chrisvoncsefalvay/vaers-outcomes huggingface dataset:
R Leg reaction started day of injection. Persists at 48 hrs. Swelling, tenderness and red. Red rash around injection site. Swelling involved Ant. thigh
pt recvd vax 27AUG94 & devel wheals on extremities, trunk & around waist-line; c/o nausea, h/a & malaise; took DPH seen by PMD; rx Pred;
Patient noticed bruising beginning at injection area several days after receiving vaccine that slowly expanded down the arm, almost to the elbow. Patient came in 2 weeks after receiving vaccine and 3 weeks after receiving vaccine to show pharmacists the bruise; it is now faint and yellow in color and appears to be healing. Due to size of bruise, patient wanted it reported to VAERS. No treatment was done at home.
Approx 10 min after 4 yr old immunizations were given child complained of feet feeling hot, hurting, nausea, emesis 3x, rash to face and body. Provider notified of reaction, ordered 7ml Benadryl by mouth at 13:50. No wheezing, airway obstructions. Child observed until 15:10, released with parents. Verbalized understanding of s/s for Dr.
After administering  vaccinations, I realized that the >65 dose of Flu vaccine was administered.  I notified Patient, who was feeling fine and was having no adverse reactions.  I faxed/phoned  Patient's doctor.  I  filed Self report and completed this vaers.
Pt recvd vax 13APR92 & on 28APR92 & devel diffuse hair loss in the occipital area, which was fairly rapid over a period of several days;
No adverse signs or symptoms reported. Dose of 0.25 booster given from vial that was punctured and at room temp for 24 hours.
Chills, fever, swollen lymph node, muscle spasms in legs/arms, fatigue
Tugging at ears; cold symptoms; increased crying and irritability; teary left eye.  Office visits on 12/18 and 12/21.  Emergency Department visit while traveling on 12/24/14:  given oral steroids for croup.  Seen again in office on 12/28/14.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 at 10:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 22Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Diabetes type 2" (unspecified if ongoing), notes: Diabetes type 2; "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included treatment with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I just wanted to report that I'm experiencing an adverse reaction to the flu shot beyond what I would consider normal limits. At approx 7PM 9/12/2023, I started experiencing severe chills, muscle fatigue, inability to stand up straight (weakness) tingling in jawline, difficulty swallowing, and high fever (104-105 degrees farenheit at the highest). Fever slow to respond to Tylenol and cold compress. This is an early report so final outcome is not available yet.
Pt arrived from outlying facility with shortness of breath. She has a history of CHF, cardiomyopathy, DM, and was admitted due to COVID-19 and hypoxic respiratory failure.
severe muscle and joint pain, swelling of axillary lymph nodes, headache; ongoing X 2 days
Exacerbation of butterfly rash on face. Bullae and vesicles scalp and L lateral canthus area. Erythema/edema (L) shoulder. Pt has had a butterfly rash since birth. Her work up had included a diagnosis of food allergies. She was Dx with lactose intolerance and formulas are being switched. Pt. mother PMH (positive), Sjogren's, RA, hypothyroid. On 8/8/18 she received vaccines as noted in the right and left thighs. By 8/9/18 patient had an exacerbation of butterfly rash, with increased erythema covering both cheeks. She had upper eyelid edema. Mother gave TYLENOL for fever. Patient developed small bullae on left malar cheek, erythema prominent over left shoulder. Patient then developed a large bullae covering entire vertex of scalp. This had very little serum in it on exam. The bullae on the left cheek were superficial and debrided with serous crust. Patient was referred to pediatric dermatologist 8/10/18 at 8:30 AM for further evaluation. No meds were given except for warm compresses. An unofficial consult was done with Dr., employee of CDC, expert in vaccinations. She confirmed this was not a common reaction.
Very bad chills, Eyes were very bloodshot. Irises were large and pale, pupils were very small. After talking to the on call physician, took 25 mg BENADRYL with water. Vomiting began and lasted for several minutes.
pt recvd vax;exp abd pain,fever,fatigue & loss of appetite w/ 1st & second dose of varivax;
Maculopapular rash began on right arm and spread throughout the body 1-2 days after the second vaccination. No fevers, pain, itchy or joint pain was involved. Rash is asymptomatic.
Arthus reaction, redness, swelling, induration, warmth, pain. Started at about an inch and grew to over 4x2.5 with whole arm and hand swelling.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 82-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than an hour after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. This case was previously not reported to anyone. The patient received SHINGRIX on the left arm, approximately two months ago from the date of reporting. Within half an hour after receiving SHINGRIX, her arm became sore. The soreness has almost fully resolved although sometimes she does get an ache in the arm. The patient would not provide additional information. The patient denied permission to contact their physician. This case is 1 of the 3 linked cases reported by the same reporter.
Fever, redness and swelling at injection sites, fussy, irritable, fear of falling, decreased eating (although still takes 1/2 bottles), but have to go back to tube feeds for enough calories through her G-tube and to prevent dehydration. Here I am filling out ANOTHER VAERS form for each of the little twin girls we have had in our home through foster care since they were released from the hospital weeks after they were born. We are in the early stages of the adoption process. Due to the severe adverse reactions each girl experienced in April 2014, we were able to obtain a court order to suspend any further vaccinations for 6 months. After this court order was issued, the girls each had to have G-tubes surgically placed due to the severe side effects of previous vaccinations given. Their G-tube surgeries were in June 2014. In January 2015, the PCP and the dept. decided since the court order was no longer valid (past the proposed 6 month time period) that the girls needed to get caught up on ALL their vaccines (with the exception of the live virus vaccines - as we currently have a child doing chemo and his PCP recommended that NO family members get ANY vaccines while he is undergoing chemo). During this time, the girls have progressed tremendously and were not being tube fed all the time. We were working towards bolus feeds along with oral eating via table meals and bottles with their high calorie formula. I went to another licensed medical doctor for a 2nd opinion on January 19, 2015 concerning getting any more vaccines due to their previous documented reactions. After examining each girl and thoroughly going over all the documentation from previous appointments with their PCP, my own documentation and their O/T, he made strong recommendations that it would NOT be in their best interest to get any more vaccines. He then filled out a permanent MEDICAL EXEMPTION form so they would not receive any further vaccines due to their previous adverse reactions that seemed to be getting worse each time they received a vaccination.
2 hours after receiving vaccination, developed diarrhea which lasted for 48 hours. Minor nausea. No fever. Muscle aches 72 hours after vaccination.
Day 1-within 8hrs- left lethargic up to 48hrs after; temp 99.8 Day 2-rash localized to forehead, eyelids and scalp; temp 98.6 Day 3-rash continued same locations- took Benadryl  Day 4-rash still on forehead, eye lids- Vaseline eyelids as terrified of anything being placed in my eyes Day 5-continuation of same- Vaseline again Day 6- continuation of same- Hot compress 5 times daily; didn't use Vaseline  Day 7-continuation of same- Hot compress 3 times daily; used Vaseline again as I'm very itchy Day 8- continuation of same- Vaseline eyelids Day 9- continuation of same- Hot compress Day 10-continuation of same---By this time I'm tired of this situation Day 11- Being 1--17-21 through--- today I continue to have the same exact itching and only on upper face, eyelids and scalp.
This spontaneous report as received form a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 23-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # reported as 1004743 with expiration date 01-JUN-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Attempt to reach parent with assistance of interpreter to check on patient. Left message to call to the office.
Briefly, this patient is a 68 year old female presenting in respiratory distress.  She was diagnosed with Covid 4 weeks ago.  She has been at home recently with home O2.  She notes the gradual onset of increasing work of breathing to where EMS was called.  She was satting 60% on their arrival, and CPAP raised her to 80%.  She arrived awake and alert, in respiratory distress.  We could not get her above 85% despite settings of 18/10 with 100% on BiPap, so we intubated her.  She initially had improved Bps but they have now dropped so we are starting a norepi drip.  Admitting to the ICU for further care.
Acute on chronic congestive heart failure, unspecified heart failure type; Bilateral pleural effusion; COPD exacerbation; COVID-19 virus not detected; Hypoxia; SOB (shortness of breath)
Information has been received from a nurse concerning her daughter, a 38 year old female, who on 31-JUL-2007 was vaccinated with ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck). It was reported to have been a mistake, and not product confusion. There were no adverse reactions reported. It was noted that the patient had previously received VARIVAX (Oka/Merck) in October 2007. There was no product quality complaint; Additional information has been requested.
At the time of the vaccine, the patient reported she felt an "explosion" when the needle was inserted into the left arm. She had left arm soreness over the subsequent days. After a week or two symptoms got worse with increased pain noted on 4/20/21.  Supportive care with analgesia was recommended by her primary care doctor. The pain in the left arm continued and the patient noted impaired range of motion  of the left shoulder with sensation of swelling in the arm  on 4/30/21. She was advised on shoulder exercises. There continued to be worsening pain and decreased range of motion of the left shoulder with notably impaired function. The patient also complained of ongoing tiredness and impaired sleep due to shoulder and arm pain.  She was assessed on 5/3/21 by her primary care doctor where exam showed swelling of the anterior left shoulder without erythema. There was severely impaired range of motion. She was diagnosed with frozen shoulder on the left. She was referred to orthopedic specialist and was seen on 5/4/21  where the diagnosis was confirmed along with impingement syndrome of the left shoulder. She received an intra-articular injection of steroid and was referred to physical therapy.  An MRI was recommended.
Case number PHEH2014US015495 is an initial spontaneous report received from a nurse on 31 Jul 2014, and with a follow up report received from nurse on 04 Sep 2014. This report refers to a 16 year old male patient. His medical history and concomitant medication were not reported. On 30 Jul 2014, he was vaccinated only with the liquid component of MENVEO (batch number: X12024) via intramuscular route instead of being reconstituted with MenA. His mother reported that the vaccination will be repeated in this month. No adverse event was reported following this maladministration error. Follow up report received from nurse on 04 Sep 2014. Updated patient details and mother comments.
within 10 mins, heavy muscle spasms all over body, bones aching, restless days, can barely move, memory loss, fatigue
she has been itching ever since and it wont; Redness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (she has been itching ever since and it wont) and ERYTHEMA (Redness on arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRURITUS (she has been itching ever since and it wont) and ERYTHEMA (Redness on arm). At the time of the report, PRURITUS (she has been itching ever since and it wont) and ERYTHEMA (Redness on arm) outcome was unknown. Not Provided          This case was linked to MOD-2021-114662 (Patient Link).
Hives, itching, heat, redness and swelling to the right upper arm, hives up to chin. Then 10 minutes after that started to get tremors to the right hand. Allergic to antihistamines was sent to ER.
pt recv vax 1995 & APR97 pt devel chickenpox w/200-300 lesions;
Breakthrough case admission after two vaccines Moderna 4/2/21 Lot# 002C21A;  Moderna 5/20/21 Lot# RY864602
Got inoculation and got shingles/suspected vaccination failure; Shingles again; Horrible and painful; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got inoculation and got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles again) and pain (Verbatim: Horrible and painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. The reporter stated that, it was horrible and painful, she knew several people including her poor late husband who had got the inoculation and had shingles again in spite of the inoculation another equivocated result. This case was considered as suspected vaccination failure as details regarding, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available. This case was linked with US2023AMR039364 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR039364:Same reporter
Within a few days of receiving one dose of varicella virus vaccine live the pt developed an erythema multiforme rash everywhere with approximately 70 lesions. It was noted that the rash was not a typical varicella type rash and the pt was afebrile.
Unable to sleep due to level of fever, shaking, nausea and dizziness. Fever, SOB, and dizziness continued until around 10:30 am the next day. Caused a migraine.
This case was reported by a consumer (subject's wife) and described the occurrence of injection site soreness in a 37-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Vitamin C and Mens formula multivitamin. On 9 March 2013 at 13:00 the subject received a dose of BOOSTRIX (unknown route, left arm). On the morning of 10 March 2013, 1 day after vaccination with BOOSTRIX, the subject experienced injection site soreness. The subject did not consult a health care provider regarding the event. On 11 March 2013, the event was resolved. The reporter also reported another case involving BOOSTRIX. See case A1016239A for details on the other case.
Information has been received from a physician concerning a female with no pertinent medical history and no drug reactions/allergies who, "as a child", was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. In junior high school, the patient "showed low titer". The patient was revaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). In approximately July 2006, at 19-years-old, the patient was tested prior to working and was found to have low titers again. No further information was available. Unspecified medical attention was sought. The outcome was not reported as not recovered. There was no product quality complaint. Additional information has been requested.
Patient had recurrence of panic attacks after clinical remission on medication for panic disorder. Patient concerned this recurrence was triggered by Anthrax vaccination, but other stress factors likely in the military environment in which it was given.
Swollen, Tender Armpit lymph node on the same arm as injection site; Hives; This is a spontaneous report from a contactable other hcp (patient).   This 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL1283), intramuscular at single dose in the left arm on 20Jan2021 09:45 for COVID-19 immunisation. Medical history included Penicillin allergy.  Concomitant medications were not reported. On 01Feb2021, the patient experienced swollen, tender armpit lymph node on the same arm as injection site with outcome of not recovered (as reported), hives with outcome of not recovered (as reported). Treatment was required and included Benadryl and Cortisone cream for hives. The events were described as follows: "Swollen, tender armpit lymph node on the same arm as injection site, noticed a week after injection and resolved 10 days post injection. Hives reaction approx 2 weeks post injection, has continued 3 days". The events required a visit to the physician's office. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.
Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown date the patients were vaccinated with (Oka/Merck) VARIVAX that underwent a supported temperature excursion (dose, dose number, lot #, route and application site were not reported). Concomitant therapy was not reported. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
This literature marketed report was received and refers to a 17 year old female patient. At the age of 7 years, the patient presented with recurrent pneumonias and sinusitis. Laboratory investigations at the age of 13 years showed severe panhypogammaglobulinemia associated with lymphopenia, and low B cell count in particular (severe B cell lymphopenia). The patient was started on intravenous immunoglobulin (IVIG) treatment and antibiotic prophylaxis with trimethoprim (+) sulfamethoxazole. At the age of 13 years, her short stature and small head circumference prompted investigation for a DNA repair defect. Radiosensitivity testing on peripheral blood cells was performed and the results were suggestive of ligase-4 (LIG4) syndrome. Sequencing of the LIG4 gene revealed two compound heterozygous mutations leading to immunological abnormalities. On an unknown date, the patient was vaccinated with a dose of tetanus toxoid and had protective titers of antibodies to the vaccine. On an unknown date, she was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiry date were not reported). Upon immunization, protective antibody responses were detected against only 2 of 23 serotypes. The outcome of antibody response abnormal was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of two reports received from the same literature article (cross referenced with # 1606USA000282). Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to an unknown number of patients. It was reported that on unspecified dates, an unknown number of patients were vaccinated with PNEUMOVAX23 (lot #, expiration date, dose, route of administration and indication were not provided) that had been improperly stored. No adverse effects were reported. No further information was provided. Additional information has been requested.
I had a cough for about 2 weeks, but it got much worse on 5/1/22. I officially tested positive on 5/5/22. Z PAK, Promethazine cough syrup, Zinc and vitamins C and D prescribed by doctor.