chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on the leg; Initial information received on 26-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of an unknown age and gender who experienced rash on the leg after receiving diphtheria-15/tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect diphtheria-15/tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine suspension for injection (strength, expiry date and lot number: not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed rash on the leg (rash) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
pt recvd vax;devel redness & pain in the arm of inject;sx resolved
PT c/o NVD fever malaise, URI. lymphadenopathy of afillary in cervical area left groin vaccine site f/u and wnl. PTS primary physician examined 3-11-03 continued adenopathy wound is scabbed approx. 2 cm rx's cipro.
Extreme fatigue.  I slept close to 24 hours, woke for about 10 min and had horrible muscle/joint aches.  Returned to bed for another 5 hours.  Had a lingering headache (pain behind my eyes) for about 2 days afterwards.
This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (dose strength, route unspecified). No adverse effects reported. Follow up information has been received from the pharmacist who provided additional information. It was reported that a current 57 year old patient (gender not provided) received a dose of ZOSTAVAX Lot # K021953, expiry date on 10-FEB-2016, that was inappropriately storage. This is one of several cases received from the same source. Additional information has been requested.
Varicella administered on Tuesday,6/2/09. On Thursday a 2.5 inch x 2 inch erythematous, raised, tender, area noted around injection site. This area was warm to touch. Denied fever, itching, streaking, or any other systemic symptoms. One tablet of Benedryl taken Friday night before bed. Woke up Saturday, 6/6/09 and less reddness and edema noted. Spoke with mother today, 6/8/09 and the area of erythema and edema has cleared. Area no longer tender.
I had a sore arm and fatigue for about day after receiving the vaccine. I tested positive for COVID-19 in 02/2023. I had a lot of coughing and fatigue.  I contacted my doctor and got a prescription for Paxlovid. It took a long time for the cough to go away. I developed a sinus infection and ear infection with a terrible cough. I am on a round of antibiotics to take care of the infections. As of today, I am showing signs of long COVID-19.
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 27-year-old female. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: Product Complaint Investigation results.
Broke out in hives seven days after my first shot, waited about a week to see if they would go away, treated with Prednisone and Zyrtec, no change, they got worse. A week or so later went to an allergist a couple of days before my second shot who assured me it wasn't from the vaccine, prescribed Triamcinolone Acetonide which helped with the swelling but kept getting outbreaks, went to my dermatologist about 1 and 1/2 weeks later who took a biopsy and said the biopsy showed a "drug" reaction. Told me to wait it out another month until it got through my system. That was 3 days ago and I'm still breaking out.
Tetanus shot administered Saturday rt deltoid through tattoo, Sunday noticed tenderness (fine, no sx until Sunday) and mild tenderness, warm to touch. Sx's continue today: 2 inch diameter swelling and redness, warm to touch. Tx: monitor.
Numbness in lips and tongue, lightheaded and headache after 15 mins of getting vaccine. Fluids given at 1030am
18NOV96 pt recv vax;20NOV96 mom reported rxn-10x13cm area of heat, induration, edema @ site of DTAP;no sign of pyoderma or cellulitis;tx cool compresses & advil;
Patient fainted around 5 minutes after injection.  Patient has a history of fainting  with injections dating back to pre-adolescence.  Pharmacist asked patient to please plan to stay 30 minutes instead of the usual 15 due to history.  Patient's mother was present, just in case he fainted.  Patient seemed fine with injection and pharmacist sat with him first 5 minutes after to make sure.  Almost immediately after the pharmacist walked away, patient fell over in chair in waiting area.  Patient completely lost consciousness for less than a minute.
breaking out with hives; This is a spontaneous report from a Pfizer-sponsored program. This is a report from contactable 52-year-old female consumer (patient herself), she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on 18Apr2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 52 years). The patient medical history included celiac disease. The patient concomitant medications were not reported. On 18Apr2021, two hours afterward the patient experienced breaking out with hives. It was reported that, she took Benadryl (Batch/Lot number: Unknown, Expiry Date: Unknown) twice, but still, she continues to break out in hives on 19Apr2021 morning also. Therapeutic measures were taken as a result of breaking out with hives includes Benadryl. The outcome of the event was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Lt. arm swells following injection of PNEUMOVAX 23 on 10/28/2013, leading to skin infection. Pt is currently taking KEFLEX.
pt recv vax 27SEP96 & 30SEP96 pt devel two spots under each arm & larger blotches on face;
Severe muscle pain in lower back and shoulders/Site injection arm pain in the form of muscle soreness; Severe joint pain in lower back and shoulders; injection site arm pain; fatigue; Stimulated immune response (more than normal) of arthritis already diagnosed between L4 and L5 of the spine; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the left arm on 20Jun2021 at 16:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and possible degenerative disc disease. Concomitant medications included duloxetine hydrochloride (CYMBALTA), ethinylestradiol, levonorgestrel (AVIANE), cetirizine hydrochloride (ZYRTEC) and omeprazole (PRILOSEC); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took Ceclor and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jun2021, at 08:00 the patient experienced severe muscle and joint pain in her lower back and shoulders, stimulated immune response (more than normal) of arthritis already diagnosed between L4 and L5 of the spine, injection site arm pain in the form of fatigue and muscle soreness. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of severe muscle and joint pain in her lower back and shoulders, stimulated immune response (more than normal) of arthritis already diagnosed between L4 and L5 of the spine, injection site arm pain in the form of fatigue and muscle soreness were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Myalgia, Fever, EAR ACHE Narrative:  Other Relevant History:
Child developed redness & swelling right thigh.  Fever to 101 degrees at home, very fussy.  Has 5x3cm area of erythema - not indurated.  Afebrile in clinic 9/19/08.
Post vax, the pt developed petechiae, ecchymosis, and tenderness at injection site. Treated with oral antihistamines.
Less than 24 hours post imm started with arm pain on R. Nausea, vomiting. Achyness all over and fever 1st to 101 --> TYLENOL --> 103.4 seen in office after 400mg MOTRIN still 103.4 and vomiting.
Left/flu arm started itching immediately. Ignored it for awhile, then decided bandaid might be causing itch. Removed band aid and the itching did not improve. Now, 5 days later I still have an itchy rectangular patch on my arm approximately 1" wide & 3" long. No hives but itching still hard to resist. Shower/warm water seems to increase appearance of rectangular patch. Have tried a Benadryl itch stopping gel which gives some relief. Also have had swollen lymph nodes in left underarm for several days (which I expected). Right/COVID arm  started itching a little immediately, Removed band aid at same time as left arm. Occasional itching, but not like left arm. This is the third flu shot that has given me itching. I'm concerned I may be "becoming allergic" to something in the shots? Not sure who to consult. I have seasonal hay fever for which I take Loratadine. I had taken it that morning due to itchy eyes. I had NO OTHER allergic signs; just the itching sensation. I've been able to resist the itching.
WAS CONSENTED TO RECEIVE A BOOSTER, ALTHOUGH BOOSTERS ARE NO LONGER BEING GIVEN. THEN RECEIVED BOOSTER COVID-19 VACCINE. DID RECEIVE A STANDING ORDER OF TYLENOL 350MG TWO TABS PO X 1 DOSE DUE TO REPORTING POST VACCINATION PAIN. NO FURTHER ADVERSE SIGNS OR SYMPTOMS WERE NOTED OR REPORTED. STAFF WAS RE-EDUCATED THAT BOOSTERS ARE NO LONGER GIVEN AT THE FACILITY.
approx 1 month p/vax pt saw MD for an eye infect (OCT93); pt found to have elevated glucose; dx diabetes mellitus; hospitalized from 5NOV93 to 7NOV93; felt shaky; poss graves disease;
Chills, Fever 102 for 3 days, body aches, headache,  Treatment fluids, rest, ibuprofen and acetaminophen  Several weeks later I lost hearing in right ear.
Parent reports redness at injection site  upon awakening 9/29/21. Upon awakening on 9/30/21, parent reports 5 inch diameter  redness at injection site. In the office 9/30/21, on exam, redness measuring  11cm diameter around injection sites Afebrile. Parent reports vomiting and  diarrhea started 9/29/21. Vomited 3 times, 3 loose stools.
In 2021 I started getting small little rashes on my side and I could treat them with over-the-counter stuff, and it would come and go. In January of 2022 I did see a doctor about my regular physical and doctor glanced with no formal diagnosis, and he gave me a prescription that didn't help. August 2022 started growing out of control, I tried canceling everything in my diet and nothing changed. Only thing SELSUN BLUE shampoo only thing that seems to be working.
Friday 3pm shot. 5pm headache and feeling really bad pain, feeling ill like the flu with achy bones. The same day, pt feels tightness in arm with swelling. Pt noticed red rash close to underarm Saturday.
On 6/18/2020 Mom called c/o redness swelling and discomfort of Left upper extremity, at the injection site.  Mom instructed to apply ice to the area for 10 min every 2-4 hours. Patient diagnose with cellulitis and placed on Cephalexin 250 mg/5 ml by mouth every 12 hours. Mom instructed to call or take patient to ED if s/s of fever, condition worsens or s/s of dehydration.
Fatigue; Chills; Pain at the injection site; Swollen/enlarged lymph nodes on the top of the shoulder; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 12Apr2021 at 09:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced fatigue, chills, pain at the injection site, swollen/enlarged lymph nodes on the top of the shoulder. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fatigue, chills, pain at the injection site, swollen/enlarged lymph nodes on the top of the shoulder was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Administration site turned red, swollen the size of a baseball, and hot to touch. Recommended to patient to visit urgent care. Urgent care gave her a prescription for Doxycycline.
Severe, debilitating fever reading 102.  Red splotches and tendrils around shot site and significant bruising.  Today 9am 5/16 the fever has broken but I haven't been able to eat anything but two bananas over the course of the last 2 days.  This is the sickest I've been in at least the last 10 years.  I was given the last dose from the vial.  The dregs.
Immunizations received 5-27-04. Redness & swelling to left arm 5-29-04 with pain at site. Benadryl 12.5 mg given IM.
chills, fever, shallow & quick breathing, overall soreness, fatigue. Symptoms started 30 hours after injection, strong chills for 2-3 hours, sleep for 2 hours, sweats during following night, fatigue throughout next 24 hours.
chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "chest pain".  Additional information: Patient stated that he experienced chest pain after taking the vaccine and he wanted to know if it's normal to experience chest pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid-19 Booster, Moderna. Approximately 12 days later, I developed an allergic reaction. Hives that itch have been all over my body. They often will appear for 10-30 minutes and then disappear. They have appeared on arms, legs, back, stomach, neck, face, hands, feet, buttocks. They improved slightly with a brief prescription of Prednisone, but have otherwise consistently appeared throughout the day at random times and on random parts of the body. So far, it has been 11 days, and the reaction continues. I have no known allergies. I have spoken to 3 other people with the same symptoms, all who had the Moderna Booster.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 15-MAR-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were unknown) (lot# reported as No14633 which was verified as not valid and expiration date reported as 07-NOV-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Pfizer on 3/24/21 and 4/14/21. Positive on 8/4 admitted 7/27-8/6
The Hospital had this patient in their facility for rehab and requested a vaccine to be administer to him on 4/21, they said they confirmed that he was due for the Moderna vaccine since the patient was unsure of what he originally received. One of members of covid operations team brought over a Moderna vaccine to the patient during one of our mass vaccine clinics and had one the nurses administer the vaccine. During entry of the vaccine it was noted that the patient's 1st vaccine was actually pfizer. Hospital was notified of the error and they reported the the patient was doing well after the vaccination was received. No adverse reaction was noted.
Patient developed a rash over her trunk that spread towards the extremities.  She has been getting flu shots for over 20 years (and had gotten the Fluzone High-Dose in 2014 as well as this year); she has never had a reaction before. She is unaware of any other possible causes for the rash. She was not in any discomfort from the rash.
1 WEEK POST-VACCINATION, WARM, RAISED, RED ITCHY 4X4CM AT INJECTION SITE
Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 13-JUN-2015 by a physician, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster (onset not reported). On or about 29-FEB-2016, patient was treated by physician for an ongoing painful rash and persistent nerve pain which was then diagnosed as shingles. On or about 31-MAR-2016, patient was treated again by physician for continuing and worsening symptoms of shingles outbreaks. Although shingles is an incurable viral condition, patient was prescribed valacyclovir (VALTREX) for management of her symptoms and future outbreaks. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
pt recv vax 1MAY95 & 10mins post vax pt became pale,nauseated,shallow resp rat & Bp 78/50;pt was placed supine & legs elevated;p/5mins pt felt better but still pale & resp quality rate improved;5mins later pink color back in cheeks;
Frequent nosebleeds, congestion, ear infection, negative pressure in ears, temporary hearing loss, chest congestion, regression of toileting abilities, symptoms of SPD, APD, ADHD, ODD began with official diagnosis to follow.
Presented to the ED for evaluation of shortness of breath.  He has tested positive for COVID previously on 09/02/2021 symptom onset was on 09/01 with cough, exertional shortness of breath and rhinorrhea.  Symptoms have been progressively worsening.  Today he fell down hitting left side of his body and his head on a bar in the bathroom.  He did lose consciousness.  Denies any significant complaints apart from nonproductive cough.   Workup in the ED did reveal temperature that was afebrile at 98 pulse is in the 70s respirations of 19-20 blood pressure is stable was hypoxic in the ED at 88% on room air had to be placed on supplemental oxygen 2 L his ESR was 13 CRP was 21.2 electrolytes within normal limits BUN creatinine mildly increased at 24 and 1.40 S LFTs within normal limits BNP less than 5 ABG did reveal a pH of 7.410 pCO2 of 35.9 PO2 of 70.0 blood counts within normal limits CT head did reveal no acute intracranial abnormalities and the chest x-ray did reveal left basilar consolidation. Admitted to hospital 9/8/21. Patient started on dexamethasone, remdesivir, and levofloxacin. Consistently requiring 2L NC, passed walk test 9/10, requiring no oxygen at rest or on exertion. Did have hyperglycemia during hospital stay, likely steroid induced, managed.   Patient is to follow up with PCP within one week and for further management of hyperglycemia. Can d/c COVID isolation precautions 9/12.