chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist and a mother concerning her 25 month old son with food allergies who on 8/29/02 and 10/9/03 was vaccinated by injection with the first and second doses of varicella virus vaccine live. Concomitant therapy included HIB conjugate vaccine and hepatitis B vaccine, recomb. It was noted that the three year old child is at 2 year old level mentally and has been placed on autistic spectrum. Unspecified medical attention was sought. There was no product quality complaint. The reporter considered the three year old child is at 21 year old level mentally and has been placed on autistic spectrum to be disabling. Additional information has been requested. Follow up 03/03/05: Patient's recovery status is unknown. Followup report received 06/14/2005:  Patient's recovery status still unknown.
Severe flu-like symptoms within 24 hours including body aches, stiffness, headaches and dizziness. Began sleeping 16 hours/day. Saw FNP on 2/18 advised to go to emergency. Was diagnosed with viral meningitis at emergency hospital.
48 hrs after receiving the 2nd dose, the patient had nausea and vomiting. Could barely function, fatigue/bodyaches. Currently, 4 weeks after receiving 2nd dose, the patient has achy hands esp. the left hand- their hands turn black and blue sometimes, not swollen.  Her hands hurt but she plays tennis so has been taking advil to manage the pain. Did take anti-inflammatories before receiving the vaccine. We ordered labs for the patient to check for an underlying immune disorder which is flaring up. Advised pt to keep hands warm and to not overuse them and to continue on NSAIDs as needed for pain.
Chest pain (5/10), bilateral jaw numbness, left back pain, and headache. Oxygen 6 liters. Taken to the ED>
Pt c/o lightheadedness following Pfizer vaccine. VS: BP=140/90, HR=69, SP02=99%, RR=18. Pt monitored for 45 minutes and symptoms fully resolved. Pt released by medical provider.
I had headaches on the top of my head, shortness of breath, I was also dizzy at times. I made an appointment with my doctor, who had an MRI done and found that I had a sinus infection, a chest x-ray and discovered my lungs were clear. I was referred to my cardiologist who did an ultrasound on my carotid artery to determine if it was helping to cause my headache. I was given an antibiotic to get rid of the sinus infection. The headaches are now gone, the shortness of breath comes and goes.
I received the shot on 7/22/21. I started my period on 7/23/21.  Excess bleeding on Saturday 7/24/21. I bled through a 10hr pad, my panties, and my pants, down my thighs in less than 2 hours. It was very scary; it had never happened before. I had a Telehealth session with an MD. I was instructed to stay in bed and stay hydrated.  I took a pregnancy test, as instructed, and it was negative. We were  not trying to get pregnant at the time. I also scheduled an appointment with an OBGYN
Pt states injection given was to close to her shoulder, and feels like that area has been hurting ever since. Pt called pharmacy to state this and that she was going to have an MRI.
Pain in Right deltoid area since next day after she received flu vaccine. Rt deltoid hurts - sometimes even without movement. Pain med (Advil etc) doesn't help much. Bro Freeze helped "a little".  Right deltoid area appears slightly larger than left. Referred to med clinic.
Patient pulls his arm while getting immunization, therefore  he got 3/4  dose, later gave him 1/4 dose to complete full dose.
Syncopal event 30 minutes after shot given.  Transported to ER for possible seizure activity.
03/01/2004: 18 month check up: Mild URI symptoms also DTAP #4, IPV #3 administered.  03/02/04 (AM): Unusual "spell", ?breathholding, limp and extreme irritability that lasted through PM.  No seizure.
This is a spontaneous report from a contactable pediatrician via a company sales representative. A male patient in his 80s received TRUMENBA (lot# J28923, exp date Jun2016), intramuscularly in right deltoid, on 12Oct2015, at 0.5 ml single. Relevant medical history included ongoing asplenic and spherocytes from 06May2991 and unknown if ongoing. Concomitant medications were none. ON 12Oct2015 the patient experienced high fever, headache and overall myalgia. It was unknown if the patient took any treatment for high fever. The patient recovered from the events on 14Oct2015. The physician believed that the event was related to the vaccine. The reporter considered the event as related to TRUMENBA. Follow-up (29Jan2016): New information received from a contactable physician includes: vaccination site, new events, medical history added, causality assessment.
approx 1hr p/vax pt became very hot (no temp taken) became dizzy & sleepy for the next 3 days;pt mom states that pt gradually improved over the next 7 days & did not seek med advice;
runny nose, symptoms occurred 14 hours post vaccine, reaction site pain, nausea, fever 100.5, muscle aches, chills, abdominal pain, fatigue, joint pain and headche
Red; Pain(sore to touch); Feels like a golf ball under my skin; Extremely uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Red"; PAIN (non-serious), outcome "unknown", described as "Pain(sore to touch)"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feels like a golf ball under my skin"; DISCOMFORT (non-serious), outcome "unknown", described as "Extremely uncomfortable". Additional information: The patient received second vaccination. Patient have had what they are calling COVID Arm for almost a week now. Red, circle, pain (sore to touch) and feels like a golf ball under skin. How much longer does this last. It was Extremely uncomfortable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient at clinic today presenting with 7 x 10 cm asymmetrical erythematous rash on left anterior thigh. Rash appeared 1 day after receiving flu vaccine. Vaccine was given in left thigh on 10/28/2015. Patient having pain and limping when walking. Patient prescribed cephalexin 250/5 7.5 ml every 12 hours for 10 days and cold compress to affected area. ER precautions given to mom.
Information has been received from a licensed practitioner nurse concerning a 17 year-old patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 28-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL, lot # K023432, expiration date 18-JUN-2016; dose and route were not reported), which underwent supported temperature excursions. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Received the vaccine on 23Dec2020. She tested positive for COVID on 31Dec2020.; Received the vaccine on 23Dec2020. She tested positive for COVID on 31Dec2020.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable other healthcare professional (patient herself) reported that a 37-year-old female patient received bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899), via an unspecified route of administration in the left arm 23Dec2020 at single dose, for Covid-19 immunization. Medical history included migraine (takes a migraine medication). Her height was 168cm, weight of 72.5kg. There were no concomitant medications. Received the vaccine on 23Dec2020. She tested positive for COVID on 31Dec2020. Then she had another test and was negative for COVID on 03Jan2021 and was also negative for another test on 05Jan2021. She was wondering if this was like a super vaccine and knocked it out or if there was an error with the test. She acknowledged that there was a lag time for the second dose of 21 days. She was wondering if there was a grace period for that since she cannot be cleared for work. She was also wondering what to do before her second dose of the vaccine. The outcome of event was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported positive Sars-Cov-2 test, which is considered ineffective of BNT162B2, and the administration of BNT162B2.
Hives appeared one hour after administration of flu vaccine.  Started at neck and spread to torso, arms, legs, chin, around lips, ears.  Benadryl every 6 hours administered for 24 hours.
pt devel nausea, weakness, bowel movement, diaphoresis & apparently fainted @ grocery store;EMT found slow junctional heart rhythm w/BP 110/70;adm to ER pt was NSR & feeling better;pt was adm for monitoring;vagal tone rxn suspected
The pt experienced the onset of flu like symptoms 4 days post vax, with increased WBC and LFT. The pt was hospitalized for 3 days with a complete work up. The pt experienced a fever and nausea.
Swelling in lymph node under left armpit, which is the same arm in which booster shot was administered.
Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not informed. On 16-DEC-2016, the patient was inadvertently vaccinated with a expired dose of ZOSTAVAX, expiration date 15-DEC-2016, (lot #, dosage and therapy route were not provided), for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
PT GOT SWELLING, REDNESS AND MILD PAIN ON VACCINATION SITE SAME DAY WHEN SHOT WAS GIVEN.
This case was reported by a nurse and described a 40-year-old female subject who did not repond to immunization with HepB (manufacturer unspecified). On an unspecified date in 1993, the subject received 3rd dose of HepB (manufacturer unspecified). Approximately 12 years later, on 07 November 2005, a hepatitis B surface antibody titer indicated that the subject was "not immune."
Information has been received from a physician concerning his 11 year old son who on 16-MAR-2012, was vaccinated with a first dose of GARDASIL (lot number 671994/1537AA, expiration date 21-JUN-2014) (dose, route not reported). There was no concomitant medication. On 18-MAR-2012, the patient experienced "joint pain in both knees and both ankles". At the time of the report the patient's outcome was not recovered. The patient sought medical attention, the patient was the physician's son. Follow up information has been received from a Certificate Medical Assistant concerning an 11 year old male with intermittent mild asthma and no illness at the time of vaccination who on 16-MAR-2012, 2:33 PM, was vaccinated with the third dose of GARDASIL (lot number 671994/1537AA, expiration date 21-JUN-2014) IM in the left deltoid. On 16-MAR-2012 the patient experienced transient myalgia in ankles/thigh and knee, initially could not walk, the patient was improved with time, heat, NSAIDS (nonsteroidal antiinflammatory drug). On 22-MAR-2012, the patient was recovered. Additional information is not expected.
Within 24 hours of booster administration I started spotting. This turned into a standard period that was two weeks early. I have very regular cycles.
Itchy rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 11:00 (Lot number: Ew0169) at the age of 14 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Reactive airway disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, lot number=Ew0150, administration time=11:00 AM, vaccine location=Left arm), administration date: 22Jul2021, when the patient was 14 years old, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Itchy rash". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of rash pruritic.  Additional information:Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks. The patient did not had any other medications the patient received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
I has moderna for the first two vaccines, then phizer for the booster. Ever since the booster, I?ve been horribly dizzy and light headed, making me pretty nauseous.  Time: normal post 24hr symptoms (sore arm, weak/tired) plus the symptoms above (which never left) At first I didn?t want to think that was the reason, but after undeniable evidence surrounding this, I know it?s specifically from the booster.
Night of injection - fever, chills, aches, pain in joints, sleeplessness Monday - unable to remain awake, difficulty walking, thinking, sitting Tuesday - 95% better, some lingering soreness Tuesday evening - facial virus triggered - cold sore/fever blister on lips, raised soreness inside right nostril, painful right eye with excessive tearing.  (Facial virus may be part of Herpes Simplex, triggered once a year or less, infrequently)
He is the person who received smallpox vaccination a day ago (20190415) and presented to the immunization clinic with erythematous pustules on chest, upper back, and shoulder today. Received the vaccine 0900 and symptoms started 1200-1230 during lunch time. The person also c/o itching sensation last night. He otherwise is healthy male who denies recent infection including skin, use of any meds, new exposure to anything or no recent travelling / insect or animal bites. No allergy or shaving on the area recently. He was given antihistamines / H2 blocker / epipen along with precaution for ER or RTC
Reported bumpy and itchy rash down both arms after receiving flu shot.  Recommended that patient take antihistamine and be seen immediately at ER or clinic.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 11-SEP-2017, the patient was vaccinated with a properly stored by expired dose of ZOSTAVAX lot number M042503 with expiration date 18-AUG-2017 (dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported.
After 1.30 minutes after  i got my first dose of the Prizer vaccine.  I  have experienced sore throat, light fever, muscle ache, and blurt vision, the left arm was a little bit swollen. The next day I have experienced the same symptoms and additionally felt nauseas and threw up several time . Today is the day number 5: I still experiences  fever,  running nose, sore throat, and cough. I have to report to work tomorrow and i feel so sick.
Healthy 5 year old, Dtap left arm 10/26/04. Phone call from mom 10/28 site raised, red, silver dollar size 10/29/04 pt awake with significant swelling, erythema, edema 14x9cm. No evidence of abscess. Treated with cool compress, Ibuprofen.
The patient reported feeling dizzy and lightheaded 30 minutes after receiving her second Covid-19 vaccine. The lightheadedness then caused the patient to fall while walking to her vehicle after leaving the pharmacy waiting area where she had been sitting for 15 minutes under observation.
Rec'd imm. at office on 5/21/12; LA at MMR site developed redness (6 x 8 cm area); induration, edema & warm to touch on 5/23/12 in AM. Seen in office -> Tx with cold packs to area 2) ADVIL for pain; 3) Return/call if s/s increase.
Initial physician report received on 01 Apr 2010: This patient received three vaccination of RABIPUR (batch number unknown) for post-exposure rabies prophylaxis due to cat bite on unspecified dates. The patient also received rabies immunoglobulins. On an unknown date, the patient experienced infection of intestine with fever. Outcome of the events was not reported. The physician did not suspect any causal relationship between the event and RABIPUR.
Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4496042-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Intramuscular), administration date: 01Jan2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Intramuscular), administration date: 01Feb2021, for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up". On an unknown date, the patient experienced rheumatoid arthritis flare ups. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "rheumatoid arthritis flare up" related (possible) to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hands are really itching, palm of hands itching, knee might itch a bit; This is a spontaneous report from a contactable consumer reporting for herself. A 91-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (injection given in left arm) on 27Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. The patient has no medical history. The patient was taking unspecified concomitant medications (takes a lot of mediations but they are the same thing she has taken for a long time. Nothing was new). The patient experienced palm of hands itching, knee might itch a bit on 27Jan2021. Patient reported she walked outside for about a half an hour; she didn't have anything on her hands. However, when she came back inside, her hands were really itching, specifically the palm of her hands. She has never had this happen before. She came back inside and took her mask and coat off and when she started to get warm, her hands started itching. She stated it's like the cold caused the itching or something. The itching has stayed the same. It was just itchy. She stated her knee might itch a bit, but her hands are really itching. She was not given her vaccine record card. Her facility is saving it and will give it to her after her second vaccine. No investigation assessment reported. Event outcome was not recovered.    Information on Lot/batch number has been requested.
Muscle aches & joint pain througout body, intermittent fever (incl. sweats, chills), fatigue, pain (bruised muscle ache) at injection site
Pt came in to get her 2nd Moderna vaccine; dose was administered by my tech. 15-min timer goes off then I went to check on the pt and pt stated that she was dizzy and about to throw up. Pt collapsed and threw up. I asked her if she wanted a some water, she said yes. Pt did not want us to call 911. After about 10 min, pt stated that her lungs 'were on fire.' I advised her that I think it is in her best interest to seek medical attention and my tech called 911. Paramedics took pt's vitals and BP was 130/80 and O2 sat was 99. Paramedics took pt to Health facility.
no adverse event. patient is 5 yrs old and came to clinic to receive age appropriate booster. Patient was given an infant toddler pfizer dose instead of pfizer 5 yrs to 11 yr.  patient was underdosed.
Red swollen arm for 2 days. Fever, severe arthritis pain in fingers, nausea, insomnia, body aches, fatigue for 24 hourd
The afternoon of the shot I got a sharp pain in shoulder blade on left side - also sharp pain on left side of chest - neck pain - headache. No treatment so far except ibuprofen in the afternoon of the 13th and today, the 14th. Sharp shoulder and chest pain lasted for about 30 mins. Still sore in shoulder blade. Neck pain has been the entire time since it started. Headache has been the entire time with occasional sharp pain in the back of my head. Achy and stiff since the afternoon of the 13th. Completely exhausted. Brain fog today, the 14th.
Fever; Sore arm; Two seizes; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Two seizes) in a 4-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. AS1416B and AS1416B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient born 24 weeks BPD.  Concurrent medical conditions included Latex allergy and Asthma.   On 27-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced SEIZURE (Two seizes) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Fever) and PAIN IN EXTREMITY (Sore arm). At the time of the report, SEIZURE (Two seizes), PYREXIA (Fever) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Patient was taking other medication. The patient had two seizes on 26-Jul-2022 back-to-back. He also had a fever and sore arm. The ambulance picked him up on 26-Jul-2022 to bring him to the hospital. No treatment information was provided.  Company comment: This is a spontaneous case concerning  a  4-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) AESI event of Seizure and unexpected non-serious event of Pain in extremity and expected non-serious event of Pyrexia. The event Seizure occurred 1 day after the second dose of mRNA-1273 Vaccine. On an unknown date events Pain in extremity and Pyrexia occurred. The patient had two seizures, fever and sore arm. It was reported patient was taking other medication. Patient was picked up by the ambulance and brought to the hospital. No treatment information was provided. Outcome of the events was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  4-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) AESI event of Seizure and unexpected non-serious event of Pain in extremity and expected non-serious event of Pyrexia. The event Seizure occurred 1 day after the second dose of mRNA-1273 Vaccine. On an unknown date events Pain in extremity and Pyrexia occurred. The patient had two seizures, fever and sore arm. It was reported patient was taking other medication. Patient was picked up by the ambulance and brought to the hospital. No treatment information was provided. Outcome of the events was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.
The pt experienced a heart attach and died. The pt had a hx of heart problems in the past.