chrisvoncsefalvay/vaers-outcomes huggingface dataset:
60 years patient received expired ACT-HIB with no reported adverse event; Initial information was received on 19-May-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 60 years old male patient who received expired hib (prp/t) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2023, the patient received 0.5 ml, total dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot UJ738AA, expiry date:29-Apr-2023) of unknown strength via intramuscular route in the left deltoid for prophylactic vaccination (Immunization).  On 17-May-2023 the patient received expired act-hib with no reported adverse event (expired product administered) (Latency:same day) following the administration of hib (prp/t) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
developed very severe stomach aches (went to emergency room) and shortly following that severe keratoconus (blindness) in my right eye, from which i've been suffering ever since.
Moderna COVID-19 Vaccine EUA  Site of injection increasingly sore.  Unable to sleep.  Chilled the morning after the injection. Continued to increase in soreness through the next day.  Unable to sleep next night.  Took 500 mg acetaminophen at 1 am, 2/19/21.  Still sore.
*  ~10 pm on day vaccine given (Friday, 1/8/21), developed mild headache *  Progressed to severe migraine with some nausea during night, and lasted all day Saturday (~20 hrs.)  I took Children's Tylenol dye free liquid late in day which took slight edge off headache. *  Developed severe central chest pain in night, which felt like pain I experienced with esophagitis/gastritis in past.  This lasted for about 20-30 minutes, then resolved. *  Awoke next morning (Saturday, 1/9/21) with low grade fever (~99.3 degrees F), and had fever for 2 days (never exceeded 100.3 degrees F that I detected)--no appetite all day *  Developed central low back pain/ache on Saturday ~ mid-day, which lasted through at least Sunday *  Awoke Sunday morning with rash on torso (same rash familiar to me when I have infections--biopsied in past and determined to be interface dermatitis).  Rash progressed throughout day to portion of arms, neck, groin (as always does with illness), and faded until resolving Monday am/mid-day.  Itching then occurred over next couple of days (as it always does with illness).  Appetite still limited. *  Sunday evening experienced acute abdominal pain and urgent diarrhea x 3 or 4 episodes *  Monday I felt better, but was fatigued and trying to get back on my feet
This patient developed probable staphylococcal scalded skin syndrome within 24 hours of receiving these vaccines. She was treated at hospital with an anticipated full recovery. Discharge Summary received on 12/15/2004 states final diagnosis of staph-scalded skin syndrome confirmed. Pt also experienced symptoms of facial edema, facial excoriations, pruritus, blisters and edema of arms and chest, neck pain, fever, emesis, and epidermolysis of neck, chest, bilateral upper extremities, back and buttocks with some sloughing noted.
Information has been received from a health professional concerning a patient (21 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F). It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day. Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the agency and was released. Additional information has been requested.
Mom called 9/19/03 stated child broke out with about 10 chicken pox on back, stomach.
prescription was written for a 73 year old male patient for GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 73 years old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 04-DEC-2020, the patient was written a prescription for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The pharmacist called to see if there was any information on giving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in a patient of this age, and if the prescription was correct.
pt recv vax & A coombs test performed subsequent to immunization was determined to be positive;the reporter did not know where a direct or indirect coombs test had been performed;
This spontaneous report as received from a pharmacist, as part of a marketing research program conducted, refers to a 16 year male patient with no relevant concurrent conditions". Medical history was not provided. In March-2014 the patient was vaccinated with the first dose of GARDASIL (Dosage, Lot number and expiration date were not provided) in the arm for prevention of HPV. There was no concomitant therapy. Approximately in March-2014, the next day after the vaccination with GARDASIL, the patient experienced a sore arm and he was complaining about how much his arm hurt. There was no diagnostic test performed. On unknown date the patient got all remaining doses of GARDASIL. The outcome of a sore arm was reported as recovered/resolved. The reporter considered a sore arm to be related to GARDASIL. Additional information is not expected because there is not consent to contact the physician.
On 9/19/00, the pt complained of redness, itchy rash, sore throat, low grade temperature, and parotiditis. Sent to MD.
burning, itching, raw feeling that extended from site of injection up neck and along side of face - face broke out in small bumps as well
patient experienced swelling, warmth to the touch, and hardness at the injection site; patient experienced swelling, warmth to the touch, and hardness at the injection site; patient experienced swelling, warmth to the touch, and hardness at the injection site; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 5 years old and unknown gender patient who experienced swelling, warmth to the touch, and hardness at the injection site, after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received a 0.5ml total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation was unknown, lot C5816AA and expiry date was unknown) via unknown route in unknown administration site for Immunization. Information regarding batch and expiry date was requested.   On an unknown date the patient developed a non-serious event of patient experienced swelling, warmth to the touch, and hardness at the injection site (vaccination site warmth, vaccination site induration, vaccination site swelling) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. PTC (product technical complaint) assessment medical/Physical : Medical   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: Unknown
no adverse event; patient was received a dose of Rotateq on 3/18/2019 and inadverently administered another dose on 4/9/2019; patient was received a dose of Rotateq on 3/18/2019 and inadverently administered another dose on 4/9/2019; This spontaneous report was received from an other health professional referring to a 4-month-old male patient. His pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 18-MAR-2019, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 09-APR-2019, the patient came to the office for the remaining unspecified vaccines and inadvertently received another dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # R022221 and expiration date:23-MAY-2020 (strength, dose, unit, route, anatomical location were not reported) (wrong product administered and extra dose administered). No adverse effects were reported. No product quality complaint (PQC) was involved.
Patient is a pleasant 54 year old male, known to Dr., treating for recurrent liposarcoma. He has a PMH including HTN, OSA, and liposarcoma. He is S\P radical resection of retroperitoneal liposarcoma including cholecystectomy and right nephrectomy. He is comanaged with MSK. He has had multiple lines of therapy. He was on trial APG 115 trial with study drug and Keytruda. He most recently had POD at the end of 2021. He had unsuccessful bland particle embolization at MSK due to further progression in the liver on CT. Per Dr. last note, he may be a candidate for Y90. On 12/29/21 he was given his first cycle of Trabectedin. He had some increased n/v w/ this so olanzapine was added back with plans for IV fluids and antiemetics prior to his next cycle. He was also started on a bowel regimen. Most recent ECHO on 12/23 w/ EF of 60%. Patient presented to clinic this morning (1/6) with increased SOB/ DOE, epistaxis, rectal bleeding. He purchased a pulse OX to monitor his O2sat and he states it is averaging around 88% at rest with peaks to 90% on RA. SOB/ DOE has worsened over 24/­48 hours. He has mild conversational dyspnea with longer sentences today. Supplemental O2 improves this. Denies fever/chills, headache, sore throat, body aches, N/V/D/C. Denies chest pain. He is s/p C1 of Trabectedin last on 12/29/21: Hgb = 8.3. CT­A chest this morning was negative for PE. increase in right pleural effusion from small to moderate with trace left pleural effusion. Increased atelectatic changes in RML and RLL. Small amount of perihepatic ascites. Labs with WBC ­ 1.63, HGB ­ 13.3, HCT ­ 38.2, PLT ­ 25.0, ANC ­ 0.9, COVID swab was sent for PCR and was positive. Reports epistaxis with periods of dripping blood likely due to low platelets. He is also experiencing more hematochezia with stools. Hgb remains stable at 13. He was scheduled  to get 2u of plts. He was given Zarxio 1/6 w/ plans for 2 more days. He was also referred for home o2 due to his low oxygen saturations. His PCR came back positive for COVID on 1/7 and due to his thrombocytopenia and hypoxia he was sent to the ER. Upon arrival to the ER his o2 was noted to be 75% on RA.  However, when he got back to the room his oxygen was 96% per ER MD report. He has no CP. He notes blood in his vomit and BRB in his stool. He also has ongoing diarrhea. His labs on arrival revealed WBC 2.4; ANC 1.5; HGB 13.3; plts 16.  He is getting 2 units of plts in the ER w/ solumedrol, Benadryl, and Tylenol as premeds. His vitals are stable. CXR w/o acute issues. ProBNP WNL. PCT/LA pending. Troponin negative. Discharged: Discharged patient home with family care. Instructed patient to follow up with any previously scheduled appointment. Removed IV.
Fever 101.3'F Erythema and swelling to Left upper arm (injection site) Treated with Tylenol prn Keflex 500 mg tid x 10 days Patient presents to clinic today for evaluation of possible reaction to Prevnar 13. She received the vaccine yesterday and then went to work. She reports a few hours later the arm became red and warm so she put ice pack on it off and on. She also felt bodyaches. She reports the morning she felt like she had fever so she took 2 ibuprofen and continues to have bodyaches and continues to have arm redness. She feels the red area on her arm had gotten bigger so she came to the doctor's office to be evaluated.
Pt. Report ?warm? feeling in neck, upper chest, upper back. Started ~15 minutes post vaccine. V/S - 140/79, 98%-O2, 77-HR, 18-Resp. Pt. in 30 min. observation due to reported topical allergic reaction post 1st dose. Pt. reports ?warm? feeling subsided, released to home. Education is feeling worsens to report to urgent care or PCP. If issues with breathing notify EMS. Patient expresses understanding.
rapid heart rate; heaviness in chest; light-headed; need to catch breath; This is a spontaneous report from a contactable consumer (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration in the right arm, on 24Mar2021 15:45, as single dose, for COVID-19 immunisation. Medical history included DCIS stage 0 in left breast in 2017 and known allergies to sulfa based medications. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). The patient did not receive other vaccines in four weeks. On 26Mar2021, the patient began to experience rapid heart rate and heaviness in her chest. She went to the hospital and was admitted for 1 day on an unspecified date. It was reported that after so many tests (unspecified) in Mar2021, they found nothing. The patient felt light-headed and felt like she needed to catch her breath. Her heartbeat was prominent at times. At the time of the report, the patient was wearing a heart holster for 48 hours. The events resulted to emergency room and physician's office visits. Treatment for the events was reported as unknown. The patient had COVID-19 Nasal Swab in 31Mar2021 and was negative. The outcome of light-headed and need to catch breath was not resolved; and the outcome of rapid heart rate and heaviness in chest was unknown.
Significant arm pain at the site of immunization. Couldn't lift my arm for 2 days. Fever. Extreme fatigue and body aches.
Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included MERCK STERILE DILUENT. On 21-MAY-2018, the patient was inadvertently vaccinated with an expired dose of Oka/Merck VARIVAX) lot # M009769, expiration date on 25-FEB-2018, subcutaneously (anatomical location was not reported) for prophylaxis. No adverse effects were reported.
Soreness, redness in shoulder where vaccination occurred. Patient complained shoulder being swollen by ~1". Redness up to the lower arm. patient has taken over the counter ibuprofen.
Nausea; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 56 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case received from a pharmacist via a field representative referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received a ZOSTAVAX (dose, frequency, lot number and expiry date not reported) and the patient later had developed shingles (severity, duration, and lesion locations unknown). The current status of the patient is unknown. Causality for shingles is not reported. Additional information has been requested.
The shot was less painful than the first dose, but by that night, I was shivering with fever (around 102° F). The fever lasted about 6 days, fluctuating between 99.5° and 102.5°. Over the week after the vaccine, I experienced nausea, dizziness, diarrhea, headache, body aches, joint pain and extreme fatigue. I was surprised that it was so bad and lasted such a long time, but I called my doctor's office, and they told me that the symptoms I was having were not unusual, but if they persisted for more than a week after the vaccine, I could come in to be evaluated in person. Fortunately, I started feeling better by Wednesday (I had the vaccine the previous Thursday morning) and by the next day I felt back to normal.
had slight itching to arms; no trouble breathing; no other problems; observed additional 15 minutes;
Severe headache began about 8 hours after injection. Severe headache continued into the next day--I had to cancel planned activities and spent most of the day sleeping. Severe headache duration was 24 hours.
7/13/05, received MMR vaccine to left arm. States that evening was just not feeling well. 7/20/05, lymph node swelling bilaterally to the neck. Then complained of swelling (lymph node) to left arm. Had fever (highest was 99.8F). Had no other meds except for PPD on 7/12/05. May 16, had TD. Did miss work for 2 days due to cold-like symptoms.
Itchy all over different parts of my body. Not all body parts at once. For instance, under my feet then after that stops itching, it will be on my arm, or palm of my hands, etc. I have been taking Benadryl and anti-itch creams.
LEFT UUPER ARM WITH MODERATE -LARGE DEGREE OF SWELLING . MULTIPLE URTICARIAL PATCHES ON UPPER ARM ; ARM WARM TO TOUCH . MILD PAIN WITH TOUCH   This reaction has happened with the 2018 and 2019 flu vaccine, but not previous to those years.
woke up with allergy all over the body; rash all over my body; minor pain; pain and swollen eyes; pain and swollen eyes; Swelling all over my face; my neck and my body is very red and Itchy; my neck and my body is very red and Itchy/body very red like sunburn; Nausea; This is a spontaneous report from a contactable consumers (one of them is the patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0168) via an unspecified route of administration into left arm on 10Jun2021 (at the age of 33-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jun2021 patient woke up with allergy all over the body, rash all over the body, minor pain, pain and swollen eyes, swelling all over the face, neck and body is very red; further reported as body was very red like sunburn and itchy and nausea. Patient went to the emergency room and was given a shot of steroid and a shot of Benadryl. Outcome of event "nausea" was unknown while the outcome of all other events was not recovered.
Allergic reaction first day with itching of left arm. Benadryl made symptoms subside. One week later left shoulder pain for 4-5 days and then left elbow pain persists to this day of 09/12/2021.
Left arm red and swollen - found that night after shots given.  Mother stated on 10/5/07 that it is "getting better".
Caller stated she missed an email notification on scheduling her second dose.; sweating; hot/cold for 24 hours; pain in left arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING OF BODY TEMPERATURE CHANGE (hot/cold for 24 hours), MYALGIA (pain in left arm), CHILLS (chills) and PRODUCT DOSE OMISSION ISSUE (Caller stated she missed an email notification on scheduling her second dose.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HYPERHIDROSIS (sweating), FEELING OF BODY TEMPERATURE CHANGE (hot/cold for 24 hours), MYALGIA (pain in left arm) and CHILLS (chills). On 10-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller stated she missed an email notification on scheduling her second dose.). On 14-Mar-2021, HYPERHIDROSIS (sweating), FEELING OF BODY TEMPERATURE CHANGE (hot/cold for 24 hours), MYALGIA (pain in left arm) and CHILLS (chills) outcome was unknown. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller stated she missed an email notification on scheduling her second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
Mild rash to left arm No airway compromise  Treatment observe for 30 minutes Symptoms did not get worse  No meds were given