chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for COVID-19; They both missed their second dose due to quarantine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (They both missed their second dose due to quarantine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (They both missed their second dose due to quarantine). At the time of the report, COVID-19 (tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (They both missed their second dose due to quarantine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.  The patient missed their second dose due to quarantine and are now going to get vaccinated past the 42 day window. This case concerns Product dose omission in a 44 year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. It was reported that the second dose had not been administered due to quarantine and that it was outside of the 42 day window at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns Product dose omission in a 44 year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. It was reported that the second dose had not been administered due to quarantine and that it was outside of the 42 day window at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Feb 25th afternoon I started feeling pretty yucky. As the evening progressed I had chills, body aches, and fever. I thought I had covid. On the 26th I was worse. on the 27th I went to the ER, and the diagnosis was "unknown virus" I continued to get worse. On March 3rd I called the nurse and she said "I need to go to the ER, don't go to the  ER, go to the closest ER to you". I received the same diagnosis. I thought maybe my CPAP machine had bacteria and they tested for bacteria and it was negative. I went home. On march 8th I was really bad off, I had 103.7 fever still and O2 was 70-80. I was admitted to the hospital. they tested me again and I had bacterial pneumonia. 3 days later they were going to send me home but when I woke up that morning I felt like I had been kicked in the ribs on my right side. I sat in a chair and if I coughed, hiccuped or anything It felt like a knife through my chest. a CT scan showed a massive blood clot in my lung. I was put on medications and I was discharged on March 17th. My left lung had 100% pneumonia and the blood clot was in the right lung and my lungs were unable to help each other. With any exertion, my heart rate jumps and my O2 drops. I can only sit. The theory they had at the hospital is that the Moderna vaccine had the full attention of my immune system which allowed other infections to come into my body unchecked. Since the pandemic started I have left my house on my bicycle to the store and that is it. I have had almost no exposure.
TOOK FOUR UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case (PVX2019-1634) was received from a caregiver on 24-Jun-2019. It describes a female consumer who "took four unrefrigerated doses of Vivotif". She was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took all unrefrigerated doses of Vivotif. She took the last dose on 23-Jun-2019. She stated that she would be leaving for an endemic area on 05-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses of Vivotif" was considered as not applicable.
I had my second Covid-19 booster on December 15, 2022 in Covid shot clinic. I was feeling fine that day and next day when I woke up, I noticed more weakness on my lower legs particularly right legs, I had fever, 102 to 103 at home, I have severe headache, nausea, and atypical chest pain and also have hardness and elevation on my injection site. In the hospital, they gave me Tylenol IV, po; Lipitor, aspirin, IV fluids, Motrin. When I went home on Saturday, I felt the tingling on my face and followed by rashes and patches of somewhat fluid collection on my right face.  I only ate 1/4 of my Pho soup that night
I am an employee/patient receiving the Moderna Covid-19 Vaccine.  My injection site may have been too high on the left shoulder, too close to the joint.  Within 3-4 minutes I had left hand pain that was about to the forearm.  Also, started back pain from left shoulder to the center of the back.  Both areas have had continued pain and hand transitions from tingly to numb since receiving the injection.   Shoulder does have continuous pain around the injection site and is extremely tender to touch.  Injection site does have bruising as well.
Patient is immunocompromised having recently completed chemotherapy at the end of December 2021.  He came to the pharmacy for his 3rd dose of Moderna vaccine which should have been the full dose of 0.5ml.  He was mistakenly given what a non-immunocompromised individual would get as a booster dose of 0.25ml of Moderna vaccine.  No symptoms or issues reported by the patient or caregiver.  Patient is coming in later to receive proper dose.
This case was reported by a consumer and described the occurrence of swelling arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching were unknown.  It was unknown if the reporter considered the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient presented with similar symptoms after vaccination with SHINGRIX. This case was linked with case US2018GSK216506 and US2018GSK216507, reported by the same reporter.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 positive) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Shingles from 26-Jan-2021 to February 2021. Concomitant products included SMARTY PANTS WOMEN'S FORMULA from 01-Jan-2020 to an unknown date for Vitamin supplementation. On 10-Dec-2021 at 4:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 30-Dec-2021, the patient experienced COVID-19 (Covid-19 positive). On 10-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, COVID-19 (Covid-19 positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. No treatment information was provided. Company comment: This is a case of maternal exposure during pregnancy concerning a 35-year-old female patient, with no relevant medical history, who experienced the non-serious, unexpected event of COVID-19, 20 days after the third dose of mRNA 1273 COVID-19 vaccine. The patient was exposed to the vaccine on unspecified age of gestation. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. This case was linked to MOD-2021-428256 (Patient Link). Sender's Comments: This is a case of maternal exposure during pregnancy concerning a 35-year-old female patient, with no relevant medical history, who experienced the non-serious, unexpected event of COVID-19, 20 days after the third dose of mRNA 1273 COVID-19 vaccine. The patient was exposed to the vaccine on unspecified age of gestation. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
18 hrs of symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported, Expiry date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Medical history included allergies to sulfa. The patient's concomitant medications were not reported. The patient had no prior medical history, relevant drug history, drug or alcohol abuse and family history. The patient previously took bactrim and experienced drug hypersensitivity, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 28Dec2020 as dose 1, single for covid-19 immunization and experienced positive Covid test, bad reaction. On an unspecified date, the patient experienced 18 hrs of symptoms. On 29Jan2021, the patient experienced vaccine reaction. It was reported that the first vaccine resulted in a bad reaction resulting in positive covid test. The second shot was 18hrs of symptoms and the patient had fully recovered. The patient was not admitted to hospital and emergency room visit was not required. Patient was not deceased. No specific tests were required. No treatment or surgery was received. The event was recovered on an unknown date. There was no causal relationship between the event and bnt162b2 a reasonable possibility.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient reported that hand was numb, that she couldn't feel her hand.  She had an interpreter since she spoke anther language.  Observed patient for 30 minutes and was still numb when she left.  I attempted to verify her phone# that we had on profile which she said was correct and told her I would call her later to see how she was feeling.  However, when I attempted to contact her I got an error message, so I'm unsure if she felt better or not.  I did direct her to scan the CDC V-safe vaccination
Gray color, diaphoretic, 80% O2 SAT, agitated, coughing, yelling.
Discharge Provider: MD Primary Care Provider at Discharge: MD   Admission Date: 4/1/2023 Discharge Date:  4/4/2023 PRESENTING PROBLEM: ESRD on hemodialysis [N18.6, Z99.2]   HOSPITAL COURSE: Patient is a 81-year-old male with a history of recurrent aspiration due to esophageal dysphagia status post feeding tube, vascular dementia, persistent atrial fibrillation status post Watchman, not on oral anticoagulation due to history of subdural hematoma, chronic respiratory failure on 2 L/minute baseline, history of lumbar spinal infection on chronic suppression with Augmentin as well as end-stage renal disease on HD TTS.  Patient currently resides at a long-term care facility, and was diagnosed with COVID infection, limiting his ability to pursue dialysis at his normal unit.  The patient was admitted on 04/01/2023 after missing his regularly scheduled dialysis.  The patient was seen by Nephrology and underwent dialysis on 04/01/23.  The patient was noted to have mild worsening of his hypoxia requiring 3 L/minute the time of admission.  Given his positive COVID test and worsening hypoxia he was started on dexamethasone at 6 mg daily.  With steroids and supportive care the patient's hypoxia returned to baseline.  Care management was consulted for arranging outpatient dialysis at a unit that could accommodate him being positive for COVID.  This was arranged at facility.  The family had also recently worked on changing long-term care facilities.  At the time of discharge, the patient is being sent to facility.   As patient was clinically stable, he was discharged to ALF on 04/04/2023.
1/23/2023 I had CT of lungs and had ground glass nodules that had increased in size.  On 5/4/23 another CT was done and the nodules had doubled in size.  They were doing lung cancer surveillance.  Last week all the physicians working on my care got together and decided to hold off on doing anything until after doing another CT scan in 6 months.  These nodules are like free floating, nothing solid, so they are unable to biopsy.
Varicella was given in right leg. White bumps had appeared with red surrounding them. Within seconds of giving shot. Gave Benadryl.
This spontaneous report as received from a medical assistant, and refers to a 2 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were unknown. The patient's past drug history included PREVNAR 13 administration. On 09-AUG-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # L003228, expiration date 30-JUL-2016, 0.5 ml, intramuscular (anatomical location was unspecified). No adverse effects were reported since the administration of the expired vaccine. Additional information has been requested.
Patient had multiple interventions done. Patient presented to the emergency room with right lower extremity pain that he reported started on Tuesday morning. Arterial ultrasound was done was read demonstrating an occlusion of the stent in the right common femoral artery, superficial femoral artery and near occlusion occlusion of the popliteal artery with flow in the peroneal artery.  Patient was taken to the cath lab for an angiogram of the right lower extremity via left femoral access.  Patient has occlusions of the iliac artery with tissues. Angiogram shown occlusions of the common iliac artery stent.  Stents were from the common iliac artery through the external iliac artery common femoral artery superficial femoral artery into the below-knee popliteal artery.  There was no contrast opacification of the stent. The profundofemoral artery with reconstitution from collateral however the profundofemoral artery was jailed by the stent.
Pain at Injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at Injection arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain at Injection arm). At the time of the report, INJECTION SITE PAIN (Pain at Injection arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Hives around neck. No SOB, no throat or tongue swelling. Then today 10/21/13 started diarrhea. O/w well.
Increased seizure frequency beginning one day after vaccination. Per patient, typically experiences 1 seizure per month; increased to 3 within a 48 hour period
Within 5 minutes my chest was very itchy.  I left 15 minutes after injection and then when I got home, I noticed hives all over my face. My face, chest and back of my neck were very very itchy.  Had the chills all night long. By the morning, my hives were down.
This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite). At the time of the report, DECREASED APPETITE (Loss of appetite) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
On day 9 felt both sides of neck tender under ear by jaw line.   Upon palpation  both sides painful however left side more.   Paid no attention to it except on  day 10 because pain still felt  with left side more painful.  No lump or bump felt just very sensitive and painful upon palpation.   Left side more painful when palpated.  It seems to be going away slowly.   Did not put this on my daily  report because I chalked this up to being maybe a cold or something coming on.  After thinking about this symptom I realized it is slowly going away and as an R.N. contributed to it now as a side effect.  Below I put "No" regarding recovery because the pain is still there however not as bad.  It seems to be going away slowly.  Hoping it will be gone in a few more days.
Painful rash on (L) buttocks which started approx 1 wk after vaccination. Also feeling weak & faint at times. Pain in (L) buttocks & leg. Noted rash on face on 10/3/11. Treated with VALTREX, Gabapentin, MEDROL dose pak, PERCOCET.
It started out with entire body going completely, while he made very tight fists with his hands and then would blank out and shake quite violently, these would last anywhere from 45 sec to an entire minute long.  There would be several of these episodes throughout the day!!  We only had one night in which this took place.  The started on the 12th of January 2006 and did not quit until the 23rd of January.  We never saw any signs that he would go into these at all nor were we sure of what kinda signs to be looking for... MY biggest fear was once he stopped shaking the blank stare would sometimes continue even with me calling his name, making loud noises around him etc.  Even touching him didnt work, he mainly had to come out of it on his own.
no adverse reaction. Patient tolerated first vaccination shot fine, however he was 17 years old at the time it was administered which is under recommended age. Pt's mom knew and scheduled the appointment. Patient came in for second shot yesterday.
Initial non-serious report received from a consumer on 10 October 2011 under the local reference number 11-0767. A 72-year-old female patient with no reported medical history had received an intramuscular dose of FLUZONE HIGH-DOSE (batch number UH458AB) in the left deltoid on 09 October 2011 at 6:45 p.m. The patient had received FLUVIRIN vaccine the year before with no adverse events reported. On 09 October 2011 at 7:00 p.m., the patient had coughing, white foam expectoration, bilateral red eyes, blurred vision, muscle aches and slight fever. At the time of the report, the patient had not recovered.
muscle pain presented in her right arm; muscle is tensing up; unable to sleep on her right side due to the pain; pain as though her muscle feels like it is in a bind and it won't pop out of it / pushes or pulls / intense pain / down her arm to the elbow; bump or knot at the injection site; shot itself was painful; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sepsis (Lost fingers on right hand and all toes due to being septic) and streptococcal sore throat.   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th October 2020, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling, myalgia upper extremities, muscle tension, sleeplessness and pain in arm. On an unknown date, the outcome of the injection site swelling and myalgia upper extremities were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved and the outcome of the muscle tension, sleeplessness and pain in arm were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, myalgia upper extremities, muscle tension, sleeplessness and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The patient received vaccine in right arm. The patient said the shot itself was painful but she did not experience any other side effects until one month later when muscle pain presented in her right arm.  At first she thought it was her shoulder and had an x-ray but that did not show any damage.  She described the pain as though her muscle feels like it was in a bind and it would not pop out of it.  Like the muscle was tensing up.  When she pushes or pulls, an intense pain shoots down her arm to the elbow.  She was unable to sleep on her right side due to the pain. She reported that she could see a bump or knot at the injection site. The reporter consented to follow up.