chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical professional concerning a 76 year old female patient, who on 07-APR-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 664090/0139Y) SQ. The medical professional reported that on 01-JAN-2011 the patient went to the emergency room, but was not admitted to the hospital, with a case of shingles. While at the emergency room the patient received acyclovir and hydrocodone of unspecified doses. On 05-JAN-2011 the physician indicated that the patient had eruptions on the left lower quadrant descending down the left lower back which were identified as shingles. On 05-JAN-2011 the physician discontinued the two preceding medications acyclovir and hydrocodone and put the patient on VALTREX, PHENERGAN and LYRICA. At the time of the report, the patient was recovering. Additional information has been received from a physician, medical records and questionnaire concerning a 76 year old female who on 07APR2009 at 10:53 AM was vaccinated with ZOSTAVAX (Merck) (Lot # 664090/0139Y) SQ left upper arm. No rash occurred at the site of injection or elsewhere within 42 days of vaccination. On 01JAN11, she presented to ER with pain and a moderate rash, described as zoster, on the posterior aspect of the lateral abdomen, anterior aspect of left lateral abdomen and left lower quadrant. The quality of the pain described as aching and stabbing which began four days ago. Rash described as erythematous, vesicular (also described by the patient as "red raised rash with blisters") that began three days ago. Pt complaining of pain and itching in areas of rash. It was reported that the patient had history of sulfa, erythromycin and stadol allergy, scoliosis, chronic bronchitis, asthma, osteoporosis, mitral valve prolapse, rapid heart rate and past surgical history bladder suspension, hysterectomy and appendectomy (onset dates not reported). Current medications include: magnesium oxide, CITRUCEL fiber laxative daily, alendronate (MSD) weekly, simvastatin (MSD), ADVAIR diskus, SYNTHROID, lisinopril-hydrochlorothiazide (manufacturer unknown) and metoprolol. Patient stable, diagnosis was made of shingles and the patient discharged with prescriptions for NORCO (5-325mg tablet prn q. six hours) and ZOVIRAX (800mg, 5 times /day x 10 days) and she was to follow up with her physician in 3-4 days. On 03JAN2011 office visit exam: patient with severe shingles left side, large eruption LLQ but extended down abdomen and to mid back. Patient denied pain. It was noted that patient experienced nausea and vomiting caused by acyclovir and hydrocodone. Acyclovir was discontinued and prescriptions were given for VALTREX and promethazine HCL. It was noted that if hydrocodone causes more nausea, it would be changed to LYRICA. All available medical records will be provided upon request. Additional information has been requested.
This spontaneous report as received from a health professional refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported a swollen left arm for about 2 days after the vaccine. She also had chest pain under her left breast, and severe depression that occurred for a few days after the vaccine.
a 4 months old patient accidentally received DTAP and Ipol portion of the Pentacel vaccine, however the ActHIB portion was not mixed /No AE; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old male patient who accidentally received dtap and ipol portion of the pentacel vaccine, however the acthib portion was not mixed, while he received a 0.5ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL] lot UJ061AA, Expiration Date: 04-OCT-2020 via intramuscular route in the left thigh On 22-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
First evening was fine, typical soreness in arm was only symptom.  Next day was fine, feeling a little 'out of it', moderate soreness in arm continued.  Second evening, extreme chills lasting the entire night (did not sleep at all).  Felt I could not get warm despite plenty of heat and blankets used.  Symptoms dissipated by morning.  No further symptoms after that.
pt recvd vax 27OCT95 1030AM & 2:30 chills/dizziness by PM feverish/achy/chills-sore throat cold a/29OCT AM;
PT RECEIVED PFIZER 12+ AND OLDER, AND NOT THE PEDIATRIC PFIZER FOF 5-11 YEARS; PT WAS MONITORED CLOSELY BY RPH ON DUTY. PT REPORTED NO SIDE EFFECTS. PT'S PEDIATRICIAN WAS CONTACTED AND RECOMMENDED PT TO RECIEVED OTC BENADRYL
Pain & swelling in left under arm (lymph node); Pain & swelling in left under arm (lymph node); Discomfort; Swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Oct2021 20:15 (Lot number: FF2589) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN A [RETINOL]; VIT D [COLECALCIFEROL]; PROBIOTICS; CIPLOX [CIPROFLOXACIN HYDROCHLORIDE] taken for eye injury, start date: 27Sep2021, stop date: 03Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 11:00), administration date: 22Mar2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 11:00), administration date: 01Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 05Oct2021 19:00, outcome "recovered" (Oct2021) and all described as "Pain & swelling in left under arm (lymph node)"; DISCOMFORT (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Discomfort"; SWELLING (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Swelling". Therapeutic measures were taken as a result of lymph node pain, lymphadenopathy.  Additional information: The patient had no covid prior vaccination. The patient did not tested covid post vaccination. No known allergies were reported.  The patient had Motrin/rest.  No follow-up attempts are possible. No further information is expected.
I got the Moderna vaccine on 04/13/2021 around 5:30 pm, waited 15 minutes in observation, by the time I got home  around 7pm I had a really bad rash around different parts of my body
Stated that he had shot on May 15, 2021 and had flu like symptoms for 48 hours afterward (fever, belly aches, very tired-and slept for 14 hr.) Seven days later he noticed feeling dizzy, having chest pain described as very heavy feeling in chest, light-headed and exhausted. Had biometric screening done at work on 6/29/21 and began to "feel faint". BP 73/42. He layed supine on floor, took deep breaths and drank apple juice and felt better. He said he had gone to the ER on 6/28/21 with shortness of breath and chest pains. BP went up to 98/66 and he was sent home from work. He went to his family doctor who did x-rays and referred him to cardiologist. Has an appt. with Dr., cardiologist, on July 12, 2021.
Nausea, flushing, headache, fatigue, body aches, raspy voice.
This case was reported by a nurse and subsequently by the subject's mother and described the occurrence of injection site redness in patient who was inadvertently vaccinated with a dose of Pediarix sooner then recommended.  Medical history included "no allergies."  On an unspecified date in either September or October 2005, the subject received the 2nd dose of Pediarix.  "Approximately two weeks later," on October 2005, the subject received the third dose of Pediarix in the right thigh.  This is sooner than the recommended interval of six to eight weeks between the 2nd and 3rd doses of Pediarix.  On October 17, 2005, the subject also was vaccinated withHaemophilus influenzae type b conjugate vaccine and Prevnar in the left thigh.  On 17 October 2005, less than one day after vaccination with Pediarix, the subject experienced injection site redness at the site of administration of Pediarix.  At the time of initial reporting, 18 October 2005, the injection site redness was ongoing.  Follow-up was received from the reporting nurse on 09 November 2005.  The nurse stated that the patient was, "medically well."
itching; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 753RM, expiry date 3rd December 2021).   On 16th September 2020, the patient received the 1st dose of Shingrix. On 26th September 2020, 10 days after receiving Shingrix, the patient experienced shingles and pruritus. On an unknown date, the outcome of the shingles was recovered/resolved, and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient experienced shingles outbreak and itching, after receiving the 1st dose of Shingrix. The patient had 3 weeks active shingles and still had itching. The reporter consented to follow up.
Information has been received from a female consumer, for GARDASIL, a Pregnancy Registry product, reporting on herself who on an unspecified date was vaccinated with a dose of GARDASIL (lot# not reported) while she was pregnant. It was reported that on an unspecified date the consumer had a miscarriage. The patient's LMP and EDD were not reported. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Upon internal review, miscarriage was determined to be an other important medical event. Additional information is not expected.
Systemic: Exhaustion-Severe, Systemic: Nausea-Severe, Systemic: Other- pt complained of not being able to walk/leg weakness-Severe; symptoms lasted 1 day
This is a non-serious spontaneous case, initially received from other healthcare professional on 29-Jun-2018 and concerns an adult, female patient of unspecified age. On an unspecified date in 2009, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2009, following vaccination, the patient experienced pain, aches and sniffles. The outcome of the event was not reported. This case 201802743 was cross-linked to case 201800197 due to same patient/reporter. Update 31-Jul-2018: Significant case correction was performed with IRD 29-Jun-2018: The 'as determined causality' of the events (Sniffles and Pain/aches) was changed from unassessable to related. The narrative statement was corrected, and case comment was correct accordingly.
Screaming then unresponsive for 30 minutes - no seizure activity or colour change; Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 1 year old male patient. Primary reporter is a physician. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 13-DEC-2018, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 dose unspecified; strength, route, lot # and expiration date were unknown) for vaccination.  On the same day, the patient was also vaccinated with meningococcal acyw conj vaccine (tet toxoid) (NIMENRIX) (1 dose unspecified; strength, route, lot# and expire date unknown) for vaccination.      On the same day after vaccinations, the patient was screaming then unresponsive for 30 minutes- no seizure activity or colour change (hypotonic-hyporesponsive episode). The management of the event was hospital admission. The patient recovered from the event on 13-DEC-2018. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was assessed as possible related by Agency.
Extreme sensitivity in mouth,  including gums, tongue, and base of my teeth,   Sensitivity has continued through today.  Water flossing  is very painful.
Pt recd 3 doses of Engerix-B 24MAY90, 26JUN90, & 29NOV90 & it was determined that pt did not respond; 4th dose Engerix-B administered 14JAN91 p/this pt did not respond; 5th dose given & did not respond; poss enlarged thyroid, yeast infect;
This spontaneous report as received from an approximately 60 years old male physician refers to himself. On approximately 18-SEP-2012 (reported as "about a week ago") the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # not reported) for prevention shingles. On approximately 18-SEP-2012 (reported as "about a week ago") after the patient got the ZOSTAVAX shot, the shot hurt and his arm was sore for a couple of days then he was fine. No treatment was given for the adverse event. The patient did not seek medical attention. The outcome of the events was reported as recovered. Additional information is not expected.
Day 1, Swollen lips within 1hour, which disappeared when I took allergy medicine  Day 3-14,  Elongated red rash on arm below the injection site.  Arm was very sore - could not turn in sleep .  I went to another urgent care around day 11 and they said it was the vaccine.  The rash cleared up but arm is discolored.
At 04:30 on 1/22/2021, facility was notified of employee death at home.
In April, I noticed swelling in my left leg and went to urgent care, this swelling spread to my left arm as well. I was diagnosed with peripheral edema. I started getting hand and food pains, and joint inflammation.  Went to primary doctor who sent me to rheumatologist, rhematologist sent me to neurologist. I am still tryin to find the cause of my swelling, pain, inflammation, and heat radiating from my left side.
developed a knot on my arm and then under my left armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NODULE (non-serious) with onset 2021, outcome "unknown", described as "developed a knot on my arm and then under my left armpit".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300234293 Same patient/product, different dose (dose 2)/event;US-PFIZER INC-202201391338 Same patient, different product/event;
About 2-3 hours after receiving the vaccine, the patient noticed that her arm was sore. The area around where she received the shingles vaccine is red, and the spot where the vaccine was given is raised (about 1 mm, and 1/4 inch circle.) The patient took BENADRYL, but her arm was still sore the next couple days, and her arm still red and raised at the spot.
Patient given Flu vaccine, came back within 5 minutes to pharmacist and told her that her arm at injection site was swollen. She was not having trouble breathing, swallowing- just swollen arm and could not raise arm. She mentioned her blood pressure was maybe elevated. We called EMS. Patient was given a BENADRYL 25mg and cold compress.
Supected Vaccination failure; Shingles outbreak in eye after shot; Had double vision in eye; This serious case was reported by a consumer via market research programs and described the occurrence of vaccination failure in a 59-year-old male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included Herpes zoster (Hz/su + AS01B) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Hz/su + AS01B (intramuscular) and the 1st dose of Hz/su + AS01B (intramuscular). On an unknown date, an unknown time after receiving Hz/su + AS01B and Hz/su + AS01B, the patient experienced vaccination failure (Verbatim: Supected Vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles outbreak in eye after shot) (serious criteria GSK medically significant) and double vision (Verbatim: Had double vision in eye). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and double vision were resolved.   The reporter considered the vaccination failure, ophthalmic herpes zoster and double vision to be possibly related to Hz/su + AS01B and Hz/su + AS01B.   The company considered the vaccination failure, ophthalmic herpes zoster and double vision to be possibly related to Hz/su + AS01B and Hz/su + AS01B.   Additional Information: GSK Receipt Date: 24-MAY-2023 This case was reported by a consumer via market research programs. The patient got Shingles in 2019, could not remember specific dates and reported he had an outbreak of shingles that went into his eye causing double vision in 2019.  The event was recovered in 2019 after a couple of months. There was concern of loss of vision but that did not happen.  The patient was not able to recall if it was Shingrix, which apparently, he got as his second shot or zostavax so he reported in this case.  The reporter thought that the event might had been related to product/device. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Shot noon 9/28. Erythema that night. 9/29 cellutitis like reaction 3x3cm. 9/30 continued to worsen with increased diameter. Started OMNICEF. 10/1 improving, playing, better.
Pfizer-BioNTech COVID-19 Vaccine EUA:  dizziness, headache, muscle aches, nausea, chills, fever, tiredness, feeling sick
Within minutes of receiving Gardasil vaccine turned green and became lightheaded. After laying down for 20 minutes sat up and became nauseous. Patient able to leave after being observed for 45 minutes - 1 hour.
Intestines froze up, can?t breathe normally and my tumor and abdomen has been inflamed. My spouse also got a shot and has been projectile vomiting and has flu like symptoms. Both of us are lethargic.
I had an itch on the left shoulder, not specifically at the vaccination site, after I scratched the shoulder I immediately had a welt the size of a quarter at the vaccination site. It was slightly raised, red,  warm to the touch, and itchy. After an hour of no change I took OTC allergy pill. Symptoms resolved by later in the day though the vaccination sight continues to feel tender.
Roughly 8 weeks post second-vaccination, left (the side of injection) deltoid and brachioradialis began experiencing sudden onset of muscle tightness and twitching. What started as an occasional occurrence throughout the the day has progress to a nonstop event that has persisted day and night for a week and a half straight. Sleep is being affected. Even through proper hydration, potassium, calcium, and Vitamin D supplementation, the symptoms persist.
Flu like symptoms, headache, fever, body aches , pain, fever, chills, shaking, cough, extreme fatigue and weakness, developed into Pneumonia, Shingles, Sepsis, Urinary Tract infection, total loss of urinary control, balance issues, falling, dropping things, difficulty sleeping, itchy dry mottled skin, swelling of eyes and face, redness of skin,
About 20 minutes after the shot, my boyfriend and I were driving home and my arm where I received the shot felt hot then my whole body felt hot. I started feeling dizzy and then passed out for approximately 2 minutes. I came to. We stopped driving so I could get some air.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/5/2021 and 2/26/2021. Presented to ED on 1/15/2022 with complaints of rectal bleeding and SOB. Admited for acute hypoxemic respiratory distress due to Covid PNA. In ED, noted to be borderline hypotensive and hypoxic at 87%. Placed on BiPAP and his O2 improved. Labs revealed significant metabolic derangements including creatinine 6.24, BUN 120, CO2 18, sodium 160 but K was normal. Lactate was 1.1 and WBC was 5.9. Non-contrast CT chest confirms GGO consistent with Covid pneumonia. Treated with azithromycin, rocephin, and decadron. DNAR status. Expired on 1/26/22.
Full body rash/hives covering face, bilateral upper and lower extremities, trunk, and back. Erythematous and flushed face, swollen cheeks and mouth. I took Benedryl (2 tabs) without change in symptoms and called my residency program director, who prescribed Prednisone and encouraged me to follow up at the nearest Urgent Care.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 02-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K019502 with expiration date 14-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
REPORTS ITCHING THROAT,ALTERE SENSATION IN MOUTH AND THROAT. BENADRYL 25MG WAS ADMINISTERD . REASSESSED HALF HOUR LATER. PATIENT WAS FINE AND ABLE TO DRIVE HOM. NO SOB OR RESP DISTRESS
slight pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight pain in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (slight pain in the arm). At the time of the report, PAIN IN EXTREMITY (slight pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
The morning after receiving vaccine pt awoke 6:30 am to red, sore, swollen area at injection site. Area swelled for 5 inches surrounding site, sore, hot, red, itching for 4 days.
Fainted; woke up; went to bed. People checked on me often. Got up at 4 pm.