chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report concerning a 33 year old female patient was received from the patient herself via Pfizer Inc. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (Manufacturer unknown) (the dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). No concomitant medications were reported. Subsequently, on 10-APR-2002, the patient experienced swelling, itching and redness, as a result of an allergy to Hepatitis B Vaccine (Recombinant) (Manufacturer unknown). At the time of reporting, the outcome of the events were unknown. The patient considered swelling, itching and redness to be related to Hepatitis B Vaccine (Recombinant) (Manufacturer unknown) while being silent on the relationship with the allergy. This is one of the three reports concerning the same patient (US-009507513-1606USA001646) (US-00907513-1606USA001647). Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of pallor in a 12-year-old male patient who received BOOSTRIX (batch number 7Y29Z, expiry date 17th August 2019). Co-suspect products included MENVEO (batch number M16127, expiry date 31st July 2018) and GARDASIL (batch number N012093, expiry date 13th January 2020). On 25th July 2017, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml, the 1st dose of MENVEO (intramuscular) .5 ml and GARDASIL (intramuscular) .5 ml. On 25th July 2017, immediately after receiving BOOSTRIX and MENVEO, the patient experienced pallor, tremor, eye movement disorder and stiffness. On an unknown date, the outcome of the pallor, tremor, eye movement disorder and stiffness were recovered/resolved. It was unknown if the reporter considered the pallor, tremor, eye movement disorder and stiffness to be related to BOOSTRIX. It was unknown if the reporter considered the pallor, eye movement disorder and stiffness to be related to MENVEO. The reporter considered the tremor to be probably related to MENVEO. Additional details were reported as follows: The case was reported by nursing assistant. The patient received BEXSERO on left deltoid, MENVEO on right deltoid and GARDASIL into his right deltoid.
Information has been received from a physician concerning a 79 year old male who on 6-JAN-2009 was vaccinated injection with ZOSTAVAX (LOT # not provided) 0.65ml. On 20-JAN-2009, the patient developed chickenpox after getting ZOSTAVAX. The patient's chickenpox persisted. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
p/ pt recv vax approx 3 days later pt exp headache & fever of 100.6f. addl info requested
On December 20, 2022, I woke up sore like I had been run over. I tested negative for COVID-19 on my home. I had body aches, headache, congested, chills, and sore throat. These symptoms lasted about three days. I consulted with my doctor on the next day, Wednesday. It was confirmed positive for COVID-19, and I was prescribed PAXLOVID. I took it as prescribed. I still have a lingering cough. Last week I do remember noticing I had trouble breathing, even when at rest. It felt like a little pressure, but this did not last long.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
evidently attacked my immune system and sent my RA into overload; taking out my ability to walk or stand; pain in my knees and legs.; RA into overload; I felt excruciating pain below my knees/ Knees were swollen and very painful; My knees were swollen and very painful; I couldn't walk/ very unstable walking as my legs give out; couldn't move my legs; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186), via unspecified route of administration on 17May2021 (at the age of 62-year-old) and non-pregnant at the time of vaccination, as dose 2 in left arm, single for COVID-19 immunization. The patient medical history included hypertension, fibromyalgia, rheumatoid arthritis, epstein-barr virus infection. The Concomitant medication(s) included Amlodipine, Methotrexate. The patient previously took Bactrim and experienced drug hypersensitivity, Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0175), via an unspecified route of administration on 26Apr2021 at 10:30 as dose 1, single in left arm for covid-19 immunisation. On 17May2021 at 23:15 patient experienced couldn't move my leg, my knees were swollen and very painful, I couldn't walk/ very unstable walking as my legs give out, evidently attacked my immune system and sent my RA into overload, taking out my ability to walk or stand, pain in my knees and legs, RA into overload, I felt excruciating pain below my knees/ knees were swollen and very painful. Seriousness criteria (hospitalization, disability). The patient was hospitalized from 18May2021 to 20May2021. Therapeutic measures were taken as a result of couldn't move my legs, my knees were swollen and very painful, I couldn't walk/ very unstable walking as my legs give out, evidently attacked my immune system and sent my RA into overload, taking out my ability to walk or stand, pain in my knees and legs, RA into overload, I felt excruciating pain below my knees/ knees were swollen and very painful. AE treatment included Pain medications, tests, drained fluid off right knee. The patient had no covid prior vaccination, nor tested post vaccination. The clinical outcome of the events were recovering.  Follow-up attempts are completed. No further information expected.
Vaccine not removed from freezer at 2wk mark- at 3wks and administered Notified pt offer repeat dose
itchy rash occurring on Face, Arms, and Legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy rash occurring on Face, Arms, and Legs) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history recorded).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (itchy rash occurring on Face, Arms, and Legs). At the time of the report, PRURITUS (itchy rash occurring on Face, Arms, and Legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provide Treated with Allegra 180mg, Benadryl 25mg, Zyrtec 10mg, epcid 40mg
I thought I was in the clear because the day I got the vaccine, my arm got stiff in the afternoon. The next day when I woke up, I was in so much pain from head to toe. My pain level was at a 10. I had muscle, bone, and nerve pain. My skin was also sensitive to the touch. I had a constant migraine. I had a fever of 104.5. I had diarrhea, stomach pain. The light was affecting my eyes as well. I wasn?t able to keep my sheets on my skin. I took a Phenergan for nausea to help the nausea as well as knock me out. It put me to sleep for 4 hours. When I woke up, I was in the same state I was in in the same morning. I called the CDC, but they wanted me to contact my doctor. I didn?t know what to take so I was taking 1000mg Tylenol every 6 hours, but it was not helping. The pain continued but the nausea had gone a little bit. I still had a fever and nausea all day. At the end of the day at around 11pm, it started going away all of a sudden. My pain had dropped down to a 7 by 11:15pm, by midnight I was absolutely fine. It came on at 6:30am and ended at midnight as if nothing had happened. I had no nausea, diarrhea and fevers by midnight. I still have lingering symptoms such as headache, but nothing compared to the way it was that day. I have had MRI's done but nothing was found.  I am currently getting accupuncture to try and treat the pains.
Received a Janssen product 3 weeks earlier.  His wife had received the Pfizer and she had a 2nd appt and he thought he needed one as well.  Cough, generalized soreness, lethargy, shortness of breath, joint pain, watery diarrhea, night sweats.
Severe hives, fever that would not go down with medicine, swelling in joints, feet, and hands, inability to walk due to pain and swelling,   Given prednisone, 3 different antihistamines (both h1 and h2 blockers).  Worsened before it improved.  Symptoms lasted total of 11 days.
LARGE RED ITCHY RING AROUND SITE OF INJECTION, PAINFUL AND FIRM TO TOUCH AT LEAST 1.5 INCHES IN DIAMETER.
Tachycardia/Palpitations. Did not occur at pharmacy. Occurred later in the day at home and patient went to the ED.
allergic to the Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic to the Pfizer covid vaccine".  Additional information: Caller would like to know what type of vaccine is Abrysvo. Caller added that she also wants to know the ingredients of the vaccine. Upon providing response, Caller mentioned that a patient who is to receive the Abrysvo vaccine is allergic to the Pfizer covid vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
When I recieved the injection there was a slight sting. My arm swelled at the injection site. I had a whelp 1.5 by 2.5 with burning,itching at sight for 5 days now. It is starting to clear. I had recieved a flu vacination last December for the first time, this is my second flu shot. I did have some tightness in my chest for 1-2 days. Since I have asthma, I just used my inhaler and was not overly concerned, I did call the wellness center and also my allergy specialist just to have it documented.
developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injection.; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE ERYTHEMA (developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injection.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injection.). At the time of the report, INJECTION SITE ERYTHEMA (developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injection.) outcome was unknown.    mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.     Reporter did not allow further contact.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
dizziness; extreme fatigue; diarrhea; nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. It was reported that, I had prolonged side effects since I received my second shot of the vaccine which was last week Wednesday. On an unspecified date Feb2021, one day and half after receiving the vaccine, the patient experienced diarrhea, nausea, dizziness, and extreme fatigue. Most of my symptoms had resolved except the fatigue, tired more then usual it was getting hard to focus and wanted to know if Pfizer had any recommendations. The clinical outcome of the fatigue was not resolved and rest of the events on an unspecified date Feb2021 was resolved.  Follow-up attempts are completed. No further information is expected.
On 2/5/2023, I was very fatigued. I was working that day, so I just assumed the fatigue was caused by that. I went to bed that night. I woke up the morning of 2/6/2023, and I was still fatigued, but I assumed it was because I had worked so hard over the weekend. I took a home antigen test later that day, though, and quickly got a positive result. I waited for a day or so before calling my doctor to ask for an antiviral. At this point, I didn't really have any symptoms other than fatigue, and I spent a lot of time sleeping. I called my doctor on 2/7/2023, and I was prescribed Paxlovid. I started taking the Paxlovid on 2/8/2023. I never really developed any major symptoms other than the fatigue, though I also had a little bit of muscle ache. However, the muscle aches felt like the ones that accompany fatigue rather than the ones that accompany an illness like the flu. I followed the CDC isolation protocols, and I returned to work about ten days later.
Approximately 4 days after the vaccine, I started experiencing elevations and drops in my blood pressure. I take my health seriously and check it daily. I am always around 110/80 or 115/80. On Saturday, July 24th, I went to get fluids at a hydration clinic (for health, elective) and my blood pressure was 150/90. The nurse asked if I have always had blood pressure and I indicated never. Since then, it has spiked and dropped in the high 140's to the low 109's.   The more severe issues started on July 26th. I woke up at 1am throwing up. I didn't think much about it, but the entire next day, my chest hurt. I continued to monitor my blood pressure via a monitor. It was in the 130's. I still didn't feel well, but I thought maybe it was the result of something I ate, etc. On the morning of July 28th, I woke up with pain and radiating aches and stabbing pains/soreness in my back around my shoulder blades. It didn't seem to let up. I continued to monitor my blood pressure via a home monitor. I watched it climb rapidly. When it went up to 141/90 and continued to climb along with me experiencing nausea and confusion, I knew it was becoming serious. I went to the emergency room and at arrival, my blood pressure was 223/117 so I was in a crisis and close to having a stroke. They had to immediately administer 20mg of Lisinopril which then brought it down to 117/85. I had a chest xray and a CT scan with dye. Thankfully, no damage that I was informed of, but I am still experiencing chest pain and issues with my blood pressure even after the emergency room putting me on lisinopril at home. Covid test was negative. It started to edge back up the next day.  I do hope these symptoms are temporary and not permanent. These issues need to be taken seriously and the whole person looked at holistically. Please do not brush this off as a coincidence because more people get hurt and die from not being taken seriously. For me, this is a big deal. I eat well and exercise almost daily. Health is extremely important to me.  As a result, I will not be getting the second dose. I'm worried it will kill me. I will likely need a cardiologist now and the medical bills from this one event will be astronomical (even with insurance).
Headache - pain scale 3/10 - not worst headache of life.  patient took Aleve and drank water with full resolution.
mild phlegm; Body temperature goes from hot to cold; Chills; Headache; low grade fever; muscle ache; tingling around the neck; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (tingling around the neck), PRODUCTIVE COUGH (mild phlegm), FEELING OF BODY TEMPERATURE CHANGE (Body temperature goes from hot to cold), CHILLS (Chills) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PARAESTHESIA (tingling around the neck), CHILLS (Chills), HEADACHE (Headache), PYREXIA (low grade fever) and MYALGIA (muscle ache). On 14-Jan-2021, the patient experienced PRODUCTIVE COUGH (mild phlegm) and FEELING OF BODY TEMPERATURE CHANGE (Body temperature goes from hot to cold). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (tingling around the neck), PRODUCTIVE COUGH (mild phlegm), FEELING OF BODY TEMPERATURE CHANGE (Body temperature goes from hot to cold), CHILLS (Chills), HEADACHE (Headache), PYREXIA (low grade fever) and MYALGIA (muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.   Reporter did not allow further contact
Fever 8th-10th. 0n the 14th chest pains and shortness of breath . went to ER on July 19-th
Information has been received from a physician concerning a 14 month old patient (gender unspecified) who on 23-MAR-2009 was vaccinated with 2 ml of the first dose of ROTATEQ (Lot number 663359/1661X) orally and on 15-MAY-2009 the patient received 2 ml of the second dose of ROTATEQ (Lot number 663461/0285Y) orally. On 01-MAY-2010 the patient became ill and was hospitalized. On an unspecified date the patient was positive for rotavirus antigen. As of 05-MAY-2010, the patient's was still hospitalized and not recovered. This is one report from two reports from the same source, the twin patient's experienced was reported on WAES 1005USA00434. Became ill and positive for rotavirus antigen were considered as other important medical event. Additional information has been requested.
the first dose of Shingrix on 15Jun2020 / Second dose had not been given at time of call; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th June 2020, lot no:2737P; expiry date:22nd January 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter called to request information on how to proceed for the second dose for this patient.  The reporter consented to follow up. As per sales data sheet reported 1st dose batch number was changed from Z737P to 2737P.
8 days p/vax pt devel approx 125 skin lesions. f/u fr MD rpt pt had 50-75 spots that appeared to be chickenpox, MD also stated given the incubation, it was most likely wild type
Couldn't move head; Fever of 103; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Couldn't move head), PYREXIA (Fever of 103), NAUSEA (Nausea) and CHILLS (Chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history were reported.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced HYPOKINESIA (Couldn't move head), PYREXIA (Fever of 103), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, HYPOKINESIA (Couldn't move head), PYREXIA (Fever of 103), NAUSEA (Nausea) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take Bayer aspirin as a treatment medication.; 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.
Numbness in hands; Tremors in arms; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hands) and TREMOR (Tremors in arms) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in hands) and TREMOR (Tremors in arms). At the time of the report, HYPOAESTHESIA (Numbness in hands) and TREMOR (Tremors in arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No allergies, current illness, lab data and medical history was reported by patient.  No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient went to PCP and had may test done with no answers.
Patient came in after having two tonic-clonic seizures at work. Had been vomiting, having diarrhea, and feeling off. Vision was blurry on the way to work. BG was less than 20. Had seizure in 2019.   So far Ativan has been ordered PRN for seizures and neurology to see pt for full workup.