chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient should receive an ADACEL instead of a DAPTACEL, DAPTACEL was incorrectly administered with no reported adverse event; DAPTACEL was incorrectly administered to 11 to 12 yrs old with no reported adverse event; Initial information was received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA190290.  This case involves 12 years Adolescent female patient who received an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Adacel] instead of a DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] was incorrectly administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) (Lot: U7549AA, Expiry date: 04-Nov-2024, strength: standard) via intramuscular route in the left arm for Immunization and received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number will not be requested.  On an unknown date the patient receive an adacel instead of a daptacel, daptacel was incorrectly administered with no reported adverse event (wrong product administered) (Product administered to patient of inappropriate age) (latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  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.
Expiration date expired. Dose given 4 days after expiration. Expiration date calculated incorrectly. Child tolerated well. No signs or symptoms and advised to call if questions or concerns.
Pfizer Dose 1 5/15/21 (EW0170) Pfizer Dose 2 6/5/21 (EW0176) COVID Positive 4/12/2022  4/12/22: Patient is 66-year-old with known history of Addison's disease, coronary artery disease, nephrolithiasis, past history of sepsis and other medical problems.  She presented to emergency department with sudden onset right flank pain. She also has associated nausea and reports urinary hesitancy. Pain is 10/10 in severity. Had some initial relief with fentanyl in ER. Pain started couple of hours ago and  is intermittent. She reports chills and generalized aches.  She also reported nonproductive cough.  Denies fevers, dysuria, gross hematuria, chest pain, shortness of breath.  She was found to have significant pyuria and budding yeast in urine.  CT scan showed right distal ureteric stone with severe hydronephrosis.  Lab work showed acute kidney injury superimposed on chronic kidney disease.  She underwent cystoscopy and right ureteral stent placement under care of doctor.  She tested positive for  SARS-CoV-2.  She has received SARS-CoV-2 vaccines.  4/15/22: Patient is a 66-year-old female with history of CAD, DM, and Addison's disease who was admitted on 4/12/2022 with a UTI and an obstructing right ureteral stone and right hydroureteronephrosis.  Urology was consulted, and she was taken emergently to the operating room for cystoscopy with right ureteral stent placement. Foley catheter was left in place postprocedure.  The patient's initial urine culture showed 3+ organisms growing and recommended recollect.  Repeat urine culture has grown Candida and Gram-positive cocci.  ID and sensitivity is still pending.  Patient has been on Rocephin and fluconazole for the last several days.  Her Foley was removed yesterday.  She has been voiding freely and without difficulty.  She has been ambulating independently.  She reports today that she feels well.  Patient was quite bradycardic on admission.  Her home metoprolol dose was held.  Her heart rate is currently 50-70, sinus rhythm. She denies shortness of breath at rest, dyspnea on exertion, chest pain, palpitations, dysuria, fever, chills. She is requesting to go home today.  I spoke with the urologist, and he is approved the patient to be discharged. Would like her to go home on fluconazole and Duricef for 10 days.  As she was COVID positive on this admission, she will have to be set up for outpatient ureteroscopy in about 1 month. His office will call to set this up.
Headache HA, body ache, feeling tired, feeling hot/cold, vaccine admin site with hard knot "that's growing" Narrative:
COVID breakthrough. COVID+ on 11/4/21. Patient is on 3L of Oxygen
pt recvd vax & exp hypotonic, hyporesponsive state x 5 hrs; had similar afebrile but shorter episode;
Patient had a near syncopal episode following injection. Blood pressure /HR remained stable, though patient very upset by the incident. Within 5 minutes she developed redness at the injection site and a little swelling. She also developed red patches down that same right arm. No generalized hives or swelling elsewhere, or trouble breathing. She was given a dose of Benadryl and observed for an hour afterwards. The redness at the injection site went down significantly and she felt fine, had normal vital signs prior to departure. The next day, the patient returned to the office, with complaint of severe headache and and flushed face. At that time, there was no rash or redness on the right arm or at the injection site. Neuro exam normal for this patient.
Muscle began to ache terrible could hardly use my vacinated arm spread thoughout evening to neck across back down other arm.  Next day was in leg muscles, could hardly walk without pain.
Sore right arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm) and PYREXIA (fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 045B21A and 031B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza. Past adverse reactions to the above products included No adverse event with Influenza.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore right arm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Sore right arm) and PYREXIA (fever) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2022-690818 (Patient Link).
2-3cm flat, erythematous annular lesion at injection site 1 wk after immz.
Right side of face suddenly quit working, unable to to drink through straw or cup, unable to chew or smile, pain in ear, half face paralyzed.
Rash, non blanchable, pink, non vesicular, micro papular scattered truncal rash.
4/16 515am  Itchy at vaccine area, nausea, used Sarna itching lotion, tylenol 230pm more itching lotion 315pm  redness the size of baseball, hot to the touch, went to urgent care, icing 4/17 physical aches throughout, continued icing and tylenol 4/21 4am nausea and aching all throughout the limbs, couldn't walk due to pain in thighs, short of breath, tried to rest. the pain continued for over an hour till fell asleep.
SOB, myalgias, chills, fever, feeling of throat closing, numbness in fingers, swelling in bilateral fingers
This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient's medical history included gout. The patient had no drug reactions/allergies. On 01-NOV-2013 the patient was vaccinated from an unspecified healthcare provider with a dose of ZOSTAVAX (route, lot # not reported). Concomitant therapies included methylphenidate and tramadol hydrochloride. On an unknown date recently in November 2013, the patient experienced a flare-up of pre-existing gout. Prior to this current flare-up, the patient's last flare-up of his gout was in August 2012. The patient went to his physician on 12-NOV-2013 who prescribed prednisone. The outcome of a flare-up of pre-existing gout was reported as not recovered/not resolved. Additional information has been requested.
Information has been received through the pregnancy registry for GARDASIL, from a registered nurse concerning a male baby who was born by C-section on 16-JAN-2010 and had maternal drug exposure to GARDASIL. On 13-MAY-2009, the patient's mother was vaccinated with her first dose of GADASIL (lot # 661953/1130X) (WAES # 0906USA03411). It was reported that on an unspecified date the baby was hospitalized; no other information was available regarding the baby event. At the time of the report the baby's outcome was not specified. Additional information has been requested.
Father of the client reported the client had a  generalized itchiness after the first dose of Pfizer 24 hours after the injection. Father reported he did not see any redness, hives or raised skin on her legs or stomach, where she was itching. He applied lotion and topical Benadryl at bedtime and reported the client did not have any other symptoms.
approx 12 hrs p/inject felt light-headed, weakness no nausea/vomiting, no temp; c/o sore stomach lasted 1-2 hrs; no one in family w/similar sx;
pt w/sudden onset high pitched crying, grabbing back of head/ears, inconsolable x 2hr resolved& @ this time active alert & social
Extreme back/muscle pain, unable to move due to the extreme pain.  Pain in left mid/upper back radiating to left chest/lungs.  Pain caused me to fall to floor and I was unable to move from the floor fro multiple hours.
Mo reports fever of 106 p/immun given 3APR89 also reports redness where inj given; MD told pt was nothing to worry about; mo reports did not give APAP as directed also states pt runs inc fever w/illness;
leaking occurred between the needle and the cartridge when the plunger was depressed during administration with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from a pharmacist via Agency (Reference number- 00779083) and transmitted to Sanofi on 21-Sep-2021.  This case involves a 74-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was leaking occurred between the needle and the cartridge when the plunger was depressed during administration (needle issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 17-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AC, expiry date 30-Jun-2022) via intramuscular route in the deltoid NOS prophylactic vaccination.  It was an actual medication error due to needle issue (latency: same day).  It was reported when giving FLUZONE HIGH-DOSE QUADRIVALENT to a patient, the majority of the vaccine leaked out between the needle and the cartridge. The leaking occurred between the needle and the cartridge when the plunger was depressed during administration. The pharmacist asks if the vaccine was valid or if the patient should be revaccinated.  At time of reporting, no adverse event 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 the 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.
I had fever for a few days. I had a cough, chills, and body ache. I had congestive into a running nose. The cough keep on to the point where I had to get an inhaler to help.
About a week after the vaccine, a rash developed on her thigh.  It quickly spread to rest of body.  The next day she complained of burning feet.  Red/purple sores developed on her feet and fingers along with loss of appetite, fatigue, and fever.
Severe Covid symptoms: fever. chills, body aches, severe headache,  nausea/vomiting, very sore arm (could not lay on that side)., loss of appetite, missed period.  Symptoms lasted 48+ hours with fatigue  continuing after for several days. The side effects of vaccine were the same, but more severe (had fever of 102 degrees approx 36 hours after vaccine and started much earlier (sore arm and headache started within a few hours of vaccine).
Stat after IM DTAP and Hib in left leg, red mark developed medial to site. Fever 102, fine next day. Today 3 1/2 x 2 1/2 inch red raised over hive, not indurated about 1 1/2 hours away from DTaP. Surgical consult, observe thigh.
A week later my left arm and shoulder was very sore. Doctor said it was inflammation in my rotator cup due to the vaccination being improperly administered. Currently in physical therapy for my injuries.
Allergic reaction; I can't get my second shot because I am afraid to it; Swelling of legs; Flushing of face; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169; Expiration Date: Aug2021), via an unspecified route of administration, administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reaction; patient can't get my second shot because and afraid to it, swelling of legs, flushing of face. The patient wanted to know about the vaccine (Pfizer, Covid vaccine) had first vaccine done and had a slight allergic reaction towards to it swelling in the legs, flushing on face and all. So, just took Benadryl (treatment), so was fine but cannot get second shot because patient was afraid to it. Patients need to know if he should be taking second shot because of reaction and had before or if what patient need to do because consumer do not want to get this, even the Hospital does not want gave it. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
On 4/26/2021, I got a sore throat and stuffy nose that would not go away. I also had a low grade fever. I did take Tylenol.  As the weeks went by, the symptoms got worse. I had extreme sinus congestion with complete blockage of the nasal passage and I was unable to breath through my nose. I had difficulty sleeping. I would take Nyquil and Dayquil, but had no relief. I called the COVID nurse line on 5/22/2021 and went to get a COVID test, which was negative. On 5/23/2021-I went to urgent care/convenient care. I was diagnosed with upper respiratory tract infection and were prescribed antibiotics Augmentin for 7 days. The symptoms improved and I have fully recovered.
Pt received J&J covid vaccine on 3/15/21 in.presented to the ED on 3/29 for few days of progressive weakness and urinary difficulty. Recently took a trip and returned Thursday evening. That night, she noticed mild sensitivity to her left forearm. On Friday she developed an achy feeling under both arms and across her breasts. Her eyes felt painful as well. Overnight Friday into Saturday her feet began feeling cold and numb and she developed a generalized sensitivity over her entire body that she describes almost as a burning sensation. Also had trouble urinating -. presented with pain, paresthesias and weakness below mid-chest level and urinary retention. MRI brain, C and T spi ~C and T spine c/w demyelination. Neuro consulted and impression = acute demyelinating disease, unclear etiology but may be acute disseminated encephalomyelitis (ADEM) 2/2 COVID vaccine vs. 1st presentation of multiple sclerosis. Sx gradually improved s/p solumedrol IV bid x 5d in hospital -- > transitioned to PO prednisone taper per neuro (60 mg x2 days then go down by 10 mg every 2 days until off) for discharge.  Pt to f/u with neuro post discharge. For neurogenic bladder PT had temporary foley, removed 4/2 and will require CIC QID (teaching done prior to discharge) at home. Outpt f/u Urology.
Patient was sitting in observation area c/o dizziness. Patient taken to EMS room and laid on cot and stated she felt better quickly.
rash and itching at injection site, topical hydrocortisone cream, 2-3 through 2-11, 2021
2 days following vaccine, noted petechiae so platelets drawn and 2,000.  Received 5 day course of Prednisone x2, then developed a nosebleed unresponsive to a third round of steroids requiring admission for IVIG.  There is a possibility that he has some prolonged mucosal bleeding 2 days prior to the dose when he lost a tooth.
ALMOST KILL; ARM HURTS FOR A DAY; DOWN FOR 6 WEEKS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company (on behalf of moderna) concerned a female patient of unspecified age. The patient's height was 5.4 (units not given), and weight were not reported.  The patient's concurrent conditions included: thyroid problem, and autoimmune system issue, and other pre-existing medical conditions included: The patient had no allergies (medications, food and other products), the patient did not have COVID positive test or diagnosis ever, and did not take other vaccines within 1 month prior to moderna COVID-19 vaccine. The patient received first dose as covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1805075 /1805025) dose was not reported, 1 total, administered on 25-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced almost kill and was down for 6 weeks and reported to her doctor (physician office) (Dose number in series 1). The patient also received second and third dose as moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin was not reported, Intramuscular, batch number:019F21A (second dose) and 017F21A (third dose) , expiry: Unknown) dose was not reported, second dose (first of moderna) administered on 24-SEP-2021 and third dose (second of moderna) on 22-OCT-2021 for covid-19 prophylaxis (revaccination with different COVID-19 vaccine).  On an unspecified date, the patient arm hurts for a day after first and second dose of moderna covid-19 vaccine (elasomeran) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from arm hurts for a day, and down for 6 weeks, and the outcome of almost kill and revaccination with different COVID-19 vaccine was not reported. This report was non-serious.
I got COVID after receiving the first dose of Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got COVID after receiving the first dose of Moderna Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I got COVID after receiving the first dose of Moderna Vaccine). At the time of the report, COVID-19 (I got COVID after receiving the first dose of Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Patient received monoclonal antibodies as treatment .   Reporter did not allow further contact; Sender's Comments: This case concerns a patient, unknown age and gender, with no disclosed medical history, who experienced the serious, unexpected, event of Covid-19. The event occurred  on unknown day after first dose of Moderna vaccine. The rechallenge is not applicable as only first dose details were given and patient received treatment for covid-19. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Low grade fever; tired; skin pain; joint pain; scalp pain; swollen lump under left armpit; On morning after vaccine was given: - symmetrical pain in the upper arm area (outer area between shoulder and arm, continued slightly underneath as well) of both left & right arms - in the afternoon, the arm pain persisted but ONLY in the left arm - the following morning (approx. 40 hours after vaccine was administered) left arm pain continued; no change in levels of pain from the day prior - pain levels vary with what position the arm is in: if I am standing upright with my arms at my side the pain is at its lowest, if I lay down OR move my arm away from my body (e.g.: to grab something from a shelf) the pain increases significantly  Treatment: - Tylenol & Advil
On the 17th at 9:00 PM she started itching on her thigh, didn't think anything about it, just a rash.  Through the night it increased to the whole thigh, and a little on her abdomen, and itched all night.  The next morning is dissipated, and it kept happening for the next night and then increased.  Friday night it happened to the point that 95% of her body was covered with hives, rash, and felt like her skin was burning and pins and needles throughout the areas of the rash.   She called her doctor on Thursday morning and kept in contact them him.  Was given a prescription on Friday for Prednisone and she took that morning and Saturday morning.  Her symptoms were gone during the day but at night they would return with the itching.  She started Benadryl 50 mg on Friday.  She also used Hydrocortisone ointment through the night on Thursday.  Saturday morning her entire face was swollen.  She put a cold washrag on her face and within 45 minutes it stopped hurting her, continued with the 50 mg of Benadryl every 4 hours.  By noontime she was getting short or breath on 2/20/21 she went to the ER.They gave her Solu-Medrol 120 mg, Benadryl 25 mg IV as she had just taken a 15 mg tablet 3-4 hours before that.  Then they gave her Ibuprofen and Pepcid IV.     The shortness of breath was when she was talking, and within 4 hours she was fine.  She had markings on her legs as well.   She was wiped out by this with no energy.   She has not been able to do gardening or anything due to the fatigue.  The rash and symptoms are gone, but her energy level has not returned.  Her legs felt like jelly when she walked on 17/18th.    On Monday, 2/22/20 she stopped the prednisone and Benadryl totally.
Patient had first dose of Moderna COVID vaccine on 3/12/21 on 4/3/21 patient was taken to hospital after visiting facility previously with difficulty breathing and subsequently tested COVID positive