chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 24-NOV-2015 at time- 17:34, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.0 and 1.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
I felt tired and pain at the injection site the day after the shot.  This lasted for 24 hours.  Then 5 days later I began suffering from vertigo (lightheadedness, dizziness) and also exhaustion.  It has been intermittent for 12 days.  I am beginning to feel better now, but still feeling more exhaustion than normal.
This spontaneous report was received from a physician, via company representative, referring to an 84 year old patient, of unknown gender. Medical history, concurrent conditions and concomitant therapies were not reported. On 30-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M037669, expiration date 09-MAY-2018, for prophylaxis (strength, frequency, dose, route and lot/batch number were not reported). On 01-DEC-2016, the patient sought medical attention by calling to the office and spoke with unspecified nurse to report that since unknown date he experienced redness, swelling and warmth at he injection site. At the time of the report, the outcome of the adverse events was unknown. The causality between the redness, swelling and warmth at he injection site and therapy with PNEUMOVAX 23 was not provided. Additional information has been requested.
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 23-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Narrative:  Admission: fully vaccinated, COVID positive admitted with CAP/COVID pneumonia, passed away during admission. Patient passed away 1/13/22 due to hypoxic respiratory failure reported as secondary to COVID pneumonia.
Shortly after the client received the 1st dose of the Moderna vaccine, she complained of itching andwas noted with redness to the forearm, neck, and face.  No acute respiratory distress was noted.  She was administered Benadryl 50mg PO, 911 was notified, and she was transported to the local hospital.
Right pinky went numb and is still experiencing numbness. Right arm numbness in hand and blockage feeling in upper arm close to bone.
5.5 x6cm  erythematous patch with similar sized inudurated mass @ injection site.
9/12/12 started coughing; 9/13/12 runny nose and sore throat; 9/14/12 chills, no fever; 9/16/12 @ 5PM difficulty breathing, dizzy, headache; 9/17/12 seen by MD, put on prednisone, nebulizer, ventalin inhaler-MD diagnosed asthma; 9/18/12 taken to ED, given nebulizer treatments and prednisone injection; 9/20/12 brought to ED- given penicillin and cough medication.
Redness, swelling, warmth and tenderness at injection site and from shoulder to elbow, width approximately, 8cm wide; within 24 hours of vaccination.
24 hours post vaccine developed fever (101); Nausea; lack of appetite; muscle aches (entire body); Fatigue; This is a spontaneous report received from a contactable health care professional, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FR2613) via an unspecified route of administration in the right arm on 19Mar2021 at 16:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to sulpha. The concomitant medications included losartan (MANUFACTURER UNKNOWN), felodipine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), CRESTOR and CARVIDEX; all for unknown indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was tested for COVID-19, but the result was unknown. On 20Mar2021 at 16:00, the patient experienced fever of 101 (units unspecified), nausea, lack of appetite, muscle aches (entire body) and fatigue. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with TYLENOL for the reported events. The clinical outcome of the events fever, nausea, lack of appetite, muscle aches and fatigue were resolved on an unknown date in Mar2021. No follow-up attempts possible. No further information expected.
Case number PHEH2014US020737, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 39 year old male patient. His medical history and concomitant medication was not reported. Nurse stated that the person who opened the cooler stated that the gel packs were still mushy, but temperature unknown. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 0403201A) 0.5 ml intramuscular on 03 OCT 2014 (6 days later than supposed to get). No adverse event was reported. No further information was provided.
Approximately 5 min after vaccination, pt reported weakness, nausea, and dizziness. Pt was standing and instructed to sit. Pt then laid down with knees elevated as she appeared pale. Distal pulses were found to be weak and barely palpable. Pulse oxymeter did not read and BP was taken, found to be 97/54 and HR 57. Emergency call was recommended due to paleness and difficulty in palpating HR, however pt refused and stated "I'm starting to feel better." Pt was monitored in supine position for the next 15 minutes. BP slowly trended up , found to be 112/69 HR 71 after approximately 4 minutes. Pt was able to sit up, provided with oral fluids and snacks. Pt continued to be monitored in this position w/ BP slowly rising to over 123 systolic after 10 minutes. Pt skin now appeared rosy. Pt was able to stand up and sit in chair and again BP and HR continued to return to expected parameters. Pt was told to continue recline on way home and not to drive. Pt did have a driver present. Pt told to call Emergency or drive to nearest emergency room if symptoms return.
He received MenactRa in left arm and seemed ok. Immediately after Receiving bexsero in Right arm, he turned pale and became unresponsive, followed by tonic-clonic jerks of arms + legs he was laid down on table - Episode lasted ^10 seconds. He recovered after about 30 minutes - vital signs consistent with probable vasovagal reaction. Similar events have occured to other Family members. Don't think it was due to vaccine but due to injection itself.
Rash Narrative:  Patient alerted the Covid Team/nurse she noticed a rash centrally located on her belly and her back. She states there is some mild redness and slight itching, denies any hives. She denies any pain or warmth to these sites. Suggested to patient she take benadryl to help resolve these symptoms. Patient voiced an understanding and advised patient to call with any questions or concerns. patient voiced an understanding.
Vaccine given on 11/1/16 patient presented to pharmacy on 11/19/16 with red raised rash on back (lower) said slight difficulty breathing (not in distress) was advised to go to ER. Pt returned 11/20/16 with prescription for medications for antiviral.
5 day hospitalization for severe, first-ever pancreatitis. Pt was on Ortho Evra, and had recently - 5/23/08 - completed GARDASIL series. 8/4/08-records received for DOS 7/2-7/7/08- DC DX: Acute pancreatitis possibly secondary to hypertriglyceridemia. Mild iron deficiency anema. Obesity. Protein malnutrition, fevers, elevated inflammatory markers resolving. Dyslipdemia. C/O one day history of severe abdominal pain.
it was rpt fr RN concerning a pt who was vax & subsequently pt presented in ER w/105f & body aches. pt treated w/OTC analgesics
This spontaneous report as received from a pharmacist refers to a 75 year old female patient with mild hypertension. Patient with no drug reactions or allergies. On an unknown date (years ago when it first came out) the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported) for vaccination. Concomitant therapies included atenolol. Pharmacist stated that patient came to the pharmacy on approximately 29-OCT-2013 (one week ago, the end of October) with a very light rash on the abdomen, around the side and up the back. Pharmacist noted that the rash had no blistering or oozing. Patient was diagnosed with shingles by her primary care physician. Pharmacist reported that patient was prescribed ZOVIRAX ointment and gabapentin 300 mg three times daily for the postherpetic pain. Pharmacist reported that the patient said this did not work for the pain and her primary care physician increased the dose of gabapentin to 600 mg three times daily and additionally added on an unspecified non-steroidal anti-inflammatory drug (NSAID) therapy. Pharmacist reported that patient stated that this has provided more relief, but not completely. Pharmacist reported that the rash has faded quite a bit. On an unknown date the patient sought medical attention and was prescribed with treatment for the event. No lab diagnostics studies were performed. The outcome of the event was reported as recovering/resolving. Additional information has been requested.
Swelling of the lymph nodes in the left arm and axillary area. Extreme fatigue. Fever of 101 on March 6 for approximately 12 hours. Bone pain. Severe headache.
Stroke affecting right arm and leg. TPA administered in ER less than one hour later. One week in hospital during which a carotid endarterectomy performed on left carotid artery.
Day of vaccinations he had a small red knot under his leg that went away. Two weeks later (now) the knot has returned and continues to grow in size. It is very red and my son winces when it is touched. It appears to be very tender and bothersome. He will not sleep on that leg. He generally sleeps on his side. I believe it has been affecting his attitude as he has not been acting well since the knot has returned.  Treatment: Took him to see his primary doctor, and dismissed the spot as nothing to worry about.
covid positive. symptomatic; covid positive. symptomatic; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Oct2021 (Lot number: EW0217) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing), notes: other medical history: no. Concomitant medication(s) included: LO LOESTRIN FE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Feb2021, when the patient was 31 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 19Jan2021, when the patient was 31 years old, for Covid-19 immunization.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Dec2021, outcome "unknown" and all described as "covid positive. symptomatic"; IMMUNISATION (non-serious) with onset 06Oct2021, outcome "unknown", described as "dose number=3". The event "covid positive. symptomatic" and "covid positive. symptomatic" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: Allergies were reported as none. Other medical history was reported as none. There were no vaccine in four weeks. No covid prior to vaccination.  No follow-up attempts are possible. No further information is expected.
2" x 3" injection site local reaction. Slightly raised and light pink. Patient reports sore to the touch 2 days after injection.
Sore arm dull ache for four days after injection. Chills off and on, body aches and gets hot intermittently, flu-like symptoms, little energy. 11/28 and 11/29 sweated heavy, stomach cramps. 11/29 and 12/1  unable to eat.  12/3 feeling better.
10-15-08 light fever 99.7 then starting around 11pm chills & fever 103.1 with body aches. 10-16-08 1:00pm seen by nurse red, swollen, warm & tender to touch approx. 6 X 9 cm area on upper left arm, temp 99.7 and advise to take ibuprofen and place cool packs to arm. 10-17-08 11am fever resolved, tenderness & redness resolving, no body aches
Patient reported tremors of hands (shakes) 3 days post-injection.  One month post-injection had an "episode" of severe shaking & tremors "like a seizure" and speech and gait were affected also (11/20/09).
Narrative:  56 y/o male with history of seizure disorder received second doe of COVID-19 vaccine on 1/28/21 while impatient. The following morning, he told nurses he felt like he had a seizure in his sleep. The nocturnist witnessed an active seizure later that morning, and the patient was transferred to the ICU. A total of 5-6 seizures were documented that morning. According to his chart, he also has a seizure following his first COVID-19 vaccine. Of noted, the patient has had multiple intermittent breakthrough seizures during his hospitalization since being admitted back in 9/2020.
About 14  days after the first vaccine dose  ( Pfizer)  patient presented to the ER with severe chest pain. He was sent home after labs, EKG and CT chest were reported as normal. He was told that he had a hiatal hernia. One week later he was found by his wife expired in his bedroom late morning. Patient had no medical problems such as hypertension and never smoked. He was very active  and played sports such as pickle ball.
Information has been received from a consumer regarding his 21 year old son with dystonia and no allergies who on approximately 22-OCT-2007 "two weeks ago" was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included VALIUM, baclofen, BOTOX and bromocriptine. On approximately 23-OCT-2007 "within a day or two after receiving the vaccine", the patient experienced improvement with his dystonia. It was also reported that he had shown improvement when he has taken treatments for pneumonia as well. No diagnostic laboratory studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
glassy eyed-malaise 8/14/99 evening;6AM T101.2, aches, malaise 8/15/99;8/16 fever nl-malaise;8/24/99 pt had no further problems;
Fever, achiness, high mental and physical fatigue, night sweats, elevated respiratory and resting heart rate lasting approximately 10 days after Pfizer booster dose.
Paralysis of left side of face .Drooping eyelid. Cannot shut the eye. Mouth is crooked.
From initial information received on 10/01/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 40 year old female patient received her first dose of Fluzone, lot number U1141AA, expiration date 06/30/04, administered in the left deltoid on 9/29/03. 24 hours later, the patient developed a 3.5 x 6 cm oval red area, which was sore and had mild itching. She was prescribed Atarax for the itching and cool soaks. Reportedly, the patient stated that she was light headed and felt groggy. The patient's recovery status was not reported.
28 Sep2021 - going up/down the stairs. After the vaccine, I felt mild tightness on my chest. I felt like in was in my mind. I felt a little nauseous after I took a sip. After 30 mins when I reached my home, my body was heavy. Went my stairs and my heartbeat started increasing. It was so bad that I had to sit. It was a weird sensation and called 911. I never experienced this in my life. They asked my to count my heartbeat. The paramedics came 116 was high heartbeat. Was told to stay calm and they checked my vitals and wanted to take to the ER but didn't want to go unless it was necessary . Extremely out breath and fatigue . I was scared to go to sleep. That night, I was breathless and I couldn't eat and lay down. I took my asthma meds - Symbicort and felt better. I had to lay down a lot. The next day, I had my feet elevated, when I put my feet down and there was a pain in my chest like little pins. The next day, the heart palpitated out of control. I called my doctor and on Monday they told me to go ER. D- dimmer test for blood clot was elevated. Contrast test. They couldn't do anything. I saw my cardiologist and he said I was ok. Till the 11th day, was went I felt better. Then my mensural cycle, I was having spotting after my period. 9Oct2021 I was clotting. On 17Oct2021, I was spotting straight and having cramps and bleeding. This bleeding lasted for 5 days. I just stopped and I am clear for the first time. The PHP said to hold on till my cycle is better. I am scared to take the 2nd dose.
I began experiencing dizziness shortly after the vaccine was given.  I felt dizzy while driving at full speed.  I have taken antivert and the valium 2mg and they don't help.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On 23-DEC-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported). The pharmacist reported that on 23-DEC-2013, the patient had an immediate injection site reaction. The site of injection swelled and then bruised. The outcome of site of injection swelled and site of injection bruised was reported as not recovered/not resolved. Additional information has been requested.
My first vaccination was given at Medical Center, on 1/27/21.  Medication was Pfizer, Lot # EL3302.  At time of scheduling I was told that I could get my second vaccination at facility, which was  about 50 miles closer to my home.  The scheduler verified that facility administered both Pfizer and Moderna vaccines.   On 2/16, when I reported to facility for my second shot, I reminded the intake person and the one who escorted me to the vaccination station that I needed the Pfizer vaccine, and was told by both people that  Pfizer was in the record and that I would receive that vaccine.  The person who escorted me to the vaccination station brought the syringe to the vaccinator, who asked me my name and date of birth, administered the shot, and handed me the post-administration paperwork.  While seated in the waiting area I read over my paperwork and reviewed my dosage record card and discovered, that I had been  given the Moderna vaccine., against the CDC guidance and without prior notification to or authorization by me.  I have subsequently experienced shortness of breath, an unusually high level of  nasal congestion, nad a serious lack of energy.  These symptoms began about 72 hours after the second vaccination.
Inj. site red, hot and had a "purple like" sore that broke and drained pus like drainage. Area was a little better but now red and warm again. Area has been bothering Pt since receiving vaccine. Past 2-3 days hot to touch, developed white head, picked it a green and white drainage.
16 hours after receiving Hepatitis B vaccine booser for employment, awoke with fever (102.5 F) chills, malaise, dizziness, body aches, paresthesia fingers and toes.  Treated in ER and received Tylenol 975 mg, Toradol 30 mg IV, and 1000 mL NSS IV. Discharged to home, feeling better.
Red raised papules noticed on 8/16/12. They looked fluid-filled according to mom. Mom called the client's doctor and is providing comfort care. Fever 100.7.
I felt mostly fine all day.  A little tired and my arm was sore.  About 4:45pm, I started sweating and getting really hot.  I felt like I might need to use the restroom (soon) and I was at the grocery store.  So, I immediately left.  My house is 5-7 minutes from the store.  During this time, I experienced terrible pains in my stomach and lower abdomen.  I barely made it through my door and had to run to my bathroom.  I experienced diarrhea like I?ve never experienced in my life.  It was painful and explosive.  This lasted about 30 minutes on and off.  Mostly on.  Once I cleaned myself up, I was very tired and weak.  I felt nauseous this entire night but have not had any other episodes.  I also have not invested anything except water since this happened.
July 31st I started feeling very fatigued, cough, body aches, loss of taste, runny nose, and diarrhea; on 8/2/2021 I contacted my employer and they told me that another employee that I had travelled with days before tested positive for COVID-19; they required me to get tested before coming to work; I went to where they tested me for COVID-19, and I tested positive; The P.A. prescribed me antibiotics to prevent a secondary infection.
29May90 pt vax;  devel half-dollar size redness & swelling at inject site.  W/in 15 min redness gone.
dizziness finally went away after 8 months but came back after her booster; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness finally went away after 8 months but came back after her booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 004M20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus and Overweight.   On 12-Feb-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness finally went away after 8 months but came back after her booster). At the time of the report, DIZZINESS (dizziness finally went away after 8 months but came back after her booster) outcome was unknown.            No Concomitant medications provided.. No treatment medications provided.   This case was linked to MOD-2021-408505 (Patient Link).
SEVERE HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe headaches was not reported. This report was non-serious.
Patient developed a rash in the inside part of his arm, with slight itching, some redness and swelling, slight warmth to the touch, no fever.
Massive hair shedding of scalp resulting in baldness. Symptoms started on 10/13/2021 and resulted in near baldness in 2 weeks.