chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female (age not reported) with no medical history and no known allergies reported on 15-Dec-2006 (previously reported as being approximately JAN-2007 and 15-Feb-2006), the patient was vaccinated with Gardasil intramusculary (Lot # 653735/0688F). Subsequently, the patient developed a weakened immune system, yeast infection, sore throat, sinusitis and had a rash on her leg that was lasting several days. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007, 4/6/2007. Initial and follow up information has been received. There were no known illnesses noted at the time of vaccination. On approximately 29-Dec-2006, two weeks after vaccination, the patient developed a rash on her legs, lasting two weeks, sinusitis (previously reported to have developed a weakend immune system), a sore throat, and condidal vaginitis. On 26-Jan-2007, the patient had recovered from the events. The patient was seen by her physician when the symptoms had resolved. No further information is availble. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow up information has been received from a physician concerning a 25 year old female with no medical history and no known allergies reported. On approximately 15-JAN-2007 (conflicting information also reported as 15-FEB-2008), the patient was vaccinated intramuscularly with the first dose of GARDASIL (Lot# 653735/0688F). There were no known illnesses noted at the time of vaccination. On unspecified dates, soon after the vaccination, the patient developed a sore throat (previously reported to have developed a weekend immune system and sinusitis). The patient then developed a rash on her legs lasting two weeks and then a yeast infection (vaginitis). On 26-JAN-2007, the patient had reported from the events. No further information is available.
Bad chills, headache, nausea, tired, sore arm, sore injection site, worst reaction of all vaccines taken including all the Covid vaccines I took
Light headed at 10 min. after injection.  than fine.  Sore arm.  Second day:  Consistent headache, neck ache, pain in ears, blurry vision, nausea, numbness in lips, with labored breathing at times. This is the third day with no change.  No treatment at this time.  Still home waiting to see if I need to seek medical assistance.
Chills; Body ache; red dark circle at injection site on next day that was 29Apr2021; I had very bad headache; feeling tired next day after vaccination; fever; all night it goes with hot and chills; My arm was sore on same day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (all night it goes with hot and chills), PAIN IN EXTREMITY (My arm was sore on same day), CHILLS (Chills), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (red dark circle at injection site on next day that was 29Apr2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included CALCIUM and VITAMIN D NOS for an unknown indication.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (all night it goes with hot and chills), PAIN IN EXTREMITY (My arm was sore on same day) and PYREXIA (fever). On 29-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red dark circle at injection site on next day that was 29Apr2021), HEADACHE (I had very bad headache) and FATIGUE (feeling tired next day after vaccination). On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (all night it goes with hot and chills), PAIN IN EXTREMITY (My arm was sore on same day), CHILLS (Chills), PYREXIA (fever), VACCINATION SITE ERYTHEMA (red dark circle at injection site on next day that was 29Apr2021), HEADACHE (I had very bad headache), FATIGUE (feeling tired next day after vaccination) and MYALGIA (Body ache) outcome was unknown.              Patient had cold and sinus infection. She is taking vitamins supplement .    This case was linked to US-MODERNATX, INC.-MOD-2021-064609 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064609:Dose 1
halo in both eyes; spots in both the eye which comes and goes; difficulty for him to see or drive; feels like he is seeing at a bright lights directly; This case was reported by a pharmacist via call center representative and described the occurrence of vision halo in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020).   On 8th July 2020 12:00, the patient received the 2nd dose of Shingrix. On 8th July 2020, 4 hrs after receiving Shingrix, the patient experienced visual impairment and eyes sensitive to sunlight. On 8th July 2020 04:00, the patient experienced vision halo and eye floaters. On an unknown date, the outcome of the vision halo, eye floaters, visual impairment and eyes sensitive to sunlight were unknown.   It was unknown if the reporter considered the vision halo, eye floaters, visual impairment and eyes sensitive to sunlight to be related to Shingrix.  Additional details were reported as follows: The patient received second dose in his left arm at around 12 pm and around 4 pm he started to experience spots in both the eye which comes and goes and also halos in both the eyes which comes and goes. When there were halos in the eyes, it makes it difficulty for him to see or drive, as he felt like he was seeing at a bright lights directly or like seeing the sun directly.  He had this experience on 8th and 10th July 2020. He did not have any halos or spots in his eyes on  9th July 2020. On 10th July 2020, the patient again experienced halos in both the eyes after he did his workout. The reporter did not consent to follow up.
Varicella administered in left upper outer arm - resulting in 3x4 cm tender, raised erythematous lesion; Tripedia administered in right deltoid - resulting in 2x2 tender, raised erythematous lesion
frozen shoulder; pain both knees, hips, arms, extreme weakness; heavy nosebleed while asleep 5NOV92;
24 hours post-vaccine she developed fever, chills, excessive sleeping, and loss of appetite. She went to ED for IV fluids but continues to have this excessive fatigue and loss of appetite. She has not eaten food and has minimal fluids for the last few days. She does have a history of lupus, fibromyalgia, and hepatitis C which is in remission.  PMD consulted but only offered ED visits. We advised an ED visits again if the lack of food and fluids persists.
A non-serious spontaneous report of "H1N1 LAIV was administered to 10 month old" was received from a registered nurse concerning a ten-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 20-Jan-2010 for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 26-Feb-2010 and incorporated into the narrative: gender of the patient received and changed from unknown to male.
Guillian Barre Syndrome; unsteady gait/ difficulty walking; weakness to bilaeral lower extremetie; Fall; This serious case was reported by a consumer via regulatory authority and described the occurrence of guillain barre syndrome in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included congestive heart failure (CHF) and anxiety. Concurrent medical conditions included chronic obstructive pulmonary disease, gastroesophageal reflux, obstructive sleep apnea syndrome (OSA) and nstemi (NSTEMI). Additional patient notes included No known drug allergy. Concomitant products included salbutamol (Albuterol), ipratropium bromide (Atrovent), atorvastatin calcium (Lipitor), citalopram hydrobromide (Celexa), furosemide (Lasix), losartan potassium (Cozaar), omeprazole (Prilosec), metoprolol succinate (Toprol) and warfarin sodium (Coumadin).   On an unknown date, the patient received Arexvy. On 29-SEP-2023, 10 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillian Barre Syndrome) (serious criteria GSK medically significant), unsteady gait (Verbatim: unsteady gait/ difficulty walking), lower extremities weakness of (Verbatim: weakness to bilaeral lower extremetie) and fall (Verbatim: Fall). The patient was treated with immunoglobulins nos (Ivig). The outcome of the guillain barre syndrome, unsteady gait, lower extremities weakness of and fall were resolved.   It was unknown if the reporter considered the guillain barre syndrome, unsteady gait, lower extremities weakness of and fall to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome, unsteady gait, lower extremities weakness of and fall to be related to Arexvy.   Additional Information: GSK receipt Date:09-NOV-2023 The patient self-reported this case. The patient age was in between 65-79 years old. The patient was started with unsteady Gait, difficulty walking , weakness to bilateral lower extremities and fall On 29th September 2023.  The vent onset interval was 10-14 days. The patient presented immediately to ER (emergency room) with listed symptoms.  The patient was diagnosed with Guillain barre syndrome and received IVIG(intravenous immune globulin). The patient had no prior vaccinations for this reported event. The patient did not have any current illness. The follow up would not possible as no contact details were available.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 03-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
COVID Vaccine Breakthrough Case. Patient received the two dose series with the booster dose. Dose 1: Moderna, 047A21A, 03/17/2021 Dose 2: Moderna, 025B21A, 04/15/2021
BRIEF OVERVIEW: Admission Date: 5/9/2023 Discharge Date: May 21, 2023 Discharge Disposition:  skilled nursing facility   5/9/2023 - 5/21/2023 (12 days)   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC)   HOSPITAL COURSE: Patient is a 77-year-old man with a history of coronary artery disease status post CABG, chronic systolic and diastolic heart failure, chronic obstructive pulmonary disease, insulin-dependent diabetes who presented to Emergency Department within lower extremity swelling, productive cough, worsening shortness of breath and chills.  Found to be febrile with temperature of 38.1° , hypoxic on room air saturating about 85% requiring 5 L of oxygen.  Creatinine was at 4.57 along with BNP at 47,233 elevated troponin with delta of 130. Patient was given IV Rocephin and azithromycin along with 500 mL bolus of IV fluids and transferred to Hospital for further evaluation of acute hypoxic respiratory failure and possibly CHF exacerbation and elevated troponin.  Patient's respiratory status got worse in spite of IV Rocephin and azithromycin.  He was extremely wheezy hence treated for severe COPD exacerbation, also was positive for COVID-19 and Metapneumovirus likely as primary trigger for event.  His symptoms significantly got better with scheduled DuoNebs and Symbicort along with Decadron. Overtime patient improved and transitioned to room air.     Due to elevated troponins in 1400s cardiology was consulted, restarted aspirin and statin. Repeat echo did show a drop in LVEF to 30% with consistent wall motion abnormalities. Shared decision was made between Cardiology and patient where ischemic workup was not performed in the setting of significant kidney disease would not want to perform angiography/expose to contrast. Nephrology was consulted, signficant AKI was thought to be secondary to sepsis in the setting of pneumonia rather than CHF exacerbation as he did not appear to be fluid overloaded.  With time kidney function slowly returned to baseline. Since kidney's did improve cardiology eventually proceeded with nuclear stress testing which showed evidence of large infarction, without underlying residual ischemia.
A pharmacist reported that a 12 month old male received his 1st dose of Prevnar, as well as, doses of MMR (Merck) and Varivax (Merck) on 6/13/2000. On 6/16/00, he developed injection site erythema, measuring 2" by 3", at the site of the Prevnar administration. He recovered. The lot number was reported as 171208; however, this is not a valid Lederle lot number.
About 45 minutes after the Prevnar 13 shot in my right arm, I fell to the ground literally screaming in pain on the right side of my body.  Every joint on my right side felt light someone was stabbing me with a sword and ripping my joints apart.  After about 20 minutes of this 'episode' I tried to stand up but my right hip and knee felt like it wasn't there and I fell down.  I tried for several hours to walk and kept falling down.  To this day, 14 months later, I am still in chronic pain in my right hip and it still 'goes out on me' and times and I collapse to the ground.  I can't explain the pain I feel.  If I happen to roll over on my right side in my sleep, a sharp pain rips through my hip.  My right wrist also still hurts and is much weaker than before the shot.
Ecchymotic circular area 5 cm x 5 cm on Right upper arm. No visible swelling, redness or discharge. Patient afebrile.
Patient was experiencing swelling from neck to elbow, shaky hands, dizziness, blurred vision. Was seen at an clinic where she was prescribed prednisone to be taken once if needed.
Myalgia, Arthralgia, Diarrhea, Pain/Discomfort at injection site, fatigue Narrative:
Ischemic Stroke; dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 91-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Sep2021 14:15 (Batch/Lot number: FD8448) at the age of 91 years as dose 3 (booster), single for covid-19 immunisation, administered at Pharmacy or Drug Store.  The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Right), administration date: 21Jan2021, when the patient was 90 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9264, Location of injection: Arm Right), administration date: 11Feb2021, when the patient was 90 years old, for COVID-19 Immunization. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: ISCHAEMIC STROKE (hospitalization, disability, medically significant) with onset 17Oct2021, outcome "not recovered", described as "Ischemic Stroke"; IMMUNISATION (non-serious) with onset 24Sep2021 14:15, outcome "unknown", described as "dose received 3". The patient was hospitalized for ischaemic stroke (hospitalization duration: 5 day(s)). The event "ischemic stroke" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown results. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Patient's family report patient was found unresponsive this morning after being at baseline status when seen yesterday (9/22/21). Per EMS report, patient was hypoxic and improved slightly with supplemental oxygen. Upon reaching the ED, the patient further decompensated and required intubation. he patient is positive for COVID-19. The patient is chronically on dexamethasone 4 mg BID relating to his cancer diagnosis, which has been continued in hospital as an IV medication. The patient is not currently a candidate for either Actemra or remdesivir. The patient's potassium was low and this was replaced in ED. The patient is on a midazolam drip for sedation while ventilated. Patient will be admitted to ICU.
IM injection given in right lateral thigh and SQ IPV. Infant crying very very hard. IM injection given in left lateral thigh of PCV and Comvax. Infant crying even harder.
Intussusception on 10/19/2020, bilious vomiting, fussiness, lethargic, dehydration. Admitted to Hospital 10/20/2020, air enema done and symptoms improved.
10MAR98 pt recv vax;17MAR98 pt described site itching-upon inspection site was raised & red;approx 5cm x 7cm;soft & non-tender to touch;
12/29/2020 vaccination About 2 weeks later, I woke up with both of my hands and wrists hurting .It was to the point where I could barely hold a pen in my hand. No swelling nor redness. It went away after 1-2 days. It came back a couple of days later; more predominantly in my right hand. I would take 600 mg Ibuprofen. The following week, it came back and lasted longer then a day; redness and swelling R hand. I called my Dr. She ordered all this lab work; came back Neg. Meloxicam It went away on R wrist. Came back on my left knee; went away. Then had pain in my L hand joints; no outside welling nor redness. I took the Meloxicam again. I didn't notify the Dr of the knee pain as my lab work was all negative.  The symptoms were for 2-3 weeks. I only too the Meloxicam until pain subsided; not continuous.
Pt received vaccine at clinic at 5pm 3/25/21. During screening process, pt was asked about hx of allergic reaction. Pt reported history of anaphylactic reaction to penicillin in the past. Pt was informed to wait for at least 30 minutes after the vaccination due to potential of anaphylaxis to the COVID19 vaccine. Shortly after patient received the vaccine, pt stated she she felt symptoms at around 5:08-5:15PM and alerted the staff at around 5:20PM. Pt reported swelling of the throat and was given 1st dose of Epipen 0.3mg at 5:24PM. Campus safety was notified at the same time.. Pt reported improvement in symptoms after the first injection. Pt was monitored by pharmacy staff and was given a 2nd injection of Epipen 0.3mg at 5:47PM due to symptoms not being completely alleviated with 1st dose (per anaphylaxis action procedure). Pt reported improvement of symptoms and denied any wheezing, chest or throat tightness, or lip/tongue swelling.  Pt refused further medical care from EMT/ambulance to the campus safety officer on site. Pt blood pressure of monitored every 2 minutes from 5:26 to 5:54PM and left the vaccination site with public health staff. Pt was instructed to follow up with PCP and seek emergency help if symptoms worsen or development after she leaves clinic site.
At 0729AM. Sitting in chair - called out after last shot "ouch" - stopped talking and won't talk- head went flaccid - protected with head down. Recovered quickly mom and dad present. No other problems allow to sit after shots took water. Refused power bar - mom comfort her at 0739 - laughing on mom lap encouraged to call Dr or go to ER if any concerns. 8/16/10 called mom to call if any questions.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 24-APR-2018 and 30-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N030174 and expiration date 13-JUN-2019) orally for prophylaxis, respectively. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Breakthrough case of Covid, sx onset 05/31/2022. I did a home test after day 4 & 5 after close contact with infected person came back negative. Sx began on 05/31/2022 (day 7 after exposure) with congestion, body aches, chills, cough and fatigue, took a home test that came back positive. I was not sure if the cough was from my Asthma. That day I texted my doctor and we did a teleconference visit and she prescribed PAXLOVID. I started the first dose that evening. I was in bed for two days; I was pretty wiped out for two days and then started to feel better. Currently I am doing fine, I feel pretty much back to normal. I still have the cough, but typical for me to have a cough with the asthma. It is hard to decide if the cough is from Covid or asthma.
About 25 minutes after vaccine a pain started at the injection site and went to left shoulder and up the left side of my neck. I had a lot of pain for about 10 minutes. Most of the pain went away about 10 minutes after it started.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 65-year-old female patient received first dose of PREVNAR 13 (lot: W09943), intramuscular on 01Aug2018 at 0.5 ml, single as routine vaccine. The patient's medical history and concomitant medications were not reported. In Aug2018, the patient had site reaction and redness. On 01Aug2018, shortly after administration, the patient became dizzy and pale. She developed a rash at the site on 06Aug2018. Therapeutic measures were taken as a result of rash at the site which included BENADRYL. Outcome of the events was unknown.