chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recv vax on 3/8/99; post vax pt exp chills, fever then seizures
Moderna was administered as second dose in series in error. First dose was Pfizer COVID vaccine.
A nurse reported the occurrence of lethargy in an approximately 18 to 20 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject had no known drug allergies. Concurrent conditions were not reported. There were no concurrent medications or vaccines. The subject experienced no adverse events following previous immunizations. On 12/5/02, the subject received her second Engerix B injection. She "immediately developed a red line that started at the site of injection and continued to her neck. It did not follow a vein or artery." Approximately two hours post-immunization, the subject experienced nausea, vomiting, "severe" headache, and lethargy. The subject was examined in the emergency room and hospitalized. Computed tomography and lumbar puncture have "shown nothing." The subject remained hospitalized as of 12/9/02. The red line persisted; the outcomes of the other reported events were not known. The reporting nurse considered the events to be probably related to Engerix B administration. The nurse stated that the subject's physicians "believe it is due to a bad lot rather than a hypersensitivity reaction." The Engerix B immunization series was discontinued.  Reported on 03/25/2003: "The most recent information was received on 03/18/2003.  The erythema had resolved.  The outcomes of the other reported events were not specified.  The reporter indicated that the subject returned to work after an approximately six-week leave of absence.  Therefore, the events are considered to be persistently incaparitating.
Chest aches; Legs and whole body hurts; Legs and whole body hurts; Left ear hurts; Not feeling well; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a male patient (reporter's husband).   A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number unknown) via an unspecified route of administration on 05Aug2021 as DOSE 2, SINGLE for COVID-19 Immunisation. The patient's medical history and concomitant medications were not reported. He previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number unknown) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 Immunisation. The patient was not feeling well, chest aches, legs and whole body hurts and left ear hurts. Reporter agreed that she will contact her husband's healthcare provider and she stated that patient got the second vaccine on the previous day of reporting. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and requested during follow up.
A RED, RAISED, CONTINUOUS RASH APPEARED AROUND THE INJECTION SITE WITH A DIAMETER AROUND 1 TO 2 INCHES.
Cellulitis Rt upper lg. Red, hot, swollen thigh. Placed on ABX.
I don't know if this a side effect of the vaccine, but I feel like I am suffering a long viral syndrome, like a flu.  Anergic, weak, myalgias, occasional arthralgias, that have become severe for over two weeks. I do not see anywhere if the vaccine was tested on patients with cancer.  I have ovarian cancer with metastasis, currently at a standstill (according to my oncologist) most likely due to the activity of my immune system.  If this makes me immunosupressed, should it have been so indicated?
Myalgia & Fever  Narrative: left upper arm edema and pain, bilateral eye swelling
noted to have red dots on 9/23/ or 9/24/07 per mom. (-) h/o fever (+) h/o new sun burn. Exam 9/25/07 revealed macules on arms/legs. Now on trunk
Had influenza vaccine 10/28/02. On 10/29/02 developed "hives" all over-especially in warm areas of body. Tried Benadryl-stated continued to get worse. Instructed to see MD stat. Follow up TC 11/5/02. Seen at hosp ER x 2 2 hrs on 10/29 then again 11:15pm 10/29 and observed til 5am 10/30/02. Given Benadryl, Epenipherine and steroids in ER.
Dermatographia - Intense itching with hives in shape of scratching marks, itching palms, itchy head, with hives on scalp. Using Zyrtec and Pepcid to control symptoms
Arm sore for 3-4 days, subsided, then on day 8, rash developed and has spread; pt reports shooting pains, itching, hot to touch; no fever reported; has been taking Benadryl and using hydrocortisone cream; has gotten a little better; still has nerve pain -- pt also reports racing heart/increase heart rate
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; RIGHT SIDE GLANDS UNDER JAWLINE SWOLLEN; This spontaneous report received from a patient concerned a 46 year old. Initial information was processed along with the additional information received on 07-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 was not reported, batch number: 043A21A, expiry: Unknown) dose was not reported, 1 total administered at left arm on 07-APR-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 04-JAN-2022, the patient had her throat hurted, headache, fever, and right side glands under jawline were swollen. On 05-JAN-2022, she had suspected clinical vaccination failure, suspected covid-19 infection and positive antigen test. The JnJ supplied rapid antigen test BinaxNOW, through this rapid test was performed. Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right side glands under jawline swollen, suspected clinical vaccination failure and suspected covid 19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220108126. This case was associated with product quality complaint: 90000210471.; Sender's Comments: V0; 20220108630-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
Swollen face, swollen lips, extreme, fever, extreme fatigue, headache that lasted 3-5 days, splotchy red cheeks also
swelled her arm up from the injection site all the way down to her wrist; swelled her arm up from the injection site all the way down to her wrist; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program Pfizer First Connect. A 73-year-old female patient received first dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (trade name unknown, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at single dose and second dose via an unspecified route of administration on 2019 (about 6 months after first dose) at single dose for immunization. Medical history included ongoing high blood pressure. The patient's concomitant medications were not reported. It was reported that, patient received first dose of pneumonia vaccine and she had no adverse event with; Second dose was given in 2019 about 6 months after first dose. Second dose of Pneumonia Vaccine swelled her arm up from the injection site all the way down to her wrist on an unspecified date in 2019; she went to the urgent care for that. They gave her some medicine (unspecified) and eventually the adverse events went away. Second dose was when she experienced adverse event. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Patient  did not have any reaction, however an expired vaccine was administered. Moderna Vial was punctured on 9/13/21 a little after 1:13 PM. Dose was given  a little after 11:50 PM on 9/14/21
2 hrs after-hurting, swollen 2.5-3 in diameter-took TYLENOL/IBU overnight pain went up to neck. Blister today almost around arm top to bottom of arm and hurts, hot to touch. Also reported feeling "Wonky" or out of sorts.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-NOV-2012 17:15, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient fainted shortly after receiving the vaccination. She was seated in the post observation area.  It occurred approximately 3 minutes after receiving the vaccination.  Patient stated that she started feeling dizzy and then remembered waking up.  She woke up quickly and EMS arrived to assess the patient.
The first dose vaccination on Jan 8, 2021 very mild symptoms of arm soreness about 12hrs after injection. Lasted only a few hrs. Second dose vaccination on Jan 29, 2021 had more symptoms. Arm pain again about 10hrs after, lasted longer, about a day. About 18 hrs after injection was very fatigued and had a headache. This lasted about 24 hrs. Also had episodes of chills and slight fever. All symptoms were better a day later, though have noticed more headaches the following week.
Information has been received from a phyisican concerning a 61 year old female who on 25-Oct-2006 was vaccinated with a dose of varicella-zoster virus live (lot#652925/0621F). On approximately 07-Nov-2006, the patient developed a tingling sensation in the trunk area (or on her side) which turned into a stabbing pain and then a slight rash developed after receiving the vaccine. The physician thought the rash and the other reported symptoms was possibly shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 7/10/2022 Discharge Date: Jul 11, 2022   PRESENTING PROBLEM: Hypoxia [R09.02] Laceration of left eyebrow, initial encounter [S01.112A] Blunt head trauma, initial encounter [S09.8XXA] Fall from ground level [W18.30XA] Acute hypoxemic respiratory failure (HCC) [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE:   "Patient is a 77 yo male with a PMHx of chronic obstructive pulmonary disease, prostate cancer in 2007 s/p radiation, hypothyroidism, osteoporosis on Prolia who presented after a fall from ground level height.  Patient states that he was going for a walk and tripped when he fell into some bushes and hit his head on the ground. Noted patient is not on blood thinners but is on aspirin daily. He did not lose consciousness. He does not remember the events clearly. Bystanders who witnessed the fall helped him stand up called EMS. Patient states that prior to the fall he had no symptoms and was healthy. He is unsure if he had been around any sick contacts. He does not wear O2 at baseline and states that he lives alone. He states that prior to the fall he can usually remember his medications but is unable to at this time.    In the emergency department patient noted to be hypoxic requiring 4 L of supplemental oxygen.  CT of the head, CT cervical spine negative for acute findings.  Tetanus shot was updated due to a laceration to his lateral orbit which was repaired.  COVID-19 noted to be positive.  CT angiogram negative for any acute findings.  Labs unremarkable except for hemoglobin at 12.3.    Spoke with family upon patients permission who stated that patient has an "odd" personality but they did not feel he is usually confused at baseline. They did state that he will go back and forth with decisions frequently or never give a for sure answer. They were unaware of his PMHx or current medications as patient lived alone"   Patient was weaned off of oxygen overnight. He was seen by PT and OT who recommended home with home health care services. Patient was sent home with 8 more days of decadron for COVID-19 infection.
Patient received MMRV in office on 3/10/15. On 3/18/15 or 3/20/15 patient noticed painful/itchy area on back and mother began applying hydrocortisone. Appeared to spread under arm and to chest. Patient seen 3/28/14 and diagnosed with shingles. Patient given Rx of ZOVARIX to start if painful, but right now continues to just itch.
3/23/11 Fever; hot red firm swelling around injection site (PROQUAD given), itchy, painful site, child irritable. Treated with cold compresses & ADVIL, Topical Antihis.
Sore arm, itching around injection site, headache localized in the back of my head, and stiff neck
Patient says her ribs got sore and because of that she could not get deep breath. Now she feels better. However, she has an appointment with MD next week to rule out cause.
Pt received both vaccines of Pfizer. Pt was admitted to the hospital on 6/15 for SOB/dyspnea. SOB contributed to CHF exacerbation. COVID was incidental. No COVID treatments so far during admission.
Vaccine received on August 18th, and side effects started two days later. Patient reports to be as healthy as a horse and was swimming like the young people. Body started aching and patient started to measure her body temperature. The temperature kept on increasing until it got to 102 or 103, where she then started to take Dayquil/Nyquil. The temperature decreased to 100 with this, then it would increase. After, patient tried taking 400mg Ibuprofen every 6 hours but it would also increase/decrease the temperature the same. The patient then got bad chills and fever. She reports a little cough and coughing up a little bit . She reports having a bad fever and being very very dehydrated from this vaccine and that it is not going away.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 01-JUN-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL (lot # K006191 expiry date: 02-FEB-2017) (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports from the same reporter. Additional information is not expected because the reporter refused additional contact.
Pt. received the first pfizer vaccine on 1/28/21 at 2:10 pm to left arm and noticed that there was a significant amount of liquid running down patient's left arm while receiving the pfizer vaccine. Pt. said that she heard  a pop at the beginning when the needle was placed in patient's arm and the liquid was being injected into arm. Pt. states that she does not believe she received the full dose of the vaccine and is concerned.
Initial unsolicited report received from a nurse on 16-Mar-2017. This case involves a male patient (age reported as 40's) who was vaccinated with a dose of ACAM2000 (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 26-Jan-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) included gout. Illness at the time of vaccination was also not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 08-Feb-2017, 13 days following the vaccination, the patient reported pain, swelling in left ankle. It was also reported that patient continued to foot swelling and joint pain. Patient required emergency room (ER)/ doctor visit. Laboratory investigations were not reported. It was also reported that patient was sent for diagnostic tests and referral, with unknown results. Corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Pfizer orange cap booster dose administered 11 days past expiration date. Manufacturer contacted to report and consult on stability of vaccine. RN attempted to call Pt's father, no answer, VM left requesting call back.
He fainted and hit his head hard on the floor. Lost consciousness and went gray. Had a convulsion.
This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient's daughter was vaccinated with a dose of VARIVAX (Merck), 0.5ml on 05-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 15-JUL-2012 the patient experienced shingles. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
It began with chills, congestion and body aches and cough and congestion.   I had a low grade fever. I felt bad for about five days including racking coughing.  Then I started feeling better but I still had a and cough and congestion for the next five days. I tested positive for up to twelve days.  I had a cough for about month and up to today periodic coughing or a coughing fit two to three times a week.
UTI; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received the first dose of bnt162b2 (Lot number: EL3249), via an unspecified route of administration in left arm on 21Jan2021 09:00 at single dose for covid-19 immunization. Medical history included hypertension (HTN), atrial fibrillation, Allergies to Sulfa. Concomitant medication included diltiazem, apixaban (ELIQUIS), metoprolol, budesonide, formoterol fumarate (SYMBICORT). The patient experienced urinary tract infection (UTI) on 24Jan2021 14:00. The patient received the Antibiotics as treatment. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was no pregnant. The outcome of event was recovered on Jan 2021.
Sob/very sob at rest position; Palpitations/severe palpitations of 128 to 133; Severe skin rash was developed through my arms,legs, belly and under chin neck and upper arms; Skind feels like sand paper; This is a spontaneous report from a contactable other HCP. A 56-year-old other HCP (patient) of unknown gender reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN 6208), intramuscular into the left arm on 17Mar2021 at 09:15 AM (at the age of 56-years-old) at single dose for COVID-19 immunization. the patient had no known allergies. Medical history included High bp. Prior to vaccination,  the patient was not diagnosed with COVID-19. Concomitant drugs were unknown. 24 hrs from first dose of vaccine on 18Mar2021 at 08:00 AM, severe skin rash developed through the arms, legs, belly and under chin neck and upper arms. Causing sob and palpitations. The patient got an appointment with primary care Dr and he asked not to do 2nd dose and the patient did not took. At he time of reporting as almost 2 months from vaccine day and the patient still presented sob symptoms, also rash on legs, arms and neck has considerably increasing, further also skin feels like sand paper. Had an emergency room visit due to severe palpitations of 128 to 133. Also very sob at rest position After the patient followed up with primary order more meds and lab test. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was treated with Pills and creams. The reporter considered the events as non serious. The outcome of the events was not recovered. Covid Nasal Swab post vaccination done on 09May2021 was negative.
This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-FEB-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # K020185, expiration date: 27-JAN-2016 (dose and route of administration were not reported). There were no known adverse effects reported. Product quality complaint (PQC) was not involved. Additional information is not expected as the reporter did not wish to be contacted.
anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the fourth of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020.  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
Patient developed bilateral tinnitus and dizziness within a few days after her covid vaccination. Pt also reports irregular menstrual flow since vaccination. Menses have come every month but have been either very heavy or very light.
Administered Moderna COVID Vaccine at 10:39, patient reported headache and difficulty breathing at 10:49.  Patient's vitals taken and observed by myself as well as provider.  BP 155/74 patient reported they did not take their blood pressure medication today.  O2 97 % on room air with 95 HR.  Patient reported they needed to go to the bathroom, escorted patient to the bathroom, upon exiting the bathroom the patient reported she could not breathe.  Placed patient on 2 L NC, and Provider administered Epi pen as recorded in previous append.  EMS activated at 10:55 and patient vitals retaken.  O2 100%, Blood Pressure 171/106, HR 98.  Patient denied any change in the shortness to the shortness of breath, patient still reports they can not breath, patient used rescue inhaler at 10:59 two puffs, denies any releif from the shortness of breath.  EMS arrived at 11:05 and took the patient to DVH at 11:10.
Redness, tenderness, itchy, swollen increase thigh, 2 x original size, warm to touch, Taken to MD and dx with cellulitis.