chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 month old patient received a dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 practice manager reported that, the patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up. Note:In narrative the patient age was reported as 15 months, however it get autocaptured as per date of birth and vaccination date, hence captured as autocalculated.
Headache; Chills; my heart rate is up; body ache ever since; I have abdominal pain on the right left side and its like my kidney area; This is a spontaneous report from a contactable consumer (patient).     A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included hypothyroidism (dates unknown). Concomitant medications included thyroid (ARMOUR THYROID) taken for hypothyroidism, start and stop date were not reported. On 18May2021, the patient experienced headache, chills, abdominal pain on the right left side and it's like my kidney area, heart rate is up, body ache. Outcome of events was unknown.   Additional information has been requested.
Complaint of arm pain at site of injection. Prolonged pain, getting better but still uncomfortable per patient.
Headache, Chills, Fever.  Headache began in the evening around 6:30 pm (approx. 7 hours after receiving the vaccine).  Headache combined with chills and a fever (99-100 degrees) continued into the next day.   Treated with alternating acetaminophen (500 mg) and ibuprophen (800 mg).
Information has been received from a pharmacist concerning a 66 year old female with no known history or allergies who on 16-MAR-2007 was vaccinated SC in the left deltoid with a dose of Zostavax (lot# 656607/0163U). On 17-MAR-2007 the patient experienced redness, swelling, itching, warm to touch and tenderness at the injection site. The skin area is raised a little bit and the size of the area is the diameter of an apple. The patient has no pain. When pressure is applied to the injection site there is a lump that is felt. Unspecified medical attention was sought. No laboratory test were performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is expected.
patient took one flu shot and was sick; Initial information was received on 12-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves patient (age and gender unspecified) who was sick (illness), while patient received vaccine INFLUENZA VACCINE [flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced sick (illness) for 6 days (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Conducting Covid Vaccine Clinic.  Patient had already received his vaccination. At 2:74PM  Staff yelled to nursing staff for help. Patient was passed out, hyper extended in chair.  He jerked once and staff got him on the floor.  He took 15 seconds to speak at which time he refused Epinephrine.  Staff got him up into chair once he was alert and oriented.  He was able to speak clearly, stating he felt tingling in his right arm and then throughout the rest of his body before passing out. Blood pressure was 118/82.  At 3:05PM, he was up, walking around, alert and oriented x3.  Staff drove him home and instructed him to contact his physician. Follow up today, 2/24/21 patient states injection site is sore but he is ok an d has an appointment to speak with his physician.
Slight dizziness  immediately following injection bout Of vertigo began about  2 weeks later. Accompanied by major brain fog and severe memory and cognitive decline , weakness and fatigue in 1 months time. Treatment for dizziness did not have any effect. This was abrupt and severe. Patient was running a full time business up until the point of vaccination and now is essentially disabled.  Cannot work and normal daily function is very limited.
Corner of eye twitched; Muscle spasm in right eye as if someone takes a finger and touch your eyebrow; Sensation feeling at the back of her head; Eye feels kind of dry; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasm in right eye as if someone takes a finger and touch your eyebrow), SENSORY DISTURBANCE (Sensation feeling at the back of her head), ABNORMAL SENSATION IN EYE (Eye feels kind of dry) and MUSCLE TWITCHING (Corner of eye twitched) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced MUSCLE SPASMS (Muscle spasm in right eye as if someone takes a finger and touch your eyebrow), SENSORY DISTURBANCE (Sensation feeling at the back of her head) and ABNORMAL SENSATION IN EYE (Eye feels kind of dry). On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE TWITCHING (Corner of eye twitched). At the time of the report, MUSCLE SPASMS (Muscle spasm in right eye as if someone takes a finger and touch your eyebrow), SENSORY DISTURBANCE (Sensation feeling at the back of her head) and ABNORMAL SENSATION IN EYE (Eye feels kind of dry) had not resolved and MUSCLE TWITCHING (Corner of eye twitched) outcome was unknown.            Patient had received no treatment. The patient went to doctor and they ruled out Bell's palsy.
Received COVID19 Pfizer vaccine x1 dose despite having previously received the full Moderna COVID19 vaccine 2 dose series.
Patient had severe herpes outbreak. Had multiple lesions arise on lip, inside nose, on buttox and groin area.  Pt began taking Benadryl 25mg for 2 days, and then increased to 50mg on 9/21.
Pt. received vaccine(s) on 11/07/11. Pt. returned to ofc 11/11/11. Had been vomiting x 3 on 11/11/11. Had CBC in ofc. (normal) TC neg in ofc. Pt sent to hospital; 3-way Abd = positive intussusception -> air enema reduced.
May 15 - May 17: Fever, chills, body ache, loss of appetite  May 17 - Present: Tight chest, cough, deep breaths are painful
R Arm red, warm and swollen on PM 1/8/03. To use compresses that are warm and motrin.
Patient lost consciousness shortly after vaccination was administered.  Administered one dose Epi-pen 0.3mg  and called 911, and he regained consciousness after a few seconds.  Checked BP while waiting for EMT and it was 90/62 and pulse was about 40.  No rash or difficulty breathing,  but we administered 25mg diphenhydramine PO as a precaution.  Emergency services took him to the ER to be monitored.
Narrative:  Vaccine was given in Feb(second dose of Pfizer) and patient tested positive for COVID in Aug 2021. Unlikely a reaction to the vaccine. Did have breakthrough COVID despite 2 doses of vaccine. Was due for booster at time of infection. Has since recd booster vaccine (10/21)
How does this vaccine effect pregnant women; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (How does this vaccine effect pregnant women) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (How does this vaccine effect pregnant women). At the time of the report, EXPOSURE DURING PREGNANCY (How does this vaccine effect pregnant women) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
AFTER VERIFYING VACCINE, MOTHER WAS HOLDING CHILD ON HER LAP. MOTHER WAS LIGHTLY RESTRAINING CHILD. TECHNICIAN, ASKED MOTHER AND CHILD IF THEY WERE READY FOR THE VACCINE. THEY BOTH CONFIRMED THAT THEY WERE READY. ASKED CHILD IF IT WAS OKAY IF HE TOUCHED HIS ARM BEFORE APPLYING ALCOHOL, AND CHILD RESPONDED THAT IT WAS OK. TECHNICIAN APPLIED BARRIE BANDAGE OVER PATIENT'S RIGHT DELTOID MUSCLE. PATIENT WAS TELLING TECHNICIAN ABOUT THE GAME HE WAS PLAYING ON HIS PHONE, AND TECHNICIAN ADMINISTERED SHOT. 3/4 OF THE VACCINE WAS ADMINISTERED SUCCESSFULLY, HOWEVER PATIENT JERKED HIS ARM IN A DIAGONAL MOTION AND APPROXIMATELY 1/4 OF THE VACCINE WAS NOT ADMINISTERED AND THERE WAS A SCRATCH MARK (APPROXIMATELY AN INCH) ON THE ARM FROM THE NEEDLE TIP. TECHNICIAN INFORMED MOTHER. MOTHER DID NOT EXPRESS CONCERN.  IN FACT, WHILE TECHNICIAN ENTERED PHARMACY TO GET A TRADITIONAL BANDAID, THE MOTHER HAD ALREADY APPLIED A BANDAID FROM HER POCKETBOOK.  MOTHER AND PATIENT WILL RETURN IN 21 DAYS FOR THE 2ND SHOT.
swelling in arm; have swelling in arm and pain; This is a spontaneous report from a contactable consumer reporting himself. A 90-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that, he received the Pfizer covid vaccine second dose 03Feb2021. He has been seen a doctor twice and had his arm dopplered. Approximately on an unknown date in 2021, the patient had swelling in arm and pain. Also reported that, first time I went he felt my whole arm with his fingers and said no blood clot. Then he went to another doctor, they wanted a doppler and they said he had no blood clot after doppler on an unknown date in 2021, it was negative. They put him on prednisone 10mg twice a day for 5 days and it didn't help. The doctor told me the pain may last 2 to 3 months more. The patient wanted to know that he is going to have put up with this for that long or more. He stated that, I saw the doctor last Wednesday. He wanted to be reassured that he knows what he is talking about. As he is 90 and can't take a shower on his own, and the girl that helps told him that his arm is still swollen. The outcome of the event pain was unknown, and the patient did not recover from the swelling at the time of report. NO PQC present.   No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a 5 year old female with no pertinent medical history or allergies, who on 7/7/06 was vaccianted subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot# 647538/0784R). There was no concomitant medications. About fifteen minutes after the vaccination, on 7/7/06 the patient experienced hives, facial swelling, coughing and itching. The child was treated with epinephrine and Benadryl then sent to the local ER. She was admitted to the hospital for observation and was released the next day. Subsequently the patient fully recovered. Hives, facial swelling, coughing and itching were considered to be immediately life threatening. The reporter considered the adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Approximately an hour after injection (Wednesday 4-19-2023), started to feel weak and tired, later in afternoon had severe headache and was nauseous but did not vomit. Every part of my body ached. At 8pm. went to bed with extreme chills which made my whole body shake and were continuous for approximately 12 hours. . I was unable to get out of bed in the morning or even drink much water due to nausea and aching head (felt like it was going to explode). It hurt to even try to talk. I was so weak and achy I remained in bed Thursday and had sporadic shaking chills throughout the day. By Thursday evening, I felt slightly better but remained in bed and was able to drink sips of water. Friday morning, I was able to get out of bed: head felt better, no chills, was still extremely  weak. Drank water and chicken broth in morning.  By Friday afternoon, felt much better but remained weak throughout Saturday and Sunday.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; HAD A KIDNEY TRANSPLANT; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media (J and J Corporate) and concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The patient received non-company suspect vaccine included: elasomeran (Spikevax vaccine) (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2).  On an unspecified date, the patient had a kidney transplant (dose number in series 2) and got tested for antibodies, which showed that the patient had not developed any antibodies, which was associated with suspected immunological vaccine failure (dose number in series 1). After one week, the patient became infected with COVID-19 (suspected covid-19 infection) (dose number in series 2). The reporter stated "I got JJ my first shot then the moderna got tested for antibodies because I have had a kidney transplant found out I didn't developed any antibodies. One week later I got covid-19. Lucky it was a mild case so I was ok ". The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the had a kidney transplant, suspected covid-19 infection, suspected immunological vaccine failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000264911.; Sender's Comments: V0-20221259453- Had a Kidney transplant-Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221259453-Suspected Immunological vaccination failure. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Patient stated she started to feel body pains 10 hours after vaccine administered. Patient administered ibuprofen helped. patient stated for 10 days she was unable to walk well, was better for 5 days, Then was exposed to a family member that was sick then patient felt sick again with body aches and fatigue. Ever since exposure patient has been feeling exhausted, low back pain, tingling in feet.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
pt recvd vax for prophylaxis;15 mins later exp anaphylaxis,throat tightness, shakes,& tachycardia;tx w/ epi,solu-medrol & dph;anaphylaxis resolved w/in 1hr;2-3 times p/ dec94,exp shaking & exhaustion;as of 4aug94 pt states neck hurts;
Received his 2nd Pfizer Covid-19 vaccine today and while waiting the 15 minute observation time, he had a witnessed syncopal episode. Writer noticed him and lowered him to the floor out of his chair. He did not hit his head, nor have any injury. He quickly became alert and oriented x 4, denied any other symptoms. Mom states this has happened to him the past with vaccines. VSS, BP 115/65, pulse 73, and 98% on room air. Observed on floor for an additional 10 minutes before returning to chair. RN assisted him to chair within another 10 minutes he ambulated out of clinic. Advised him to eat some lunch, stay well hydrated and to avoid any strenuous activity today. Patient and mom verbalized understanding and agreement with plan, no further questions or concerns.
Developed burning in and around ear, ear ache, then rash after a couple of days  , was out of town, so not diagnosed till the following week with Shingles. I still have it, it has not gotten any better after a month
Discharge Summary (Physician) ? ? Hospitalist Physician Discharge Summary   Age: 73 y.o. Admit Date: 8/14/2022  3:35 PM Discharge Date:  8/17/2022   Discharge Diagnosis: Principal Problem:   Cellulitis of right lower extremity Active Problems:   COVID-19 virus infection   Hyponatremia   Chronic anticoagulation   Essential hypertension       HPI: " Patient is a 73 y.o. female with a history of venous stasis and right lower extremity from chronic DVTs states over last 1-2 weeks as had increasing swelling in his right leg gotten  worse over last 2 days temperature 101 took a course of doxycycline without improvement over last day or so his had some nausea and vomiting bowels have been regular. Patient states has not been able take medication at times due to nausea and vomiting. No sick contacts patient began noticing a blister formation on anterior shin seen in the emergency room being admitted for further management and care".   Hospital Course:   The patient was admitted to the hospital and was evaluated and treated per below.     * Cellulitis of right lower extremity Description of the Problem/Progression:  Plan:  o Cellulitis of the right lower extremity. Improved on current treatment. Patient failed doxycycline on outpatient basis. Followed by infectious diseases. Continue Rocephin and daptomycin. MRSA swab is negative. DCed Daptomycin per ID. Continue same treatment otherwise. Seen by wound care, consult appreciated. Vision continues to show progressive improvement. ID advised transitioning to by mouth Omnicef on discharge. Patient discharged accordingly to complete a by mouth course of Omnicef for 10 days. Follow up patient with wound care, ID, primary care provider, and referral given to home health. o COVID-19 virus infection. Patient reportedly had a desaturation last night necessitating initiation of treatment with oxygen at 2 L. She was weaned off oxygen and remained off oxygen with good saturation. Completed a course of Remdesivir d3/3 days. Follow-up with PCP and ambulatory care manager o History of DVT with subtherapeutic INR. Venous ultrasound is negative for DVT. Coumadin per pharmacy dosing. INR up to 1.9 today. Follow up with PCP/Coumadin clinic.  o Hyponatremia. Resolved with serum sodium up to 136 from 1:30 on admission. Continue same treatment. o Nausea and vomiting. Resolved. Improved by mouth intake. Continue Protonix and IV antiemetics as needed. o Hypertension. Controlled. Continue same treatment. Follow up daily labs.        Physical Exam on the Date of Discharge: Stable and improved.      Consults:   IP CONSULT TO WOUND CARE IP CONSULT TO DIETARY IP CONSULT TO INFECTIOUS DISEASES IP CONSULT TO SOCIAL WORK   Significant Diagnostic Studies:    labs, microbiology, radiology, and cardiac graphics: per chart.     Disposition:  home   Discharge Condition:  good
Positive COVID-19 on 8/11/21 in fully vaccinated individual. Developed symptoms of fever, malaise, and congestion on day of test, approximately 5 days after exposure to an unvaccinated individual in her household who had tested positive for the virus.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received BOOSTRIX (batch number 34EB5, expiry date 14th February 2017). On 10th July 2015, the patient received BOOSTRIX (intramuscular) .5 ml. In July 2015, 17 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be probably related to BOOSTRIX. Additional details received as follow: The patient came to the doctors office because he was experiencing sharp, stabbing pain in left arm whenever he moved. The lot number was reported as 34EB (B or S) from the reporter. However, based on a safety lot number review, the lot number was updated to 34EB5.
Probably had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Probably had a sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant. Concurrent medical conditions included Kidney disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Probably had a sore arm). At the time of the report, MYALGIA (Probably had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Injection site has egg sized lump that mom describes as red, hot and swollen. No pain or fever.
Patient noticed a small lump at the injection site almost immediately after vaccine given. That night patient developed 'pins & needles' down her left arm, arm/hand tremors, chills/fever (102.3), nausea, body aches, fatigue and shoulder pain. Patient took ibuprofen at 4 am on 4/9. Saturday (4/10) patient noticed a lump on her left forearm. She went to the doctor and an ultrasound was done on 4/14 which revealed a superficial venous thrombosis in the cephalic vein of the left forearm. Patient was told to start on aspirin 81mg on 4/15. Dr also measured injection site identified by patient as 1.5 cm below acromion process. Physical therapy will also be set up.