chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented with AMS, + covid 11/1; CXR "bibasilar airspace disease left greater than right that is nonspecific and may be related to atelectasis, pna, and/or aspiration"; CT chest with PE, no severe Covid PNA;  Labs: D-dimer 17.06; CRP 24.92; Ferritin 982.9 Tx: maxipime, solu-medrol, redesivir, vancomycin, lovenox; He was hypoxic in the ED 92% on RA and started on on 4 LNC,  also had MRSA bacteremia, on high risk antibiotics,  dysphagia, treated with dobhoff tube ,  pulmonary embolus treated with therapeutic lovenox.On the night of 11/21/21, he vomited blood and aspirated, had low blood pressure, low oxygen saturation in spite of HFNC 100%, and was imminent. He was supported with IV fluids, prbc transfusion, IV ppi gtt, supplemental oxygen, but failed to improve. His wife decided to change to complete DNR. He passed at 1939.
I was at home getting ready for bed when my arm felt a little funny so I looked at it and saw about 15 small bumps at and around the injection site. After about 1/2 hour they were getting bigger and had merged in to fewer larger bumps. I took a picture. about 2 hours later it had merged into 1 bump was hot and red. I called health because they were the ones who administered the vaccine. After speaking with the on-call nurse she recommended I see my primary care doctor with in 24 hours. The next morning the area was swollen about the size of a baseball , raised about 1/2 inch and hot as well as itchy. I was able to conduct a tele visit with my doctor and she said it looked infected and prescribed an antibiotic. When I got off work that evening I went and picked up the antibiotic and started them right away, by this time the swelling had grew to about a softball diameter. the next morning the swelling was greatly reduced and continued to shrink and disappear 3 days later. My skin had a strange texture to it in the area for about a month and a half.
Onset of rash consistent w leukoclastic vasculitis followed by belly pain, hematuria and diagnosis of HSP.
47 yo female with PMH asthma presents with chest tightness for 3 days. States she got the 2nd dose of the moderna covid vaccine 4 days ago. She had side effects of fever, body aches, chills for 24 hours after the injection. She has developed this chest tightness and SOB however that feels like an asthma flare. When she takes a deep breath, it triggers a coughing fit. Her asthma is generally well controlled. She tried using an old albuterol inhaler yesterday once which provided some relief. Denies any recent fevers, chest pain, vomiting, diarrhea, lightheadedness, hemoptysis, leg swelling, recent travel or surgery, h/o blood clots. Non smoker.
Patient was extremely lethargic and unresponsive to sound, touch, and visual stimuli.  Twice, he seemed to be completely absent mentally.  He was very difficult to wake when he did sleep to the point where wet rags were used to gain even a mild response.
Initial report received from a physician on 25 June 2007. A male patient in his 70s (exact age, date of birth not provided) developed a non-healing lesion at the injection site after he received YF-VAX (lot number, route, site and date of administration not reported) at another facility. It was reported the patient had not recovered. Follow-up information received on 21 September 2007 from a health care professional. Per the reporter, "The patient did not have a reaction. The lesion was actually a basal cell cancer near the vaccine site." The event in this case was amended in order to reflect this new information. Additional information was not provided.
Per Review of Charge Nurses Notes. Please see Below  Called in to residents room by CNA, resident without respirations or pulse, resident placed on floor and CPR initiated at 0725, EMSA notified and called time of death at 0751. Specialists on call for Dr.  notified. daughter notified. cremation services notified.
Became very dizzy with loss of balance. Sight in left eye became very blurry. Significant difficulty walking. Significant cognitive impairment including loss of memory and not understanding what was being said to her.   Fell over and broke her left arm that required surgery.
patient that qualifies for fluzone hd was instead administered fluzone quad with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2022SA383304(CLUSTER).  This case involves an unknown age and unknown gender patient who qualifies for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was instead administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date the patient who qualified for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number, expiry date: not reported) was instead administered INFLUENZA QUADRIVAL A-B VACCINE at unknown dose (lot number, expiry date, form, strength: not reported) with no reported adverse event (wrong product administered) (same day latency). Pharmacist wanted to know how should they re-dose the patient. Wanted to know the concentration of the 2 vaccines. Patient was to be administered the Fluzone High Dose but was given other.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
POOR CIRCULATION (IN FINGERS, FOOT, ANKLES, ARMS); BLOTCHY RASH WHICH GOES UP THE ANKLE AND LEG ABOUT 2 INCHES; TINGLING DOWN LEFT ARM AND IN FINGERS; LEFT ARM AND FINGERS ARE NUMB; RIGHT ANKLE SWELLS AT NIGHT; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included parkinson's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced poor circulation (in fingers, foot, ankles, arms). On 26-MAR-2021, the subject experienced blotchy rash which goes up the ankle and leg about 2 inches. On 26-MAR-2021, the subject experienced tingling down left arm and in fingers. On 26-MAR-2021, the subject experienced left arm and fingers are numb. On 26-MAR-2021, the subject experienced right ankle swells at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from poor circulation (in fingers, foot, ankles, arms), blotchy rash which goes up the ankle and leg about 2 inches, tingling down left arm and in fingers, left arm and fingers are numb, and right ankle swells at night. This report was non-serious.
pt recv varicella vax on1/96 & in 4/98 pt devel 17 skin lesions w/no associated fever
This spontaneous report was received from pharmacist and refers to a 69 year old female patient with asthma and hypertension. The patient had no drug reactions or allergies. On 09-DEC-2015, the patient was vaccinated with ZOSTAVX injection (lot# L024997, expiration date 06-OCT-2016) 0.65 ml, subcutaneously in the left arm. There was no information about patient's concomitant medications reported. Within 24 hours after vaccination, the patient experienced white, sticky, gooey substance at the injection site. She also stated that some of the vaccine leaked from the injection site and that she slept on the arm where the vaccine was administered. The pharmacist stated no rash, no papules, no other complaints at the patient's injection site. No treatment was given. The outcome of the events was reported as not recovered. The patient sought medical attention and called pharmacist. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Had the 2 doses, had shingles/ Suspected vaccination failure; minor case of shingles; rash; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had 2 doses of shingles shot and had a very minor case of shingles about 4 months later. The physician said that, it would had been a bad case if the patient had not had the shot based on locations of the rash. The patient was thankful for getting the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided.
approx 12-14 days p/vax mom reports began noticing petechia appearing on child;approx 18-20 days later pt appeared very bruised p/a nap;went to family MD who referred to hosp ER;hosp x 4 days;
Patient local reaction and hematoma about four inches long and one inch wide appeared about 24 hours after vaccine administration. Patient said that there was some pain but it subsided. A week later hematoma is still present but it is starting to go away.
Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained of head tingling and body itchiness.
This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age. The patien's concurrent conditions included asthma and cardiomyopathy. The patient had no drug reactions or allergies. On 17-FEB-2017, the patient was vaccinated with PNEUMOVAX23 lot # M041394 with expiration date 23-MAY-2018 (dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant therapies included losartan potassium (manufacturer unknown), pravastatin sodium (PRAVACHOL), metoprolol succinate (TOPROL) and aspirin (manufacturer unknown). At the end of the day on 17-FEB-2017, the patient experienced headache; flu-like symptoms (reported as: aching, congestion, chills) (influenza like illness) and her left arm was sore (pain in extremity). On 18-FEB-2017, she continued with the symptoms and treated herself with acetaminophen (TYLENOL). Then, on 19-FEB-2017, the patient continued with influenza like illness and found that on that same date, her left arm had red blotches and erythema (rash macular and erythema). No product quality complaint was involved. No laboratory diagnostics were performed. At the time of the report, the outcome of pain in extremity, erythema, rash macular, headache and influenza like illness was reported as recovering. The relatedness of pain in extremity, erythema, rash macular, headache and influenza like illness with PNEUMOVAX23 was not reported. Additional information has been requested.
I started getting symptoms of feverish, sinus issues, vomiting, aches, and chills. I got a positive COVID-19 test. My symptoms lasted for 5 days. I did a telehealth visit for a release to go back to work.
Evening of vaccination, pt developed swelling and erythema with tenderness at vaccine site, described as "size of hand".  Slight pruritis.  No significant systemic signs.  Pt did not seek medical care.  By one week later swelling down to size of "egg yolk".  Pt reported event by phone to physician.  Received HiB at same time, same arm.
Hives started on left leg 3 days after vaccine- continued to worsen x 5 days, then more hives appeared on bilateral arms and face
pt inadvertently recv ID inj of Td & devel redness @ inj site;addtl info was recv 25NOV96 pt was advised to apply ice as needed & recovered p/1wk;
5 min. after the injection, pt. got up to get water. Started twitching, stiff, some rolling of eyes & fainted. Fell & hit her head on the floor. No incontinence. Came to in a few min. 2" x 3" hematoma. Headache & vomiting.
190 patients (9 different lot numbers) received a vaccine past the beyond; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond).    Concomitant product use was not provider by the reporter.  It was unknown whether patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.  This case contains information for the 183 of 190 patients described by the reporter   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335:Master case
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with GARDASIL (lot number, dosage, route and injection site were not known) injection in 2010. No other co-suspects were reported. No concomitant medications were reported. In the year of 2010 the reporter informed that the patient used GARDASIL back in 2010 and the patient felt faint for one week after receiving the vaccine. The patient was recovered at the time of report. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Puritis without rash to upper back and upper right arm. The upper back resolved withing a few hours. The upper right arm persists. Thirdy days after first COVID vaccine. No reaction from second dose which was given 1/21/21 in the left arm
TYPHIM VI was administered to a patient subcutaneously instead of intramuscularly with no adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient to whom typhoid VI polysaccharide vaccine (Typhim VI) was administered to a patient subcutaneously instead of intramuscularly with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect TYPHOID VI POLYSACCHARIDE VACCINE at a dose of 0.5 ml (lot number, expiry date, strength: not reported) via subcutaneous route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious typhim vi was administered to a patient subcutaneously instead of intramuscularly with no adverse event (incorrect route of product administration) (unknown latency) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. They just wanted to know if they need to repeat the dosage.  Action taken: Not applicable.  Outcome: Unknown for the event typhim vi was administered to a patient subcutaneously instead of intramuscularly with no adverse event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
inability to move my arm; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; This is a spontaneous report from a contactable consumer who reported for herself. A 47-year-old non-pregnant female patient received her first single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration in left arm on 11Apr2021 16:30 (lot number EW0153) at age of 47-year-old for COVID-19 immunization. The patient's medical history was not reported. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received Vicodin. The patient experienced "severe pain up to my neck and down my arm (just on the left/injection side) then tingling and numbness, then inability to move my arm with twitching muscles (neck pain)" on 13Apr2021 19:00, "I thought I was having a heart attack or a stroke" on 13Apr2021 19:00. On 13Apr2021 19:00, severe pain up to patient's neck and down her arm (just on the left/injection side). Then tingling and numbness, then inability to move her arm with twitching muscles. She thought she was having a heart attack or a stroke. It lasted for about a minute then it subsided. It happened again 20 minutes later and again the next day. No lasting effects that she noticed and had not returned. The patient did not receive treatment for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had her second dose on 02May2021. Information about batch no/lot no has been requested.
History of syncope with injections in the past. 10 min after vaccine, felt dizzy, laid himself on the ground under. Bystander witnessed him lose consciousness for a few seconds. No seizure like activity seen. No confusion after the event and patient recalled when everything that happened. Also states he didn?t eat today. Drank Gatorade, stayed recumbent for 30 min and felt better. Ekg sinus rhythm, vital signs stable. Declined to go to the ER. Went home with his fiancée who is a PA.
REDNESS, SWELLING, PAIN, SLIGHT BRUISING AT INJECTION SITE. PAIN UNDERNEATH ARMPIT, SOME CHEST PAINS UPON INHALATIONS.
Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CLONIXIN LYSINATE, PARGEVERINE HYDROCHLORIDE (SERTAL C NF), MULTIVITAMIN, FAMOTIDINE (PEPCID) and PROBIOTICS for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-May-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Flonis.  Treatment information was not provided.
pt recv vax 1SEP98 & 1SEP98 pt exp itching;
Sore muscle throughout bicep, not just at injection site. Occurred about 3 hours after initial injection.
Vomiting, extreme pain in limbs, stiff neck, insomnia, fever of 100F
Patient previously received Janssen lot #1805022 and chose to boost with Moderna. 12/29/2021 at approximately 15:50 RN administered vaccine in left deltoid. Patient complained 3 minutes after receiving Moderna booster in left deltoid that he was experiencing left arm pain at injection site, patient was A&Ox3, patient was in wheelchair and was escorted to observation, no complaints at that time. Approximately 5 minutes later RN heard "I need a nurse" coming from observation. RN went to observation and found patient sitting upright in wheelchair, appeared drowsy and non-verbal. RN instructed the Guard in observation to call 911. RN asked patient's wife and daughter about patient's medical HX. Wife stated to RN that her father has diabetes, COPD, and a pacemaker. Patient then became coherent and told RN that his left arm was hurting where he had rotator cuff issues. Patient then had a syncope episode and was tremoring and diaphoretic. Patient again become coherent and told RN he was experiencing lower abdominal pain. Patient then had another syncopal episode. Each episode lasting approximately 5-10 seconds. Patient become coherent again, Fire and Rescue and EMT arrived and assessed patient. Patient was able to converse with EMT's and was placed on stretcher and left via ambulance from Mall and transported to Hospital.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Vaso-vasal syncope; patient waited required 15 min observation and had sudden onset dizziness, fainted in front of pharmacy. EMTs were called for physical check due to patient hitting head and having a small scalp laceration. BP/pulse taken by pharmacist both normal. Patient was cleared by EMS and able to leave under own power. BP 116/59, pulse 50, temp 95.5 F. Has never experienced this before with prior vaccinations of any kid. Stated she was nervous before the vaccine.