chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Assessment and Plan Patient is a 70 y.o. female patient of local DO with history of COPD/asthma, hypertension, CAD status post CABG, hyperlipidemia presented to a local Hospital with shortness of breath.    Shortness of breath Acute hypoxemic respiratory failure On 2 L nasal cannula in no acute respiratory distress VBG; 7.38/48.6/30 X-ray with increased distal markings suggesting pulmonary edema small bilateral pleural effusion proBNP 962 increased from baseline 545 a year ago Etiology of acute hypoxemic respiratory failure likely multifactorial. Presumed heart failure with preserved ejection fraction and in the setting of COVID pneumonia.   Continued oxygen therapy and titrate as tolerated Evaluated for home oxygen, she qualifies for home oxygen. Face-to-face evaluation performed for home oxygen.   Covid-19 Virus Infection Date of onset of symptoms: 1/8/2023 Symptoms present on admission: Shortness of breath Date of covid positive test: 1/9/2023 Vaccination status: vaccinated Imaging: Chest x-ray?vascular congestion with increased interstitial lung markings, small bilateral pleural effusions Oxygen requirements on admission: 2 L Current oxygen requirements: 2L Medical therapy: steroids Consultants following: Infectious disease Continue dexamethasone 6 mg daily to complete a 10-day course   New onset A. fib with RVR. Heart rate fairly controlled at rest but was for a short on 1/11 in the 140s to 150 range with activities 2D echocardiogram showed EF of 40% which is unchanged from July 2021. Consulted cardiology for input. TSH is normal. Cardiology recommended Eliquis. Continue current dose of carvedilol.   Acute on chronic HFrEF CAD status post CABG Essential hypertension Echo 3/21 with EF 40% with grade 2 diastolic dysfunction On home carvedilol and Lasix  Started on Lasix 40 mg IV twice daily Resume home carvedilol and losartan at discharge Resume home ASA, ezetimibe, statin Hold Aldactone at discharge due to hyperkalemia Follow-up with cardiology as outpatient.  AKI on CKD 3B Creatinine on admission 2.80, now 2.66  Baseline creatinine 1.37 about a year ago Etiology likely multifactorial in the setting of nephrotoxic medications, acute HFrEF, COVID-19  Management as above Avoid nephrotoxins?holding home spironolactone and losartan Creatinine slightly increased because of diuresis. Follow-up with PCP for close monitoring.   Hyperkalemia-resolved Potassium 5.4--- >4.9 Patient was on losartan and Aldactone at home. Will discontinue Aldactone at discharge.    COPD/asthma Without exacerbation Denies any smoking currently Resume home inhalers   Gout Resume home allopurinol   Hyperlipidemia Resume home ezetimibe and statin   Morbid obesity Body mass index is 41.27 kg/m². Lifestyle modification
I mistakenly gave patient Flu-Blok during his visit with me.  He has had no adverse reactions to my knowledge.
Tightness in chest, cough and hives.  Awoke with symptoms in middle of night.  Did not seek treatment.
received vaccine in left deltoind. Initially no discomfort, but discomfort began and worsened into the evening hours
Sept 23 - 2nd covid vaccine (Pfizer) Sept 24 - Normal Sept 25 - Fever by the end of day and no appetite  Sept 26 - Fussy, high fever, non stop crying, not eating Sept 27 - Fussy, high fever,  inconsolable crying, not eating and drinking milk, lesion on mouth Sept 28 - Mild fever, fussy Sept 29 - Fussy Sept 30  - Fussy
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted about 5 minutes after vaccination. patient was immediately repositioned on the floor on her back and regained consciousness right away. She stated she felt dizzy, nauseated and sweaty before the fainting. Patient was observed additional 15 minutes before letting go.Followed up with patient 3 hours later and she states that she is feeling fine.
12/31/20: Sore/Tender at site with some redness 1/3/2021: Redness at site with some itchiness 1/5/2021: Redness, swelling, warm to touch, and very itchy at site
patient is experiencing pitting edema to her feet and ankles starting 2 days post covid19 vaccination
The same day, I started running fever about 5:00pm (106) that night, and I fainted. My husband found me and took me to the doctor, not then, but the next day on the 20th. and slept all day and started having asthma and had to use my nebulizer. I did not do anything for the next couple of days. I was with nauseas, throwing one time, Brain fogs, did not see clearly.
Right after the shots I experienced body aches to the point where I had to roll out of bed in the morning. This seemed to ease up somewhat, but now I am having problems in my shoulder joints.
upset stomach in the middle of the night; didn't feel well; started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue; Mouth Ulcers; really bad headache; fever of 101.5 for two days; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach in the middle of the night), MALAISE (didn't feel well), ACNE (started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue), MOUTH ULCERATION (Mouth Ulcers) and HEADACHE (really bad headache) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach in the middle of the night), MALAISE (didn't feel well), ACNE (started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue), MOUTH ULCERATION (Mouth Ulcers), HEADACHE (really bad headache) and PYREXIA (fever of 101.5 for two days). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach in the middle of the night), MALAISE (didn't feel well), ACNE (started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue), MOUTH ULCERATION (Mouth Ulcers) and HEADACHE (really bad headache) outcome was unknown and PYREXIA (fever of 101.5 for two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5.         No concomitant medication was reported.  The patient had fear that mouth ulcer would spread, patient stated took Celebrex and rinsed mouth out with salt water.   This case was linked to MOD-2022-682167, MOD-2021-168219 (Patient Link).
02/18/21- 12 hrs after 2nd dose, chills, went to bed, during night got up to go to BR, dizzy, then woke up flat on back-no memory of falling , had to get up 2 more times in night,  same thing happened, lost consciousness waking up flat on back both times as well. Slept the next day, headache similar to sinusitis, lost her appetite and swollen glands for 2 days. Today 2/26 appetite returning, scheduling MRI next week per primary care
was ill as soon as she got home; Hasn't been able to get out of bed. The patient states she has been taking ibuprofen but it doesn't help much; Says she's never had to stay in bed this long; We recommended being evaluated by a doctor at an Urgent care center because of continued a/e that are reportedly worsening.
Patient was admitted on 3/26/2021 for hyponatremia within 6 weeks of receiving COVID vaccination.
Dizziness and tightness in throat but subsiding- Allergy to shellfish: 13:31 Stated feeling better and was offered drink: 13:32 Advised to breath slowly:13:32 Stated that was feeling better by 13:35
Upper arm felt warm and swollen 15 mins after administration of vaccine. Gave BENADRYL 50mg PO in clinic.
Patient stated he was sore at injection site and then developed a fever. He went to the hospital and they admitted him and he stayed for 3 days.
After this patient's immunizations, about 9:45, the patient had an episode of staring, he would not respond to his name or touch, and he got listless. The EMS was called, the patient was taken to the ER. His episode lasted maybe 10 - 15 minutes. Upon arriving to ER the patient was more alert, crying, looking for guardian (grandmother). The patient was monitored all day and released from ER. The patient is to follow up with pediatric neurologist. As per grandmother the patient is doing well.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medical history and drug reactions and allergies. On unspecified dates in July 2015, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot#, expiration date, dose, frequency, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Onset of pruritic papules, swelling across maxillae about 6 hours after injection, gradual progression of edema which extends into orbits.  No respiratory or airway symptoms. Injection site had tenderness which gradually resolved over 3 days, but no injection site swelling, redness.  She has not taken other medication or used any other products that might provoke this reaction.   Evaluated on day 3 of symptoms, Started on Medrol taper and advised to start cetirizine.  Advised to seek care urgently with further progression of symptoms.
1- Severe  Chills on first night 2- Arm pain 3- Fever on day 2 and 3 4- Ongoing a lump or swelling under skin at injection site
This spontaneous report as received from a healthcare worker and nurse refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of oral, ROTATEQ were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. This is one of sevearl reports from the same reporter. Follwo up has been received from healthcare worker on 06-JUL-2015. It was reported that on 17-MAR-2015, the patient of unknown age and gender was vaccinated with improperly stored oral, ROTATEQ (lot number: K010219, 02-JUN-2015). This is several reports from the same reporter. Additional information has been requested.
minor fever and sore arm until bedtime. I awoke about 10:30 PM with nausea and abdominal pain, even to the touch, higher fever, mild headache and significant thirst. When I awoke a few hours later and tried to get out of bed my feet were cramping so I couldn't stand comfortably, also achiness in ankles, hands and wrists. I was very thirsty and cold, so cold that I could not get a thermometer in my mouth as my teeth  were chattering. I tried to drink some water and went back to bed. A few hours later I woke up, thirsty, kind of crawled into the bathroom. I had a 101 temperature, still nauseous and achy joints. I tossed and turned all night. When I got up at 6:15 AM I went into the bathroom, tried to drink water but was feeling very nauseous and felt like I was going to pass out. I woke up on the floor when my husband came in - he heard my head hit the floor from another room. My first instinct was  for water, which he squirted into my mouth. Both of my arms and hand were tingling. He managed to help me up, and I crawled back to the bed. My temp was about 100.5 where it stayed for most of the day. I called a friend, she told me to take some ibuprofen -I can't take acetaminophen- I took one, drank lots of fluids, and spent the rest of the day sleeping on and off. I did cut my head but not significantly enough to go to a facility.  I was literally unable to do anything for the entire day. When I woke up today my temperature was down to 98.1 - its normally in the 97's - and feel much better except my sore arm and aching head
is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people) had not resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Patient received the Moderna vaccine earlier this year, and was now experiencing an adverse reaction which he does not know if it was related to the vaccine but he says it might help a lot of people, he was currently in the hospital.  Based on the 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.; Sender's Comments: Based on the 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.
01/08 to 01/09 - first dose had some spots appear on left chest, hip, and 2 mid- abdomen. Have seen others link this to the vaccine but were gone right before the second one.  02/06/2021 - woke up with stiff arm around 9 am and took some Tylenol. Within a few hours, almost 24 hours from the second shot I started  having body aches, shortly after the chills started.  Sleep most of the day so far with body aches and chills alternating Tylenol and ibuprofen. Checked the injection site and have a golf ball size lump that is red and hot to the touch.
abscess/mass in her intestine; lower abdominal pain; Terrified to receive the 2nd dose; itching; Postponed 2nd dose of the vaccine; urticaria (Hives) all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS INTESTINAL (abscess/mass in her intestine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced URTICARIA (urticaria (Hives) all over her body.). On 25-Mar-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Postponed 2nd dose of the vaccine). On 01-Apr-2021, the patient experienced PRURITUS (itching). On an unknown date, the patient experienced ABSCESS INTESTINAL (abscess/mass in her intestine) (seriousness criteria hospitalization and medically significant), ABDOMINAL PAIN LOWER (lower abdominal pain) and FEAR (Terrified to receive the 2nd dose). On 25-Mar-2021, INCOMPLETE COURSE OF VACCINATION (Postponed 2nd dose of the vaccine) had resolved. At the time of the report, ABSCESS INTESTINAL (abscess/mass in her intestine), ABDOMINAL PAIN LOWER (lower abdominal pain) and URTICARIA (urticaria (Hives) all over her body.) had not resolved and PRURITUS (itching) and FEAR (Terrified to receive the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My arm has been sore; It has just been over my neck; my arm, shoulder was swollen; my arm, shoulder was swollen; I got up and my arm, shoulder was swollen, that hurt and then it stop hurting; This is a spontaneous report from a contactable pharmacist (patient).A 81-year-old female patient received unknown dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 11Jun2021 (Lot Number: EW2178) at the age of 81-year-old as a single dose for covid-19 immunisation. Medical history included back injury from an unknown date and unknown if ongoing and patient on morphine for back injury. The patient's concomitant medications were not reported. The patient's arm has been sore which just been killing her and pain was also over her neck. patient was on morphine but that morphine did not even touch this and her neck is about to kill her. On 12Jun2021 patient's arm, shoulder was swollen and that hurts. The outcome of events pain in arm, shoulder pain was recovered and event pain neck, swollen arm, joint swelling was unknown. No treatment received for the events..
This spontaneous report has been received from a pharmacist via a company employee referring to a 17 years old female patient. Information about concomitant medication, concurrent condition, and medical history was not provided. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly for prophylaxis (strength, dose number, frequency, batch/lot #, and expiration date were not reported). It was unknown which shot in the GARDASIL 9 series that was being administered. On the same day, the patient experienced syncope (reported as "syncopy"). The patient sought medical attention in doctor's office at the time of the event. The patient stayed longer than required 15 minutes and required juice at doctor's office. Treatment was given for the event. No lab diagnostics were performed. It was also reported that the therapy was continued. At the time of the report, the outcome of syncope was reported as recovered. The causality assessment was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA008503.
Chills, sweating, body aches, headache, sore throat, weakness, nausea
All over body rash, with extreme itching, began on day 2 [Feb 9th] of receiving 2nd vaccine. It has gotten progressively worse. Tried taking Benadryl.
pt recvd vax;pt crying non stop since recving inject @ 9:30am; called in @ 1:30pm;MD notified;apap ordered prior to next day; not to recv any more pertussis;
24 hours after vaccine got fever for 48 hours up to 101.3 F Then 15 days after got an acute Vertigo episode with lost of balance, lost of speech. Went to hospital and many they did to verify it was not a TIA, and nothing was found. Everything came normal.  My clinical doctor followed up with more test in brain electroencephalogram and more, but nothing was wrong. The ear-throat specialist decided that was an acute vertigo episode.  After my third dosis, again after 10 days I got another vertigo episode. This time not as acute, but my head spun around suddenly.
Hasn't yet received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose intramuscularly in 2018 ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The patient mentioned she has not yet second dose. The reason for delay was unknown. Nothing else was reported. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Stomach diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Stomach diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder NOS.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Stomach diarrhea). At the time of the report, DIARRHOEA (Stomach diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported. The reporter reported that her friend received Moderna vaccine and she experienced stomach diarrhea as one of the side effects, which lasts longer than they expected.
1ST DOSE: 004M20A 2/1/21 MODERNA 2ND DOSE: 023M20A 4/2/21 MODERNA 3RD DOSE: 020B21A 4/30/21 MODERNA  PATINET GOT THREE DOSE OF MODERNA.
Initial unsolicited report received from other health professional on 03-Aug-2018. This case involves a 16 years old male patient who was vaccinated with 0.5ml suspect MENACTRA, Batch number: U5948AB, expiration date: 02-Jul-2019, route intramuscular and site of administration right deltoid (dose was not reported) on 03-Aug-2018 and on 27 Jul 2018. The patients medical history was not reported. Concomitant medications was HEPATITIS A VACCINE on 23-Jul-2018. It was an actual medication error due to extra dose administered. Patient is not experiencing any adverse reactions at the moment. It has been approximately 45 minutes since the vaccine was administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Red rash on bilateral arms, no acute distress. Patient was given Zyrtec 10 mg PO. Watched for additional 15 minutes. Patient was discharged home.
7/6/2021: Hemoptysis, ringing in ears, felt like fainting, shortness of breath -- Right Lower Chest Pain -- EMS called 7/7/2021: ER evaluation showed Acute Pulmonary Embolism --- > Admitted to hospital--- > IV Heparin --- > Xarelto. Also IV Rocephin + Azithromycin. Blood Cultures Negative x 2. EKG Sinus tach 103.  Light Hemoptysis continued x 3 days. Venous Duplex Bilateral Lower Extremities Negative for DVT.  7/10/2021: Bilateral Upper  Extremity Venous Duplex Negative.  7/12/2021: Discharged Home