chrisvoncsefalvay/vaers-outcomes huggingface dataset:
few splotches further down my leg from my hip down to my knee just a few scattered her and there but there is no blisters so I'm hoping it isn't shingles; rash located almost on right buttock, 2" circumference area; bad muscle aches but didn't last long; burning in the groin area and on top of right leg burning, it's a weird feeling; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning in the groin area and on top of right leg burning, it's a weird feeling), SKIN DISCOMFORT (few splotches further down my leg from my hip down to my knee just a few scattered her and there but there is no blisters so I'm hoping it isn't shingles), RASH (rash located almost on right buttock, 2" circumference area) and MYALGIA (bad muscle aches but didn't last long) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced BURNING SENSATION (burning in the groin area and on top of right leg burning, it's a weird feeling), RASH (rash located almost on right buttock, 2" circumference area) and MYALGIA (bad muscle aches but didn't last long). On an unknown date, the patient experienced SKIN DISCOMFORT (few splotches further down my leg from my hip down to my knee just a few scattered her and there but there is no blisters so I'm hoping it isn't shingles). At the time of the report, BURNING SENSATION (burning in the groin area and on top of right leg burning, it's a weird feeling), SKIN DISCOMFORT (few splotches further down my leg from my hip down to my knee just a few scattered her and there but there is no blisters so I'm hoping it isn't shingles) and RASH (rash located almost on right buttock, 2" circumference area) had not resolved and MYALGIA (bad muscle aches but didn't last long) outcome was unknown.            Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-043177 (Patient Link).
Terrible headache, very dizzy, 102.2 fever, sick at stomach.. Fell like flu time 10..very cold.  Took some tylenol but didn't help..
Pain, numbness, severe swelling, rash on most of arm. Rash, swelling, pain has lasted 2 weeks (though shrinking, has not yet subsided completely on 12/14).
Chest pains, short of breath, unable to sleep, heart rate 146. Was referred to a cardiologist by PCP.
dose 01Aug2022, had an expiration date of 18Jun2022; received one dose as a child, did not receive second dose until 01AUG22; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Previously administered products included Havrix (received one dose of Havrix as a child ).   On 1st August 2022, the patient received the 2nd dose of Havrix. On 1st August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 2-Aug-2022 Reporter's comment: The nurse reported that the patient was administered a dose of Havrix one day before the reporting day, which had an expiration date of 18th June 2022.  The reporter stated they were trying to get this patient caught up on her vaccines.   The patient had received one dose of Havrix as a child but did not receive second dose until one day before the reporting day (yesterday).   At the time of reporting, dose has not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Havrix which was already expired in past, later than the recommended interval, which led to expired vaccine used and lengthening of vaccine schedule.
Redness & itching at vaccination site, (R) arm itching gradually spreading down right arm-itching in isolated patches.
Initial unsolicited report received from a consumer (via social media) on 25 July 2015. An 11-year-old female patient had received a dose of meningitis vaccine (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. Medical history and concomitant medications were not reported. On an unknown date after vaccination, the patient experienced soreness and had some negative symptoms from the vaccine for few days. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient was recovered from the event. Documents held by sender: none.
Experienced stroke; I'm not speaking well; A spontaneous report was received from consumer a 73 year old female patient who developed stroke/cerebrovascular accident, I'm not speaking well/aphasia.   The patient's medical history included claustrophobia. Products known to have been used by the patient, within two weeks prior to the event, included multivitamins. Laboratory test include MRI.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 (Batch number: 044A21A) on 10 Mar 2021 in the left arm for prophylaxis of COVID-19 infection. The batch number of first dose is mentioned as 00M20A.   The patient experienced stroke about a week ago, between the first and second dose. She stated she wasn't sure, but she went to the hospital over the weekend. She also stated that she was not speaking well. The medically significant event is stroke. Open magnetic resonance imaging (MRI) was performed but no results were provided. Treatment for the events was not known.   Action taken with mRNA-1273 in response to the event(s) was not applicable.   The outcome of the events stroke and I'm not speaking well was not known.; Reporter'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
Bexsero was accidentally given instead of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number 3YB52, expiry date 30-APR-2024) for prophylaxis.   On 17-JUL-2023, the patient received the 1st dose of Bexsero. On 17-JUL-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero was accidentally given instead of Menveo). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Jul-2023 A medical assistant called in to asked that wished to know how to proceed. Information about the vaccine, patient and event were collected. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient accidentally received a dose of Bexsero instead of Menveo, which led to wrong vaccine administered.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site). At the time of the report, VACCINATION SITE WARMTH (Warm at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) had resolved. Patient visited a Healthcare Professional and received an unknown shot for the reaction and same resolved. Patient is alright now, the rash on her lasted for few days after vaccine. Concomitant medications included bad stomach medications. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Significant Followup was received on 16-Jun-2021. Added patient information and treatment information. Updated outcome of events as resoleved On 08-Jul-2021: Follow-up information received on 08-jul-2021 and does not contain any new information
Information has been received from a medical assistant concerning a 17 year old female had a negative PAP and was negative for HPV in 2007 who on 02-AUG-2007 was vaccinated with the first dose of GARDASIL. On 11-OCT-2007 the patient was vaccinated with the second dose of GARDASIL and on 04-FEB-2008 the patient was vaccinated with the third dose of GARDASIL. On 21-JUL-2009 a PAP test and HPV test were performed and revealed that the patient was positive for the following HPV types: 16, 18, 31, 35, 39, 45, 51, 52, 56, 58, 59, 68. The patient's recent PAP was negative. The patient had sought medical attention, "test taken in office". At the time of report the patient's status was not recovered. Additional information has been requested.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 21-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015)  single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
eceived 2nd dose at 1350, stated to staff at 1605 that she was "not feeling well". Pt now c/o numbness of the lips, left arm, and left leg, feeling dizzy and tired.  1605 VS: 177/118, 104 HR, 96% O2 EMS alerted at 1616.  1620 VS: 168/104, 89 HR, 98% O2, POCT Glucose 82mg/dL.  Pt sitting upright on a chair talking with staff, speech delayed.  EMS arrived at 1622. Pt left with EMS via gurney at 1630 to ED for further assessment.
Patient called office on 3/28/05 to report that 2 days ago, she had swelling of ankles and itchy feet, hands, and smokers cough on awakening. Patient stated that she felt OK at present. 4/1/05: Follow up revealed that patient is feeling better; swelling is resolved.
Red, hot to touch, painful lump. Stomach ache/nausea. Headache. Fever. Body ache. Fatigue.
I received my vaccine in a drive through clinic held in a parking garage. I waited in my car after the vaccine. Right before I was told i could leave I started to get a headache but it wasn't until I left the garage and he sun was super bright did I realize I was having a migraine. My headache was piercing and I could not handle the bright light, I almost had to pull over. I do not have a history of migraines. I got home and went to bed immediately and had to lay still because the migraine was so bad. By 3 pm I had started vomiting, dizzy, unable to tolerate any light, was shaking and my body was hurting in my joints and abdomen. By 4 pm I was not talking clearly and was neurologically confused and my husband took me to the ER. They had to give me several medications to reverse the migraine and nausea.  They said I had a complex migraine and my blood sugar was elevated near 200 (had not eaten all day and normally do not have high bloodsugar). The doctor said it appeared my body was having an adverse autoimmune response.  Since the reaction I have gained 10 lbs and have an appt with an endocrinologist to follow up on reaction
Patient came in office 10/14/05 and had a red, swollen deltoid. Pt advised to use Benadryl for redness and swelling.
Non-tender, warm area of erythema about size of tennis ball. Right leg at injection site.
Roughly 12hrs after receiving 2nd Pfizer Covid-19 dose I woke up with a stabbing headache, dizziness, lightheadedness, slight chills and bodyaches. As the day progressed I began to develop extreme bodyaches, extreme joint pain, I couldn?t regulate my body temperature which fluctuated between feeling very cold and very hot/feverish. My eyes were bloodshot from having a fever of 102.5 at it?s highest. I was in significant pain and unable to sleep and rest due to the severe bodyaches and joint pain in my hips, knees and wrists. I also had significant pain in my low back. I don?t have pain anywhere in my body generally. The dizziness and lightheadedness also continued to worsen to the degree that I couldn?t sit up or walk without losing balance. Around 11:30pm on Saturday 4/17, my fever broke and my aches and pains started to dissipate.  As the aforementioned symptoms began to dissipate, I started having difficulty breathing. I felt as though I was having trouble breathing, specifically inhaling. I felt like I couldn?t catch my breath at times, though I was sitting or lying down and not exerting myself. I also developed wheezing and a mild cough, both of which have continued to worsen. Today is Monday 4/19/21 and I?m still having mild lightheadedness and dizziness, mild headache that feels like stabbing pains and my cough continues to worse as is the wheezing and feeling like I?m having difficulty breathing at times, without exertion. Injection site continues to be sore. My first dose, I had fatigue and injection site soreness, both of which were completely resolved as of 24hrs after being vaccinated.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Additional Details: After receiving vaccine, patient was leaving with father and fainted. When patient awoke she was unable to hear her father speaking to her and appeared confused. Patient appeared frightened/nervous while receiving the vaccine and tried pulling away as I was giving the vaccine. The needle was in the arm and I was able to administer the vaccine in the correct place. Patient did not eat since 12pm. she was given orange juice when she awoke. Ambulance was called and patient left in ambulance
One day post vax pt experienced swollen and reddened right leg from injection site of DTaP to below the knee. Prior to that it was just a quarter sized reddened mark. Pt recovered the next day.
Exposure to COVID-19; Lack of drug effect; Tested positive for COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for COVID), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 011J20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced COVID-19 (Tested positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). At the time of the report, COVID-19 (Tested positive for COVID) had not resolved and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  Patient was 100 percentage asymptomatic. Patient tested for covid-19 on 06 Jan 2022 and results came back positive later on the day. Patient decided to get tested because she was exposure. HCP was not taking any medications at the time of report.; Sender's Comments: This spontaneous case concerns a female patient with unknown  age , healthcare worker, with no medical history reported ,  who experienced non-serious unexpected, AESI event of Covid 19 which occurred 2 months 13 days post vaccination with the 3rd dose of mRNA-1273 vaccine  ( Moderna Covid 19 Vaccine ) . This was accompanied by other non-serious , unexpected events of Drug ineffective and Exposure to SARS COV-2 . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
faint & flu like sz;no temp 98.6;stiff neck & back-emesis
pt recvd vax & devel gastrointestinal upset & flu-like synd;
Had usual reaction on day two: chills, tired, sore, etc  On day 5 I experienced very painful chest pain quite suddenly- went strait to ER, turned out to be lung pleurisy.  I?ve never had this, nor have I ever had chest pain or been to the ER before this.
Jan vaccine- 1 hour later and persisting for 1 week- left facial nerve neuralgia with left eye twitching (up to 2 weeks afterwards) Feb vaccine(2/11/24)- 24 hrs after vaccine- extreme SI, hip pain with inability to sit or stand-  lasting 24 hours
I had a severe headache, but no fever. Severe body and joint aches with congestion.
4 hr.after vax, pt devel maculopapular rash on anterior torso & upper thighs. A few papules on forearms.Reporter noted pt finished 7 day course of amoxicillin that AM.
A female pt in her 40's experienced tingling around the mouth and flu-like symptoms for about 1 week after each post exposure shot of rabies vax. The pt had reservations about getting the fifth shot. The tingling was transient with a duration of about one week.
shingles; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Mar2021, patient had a case of shingles. Outcome of the event was unknown. Next second dose was scheduled on 24Mar2021.  Information on the lot/batch number has been requested.
Dizziness; Bipolar depression; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BIPOLAR DISORDER (Bipolar depression) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concurrent medical conditions included Psoriasis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 75 milligram. In 2021, the patient experienced FATIGUE (Fatigue). In 2022, the patient experienced BIPOLAR DISORDER (Bipolar depression) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, BIPOLAR DISORDER (Bipolar depression) had not resolved and DIZZINESS (Dizziness) and FATIGUE (Fatigue) had resolved.            No concomitant and treatment medications were reported.  Patient had been taking only 75 milligram per every 12 weeks of SKYRIZI.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company Comment:  This spontaneous case concerns a 53-year-old female patient with no relevant medical history, who experienced the unexpected, serious  (medically significant) event of Bipolar disorder (Bipolar depression) on an unknown date after receiving the third dose of mRNA-1273 vaccine.  Onset latency could not be determined as exact onset date of event was not provided. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 35 days apart, with the second dose given approximately 7 months prior to current vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-623876 (Patient Link).; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with no relevant medical history, who experienced the unexpected, serious  (medically significant) event of Bipolar disorder (Bipolar depression) on an unknown date after receiving the third dose of mRNA-1273 vaccine.  Onset latency could not be determined as exact onset date of event was not provided. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 35 days apart, with the second dose given approximately 7 months prior to current vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
swelling of upper arm @ inj site approx 15mm;n/v, severe h/a started approx 6hr p/vax;
Temp of 103.2 per day care advised ibuprofen & watch for increased 5x or concerns.
arthritis; mild malaise; little redness at injection site; chills; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and. concomitant medications were not reported. The patient experienced arthritis, mild malaise and little redness at injection site on an unspecified date and patient got the chills 2 nights after the 1st dose that lasted one hour on an unspecified date in Feb2021. The patient called and queried that can he take acetaminophen for arthritis. The outcome of the event chills was resolved on an unspecified date in Feb2021 and unknown for other events.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.