chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doctor prescribed Daptacel but patient accidentally received Pentacel/no AE; Initial information received on 17-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional (Medical assistant).              This case involves a 4 year-old female patient who accidentally received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 17-Aug-2020, the patient received fifth dose 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ259AA; UJ331AA and expiration date 14-May-2021, 23-Nov-2020) via intramuscular route at an right Vastus lateralis for prophylactic vaccination.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong drug administered (latency: on same day).  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 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.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # N010105 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.
Stress cardiomyopathy; This is a literature report. This author reported different events for four patients. This is second of four reports.  A 60-year-old woman with a history of a stent placed in the left anterior descending artery (LAD) three years ago, and normal LV function and wall motion on echocardiography five months ago, presented to clinic four days after receiving her second dose of the Pfizer-BioNTech vaccine, with exertional chest pain and new inferolateral T wave inversions (ECG: T wave abnormalities In the lnferolateral leads (II, Ill, aVF, V3-V6)). She was admitted to the hospital for further evaluation, and echocardiography revealed mildly reduced LV function with apical akinesis (Figure 3B-3C). Coronary angiography demonstrated a patent LAD stent and no obstructive disease. Based on these findings, the patient was diagnosed with a stress cardiomyopathy, and she was discharged on metoprolol succinate and lisinopril. Summary of diagnostic testing for this patient included Viral serologies: SARS-CoV-2, influenza, and RSV negative; Cardiac Biomarkers: Troponin T: 0.129 ng/mL (reference range: less than 0.03 ng/mL); Transthoracic Echocardiogram: LVEF: 44%; LVIDd: 3.5 cm; Normal RV size and function; Apical akinesis; Coronary Evaluation: Coronary angiography: Patent LAD stent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the event of stress cardiomyopathy and the suspect product of BNT162B2 cannot be completely ruled out. 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.,Linked Report(s) : US-PFIZER INC-202101513854 Same article/drug and different patient/event.
Pt recvd vax on 16JUN92 & on 17JUN92 mouth started to droop; speech became slurred; seen by MD dx condition as Bell's palsy;
Patient received ADACEL injection in right arm at 1310 on September 23, 2017. At 1313 she returned and showed me a welt/welp 1 in. wide and 0.5 inch deep. I marked it with a marker, administer generic BENADRYL capsule x 1 dose, and had her stay in the pharmacy area for 20 min. to ensure the swelling went down and she did not complain of any difficulty breathing/swelling of mouth or tongue/itching or hives.
Felt slightly itchy; immediately felt sick; Dizzy; Arms and legs felt numb; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: unknown) via an unspecified route of administration in the right arm on 21May2021 at 14:45 (at the age of 57-years-old and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included high cholesterol and once hospitalized for an arrhythmia, egg allergy, sulfite allergy and chocolate allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 15:00, after fifteen minutes the patient immediately felt sick, dizzy, arms and legs felt numb, vomiting and dizzy. On 21May2021 at 16:00, after one hour and fifteen minutes, felt slightly itchy. Since the vaccination, the patient had not been tested for COVID-19. The events did result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and was monitored by EMT. The clinical outcome of the events felt sick, dizzy, arms and legs felt numb, vomiting and felt slightly itchy was resolving at the time of this report.   The lot number for the vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was not provided and will be requested during follow up.
started with swelling at the hands and tingling, she then progressed to flush face with swollen lips and eyelides
Information has been received from a physician concerning an unknown number of patients who were vaccinated with a dose of GARDASIL and experienced pain after vaccination.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Follow information received on 30-JAN-2009 stated that the reporter didn't had more information to provide.  No further information is available.
Arm pain at the injection site starting around 4pm.  Fatigue started around 8:45pm, with fever (99.3 F), Chills, headache, joint pain, stomach cramping, nausea and eye pain/ pressure shortly after and lasting throughout the night.  Chills ended around 8am on 01-22-21, all other symptoms with the exception of sore arm resolved by 12 noon on 01-22-21.  Arm pain subsided on 01-23-21.  No other symptoms reported.
Wrong vaccine administered. Patient was to receive Infarix (Dtap) and received the Pediarix (Dtap, IPV, HepB)
So far, within two hours, when I walked, I felt pain in my left hip or just above it. I couldn't quite figure out where. Only when I walked. Never had this before. It hurt to stand on my left leg. Lasted a few hours.  About an hour into that, I had short, sudden stabbing or shooting occasional pains (nerve pain probably) toward that left hip, then to my right shoulder/bicep (where my tendonosis is.) That ended by 10 or so.  Mild, "pressure" headache on left side of head for 24 hours.  Minimal pain at injection site but within 3-4 hours of shot, I had much more pain in my right bicep (site of injury)- this has continued. My bicep and shoulder feel weak, harder to raise that arm and moderate to high pain when I use. Still continues at 28 hrs past vaccine. A few occasional chest area pains (muscle maybe?) that I don't usually have. They were very brief, a little concerning but fine. Between 18-22 hours, I got very lightheaded, balance felt off, felt brain fuzzy very suddenly. Lasted about two hours. Was concerning. I saw online that some people get this. I wondered if I should call someone because I felt very "off" - like I was going to pass out.  I expected to have a full blown herpetic episode. Because I had to start taking acyclovir before the vaccine, I don't know. I AM having a massive rash, buzzing face, etc and on anti-virals but not worsening (yet) from vaccine. I won't come off of them until the episode subsides.
First shot resulted in fever for 3 days with a maximum temperature of 103. Second shot on 7/24/2019 caused canker sores to erupt on tongue which resolved in 2 days.
under her chin was hard & swollen; under her chin was hard & swollen; she was itching here & there/random itching spots/was itchy & bumpy from the waist down; right eye was swollen again but not as much/eye swelling again but not as bad/right eye was swollen together; her upper lip was swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (her upper lip was swollen), INDURATION (under her chin was hard & swollen), RASH PRURITIC (she was itching here & there/random itching spots/was itchy & bumpy from the waist down), EYE SWELLING (right eye was swollen again but not as much/eye swelling again but not as bad/right eye was swollen together) and SWELLING (under her chin was hard & swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 030L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (her upper lip was swollen). On 14-Nov-2021, the patient experienced RASH PRURITIC (she was itching here & there/random itching spots/was itchy & bumpy from the waist down) and EYE SWELLING (right eye was swollen again but not as much/eye swelling again but not as bad/right eye was swollen together). On 15-Nov-2021, the patient experienced INDURATION (under her chin was hard & swollen). 15-Nov-2021, the patient experienced SWELLING (under her chin was hard & swollen). On 13-Nov-2021, LIP SWELLING (her upper lip was swollen) had resolved. At the time of the report, INDURATION (under her chin was hard & swollen) had not resolved and RASH PRURITIC (she was itching here & there/random itching spots/was itchy & bumpy from the waist down), EYE SWELLING (right eye was swollen again but not as much/eye swelling again but not as bad/right eye was swollen together) and SWELLING (under her chin was hard & swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Tachicardia diagnosed by doctor starting on third day after vaccination in the a.m.,  heart pounding hard and feel it pounding throughout upper body and back.    Evening of third day after vaccination severe Tinnitus of both ears, came on suddenly and has not stopped and now in 6th day of these adverse reactions.  I had a full workup with my cardiologist in the summer of 2021 and my heart was very healthy with no issues.  Have no previous problems with my ears, in fact have had excellent hearing up to now.  no treatments have been taken by my doctor.  Cardiologist
This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 10-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Drug taken beyond expiry date; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for covid-19 immunization.  The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Drug taken beyond expiry date".  Additional information: Medical Information Inquiry received from AE. Reporting via database. It has reviewed report. Per Database report dated 27Apr2021 verbatim: "No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Pharmacy Manager with Pharmacy said their Pharmacy Technician gave a patient the 2nd dose of Pfizer-BioNTech Covid-19 Vaccine after it has expired. HCP wants to know what the next step is for patient. She also wants to know if they should revaccinate the patient. Callback was placed on 30Apr2021 at 3:50 PM. Outbound call disclaimer was provided.  E-transmitting; Possible AE duplicate. Response: Provided disclaimer, and responded from the attached SRD, "Revaccination after Administration of Invalid Dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On April 30, 2021, I received the 2nd dose of the COVID-19 (Pfizer-BioNTech) vaccine which was 3 weeks after receiving the 1st dose. Then on May 3rd, I experienced pronounced shortness-of-breath while at work lifting objects up to 20 lbs and walking short distances of 20 to 40 m on flat ground. Then on May 4th, 2021, I went into a nearby Urgent Care Clinic (UCC) with shortness-of-breath and exertional dyspnea as the main symptoms.  At the UCC blood tests were done along with EKG and chest x-ray. Blood tests revealed several results that were not within standard ranges: troponin (1.25 ng/mL), BNP (5130 pg/mL), D-dimer (1320 ng/mL FEU), and C-reactive protein (75.5 mg/L). I was told that I had congestive heart failure and NSTEMI. UCC then directed me to go to the Emergency Department (ED) at a nearby hospital.   In the ED, more tests were done: EKG, CT scan chest (no blood clots were found in the lungs), and cardiac ultrasound (estimated ejection fraction 40-45%). That evening I was transferred to the main hospital for further observation and tests. Not much happened on May 5th and I was not seen by a doctor until 5pm. Then early in the morning of May 6th, I experienced chest pain which lasted between 5 and 10 minutes. I was given oral nitroglycerine. My primary care physician (PCP) and a cardiologist elected to move forward with an angiogram. On May 6th, I underwent cardiac catheterization (CC). The CC report states: (a) 2nd Diag lesion is 50% stenosed (b) Mid RCA to Dist RCA lesion is 80% stenosed,(c) RV branch lesion is 80% stenosed, (d) RPDA lesion is 80% stenosed. Likely spontaneous coronary artery dissection of the mid to distal RCA and postal to mid PDA status post PCI with 2 Xience drug-eluting stents.   Post-angiogram+angioplasty tests were done, including carotid artery ultrasound (results within normal limits. No hemodynamically significant stenoses) and MRI brain (punctate foci of restricted diffusion in both cerebral hemispheres. Multiple vascular distributions w/o larger territorial infarct suggest emboli). Other blood test results were: antinuclear antibody (ANA) IFA screen (positive), BNP (8631 pg/mL). I was released from the hospital on May 8, 2021. Follow-up care included cardiac rehab therapy and consultations with the cardiologist, PCP, a neurologist and rheumatologist. Incidentally, 12 days after the angiogram and angioplasty, I experienced temporary numbness and loss of movement in my right arm which lasted no more than a minute, indicative of a transient ischemic attack (TIA). Root cause investigations focusing on SCAD and TIA are on-going.
Arm Pain, Nausea, Headaches,  Fevers, Chills,
Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm where injection was given; ice was used to reduce swelling and was alternated with heating pad.  soaked in warm bath with epsom salts.   relief was finally achieved by taking 1 Aleve liquid gel capsule - 220 mg.   Swelling and pain began within 24 hrs after injection and pain increased intensely by hour 36.  Some tenderness to touch still in lymph glands in armpit/chest and to underside of arm.  minimal tenderness at actual injection site - no more than normal for a injection.
Only 0.8 ml of 0.9% sodium chloride diluent, not 1.8 ml of diluent was added to the vaccine per recommendation.  The patient received a more concentrated dose of the Pfizer COVID vaccine.  The patient was contacted following the adminsitration of the vaccine to notify her of the error. On 6/14 the patient reported the following: States she is feeling well.  Woke up with slight headache yesterday that self resolved shortly after. No erythema at injection site. Patient advised to call Thundermist with any concerns or questions.
Vesicular rash on legs radiating to thighs, buttocks, back, abdomen, arms.
suspected vaccination failure; shingles; ill; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and unwell. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and unwell were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient became ill with shingles. The patient's recovery time was lengthy of many many months. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
I became very dizzy, nauseous, and hot during a workout.  Quit and went home where I had chills and weakness.  I missed work on 10/11/2011 due to headache and weakness.
I had soreness in the arm, cold and hot sweats, temperature was normal, body ache, nausea. I was given a Z-PAK or something like that. My symptoms lasted about 5 days and were mild. The medication they gave me knocked it down pretty quick. A week or more later I ended up having high cardiac enzymes when I was transported to the hospital and they did open heart surgery. 8th I had 5 clogged arteries and they did 5 bypass surgeries on me. I had a doctor's appointment on the 7th and when they found that my enzymes were high I was told to get to the ER. I was in the hospital for 24 days.
no adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    ID number was reported as 80777027399.  Patient age was reported as 51 Year 9 Months.  Concomitant product use was not provided by the reporter.  Reportedly, the number of patients at facility that received this Moderna vaccine between 08-Apr-2022 and 15-Dec-2022.   Completion date provided as 22-Sep-2022.  Treatment information was not provided.
Developed left sided numbness involving entire body 10-11 days after first Pfizer vaccine.  This is persistent and has not improved since.
PCV20 vaccine given in left arm on 7/22.  Patient developed erythema and itching at the injection site two days later 7/24.  Pt  called on 7/25 to report pain, redness, soreness, was advised to use warm compress and go to urgent care if persisting. Called again on 7/29 due to continued redness and pain. Had video visit on 7/29 where MD noted significant erythema on left upper arm ~3 centimeters below the injection site.  Treated for cellulitis with cephalexin/doxorubicin and antihistamine, topical cortisone and cool pack.
Information has been received from a nurse practitioner concerning an 18 year old female patient with no known drug allergies or reactions and no pertinent medical history who in "early October 2009" was vaccinated with her initial dose of GARDASIL at a local health department. Concomitant suspect vaccine therapy included a dose of RECOMBIVAX HB (manufacturer unspecified). Other concomitant vaccine therapy included Tdap. The nurse mentioned that the patient developed hives after administration of the vaccines at that visit. On an unspecified date, the patient recovered. The patient sought medical attention contacting the office. Additional information has been requested.
Presented to ED on 10/28/2021 with hypoxia, SOB, fever, cough, congestion. Entered Hospice on 11/3/2021 with terminal diagnosis of Covid-19 pneumonia, and passed away 11/5/2021 Previously fully vaccinated: Pfizer 1/28/2021 and 2/18/2021 Submitter does not have access to full medial record. If further information is needed, please contact the admitting hospital.
on day 7   (1/14/21)my arm was warm, red and swollen .  Continued to be  swollen, red and warm till 1/17/21.  I took Benadryl  on the 14,15,16, and 17th.   after the 17th  Arm area is fine.
Received #1 dose of Hepatitis A and #2 dose of varicella on August 7,2006. The morning of August 10, she developed dizziness, fever, stomach cramps and diarrhea. Mother denies any rashes. Mother reported that her other two children also received vaccines on August 7 and developed similiar symptoms on  August 11, 2006. Mother states that symptoms are resolving.
3/29/2021 metallic taste in mouth, 15 min after leaving the clinic. Tingling in lips and chin.  3/30/2021 hives, mouth sores on roof of mouth. went to ER received steroid and magic mouth wash. patient is at home recovering at this time.