chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is ex-23 weeker with hx of seizure disorder received influenza vaccine on 10/14 and approximately 1 hour later starting having a seizure; the seizure lasted 5 hours and persisted despite multiple AEDs (Ativan, fosphenytoin, phenobarbital, Diastat). The seizure was consistent with his previous seizures but had an additional element of "whole body stiffening." He normally seizes approximately once every 1-2 months. Was apparently afebrile at the outside hospital, though he developed a low-grade fever the day after the seizure.
3 x 2 cm local central 3-4 red area with loss of skin on right leg. Right thigh circum 24 1/2 cm. Left thigh circum 23cm.
Began day after injection/administration. Shooting pains throughout her body, feeling of heaviness, fever x4 days. Heaviness lasted x4 days, and then felt off balance x2 weeks. Feeling of tingling in her feet.
Headaches, low grade fever, exhaustion, chest palpitations, shortness of breath, depressive episode.
pt recvd vax & c/o localized redness & swelling @ inj site
The day after both vaccines were injected in my LEFT arm, I have had (nerve?) pain at my elbow.  It radiates to my hand/fingers.  I have much difficulty with movement, grabbing objects/lifting objects, and dull constant pain when not doing these activities.  Sleeping is difficult as I wake up in pain while shifting in bed.  This pain is constant and makes everything (daily activities) more difficult.  There was no injury sustained at my elbow prior to, or after, injection  The person injected both vaccines in LEFT arm (one appears to have gone into a muscle other than the deltoid, as she decided to inject lower on my arm - halfway between shoulder & elbow...the other one was 1-2" above this site.  When injection took place in this area she told me my arm "spit" out the vaccine.  No pain out of the ordinary at time of injection. I took picture of bruise on my arm of lower injection site (9/13/22).
fainting sensation; disoriented; haziness in vision; anxiety; claustrophobia; light-headedness; headaches; cloudiness; cold; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a male patient (colleague's brother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced fainting sensation, disoriented, haziness in vision, anxiety, claustrophobia, light-headedness, headaches, cloudiness, cold. In line with this, reporter would like to know if this side effects were reported and if it will go away. Outcome of all the events was not resolved.  Follow-up (29Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951344 Same reporter/ drug/ AE, different patient
Site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen; Site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen; Site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen; Site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen; Site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), via an unspecified route of administration, administered in the left arm on 23Feb2021 08:30 (at the age of 42-year-old) as single dose for covid-19 immunisation. Medical history included anemia, jaw trismus, anxiety, migraines, and latex allergy; all from an unspecified date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not have covid prior to vaccination. Concomitant medication included celecoxib (CELEXA [CELECOXIB]). There were no other vaccine in four weeks. On 03Mar2021 at 16:00, the patient experienced at the site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen. The patient took unspecified over the counter antihistamine. The patient was not tested for covid post vaccination. The patient had not recovered from all the events at the time of the report.     No follow-up attempts are possible. No further information is expected.
Engerix B was administered from a expired vial; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 30th September 2021) for prophylaxis.   On 4th October 2021, the patient received Engerix B. On 4th October 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a dose of Engerix-B was administered to a patient from a vial that expired on 30th September 2021. The pharmacist did not have patient information or vaccine lot number. The pharmacist did not provide contact information. The reporter did not consent to follow-up.
Around 0855, patient stated she was having tingling on tongue and didnt feel well. Gave 25 mg Benadryl po. 0900 pt co tightness in chest. Monitored patient and vital signs until 0945. Pt stated she felt better around 0935. Patient ambulated from clinic without episode
Arm significantly sore for 14 days after shot.  Small lump still present.  Pain subsided on 15th day.
Fever of 100.5; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 16Mar2021 at 14:00, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 11:30 as a single dose for COVID-19 immunisation. On 17Mar2021 at 17:30, the patient experienced fever of 100.5 (units unspecified). The patient didn't receive any treatment for fever. The clinical outcome of the event fever was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Next  Friday morning Right shoulder, all of neck, Right elbow, all hurt and ached badly, and my right hand was completely numb and could not stop my right thumb from twitching.....  then later that night my right hip hurt so bad that I could not sleep.  by Midday Saturday I started coughing ....   went to immediate care on Saturday and didn't have a fever and tested negative for COVID. ....  and Saturday and Sunday was hacking up flem from my lungs missed work on Saturday and Sunday....  Monday and Tuesday (today) still trying to recover with mixed coughing some dry and some coughs productive.
This spontaneous report as received from a pharmacist refers to a 62 year old male patient with cardiac disorder, diabetes mellitus, blood disorder and Guillain-Barre syndrome. On 06-OCT-2009, the immunocompromised patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously in the left arm, lot # M041086 with expiration date on 03-JAN-2018. Other suspect therapies included PREVNAR on 07-AUG-2015, 0.5 ml, intramuscularly in the left arm, lot # UI837AA with expiration date on 30-JUN-2018 and on 05-NOV-2015, 0.5 ml, intramuscularly in the right arm, lot # R73811 with expiration date in May 2018.
Lump in arm, redness, looks like there is a sore in that spot, entire arm is constantly in pain and throbbing
Vaccine time- 1335 S/S onset- 1345 51/F reports SOB, chest tightness and heart racing 10 mins after vaccination. She states it feels like a panic attack. Pt AOx4, Tachypnea, Shallow respirations, speaks in short sentences but able to follow commands. Lungs CTA, heart sounds wnl. Instructed to bring mask down and take deep slow breaths.  BP-140/100, Hr-76, O2-99%, RR-22. 1400- 122/90, Hr-70, O2-97%, RR-18. Denies any symptoms at this time. Lungs CTA, speaks in clear complete sentences. No chest pain. 1415- BP-119/90, HR-72, O2- 96%, RR-16. Pt AOx4, resp even, skin wnl, lungs CTA, ambulates with an even gait, denies any symptoms, chest tightness and SOB have subsided. RN
This case was reported by a consumer via call center representative and described the occurrence of white blood cell increased in a 60-year-old male patient who received SHINGRIX. Concomitant products included FLONASE, omeprazole, Rosuvastatin and lisinopril. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 2 days after receiving SHINGRIX, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was unknown. It was unknown if the reporter considered the white blood cell increased to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The caller was the patient who received a dose of SHINGRIX approximately 2 weeks before the time of reporting. The caller reported that 2 days after the vaccine received, the patient had routine blood work done and his white blood cells were slightly elevated at a value of 15. The patient reported that all other labs drawn were normal. The patient did not have lot number available and was not able to provide phone number for the pharmacy. The patient had denied permission to contact their physician.
The day following the vaccine (Wednesday 4/7/21), I woke up with body aches, a strong headache, feeling quite warm (no fever throughout the day, but I felt quite warm), and felt a lot of fatigue. There were no respiratory symptoms, but many of the body symptoms that I typically associate with a regular cold. I slept for much of the day Wednesday as the course of treatment - no medications were taken.  The symptoms persisted all day, and were essentially gone when I woke up the next day (Thursday 4/8/21).  I had varying levels of pain in my arm, where I received the shot. There was more pain than expected when the needle went into my arm, then all pain subsided by the time I went to sleep on the day the shot was received. The day of the cold-like symptoms there was significant pain at the injection site that persisted through Thursday. All pain resolved by Friday.
client reports having, left sore arm still one week later with left neck soreness. Lethargic, body ache, brain fog, nausea, extreme dizziness.
got rashes on her right arm to her elbow down and also scattered to different parts of her body; This is a spontaneous report from a contactable consumer or other non health care professional (Patient herself). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number: not reported Expiration date: Unknown) via an unspecified route of administration on an unspecified date (at the age of 70-year-old) as dose 2, single for covid-19 immunization. Patient previously received dose 1, COVID-19 on an unspecified date. The patients medical history and concomitant medications were not reported. Patient stated that she has gotten both dose of the Pfizer COVID-19 vaccine and got rashes on her right arm to her elbow down and also scattered to different parts of her body on an unspecified date. Patient was asking  if this is normal, duration of this side effect and how she should treat it. Outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Fever, vomiting, unable to keep fluids down, screaming, inconsolable, body rash, slight dehydration.
I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015090 same reporter/event/drug, different patient.
headache, temp 99.7 last night 98.5 this morning with Tylenol
rt rotator cuff pain & tenderness starting 3 days post vax;had achiness of rt shouder & upper arm aorund site 2 days p/vax;
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was recommended and prescribed the ZOSTAVAX for long-term prevention against shingles. On or about 09-MAY-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 16-JUN-2016, the patient was treated for injuries associated with the shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 8 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose and frequency were not reported) subcutaneously for prophylaxis. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA002375:Original Case : 1811USA002232 US-009507513-1811USA002373:Original Case : 1811USA002232 US-009507513-1811USA002232:Original Case : 1811USA002232 US-009507513-1811USA002371:Original Case : 1811USA002232 US-009507513-1811USA002372:Original Case : 1811USA002232.
This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 76-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 5th January 2007).  On 28th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fever and influenza-like symptoms. On an unknown date, the outcome of the chills, fever and influenza-like symptoms were unknown. The reporter considered the chills, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 75 years or 76 years. The patient was a hospital employee. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
SYMPTOMS AND SECONDARY ILLNESSES LEADING UP TO PORTAL VEIN THROMBOSIS WHICH WAS DECIDED FINAL DIAGNOSIS AFTER SERIES OF THREE VACCINATIONS FOR HEPATITIS B.  I DO NOT HAVE ACTUAL KNOWLEDGE IF VACCINATIONS AND FINAL DIAGNOSIS CAN HAVE A POSSIBILITY OF BEING CONNECTED TO EACH OTHER AS CAUSE AND EFFECT.
0820 Covid Vaccination given 0842 Pt honks horn in in distress 0843 Pt is extricated from her vehicle 0843 Medical Provider called 0844 Pt noted to have four separate tonic-clonic events without incontinence, oral injury or post ictal period 0854 ambulance arrives 0859 pt loaded into ambulance 0907 ambulance left for ER, the patient has a H/O of such events and did mention she was taken off anti-convuls. medications and had a possible diagnosis of pseudo-seizures. -
Patient?s first time obtaining any Covid Primary series and was provided the Moderna Bivalent dosage.
Pfizer-Biotech COVID-19 Vaccine EUA Vaccine administered 12/30/20 1202 PM Starting 1/1/2021 - mild headache, numbness in both hands but more significant in the left hand, left foot numbness.
Difficulty with hearing.. feels as if he has lost hearing and has feeling of fullness in both ears.  I took him to an ENT where he was observed and then given a hearing test.. lower end of normal on test Went to pediatrician and did hearing tests and he failed twice in left ear Went to another audiologist  and his hearing test showed the lower end of normal . Going back to ENT this week on 1/6/21
Prolonged generalized seizure less than 24 hours after vaccines 6/6/08-records received for DOS 5/15/08-DX: First time seizure. Seen in ED with history of seizure that morning. Full tonic-clonic seizure, postictal state.
Fatigue, Nausea, Leg pain, ?jello? legs,  sweaty palms
This case was reported by a pharmacist via call center representative and described the occurrence of back pain aggravated in a 56-year-old male patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included chronic back pain. On 10th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced back pain aggravated, fever, fatigue and muscle pain. On an unknown date, the outcome of the back pain aggravated, fever, fatigue and muscle pain were unknown. It was unknown if the reporter considered the back pain aggravated, fever, fatigue and muscle pain to be related to SHINGRIX. Additional details were provided as follows: A day before reporting, the patient received SHINGRIX. The patient stated that after receiving SHINGRIX his back pain was worse and also experienced fever (body temperature: 102 degree F), fatigue and muscle aches.
Angioedema of lips, and hives covering trunk.  Happens intermittently, almost every day, either hives or swollen lips
On 11/2/2017 She noticed a dark discoloration to skin and fungal looking rash under her breast. Decided to apply antifungal cream and powder to site for a week. Within a week the rash dried and skin started to peel as of today the rash is gone and skin color back to normal.
Cough  Fatigue  Muscle or body aches  Headache  Sore throat  Congestion or running nose   Care Coordination Progress Note  RN (Registered Nurse)    COVID 19 MAB Infusion Navigator Initial Patient Assessment   Ordering Prescriber has completed required FDA elements.    COVID-19 Positive Result Date (and on chart/file): 5/3/21   Start of Symptoms Date: 5/2/21  Meets Criteria:   ANY AGE: ? Body mass index (BMI) ?35 ? Chronic kidney disease ? Diabetes ? Immunosuppressive disease AGE SPECIFIC: ? ? 65 years of age       ? ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease   Reviewed present symptoms with patient. Cough, chest pain w/coughing, chills & sweats, diarrhea, body aches & fatigue.    Purpose of Infusion Assessment: Can you tell me why you are receiving this infusion? Reviewed by Physician   1. Date/Time of Infusion: 5/5/21 @ 9am. Location of Infusion: Ephrata
STROKE; BRAIN BLEED; This spontaneous report received from a consumer via a company representative concerned a female 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: unknown, expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  It was reported that on an unspecified date, "mother (patient) had a stroke and a brain bleed." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and brain bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220246736-covid-19 vaccine ad26.cov2.s-Stroke, Brain bleed. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Pt became nauseated after vaccination & had small clear liquid emesis.  Parents replied " She's always like this." Nurse recommended that she get a flu shot from her MD next year.
The patient was given Tdap and less than a minute the patient had a seizure. The patient heart rate dropped into the 40's. Patient was given an IV and EMT was called to transport the patient to the hospital.
Sore at injection site 2 hours after the injection.  The following day I had soreness, tightnes, red  in the injection site, warm and tender to the touch. 48 hours later,I had a round lesion about 4 inches long and wide. Red, painful, warm to the touch and itchy. Resembles what they call ?Covid arm? but this was on the second dose. Still experiencing soreness, pain and itchy ness. Going onto  day 3 since injection with the second dose of moderna.
Fever, mild respiratory symptoms, sent to ED for septic workup, admitted and ultimately diagnosed with incomplete Kawasaki's disease.