chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left BELL'S PALSY-Patient has received a course of oral steroids, but the palsy has not resolved. May not be related to vaccine, but it was a new neurologic finding after vaccine.
Fever, chills, body ache, bad headache, nausea.        36 hours in bed.         No eating, no meds
Pain at injection site for 2 days.  Difficult moving  left arm and unable to move arm above shoulder height. One large bump/lump at left armpit about 2 inch diameter in size.   It does not hurt and did not increase in size over time.
Chills, pain at injection site, headache, swollen lymph nodes, weakness, fatigue, muscle pain/soreness. It started at 6:00pm on March 3, 2015 and I am still dealing with these symptoms and it is 11:15 pm on March 4, 2015. No treatment.
Pt. rptd. on 02/01/2021 having severe body aches, fatigue, inability to taste, (R) arm achy swollen & red "looked like bite mark", & itchy rash allover body Pt. declined injection of solumedrol benadryl or treatment. Wrote script for hydroxyzine 10mg tab, po, 1tab TID, prn. Tylenol (acetaminophen) 500mg 2tab po q8hrs prn. for body aches. Called 02/02/2021 to check on pt and no answer. Left vm.
pt recv 1dose varivax+ 2 other vax 4/17/98 & 4/20 pt devel facial twitching. 4/21pt unable tightly close left eye, drooping on left side of mouth, weakness in muscles left eye & mouth. dx w/Bell's palsy, treated w/acyclovir for 5 days
High fever 103.7 (axillary) within 12 hours of vaccine. No other symptoms such as rash, vomiting, etc.
A few hours after his well child check up he was not himself.  I would describe him as having an extremely decreased and inconsistant response to surroundings, sounds, and family members. My sister who he loved could not get him to smile or focus on her.  We did not take him to the doctor because this seemed slightly normal after shots.  He did perk up a little the next day, then he seemed like he was coming down with a cold, I could hear and feel congestion in his lungs.  3/20/09 Autopsy report states COD as sudden infant death syndrome.   Report states patient placed down for nap in crib on stomach on top of baby blanket.  Found cold & unresponsive.  Patient's bedroom noted to be very warm on investigation.
LARGE RED AREA AT INJECTION SITE. PAINFUL AND ITCHY AT SITE BUT ABLE TO MOVE L ARM ICE APPLIED. 8/28/2010 4 SMALL RED WELTS APPEARED ON L SIDE OF ABD. ALSO ITCHY. BENADRYL GEL APPLIED TO ABD. NO DRAINAGE OR VESICLES NOTED JUST WELTS. NO SOB.
a child under the age of 4 received the Quadracel vaccine, no adverse event; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a under four years old child patient who was vaccinated with a dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number, Exp. Date. Dose, route and site of administration not reported) on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.  No adverse event was reported post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Information on the batch number was requested.  List of documents held by sender: none.
Immediate itching at injection site. Benadryl 12-5 mg po given itching resolved in 20 minutes.
itching; RASH; plushed face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching), RASH (RASH) and FLUSHING (plushed face) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism, GERD, Osteopenia, Vitamin D deficiency and Vitamin B12 deficiency. Concomitant products included OMEPRAZOLE for GERD, VITAMINS NOS and LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, IBUPROFEN from 25-Mar-2021 to an unknown date for Knee pain, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for Vitamin B12 deficiency.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (itching), RASH (RASH) and FLUSHING (plushed face). The patient was treated with CALCIUM ongoing since an unknown date for Osteopenia, at a dose of 500 UNK, qd. At the time of the report, PRURITUS (itching), RASH (RASH) and FLUSHING (plushed face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment provided
Rash on both legs, arms, buttocks and waist. She was given Benadryl-D.
Overnight early am 7th woke up to  shaking chills fever >101, muscles, joints aches, headache, nausea sinus congestion   Treated fevers  for 3 days. Felt horrible missed 3 days wrk and  call  due to symptoms.  Tested for COVID-19 was negative on01- 11-21 FLU  test done also  NEG..01-11-21
Patient is 12 years old and was given the Moderna vaccine instead of the Pfizer vaccine by the nurse, patient is not having any adverse reaction at this time.
energy increase; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ENERGY INCREASED (non-serious), outcome "unknown", described as "energy increase".  Additional information: The reporter reports that after receiving all four doses of the Pfizer COVID 19 Vaccine he experienced an energy increase that lasted a day. reports that his neighbor also experienced an energy increase after his vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Skin necrosis; Severe dermatitis; Left side macerated with stuff all over it; Bilateral axillary pain that got worse and worse; Left side-patient reported that it was draining; Bilateral axillary swelling that got worse and worse; A spontaneous report was received from a physician concerning a 34-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe dermatitis, skin necrosis, bilateral axillary pain that got worse and worse, bilateral axillary swelling that got worse and worse, left side macerated with stuff all over it and left side-patient reported that it was draining.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On unknown date, the patient developed systemic reactions for a couple days with bilateral axillary swelling and pain that got worse and worse. She developed severe dermatitis with skin necrosis.  On 10 Jan 2021, the patient went to urgent care and was given methylprednisolone 50 mg for four days. Her left side especially was swelling and was macerated with stuff all over it. The patient reported that it was draining also. A computerized axial tomography (CAT) scan did not show any abscess; it showed several lymph nodes on left axilla with the largest being 1.5 centimeters (CM), nothing impressive and nothing that explains skin necrosis. Her white blood cell count (WBC) was 18 (units and reference ranges were not provided) and vital signs were stable with no fever. On exam, the only thing the doctor found was a small lymph node in the right axillary area, and the left axillary area was significantly more swollen. The injection site on the left arm has nothing.    On unknown date, the patient was at the hospital and given antibiotics and methylprednisolone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, severe dermatitis, skin necrosis, bilateral axillary pain that got worse and worse, bilateral axillary swelling that got worse and worse, left side macerated with stuff all over it and left side-patient reported that it was draining, were not reported.; Reporter's Comments: This case concerns a 34-year-old, female patient, who experienced a serious unexpected event of skin necrosis, non-serious unexpected event of dermatitis, skin maceration, axillary pain, wound secretion, and non-serious expected event of lymphadenopathy. The events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown.  Laboratory tests revealed WBC 18 and a CT scan showed several lymph nodes on left axilla with no abscess. Treatment included antibiotics and Medrol. Very limited information regarding these events has been provided at this time.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Fatigue; Chills; Headache; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Mild fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02LA20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-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 FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Mild fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-033985 (Patient Link).
dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 22-Sep-2021.  Vial did not undergone any temperature excursion.  No adverse event was reported.  No treatment medications were reported.
Inj given 05/11/04. Mom called 05/12/04. Mom called 5/12/04. Arm red, swollen, daughter.
This spontaneous report was received from a male physician of unknown age regarding himself via a company representative. No medical history and concurrent conditions were reported. On an unknown date approximately in 2011 (also reported as 5 years ago) the patient was vaccinated with a dose of VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date approximately in 2011 (also reported as the day after the injection) the patient became weak (hospitalization) and passed out (hospitalization) the physician was then taken to a hospital (unspecified duration of hospital stay) and was tested for a possible heart attack (hospitalization and medically significant). On an unknown date approximately in 2011 a hospital physician had stated to the reporting physician that he could have suffered a possible reaction to the VARIVAX injection. On an unknown date approximately in 2011 the patient underwent a magnetic resonance imaging (MRI) and an unspecified test (details unspecified) the results were not reported. It was reported that the patient sought medical attention but it was unknown if the physician received treatment for the event. The action taken with the therapy with VARIVAX was unknown. It was reported that after a few days after the incident the physician was recovering well and felt normal again with no other reactions. The outcome of syncope, myocardial infarction, vaccination complication and asthenia was reported as recovered. The relatedness of the events to the therapy with VARIVAX was unknown. There was no product quality complaint reported. Upon internal review the event heart attack was considered to be medically significant. Additional information has been requested.
LOSS/CHANGE OF HEARING IN THE LEFT EAR FOLLOWING HIS SECOND COVID VACCINE Narrative:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-APR-2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) (by an unspecified healthcare professional) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2013, the patient was treated at a hospital (by an unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
I have had a fever daily since receiving the 2nd vaccine ranging from 99.4-100.8.  In the past week it has been above 100 in the evenings
Swelling in joints with pain and swelling in bilateral knee, bilateral lower leg, bilateral shoulder, bilateral hand and fingers. Pain in neck and base of skull.   Severe fatigue, hot flashes and cold chills.
sz 6hr p/vax & 13hr p/vax seen in ER also had LP, CT;ear infect diagnosed;
Tenderness at injection site; some bruising in hands; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (some bruising in hands) and INJECTION SITE PAIN (Tenderness at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     THERE IS NO MEDICAL HISTORY PROVIDED BY THE REPORTER.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CONTUSION (some bruising in hands). On an unknown date, the patient experienced INJECTION SITE PAIN (Tenderness at injection site). At the time of the report, CONTUSION (some bruising in hands) and INJECTION SITE PAIN (Tenderness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant drugs includes thyroid medication,blood pressure medication, cholestreol medication. no treatment drugs included   This case was linked to MOD-2021-039961, MOD-2021-039961 (Patient Link).
Developed headache within one hour. Dizziness began approx. 2 hours after that. Body aches shortly thereafter. Headaches lasted into the second day, dizziness and aches into the third. All gone by the 4th day.
suspected vaccination failure; suffering because of getting this vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included polycystic kidney.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter's husband was suffering because of getting this vaccine and to add insult to injury.  The reporter asked if one could not be guaranteed that a vaccine would not prevent shingle in each person, why recommend it for a person with polycystic kidney disease. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. The polycystic kidney disease was considered as current condition conservatively as per description.  The case was considered as valid and shingles conservatively.  Follow-up would not possible as no contact details were available.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 24-NOV-2015, patient received improperly stored VARIVAX from batch/lot # L015045 (expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Shortly after my heart felt funny and I became somewhat  dizzy.  My actual shot was at a Pharmacy.  I drove home and from there laid down.  Woke up and felt horrible.   Diarrhea, heart was racing, dizzy.   Couldn?t eat so went back to sleep around  7 pm.  Slept for 15 hours.  I was exhausted and my heart felt funny.  I missed work Friday.  Returned to work Saturday.   Almost passed out so went to the ER.   My blood pressure and heart rate were high.  They said it was just a shot reaction and to rest.  Went home.  Felt bad for several more days.  My heart rate stayed elevated for a week along with my blood pressure
Pt recvd 2 doses Engerix-B 14DEC90 & 18JAN91 & on 28MA91 devel fever, chills, malaise & productive cough; Mid-April sx cont along w/night sweats & non-productive cough; MAY91 sx continued w/chest pain, tachycardia, costochondritis;
Pt developed injection site reaction a bump on injection site that kept getting bigger. Advised pt to go get it seen by her Dr. She stated kept growing (dime size and growing).
Neck, shoulder and all the way down to hand, dull most of the time but when moved or put pressure it was sharp. Was given physical therapy and gabapentin, ibuprofen, for the course. Still light pain but bad if moved or put pressure.
A report has been received from a health professional  concerning a 7 year old male patient. Health professional reported patient received 2 doses on FLUMIST on 02-OCT-2014. Health professional reported there was confusion at a school based clinic and the child inadvertently received 2 doses, patient had not reported any adverse effects. The outcome of the event of patient received two doses of FLUMIST QUADRIVALENT same day was unknown. The reporter was considered the event received two doses of FLUMIST QUADRIVALENT same day to be non-serious. Corrected report 22-OCT-2014. The source of the case was corrected from non-interventional / Post-marketing study to spontaneous and company causality was removed.
Initial itching at injection site within first hour followed within hours by redness, swelling and pain from top of shoulder to lateral elbow. Took Benadryl in evening and Ibuprofen. 10/26/16 evaluation at Clinic: symptoms resolving, some persisent redness measuring 10x6cm, slight warmth and tenderness.
Mother came with 4 children under 12 to receive COVID vaccinations. All children were crying. When mother filled out registration form, she wrote patient's date-of-birth as 6/4/2016, which would make the child 5. When the nurse asked the mother the child's age again, she said he was 5. The mother thought she was referring to his K4-5 class at school and answered he was 5 so child was vaccinated.  After family left, research showed the child's DOB is 6/4/2017 making the child only 4. Talked with mother on 11/29/2021, she already realized the child was too young. Child is doing fine and has no side affects. She understands he cannot get a second dose at this time and will work with her PCP in the Spring when he turns 5.
Pt was standing in hallway after getting her HIB vaccine; While sister got a drink of water. Pt fell forward on to face/trunk. No LOC pt didn't appear to trip. she was crying after the fall but was very upset with getting the HIB vaccine. Exam was normal, pt was alert and fine afterwards.
Information has been received from a consumer concerning her son with a history of migraine and no drug reaction or allergies, who on 21-AUG-2007 went to the doctor's office for physical and was vaccinated with first dose of Gardasil (lot # not provided). Consumer stated that the patient's breasts were tender and sticking out, but she thought that it was part of puberty. Unspecified medical attention was sought. No additional information was provided. Additional information has been requested.
This spontaneous report was received from a register nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of COMVAX (lot #, expiration date, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported, product quality complain was no involved. This is one of several reports received from the same reporter. Additional information has been requested.
A patient age 11 was given a DTaP vaccine, DAPTACEL, instead of Tdap, ADACEL, that was appropriate.