chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient being administered PENTACEL after the liquid and lyophilized components were not properly reconstituted together and some of the lyophilized vaccine component was still left in the vial after administration with no reported adverse event; patient being administered PENTACEL after the liquid and lyophilized components were not properly reconstituted together and some of the lyophilized vaccine component was still left in the vial after administration with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] after the liquid and lyophilized components were not properly reconstituted together and some of the lyophilized vaccine component was still left in the vial after administration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 10-Apr-2023, the patient was administered 0.5ml  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength; not reported) (lot UJ668AA; Expiry Date: 13-May-2023) via unknown route in the right vastus lateralis (Rt thigh) for Immunization after the liquid and lyophilized components were not properly reconstituted together and some of the lyophilized vaccine component was still left in the vial after administration with no reported adverse event (product preparation issue) (incorrect dose administered) (latency; on same day).  It was reported that she reconstituted the liquid component (DTAP-IPV) of vaccine with the powder component (lyophilized ACTHIB vaccine) and after they were mixed it was some powder component still stuck to the bottom of the vial once she withdrew the vaccine into a syringe. It was hard to dissolve the powder into the solution even after shaking for about 1 minute and tapping on her hand. The vaccine was administered to a patient.  Action taken : not applicable.  Outcome : Unknown.   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.
Patient reports fever and headache on 10/27/14.  Brought to the emergency room on 10/29/14 and admitted with encephalopathy.  Resolved after 3 days, CSF 15wbc, MRI negative.
swollen lymph nodes under left arm; rash; headache; overall malaise; chills; This is a spontaneous report from a contactable consumer (patient herself) reported that an elderly (65+ Years) non pregnant female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in left arm, on 04Mar2021 at 11:00 AM as a single dose for COVID-19 immunization. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in left arm, on 11Feb2021 at 11:00 AM as single dose for COVID-19 immunization. The patient medical history was not reported. The patient had a history of known allergies to Skelaxin. Concomitant medications included Tramadol (TRAMADOL), Atorvastatin (ATORVASTATIN), both for unknown indication and from unknown date. The patient had not received any other vaccines in four weeks. On 05Mar2021 at 05:00 PM the patient experienced swollen lymph nodes under left arm, rash, headache, overall malaise, chills. No treatment was received for the adverse events. The patient had not been diagnosed with Covid-19 prior vaccination and had not been tested for Covid-19 post vaccination. The outcome of the events was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "BPH" (unspecified if ongoing); "PVCs" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; ATORVASTATIN; FLOMAX [MORNIFLUMATE]; MULTAQ. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient had no known allergies. Anti-viral COVID 19 treatment with Paxlovid.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported events and suspect BNT162B2 cannot be excluded .The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
day after felt "strange".  Waves of hot flashes that targeted mainly my face, literally dripping sweat. Mild nausea.  Mild aches. Little out of it feeling.  This was pretty much done by 1/1/21. 1/7/21 one week and a day after injection, injection site became raised, hard, inflamed looking  and was itchy. Site was visibly red and raised and had approximate 3 in diameter.  Previously mentioned symptoms began again (waves of hot flashes, nausea, aches).  This lasted at least until bedtime.  Next day, 1/8/21 felt better and injection site, though still hard and red, reduced down to size of quarter.  No further symptoms BUT injection site now as of 1/20/21 still looks like a quarter sized bruise.
This spontaneous report as received from a medical assistant refers to an approximately 62 year old female patient. The patient's pertinent medical history included hypertension, hyperlipidaemia and Barrett's Oesophagus and had no reported allergies. On an unknown date in 2001, the patient was vaccinated with pa dose of PNEUMOVAX 23 (dose, frequency and route were not reported) for pneumonia prevention by an unspecified allergist. Concomitant therapies included Simvastatin (manufacturer unknown), Omeprazole (manufacturer unknown), Lisinopril (manufacturer unknown) and hydrochlorothiazide. On an unknown date in 2001, the patient's arm blew up, the patient experienced large swollen area locally at the injection. Medical assistant stated that it was unknown if any treatmentt was administered at the time of reaction and also stated at unspecified time in the past, a flu (manufacturer unspecified) vaccines were given to patients in smaller, split doses but that was a while ago. The outcome of the event was unknown. The relatedness of the event with the PNEUMOVAX 23 was not reported. Additional information has been requested.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt s/p IM vaccine laughing walking around while sister being vaccinated pt fainted while standing, pt was responsive immediately afterwards mother informed this nurse afterwards of Hx of dizziness with flu vaccine. pt was cryting s/p vaccine mom holding pt. No cervical spine or para spine tenderness. pt A&Ox3 clear speech no Hx of blood thinners. Mother ED nurse agreeable to watch pt for any issues and bring pt to ED for any issues. BP prior to leaving 114/75 LA sitting and HR 102 Regular
Patient reports that when vaccinated she feels numbness in her left arm and on the left side of her neck.
Itching at site 5-12 hours post injection, severe muscle pain at sight 8-16 enough to wake from sleep in any pressure was applied, 12 hours post injection sever migrain, chills borderline hypothermic, immediate hot flashes as though I was in boiling water, sneezing. All subsided by 24 hours post injection beside migrain which became vary minor and at 24 hours full body soreness and fatigue equivalent to an extreme full body workout set in.
Extreme soreness throughout body, 3 days duration Hives I'm multiple areas, unresolved with over the counter allergy medicine, 2 week duration (ongoing)
An 8-year-old patient was administered 0.3 mL of the COVID-19 Pfizer 12 years of age or older formulation on 1/27/22 at approximately 3:50 PM. The vaccinator attested that they received clearance from registration to vaccinate the patient assuming that the screening questionnaire was already completed. She did not verify the date of birth or age of the patient prior to administering the Pfizer vaccine into the patient's left arm. Once the vaccine administration error was noticed, the parent was informed immediately at observation. The healthcare team on-site assisted and observed the patient closely. The nurse performed a blood pressure check. Blood pressure was 122/78 and pulse rate 88. The parent was offered information on the vaccine side-effects and the patient was observed for 30-minutes. During the observation period, the patient reported a "slight stomachache" but did not exhibit any signs or symptoms of immediate adverse reactions that required further intervention. They were cleared to go home and the pharmacist on site followed with the patient about an hour after they left the observation period but was unable to reach the parent.
On 12/14/2022, I started to experience symptoms of wheezing, head congestion, body aches and a headache. I received a call from a friend, that I had been around, and she tested positive. I did not test, for COVID-19, until 12/15/2022. I contacted my GP, because I had an expired test. I went into the doctors off and had a blood test ran and it came back positive as well. I was prescribed PAXLOVID and I feel that it did not help. I tested negative on 12/18/2022.
Info has been received from a pharmacist concerning an adult male who, as a child, was vaccinated with MMRII. "Now", on approximately 7/21/05, the pt has a negative titer. The reporter indicated that he was  unsure which component was negative. or if it was all 3. Unspecified medical attention was sought. No product quality complaint was involved. Additional info is not expected.
increase in frequency of Raynaud's symptoms since 2nd vax; both hands, multiple fingers and lasts no longer than 20 minutes per occasion; definite increased frequency as compared to baseline.
This spontaneous report as received from a pharmacist refers to a 74 year old male patient. No medical history and concurrent conditions were reported. On 17-MAR-2016 the patient was vaccinated with ZOSTAVAX (lot # L015416, expiry date August 2016) subcutaneously (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date in 2016 (also reported as now) the patient was scheduled to begin therapy with Prednisone (manufacturer unknown) (circumstance or information capable of leading to medication error) at 40 mg per day as prescribed by his physician for an unknown condition (adverse event) (details unspecified), it was reported that the condition began on an unspecified date approximately in 2016. It was reported that the patient sought medical attention and was seen by an unspecified physician. The pharmacist also reported that the patient has not yet started Prednisone (manufacturer unknown) therapy. The action taken with therapy with ZOSTAVAX was unknown. The outcome of the event was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint reported. Additional information has been requested.
Information has been received from a registered nurse referring to a 12 month old patient of unknown gender. The patient's concomitant therapies pertinent, medical history and drug reactions/allergies were not reported. On 17-SEP-2018 the patient was vaccinated with PROQUAD (route, strength, dose, frequency, batch/lot # and expiration date were not reported) instead of M-M-R II for prophylaxis. On the same date, the patient also vaccinated with VARIVAX (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Red, swollen, tender, knot at injection site approximately 4 inches in diameter started on 6/11/2016...still present on 6/12/2016 at 11 am.
Client complained of redness, swelling, warmth, and tingling sensation to left arm that begun 8 days after vaccine. Vaccine given in left arm, tingling sensation from hand to left side of neck. Sensation and motor function intact. Client advised to follow up with MD.
Flu-like symptoms, chills, shakes, tingling, headache, body ache, arm very sore, upset stomach.
The patient was given expired J&J vaccine doses. The vial was punctured at 9:40AM and expired correspondingly at 3:40PM. The respective time the shot was given outside this window was  5:21PM.
Information has been received from a pharmacy technician concerning a 75 year old (previously reported as "about 75 year old") female "in poor health" with heart problems and a history of stroke and other unspecified medical conditions who on 02-AUG-2007 was vaccinated with a dose of Zostavax. For an unspecified amount of time after vaccination the patient was observed for any reaction. The patient then left the pharmacy without any signs of an untoward reaction. Several days later the pharmacy technician read in the paper obituaries that the patient passed away on 06-AUG-2007. The cause of death was not reported. There was no product quality complaint involved. No further information was available. Additional information has been requested. 08/23/2007 Per email from FDA: A 75 y/o female in poor health with heart problem and a hx of stroke died 3 days after receiving Zostavax. Her name was in newspaper obituaries. She did not experience any immediate AEs after vaccination. Called Meck for follow up information including cause of death.  8/27/07 FDA obtained patient name & DOB from Merck.  No autopsy was done. COD was intracranial hemorrhage.  Merck will provide additional medical records.  9/7/07 Reviewed pcp medical records which reveal patient on chronic anticoagulant therapy for mitral valve replacement & was seen approx every 2 weeks for labs & eval.  Weight & vital signs stable.  10/29/07 Reviewed Death Certificate which states COD as subdural hematoma with anticoagulation for valvular heart disease as contributing factor.
A patient was inadvertently administered one dose of MMR II today. Nurse noted that the patient got received her first fose in 1995; The patient did not experience any symptoms; Nurse reports that a patient has sarcoidosis, and takes an immunosuppressive drug called Imuran, was inadvertently administered one dose of MMR II today; This spontaneous information has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's current condition included sarcoidosis and concomitant medications included azathioprine (IMURAN). The patient's medical history, previously drug reactions and allergies were not provided.  On an unknown date in 1995, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis(strength, dose, route of administration, anatomical location, lot number and expiration date were not reported).  On 10-DEC-2019 (reported as today), the patient was inadvertently vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneously as prophylaxis (lot number: R000555 with expiration date: 08-JAN-2020) (strength and anatomical location were not provided) (contraindicated product administered/inappropriate schedule of product administration).  The patient did not experience any symptoms.
Varicelliform rash noted 11/29/2001 (approximately 20-100 lesions).
Intussusception dx 10/6/07 and had surgery same day -----> has vomiting since 10/5/07.11/8/07-records received for DOS 10/6/07-10/8/07-DX: Intussusception. C/O crampy abdominal pain since morning. Some nausea and emesis. PE: abdominal distention. Surgery laparoscopic reduction of ileocolic intussusception.
Patient presented to her PCP office on 04/20 reporting that on 04/16 she received her 2nd Pfizer vaccine and the following day on 04/17 she started feeling muscle aches, fatigue and R calf pain from high ankle to the back of knee. On 04/18, all symptoms except the calf pain resolved. She continued to have 1-2/10  calf pain w/o skin changes but mild R > L enlargement of the lower leg. Reported a 3 hour car ride on 04/18 after the calf pain had already started. Denied chest pain, shortness of breath or palpitations. On exam, vital signs stable, right lower leg diffusely tender to palpation and noted to be 4 cm larger in circumference than the left side.  Patient was sent for an urgent outpatient duplex ultrasound of her right lower extremity. Ultrasound showed distal DVT in right peroneal veins. She was immediately instructed to discontinue the use of the Nuva ring and started on Xarelto 15 mg BID, with good symptom improvement. Was followed up in clinic on 05/05 with plan to transition to the Xarelto 20 mg QD on 05/13 for a total of 3 months of anticoagulation.
blood pressure has been consistently high/ in crisis mode; Severe headache; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6201), via an unspecified route of administration in left arm on 19Feb2021 at 03:45 PM as first dose, single dose for covid-19 immunisation. Medical history included patient had known allergies. The patient received other medications in two weeks (Unspecified). The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. One-week post vaccination, on 26Feb2021 at 07:30 AM patient experienced severe headache and elevated blood pressure readings. Blood pressure was been consistently high ever since and now she was on medication to try to control it. Patient had normal BP readings prior to getting the vaccine on an unspecified date. Now patient was in crisis mode trying to avoid a stroke. The event resulted in visit to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment of blood pressure medication due to the elevated blood pressure. Since the vaccination, the patient hasn't been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure: normal (prior to getting the vaccine) on an unspecified date and blood pressure: elevated on 26Feb2021. The outcome of the events was not recovered.  No follow-up attempts are possible; no further information is expected.
17 year old patient was due for Meningococcal conjugate vaccine and was given the HIB instead of the dose needed. Patient did not have any symptoms of side effects and left the office fine.
24 hrs p/shot exp low grade temp w/fine rash to arms & legs only; took DPH for itching;
About midnight, I woke up feeling really bad chills and I checked my temperature and I had fever of 101. I took Tylenol. No amount of blankets could make me feel like I wasn't freezing. After a few hours, I went back to sleep and had off and on fever and chills and whole body aches - especially stomach - for next four days. I rotated Tylenol and Motrin every 4-6 days. After fourth day, stomach pain got worse where it hurt to breathe. The chills had gone away. I thought I had constipation because  of the pain meds and I tried to take a laxative but that didn't help it all and it made the pain worse.  I went to URGENT CARE January 18- gave me Flagel and Cipro  and they ordered Ultrasound which I had on the 19th. - Covid test - negative. Put me on Vancomycin - after the Flagel - I took that for 10 days. That helped with symptoms.
This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old patient received Moderna booster) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old patient received Moderna booster). On 12-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old patient received Moderna booster) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   8-year-old patient accidentally received the first dose of Moderna COVID-19 vaccine on 12 Nov 2021 (from a 14 dose size vial). 0.25ml of Moderna COVID-19 booster vaccine was drawn up to be given to the father but mistakenly was given to the 8 year old daughter. Pharmacist stated that the 8 year old patient did not have any previous COVID-19 vaccines of any brand, this was her first time to be vaccinated with the COVID-19 vaccine.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
sore throat, and was feeling poorly. She has had fatigue, fits of dry cough, and laryngitis in the morning along with body aches starting 9/12 and 9/13/21