chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on 09/02/2021, the patient was administered both his influenza vaccine and his 1st in a 2 part  series of the Pfizer-BioNtech COVID-19 vaccine.  Roughly 4 days later he was seen in the ED for diffuse inflammatory reaction the patient was suffering from polyarthralgia swelling of the affected joints in upper extremities lethargy and fatigue.  He was initially diagnosed with a vaccine reaction and discharged.  He was subsequently seen several more times in the ER in the coming weeks.  Eventually he presented to me his PCP for assessment.  He was noted at our initial visit for this issue to have had significant elevations in CRP.  An ESR was later found to be severely elevated.    He was initially treated with prednisone for suspected PMR, any responded favorably.  Unfortunately his symptoms persisted.  He was eventually seen by Rheumatology and treated for suspected seronegative rheumatoid arthritis with methotrexate.    On 11/04/21,  the patient began experiencing a scotoma and visual deficit in his left eye.  He presented for assessment with Optometry on 11/10/2021 who noted the patient to be suffering for left optic nerve edema.  This prompted yet another ER visit, CT scans were negative for obvious intracranial process.  a later MRI suggested potential  cerebral microvascular.  Eventual follow-up with Ophthalmology raised further concern, and eventually the patient was seen by Neuro-Ophthalmology.  By this time an RPR had returned positive.    On 12/01/2021 the patient was admitted to hospital important and treated with IV penicillin for tertiary do neuro syphilis with ocular syphilis  and diffuse syphilitic arthritis.  FTA Abs  eventually returned positive, and patient is responding well to IV antibiotics.   The patient has been in a monogamous relationship with his wife for several decades.  The patient himself continues to attribute his symptoms and the events  in his health to his vaccine.  Although this event suggests the presence of syphilis for many years, the acute worsening in sudden onset of severe symptoms of tertiary syphilis  within a very short time of receiving his vaccines bears consideration and assessment.
This is a non-serious spontaneous case, initially received from a pharmacist on 29-Oct-2018, concerning a 42-year-old, adult male patient. On an unspecified date in Oct-2018, the patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number and expiry date: not reported]. On an unspecified date in Oct-2018, after vaccination, the patient experienced pain in arm. The outcome of the event was not reported at the time of this report.
Red bumps to her legs and neck and they are itchy; red bumps to her legs and neck and they are itchy; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Support. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 23Apr2021 09:00 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on 02Apr2021 as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced red bumps to her legs and neck and they are itchy. Caller got the first dose of the vaccine on 02Apr2021 and the second was received yesterday 23Apr2021 at 9am (correct dosing schedule). Reporter said she woke up this morning with red bumps to her legs and neck and they are itchy. She wanted to know if it was okay to take Benadryl. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The day after 1st dose I woke up with excessive numbness in my front foot and toe area of my left foot.  After 2 weeks, it became red and swollen also.  This has continued to have the same symptoms since March 4, 2021, even though I have had several treatments from my Podiatrist--on anti-inflammatory medication, had cortisone shot.  Nothing working.  It's improved slightly.
About a 102 fever starting around 5 am 4/28. Severe body and headaches, along with extreme fatigue lasting until and up through the morning of 4/29. Tylenol and ibuprofen as needed.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (MRK INJ). On 10-APR-2018 the patient was vaccinated with dose of expired M-M-R II injection (dose, frequency and route were not reported) (lot # M016234, expiry date: 31-MAR-2018) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Albumin status for M-M-R II is recombinant human albumin (rHA).
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR ("had a big scar" that keeps getting bigger at injection site of right arm), VACCINATION SITE DRYNESS (skin at injection site is still dry) and VACCINATION SITE SWELLING (skin at injection site is still dry and swollen) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SCAR ("had a big scar" that keeps getting bigger at injection site of right arm), VACCINATION SITE DRYNESS (skin at injection site is still dry) and VACCINATION SITE SWELLING (skin at injection site is still dry and swollen). At the time of the report, VACCINATION SITE SCAR ("had a big scar" that keeps getting bigger at injection site of right arm), VACCINATION SITE DRYNESS (skin at injection site is still dry) and VACCINATION SITE SWELLING (skin at injection site is still dry and swollen) had not resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient takes other concomitant medicine but not specified Patient used oil for treating dried skin
myocarditis; pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) and PERICARDITIS (pericarditis) in a 19-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization and medically significant) and PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (myocarditis) and PERICARDITIS (pericarditis) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning a 19-year-old male patient with no medical history reported, who experienced the serious (per hospitalization and medically significant) expected events of pericarditis and myocarditis. The events occurred on an unknown onset date and latency with a dose of mRNA-1273.815 for COVID-19 Vaccination. The events had resolved. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.
This spontaneous report was received from a registered nurse, referring to a 66 patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (20 patients with doses of lot number: L042631, expiration date: 16-DEC-2016, 26 patients with doses of lot number: L034381, expiration date: 22-DEC-2016, 20 patients with doses of lot number: L030442, expiration date: 19-DEC-2016) (doses, anatomical sites and routes were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complain involved. This is one of several cases from the same reporter. Additional information has been requested.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Received vaccines on 12/14/17. The case had 2 bowel movements on 12/15/17 and then did not have a bowel movement  for the next  6 days. Mother reports that the baby is breast fed and normally has 4-5 stools per day. The baby became distended and cried when abdomen was touched. Mother did not report any vomiting. The baby resumed  having bowel movements on 12/22/17.The baby did not receive any special treatment for the decrease in stool. Mother did not note blood in the stool after he resumed having bowel movements. Symptoms disappeared.
Headache, Arthralgia, Fatigue, chills, injection site pain and swelling, tenderness and swelling of the local lymph nodes on the injection side
Itching that is still ongoing 1 week post vaccination that started 10 minutes after vaccination. I flushed initially, was dizzy, and then began itching to the head and neck. Itching eventually spread to the torso and legs and became generalized. I began taking benadryl 25-50 mg and continuing pepcid as needed afterwards. GERD also severely worsened and has waxed and waned. Itching overall has waxed and waned, but as soon as medications wear off, itching will very quickly return and is intense to the entire, head, neck, torso and upper extremities. I am also getting breakthrough itching as well even with higher dosages of antihistamines. I had to call out from work 2/5/21 today as a medical provider in primary due to the effects of the antihistamines.   I called my allergy/immunology specialist on Tuesday 2/2/21 and he prescribed xyzal 5mg twice daily and hydroxyzine 25 mg at night. I saw him in the office yesterday, and after discussion, overall decided I should not receive the second dose of the vaccine, and when itching subsides and able to be off of antihistamines for 3 days we will do the PEG protocol testing, and in another 1-2 weeks (14-21 days after initial injection) we will do an IgG spike test to see if I developed antibodies.
Rapid heart rate and blood pressure. Rapid breathing. Shortness of breath. Partial leg paralysis. Second time filling out this VAERS other one didn?t show up
Within 10 minutes of receiving the flu vaccination, my fingertips on my left hand began to tingle and burn. I was still in the store, so I went back to the pharmacist to ask if this was a concern. He said he may have hit a nerve and it would most likely go away. I continued my daily activities and didn't notice the tingle when I was working, but at rest it was still noticeable by 8:00PM so I began to fill this out. I'll seek an appointment with my Primary Dr. tomorrow if it continues, but not certain if I can get in on a Saturday. Will go to a clinic if it still persists. Am VERY concerned about getting GBS.
after first dose arm was sore for about 48 hours after second dose at 16 hour mark woke up with rigors and fever; the next 24-28 hours very tired and achey with head ache now 10 days later have very sore arm from second dose
On 02/01/2023, I woke up with a little tickle in the back of my throat. I normally wouldn't think much of it, but we have been super healthy these past few years and my husband was preparing for a hip surgery. I continued to feel worse over the next twelve hours. When I woke up on 02/03/2023, I took a COVID-19 test and was positive. I developed a fever and a cough. I called my clinic to inform them of my positive test. They prescribed PAXLOVID, which I took for 5 days. During that time, I felt like I had a pocket full of dirty coins in my mouth. It was a horrible taste. My symptoms didn't really improve during the 5 days. My coughing was really horrible, and I had chest pain. My fever was around 100 to 101. My husband tested positive a few days later and our symptoms gradually improved over the next few weeks. Since 02/02/2023, the fatigue really hit us hard, but I think we are back to where we were.
FELT COLD ALL OVER HER BODY; FELT TIRED; HEADACHE; This spontaneous report received from a patient concerned a 59-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: cancer (in 2014), and concurrent conditions included: remission of cancer (in Dec-2019). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1), the patient experienced felt cold all over her body, felt tired, and headache (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt cold all over her body, felt tired and headache was unknown. This report was non-serious. The suspected product quality complaint has been confirmed to be voided as this does not meet the definition of a product quality complaint based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20211209858 (booster dose case with both dose numbers in series). This report was associated with product quality complaint number: 90000205465.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA (Strength, dose, frequency, route and anatomical location were not reported) of lot # M002268 with an expiry date of 20-SEP-2017, for prophylaxis. There were no concomitant therapies reported. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 21 hours and 6 minutes. There was previous temperature excursion which involved exposure to 47°F to 77°F for 6 hours. Digital data logger was involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA007255: US-009507513-1708USA006435:
Feverish, body aches - Patients relates having fever with pertussis as a child.
Received Flu and pneumonia vaccine 10/13/2010. Felt sick the next day. Came to office 10/21/10. Left arm swollen and tender. Given anti-inflammatory med & antibiotic for potential infection.
-Headache -Fever -Chills -Body aches -Joint pain *These symptoms started at 11pm on 8/23 and lasted through 8/27 -Dizziness -Hot flashes *These symptoms started at 11pm on 8/23 and are ongoing to this date
pneumococcal meningitis; pneumococcal meningitis; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  An 8-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "chromosomal abnormality" (unspecified if ongoing); "health issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MENINGITIS PNEUMOCOCCAL (hospitalization), DRUG INEFFECTIVE (hospitalization), outcome "unknown" and all described as "pneumococcal meningitis". Patient had at least 3 doses of Prevnar 13. He was hospitalized for about a month, was home now, but on home antibiotics. Therapeutic measures were taken as a result of meningitis pneumococcal, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
body aches; she could hardly walk; joint pain that was so severe; chills; fever (less than 38 degrees Celsius and just felt warmer than usual per Caller); headache; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "joint pain" (ongoing), notes: she normally has joint pain. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, she had no reactions), administration date: Feb2021, for Covid-19 immunization, reaction(s): "Had no reactions"; Flu shot (she has had a strong reaction to the flu shot (did not specify the reactions) in the past.), for Immunization, reaction(s): "a strong reaction". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "she could hardly walk"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain that was so severe"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever (less than 38 degrees Celsius and just felt warmer than usual per Caller)"; HEADACHE (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "unknown" and all described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not have any known drug or food allergies. She reported that reports that she had a lot of side effects for three months afterwards.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pt noticed rash (itching) under right breast and left side and right side at 10 am 1 week after vaccination. Pain rated #5 then used an anti itch spray and this brought the discomfort to a# 1-2.
On 20APR91, pt devel temp, rash on body in AM, by late evening became flaccid rushed to ER about 1250AM 21APR91 pronounced dead 124AM;
Full body aches at 5:30 PM followed by chills in the middle of the night. Ibuprofen cleared up the symptoms. Woke up with very mild sinus congestion. Soreness at injection site 4 hours from time of injection, continuing to now (9:15 AM 1/6/2010).
Within 10 minutes of getting TWINRIX Vaccine, I had an extreme headache, nausea and a wave of bad feeling. Around 4:00 my defibrillator went off and I lost consciousness for several seconds; when I woke up on 6/1/2016 had another firing of device but did not lose consciousness.
This non-valid spontaneous report was received from a Registered Nurse referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA 0.5mL by mouth one time, lot number N019924 with expiration date on 02-SEP-2018 (15 doses) and lot number N020689 with expiration date on 22-OCT-2018 (34 doses) or with an improperly stored doses of ROTATEQ 2mL by mouth one time, lot number N010706 with expiration date on 02-DEC-2018 (50 doses), lot number N013885 with expiration date on 09-DEC-2018 (20 doses), lot number N013992 with expiration date on 27-JAN-2019 (10 doses) and lot number N029868 with expiration date 12-MAR-2019 (10 doses), both vaccines for prophylaxis. The administered doses of the vaccines experienced a temperature excursion in the range between 44 degrees Fahrenheit to 77 degrees Fahrenheit (53.1 degrees Fahrenheit) for 4 hours and 30 minutes, as recorded by a data logger. The vaccines had not had a previous temperature excursion. There was no adverse effect reported. No product quality complaint was involved. Lot number N029868 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent. Follow up information has been received from the reporting nurse on 19-MAR-2018, via a phone call. The reporter stated that her vaccines were not at risk, therefore there was no need to identify any patients that received at risk vaccinations.