chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertently administered Daptacel (DTaP) instead of the intended vaccine, Boostrix (Tdap) with no reported adevrse event; Initial information received on 22-Dec-2021 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced inadvertently administered daptacel (dtap) instead of the intended vaccine, boostrix (tdap) with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunization; and INFLUENZA VACCINE (INFLUENZA) for Immunization.  On 21-Dec-2021, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5829BA via intramuscular route in the left deltoid for prophylactic vaccination.  On 21-DEC-2021 the patient developed a non-serious event "inadvertently administered daptacel (dtap) instead of the intended vaccine, boostrix (tdap) with no reported adverse event" (wrong product administered) (latency-Same day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "patient was inadvertently administered Daptacel (DTaP) instead of the intended vaccine, Boostrix (Tdap). Yesterday, the patient would have been one day short of her 12th birthday. The Daptacel was administered intramuscularly into the left deltoid. Concomitant vaccines were the meningococcal vaccine and the influenza vaccine".  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered daptacel (dtap) instead of the intended vaccine, boostrix (tdap) with no reported adverse event.  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.
had dizziness & severe itching over all of body;nurse @ ER stated pt face swollen & eyes red;pt denied any SOB;pt was given DPH & Solu-medrol IV push;
Diagnosed with shingles.  Currently being treated with an antiviral, Famvir. No serious complications, just a painful rash.
Following vax pt exp crying; MOC said was warm to fever, eyes appeared glassy; given APAP during day; t104.8, awake all noc; leg was puffy & red 2-3 days;
One in our group had tested positive, I had a tickle in my throat but was testing negative. As the day progressed the tickle became a sore throat and I got a post nasal drip I went to the drive through testing sight and my PCR COVID test was positive. By this time I had a runny and stuffy nose, muscle aches, the testing sight advised me to isolate. Thursday May 12, 2022 I did a telehealth visit and was prescribed Paxlovid because of my genetic blood clotting factor. I felt fine May 16, 2022 but had a residual cough.
hives from neck to bottom of feet/ Hives or nettle rash, also urticaria from the neck to the foot; This is a spontaneous report from a contactable Other health care professional (HCP) (patient). A female patient not pregnant of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on unknown date as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. Patient stated that four days after first dose had hives from neck to bottom of feet. Resolved after diphenhydramine hydrochloride (BENADRYL) 100 mg per day for 3 days. It was also reported hives or nettle rash, also urticaria from the neck to the foot, patient wanted to know whether she could take the second dose. Patient recovered from the event on unknown date.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
WHITE BLOOD CELL COUNT DECREASED; This spontaneous report received from a patient concerned a 73 year old white and Not Hispanic/Latino female. The patient's weight was not reported and height was 74 centimeters. The patient's past medical history included prediabetic and swelling, and concurrent conditions included penicillin allergy, nonalcoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: D11-458, expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 30-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, patients white blood cell count had dropped from 3600 TO 2400. Also, patient wanted to know if this is cause by the vaccine, and if it is would it be temporary or permanent effect. She did not report any other side effects. On 22-May-2021, the patient is scheduled to have ultrasound and another blood work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of white blood cell count decreased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210458935-covid-19 vaccine ad26.cov2.s- white blood cell count decreased . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
After a couple of days, the patient began with chills and fever. Her pulse is fluctuating between 114 and 40. She feels hot on the left side of her head. She stated she feels out of sorts and wierd and has had a headache since the immunization. She has a warm, round, red, raised area about 3x2.5 inches at the area of the injection.
Swelling in face, neck, ears. Extremely ill feeling. Rash all over. Redness in skin. Skin extremely itchy. Diarrhea stools. Blurred vision. Trouble concentrating.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 19-NOV-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Information regarding Flumist nasal solution was received from a consumer regarding a female patient who experienced very sore throat, feeling tired, weak and yellow nasal discharge. The patient received a dose on 12/9/03. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/9/03. dose regimen was 0.5mL (IN). Concomitant medications were not reported. On 12/10/03, 1 day post immunization, the patient experienced a very sore throat, feeling tired, and weak. On 12/11/03, 2 days after Flumist, she had a yellow nasal discharge. The reporter declined to provide additional information and declined to grant permission for follow up investigation.
Initial misuse report received from a healthcare professional (nurse)on 18 December 2013 and the case was received on 21 March 2014. A patient (gender and date of birth was not reported) had received a dose of 0.5 ml of FLUZONE (batch number, route and site of administration was not reported) on an unspecified date. The patient was given 0.5ml of FLUZONE vaccine instead of 0.25ml. No adverse event was reported. List of documents held by sender: none.
HAD RECEIVED 2ND MODERNA VACCINE ON 03/20/2022, NURSE ADMINISTER THESE AS 1ST BOOSTER DOSE AT 10 WEEKS INSTEAD OF 5 MONTHS ON 05/31/2022.  NO NOTED REPORTED SIGNS OR SYMPTOMS OR TREATMENT REQUIRED FROM RECEIVING TO EARLY. UNDERSTAND DO NOT NEED TO REPEAT DOSE
loss of consciousness for about 20 seconds ,Nurse found him sitting on floor, he thinks he hit his head and right ear moved to cot via wheelchair,VSS,gave water, was assessed by MD at clinic He called his PCP and wife who will transport him to ER
some achiness at the site of the vaccination; she had a 102 fever for a day; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (some achiness at the site of the vaccination) and PYREXIA (she had a 102 fever for a day) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (some achiness at the site of the vaccination) and PYREXIA (she had a 102 fever for a day). On 04-Mar-2021, PYREXIA (she had a 102 fever for a day) had resolved. At the time of the report, VACCINATION SITE PAIN (some achiness at the site of the vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 102 (High) 102 Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no concomitant medication.  The patient did not use any medication to treat the symptoms.   This case was linked to MOD-2021-407803, MOD-2021-407826.
pt recvd vax & a few hrs later felt fatigued & slept; pt exp generalized twitching of face & extremities, & weakness; On the morning of 22JUN94 felt weak w/worsened sx; ER/MD was required & pt was hospitalized for one day;
Shortness of breath, fatigue, hypoxia  Transferred for higher level of care to a major hospital.
Currently pregnant patient (30 weeks) vaccinated 10/6/2021; presented to the ED on 10/1/2023 with fever, cough, rhinorrhea, body aches.  Tested positive for COVID during that visit.  Admitted to the OB unit for observation 10/1/2023.  Discharged 10/2/2023.
FEVER OVER 101 AND INFLAMMATION, REDNESS AND TENDERNESS AT INJECTION SITE AS WELL AS BODY ACHES
Patient received the ZOSTAVAX injection on Mon, 7/11/11, and called on Thurs, 7/14 saying she got shingles.
This spontaneous report has been received from a licensed practical nurse referring to a 13 year old male patient. The patient had no concomitant medications, medical history or drug reactions/allergies. On 06-NOV-2004 and 15-JUL-2009, the patient was vaccinated with a dose of VARIVAX subcutaneously for vaccination (prophylaxis) (dose, lot # and expiration date were unknown) respectively. On an unknown date in 2017 (reported as an unknown recent date), the patient developed a case of shingles. The patient was prescribed acyclovir 800mg orally four times daily for 7 days. At the time of the report, the patient's condition was unknown. The nurse declined Varicella-Zoster Virus (VZV) packet since the patient had been receiving treatment. The causality between the shingles and VARIVAX was unknown.
10 days fatigue has continued. My husband is a cross country and track coach and runner himself. He is very very fit so it is very unusual for him to not be outside doing major work in the yard or out running. Instead he does anything for a short period like 30 minutes and he comes in and goes to bed middle of day and retires to bed right after eating dinner even as early as 6 pm.  His appetite is less than usual.
1 hour after receiving vaccines, patient developed urticaria and wheezing - mom gave him EPIPEN Jr. and Diphenhydramine (1mg/1kg).
following 2nd dose of vax pt exp itching, 2-3 dime size red sl blistery lesions, erythema multiforme; hypersensitivity synd, ringworm;
ErythemaMultiform, UrticariaPruritus, at vaccine site Narrative:
Immediately after getting the vaccine in my left arm I had tingling and numbness in my  pinky finger of my left hand. It has been 4 weeks and I still have it.
High blood pressure. I?ve never suffered from high blood pressure before. I even had a physical done in January 2021 and it was perfect. Since the vaccine it has suddenly changed.
Caller stated he tested positive for covid 19 yesterday on 28Jan2021 after his first dose of the pfizer covid 19 vaccine on 14Jan2021; Caller stated he tested positive for covid 19 yesterday on 28Jan2021 after his first dose of the pfizer covid 19 vaccine on 14Jan2021/ runny nose; This is a spontaneous report from a contactable consumer (patient himself). An unspecified aged male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient stated he tested positive for COVID 19 yesterday on 28Jan2021 after his first dose of the Pfizer COVID 19 vaccine on 14Jan2021. Caller stated his second dose is on 04Feb2021 and caller wants to make sure he can get the second dose as long as he is not feverish or sick. He took the first dose of the COVID vaccine on 14Jan2021. He is supposed to take the second on 04Feb. About two days ago he developed a regular classic cold that he gets this time of year. He went to the MD now and they suggested he get a COVID test and he has COVID. He has no COVID symptoms except a bit of a runny nose and that is it. The data came back and said COVID19 results from (site name). Caller began reading the lab test. "It says latest test 1 out of range 1. Most recent results positive for COVID19. COVID19 is under emergency use. Outcome of events was unknown.  Information about lot/batch number has been requested.
Two large swollen glands at left clavicle, one very sore; Two large swollen glands at left clavicle, one very sore; Breakthrough bleeding 7 days before period; Then very heavy period 5 days earlier than predicted period start; Then very heavy period 5 days earlier than predicted period start; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 15:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Jan2022 (unspecified if ongoing), notes: Had Covid in Jan. 2022. Concomitant medication(s) included: SERTRALINE; KRILL OIL; VIT D [VITAMIN D NOS]. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 18Oct2022 at 17:00, outcome "recovering", described as "Breakthrough bleeding 7 days before period"; MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 18Oct2022 at 17:00, outcome "recovering" and all described as "Then very heavy period 5 days earlier than predicted period start"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 18Oct2022 at 17:00, outcome "recovering" and all described as "Two large swollen glands at left clavicle, one very sore". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, intermenstrual bleeding, menstruation irregular, heavy menstrual bleeding.  Additional information: Two large swollen glands at left clavicle. One very sore. Breakthrough bleeding 7 days before period Then very heavy period 5 days earlier than predicted period start. The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Pulsing in and out chest pains,  in for about 20-30 seconds, then away for 5mins -1 day later  gotten a little worse as the the month continued  Feels like a bad stomach ache in the chest.
This spontaneous report as received from a Licensed Vocational Nurse regarding unspecified patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 28-JUL-2015, the patients were vaccinated with 8 doses of improperly stored doses of VARIVAX (Merck) lot# L003774 and expiry date: 04-FEB-2017. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
I had one really bad day of being light headed and dizzy, I had to lay down most of the day and had no appetite. Since that day the dizziness and light headed has been coming and gong ever since.
Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z0F21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). At the time of the report, PAIN IN EXTREMITY (Arm Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment drugs were not provided   Reporter did not allow further contact
Pfizer 4/1/21, 4/29/21, 12/28/21. Positive on 1/29/23
Called on 09/29/2014 stating that she was in a great deal of discomfort/pain. She felt that the pharmacist had possibly injected her in her joint.  She wanted to report the event because she has never had such discomfort with a previous vaccination/flu shot.
Both vaccines administered caused onset of colon infection which resulted in hospitalization including a blood transfusion being needed due to persistent nausea, vomiting, rectal bleeding, etc. Second hospitalization occurred on April 21st through 24th. First hospital stay was April 9 through 11.
MMR given 3-16-12 - rash started 25 - Sun 28 - classic "measles" rash with palpable lesions face & trunk - happy afebrile - palms inflamed.
Hospitalization: 12/31/2022 - 1/4/2023 (4 days).  Presentation to the ED: MECHANICAL FALL, R HIP PAIN.  COVID + date: 1/2/2023. Treatment: NO TREATMENT SPECIFIC TO COVID.  Discharge to: SNF.   036B21A 4/23/2021 013F21A 11/9/2021
pt was tested before vax & tested negative, since the hep b vax test positive for hepatitis & can no longer be a blood donor;the same rxn occurred to child;Annual follow up states unknown if pt has recovered.
Broke out in a rash after 9 days down left arm.  I went to see Dr. on 2/10/21.  She prescribed Prednisone 20MG Tablets for 5 days, 2 per day. I have a slight itch on a small area, so I am going to use Benadryl Cream when there is an itch.
Having bouts of diarrhea every 2 weeks since getting the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse and diarrhea. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication received included multi-vitamin (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and unknown if ongoing.  The patient did not receive any other vaccine within four weeks prior to the COVID -19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 11Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021, the patient had been having bouts of diarrhea every 2 weeks since getting the vaccine. The patient only had diarrhea once a year before that. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event bouts of diarrhea every 2 weeks since getting the vaccine was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
I received the vaccine on 3/18, and the next morning I started feeling the pain at injection site and it slowly progressed and yesterday I barely moved an object and today there's a pain and I'm concerned about getting the 2nd dose. I had surgery 15 years ago and now I'm in pain from the vaccine. Also my temperturate is reading 99, which is up from my normal 97, I've also gotten chills off and on.
Vomiting  ED Discharged  8/4/2021 (3 hours) Hospital ED  Clinical impression Diarrhea ? Vomiting , Vomiting and diarrhea  Dehydration  AKI (acute kidney injury)   Admission 8/8/2021  Source Organization Discharge Summary     Patient - 66 y.o. Female; Discharge Summary, generated on Aug. 11, 2021 Weakness - Generalized Encounter Details  Date Type Department Care Team Description 08/08/2021 - 08/11/2021 Hospital Encounter      Hypoxia (Primary Dx);  COVID-19;  Hypokalemia;  Acute respiratory failure with hypoxia;  Hypomagnesemia;  Hypocalcemia;  Weakness
Atrial fibrillation (high, chaotic pulse rate). Additional metoprolol and MULTAQ above normal doses. Returned to normal rhythm around noon on 10/16/2018.
This spontaneous report as received from a physician, as part of a marketing research program, refers to a 72 year old male. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, in 2006, the patient received a dose of PNEUMOVAX23, 0.5 ml, (Lot #, expiry date, and route were not provided). Co-suspect therapy and concomitant medication were not provided. In autumn of 2010, approximately in September 2010, the patient experienced pneumonia (atypical bacteria) and was hospitalized (hospitalization dates were not provided). On an unspecified date, in February 2011, the patient recovered from the event. The reporter considered pneumonia (atypical bacteria) to be not related to PNEUMOVAX23. Additional information is not expected.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 25-NOV-2015, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336 (dose, route and the expiration date were not reported). The total cumulative hours out of range were 64 hours with 48 degrees C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 328 hours with 29 degrees C, 264 hours with 33 degrees C, 88 hours with 30 degrees C and 40 hours with 34 degrees C as the lowest recorded temperature. The storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint (PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.