chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was retrieved via a search of scientific literature on 11 November 2011. The reporter for this case is the same as in case numbers: 2011-11264, 2011-11265, 2011-11267, 2011-11271 and 2011-11371. Verbatim form the abstract: "Background: Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine was not licensed for use in adults aged greater than or equal to 65 years due to lack of sufficient efficacy and safety data. Objective: To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than or equal to 65 years who received Tdap vaccine 'off-label' to assess for potential vaccine safety concerns. Methods: We searched VAERS for reports of adverse events (AEs) in subjects aged greater than or equal to 65 years who received Tdap vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports coded as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after Tdap compared with Td reports in subjects aged greater than or equal to 65 years. Results: VAERS received 243 reports following Tdap administered to persons aged greater than or equal to 65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after Tdap compared with Td. Six of seven Tdap reports containing the term 'Cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Conclusion: Our VAERS review of the 'off-label' use of Tdap vaccine in adults greater than or equal to 65 years did not find any safety concerns that warrant further study. These data will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for Tdap in older persons are adopted." A 70-year-old female patient had received Tdap (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced encephalitis. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Received vaccinations on 3/4/11. On 3/6/11 PM woke up from nap and parents noticed dropping of left side of face, asymmetric smile, also decreased use of left arm. Mom noticed occasional stiffness of (R) leg, which has improved. No fever. Slightly decreased appetite. Facial palsy (L) only affecting (L) side, not affecting eyes. (L) arm is hypotonic, no volunteer motion with (L) arm on 3/7/11. Baby active, no distress.
COVID-19 breakthrough. I started with a persistent cough. The next day it felt like sinus and a persistent cough. I thought it was a sinus infection so I went to the doctor because when I get those they can be very bad. Now what is persisting now is the cough. The symptoms weren't that bad but I had a slight fever of 99-100 degrees. The doctor gave me erythromycin 500mg, ZYRTEC, benzoate 100mg. She also told me to take vitamin C zinc and B12.
Very elevated blood glucose levels. Normal around 100, after shot 24HRS, still way over 300
Reddened & slightly edematous area, extending from injection site at deltoid into inner arm/bicep area. Tender and intermittently pruritic.
2/8 begin small area of rash below Adam?s apple 2/13 very itchy rash spreads to chest, neck back, hands and ears 2/18 rash and itchiness is declining
1/11/2021 vaccination. I had chills, felt feverish, sore arm. I took the rest of the afternoon off from work. That evening had trouble sleep. Felt like stomach was 'burning'. Nausea. Stomach cramping. Had these symptoms for 24-36 hours. I went to urgent care. They gave me Zofran. to help with nausea and a acid reflux medicine.  Symptoms were gone by that evening.
1 of 4 pts (out of 38 pts vaxed) who had an adverse event following vax; pt had local rxn w/redness, soreness & swelling; resolved w/in 24 hrs spontaneously; no known allergies;
Sedation, Arthralgia,  Pain @ injection site, Swollen lymph nodes Narrative:
nausea; throwing up; headache; pain in left arm increased; arm started to hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm started to hurt a little bit), VACCINATION SITE PAIN (pain in left arm increased), HEADACHE (headache), NAUSEA (nausea) and VOMITING (throwing up) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017ELIA) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE PAIN (arm started to hurt a little bit). On 19-Aug-2021, the patient experienced VACCINATION SITE PAIN (pain in left arm increased). On 20-Aug-2021, the patient experienced HEADACHE (headache). On 21-Aug-2021, the patient experienced NAUSEA (nausea) and VOMITING (throwing up). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm started to hurt a little bit), VACCINATION SITE PAIN (pain in left arm increased), NAUSEA (nausea) and VOMITING (throwing up) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.
fever; This case was reported by a physician via sales rep and described the occurrence of fever in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter wanted us to know they just started giving shingrix in office. and have had a lot of patient complain of fevers reviewed package insert with them again. They were good with information and realize fevers might happen. The reporter did not agreed to follow up with GlaxoSmithKline.
1 of 5 pt immunized from the same vial who exp a 102" area of induration & erythema @ DTP site; reaction occcurred in pt w/in 24-48 hrs following immun; required ER/MD visit;
arm pain, swelling at injection site, chills, body aches, low-grade temp 100.9  treated with OTC analgesics, cold compress
About 15 minutes after the shot started having sever itching on face & neck.  Had taken a benadryl before going due to getting hives on first shot.  No hives this time.  They had me take a 2nd benadryl when this started.  About 10 or 15 minutes later had asthma cough start with severe itchy throat.  After 2nd benadryl started working it went away.
Information has been received from a nurse concerning a 6 month old patient who on 05-MAR-2009 was vaccinated with the first dose of ROTATEQ (lot number not reported).  On 16-JUL-2009 the patient was vaccinated with the second dose of ROTATEQ (lot number not reported).  There was no adverse effect reported.  Follow-up information has been received from a nurse practitioner who reported that the patient did not have exposure to ROTATEQ nor was there an adverse experience.  It was reported that they were checking on time between vaccines to ensure child could get all three dosages within time frame.  Additional information is not expected.
Tenderness on the injection site left arm,  Right hip pain, Right elbow pain,  Headache and fatigue
Itchy, red, swollen, and 4 inch in diameter rash at site of injection starting 7th day after injection and lasting   5 days. Also on the seventh day began aching legs at evening and through the night, disrupting sleep. This lasted  7 days. Also on Seventh day started extreme fatigue, and anxiety. Symptoms of anxiety included shallow breathing, Heaviness in chest, fleeting  thoughts. These symptoms are continuing  through now being the 22nd day.
Throat irritation Narrative: Patient was evaluated after reporting a "scratchy throat" at Facility post injection. He reports that this happened with his first vaccine as well, but it resolved after 10 minutes. His symptoms again resolved after 10 minutes. He takes anti-histamines daily for allergies and uses a nasal spray. T 99.2 F, O2 Sat 96% RA, R 16, P 81 and Alert. It started after he sat in the chair and stopped in 10 minutes. He was monitored for 15 additional minutes at the Facility and the scratchy throat never returned. He feels comfortable to drive home. Flagging PCP for continuity.
upper arm pain at injection site, muscle and joint pain, feeling of malaise starting on 7/29/2020
My arm became red and blistering at the injection site, which lasted for about 8 days. After that on 02/19/2021 I started to get bruises on my legs and arms about 20 of them , which I didn't know where they came from, like small bruises bunched up on my leg. Went to Dr. office and drew blood and my white blood count was very low, my mpv was at 10.5,  did another blood count at 03/19/2021 and my blood levels were back up to normal but my white blood count was still low.
swelling and pain on the arm that was injected; swelling and pain on the arm that was injected; Lethargic; Fever/temperature reached 100.7; fatigued/ tired; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect from a contactable Female consumer (Patient). A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142, Expiry Date: 20Mar2021), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included torn rotator cuffs, ongoing chronic obstructive pulmonary disease (COPD), immunocompromised, shoulder pain that she was getting the cortisone shot for was prior to the COVID shot. She also reported that she took prednisone regularly. The patient's concomitant medications were not reported. The patient got the first dose of the vaccine on 04Jan2021. She was scheduled to have cortisone injections to both of her shoulders for torn rotator cuffs on 13Jan2020 and then scheduled to get the second dose of the covid vaccine on 24Jan2020. The caller confirmed that the shoulder pain that she was getting the cortisone shot for was prior to the COVID shot and she had been getting them for some time. She mentioned she had a reaction to the first shot, she had swelling and pain on the arm that was injected. Also, she had a fever and felt lethargic that night but the next day she felt fine. The next day she actually could hardly get out of bed and felt fatigued and tired. Her temperature reached 100.7. This happened on 05Jan2021. At time of the report, she felt fine and the events resolved. She really just wanted to know if the shots would interfere with each other. Events reported as non-serious. The outcome of event fatigued/ tired was unknown, of the other events was recovered on 06Jan2021.
This literature marketed report refers to a 57 year old male patient. Patient's past history included splenectomy at age eleven after a motor vehicle accident. The patient's medical condition included End stage renal disease (ESRD) and the patient was on haemodialysis. On an unknown date the patient was vaccinated with hepatitis B (recombinant) (manufacturer unknown) (strength, dose, dose number, route of administration, indication, lot number and expiration dates were not reported). He had received the vaccine previously with no documented adverse reaction. No concomitant medications were reported. On an unknown date (reported as two days after the vaccination) the patient was transferred from nursing home to a hospital due to an abnormally low platelet count (3000/ mm3) found on a blood test. The patient had noticed bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucosal bleeding in the mouth. A CT head on an unknown date showed no intracranial haemorrhage. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology. On an unknown date prothrombin time and active partial thromboplastin time were normal. Assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies were normal on an unknown date. On an unknown date serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. He was initially transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura (ITP) (life threatening, hospitalization) was made on an unknown date. The patient was started on IV SOLUMEDROL, intravenous immunoglobulin and aminocaproic acid. By the end of the fifth day, the platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow up on an unknown date. The event was considered as recovered. The author stated that the vaccine is usually well tolerated, with few side effects; but several cases of thrombocytopenia after recombinant vaccine have been described. ITP is thought to be caused by the presence of autoantibodies to glycoprotein II b/III a molecules present in the platelet membrane. Repeated doses of vaccine may function as a booster to autoantibody formation. The patient had rapid onset of thrombocytopenia. The author stated that immune thrombocytopenia can be a potential life threatening complication of Hepatitis B vaccination in adults. Additional information has been requested.
Reported temperature of 101 degrees 24 hours post vaccine Eased with TYLENOL. Also developed red streaks from injection site (L) Deltoid to elbow which persisted x 4 days.
Severe arm pain, swelling, redness, fever. Patient admitted to infirmary for observation, resulting of blood work, and empiric antibiotics to treat possible cellulitis.
1st event: March 15th -It felt like I had indigestion; I had pain in my chest. I went to URGENT CARE. She told me to go to ER when I said I had chest pain. Went to ER; They put me on a gurney. That was a blood clot and they treated me with ER - two days in patient hospital. IV fluids and they put me on Eliquis. They sent me home with Eliquis and said to take it for the next 6 months. 2nd event: in  July -I had abdominal pains. I went to ER; I was having issues urinating. I felt all blocked up. My prostrate was blown up. I had acute Kidney failure. They had to drain my bladder. They admitted me for three days and I had  IV catheter for a week. Put me on medication: Flomax.  They still have me on Eliquis. I am still taking Flomax, too. I have had follow ups with doctors from the hospital.
I started to get swollen, my stomach was big, I had severe headaches, I was swollen, I felt sick, not strong, like if I had the flu, my eyes were really dry and big, I noticed my hair got really dry, I could not do my normal day activities, I was moving too slow, I was struggling, I was frustrated brushing my teeth, I was tired and drained, I could not taste food, I started to get bloody mucus. I got really worse with my second dose. I decided to go to the doctor maybe 2 weeks after getting my second dose. He gave me Loratadine because he thought it was an allergy.
On 10/30/08 pt stated arm swollen, extremely hot and sore at elbow which lasted until Friday.  On Saturday symptoms improved and he returned to work on Monday.  On 10/30/08 he also went to Dr. and they gave him penicillin QID.
1-2 days after receiving DT immunization, patient complained of redness, itching and swelling.  Limited to injection sight on left upper arm.
10 days after the vaccine I experienced terrible dizziness, falling into the wall, nausea, and headache. The next morning my arm was swollen, red, hot, and sore where I had received the injection. The arm remained that way the entire day but was gone the next day.
Temp elevated 12 hours later Next morning Temperature 99.3,  body aches, upset stomach continues with same symptoms at 10AM
Age: 86 y.o. Admit Date: 8/1/2022 10:50 PM Discharge Date:  8/5/22 Admitting Physician:  Discharge Physician:     Discharge Diagnosis: Principal Problem:   Fall Active Problems:   Dehydration   Hyponatremia   Hypokalemia   Hypocalcemia       HPI: Patient is a 86 y.o. female who was brought here by EMS after she called her family stating she could not get up. She lives alone. When they arrived, the door was locked and they had to call the fire department to break down the door. The patient was found sitting at the kitchen table but could not get up without assistance. She is not cleared about whether she fell prior. She is a poor historian. She has electrolyte disturbnaces on labs. Family is requesting for possible placement since they do not think she can live alone anymore.   Hospital Course: Patient was given IVF. COVID +, asymptomatic and was not treated. Urine culture positive for Ecoli however patient denied symptoms. She will DC to rehab      Dehydration -s/p IVF   Falls-PT/OT. Nursing facility placement   COVID-asymptomatic. On room air, not on treatment   Urine culture + ecoli. She denies urinary symptoms.   Heparin SC Nursing facility on DC.        Physical Exam on the Date of Discharge: Physical Exam Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Breath sounds: Normal breath sounds.  Abdominal:     General: Bowel sounds are normal.  Musculoskeletal:     Right lower leg: No edema.     Left lower leg: No edema.  Skin:    General: Skin is warm and dry.  Neurological:     Mental Status: She is alert.       Consults:   IP CONSULT TO SOCIAL WORK     Disposition:  Nursing facility   Discharge Condition:  good
C/O numbness tingling sensation in both arms and buttocks area.  Lightheaded feeling.  All symptoms have subsided at 0515.
Increased heart rate to 131 at 11:29 am; dizziness; muscle weakness; swelling of tongue; This is a spontaneous report from a contactable consumer. This 42-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 11:15 (Batch/Lot Number: EN6206; Expiration Date: Jun2021) as Ist dose, single dose for covid-19 immunisation. Medical history included chronic sinusitis, ventricular extrasystoles, covid-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. Concomitant medications included azelastine (AZELASTINE); fluticasone (FLUTICASONE) taken for an unspecified indication, start and stop date were not reported. The patient previously took pseudoephedrine and experienced drug hypersensitivity. On 05Mar2021 11:30 the patient experienced increased heart rate to 131 at 11:29, dizziness, muscle weakness, swelling of tongue. The patient underwent lab tests and procedures which included heart rate: 131 on 05Mar2021. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was recovered.
I did not have an adverse reaction to the vaccine. On 03/26/2023 I went to the emergency room for appendicitis. I had a appendectomy on 03/27/2023.
Information has been received from a nurse practitioner concerning a 28 year old female who on 10/08/01 was vaccinated with MMR II (lot 637837/0373L). On 10/09/2001, the pt experienced malaise and nausea. The pt had sought medical attention for her experience. Additional info has been requested.
blister on his right elbow; red patch 3 inches diameter, 0.5inches below injection site; was warm to the touch; This case was reported by a consumer via call center representative and described the occurrence of skin red in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 30th March 2022, the patient received the 2nd dose of Shingrix (injection). On 30th March 2022, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced skin red and skin warm. On 4th April 2022, the patient experienced blister. On 31st March 2022, the outcome of the skin red was recovered/resolved. On an unknown date, the outcome of the skin warm and blister were recovered/resolved.   It was unknown if the reporter considered the skin red, skin warm and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix in mid January 2022 (unspecified date) The patient reported that after second dose of Shingrix within 1-2 hours he developed a red patch 3 inches in diameter about 0.5 inches below the site of injection that was red and warm to the touch.  The patient reported that the red patch went away the following day.  The patient reported that on day of reporting, he noticed a blister on right elbow. The patient wants to know if Shingrix can cause shingles. The patient did not want to provide DOB (Date Of Birth)and HCP (health care professional) contact information. The consent not obtained to contact HCP (health care professional) and consumer for follow-up.
Breakthrough case admission after two doses Moderna 5/18/21 Lot# 023C21A;  Moderna 6/15/21 Lot# 050C21A
The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 21 months old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 11-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Parents woke up to patient seizing at ~ 0700 11/22/19. Status Epilepticus x 45 minutes. Intubated Remained in ICU x 28 hours. CT scan, LP and all labs negative. Still has altered neurological status. Still hospitalized
Felt very tired and had runny nose.  This progressed into headache, cough and flu like symptoms.  Fever on 10/23/13 was 101.  Routine measures such as aspirin and nasal spray and rest worked fine.
Diarrhea developed 1 day after immunizations given. Large volume watery stools with no vomiting. Fever to 101 x 24 hours. Not dehydrated.