chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health professional on 16Oct02, concerning a 6 month old male vaccinee who was inadvertently administered the Fluvirin vaccine on 16Oct02. On 16Oct02 the vaccinee was inadvertently administered 0.25ml of the Fluvirin vaccine in the thigh. The vaccinee had not received a previous influenza vaccine. The vaccinee has not exhibited any signs or symptoms of an adverse event. The vaccinee will be closely monitored for adverse reaction. There was insufficient information to determine the reporter's causality assessment.
Patient was given a 1.0ml dose of Moderna CVID19 vaccine.  Double the single dose recommendation. At this time no adverse side effects.  Reporting due to dose administration error.
MILD TO SEVERE HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced mild to severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild to severe headaches was not reported. This report was non-serious.
High fever, chills, splitting headache from mid-afternoon Tuesday lasting until Friday mid-afternoon, with Wednesday and Thursday being the worst.  Felt like a Mac truck ran me over and could not take enough Advil to get rid of the blinding headache. By Friday evening all signs were gone, but left very weak as though I just had the flu.
Nauseous and dizzy after 45mins, feeling off and tired. Achy and feverish after 2hrs, tachycardia after 5hrs. Called EMS and heart rate was sustaining at 135 bmp, lowest at 122 bmp for over hour.
Pt. stated that she has a fist size red area on her arm where the shot was given. When asked, Patient said, "yes it is warm to the touch". Recommended ER or Walk in Clinic. Pt. declined and asked us to call her Dr. in the morning.
The next day had a fever of 101; chills; headache; nausea; Extreme exhaustion for 4-5 days following; Missed menstrual cycle (delayed by 3 weeks); Consistent diarrhea for the following month; This is a spontaneous report from a contactable consumer (patient, self-reported). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW162), via an unspecified route of administration, administered in the left arm on 17Apr2021 14:15 (at the age of 31-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history was reported as no, and no known allergies were reported. Concomitant medications included famotidine (PEPCID AC), astragalus mongholicus root (ASTRAGALUS ROOT), multivitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in the left arm on 27Mar2021 14:15 (at the age of 31-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination. On 18Apr2021 at 05:00, the patient experienced fever of 101, chills, headache, nausea, extreme exhaustion for 4-5 days following, missed menstrual cycle (delayed by 3 weeks), consistent diarrhea for the following month. The patient underwent lab tests and procedures which included body temperature: 101 on unspecified date. Patient did not receive any treatment for adverse events. The outcome of all events was recovered.  This follow-up is being submitted to notify Follow-up attempts are completed. No further information is expected.
(R) arm - swelling/red, red spot - 3in long 2in wide, 1/4 in swelling - arm circ.
"Moderna COVID-19 Vaccine EUA temp of 101.6, extreme letheragy, dizzy, weak, cognitive impairment, body aches, chills, loss of appetite
MUCH OF THE FLUID LEAKED OUT OF ARM; INCORRECT ADMINISTRATION; INCOMPLETE ADMINISTRATION; This spontaneous report received from a health care professional via a company representative concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast cell activation syndrome, fibromyalgia, gastroparesis, and seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced much of the fluid leaked out of arm. On 17-MAR-2021, the subject experienced incorrect administration. On 17-MAR-2021, the subject experienced incomplete administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the much of the fluid leaked out of arm, incorrect administration and incomplete administration was not reported. This report was non-serious.
Has multiple blood clots; He had been feeling different for about a week since he got the second shot.; This is a spontaneous report from a contactable consumer. A 24-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in upper right arm on 19Jun2021 at 12:00 (at the age of 24 years) as dose 2, single for covid-19 immunisation. The patient had no medical history and family medical history relevant to adverse events. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number was not reported) via an unspecified route of administration, in left arm on 29May2021 as dose 1, single for covid-19 immunisation. Patient had no additional vaccines administered on same date of the pfizer suspect and no prior vaccinations within 4 weeks. The reporter wanted to inform that the patient had a bad reaction to the Pfizer vaccine. On an unspecified date in 2021 patient experienced had multiple blood clots, he had been feeling different for about a week since he got the second shot. The patient was hospitalized for has multiple blood clots from 15Jul2021 to still in hospital. The blood clots were persisting and was not dissolving. On 18Jul2021 patient underwent lab tests which included CT scans, ultrasounds abdomen, and blood work waiting on results. Therapeutic measures were taken as a result of has multiple blood clots (thrombosis) includes treatment with IV Heparin. The outcome for event multiple blood clots was not recovered, and for feeling different for about a week it was unknown.  Information about Lot/Batch number has been requested.
Rapid heart rate. Difficulty breathing.  Follow-up letter received states - Unfortunately, this information is not available to us.
This spontaneous report was received from a healthcare student refers to a patient of unknown age. On an unknown date in OCT-2014, the patient was vaccinated with first dose of ZOSTAVAX, L032403, 26-NOV-2016 subcutaneous. On 11-DEC-2015, the patient was inadvertently received a second dose with ZOSTAVAX. No adverse effects reported. Additional information has been requested.
The patient was standing  in the immunization room with the pharmacist and while he waited for his father to receive his immunization.  As they wrapped up and began to exit the room, the pharmacist noticed that he seemed confused and as if he was about to faint .  The pharmacist got him to the nearest chair.  He never lost consciousness, he was just dizzy.  He was given water and his pulse was taken.  The patient also reported at a later time he had just finished a long shift at work with little to eat or drink.
This spontaneous report as received from a Nurse Practitioner via Company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with an unspecified Hepatitis B series which may have been RECOMBIVAX HB thimerosal status not provided (route, dose no., dosage and lot number unknown). On an unspecified date, the Patient was diagnosed with an unspecified cancer which was treated with unspecified chemotherapeutic agents and was in remission. The outcome of the event was unknown. Upon internal review cancer was considered as medically significant. Additional information has been requested.
2.5 mo Female received the Oral Rotavirus Vaccine on 8/18/2009 under FDA IND #13843.  Patient tolerated vaccine well.  Patient had follow-up clinic visit exam on 8/25/09 and mother related patient had been having loose, watery stools for three days.  On 8/22/09 this patient had one loose stool, on 8/23 and 8/24 she had four to five loose stools above her baseline, each day.  On the day of the clinic exam, the patient had a normal stool in clinic.  Her weight was 5.82 Kg up from one week before when it was 5.6 Kg.  She was eating well with a good appetite.
entire rt arm swelled from shoulder to fingers 12hr post vax aches;no local redness;no local warmth;taking advil;arm not swollen-has throbbing & tingling distal worse;
5.5 yo, post meningomyelocele repairs was immunized in thigh & 2 1/2 days later developed 2x2' induration & redness; area increased to 4x4'; tx Keflex, redness markedly reduced & totally gone @ 24 hrs; Child also had 5 bullae @ inject.
The day after the vaccine was received, the patient noticed arm and face swelling. She also experienced shooting pains and tingling in the same arm she received the vaccination. At work, it hurts when she carries things and has dropped items, which is unusual. Pain is mainly in the shoulder, but sometimes in the forearm. She has tried Tylenol, ice and naproxen with no relief. She received methylprednisolone on 4/12, and now feels that she is having an allergic reaction.  Complaints of increased wheezing, shortness of breath and swelling of her skin, she has used her albuterol inhaler at home which has provided no relief.   On 4/13 she received albuterol by nebulizer and an IV dose of methylprednisolone at the emergency department. She is going to start albuterol nebulizer at home, continue OTC antihistamine, discontinue the methyprednisolone and start prednisone tomorrow.
Patient began complaining of pain at injection site approximately 30 min after injection, 45 min after injection patient was found to have moderate swelling of her left upper arm with extreme tenderness, no respiratory problems, MD notified, patient was given Benadryl 50 mg orally and Solumedrol 125 mg IM.
56 yo F with history of depression and hyperlipidemia received Covid-19 Janssen vaccine lot # 207A21A in her right arm ~1600. During the 5 minute observation period and immediately following vaccination, patient reported feeling "weakness, nausea, and headache." BP and HR stable. Patient without any known history of reactions after vaccines or blood draws.  Patient reclined with ice pack under neck. Transferred to provider room for assessment by provider and observation. Symptoms resolved without further intervention within 30 minutes. Discharged to home.
Symptom onset was 05/05/2022 with severe SOB, abdominal discomfort, diarrhea, fatigue, headache, nausea and vomiting. These symptoms were staying the same and not improving. Case was admitted to hospital 05/11/2022.
"Just a heads up that I am sick today, fatigue, body aches and low grade temp (100.5 has been the highest). I have been taking tylenol to help. I plan to be at work tomorrow with the expectation that it is the shot and I should be feeling better."
This morning I woke up with a rash on my arms and stomach. Now it spread to my legs
pt recvd vax 3JUN91 & 6 hrs p/vax devel fever of 102, muscle aches & fatigue; fever persisted for 4 days a/remitting; pt later recovered; no further details are provided;
Rash on face/entire body red bumps appeared; entire body red bumps appeared; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccinev), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 12:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Aug2021 14:00, the patient experienced rash on face/entire body red bumps appeared. The patient was treated with Benadryl and witch hazel. The outcome of the events was recovered on unspecified date in 2021.  Follow-up attempts are needed. Information on the lot/batch number is expected.
Menstrual cycle delayed . Never ever has happened in my life. Typical cycle length 27-30 days. After COVID second shot , mentrual cycle 40 days.
The patient did not have any other adverse events; The patient received a dose of GARDASIL 9 on 13-JAN-2021. The dose received had an expiration date of 12-DEC-2020; This spontaneous report has been received from a an administrator, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 13-JAN-2021, the patient was vaccinated with 1 dose of an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine (exact dose, route of administration, anatomical location and vaccine scheme were not provided; lot number R011630 has been verified to be a valid lot number, expiration date was  reported and established on 12-JAN-20210), as prophylaxis (expired product administered). The patient did not have any other adverse events. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. device lotnumber: R011630; expirationdate: 12-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Donor had just recieved shot 15 min prior to him feeling faint and then landing on the floor where he hit his head. He got up and walked to the office. He then was very sweaty and had a large bump on the back of his head and stated that his neck hurt. EMS was called and an IV was started. Donor was responsive to the saline how ever EMS was concerned about his neck, so he was transported to the hospital for further evaluation.
Scattered urticarical lesions within 4 hours of receiving varicella vacxcine, Hx of fever previous 2 days, Afebrile at time of vaccine, Afebrile with rash
Pain at injection site; Redness at injection site; Swelling at injection site; Warmth at injection site; Continued pain at injection site described as adhesion muscle pain; Continued pain at injection site since vaccination; A 52 year old female patient received MassBiologic's Td Vaccine (Lot # A112A) via IM in her deltoid muscle on 11/07/2019 at Care Center. The patient indicated she immediately experienced pain, redness, swelling, and warmth at the injection site after receiving the Td product and experienced worsening pain  in her muscle at the injection site. The patient initially went to her primary care physician (PCP) for treatment, however the PCP was unable to provide satisfactory treatment for the worsening pain, so the patient sought treatment from her husband since he is a chiropractor. The patient indicated that all adverse events had resolved shortly after the vaccination (date not provided) except for the continued deep muscle pain that she described as "adhesive muscle pain."    During the follow up on, 10/05/2020, the patient confirmed that she is still experiencing the muscle pain and continues to be treated by her chiropractor husband.; Sender's Comments: MassBiologics medical reviewer assessed all adverse events as labelled and non-serious.  All reactions have resolved except for chronic pain and muscle pain at injection site.
HEART RATE WAS 130/ RAPID HEART RATE; FEEL DIZZY/ FEEL VERY LIGHTHEADED; WHOLE BODY FEVER/ BURNING UP REAL BAD; NAUSEA; FELT WEAK WHEN WALK; HEADACHE / MIGRAINE; This spontaneous report received from a patient concerned an 18 year old female. 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced headache / migraine. On MAY-2021, the subject experienced felt weak when walk. On 04-MAY-2021, the subject experienced heart rate was 130/ rapid heart rate. On 04-MAY-2021, the subject experienced feel dizzy/ feel very lightheaded. On 04-MAY-2021, the subject experienced whole body fever/ burning up real bad. On 04-MAY-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 130. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel dizzy/ feel very lightheaded, nausea, whole body fever/ burning up real bad, and heart rate was 130/ rapid heart rate, and the outcome of headache / migraine and felt weak when walk was not reported. This report was non-serious.
Situation Patient called the COVID-19 Nurse Holtine with post-dose vaccine related symptoms/guidance. Pt called PCP office after hearing several news regarding J & J  Vaccine/side effects. Pt was advised to call Nurse Hotline.   Noted from pt's PCP notes from today 4/13/21: "has some anxiety at baseline."  Background Patient received her J & J on 3/7/21 on the left arm.  Number of days post vaccine (today's date minus vaccine date): 6  Initial reaction was noted on : 1 day post vaccine: 3/8/21 around 8 or 9 am.   Symptom Screening  c/o Bilateral leg "achiness."  Pt rated pain 5 out of 10 on the pain scale. Pt denies any hives, itchiness, wheezing, swollen lips, tongue, eyes, difficulty breathing. Chest tightness/pain. Denies any swelling, redness, or itchiness to the both injection sites and to BLE. Pt denies numbness and tingling on the bilateral toes. Pt denies bilateral calf pain.  Pt was able to ambulate without any difficulties.  Medication:  Pt took one dose of  OTC Aleve at 5pm at 3/8 with a good effect.  Pt back to baseline until today.   Pt denies any unusual changes.  No distress noted.  ALLERGIC Reaction  Did potential immediate allergic reaction (less than 4 hours after receiving vaccine) or anaphylaxis to first dose of the COVID vaccine occur? No  Within 24 hours of vaccine administration,  did patient experience symptoms of a severe allergic reaction? No   Assessment/Action Patient experienced a MOD reaction to the vaccine. Symptom relieved with over the counter medications.  Patient answered NO to any of the Allergic Reaction  questions.   Patient referred to allergy:Yes Placed a referral for now for the further evaluation if needed VAERS Complete: Yes Patient experiencing any COVID-19 Symptoms AND >3 days post vaccine? No   Response/Recommendation .  Teaching -Provided education to patients as appropriate to the patient's clinical presentation.   -Provided home remedies/OTC medication use.   -Educated the reasons to call the Nurse hotline, PCP office and the reasons go to the nearest ED if symptoms change or worsen.   -Informed to make sure to call in advance if seeking medical care so sites can be prepared to receive the case.   Good verbal return and agreed with the plan.
Numbness to injection site  L Deltoid , Numbness radiates down to left forearm
3-5 min following vaccine complained of dizziness, hearing loss right ear; became desiphoretic, complained of nausea, pale. Remained conscious. Elevated blood pressure 100/60; cool cloth to head; head lowered between knees. Began to feel better after 15 min. Dr in attendance. Hearing returned to right ear.
After the 2nd dose around 8 PM on 01/06/2021 I had some side effects that were expected like achiness and headache for a couple of days and also tiredness that lasted for 30 days. It was an extreme tiredness and most days I would come home early from work and just go to bed. I just felt very incredibly tired but not sleepy. My doctor said if it lasted more than a month than they would look to see if it was anything else. I also got a tremendous pain in arm where I got vaccine and that night I was drawing and doing some artwork and all of a sudden I got a horrible pain in left arm from fingertips to the shoulder and that's when everything else started. The next day the arm pain was gone.
received a Bexsero /while it was receiving the Trumenba schedule; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a Bexsero dose while it was receiving the Trumenba schedule, which led to wrong vaccine administered. The reporter stated that she was not the one who inadvertently administered the Bexsero dose, but a nurse from the facility did it as she did not know that the correct schedule was for Trumenba.
Patient felt a little dizzy right after the vaccine admisnistered. He sat down for 20 minutes and got better. He went home. At around 9:30pm that same day, he started to feel more dizzy and his "voice is hoarse", throat swelling, and severe "nasal stuffiness", and "difficulty of making decision." His friend took him to emergency room. He was given prednisone and Benadryl. He stayed in the ER for 3 hours for observation, then went home.
Patient with previous history of febrile seizures, got MMR as his on 8/13/07. Developed fever on 8/17/07 and had seizure exam 8/14/07 and examine 8/16/07. Patient found to have viral tracheoso (acute croup) after serous febrile seizure disease.
Patient's left shoulder became a little swollen and red. Patients stated she could feel the vaccine in the left side of her neck and left side of head. Applied ice to left shoulder and after 30 minutes, Patient stated she felt better. Swelling and erythema had subsided. The next day contacted patient and she reported itching to her ear and a little sore throat. Advised to go to urgent care clinic or PCP. Went to Clinic and was prescribed prednisone. Patient also took BENADRYL.