chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client reported dizziness to EMT's upon arrival to the observation area at 2:06PM. The client began drinking water. The client ambulated unassisted from a chair to the anti-gravity chair and sat down in the anti-gravity chair. The anti-gravity chair was  then placed in the reclined position. The client reported that she did eat breakfast. Client denied any shortness of breathe. Vitals obtained at 2:10PM were as follows: manual BP 176/80, HR 89, O2 94%. Provided education regarding elevated blood pressure and recommended the client follow up with PCP within one month. The client reported she does not currently have a PCP. The client has a history of hypertension. She stated that she was prescribed Lisinopril and Hydralazine daily by her PCP. The client stated her gynecologist recommended she take her blood pressure medications as needed. The client states she takes the medications as needed when she has a headache or feels her pulse is fast. The client denied taking her medications today. The client was unsure of her regular blood pressure. At 2:14PM the client responded, "No, I'm feeling better." RN  provided education regarding s/s of anaphylaxis, when to seek EMS, and V-safe. The client voiced understanding of this education. Vitals obtained by at 2:18PM were as follows: BP 176/86, HR 75, and O2 95%. The client denied feeling dizziness at that time. At 2:21 PM the client took her personal Lisinorpil and Hydralazine PO. At 2:23PM the client reported feeling dizzy and nausea. Moved the anti-gravity chair into an upright position. The client was provided an emesis bag and held it up to her face. EMT offered to activate EMS. The client was unsure if she wanted EMS activated. Vitals obtained at 2:28PM were as follows: HR 86 and O2 98%. The client stated, "my legs feel heavy." Activated 911 at 2:29PM. Manual BP taken at 2:35 by EMT was 178/75. At 2:36PM the client stated she was feeling a little better, and that the heaviness in her legs comes in waves. At 2:41PM the client reported that her legs did not feel heavy and denied any nausea. At 2:45PM the client denied any dizziness, and said her legs did not feel heavy. The client stated "I feel good now." Vitals obtained at 2:45PM were as follows: manual BP 178/89, HR 77, O2 98%. At 2:54PM EMS arrived and assumed care. The client denied EMS transportation. The client signed paperwork with EMS at 3:12PM. Client left the facility unassisted with a steady gait at 3:15PM. .
This pt developed episodes of tachycardia. It was indicated that the pt reported ongoing tachycardia and an elevated blood pressure following receipt of this vax.
red blotch on left arm; This case was reported by a pharmacist via call center representative and described the occurrence of red blotches in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date 30th November 2021) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th October 2020, 1 days after receiving Shingrix, the patient experienced red blotches. On an unknown date, the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the red blotches to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix on left arm. After vaccination patient developed a red blotch near the injection site on her left arm. Red blotch was described as 2 inches wide by 6 inches long. The reporter consent to follow up.
Information has been received concerning a 7 month old male who on 1/7/02 was vaccinated with 1 dose of Hep-B vaccine recombinant (yeast) (lot 637547/1375K), a 3rd dose IM in the right thigh of PREVNAR (lot 481543), a 3rd dose of HIB conjugate Hep-B (lot 637764/1409K) and a 3rd dose of TRIPEDIA (lot 40540CA). On 1/21/02, the infant was seen by a physician for fever, vomiting and irritability. A blood culture on 1/21/02 was (+) for Streptococcus pneumonia, serology 19F. The infant received unspecified treatment. Vaccination failure was also reported. Streptococcal septicemia was considered to be an "Other Important Medical Event". This report was originally received from a physician. No further information is available. Follow up info from the physician noted that the pt was doing well and had recovered from all of his experiences. No further info is available. It has been determined that WAES0202USA02894 is a duplicate of WAES0202USA01910. Therefore, WAES0202USA02894 is being deleted from our files and the reports consolidated into WAES0202USA01910. WAES0202USA02894 was previously submitted to the FDA on 3/7/02. Additional follow up info from the physician indicated that there was "no concern about the above stated vaccine in this given pt." No further info is available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient. A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: COVID 19 Treatment; (Nov2022) Positive, notes: Had Covid rebound 5 plus days and still testing positive with symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. which includes anti-viral Pfizer Covid 19 Treatment from 13Nov2022 to 18Nov2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201343089 Same patient, same drug/different dose, different AEs;
1:30 P Ret to immunization station with c/o feeling "jittery". A + D x 3. No c/o SOB or no distress noted. BP 164/109, SaO2 99%, pulse 90, T-98.4-no localized redness to L deltoid-allowed to rest-BP decreased 151/94-to f/u with Dr.
I am having a lot of sleep and I am tired. I feel like I'm losing my sight. My feet and joints hurt. I went to the same clinic where they gave me the vaccine and they prescribed Motrin. They did blood and urine studies that same day.
Head felt like she was swimming, headache, heaviness in chest, lump in throat, BP spiked then dropped, Fainted - was given benadryl by mouth and Solumedrol IM
Burning and tightness in chest, throat burning, mouth burning, throat tightened, triggered asthma, pain in chest. Pain in chest still persists and increased asthma issues
Pt started chilling 4 hrs after inject. Next morning arm was swollen red/warm had temp go up to 100.5. Pain is better today still sore and red no temp today.
Doses were administered after the 30 day BUD; No adverse event; Doses were administered after the 30 day BUD; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD), PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a 22-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 15-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD), PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The BUD was reported as 8-Feb-2023.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712259, US-MODERNATX, INC.-MOD-2023-712263 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712263:3rd patient (J-Y) US-MODERNATX, INC.-MOD-2023-712259:2nd patient (A-P)
- severe chills, fever (101-102), (from 10 hours to 24 hours) - fatigue, muscle aches, headache, intestinal cramps (2nd day)  - difficulty sleeping and frequent urination (first night after administration) - tooth sensitivity (mainly 2nd and 3rd day) - gum sores that burned and made chewing difficult (started the 2nd day lasted about 3 days)
04/04/2021 - Significant shortness of breath when I went for outdoor walk around lake; 04/09/2021 - Awoke in cold sweat with blinding headache - checked in with work saying I was out for day at 04:12 am, took Aleve, and slept for the rest of the day.  Slept for most of weekend
next day red spot and beat red; started itching really bad; arm swollen the size of a grapefruit; very warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (next day red spot and beat red), PRURITUS (started itching really bad), PERIPHERAL SWELLING (arm swollen the size of a grapefruit) and FEELING HOT (very warm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ERYTHEMA (next day red spot and beat red), PRURITUS (started itching really bad), PERIPHERAL SWELLING (arm swollen the size of a grapefruit) and FEELING HOT (very warm). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) (topical) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (next day red spot and beat red), PRURITUS (started itching really bad), PERIPHERAL SWELLING (arm swollen the size of a grapefruit) and FEELING HOT (very warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: TCR was received and Does not Contains any new information
Person received H1N1 vaccine on 10/13/2009 and received another on 11/13/2009, did not need two doses because of age.
Approximately 2 to 3 hours post vaccination, I had a sharp pain in my mid chest, L side; it felt like heartburn at first, then like I may have pulled a muscle.  I took ibuprofen and the pain was gone the next morning.
Client had dizziness and light headed became clamy,  Was laid on cot for 30 min with blood pressure checked.
At 1805 hours on March 11th, 2021, patient received his second dose of a two dose series for Moderna's Covid-19 Vaccine.  Patient was given an injection by a student from Institute under the supervision of a nursing instructor for the school. It was reported to Department of Health staff that she received a partial injection  into his left deltoid as observed by the nursing instructor who verified the amount given as 0.3 mL prior to the remaining 0.2 ML being ejected onto rather than into the patient's left upper arm. The remaining 0.2 mL dose was drawn into a clean needle from the same vial and administered per CDC guidance. No further incident.
pt recvd vax 11OCT95 240PM & 12OCT95 lump/hive just below rt elbow;as the day progressed pt states the hives spread;pt states nauseous & cold;13OCT95 lt hand swollen & red splotches on bilat forearms;
21-22 Sep 2018: Numbness/tingling in left arm; Body aches; Couldn't lift left arm; Swelling noted in upper left arm.
pt says she starting getting dizzy, stomach aches, and headaches.  She has a rash on the upper part of her right thigh that looks like a burn.  She went to Dr. to have a physical since she was feeling so bad.  They did blood work and everything came out fine.  She is going back to the doctor to show them the rash since she forgot to show him when she was there to get her physical.  She is applying alcohol rub which seems to be helping.  All of her symptoms have subsided excluding her rash.
No additional adverse effects were reported; A second pediatric dose of RECOMBIVAX HB, on 4/14/2020; Nurse practitioner reported patient, 39 years of age, received a pediatric dose of RECOMBIVAX HB on 3/13/202; Information has been received from a nurse practitioner regarding a 39-years-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 13-MAR-2020, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml as prophylaxis (lot number: R001530 with expiration date on 07-NOV-2020) (strength, frequency, route of administration and anatomical location were not provided) (incorrect dose administered). On 14-APR-2020, the patient received was vaccinated with a second pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml as prophylaxis (lot number: R001530 with expiration date on 07-NOV-2020) (strength, frequency, route of administration and anatomical location were not provided) (incorrect dose administered).   No adverse effects reported.
Pt was given SQ left arm of VARICELLA vaccine #2.  Soon after applying band aid pt complained of itching.  I talked to M.D. and he ordered 50mg IM of BENADRYL.  Pt was kept 30 min after for observation then was evaluated by M.D. then released home.  I called the next day to see how pt was doing.  G-mother and guardian stated he is fine.
Headache, stuffy nose, body aches , swollen glands under his throat, pain when swallowing, hard to swallow. No difficulty breathing, no wheezing, no cough, no rashes. Mother gave Benadryl. Mother reports symptoms started the day the vaccine was given. Resolved within 3 days.
tested negative for Mumps; Information has been received from a physician referring to a 7 years old patient of unknow gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On an unknown date, the patient received 3 doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number, expiration date, dose, frequency, route unspecified) for prophylaxis.   Blood work was done on the patient and they tested negative for Mumps (Mumps antibody test negative). It was unknown if the treatment was given for the event. Outcome of the event was unknown. Causality assessment was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000133:Original Case : 1906USA000133
Horrible headache, body ache and pain (like a bad case of the flu) weakness, fatigue arm swelled with hard lumps, bumps, redness, hot and itching.  The headaches continued until 5/4 with fatigue. Right arm continued to be swollen, hard, lumpy and itching until today 5/5/18. There are still some places on arm still hard. Redness is lighter but still visible.
Injection site reaction, hot to touch, pain and tenderness, redness, swelling to size of half dollar Pain lasted approximately 24 hours. Swelling, redness, and heat lasted approximately 30 hours Ice pack to site frequently, Tylenol and ibuprofen twice
After the vaccine I had a nasal congestion, couldn't breathe thru my nose, I had sore throat, I went to Urgent Care, and they gave me some antibiotic and some nasal spray. It cleared. They said it could be coincidence that happened after two days after the shot.
Information has been received from a physician concerning a 12 year old female patient who on approximately 26-MAY-2011, "about a week ago" was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (lot #, dose and route not reported). The physician reported that the patient experienced dizziness and blurred vision after her first dose of GARDASIL. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was recovering. Additional information has been requested.
Information has been received from the mother of a 9 year old female with no medical history and no allergies who in 1996 was vaccinated with a dose of varicella virus vaccine live.  On 03/17/2004 the patient broke out with the chicken pox with approximately 50 pock marks, which were spread throughout her upper torso (abdomen, chest, and back) and on her face.  Unspecified medical attention was sought and the patient was treated with Acyclovir.  The patient was recovering with sequalae.  No product quality compliant was involved.  It was also reported that two of her daughter's classmates at her school also broke out with chicken pox.  Additional information has been requested.
Developed a rash on arms and ankles approximately 5-7 days after both the first and second dose.
day p/vax pt exp pain, redness & swelling at inj site; 6/5 pt recovered
Extensive bilateral Pulmonary Embolism, saddle pulmonary embolism with right ventricular strain
I got dizzy at 4:00 pm the day of the injection and have remained dizzy ever since (currently about 10 day).  My blood pressure is very elevated from normal too.   Currently, 147/97.  Normal for me is somewhere in the 120s/80s. I have noticed the dizzy gets better if I lie down.   Also, the dizzy can vary from hour to hour on intensity.  Only 1 day since the injection did I have a day with minimal dizziness.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 01-JAN-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. 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. Additional information has been requested.
TOOK TYLENOL SINUS HEADACHE AT 2PM ON FRIDAY. WOKE UP FRIDAY AT MIDNIGHT WITH CHILLS, HEADACHE AND SHAKING. TOOK TYLENOL SINUS. REPEATED TYLENOL SINUS EVERY 4 HRS FOR HEADACHE. ON SAT AND SUNDAY WAS WEAK--MONDAY FELT BETTER.
Erythema 4 cm in diameter on left thigh, warm to touch with minimal swelling. Treating empirically with cephalexin for possible Staph infection.
Small amount of blood in stool evening of day vaccine was given as reported by parent. Mom also report that same occurred at 4 months.
26SEP94 reporter accidentally stuck self w/needle which had some acel-imune @ tip; evening of 26SEP began exp swelling/edema/pain @ inj site w/limited motion to index finger; seen by MD on 27SEP; tx w/Pred x 3 days; swelling improved;
tightness in chest 9 days later;pt reported recv vax on 23AUG96;pt reported that 11 days later noticed swollen lymph nodes;2-3 days a/calling clinic reported had fluid on knees & aching pain in joints;saw MD & is taking ATB;
This child had varicella begin on 04/18/01, only 12 lesions. He had Varivax vaccine 08/25/00, failed vaccine.
This case was reported by a nurse and described the occurrence of numbness of upper extremities in a 11-year-old male patient who received BOOSTRIX (batch number U5979AA ?, expiry date unknown) for prophylaxis. On 18th December 2018, the patient received BOOSTRIX. On 18th December 2018, less than a day after receiving BOOSTRIX, the patient experienced numbness of upper extremities (serious criteria hospitalization), rash (serious criteria hospitalization), pain in arm (serious criteria hospitalization), swelling arm (serious criteria hospitalization) and tingling of extremity (serious criteria hospitalization). On an unknown date, the outcome of the numbness of upper extremities, rash, pain in arm, swelling arm and tingling of extremity were unknown. It was unknown if the reporter considered the numbness of upper extremities, rash, pain in arm, swelling arm and tingling of extremity to be related to BOOSTRIX. Additional details were provided as follows: The patient had a rash and pain of the left arm. His left arm was swollen, numb and tingling in his arm. On the same day of vaccination in the evening, the patient went into the emergency room.
New onset polyarthritis, morning joint stiffness and fatigue persistent since the injection and still currently present.  Tenderness and stiffness MCPs both hands and shoulders.
Raised rash that occurred 1 day after injection, rash lasted at least 2 weeks, significant arm weakness which onset the day after vaccination and is still occurring, although there has been some improvement.