chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/22 Pt to ED with Shortness of Breath (pt reports ongoing SOB x one year progressively worse over 2-3 days and worse with exeration. pt c.o testicle swelling and fluid retention over 2 days. pt takes 2 of O2 at home. 89% in ED on 2 L of O2.) [Tested for COVID and resulted Negative]  11/23 Acute on chronic hypoxic respiratory failure: 2/2 above. 2L oxygen at home, currently requiring 3L. Monitor, goal O2 sat > 92%.  11/24 Acute-on-chronic systolic heart failure with evidence of volume overload / acute decompensated heart failure 12/1   He had a rough night.  He has fever, and is coughing up bile.  STAT XR chest and abdomen pending... COVID test reordered... Fever of 100.8 Fahrenheit.  12/2 COVID + test result, low grade fever persists 12/5 Systolic heart failure has improved. He is off Bumex infusion. Continue steroids, oxygen need stable at 3-4L. Some hematuria, continue to flush foley, trying to avoid CBI as patient likely will have more delirium  12/7 No new complaints noted; stable; no acute cardiac issues noted 12/8 Pt remains delerious, no acute complaints 12/9 Family still discussing the option of bringing patient home with Home hospice services. Family discussed case with their family cardiologist, whom they have a trusting relationship with. Writer discussed that the patient over all appears to be doing well. The main concern is with quality of life and the patient's wish to be home with family and stay out of the hospital setting overall. Will follow up with family regarding final decisions.  12/10 Family 100% sure they want to sign on with hospice services and take the patient home.  12/12 Remains a little delerious but is able to answer a few questions. No cough, fever or chills.  12/13 Family is undecided about hospice at this time. They would like to bring the patient home, but feel that since the patient is COVID positive they do not want to expose other vulnerable family members.  12/14 Discharged Total Brief Hospital Course:  Patient is a 93 yo M admited with acute on chronic systolic CHF. CXR showed congestion, evaluated by cardiology, started on IV diuretics and IV milrinone. 2d echo revealed EF 25%, mod-severe AS, severe LV dynsfunction. Upon iprovement, IV milrinone was discontinued. He was further found to have supratherapeutic INR, coumadin held and it was decided to switch AC to eliquis. During the course of the hospital stay he experiened increasing acute on chronic hypoxic respiratory failure, CXR showed opacities, found to be due to COVID19 pneumonia. ID consulted and started on appropriate treatments. Given age and comorbidities, palliative care was consulted and a discussion took place with family regarding goals of care, they declined hospice and opted for discharge to SAR instead. He completed treatments for COVID prior to discharge and was taken off of isolation. Cardiac medications were optimized as well. He will be discharged to SNF in stable condition. Follow up instructions provided.  All questions and concerns were answered and addressed prior to discharge with patient/family.  Prescriptions were provided.
COVID-19 Breakthrough Case, it started out with a sore throat then the typical body aches like you have a cold. Prior to this my roommate came back from a trip and was coughing all over the place so I knew something was going on. I was illness free for about 3 years prior to this. I started getting pressure to my chest, so I know something was going on and a hacking cough. I never got majorly sick. I started using Proventil/Rescue Inhaler 2 puffs every 6 hours or less. It all resolved in about two weeks. Jan19, I received a positive test and then Feb 2 I went back and tested negative.
pt had vax 6FEB95; mom called on 8FEB95 to say pt had to go to ER for react to vax on 6FEB95; mom stated ER told her that pt had an allerg react to vax; also stated pt had a high fever, redness @ erythema to area;
Pfizer Dose 1 2/17/21 (en6201) Pfizer Dose 2 3/11/21 (EN6204) COVID Positive 8/6/21  8/6/21: Presented to ED for COVID.  8/9/21: 74-year-old male with current tobacco use, prostate cancer on Lupron, remote history of colon cancer status post colectomy, hypertension, hyperlipidemia,  aortic aneurysm presented with 5 day history of progressive shortness of breath.  Patient reports symptoms started about 5 days ago with generalized weakness, muscle aches, joint pain associated with shortness of breath and the intermittent cough.  He was diagnosed with COVID-19 on 08/06 and  sent home with COVID safe at home program  he was on room air at the time, returned on the day of hospitalization with progressive worsening shortness of breath and increased generalized weakness.  Was found to be hypoxic 85% on room air 96% on 4 L of oxygen, apparently was in AFib with RVR with low normal blood pressure which improved after bolus of IV fluid in the ED.  patient was tachycardic and tachypneic as well.  ABG pH 7.38 with pCO2 34 and PO2 81. Lactic acid was 2.4 improved to 1.5.  EKG showed atrial fibrillation with rapid ventricular response and nonspecific ST changes in the anterolateral leads, converted to sinus rhythm with resolution of nonspecific ST changes on repeat EKG.  Chest CT showed no pulmonary embolism, noted infiltrates in the lingula and bilateral lower lobes, stable right lung nodule.  Patient received 1 and 25 mg of IV Solu-Medrol, 1 or long DuoNeb, 1 g of IV ceftriaxone 1 L of NS in the emergency room.  8/12/21: Patient admitted for acute hypoxic respiratory failure 2/2 covid 19 pneumonia. He was treated with Dexamethasone, antibiotics and oxygen. Subsequently weaned off oxygen and symptoms improved. He had streptococcus epidermidis in 1/2 bottles of blood culture considered contaminant. Patient was deemed stable and discharged home to complete 10 day course of steroids with oral dexamethasone and 7 day course of antibiotics. He had transient afib on admission which converted to sinus rhythm with improvement of his respiratory status. Given his history of aneurysm and bleeding and transient/reversible cause of afib anticoagulation was deferred after discussion with the patient. On discharge patient was afebrile and hemodynamically stable. He was discharged home.
get a sore; Pruritus; she has an ongoing blister that is filling up every time; weakness; This is a spontaneous report from a contactable nurse (Patient). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration in Deltoid Left on 02Sep2021 (age at the time of vaccination 55-years-old), as a 0.3 ml single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The Patient did not used other products. The Patient was not received other medications in two weeks. The patient was not received other vaccine in four weeks. The Patient was not diagnosed with COVID-19 prior vaccination and patient did not test COVID-19 post vaccination. It was mandatory patient taking COVID-19 vaccine. On 03Sep2021, the patient experienced pruritus, she has an ongoing blister that is filling up every time, weakness, and on an unspecified date get a sore. The caller has extensive side effects and has pictures of it. The caller was trying to report it online but decided to call and report it instead. The caller doesn't want to bust the blister on unspecified date she gets a sore. But the blister deflated yesterday and left drainage on the pillow. But if you leave it alone, it inflates again. The caller's body keeps feeding the blister water. The caller considers the event criteria as moderate seriousness. The Patient had not received treatment for events Pruritus, Ongoing blisters, weakness. The outcome for the events Pruritus, she has an ongoing blister that is filling up every time, weakness was not recovered, and event get a sore was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Vaccine given at 2:30 pm 1 hours later c/o of eyes burning, head hurting, dizziness (pupils large), throat hurting (tight). Instructed to give Benadryl - 1 hours later feeling much better to continue Benadryl PRN.
Fever to 101.4F and tremors of arms, legs and jaw, starting on the morning after vaccines.
Redness, swellling and induration over the Left upper arm from the shoulder to mid-upper arm.  Tender to palpation.  No fluctuance
extreme tenderness at the injection site; shooting pain that feels like a knife in the fleshy part of his right arm / feels like a knife in his arm; headache; discomfort that runs to his pinkie; sharp pains if he reaches or stretches his arm muscle; feels pressure on his shoulder which is not fun / discomfort at his shoulder joint; pain in his shoulder joint; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received 1st dose on an unknown date).   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, 2 weeks after receiving Shingrix, the patient experienced injection site tenderness, pain in arm, headache, discomfort, muscle pain, shoulder discomfort and joint pain. On an unknown date, the outcome of the injection site tenderness, pain in arm, headache, discomfort, muscle pain, shoulder discomfort and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness, pain in arm, headache, discomfort, muscle pain, shoulder discomfort and joint pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient. He had extreme tenderness at the injection site that developed two weeks after the second injection. He also had pain in his shoulder joint, headache, and discomfort that runs to his pinkie. Depending on how he moves his right arm he would get a shooting pain that felt like a knife in the fleshy part of his right arm. More recently (about a month ago of reporting date), he started to get sharp pains if he reaches or stretches his arm muscle and it felt like a knife in his arm. He was having discomfort at his shoulder joint as well. When he roll over at night he felt pressure on his shoulder which was not fun. His symptoms had not changed or improved since he received the second injection. All of his symptoms were occurring on his right arm or right side. The patient consented to follow up.
This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Child is ill with sore throat, cough and noticed some red spots this AM. Had varicella shot on 2/28/97. On exam: throat red, tonsils +1 without exudate. Onset last night, of raised papular/pustules on erythematous base on chest; several more appeared, then spread to face. Has about 6-8 lesions on chest and 6 on face and is itchy. Also had exposure to chickenpox in daycare. Dx: chickenpox and URI. Treated with Benadryl elixir for itching; lukewarm baking soda baths; keep away from other children over the weekend to observe how rash progresses. RTC if worse.
DVT - extreme pain and swelling in right leg, currently being treated with Xarelto
On 10/24/99, the pt developed a rash all over his face, ears, trunk, and upper extremities. She notified the primary physician, who instructed the mother to take the child to an ER. Upon exam, the pt's mother was told that the rash was probably secondary to the vax. The pt had normal fluid and food intake. General exam performed showed that his right TM is minimally erythematous and diffuse erythematous macular papular rash on the skin.
This infant had a fever of 102.6 on day # 10 after immunizations and had a febrile seizure (2nd time febrile seizure). The patient also had new rhinorrhea and URI sickness. The seizure lasted 30 secs.
Right upper quadrant dull pain 4/10 around the liver area, has not checked liver enzymes Narrative:  has not seeked medical care
Patient has had arm soreness in area of vaccine administered x 10 days and pain in that area with picking up his 6 month child since.  No other numbness or radiculopathy.
3 to 4 hours after administration, pt's wrist to thumb on both hands and both ankles to shin became red, ithcy, had hives and swollen. Under both breast, pt  got red and itchy and on neckline. No breathing problems
At 9:53am patient reported "pressure" in her chest. Patient described pressure as if what she may experience with asthma. Patient denied chest pain.  Vitals taken every 5 minutes. Patient declined supplemental oxygen. Patient declined IM Benadryl.  Patient administered 50mg of oral diphenhydramine at 9:55am . Patient refused to go to ER.  Patient was alert and oriented x4.
She got her vaccine that day she had a sore arm.  The next day she had cold symptoms and a headache.  Then the following day she had the same symptoms, but not that terrible and then felt a little bit worse.  She also woke up on the 2nd day menstrual bleeding with her period not due to start yet.  It call all of a sudden with spotting and then by 3 hours later it got very very heavy and lasted for about 10 days.  It came suddenly and was heavy and then it stopped suddenly still being heavy, not a normal period time reaction.  She has not had any unusual bleeding since that time.  She  normally has a periods every month.
I felt like I had a sinus infection, severe chest pain on left side of my chest, I went to ER doctor thought I had blood clot and they tested me for Covid and I had come back Covid Positive. I used my inhaler. I still get short of breath quickly and I still have a brain fog. I can't remember certain things and I was dropping things and that getting better, and I'm still using my inhaler more then normal.
This spontaneous report as received from a Registered Nurse regarding a 5 year old child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 27-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-AUG-2015, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 24-AUG-2015, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
pt to ED with worsening SOB, hypoxic, placed on HF O2 with intermittent BiPAP; hx of squamous cell carcinoma of right upper lobe, post chemo radiation, COPD, CKD; pt's condition worsened, he went into respiratory distress requiring intubation and mechanical ventilation; condition continued to deteriorate; was placed on comfort care and extubated; pt died in the hosp
This spontaneous report as received from a physician refers to two patient of unknown age and gender. On an unknown date, the two patients received ROTATEQ (lot #, dose and route not provided) and threw up the doses so another doses was given. Additional information is not expected.
Headache, soreness of nasal and throat glands, pain while swallowing, soreness of glands of left arm pit (shot was given in left arm), achiness in left arm shoulder, chest and shoulder blade.
Client c/o chest pain in the right side upon inspiration; denied past medical hx of MI or angina. Has aspirin allergy. V/S taken every 5 mins. At 12:50pm c/o feeling cold and "head hurts, feel dizzy." Water offered and accepted. At 1:00pm c/o throat tightness. Liquid Benadryl 25mgx2 offered and accepted by client. RN observer offered to call EMS at 12:34 but client's husband stated "let's wait a little." EMS offered again @ 12:54pm and was accepted. EMS fire arrived at 1:17pm and took over.followed up with client on 4/10/21. Client reported labs were done, x-ray and blood draw. All normal acc. to client. Was advised by hospital it was likely d/t aspirin allergy. Client recovered and was d/c same day as incident (4/7/21).
pt recv vax 21JUN95 5PM & pt exp nausea;approx 715PM devel diarrhea & burning stools which lasted approx 2 1/2hr;pt devel a fever;At 9:30 temp was 100;site of inj was very sore, swollen & red;no further details were provided;
17 year old received first dose Moderna on 04/19/21 Consulted with medical team and client agreed to receive second dose of Moderna today, 05/17/21
Patient informs me of upper extremity paralysis on the 11th at 11:30am.
VACCINES GIVEN ON 3/25/10.  MOM NOTICED A RED KNOT WHEN HE GOT THE SHOT BUT IT CLEARED UP.  ON 4/1/10 MOM NOTES THAT KNOT RETURNED ABOUT THE SIZE OF A HALF DOLLAR.  IT WAS RED, HOT, HARD IN THE AREA THAT HEPATITIS A WAS GIVEN.
Upon administration the needle came off and pt only received part of the dose while the rest spilled onto his arm. He was my last vaccine for the day, so I was able to use the eleventh dose in the vial to re-administer. Pt seemed to be doing well while in the waiting area. The needle was never removed from the syringe after the dose was drawn up--the same needle was used (Carepoint Safety 1ml 23G 1").
Immense swelling in the injection site and surrounding areas such as shoulder, arm and chest. High fever of 104 degrees for seven consecutive days. Fatigue and lethargic movements during the days of fever accompanied with slow speech. Flesh at the injection site is very hot to the touch, and intense pain where swelling has occurred. Called the Advice nurse and was connected to an on site doctor who listened to symptoms and determined patient did not need to be seen. Photos of patient were taken to document image of swelling and redness.
shaking that lasted 3 to 4 hours; severe headache; joint pain; muscle pain; A spontaneous report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced shaking that lasted 3-4 hours, severe headache, joint pain and muscle pain.   The patient's medical history, as provided by the reporter, included hypertension. Concomitant medications reported included unspecified hypertension medication.  On 30 Dec 2020, approximately 8 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (BATCH # 011G20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020 about 8 hours after vaccine administration, the patient experienced shaking that lasted 3 to 4 hours, severe headache, joint pain, and muscle pain. Treatment for the event included naproxen.  Action taken with mRNA-1273 in response to the events was not reported.  The event, shaking that lasted 3-4 hours, was considered resolved on 31 Dec 2020. The outcome of the events, severe headache, joint pain and muscle pain were unknown.; Reporter's Comments: This case concerns a female of unknown age, with PMH of COVID-19,  who had NS events of unexpected tremor and expected headache, arthralgia, myalgia.  Event onset occurred Day 1 after the first dose of mRNA-1273. Treatment included naproxen. Tremor resolved, but other outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Since I have taken the second dose of the vaccine, my menstrual cycle has lasted 10+ more days longer than normal (it is typically 7 days long)and irregular start dates for my cycle (I have had one occurrence of it starting up to 12 days early).
Wed. morning 10/21/09 patients upper lip was very swollen and had a red rash on his cheeks. No rash any where else.
sore throat; inject site warm to touch; head ache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE WARMTH (inject site warm to touch) and HEADACHE (head ache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (inject site warm to touch) and HEADACHE (head ache). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE WARMTH (inject site warm to touch) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included  used heating pad on the injection site.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Same day of vaccine, evening time, started with headache, fever, chills, leg/foot cramps, malaise, heart palpitations, and pain at injection site.  This continued, minus cramps, all day the next day. but fever went down towards end of day using Acetaminophen 325mg and Ibuprofen 400mg, alternating, twice during day.  The third day and today, fourth day, still body feels tired as if I have had the flu, and have a persistent "hum" in my head, as if a motor is running somewhere nearby.