient was administered two pediatric doses of VAQTA, instead of one adult dose.; the adult patient was administered two pediatric doses of VAQTA, instead of one adult dose.; No adverse effects occurred.; Information has been received from a nurse referring to an unknown gender adult patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with two pediatric doses of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 intramuscular (lot # R024007, expiration date: 12-OCT-2019, frequency were not reported) for prophylaxis instead of one adult dose. (incorrect dose administered, product administered to patient of inappropriate age). No adverse effects occurred.
This spontaneous report was received from a registered nurse refers to an unspecified amount of patients of unknown age and gender. Nurse stated that on an unknown date in 2014 within the past 2 weeks an unspecified amount of patients were vaccinated with a dose of VAQTA which was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
A small lump formed under the skin and he has had intense itching of site for the last several months. Did not start until a couple of weeks after the vaccination.