chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has asthma - received H1N1 injection, fine for 5 min. Reached car and became faint and c/o headache. (Didn't wait the 15 min prior to leaving) - at 5:55 c/o headache pain a 10 on level of 1-10 and nausea. Recommended he go to ER or walk in clinic. Without SOB, pulse WNL, felt cool to the touch (patient said he felt chilled)
Digestive upset, diareah, headache, developed large, itchy, rash on neck and chest after 3 days
Patient is an 86-year-old male with a past medical history of COPD, GERD, low back pain, T2DM, chronic sacral osteomyelitis, chronic Foley, admitted from a nursing home for acute dyspnea, productive cough, and fever. Patient has been having productive cough for the past few days and chills. In the ED, he was hypoxic with labs notable for WCC 3.2 and Covid positive. Patient is Covid vaccinated in Jan 2021. CXR showed bilateral airspace opacities. Patient was admitted to medicine for management of Covid pneumonia.     Other than Covid, he has had right lower extremity pain around the site of a previous right fibular fracture that was internally fixated.  5 months ago he fell and has been nonambulatory since.  Ortho was consulted and believe this to be a nonunion fracture that is chronic.  There was also a medial malleolar fracture that was also chronic.  Recommend to follow-up with original orthopedic surgeon upon discharge.  Safe for weightbearing at this time.    He has been doing well on 1-3 L of O2.  RPP and urine strep and Legionella were negative. Before he was found to be covid positive Ceftriaxone and Azithromycin were started for community-acquired pneumonia.  ED escalated to ceftriaxone alone.  Plan for total 5 days of treatment for CAP.  He was started on dexamethasone and remdesivir.  Will discharge on Cefpodoxime 200 mg twice daily for a total treatment duration of 5 days.  We will continue dexamethasone outpatient for a total of 5 days of treatment.   His nursing facility was able to take him back to quarantine.  At the time of discharge he was not feeling short of breath and was on 1 L of O2 satting 96%.  Discharge Diagnoses      1. COVID-19   -Dexamethasone and remdesivir  -We will continue dexamethasone at discharge for 2 more days for a total of 5 days of treatment
4 months after the 2nd dose of the Pfizer vaccine, chronic spontaneous hives began. Symptoms: hives, extreme itchiness, angioedema, fatigue, discomfort when urinating. Still taking Prednisone  once a day and antihistamines 2xday for it now. The symptoms are under control at the moment.
Rash, patient also came back on 7/29/15 with another rash on face. Original rash was on legs.
Adverse events:    Chills, shivering, fever, headache  Treatment: Slept for 4 hours, ate and then slept another 4 hours  Outcome:  Subsided
Lightheaded + sl. stomach ache" onset 10:40 am Observed x15 "> OK. T976
Patient received Pfizer bivalent and should have received Pfizer monovalent as this is her first dose.
Unilateral sensorineural hearing loss, sudden onset 9 days after vaccination.  Confirmed by audiography.  Persistent at 8 weeks despite nasal and oral corticosteroids.
Main lingering adverse event is loss of sensation in the median nerve in both hands. Waited over two months hoping it would go away but hasn?t. Brought it up at annual check up with doctor who ran labs and has recommended EMG.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, indication, route not reported) which was improperly stored, although supported. No adverse effects reported. Additional information has been requested.
The patient has a history of COPD, heart failure, emphysema, and Alzheimer's disease. She was brought to the ED by EMS from her memory care unit on 2/13/23. On 2/13, staff noticed left leg swelling and weeping, so called EMS. On EMS arrival, her O2 sats were noted to be low, so she was started on 10L O2 which brought her O2 sats up above 90%. In the ED, the patient also reported chills, bilateral leg swelling, shortness of breath, and tremors. A COVID PCR test performed in the ED resulted positive. She was admitted to the hospital 2/13/23 - 2/20/23. During her admission, she was noted to be in acute respiratory failure requiring high flow O2. She did require restraints to keep her O2 on given her advanced dementia. Ultimately, the decision was made to transition the patient to comfort cares. She was discharged on 2/20/23 to home with comfort care. Of note, the patient is vaccinated against COVID. Her most recent vaccination was administered 10/3/22.
message I sent to Doctor:  bumps on the left side of my cheek next to my ear lobe, I initially thought is was a pimple under my skin . I messed with it, now its extremely sore. About 7 more of these bumps have appeared on my neck (right side) and tonight one near my collar bone on my neck front. They are like bumps under my skin, red/ visible but they have not come to a head like a pimple. They don't itch or necessarily hurt , except for the one I messed with by my ear lobe on my cheek. The are about the size of a pencil eraser head. I did get a shingles shot almost 2 weeks ago when I was in your office these bumps are really weird since they are spreading.  Visited a Physicians Assistant who said looked like shingles; itched when touched but no pain. Not traditional shingles symptom but did follow linear nerve path. PA prescribed ValACYcloviir 1000MB tablet 3x day for 7 days .   Small Blister packs formed on chest near throat and single or small blister packs behind hear and down neck and spine area at hairline.    Visited primary physician 4 days after initial diagnosis who took me off the meds. Said I had developed Celulitis from the bumps and put me on a 2x for 10 day dose of Bactrim Antibiotics.
Healing rash under the armpit area/rash was an 8th of an inch raised and itched a lot; This is a spontaneous case, reported by pharmacist to Agency (Case: SEQ19-04608) and initially retrieved on 14-Oct-2019, concerning a 72-year-old, female patient.  Patients medical history included anxiety and concomitant medications included Lorazepam for unknown indication.  On 27-Sep-2019, the patient was administered Fluad [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF 59, dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 262000 and expiration date: 31-May-2020] for influenza prophylaxis.   On unspecified date, several days after vaccination, the patient reported a healing rash under the armpit area. The rash was an 8th of an inch raised and itched a lot. Pharmacist states it seemed more like where the band aid was removed, not where she got the injection, but the patient was insisting that it was in reference to the shot.  On unspecified date, the patient was seen at an Urgent Care and given an unknown prescription for the rash. The patient had cancelled an appointment with her doctor that was scheduled for 15-Oct-19 as she was feeling better.  On 14-Oct-2019, the patient came in today regarding rash and states it was causing her anxiety.  At the time of follow-up reporting, the patient was recovering from the event. It was reported that the pharmacist did not have further information regarding the event.  The reporter assessed the case as non-serious.  Event's causality was assessed as related to the suspect product per company.  Follow-up reported by pharmacist to Agency [reference number: SEQ19-05431] on 23-Oct-2019: The outcome of the event was still recovering, as the pharmacist did not have further information. Additional Agency reference number added. Narrative amended accordingly.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
I received my vaccine on 12/02/2021. My adverse event started in the middle of August in the evening. I had headaches, low grade fever, and chills. I was sick for a day and half but the next day I was able to do my normal things. I tested positive for COVID-19 on 08/20/2022 since having COVID-19 I always felt sick. I took TYLENOL per needed for my symptoms. I lost my voice for 1 week. It  took me 3 and a half weeks to test negative for COVID-19. On 09/15/2022 I contacted my doctor because I lost my voice, she didn't prescribed me any medication. It resolved by itself. After COVID-19 I came down with Pneumonia. On October I contacted my doctor she prescribed me ZITHROMAX Z-PAK and amoxicillin for my Pneumonia. As of today I am still recovering.
Numbness / Numbness in the left hand, described it as decrease sensation in left hand; Paresthesia of left hand, thumb, and index finger; Pain on the injection site (Left Deltoid) after bivalent booster; Chills; Fatigue; Muscle Pain; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (Numbness / Numbness in the left hand, described it as decrease sensation in left hand), PARAESTHESIA (Paresthesia of left hand, thumb, and index finger), VACCINATION SITE PAIN (Pain on the injection site (Left Deltoid) after bivalent booster), CHILLS (Chills) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Sep-2022, the patient experienced HYPOAESTHESIA (Numbness / Numbness in the left hand, described it as decrease sensation in left hand), PARAESTHESIA (Paresthesia of left hand, thumb, and index finger), VACCINATION SITE PAIN (Pain on the injection site (Left Deltoid) after bivalent booster), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle Pain). At the time of the report, HYPOAESTHESIA (Numbness / Numbness in the left hand, described it as decrease sensation in left hand), PARAESTHESIA (Paresthesia of left hand, thumb, and index finger), VACCINATION SITE PAIN (Pain on the injection site (Left Deltoid) after bivalent booster), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle Pain) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On SEP-2021, Patient received first Moderna COVID-19 Monovalent Booster dose of unknown lot number and expiry date. It was reported that all of the patient's previous shots were also Moderna COVID-19 vaccine but did not have the lot number and exact dates. Patient did not report side effects after previous Moderna COVID-19 shots. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-648147, US-MODERNATX, INC.-MOD-2022-648133 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648147:MOD22-024161 (same reporter) US-MODERNATX, INC.-MOD-2022-648133:MOD22-024156 (crosslinked case with same reporter)
Couldnt sleep; Lower back hurt; Her left  arm where she received all 3 shots was sore all three times.; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldnt sleep), BACK PAIN (Lower back hurt) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. TT2643 and TT2643) for COVID-19 vaccination.     The patient's past medical history included Polymyalgia rheumatica and Autoimmune disorder NOS.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Couldnt sleep), BACK PAIN (Lower back hurt) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Sleep difficult, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Couldnt sleep), BACK PAIN (Lower back hurt) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.) outcome was unknown.      Concomitant medications were not reported.   This case was linked to MOD-2021-306205, MOD-2021-306266 (Patient Link).
drooping OF LEFT EYE, twitching, weeping of left eye. Upper eyelid of left eye puffy and red. Chest tightness
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: patient got the shot and started breathing heavy. I told her to stay seated and the mother said lets move and sit over here. During that move she got light headed and began fainting but caught her self mainly.
Client presented to Community Center at his scheduled appointment time to receive his 2nd dose of the COVID Pfizer vaccine. While being processed for 2nd dose vaccination, the client reported that he experienced left arm and left leg weakness and numbness about 10 hours after vaccination. Client admits he received his first Pfizer COVID vaccination to his left arm. Client reports he was asleep and woke up to use the restroom. At that time, the client noticed he had a hard time walking on his left leg. He also noticed left trapezius muscle soreness, but denied any other symptoms at the time of the incident. Client reports he does not recall the time his symptom resolved, but notes he fell asleep and woke up with out any numbness or weakness to left side. Client reports left trap pain resolved after 2 days. He denies following up with PCP.
None. 11/21/07 Patient was given Rotavirus oral vaccine with 10/18/07 expiration date.
Initial and follow-up information has been received from a 63 year old female with allergic reaction to antibiotics, SULFONAMIDE and "others unspecified"  who on 17-OCT-2008 was vaccinated with PNEUMOVAX.  On 17-OCT-2008 the patient received PNEUMOVAX vaccine and right away started feeling sick, nauseous, and felt this tightness around the arm.  The arm became red, painful, very hot and hard to the touch.  The patient did not feel nauseous any more, pain and redness had decreased because of the antibiotics her doctor gave her, but it is still "itchy" and it "burns".  The patient sought medical attention.  Additional information has been requested.
Patient immediately felt pain in her arm and then described feeling "woozy". She was given a quiet place to sit and then lie down. She was given water, juice, and snacks. She felt dizzy and a bit nauseated at times. She admitted to not having eaten anything prior to the vaccine. At 1500, an hour after she received the vaccine she felt like her heart was racing and she reported that the whole right side of her body felt cold. People with her that knew her well stated that she "was not herself". She also reported at this time that she felt like her heart was racing. This nurse recommended, by phone (patient had left the clinic site by this time) that the patient's mother take her in to urgent care or the ED, just to be sure everything was okay. Upon follow up, the patient did not go in but called the ED triage nurse. She was told this was likely a normal response to the vaccine. Patient went home to rest and her mother stayed with her overnight. Today client is back at work- tired and sore but nothing more reported.
pt recv vax & 2wk p/vax pt had a spontaneous abortion;No further details were provided;
Patient inadvertently given 0.15 mL dose instead of required/recommended 0.3 mL dose. CDC contacted and advised to have patient return ASAP to receive correct dose. No adverse affects reported per patient. Patient contacted to return ASAP for repeat of COVID19 (Pfizer-BioNTech) dose #3.
Fever, myalgia, nausea, erythematous nodule for 4 weeks. Occurred post 3rd vax.
Ongoing achiness of left deltoid muscle, the one that received the vaccine.  Pain still present as of exam date 12/29/2009 but slowly resolving.
p/vax pt exp dizziness which persisted @ the time of the report;pt exp a T101.8 & hives;pt given DPH;
Moderna Vaccine given to an unauthorized age group (17 year old).  No treatment needed. No reaction from pt.  Pt. tolerated well.
Arm aches occasionally but more important when i reach to scratch my back it hurts a lot.  It has been almost 3 months since the shot and it still hurts.  It prevents me from washing my back and the pain is excruciating.
After the vaccine my blood pressure has been high everyday for the past month. Recently seen doctor and was prescribed blood pressure medication
patient laid down and never woke up (death NOS); Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional.  This case is linked to case 2020SA350305 (same reporter).  This case involves a 65-year-old female patient who laid down and never woke up (death), while she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Case Detail: Product name was not provided. it was assumed that the consumer was referring to the Sanofi flu vaccine.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  It was unknown if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented case involves 65-year-old female patient who died (death) after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient laid down and never woke up (death NOS)
Normal period ended on Friday 10/29/21, got first dose of shot Monday 11/1/21 and heavy period arrives 11/3/21.
10:00 am next day - light headed, 1:00 pm Fever 100.5, Body aches, Fatigue.  7:00pm Fever 100.8, Body Aches.  11:00pm feeling better 8:00 am on the 27th normal temperature of 98.3.  Entire upper arm sore
stuffy nose; body aches; sore throat; swollen glands in the throat; general not feeling well; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL-9265), intramuscular in left arm on 04Feb2021 at 04:30 PM at single dose for COVID-19 immunization in pharmacy or drug store. Medical history included penicillin allergy. Concomitant medications included bupropion, buspirone and several different vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL-1283) in left arm on 14Jan2021 at the age of 42 years for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced stuffy nose, body aches, sore throat, swollen glands in the throat, general not feeling well on 05Feb2021 at 05:00 AM. No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Diarrhea after 3 days. Will report again if symptoms get worse. This needs to be documented, especially if it's more common than original research.
Received flu shot at approx. 1115 AM on 10-5-2018. At approx. 815 PM that evening, I got shaking chills, my "skin hurt", achy all over body and low grade temp of 100.0. I took ibuprofen 600 mg and fell asleep. I woke up at 215 AM with fever of 104.6. Could hardly walk, severe headache, dizzy and my fingers felt numb. Took TYLENOL 1000 mg and laid on couch. Boyfriend checked on me at 530 AM and fever was down to 103.8. Took additional 600 mg of ibuprofen and stood in a cold shower. I did not want to go to ER, so I went back and laid in bed. Woke up at 9 AM completely drenched and fever down to normal at 98.3. Felt fatigued and weak x 24 hours, but no further elevated temperature. Should have went to ER, but I honestly felt too ill and they would have told me to take the ADVIL and TYLENOL.
Left leg swollen, mild redness on medial lower area, non-tender from hip to knee with limping noted. Treated with cold compresses and instructed to return if worsened or increased signs and symptoms. Was seen later in PM in clinic with increased swelling and partial blanching. Added Prelone 1 tsp X 2-3 days. Has an appointment for recheck.
Patient called pharmacy at 8:15pm on 12/7/18, stating he is feeling burning sensation when urinating and when he want again, he urinated blood. He asked if it could be related to Flu vaccination done at the pharmacy today at around 4pm. I asked if he had experienced this before, he said no, but had urinary infections before. I told him that I never came across or heard of a vaccine causing that, but he must seek medication attention ASAP.
This spontaneous report was received from a registered nurse and refers to a 13 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # reported as M010476 with expiration date of 01-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 66 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Woke up with extreme pain and burning sensations in left ankle and foot. Almost could not move it.  Lasted about an hour on and off.
A week after I received my second moderna shot, I had some spotting. The next day I was bleeding as if my period had started, although heavier than usual. This comes a little over a week after my last period. The flow has been a lot heavier that normal.
This spontaneous report was received from a  medical assistant concerning to a multiple unspecified patients of unknown ages and genders. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # reported as 1007226, expiration date 09-MAY-2017) (routes, anatomical locations and doses were not reported). Co-suspect therapies at concomitant medications were not provided. No adverse effect was reported. Lot # 1007226 is an invalid lot number for vaccinated (Oka/Merck VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received JJ COVID 19 vaccine  and had a syncopal episode 2-3 minutes later that lasted for 2-3 seconds. She complained of pain back of head and was given ice pack. There was no visible or palpable injury. She was brought to medical; observation area, VSS. She was monitored for 35 minutes and left ambulatory and asymptomatic with a friend.