chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient left the office and came immediately back in complaining of a burning throat and eyes,a racing heart and feet that were itching. He immediately had a localized reaction including swelling, warmth and redness at the injection site. He also presented with hives and swelling to his face and bilateral arms. While he was in our office for approximately one hour he received doses of oral Prednisone and oral Benadryl.Benadryl 1 tsp at 1020, Orapred 30mg at 1022, Benadryl 1 tsp 1050 and Orapred 15 mg at 1050. He had emesis after his meds at 1050. He received a half teaspoon of Benadryl at 1110 prior to him being sent to the ER down the street.  He also received an Albuterol breathing treatment that was changed to Xopenex . His oxygen saturation was 97-98% his heart rate was 134 and his blood pressure was 118/70. By the time we sent him to the ER his oxygen sat was 99% and his heart rate was 104. At the time of transfer child had redness to face, hands and feet with facial and extremity edema. Nasal congestion with tight cough/lungs clear with adequate air exchange. LOC was alert and oriented x 3 upon leaving our office.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2016, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2017, the patient was treated by a healthcare provider at a primary care office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sore/pain at injection site (difficulty sleeping). Red and swollen abscess at injection site.
Hives  -   Rash all over my back , arms , legs .  also itchy welps and bumps everywhere  . swollen left hand with red bumps in the palm of my hand.
Began breaking out in full body hives 12 days after receiving my Moderna Booster (I received 2 doses of the Moderna vaccine earlier in the year). The hives started at my neck, hips, and thighs and have traveled all over my body. They turned into hot welts one night and I had to go to urgent care where I was given a steroid injection and prescribed an Epi Pen. I have never had allergies before or hives before. I am taking Allegra during the day and Benadryl and night and nothing is working. I am still covered in hives.
Breakthrough case admission after 3 vaccines Moderna 2/23/21 lot# 007M20A;  Moderna 3/23/21 lot# 015M20A;  Moderna 1/14/22 lot# 060H21A
Patient received vaccines. Within 5 minutes, patient was lightheaded, complaining of shortness of breath, felt very strange, and said her tongue felt numb. After getting information her symptoms progressed to wheezing, so an Epi-Pen was administered and 911 was called.
re-administering the 1st V ARlV AX dose on unknown, future date with, per Physician's order; had missed the 2nd V ARlV AX dose; No additional AE; This spontaneous report was received from a pharmacist refers to a currently 33 years old female patient with hiv test positive. The patient's historical conditions and concomitant therapies were not provided.      In 2018, the patient was vaccinated with her first dose of varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously (dose and vaccination site were not provided), for prophylaxis.  On an unknown date, the patient had missed the 2nd  varicella virus vaccine live (oka/merck)(VARIVAX), dose and, at call time, had yet to be administered this 2nd  varicella virus vaccine live (oka/merck)(VARIVAX), dose. Pharmacist had received an, as of yet, un-dispensed, new Physician prescription order specific for re-administering the 1st  varicella virus vaccine live (oka/merck)(VARIVAX), dose on unknown, future date with, per Physician's order, the 2nd  varicella virus vaccine live (oka/merck)(VARIVAX), dose scheduled for '90 days' after the 1st  varicella virus vaccine live (oka/merck)(VARIVAX) dose.
Moderna COVID-19 Vaccine EUA Extreme body pain, especially wrist, ankles and knees. Fever, chills and nausea. Began about 12:00 pm the day after the vaccine and ended about 3:00 the following day. Took Tylenol. No relief.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On 30-SEP-2015 the patients received doses of improperly stored ROTATEQ (dose, lot# and expiration date were not reported) orally. Concomitant drug was not reported. All of these vaccines had been improperly exposed to 47.5F for 2 hours and 28.9F for 11 hours on an unspecified date prior to 30-SEP-2015. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Started with chills and sweating, then prg to upper left side ache (pt was afraid of the vax causing blood clots), then when pt went to walk and stand, her toes were hurting along with stiffness (like arthritis), along with slight headache and frequent urination every two hours. Headache then prg to migraine, pt took tylenol and then felt better next morning.
Large red swollen area that was warm to the touch where shot was administered. Started day after shot improving 4 days later. Headache for 2 days after shot and fatigue for one day after shot.
Within 30 min of injection I experienced tingling and numbness around my mouth, clogged ears, dizziness, abdominal pain and shakiness in hands.
Information has been received from a physician concerning a 13 year old female patient with no pertinent medical history who on 28-FEB-2008 was vaccinated with a second dose of GARDASIL (lot number, route and site not reported). There was no concomitant medication. On 28-FEB-2008, the patient developed a fever and vomited after receiving vaccine. The patient had sought unspecified medical attention. The patient refused to have her third dose. On an unknown date, the patient recovered from a fever and vomited. Additional information has been requested.
A NP reported that a pt received an injection of Prevnar and subsequently, developed a fever of 102F. The fever resolved in 2 days. The pt then developed a generalized papular rash that was described as "not quite roseola in appearance". No further information was available at the date of this report. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Upon putting a needle on a Prevnar prefilled syringe, the hub snapped off.; The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting - unspecified product. Upon receipt of follow-up information on (06Jul2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: GF1990, Expiration Date: 30Apr2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "Upon putting a needle on a Prevnar prefilled syringe, the hub snapped off.".  Additional information: Sample availability was unknown, photos were available.
Approximately 10 minutes after leaving administration site, she noted itching to arm & then tingling & itching to face & lips. Took 50mg BENADRYL. Symptoms improved & then returned in about 4 hrs. so she took a second dose of BENADRYL. All symptoms are gone.
Patient presented to MPX site for 2nd dose of Jynneos vaccine. At 1749, patient received intradermal  injection on right arm by staff Lot # FDP00015 exp 12/14/2022. Per Immunization Registry, patient's first dose was 09/16/2022 (Lot #FDP00014). At 1749, immediately after injection, PHN was called by RN to the vaccination table. Patient stated that she is dizzy. Patient appears pale and is diaphoretic. At 1750, the cot was brought to the patient. RN and friend of patient assist patient to lay down on cot. A set of vital signs were taken: BP 98/60 R:18 HR: 80bpm O2:98%. Patient reported that her vision "gets black" when she receives blood draws. Patient further stated that she has ate and drank today. PHN asked patient if she drove to site, and patient stated that her friend drove. PHN asked patient how the 1st dose went, and patient stated that she also felt dizzy after that dose. At 1755, a second set of vitals is taken. BP: 110/68, R:16 HR: 75 O2: 100%. Patient stated that she did not have dizziness at this time. At 1800, patient sat up, drank water, and ate a snack. Patient stated that  she is not dizzy any longer and requests to stand at 1800. Patient stood for five minutes with no complaints. At 1807, patient left vaccination site in stable condition with her friend.
1 of 2 pts vaxed exp an adverse event; pt devel inject site pain, cellulitis that is well demarcated-12-20cm approx 1 hr p/vax; area is red, hot & tender to touch; site of entry is hypopigmented;
This spontaneous report as received from a physical therapist, the mother of the patient, refers to a 14 year old female patient. The patient's medical history was unknown. On an unknown date in August 2013 the patient was vaccinated with GARDASIL dose 1 (dosage unknown), intramuscularly. With no adverse effects. On an unknown date in December 2013 the patient was vaccinated with GARDASIL dose 2 (dosage unknown), intramuscularly (IM) in the deltoid, about two fingers below the insertion of the deltoid, (where the IM injection should be). The patient's concomitant medications were not reported. On an unknown date in December 2012 the injection site immediately became red, swollen and very painful. The reporter reported that the swelling was determined at that time to be a hematoma. The patient couldn't raise her arm above shoulder level without severe pain (disability), and that she had trouble in pronating and supinating her arm (disability). She stated that the patient reports feeling depression, cries a lot, concerning the loss of function and that the patient couldn't participate in sports and activities. It was reported that the patient had seen many sports medicine doctors. An ultrasound was performed at an unspecified date and the mass surrounding the injection site was determined to be deltoid based, and was possibly necrotic. It was reported that the injury to rotator cuff was ruled out by the physician. She reported that the non-pharmacological pain relief had not been effective such as E-STEM and heat and ice. The outcome of the events was reported as not recovered/not resolved. The reporter stated that the physician stated that he believes the injury is a result of the GARDASIL vaccine. The reporters causality assessment was not provided. Additional information has been requested.
Sore arm; Rash on the face, neck and chest; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (Rash on the face, neck and chest) and HEADACHE (Headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), RASH (Rash on the face, neck and chest) and HEADACHE (Headache). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, Pain in arm and Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH (Rash on the face, neck and chest) and HEADACHE (Headache) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided.
Information has been received from a physician concerning a 4-year-old female who on 15-MAY-2007 was vaccinated with a dose of ProQuad (Oka/Merck upgrade process) because she was due for her second dose of ProQuad (Oka/Merck). On 15-AUG-2003 the patient received her first subcutaneous 0.5 ml dose of Varivax (Oka/Merck). The physician reported that the patient was seen in the office on 17-AUG-2007 with her sister and was diagnosed with shingles. On an unspecified date the "patient cleared up fine". A product quality complaint was not involved. It was also reported the patient's sibling had an adverse experience WAES # 0711USA03386. Additional information has been requested.
Pt. received her vaccine on Thursday 9/16. Next day the area was red and swollen but not much. On Monday 9/20 swelling was getting worse and had around the area where pt got injection. On 9/28 she saw her PCP and gave her antibiotics. Swelling is going down after few days, but is still red/hard around the area. Dr. told her to finish her antibiotics and if she does not get better to go to the ER.
two of her doctors said they felt very sick after receiving the second vaccine.; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer or other non-healthcare professional.  A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter reported that two of her doctors said that they felt very sick after receiving the second vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Patient called to report stiffness in his left side of neck 2 days after receiving his vaccine on 7/11. He call in on the weekend. He described as if like sleeping on it wrong. He also went on to say how he's gotten injuries from football and has had a similar response from a vaccine when he was a baby, but thought he should let us know anyways. I told him I would document on file.
5-10 minutes post vax, the pt began having trouble breathing, burning eyes, cough, eyes red and swollen, temperature of 104.5. Pt was given epinephrine and felt better.
shingles, rash, red/purple painful toes, vertigo, nausea, headache, intermittent fevers, rapidly changing heart rate and blood pressure, chest pain, body/joint pain especially back, eye pain, vision changes, extreme fatigue
High fever lasting more than 3 days; rash on face, arms, legs, chest; irritable mood, sudden change in demeanor that lasted over a week!
Patient is a 76 y.o. male with a history of T2DM, CAD, OSA, CVA, recent admit to hospital 8/19/23 for unstable angina who presented to facility 9/3/2023 with complaints of generalized weakness and falls. COVID 19 positive. CTA head/neck and CTPA showed incidental acute PE with RV strain, with prox Lt ICA stenosis. Transferred to facility on 9/3/23 for further management of acute PE.   1. Acute Submassive PE: likely provoked secondary to COVID-19. initially seen on CTA head/neck. Confirmed on CTPA involving Rt main PA with mild RV strain. Negative troponin, slightly elevated BNP. Venous doppler with acute LLE DVT, limited echo with EF59% and stable RV. S/p Heparin gtt, transitioned to lovenox bid per PV recs. Not a candidate for DOAC due to medication interaction, will need coumadin or lovenox on dc for 3-6 months.    2. COVID 19 infection: vaccinated x 2. Symptoms starting 9/2/23. Tested positive 9/3/23. Treated with IV dexamethasone (stop 9/14) and remdesivir (stop 9/8).  3. Acute hypoxic respiratory failure: likely due to PE, possibly COVID-19. Mild diffuse peripheral ground glass changes on CTPA. Unable to wean to RA on 9/4/2023 .Continue supplemental O2 for goal SpO2 > 90%.    4. CAD with angina: h/o with multiple stents. NM stress test 8/30/23 abnormal with mild/moderate reversible lesion. ECHO 8/19/23 showed EF 60% with grade 1 DD. Troponin negative on admit. Discussed with interventional cardio (Dr.) 9/5/23, rec likely okay to continue plavix and anticoagulation as to avoid triple therapy and plan for outpatient LHC since pt without chest pain and negative trops. 5. Carotid artery stenosis: admit CTA showed 70 prox Lt ICA stenosis. Continued AP and statin. Recommend OP follow up.  6. Falls: likely due to weakness, COVID and PE. No acute injury on trauma imaging. Denies LOC but did hit head. No fractures on admit imaging. Trauma evaluated. PT/OT eval.  7. HTN: h/o. Contiued home BB and held ACEI. Resume as able.    8. T2DM: h/o. Last HbA1c 6.8. held home PO medications. ISS for now.  9. CVA: per history. Continued aspirin, plavix, statin, consider AP adjustment given new need for AC as above  10. Trigeminal neuralgia: h/o. Continued home tegretol and gabapentin.  11. Obesity: BMI 34.46. recommend lifestyle modifications  12. OSA: per chart but noncompliant with CPAP. Rec outpatient sleep evaluation
Decline in wellbeing Decline in health status Extreme fatigue Unexplained weight gain Difficulty breathing during activity High blood pressure Pain in leg(s) Numbness and tingling Reduced range of motion Shortness of breath Death
Severe headache, 36 hours and counting.  Treating with acetaminophen .   Diarrhea, 12 hours and counting.  Fever - 101.6, chills, fatigue and body aches, all intermittent.  The headache is by far the worst side affect.
Approximately 23 hours after vaccination, erythematous rash on face, trunk/back & arms, not noted on lower extremities. Mild tingling. No other symptoms at all. Rash subsided spontaneously  in 2-3 hours. The question is: Should 2nd vaccine dose be given and if so should it be given in a facility better equipped? PCP has not responded to this question.
50 days between first and second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (50 days between first and second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced OFF LABEL USE (50 days between first and second dose). At the time of the report, OFF LABEL USE (50 days between first and second dose) outcome was unknown. Not Provided      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 medication was included. No treatment medication was provided.  Rescheduling was not made on time so the second dose passed the 42 days limit.
Rash near the site of the vaccination about 1 week after the first dose. Slight pain under armpit on the same arm of the vaccination. Went away in about 3-4 days after the first appearance of the rash.
On 12/31 finished having dinner. Thought sudden slight shortness of breath may be do to appetizer type foods we had. Drank water to help subside it with little effect. Went outside into cold air. Still had some slight shortness of breath. At 8PM continued to my other daughters home( where I've been going since pandemic) upon sitting there still felt slight shortness of breath but again manageable. We left at 11:30 as my breathing never really got better or worse. When I arrived home I Took my PROAIR-HFA inhaler that I use PRN. My symptoms resolved and went to bed. On Friday 1/1 I had again slight shortness of breath with no real excertion.  On 1/2 I went to work at Hospital in neurology dept. I was pushing collector up to SICU unit and then to M2 unit. On arrival to M2 I felt very winded and took my inhaler with results.  I then called my manager to make him aware that I was having dilemma do to fact that I didn't want to call Covid hot line as I felt symptoms were from vaccine not Covid!  I was put out of work by Covid hot line had test on 1/4 and negative results on 1/6. My symptoms seemed to subside on 1/6. I returned to work on 1/9 and am pushing collectors and patients with no symptoms
Subject in pneumococcal vaccine trial, with severe COPD, died due to respiratory failure secondary to COPD. Vaccination took place 9/19/2007. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.   10/1/09 PSCC Report DOS 6/2/09 Assessment: Death Due to COPD. Subject died in hospital from respiratory failure secondary to COPD. 10/06/09 Death certificate states COD as COPD w/diabetes mellitus, atril flutter, hypertension & CVA as contributing factors ICD-9 Code: 491.20 10/6/09 Death certificate received. Cause of death: COPD
Patient was diagnosed with COVID-19 after vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient was diagnosed with COVID-19 after vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient was diagnosed with COVID-19 after vaccination). At the time of the report, COVID-19 (Patient was diagnosed with COVID-19 after vaccination) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     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 relevant concomitant medications were reported. Treatment details included Monoclonal Antibodies.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: followup received on 25-jun-21 with NNI