chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reportedly had redness and swelling with a pneumovax shot 4-8 years ago.  #9 meds continued:  Pantoprazole, Levemir, Wixela, Vita C and D, ASA, Cranberry, D-Mannose, MiraLax, PreserVision, #10 allergies continued: "bleach, ink, Certain cleaning products and make-up products"
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 36 year old white male of unspecified ethnicity. Initial information processed with additional information received on 21-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 08-JUL-2021 at left arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had symptoms of covid (suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority. This case, involving the same patient is linked to 20220141644.; Sender's Comments: V0: 20220140123-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Chills; fever; achy; This is a spontaneous report from a non-contactable consumer (Patient) and contactable consumer (Pfizer employee) reported in response.   A 14-years-old female patient (non-pregnant) received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch No/Lot Number: Not reported) via an unspecified route of administration on 12Jun2021 (at the age of 14-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included, patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch No/Lot Number: Not reported) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. No Covid prior vaccination and it was unknown patient tested for Covid post vaccination. It was unknown if other vaccine taken within four weeks and not sure if other medications taken within two weeks. On 12Jun2021, patient experienced chills, fever, achy. Therapeutic measures taken as a result of events was unknown. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Client c/o feeling nauseous/lightheaded.  Stated was working out prior to getting vaccinated.  Client examined by medic on site, was stable post assessment.  No further action taken.
On the night of the vaccine, I stated getting symptoms of cough. My wife had tested positive or COVID-19 earlier. The cough got worse. I had a slight temperature, muscle aches, and tiredness. I did an at home COVID-19 test that was positive. I went to and got an antibody infusion. After that, I felt better. I still have the cough.
Mom states that redness and swelling appeared Sunday morning 12 x 13 cm, not sure if it is from Tdap or MCV 4, both vaccines were given in left deltoid. Started treatment 8-19-2013 of prednisone 20 mg BID for 2 days.
Fever, headache, body ache, injection site sore, unable to sleep, throwing up,   Took Tylenol
Developed quarter sized lumps on his arms that are red and itch.  Temp:  100.8F
Red, swollen, size of tangerine at injection site. Hot to touch - patient having flu-like symptoms - fever (101 degrees) achy, etc. Patient saw MD. Not concerned, gave Rx for Acyclovir should rash develop.
has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore muscles, very sore at the injection site, diarrhea, nausea, headache, tender scalp These symptoms are unchanged after 24 hours (started approx 10 pm 3/24 is is now after 10pm 3/25.
Vaccines given ~9:30 AM Fri - event at ~12:30 AM Sat.  Temp 99.6 per mom in ER. ~15 hrs after immunizations mother checked on infant because she heard her whimpering and found her with eyes rolled back and twitching arms and legs lasted ~3-4 min then recovered without further episode.
Fever 99.4 - oral x 48 hours. Body aches. Loose stools. Headache.
Pulse is been running above a hundred to about 120; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "Pulse is been running above a hundred to about 120". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated, "My daughter got the Bivalent booster (clarified as Pfizer COVID-19 Vaccine) yesterday and her pulse is been running above a hundred to about 120. We just don't know if that is normal?" Reporter was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the right department to answer the question. Reporter further stated, "That's okay I will just call her doctor."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter   This case was linked to MOD-2021-395985 (Patient Link).
WET COUGH; FELT A LITTLE OFF; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 205 pounds, and height was 71 inches. The patient's concurrent conditions included: alcohol use (once weekly), and non smoker, and other pre-existing medical conditions included: Patient had no known allergies. No drug abuse or illicit drug usage. Patient had no past medical history and medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency one total, administered on 08-JUN-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient was symptom free from the 11-AUG-2021 until the 14-AUG-2021 and Laboratory data included: COVID-19 virus test (NR: not provided) Positive coded as (confirmed clinical vaccination failure and confirmed covid-19 infection). Then patient experienced fatigue, cough, headache and became symptoms free on 16-AUG-2021. On 25-AUG-2021, he got home from work and he felt a little off and developed a headache a wet cough. Laboratory data included: Body temperature (NR: not provided) 106.1 F. Patient had not mentioned to his health care professional about testing positive for COVID-19. He might be able to access his test results, and would be willing to provide. He did not have access to his vaccination card at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and wet cough, and the outcome of confirmed clinical vaccination failure and felt a little off was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191022.; Sender's Comments: V0-20210851723-COVID-19 VACCINE AD26.COV2.S-Confirmed Clinical Vaccination Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Excrutiating headache Nausea Repeated vomiting - over the course of 2 days, about 30 times Stiff neck Stabbing eye pain Humming/ringing/muffled sounds in my ears
Patient's upper arm swelled and had heat first at the site of injection then it spread and affected her entire upper arm. It was clearly swollen and looked like it was filled with fluid. She called the pharmacy on the morning of 12/19/18 to report the side effects and I instructed her to contact her dr. They could not see her so she went to a walk in clinic. They diagnosed her with post injection inflammatory reaction. She was told to apply cold compress as she felt necessary.
As counsel, I completed this VAERS report without all the medical records. Prior to the subject event I am reliably informed the health of my client, was excellent.  On Wednesday, 2/6/2019 Patient received the pneumonoccal 13 vaccine, a.k.a. Prevnar 13, in Dr. office. On Wednesday, 2/13/2019 she visited hospital complaining of weakness, numbness and loss of sensation. She was seen by Dr. and sent home with anxiety medications and muscle relaxers. On Saturday, 2/16/2019 she visited Medical Center complaining of the same symptoms. She was admitted to the hospital for suspected Guillain-Barre syndrome (GBS). Many medical exams and tests followed....It is believed the GBS was caused by the 2/6/19 Prevnar 13 vaccination injection. Within the next week (medical records will provide exact dates) her respiratory system failed. She was intubated and placed on a ventilator for life support. She lost all consciousness and was kept sedated for many days while continuing to be supported only by the assistance of the ventilator which performed all her breathing. She was unable to come off the ventilator. She had a tracheotomy placed, a feeding tube placed and lost complete functionality in all body systems. In March of 2019, still hooked up to the ventilator and feeding tube, she was transferred from Medical Center to Hospital, where her daughter, a nurse, lives. Patient has since been placed in 4 facilities. To date she is still unable to walk and only has slight function in her upper extremities.   For efficiency Patient is in the process of requesting all her medical records from the relevant health providers attached to the required Certificate of Medical Records to be filed with our anticipated petition. From February 6, 2019 to date,  we will seek a.) medical records from Dr., Dr., Medical Center, ER, Hospital, Medicine Clinic, Hospital, School of Medicine,  and b.) her medical records from Hospital, Rehabilitation, Rehabilitation and Rehabilitation. Medical records will be compiled and attached as needed to further assist in answering any questions.  The daughter, holds her mother's Power of Attorney. Her mother's given email address and telephone number are those provded in Item # 1.
Fever; Chills; muscle soreness; joint soreness; fatigue; injection site pain; received the first dose of bnt162b2 on 21Dec2020, received the second dose on 07Jan2021; This is a spontaneous report from a contactable nurse.  A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 07Jan2021 at a single dose for COVID-19 immunization. Vaccination was done in  hospital. There were no relevant medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 21Dec2020 12:00 via intramuscular route in left arm at a single dose for COVID-19 immunization.  The patient experienced fever, chills, muscle soreness, joint soreness, fatigue, injection site pain on 07Jan2021 14:00 with outcome of not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The events was considered non serious by the reporter.  Information about lot/batch number has been requested.
L deltoid - pneumococcal vaccine, experienced severe pain scale 1-10 #10. Spoke to Dr 9/27/05. Dr thought it could be reaction from flu shot. There after she reported she were  paralyzed from neck to toes could not move. Experienced difficulty breathing, symptoms. Subsided on the third day at 08:30 am.
pt had a positive COVID test on 1/12/22 at local Pharmacy. 2/28/22 pt had another positive COVID test at alternate Medical Center; pt resides at PRIVATE under hospice care; pt passed away in the hospice facility
10/6 Received her first dose Pfizer. All previous Covid Vaccines were Moderna which was not available at the time.  10/12 Hives developed which were itching and she went to her PCP, Dr. Treated with Prednisone taper. Hives were on trunck , arms and face. 10/16 To Emergency room with hives getting worse as taper continued.  10/19  Hives not resolving and now felt like her upper throat was swelling. Taken by ambulance to ER. Given benedryl in ambulance and treated with epinephrine.  10/20 Seen by dermatologist and continued Prednisone  10/22 Given DX of bilateral ear infection .  Began antibiotics Z Pac and continued Prednisone.  10/25 Hives on race have resolved , on trunk and arms are still resolving.
On the day of the visit before the vaccination was given the doctor declared the 2 month year patient above the average in age milestones. She exhibited alertness, strength, and high consciousness. Within 12 hours after the vaccine, the 2 month-year-old patient was breathing harder than usual, making wheezing sounds, sweating, and grunting(sings of uncomfortableness).  24 hours after the vaccine the patient exhibited low consciousness, weakness, lethargicness, and an inability to hold her head up.
Pressure in head/severe headache - Severe joint pain - Pressure on chest, muscle aches, numbness, mouth sores, insomnia, confusion, vision issues.
Hepatitis B injection given on 2-6-04. On 2-11-04 client felt pain starting in L deltoid going down arm into hand.  Also noticed some tingling in hand. Pain became more severe.  Client went to ER.  Was given Darvocet for pain and arm in a sling.
Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore arm) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Very sore arm). At the time of the report, PAIN IN EXTREMITY (Very sore arm) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-069869 (Patient Link).
shortly after vaccine given I noted a rash on patient's chest and she reported that her face was feeling flushed. she stated no rash prior to vaccine. Using an interpreter I monitored patient and at no time did she report tightness of chest, throat or lips. I took her Blood pressure 128/93 pulse 82. Patient drank about 1/2 bottle of water. Continued monitoring her and rash receded. Patient said she felt better. I offered further medical attention. Patient declined. I instructed patient to hydrate and minimize activity for the rest of the day if rash returns take a benadryl. Seek medical attention in the event of any tightness in chest or throat. patient remained in store over 45 minutes and stated she felt fine and departed
This spontaneous report as received from a registered nurse refers to a 4 years old female patient. Medical history and current conditions were not reported. On 12-AUG-2014, the patient was vaccinated with VARIVAX (Merck) lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a physician concerning an 18 month old female with no pertinent medical history and no drug reactions/allergies who on 05-JAN-2010 was vaccinated with the first dose of VARIVAX (Merck) (0.5ml, SQ).  Secondary suspect therapy included MMR II (MSD). Concomitant therapy included PREVNAR, Hep A vaccine and Hib (manufacturers: unknown). On 15-JAN-2010 the patient presented to the office with a "rash that looks like scabies that is 24 hours old." "There is no tear drop blisters noted that is common in a chickenpox rash." The patient had lesions about 25-30 on her internal trunk, 15-20 on her back, a few on her forearms, and 3-4 behind her right. The rash was not in a linear pattern that was common in scabies, but was more scattered-like. There were no lab diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Initial unsolicited report received from physicians on 10 November 2016. This case involves a 39-years-old female patient who was vaccinated with a dose of  FLUZONE QIV (batch number- UI690AA, expiration date-30 June 2017) (dose in series, dose and site of administration was not reported) via intramuscular route on 11 October 2016 at 8:00 am. Illness at time of vaccination: none and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): sesame seed allergy and food. Hypersensitivities. Concomitant medications were not reported. On 11 October 2016, same day (in the afternoon) following the vaccination, the patient had experienced widespread hives and rash over the body, Shortness of breath, numbness and tingling in her arm. Patient required ER visit. Relevant laboratory data was not reported. The patient received epinephrine as corrective treatment. On an unspecified date the patient was recovered from the events. List of documents held by sender: none/yes
Blood glucose has been a little higher than usual; dizziness; bellyache; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Blood glucose has been a little higher than usual), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (bellyache), HEADACHE (headache) and NAUSEA (nausea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036?21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (bellyache), HEADACHE (headache) and NAUSEA (nausea). On 20-Mar-2021, the patient experienced HYPERGLYCAEMIA (Blood glucose has been a little higher than usual). On 22-Mar-2021, HYPERGLYCAEMIA (Blood glucose has been a little higher than usual), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (bellyache), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medication and cholesterol medication. No treatment information was provided.
Information has been received from a physician concerning a 4 year old patient who on 1/29/2002 was vaccianted with a dose of varicella virus vaccine live. Concomitant vaccine administered with varicella virus vaccine live included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient was seen on 4/28/2005 with breakthrough varicella with 10 to 12 lesions on the neck and upper extremities. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that the patient experienced chickenpox, described as mild with only 10 to 15 skin lesions. Additional information is not expected.
Chest tightness and flashing with anxiety feeling immediately after the shot.  Vital signs were stable HR 86, Sat 98% RA, BP 107/75.  Physical exam were unremarkable and she did not look in any acute distress she just felt anxious.  Lungs clear to auscultation bilaterally.  She was observed in the car for 30 minutes and was discharged home in stable condition.  Denies any symptoms before discharge.