chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient broke her ankle; Found a small clot on the same site/a huge blood clot behind her left knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Found a small clot on the same site/a huge blood clot behind her left knee) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Thrombosis since February 2022.    On 20-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced ANKLE FRACTURE (Patient broke her ankle). In 2023, the patient experienced THROMBOSIS (Found a small clot on the same site/a huge blood clot behind her left knee) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) in 2023 for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Found a small clot on the same site/a huge blood clot behind her left knee) and ANKLE FRACTURE (Patient broke her ankle) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  After fifth vaccination the patient went on vacation in Apr-2023 and broke her ankle. A small clot was found behind left knee (same site of blood clot in Feb2022), when the patient returned 5-6 weeks later. The patient was treated with Xarelto. It was reported that, the patient did not have the usual redness and swelling which usually accompany blood clots.  Company comment: This spontaneous case concerns a female patient of unknown age, with medical history of thrombosis (a huge blood clot behind her left knee), who experienced the unexpected serious (medically significant) AESI of thrombosis and non serious event of ankle fracture. The events occurred approximately 7 months after the fifth dose of mRNA-1273 bivalent BA.4/BA.5. As reported, after fifth vaccination the patient went on vacation and broke her ankle. A small clot was found behind left knee (same site of blood clot in Feb2022), when the patient returned 5-6 weeks later. The patient was treated with Xarelto. It was reported that, the patient did not have the usual redness and swelling which usually accompany blood clots. No further information about the events was provided. Considering the described information, non suggestive temporal relation, nature of event of ankle fracture and it being the likely cause of blood clot along with prior medical history of the same condition causality is assessed as not related for both events. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   This case was linked to MOD-2023-747023 (Patient Link).
A report has been received from a Health Professional concerning a 5 year old, patient of unknown gender. Patient's relevant history and concomitant disease were not reported. Patient's concomitant medication was not provided. The patient had been receiving FLUMIST (intranasal) started during the year 2013. The patient experienced asthma attack which started during year 2013. Action taken with FLUMIST was unknown. The patient recovered from the event of asthma attack during year 2013. The report was considered to be non-serious by reporter.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. No concomitant medications were reported. The reporter reported that patient was administered an expired dose of ROTATEQ (oral, lot# reported as 1344AA; exp 01-DEC-2012) on 03-DEC-2012. That was the first and only dose of ROTATEQ the patient had received. No adverse effect reported. Additional information has been requested.
Redness and swelling at injection site, Right Deltoid where DTaP was given. Treated with ice and Motrin.
Fever 102 f started 27th day after vaccination  and fluctuate between 100-104.  After 5 th days went to ER walk in and hospital team put him into ecmo in the evening due to sudden drop in oxygen level.
shingles all over; This case was reported by a physician via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (received first dose on 7th May 2021).   On 12th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case reported by the patient's spouse, who was also a physician. Retired physician reported that patient had received Shingrix and was now experiencing clear Shingles all over the body on face, neck, trunk, arms and legs.  Outbound call placed to spouse who was also a physician to gather more details.  Physician confirmed that he experienced shingles all over the body on face, neck, trunk, arms and leg after the second dose of Shingrix.  The reporter did not consent to follow-up. This case was linked with US2021177363 and US2021177365, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021177363:same reporter US-GLAXOSMITHKLINE-US2021177365:reporter´s case
Pt disclosed that he felt dizzy after PCN shot. When he was questioned about it, he clarified that he did not faint or pass out but he just felt dizzy. When was asked about the timing he said like 20 years ago and no problems since. After pt was administered Pfizer vaccine patient was feeling well and not experiencing any dizziness.  The patient was fine again stating no issues with dizziness. Patient got up and was standing in the store and fell backwards and hit his head on the floor. At that point, patient was non responsive, and EMS came and took vitals. They medically released the patient. The patient refused to go to the hospital. During questioning the patient EMS asked if he ever had any issues with passing out before and patient stated yes he has passed out before lots taking blood and with shots (which was inconsistent with what he told us before administration).
This spontaneous report was received from a consumer (patient's daughter) refers to an approximately 77 year old male patient. No medical history was reported. On 12-MAY-2015, the patient was vaccinated with PNEUMOVAX 23 (dose 1, dose not provided). No concomitant therapy was reported. On an unknown date in May 2015, the patient experienced shortness of breath. On an unknown date in May 2015, the patient sought medical attention and saw the physician. On an unknown date in May 2015, the patient was hospitalized. The patient was inadvertently administered a second dose of PNEUMOVAX 23 on 29-MAY-2015. The outcome of the event was reported as not recovered. The causality assessment was not provided. Additional information has been requested.
pt. vax'd w/ 1st dose of hepatitis B vac. & exp. diarrhea,headache,stomach cramps, & generalized achiness.
I had typical fatigue, fever, headache and chills for 24-48 hours after the shot but then a week later had diarrhea and vomiting for 24 hours. I then developed tinnitus about 3 days later that is terrible with constant high pitched ear ringing.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 10:00 (Lot number: EL9267) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid radiated" (unspecified if ongoing); "Hyperthyroidism" (ongoing); "Blood pressure", start date: 2020 (ongoing); "coffee makes her jittery" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hyperthyroidism (ongoing); LISINOPRIL taken for blood pressure measurement, start date: 2020 (ongoing); AMLODIPINE taken for blood pressure measurement, start date: 2020 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID], start date: Oct2020 (ongoing). The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; SOMNOLENCE (non-serious) with onset Feb2021, outcome "not recovered", described as "dozing off before falling asleep". Additional Information: The patient experienced the adverse event tiredness 3-5 days after receiving the vaccine. The patient stated that she did not drink coffee anymore due to her "having to take a thyroid pill and blood pressure medicine. The events did not result to emergency room or physician's office visit. The patient did not undergo any relevant tests. The patient did not receive prior vaccinations (within 4 weeks). The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. No follow-up attempts are possible. No further information is expected.
Rash on body, macular papules, erythema, papules in groin. Duricef po.
anxiety; He never went back for his second dose; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), ANXIETY (anxiety) and PRODUCT DOSE OMISSION ISSUE (He never went back for his second dose) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On an unknown date, the patient experienced ANXIETY (anxiety) and PRODUCT DOSE OMISSION ISSUE (He never went back for his second dose). On 08-May-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, ANXIETY (anxiety) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He never went back for his second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The patient had started to take anxiety medication after his first vaccine.
Pt developed rash approx 1 week after vaccine.  Pt had also started new, higher dose of Amlodipine at the same time he got Moderna Booster.  Rash started at both ankles and eventually moved up to include whole body.  Pt, at the advice of his MD, stopped all mediations.  No medications for 1 month but rash persisted and continued to develop new lesions.  Before and during this period pt had no new topical products and no new foods.   Rash mildly responsive to Prednisone 40mg daily or higher.  Not responsive below 40mg.   Pt using hydroxyzine to control itch.  While rash is getter better, new lesions continue to appear today 3/3/22.  Identified as Morbilliform Eruption.
Large red swollen area. Pt reports it was originally from shoulder to elbow. After taking antihistamines and applying ice area is now much smaller but significantly red.
Information has been received via medical records from a licensed practical nurse and refers to a 4 year old White male patient. On 06-OCT-2009, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot# and expiration date were not reported). This is one of two reports concerning the same patient. Additional information is not expected. All available medical records will be provided upon request. Sender's Comments: US-009507513-1704USA001524:
Got shingles a year after we got the vaccine/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles a year after we got the vaccine/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and after one year he or she experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available. This case had been linked with US2023AMR066798 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR066798:same reporter
Right where the shot was it´s kind of itchy; Right where the shot was it got really red; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events right where the shot was it got really red, (right where the shot was) it was kind of itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: O16M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) right where the shot was it got really red, (right where the shot was) it was kind of itchy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), right where the shot was it got really red, (right where the shot was) it was kind of itchy was unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  The events are consistent with the known safety profile of mRNA-1273.
This spontaneous report as received from a consumer refers to her daughter of a 18 years old female patient. The reporter mentioned that her daughter was due for the third dose of GARDASIL (lot # was unknown) in 2008. The reporter wanted to know if her daughter could take the remaining dose or if her daughter needed to start the treatment again. The caller mentioned she would contact her HCP. Additional information has been requested.
10/2 shot at 7:15 pm - 9:00 - severe sore throat and cough. 10:00 - vomiting, diarrhea and severe shaking. 2:30 am - finally subsided. 10/3 weakness.
Male patient took Janssen vaccine and approximately 1 hour or so later was feeling chest tightness where it exacerbated to the point of needing emergency care. Patient was taken to E.R., but do not have outcome as of yet
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-AUG-2010, the patient was vaccinated with M-M-R II, subcutaneously (dose, lot# and expiry date were not provided) and then, on 23-AUG-2010, the patient received a dose of VARIVAX (dose, route of administration, lot# and expiry date were not reported), both for prophylaxis. No known adverse effects were reported.
This case was reported by a pharmacist via sales rep and described the occurrence of tingling tongue in a adult patient who received FLUARIX QUADRIVALENT. In 2015, the patient received FLUARIX QUADRIVALENT 1 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced tingling tongue. On an unknown date, the outcome of the tingling tongue was unknown. It was unknown if the reporter considered the tingling tongue to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The reporter stated that, they vaccinated to their hospital employees. Out of them 3 patients were experienced adverse events. In 2015, the patient experienced tingling of the tongue and mouth. The reporter did not have any further information. This case was linked with case US2015152961 ans US2015152964, reported by the same reporter.
Pt came in for a Tdap (ADACEL) shot on 3/10/15. When I went through allergies she had allergy to latex. I told her I was uncomfortable and did not want to give it to her because the cap had latex in it. She wanted to proceed and have me call her Dr. I called her Dr and he wanted pt to go ahead and get but while taking 50mg of BENADRYL. On 3-11-15 pt called stated all was ok no problems to report. On 3-18-15 pt called and stated she had a rash at the injected site and took BENADRYL. I called on 3-19-15 she stated the rash was small and almost gone and she did not want to go to the dr or call the dr.
After my first Covid 19 shot I started to feel jabs of electrical jabs consistent with neuropathy in various parts of my body. Now, my hands and feet keep getting pins and needles. I keep feeling neuropathy sensations elsewhere as well. I am uncomfortable and have to keep moving to try and get rid of the sensations, but even that doesn't help. I had expected pain in the area where the dose was injected and I slept a lot...... I did NOT expect to experience pins and needles consistent with nueropathy all over, and especially in my hands and feet, that are affecting me almost two days later still. I now have deep reservations about my follow up shot. I am keeping a copy of this report for my records.
Fainted almost fell over, had a seizure for 20 seconds following the GARDASIL shot.
Approximately 2 weeks after dose #2 of moderna vaccine, pt began complaining of lower extremity pain.  Over the following 2 week, he had pain and progressive ataxia.  He presented to ED, where he had loss of LE reflexes and changes in LE sensation.  He had an MRI that showed cauda equina nerve root enhancement, which was consistent with Guillan-Barre syndrome.  He was treated with 5 days of IVIG and discharged home.  He never required respiratory support.  Of note, he also had a tick bite at around the time the symptoms began.
I experienced dizziness onset 5 minutes after the vaccine, mild. lasting about an hour. That night  I experienced intense  vivid nightmares, chills and temp 96.0. Friday night, dec 18th, awoke form intense vivid nightmares at 2 am. chills. arm 7/10 pain at injection site, all day, no erythema. On saturday chills  but no fever all day. At about  10pm abrupt onset of severe abdominal pain and prolonged projectile vomiting that awoke me from sleep after eating normal dinner that I shared w family none of whom were having similar symptoms.  This lasted  for about 90 minutes accompanied by severe abdominal pain. afebrile, 97.Dry cough started , lasting thru  Sunday morning. spontaneously resolved. Sunday dec 20th, chills, nightmares, Monday chills, sweats, 96, 97 temps. Dec 22 Tuesday 3:30 am,  awoke from sleep with sudden excruciating abdominal pain and dry heaves . Family shared  Monday night meal, no other symptomatic people. <30 min started itchy palms, tingling lips, tongue, and face felt prickly. Eyes swollen, and sclera puffy bubbly.  I took two  25 mg Benadryl w water, had trouble swallowing - immediately proceeded to  Hospital ER - admitted - steroids IV, Pepcid, IV and in 4 hours when nausea and abdominal pain began again IV Zofran. 2 liters total of NS. discharge home around 12:30pm . stable to home to rest.
Pt came in to office for a Td injection employee misunderstood and gave the injection as a sub-q in the left forearm. Gave 0.1 ml.
patient is reporting numbness at injection site. She also has a swollen red arm with a solid lump under the skin.
Nausea; body ache; fatigue; joint pain; This is a spontaneous report from a contactable consumer (patient) via a Sales Representative. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose 2, single for COVID-19 immunisation. Medical history included controlled multiple sclerosis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced nausea, body ache, joint pain and fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 01-Aug-2022 Reporter's comment: A nurse reported that a patient received an expired dose of Bexsero on the day of reporting. The reporter did not had patient details (initials, date of birth, gender) at the time of report. The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Hives on neck and under arms and on chest. Fever, increased heart rate, achy and felt very ill, had to be in bed for about 2 1/2 days.  About 2 to 3 weeks later started exhibiting symptoms that I was later diagnosed as having Lichen Sclerosis, an auto immune condition. I am presently being tested for another auto immune condition due to incredibly dry mouth and dry eyes.
COUGH, HA, FATIGUE, RN, CONGESTION, ST, FEVER, CHILLS, BODY ACHES, SOB, NAUSEA, ABD PAIN
sharp ache sensation going up Right side of neck behind ear.  Sensation decreased and turned to tingling "all feelings are internal, feels like icy hot on my neck"  no pain with palpation, injection site WNL, no redness, welling or warmth, no pain at injection site or arm, no los of ROM.