chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider:MD Primary Care Provider: MD Admission Date: 9/26/2022 Discharge Date: 10/4/22  PRESENTING PROBLEM: Shortness of breath [R06.02] Cough [R05.9] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 73-year-old male with a history of chronic obstructive pulmonary disease, myeloid neoplasm, BPH, GERD, peripheral arterial disease and prior COVID infection who presented with right-sided chest pain and dyspnea.  Patient tested positive for COVID in early August and had completed a course of PAC Slo-bid. In the ER he was found to be tachypneic and hypoxic requiring 2 L of oxygen.  COVID-19 test was positive.  Chest x-ray showed increased bronchial thickening in the posterior lung bases which could represent inflammatory or infectious bronchitis.  CT chest was obtained that showed severe emphysema as well as nodal a past Cities in the right upper lobe with central cavitation which could be infectious or inflammatory. It was felt patient had acute hypoxic respiratory failure secondary to COVID-19 pneumonia and there was also concern for secondary bacterial pneumonia.  Pulmonology was consulted and patient was started on remdesivir and Decadron.  He completed 5 day course of remdesivir.  Also placed on ceftriaxone and azithromycin and completed a 7 day course. Fungal studies were negative, TB screening indeterminate. Patient then developed worsening hypoxia with increasing oxygen needs.  He was placed on scheduled nebs as well as Symbicort and Spiriva.  He was placed on Solu-Medrol and once his respiratory status had improved, he was transitioned back to dexamethasone. Oxygen needs decreased and he was only requiring 1-2 L of oxygen. As D-dimer was elevated, lower extremity Dopplers were obtained which did not reveal any evidence of DVT Patient did have leukocytosis but had elevated WBC at baseline due to his underlying myeloid neoplasm.  Hematology was consulted and they noted that there was no transformation to acute leukemia and no indication to start inpatient therapy.  As WBCs did increase to over 100, he was given 1 dose of Hydrea 1000 mg and white coun did improve to 96.76. Pulmonology recommended that patient complete a total of 10 days of dexamethasone. Patient was weaned off oxygen to room air.   Patient was seen by pulmonary rehab and was not felt to require oxygen therapy. He was to be followed by Medical Group bridging Older Adult Care program after discharge.   Patient discharged home in stable condition 10/4/22.
Vaccine was received on 02/19/21 on her left arm at 11:55am. She said her arm soreness began at 5:00pm that day. The next day 2/22/21 she began to feel fatigue, chills, body aches, headache, and had a fever of 101. On 2/23/21 she is still experiencing a headache and body aches. She treats her headaches and body aches with Tylenol and she said it makes her feel better for about 4 hours.
Woke up in the middle of the night, around 3 a.m.,  with all my joints feeling stiff, most pronounced in my hands.  After getting up several hours later, around 7:30, and moving around the stiffness faded away.
RASH ON CHEST, UNDER CHIN AREA; SHORTNESS OF BREATH; INCREASED HR 109 ETC... DRY MOUTH; ITCHING ARMS, LEGS CHEST, AND FACE.   TOOK BENYDRYL AND ALBUTEROL INHALOR.
anaphylactic shock; Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4645344 (RA).  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
In observation area, patient was experiencing lightheadedness. She stated she was dizzy and nauseous. Patient sat on floor, was given a snack and juice and an ice pack to place on back of her neck. Patient pale, but after waiting in observation area for 30 minutes she regained color and reported that she was feeling better.
Left arm is sore / tender (the arm receiving the shot); Left arm is sore / tender (the arm receiving the shot); This is a spontaneous report from a contactable consumer. A 52-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 20Mar2021 at 19:00, the patient experienced left arm sore / tender (the arm receiving the shot). Therapeutic measures were taken as a result of reported events and included ADVIL. The events had not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event left arm was sore / tender (the arm receiving the shot) was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced a near syncopal event after administration of vaccine. It was reported afterwards that patient had not eaten anything since the previous day, patient was anxious about receiving vaccination, and patient had experienced a previous reaction to another vaccine in this same manner. Patient appeared anxious, pale, and slightly diaphoretic. Patient was on his back on the floor, legs elevated, vital signs obtained. Vital Signs WDL, pulse slightly tachycardic. After a period of time, patient's BP was WDL and pulse was WDL at which time patient was assisted to a sitting position. Patient ambulated out of department and no other interventions
No adverse reaction to FLUBLOK given to 17 year old. Pt was 37 weeks and 3 days on day of administration with EDD of 11/5/2018.
Admitted to the hospital for 5 days after ER visit. Had a heart attack. Was diagnosed with spontaneous coronary artery dissection.
About 4 hours of non stop diarrhea, headache, fatigue, weakness, severe dehydration and chills. Followed my fatigue, weakness, and headache the entire next day.
Patient recieved Rotateq oral vaccine on 9/23/08 and was taken to Emergency Room on 10/20/08 and was diagnosed with intussception 12/11/08-records received for DOS 10/20-10/21/08-DC DX: Acute intussusception. Presented to ED with projectile vomiting, no passage of bloody or mucous stool.
Received H1N1 FLUMIST. After receiving states needed to use bathroom and visitor told me someone fainted in bathroom. Upon arrival, very pale and sitting on floor, responsive, color improving, talking. 3:45 110/50 (R)-110. 4:00 106/50 (L), 86. 4:10 106/50 (L), 80. 4:20 110/50, 80. Walking before leaving building.
Patient received vaccine on 11-13-14. Came in on 11-15-14 with red swollen area on upper lateral arm. Gave BENADRYL, and told her to follow-up. On 11-16-14 looked a little better.
Starting on 1/4/21 he began having a severe headache, extreme fatigue, vertigo and lower back pain. The symptoms lasted about 36 hours.
Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a 18 year old female who on 20-JUN-2008, was vaccinated with the first dose of GARDASIL (Lot# 658558/1061U). The patient was pregnant when the vaccination was given (LMP was not reported). No symptoms were noted. The patient sought unspecified medical attention. Follow up information has been received from the program assistant, who reported that the baby girl was born prematurely on 12-JAN-2009 at 32 weeks of gestation. Birth weight was 4 lbs 3 oz. There was no mention of any birth defects. Preterm labor at 32 weeks was considered to be an other important medical event. The infant's experience has been captured in WAES 0807USA02217B1. No further information is available.
Moderna COVID-19 Vaccine EUA. It started with a sore muscle in my left arm around the injection site on Saturday afternoon that lasted for 24 hours. On Sunday, all I felt was tired. On Monday around 10 am, all of the muscles from my waist down felt like I had done a million squats.  Around Noon, I started to feel nauseous. Around 12:30 my stomach felt upset. By 1:00 pm, I had chills and I felt seriously weak. The gaseousness and chills lasted for a couple of hours. My brain was a bit foggy for a bit around 5:00 pm. As of 9:43 pm, I feel slightly nauseous (about 20%), and my legs are still sore (about 40%). All other symptoms have dissipated.
Area of red raised bumps in the shape of a square directly below injection site with accompanying pruritus.  Onset is not known however, first noticed it 2 days after injection.
Started to have chills around 7:00pm Friday night, then around 4:00am Saturday morning, I got up to use the bathroom and pasted out in the bathroom. My wife sad she heard a loud noise and came into the bathroom to see what had happened. She called my daughter and son-in law to come over and get me up I couldn't move at the time, I must have hit my back and neck because they are sore. Then Saturday night I had sweats all night, today I fell a little better except for my back and neck, I have a doctor's app. Friday. I am concerned about the 2nd shot if the 1st shot did this to me.
Lightheaded, dizzy, feeling of euforia.  At injection site became a blister and burst. Leftscaron arm. On face a large red circle appeared. Was rough to touch. Did not blister. Has not completely gone away or has the swelling. No medications prescribed helped.  Have pics I took.
Began itching lower legs (below knees) with raised red bumps. Legs (below knees) also red. Pt. continues to have sxs. Seen by MD 11-6-12 given SINGULAIR & LOTRISONE Cr. Itching more at night. Better since using meds. Pt states had some sxs after last years flu vaccine. Pt could not remember where he got his flu shot at last year.
Very minor swelling of my nose along with some redness.  No pain or shortness of breath.  Symptoms dissipated with 24 hours.
Trouble sleeping; Noticed balancing problem; Not feeling steady during walking; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Trouble sleeping), BALANCE DISORDER (Noticed balancing problem) and GAIT DISTURBANCE (Not feeling steady during walking) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01SL20A and 012M02A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced INSOMNIA (Trouble sleeping), BALANCE DISORDER (Noticed balancing problem) and GAIT DISTURBANCE (Not feeling steady during walking). At the time of the report, INSOMNIA (Trouble sleeping), BALANCE DISORDER (Noticed balancing problem) and GAIT DISTURBANCE (Not feeling steady during walking) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Reporter's contact information email id  was added.Events like noticed balancing problem,not feeling steady during walking was added.Date of second dose vaccine was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
red, itching, wheel at site of injection, warm to touch, treated with Benadryl gel, symptoms lasted x1 week. observed upon waking up in the morning of 6/1/08.
Persistent, loud  ringing in both ears for 24 hours, transitioning to  hissing in both ears. To date, has lasted  more than five weeks with no  indication of easing.  No prior history of tinnitus.
Mom called - pt has red, raised rash around injection site, pt c/o itching notified to use TYLENOL & BENADRYL prn.
This study case was received from the investigator in a trial on 28 August 2013. A 30 year-old female subject with a no past medical history had received on 15 October 2012 a ACAM2000 (lot number, route and site of administration not reported), a Typhoid vaccine (manufacturer, lot number, route and site of administration not reported) and an Anthrax vaccine (manufacturer, lot number, route and site of administration not reported) and on 23 October 2012 was found to have palpitations. The subject also reported headache and lymphadenopathy with a start date of 17 October 2012. On 24 October 2012, the subject had a Troponin I of <0.10 ng/mL and a normal ECG. No further information was available at the time of the report. The subject's outcome was recovered 23 October 2012. According to the investigator the event of palpitations was possibly related and the severity of the event was mild. Documents held by sender: medical records.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-healthcare Professional. This case involves a 58 years old female patient who received FLUZONE HIGH DOSE instead of FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 18-Oct-2018, the patient received a dose 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ010AC via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration, Wrong vaccine administered and Overdose accidental. No adverse event was experienced. Reported as has not reported any reaction or adverse effect and has not had any treatment. 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 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.
This spontaneous report as received from a medical assistant via poison center refers to a 18-year-old male patient. The patient's concurrent conditions, medical history, past drug history and concomitant medications were unknown. On 24-OCT-2016, the patient was vaccinated subcutaneously with the one 0.5 ml dose of PROQUAD (lot # M029595 with expiry date on 10-DEC-2017), for prophylaxis (reason for use reported as "vaccination") instead of prescribed one dose of M-M-R II. It was unknown if the patient had any previous varicella vaccination. According to the medical assistant's knowledge, the patient did not have any adverse effects after receiving the PROQUAD. Relevant laboratory data was unknown. Additional information has been requested.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 05-APR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
- Vertigo and nausea following injection. - Lasting 1-2 hrs.
Patient was having shortness of breath.  He came into the pharmacy and asked if it could be a side effect of the Moderna booster shot.  I instructed him to go to the emergency room now.  The hospital diagnosed him with a pulmonary embolism.   He has multiple clots in his lungs.  The hospital started him on a heparin drip and was sending him to another hospital.
Narrative: Nausea, vomiting, diarrhea and headache after COVID-19 J&J vaccine
A non-serious spontaneous report of severely ill has been received from a health professional concerning a five-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST in 2010. In 2010, the patient ended up severely ill for three days after receiving FLUMIST. The patient was not hospitalized. The outcome of event severely ill was resolved.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Joint Pain-Severe, Additional Details: shooting pain in left knee lasting 10 days; felt like a pulling while trying to run or walk; when first awaking, whole "knee exploded in pain", got better slighlty but sore all day
10/3/15 had immunization at retail pharmacy. 10/5/15 came into pharmacy and described having pain and stiffness going from site of injection up arm, across shoulders and up neck; pharmacist called covering MD who verified no red line from injection site and gave pager # if needed and advised ER if condition worsens. Pt iced and took acetaminophen and reported continuing improvement/complete recovery.
pt recv vax 22OCT96 & 23OCT96 pt devel vomiting & diarrhea w/o fever 48hr p/vax;Pharmacist related other pt exp v,d who did not recv vax;
Caller says he took his 4th Pfizer covid shot with the flu shot on 14Nov2022; Caller says he took his 4th Pfizer covid shot with the flu shot on 14Nov2022; he experienced the most horrible bitter, sour, salty taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 14Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation complete, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Nov2022, outcome "unknown" and all described as "Caller says he took his 4th Pfizer covid shot with the flu shot on 14Nov2022"; DYSGEUSIA (non-serious) with onset Nov2022, outcome "not recovered", described as "he experienced the most horrible bitter, sour, salty taste". The event "he experienced the most horrible bitter, sour, salty taste" required physician office visit. Therapeutic measures were taken as a result of dysgeusia.  Additional information: Caller said he just spoke with someone from Pfizer, a pharmacist, regarding the adverse event he experienced and was directed to call this number for questions. Caller said no reportum number was provided to him. He took his 4th Pfizer COVID shot with the flu shot on 14Nov2022, one and a half or two days later caller says he experienced the most horrible bitter, sour, salty taste (which caller rates was 10 out of 10 and was more leaning to a salty taste). Caller said that it had not gone away and that it was going to 5 weeks at the time of reporting. He already went to his HCP was prescribed Amoxicillin for 10 days after he was prescribed with another antibiotic with steroids for another 10 days but it did not work. Caller at the end of the call demanded that someone higher up call him to talk to him about this and if other patients have reported this as well. Caller said he was perfectly healthy other than what he experienced.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Itching, rubbing, nausea, dry heave, stridor, heavy breathing, cough, swelling of uvula  Given Benedryl - Patient declined EpiPen, EMS and ER. Remained tired and itchy for the rest of the day.
5 days after vaccination, I woke up to two swollen eyelids and some swelling under the eye. with itchy hands, fingers and palms and elbows. No visible insect/spider bites, not itchy, no moisture or discomfort with both eyes. No known changes in diet, only change that occurred was new use of an Eyeshadow/makeup place on both eyelids. Swelling in eyes lasted 3 days with gradual decrease in swelling, itchy palms, hands and elbows persistent for those three days, Benadryl helped ease itch.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ for prophylaxis (dose and route of administration were not reported). Reporter was unsure which lot number was administrated M016238 with an expiration date 07-DEC-2017 or L010126 with an expiration date 22-JAN-2017. Administered doses of vaccines experienced the following temperature excursions: on 15-DEC-2016 of 11 degrees Celsius for 4 hours 13 minutes, on 16-DEC-2016 of 11 degrees Celsius for 9 hours 20 minutes, on 29-DEC-2016 of 11 degrees Celsius for 3 hours 37 minutes, a total  temperature excursion was 17 hours 10 minutes cumulative hours in more than 8 degrees Celsius and less than 25 degrees Celsius. Data logger was involved. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005205: US-009507513-1701USA005206: US-009507513-1701USA005207.
MMR administered on 8/9/10. (R) Inguinal Reactive lymphadenopathy noted on 8/14/10. Treated with cephalexin for 5 days. Noted mild limping on 8/30/10. Resolved by 9/29/10.
large red area lt deltoid region, baseball size, sl swollen, warm to touch (not hot);father noticed the area 3MAY96 AM;brought to clinic 5PM to be checked;mom told to apply warm compresses;