chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 year old male patient received dose of Daptacel after the injection they scanned the bottle and it registered as Pentacel, no AE; Initial information received on 18-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional,  This case involves a five years old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] after the injection they scanned the bottle and it registered as DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 17-Feb-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered (latency on same day).  It was also reported that Caller reports vaccine may have been administered in error. Caller they were trying Daptacel. After the injection they scanned the bottle and it registered as Pentacel. Caller reports they have contacted the manufacturer of the scanning equipment but they have not heard back yet. Caller reports this was administered on 17Feb2021. There was a call back request made and she provided the inquiry number to this case. She wanted to verify that the Daptacel was not mislabeled in anyway and that they could still use it. Additional Description of event adverse events: Reported by the She states that on Wednesday they received a new package of Daptacel and they opened it and run the bar code through a machine and it automatically runs the bar code and entered it as Pentacel and not Daptacel and it was given to a five year old child who is ok. She states that they manually loaded it in the system with the codes on the vial. She said they were questioning if it was the right codes on the vial. She said they are still waiting to hear back from the manufacturer of the scanning equipment but they have not heard back yet. This is all the information she provided at the time of her call. Reporter relationship: HCP (health care professional).  At the time of report 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 holder's compliance with the requirements. 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.
15 minutes after the injection patient reported she felt a "okay" but 45 minutes after she states she was admitted to hospital and was admitted for 5 days with epiglottis. She reports no prior history of allergic reactions and presents today with continued hoarse voice.
Information has been received from the authors in a published literature article as stated below concerning 29 adult (42 +/- 13 years)patients of unknown age and gender with frequent or severe bacterial respiratory tract infections and selective subnormal lgG3 levels. It was sought to extend characterization of adults with selective IgG3 deficiency. Thus, it was retrospectively compiled clinical and laboratory features in 121 consecutive adult index patients referred to single practice because they had frequent or severe bacterial respiratory tract infections and were subsequently found to have subnormal serum IgG3 in the absence of subnormal levels of other Ig isotypes. It was recommended that all patients accept vaccination with PNEUMOVAX 23. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (dose, route, and lot # not reported). On an unknown date, the IgG levels in 29 patients did not increase after PNEUMOVAX 23. At the time of the report, the patients' outcome was unknown. A copy of the published article is attached as further documentation of the patients' experience. Additional information has been requested. Literature report:
Mild intermittent runny nose and cough started the evening of the vaccination.  24 hours post vaccination pt was with normal appetite, activity and sleep.  Afebrile.
Swelling of face and lips, rash over neck and upper chest.  Completed course of PREDNISOLONE, BENADRYL as needed.  This is a 5-year-old male who had taken a nap and woke up with swelling of his face including his lips.  He started to develop a rash over his neck and upper chest.  He does not have difficulty breathing.  No fevers. No chills.  Breathing without difficulty.  The patient has no complaints.  Pulse 98, respiratory rate 20, temperature 36.6, pulse oximetry 99%.  Normocephalic.  Patient does have moderate swelling about the eyes particularly on the left periorbital tissues.  There is moderate swelling to the upper lip.  There is no swelling about the tongue.  Oropharynx is pink, moist without erythema, without swelling, no uvular deviation.  Neck:  Supple without mass or meningismus. Heart: Regular rate and rhythm without murmur.  Lungs: Clear to auscultation.  No wheeze.  Abdomen:  Soft, nontender.  Musculoskeletal:  No focal neurologic deficit.  No weakness, numbness, cyanosis or edema.  Skin:  Pink, warm, and dry.  Does have urticarial rash over his upper chest and in his neck.  He was given steroids and BENADRYL.  Observed in the emergency department.  Continues to do well.  Swelling is improving.  Rash is improving.  Follow up with primary doctor.  Return with any increased difficulty breathing, swallowing, or any other concerns.  Final Diagnosis 1. Allergic reaction.
Chills, fever, swelling at injection site, muscle aches, joint aches, dizziness, nausea, severe nasal congestion, headache, injected arm still painful when used.
Pt states at approx 4 hrs after vaccine had muscle aches all over, chills, cough. Also start with chest tightness resolved seen at ED. Discharged.
Patient had extreme itching for 4 days after being given the vaccine. Patient missed school because the itching was so bad. Patient achieved some relief after being given benadryl.
Patient received DTAP, IPV and MMR in this office.  15 minutes later, he developed a rash-blotchy, itchy gave Benadryl 25mg per mouth.  No systemic symptoms.
Very fatigued since 2.5.2008. Seen by me, pediatrician on 2.8.08 and 2.11.08. Blood work done 2.12.08 showed occasional blasts and patient had blood marrow done. Now DX to have A.L.L. and chemo Rx started.  2/26/08 Reviewed pcp medical records & vax records. FINAL PCP DX: Acute lymphocytic leukemia (pre B-cell). Received HPV #1 0680U on 9/18/07 at GYN office & Menactra U2385BA on 8/7/07 Fluzone U2451AA on 1/4/2008 at pcp office.  Seen 11/07 for cough, sinus pressure, fever, tight chest, ear ache, HA; sibling w/similar symptoms 10 days prior.  Dx w/sinusitis, otalgia & cough.  Tx w/antibiotics.  Returned to office 1/4/08 w/o complaints for flu shot.  Returned to office 2/8/08 c/o of extreme fatigue beginning approx 2/5/08, stomach pain & intermittent hiccups.  Dx w/malaise & fatigue, r/o mono.  Referred for labs.  Returned to office 2/11/08 w/continued fatigue, pallor, feeling miserable, SOB, nausea, decreased appetite, earache.  Temp 100.7 at that time.  2/13/08 notified by lab of abnormal CBC & referred to hospital.  2/18/08 Received call from parent w/dx of ALL (pre-B cell).  Admitted 2/13-2/23/08.  Placed in study & will receive most tx as outpatient.  3/11/08 Reviewed hospital medical records for admission 2/13-2/23/2008. FINAL DX: acute lymphocytic leukemia Patient experienced extreme fatigue, excessive sleepiness, SOB, low grade fever, abdominal distention w/tenderness, petechiae on LEs, pancytopenia & hepatosplenomegaly.  Consults done by heme/onc.  Transfused x 2. Follow-up: Patient is still being treated for high risk A.L.L. at medical center. Report received from hematooncologist (dated 4.14.08) is attached. Please contact them for further information. I have reported this as part of on going surveillance post-licensure for new vaccines.
Patient received an additional influenza vaccine (administered 1/13/22) in the same flu season.  Previous influenza vaccine was administered on 11/2/2021. The error was discovered about 4 hours after the vaccine was administered.
Throat became tight; Was still able to breath, but not comfortable; Left side of face became numb.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided, Unable to locate or read the details), via an unspecified route of administration, administered in right arm on 06Feb2021, at 11:15 as dose 1, single (age at vaccination: 49-year-old), for COVID-19 immunization. Medical history included thyroid cancer and breast cancer, both from unknown dates and unknown if ongoing and known allergy to penicillin. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took dextropropoxyphene (Darvocet), alprazolam (Xanax), acetaminophen;hydrocodone and venlafaxine and had known allergies to these medications. The patient stated that, on 06Feb2021, at 11:45 AM, her throat became tight, was still able to breath, but not comfortable and her left side of face became numb. She took Benadryl and that helped relieve her symptoms. Reportedly, no other vaccine was administered within four weeks. Covid was not diagnosed prior vaccination and post vaccination, she was not tested for Covid. The outcome of the events was recovered on unknown dates in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Patient contacted provider office to state that she believed her vaccines (TDAP and PCV20) were given too high up in her left upper extremity. She reports that a couple of days after receiving her vaccinations, she began experiencing sharp pain in her joint of left upper extremity with certain movements and with holding items. Patient contacted today, 8-18-2023 and she reported improvement with symptoms. She states that the administration site is tender when touched, but otherwise her arm feels better this week.
Throat swelling, lips numbness and tingling, felt faint, oxygen level dropped to 83-felt short of breath.
NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination.The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers  No concomitant medications were reported. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on MAR-2021. This report was non-serious.
Very "Sluggish" for 2 days associated with a "slight" headache.
I95.89 CHRONIC HYPOTENSION 2/1/2022 HYPOTENSION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/8/2021 HYPOTENSION R57.0 CARDIOGENIC SHOCK 12/8/2021 HYPOTENSION R57.9 SHOCK, UNSPECIFIED 3/4/2022 HYPOTENSION I95.89 CHRONIC HYPOTENSION 2/1/2022 C DIFFICILE DIARRHEA, NOT SPECIFIED AS RECURRENT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/8/2021 C DIFFICILE DIARRHEA, NOT SPECIFIED AS RECURRENT R57.0 CARDIOGENIC SHOCK 12/8/2021 C DIFFICILE DIARRHEA, NOT SPECIFIED AS RECURRENT R57.9 SHOCK, UNSPECIFIED 3/4/2022 C DIFFICILE DIARRHEA, NOT SPECIFIED AS RECURRENT I95.89 CHRONIC HYPOTENSION 2/1/2022 ATRIAL FIBRILLATION, PAROXYSMAL J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/8/2021 ATRIAL FIBRILLATION, PAROXYSMAL R57.0 CARDIOGENIC SHOCK 12/8/2021 ATRIAL FIBRILLATION, PAROXYSMAL R57.9 SHOCK, UNSPECIFIED 3/4/2022 ATRIAL FIBRILLATION, PAROXYSMAL I95.89 CHRONIC HYPOTENSION 2/1/2022 C DIFFICILE DIARRHEA, NOT SPECIFIED AS RECURRENT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/8/2021 C DIFFICILE DIARRHEA, NOT SPECIFIED AS RECURRENT R57.0 CARDIOGENIC SHOCK 12/8/2021 C DIFFICILE DIARRHEA, NOT SPECIFIED AS RECURRENT R57.9 SHOCK, UNSPECIFIED 3/4/2022 C DIFFICILE DIARRHEA, NOT SPECIFIED AS RECURRENT I95.89 CHRONIC HYPOTENSION 2/1/2022 AMBULATORY OXYGEN THERAPY DEPENDENCE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/8/2021 AMBULATORY OXYGEN THERAPY DEPENDENCE R57.0 CARDIOGENIC SHOCK 12/8/2021 AMBULATORY OXYGEN THERAPY DEPENDENCE R57.9 SHOCK, UNSPECIFIED 3/4/2022 AMBULATORY OXYGEN THERAPY DEPENDENCE I95.89 CHRONIC HYPOTENSION 2/1/2022 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC    SEPSIS WO ACUTE ORGAN DYSFUNCTION, W MRSA SEPTICEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/8/2021 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC    SEPSIS WO ACUTE ORGAN DYSFUNCTION, W MRSA SEPTICEMIA R57.0 CARDIOGENIC SHOCK 12/8/2021 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC    SEPSIS WO ACUTE ORGAN DYSFUNCTION, W MRSA SEPTICEMIA R57.9 SHOCK, UNSPECIFIED 3/4/2022 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC    SEPSIS WO ACUTE ORGAN DYSFUNCTION, W MRSA SEPTICEMIA I95.89 CHRONIC HYPOTENSION 2/1/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/8/2021 ACUTE RESPIRATORY FAILURE R57.0 CARDIOGENIC SHOCK 12/8/2021 ACUTE RESPIRATORY FAILURE R57.9 SHOCK, UNSPECIFIED 3/4/2022 ACUTE RESPIRATORY FAILURE I95.89 CHRONIC HYPOTENSION 2/1/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/8/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION R57.0 CARDIOGENIC SHOCK 12/8/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION R57.9 SHOCK, UNSPECIFIED 3/4/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
This spontaneous report was received from a healthcare worker regarding a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient received three doses of PNEUMOVAX23 on an unspecified dates in 2003, 2009 and 2013 respectively. This is one of several reports received from the same reporter. Additional information has been requested.
pain in left arm; soreness in left arm; having trouble reaching things, and pain with movement in a certain way; First dose: arm was a little swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159559). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021755432 (Pfizer).  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: EW0175) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "pain in left arm; soreness in left arm"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "having trouble reaching things, and pain with movement in a certain way"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "First dose: arm was a little swollen".  Additional information: She received her second Covid 19 vaccine on 17May2021 in her right arm which was fine and had no pain. There was nothing wrong with the second dose, only the left arm with the first dose and sometimes reaching with her left arm hurts or turning a certain way with her left arm hurts. If she moves her left arm it was so much pain. She was left handed and it was very frustrating. She could not remember exactly what day her left arm began bothering her. Vaccine was not Administered at Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available), Additional Vaccines Administered on Same Date of the Pfizer Suspect, all vaccines administered on same date with the Pfizer vaccine considered as suspect, Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), AE(s) following prior vaccinations, Relevant Tests was none. The AE(s) did not require a visit to Emergency Room/Physician Office. Caller seeked information if the continued pain and soreness in her left arm from her first vaccine is normal. Response received and Spoke from attached document In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Referred caller to primary HCP for medical treatment.  No follow-up attempts are possible. No further information is expected.
p/vax pt exp swollen & itchy rt eye; no treatment given; symptoms subsided next morning
6 days after the vaccine, I got a small, itchy, red rash about an inch below where the vaccine was administered. It grew bigger every day and was hot to the touch. By the time I went to the doctor (8 days post vaccine), it was approximately 3 inches wide.
Fever and urticaria 2-4 hours after vaccines. Given BENADRYL in ER.
Bilateral hand pain, swelling and red. Toes swelled up, painful and beat read. Retained water. Caused a lot of pain.
Dizziness, fatigue, hot and cold chills, headache, and nauseous
Grand mal seizures! I have had 12 all together! I never had any neurological problems prior.
0925 pt reported feeling dizzy and lightheaded  with blurry vision while sitting for 15 minute post observation time. transported via wheelchair to observation area and placed on  gurney in trendelenburg position. 0930 BP 156/84 P 121 pox 96%. 0945 pt reports feeling "better" BP141/73 P 103 , placed in supine position. 0950 placed HOB at 45 degree angle with pt reports feeling "well". BP 167/83 P 83. 0956 pt report feeling "heavy headed and  vaccine arm tingly" . Drank 3 oz water. Pt reports being T2 diabetic on metformin. did not check BS this am, but ate breakfast as routine. Reports not regularly checking BS with breakfast. Primary care provider called and spoke with pt. at clinic. PCP advised pt to return to home and self monitor and contact their office if not feeling well today. Husband present and verbalized understanding along with pt of PCP instruction . PT reports BP is occasionally high when anxious. 1010 Pt sitting in chair and feeling well w/o furthur c/o dizziness or blurry vision or heavy headedness . States "feeling good to leave". BP 165/81 P 85 pox 96%. Pt left on foot with husband.
When i got 1st shot it hurt and an hour later i got a very painful knott about 3 inches down my arm from where he put the shot. I couldnt move my arm very well and the knott got red and stayed that way for about 1 week . i noticed i couldnt move my arm very well still after the knott went away about a week later and still to this day i get very painful sharpe pains that run from the top of my arm where i got shot to my elbow when i move my arm behind me and above my shoulder the pain is so intense i cant move at all . the pain lasts about 30 to 60 seconds then goes away .for example i cant use my left arm to put a rubberband in my hair without this pain accruing i cant grab my belt loops on my pants and pull my pants up either .the same thing happened after 2nd shot that was given to me at the top of my arm/ shoulder
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 67-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download  they would need to treat this issue as a temperature excursion. The data was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patient.  No treatment medication was reported.
Noted sore eyes on Saturday 3/15/03 with muscle pain on 3/16/03 and fatigue on 3/17/03.  During the evening of 3/17 also noted pain in upper right arm with increasing discomfort into the next day.  Tuesday, 3/18/03 noted read rash outside the dressing with increased pain in arm.  Seen in Occupational Health on Wed. 3/19/03 and advised this was a "robust" take.  Seen later that day by second physician and advised it was lymphangitis and to treat with ice and NSAIDs.  On 3/20/03 rash spread down arm to within 1" of elbow, but pain localized at site of vaccine.  On 3/21/03, rash receded to just outside the dressing site and pain resolved.
Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6:30pm I began to feel extremely wired and like my body would jump through my skin.  I tried to relax and started feeling sick at the stomach.  I went to bed early.  3/12/21 at 6:15am I was awakened with heart racing extremely fast and migraine starting at base  of back of head.  I could not get my heart to slow down.  My husband called 911.  Paramedics came and my blood pressure was  163/116 and heart rate 85.  10 minutes later it was 157/84 and heart rate 64.  (The day before vaccination my  cardiologist recorded my blood pressure at 110/52 and it has always run low. )  I had no energy nor appetite and slept most of the day 3/12/21  through 3/12/14.  Still feeling extremely fatigue and ears ringing and can hear heart beating in ears.
This spontaneous report as received from a Certified Medical Assistant (CMA) refers to a 14 year old patient of unknown gender. On an unknown date the pediatric patient was inadvertently administered an adult dosage of VAQTA. No adverse effects were reported. Additional information has been requested.
immediate bone/joint pain then limited ROM of left shoulder x 3 wks.  Also burping/dyspepsia and GERD which improved over 2 wks.  fatigue