chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Right arm on 11Mar2021 (65-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included Asthma and high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot number: EL9266), via an unspecified route of administration, on 23Feb2021 (65-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation and No reaction on previous exposure to vaccine. The patient received the Pfizer covid-19 vaccination in January and February, now tested positive for covid-19 the delta variant on 30Jul2021. They have advised her to get antibody testing 3 weeks from the day they tested positive due to their age. She would like to know what she is to do if they get the antibody testing back and they do not have antibodies. They received it 3 weeks from the day that they tested positive, to see if there were any antibodies. She does not know if they would need a booster. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 30Jul2021. The outcome for both the events was Unknown.   No follow-up attempts are needed. No further information is expected.
pericarditis; Initial information regarding an unsolicited valid serious case was received from a other healthcare professional via Agency (Reference number- 00438099) and transmitted to Sanofi on 20-Jan-2021.  This case involves patient (unknown demographics) who experienced pericarditis, while he/she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (lot number: UH478AC and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pericarditis (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pericarditis.; Sender's Comments: The patient (unknown demographics) who presented with pericarditis after vaccination with FLUZONE. The time to onset is unknown. Medical history, concomitant medication, lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon reported information role of vaccine cannot be assessed.
Parents came out of room stating pt fainted. Medical assistant to room and pt was was trying to sit up. She advised he continue to lay down. Pt was given cool cloth for head, juice and a supine BP was taken by RN. Pt reported no dizziness. Pt was then asked to sit and reported no sx. Second BP was taken. Vitals WNL each time. Pt was helped to stand and to take a few steps. Pt was back to baseline. Took 5 minutes.
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 29-DEC-2014 the patient was vaccinated with improperly stored VAQTA (lot # K008252, expiration date: 24-OCT-2015), .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. Reporter considered the event to be not related to VAQTA. This is one of several reports received from the same source (MARRS # 1501USA003826, MARRS # 1501USA004956, MARRS # 1501USA004957, MARRS # 1501USA004959 and 1501USA004960). Additional information has been requested.
I had upset stomach and severe diarrhea the day I received the vaccine and felt like I was coming down with something.  The next day I learned I had COVID exposure to someone I worked with.  By Saturday I had all of the COVID symptoms except COVID toe and Sunday was really sick.  I developed blood clots, COVID and COVID pneumonia.  I had to be hospitalized after 2 weeks for 5 days.  I think I also hemolysis occur due to my G6PD and really felt like I was going to die.  I could not get out of the bed and was home by myself during the day.  When I got my next COVID test I tested positive on 9/16.  I did not have COVID according to the test I took the day before the shot.
Inadvertently gave Influenza vaccine after expiration date. No symptoms, signs or concerns. Reviewed with patient.
Felt cold; Abdominal rash, rash on arm, rash on chest and rash on back/rash subsided after 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold) and RASH (Abdominal rash, rash on arm, rash on chest and rash on back/rash subsided after 24 hours) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Felt cold) and RASH (Abdominal rash, rash on arm, rash on chest and rash on back/rash subsided after 24 hours). At the time of the report, FEELING COLD (Felt cold) outcome was unknown and RASH (Abdominal rash, rash on arm, rash on chest and rash on back/rash subsided after 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment information was not provided. Patient was doing well.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up was received includes vaccine regimen details(missed from initial document), the event outcome for rash were updated.
Patient received PENTACEL and DAPTACEL this morning, no AE; Initial information was received on 19-May-2021 regarding an unsolicited valid non-serious case from a physician via other health care professional.  This case involves a 15 months old female patient who received 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ504AA) and 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5743AA) via intramuscular route in the left thigh for prophylactic vaccination on 19-May-2021 (Extra dose administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to Extra dose administered (latency same day)  At the time of report, no adverse event was reported.  A 15-month-old patient received PENTACEL and DAPTACEL this morning, so patient was duplicated on the DTAP. They were calling to see what they needed to do and what to expect. They were suggested to be on a lookout for any adverse reaction or side effect. They were requesting a response as soon as possible, preferably within 24 hours  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a physician and described the occurrence of wrong vaccine administered in a 57-year-old male patient who received INFANRIX (batch number HM4FY, expiry date 6th December 2016). Concurrent medical conditions included leukemia. In November 2014, the patient received INFANRIX .5 ml. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: 57 years old male being admitted to hospital for treatment of leukemia, has received multiple vaccinations to protect him while in treatment in the hospital. Instead of BOOSTRIX, INFANRIX was given (0.5 mL) to this man about a month ago with no reaction.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 201 Patients in the exposed cohort experienced syncope, while 250 of the unexposed cohort experienced syncope. Of the 201 patients in the exposed group age: 15 were age 18, 164 were in age group 19-24, 19 were in the age group of 25-29, 3 in age group 30-34. Sex: 69 female, 132 male. Of the 250 in the unexposed group age: 2 were age 17; 11 were age 18, 208 were in the 19-24 age group, 24 were in the 25-29 age group, 3 were in the 30-34 age group; 2 in the 35-39 group. Sex: 59 female, 191 male.
Pregnant at time of vaccination, confirmed by 8wk ultrasound with heartbeat on 1/29/21. Due date was . Missed miscarriage discovered at a routine ultrasound (nuchal translucency) at 13w2d on 3/8/21. Baby was a few days behind on measurements (so died within that week). No cause found but also no genetic testing done. No maternal illness or symptoms.  Also reported this for my 1st moderna vaccine
Right after the injection, I felt a burning sensation and immense pain. The pharmacist advised I move my arm around and apply ice to the injection spot as needed. However, the pain in my shoulder continued to progress and I brought it to my primary care physician?s attention about a month after. She recommended home exercises program and concluded I had unspecified pain chronicity in my left shoulder. The home exercises did not help. I then saw a  doctor who diagnosed me with bicipital tendonitis and bursitis of my left shoulder in the month of April 2023. The doctor recommended physical therapy and to take ibuprofen for a week straight. In June, I began to regress in physical therapy where I had first had an X-ray and then later  received an ultrasound guided injection into my left bicep tendon. The injection offer very little relief of pain. I was told to continue physical therapy and get an MRI. My PCP referred my to an orthopedic surgeon who ordered an MRI. The MRI findings showed I had frozen shoulder. My orthopedic surgeon recommended more physical therapy. My doctor also recommended more physical therapy and believe my diagnosis to be bicipital tendonitis and subdeltoid bursitis. She had recommend that I receive an MSI injection into my shoulder joint and continue my physical therapy treatment.
Information has been received from a pharmacist concerning an 81 year old female inpatient (acute ischemic MI) with diabetes, hypertension and hypothyroidism; history of ischemic stroke (admitted to hospital on 26-SEP-2008) and allergy to latex, codeine and PERCOCET who on 01-OCT-2008 was vaccinated with one dose of PNEUMOVAX 23 (lot #658493/0991U) IM in the left arm. Concomitant therapy included LEXAPRO, unspecified multivitamin, KEPPRA, ACTOS, CLARITIN, SENOKOT, NEXIUM, metformin, SYNTHROID, CORGARD, GLUCOTROL, LOVENOX and LIPITOR. On 02-OCT-2008 the patient developed cellulitis on the left arm. It was swollen, red and tender to the touch. The cellulitis prolonged the hospitalization. The patient was treated with KEFLEX. Complete blood cell count was performed. Subsequently, she recovered from the cellulitis. Additional information has been requested.
This spontaneous report as received from a healthcare worker and a consumer refers to a patient of unknown age. On unknown date the patient was vaccinated with the first dose of M-M-R II (lot number and route not reported) approximately in November 2011 (at age 18 months, on an unspecified date approximately 9 months ago) (also reported as age one by the healthcare worker). Following the first dose of M-M-R II the patient experienced a slight fever The patient appeared to be "doing fine" following the second dose of M-M-R II the patient experienced a slight fever The patient appeared to be "doing fine" following the second dose of M-M-R II (lot number and route not reported) on 15-AUG-2012 at age 27 months (also reported as age 2 by the healthcare worker). Additional information is not expected.
Patient feeling severe pain the arm that started immediately after the vaccine. Also having difficulty breathing and is feeling really sick. The arm is very sore and red.
after 2nd shot, fatigue 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: Apr2019 (ongoing), notes: Pertinent details: Mastectomy 2019; "Chronic bronchotis", start date: Oct2021 (ongoing), notes: Pertinent details: Inhaler & Monthly testing. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Date: 04Jan2021, Time: 10:00 AM, Anatomical site of Injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: Not Available), administration date: 04Jan2021, when the patient was 75-year-old, for Covid-19 immunization.  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "after 2nd shot, fatigue 2 days".  Additional information: The patient had third dose on an unknown date in Octob2021 in right arm. The patient received 1st and 2nd vaccine in assisted living home; 3rd and 4th in an hospital. The patient had no prior vaccinations nor had any concomitant medications. It was unknown if patient had any relevant test for thromboembolic events with thrombocytopenia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills, body aches, temp of 101.5, fatigue,runny nose, throat hurt, coughing
Patient refers to feeling dizzy and not having feeling in his legs which were cold to touch. He is given an alcohol to smell in. He leans his head back and the paramedic is told, who takes the vital signs, BP 123/82, P87 Sat 98.
A non-serious spontaneous report of administration of expired product was received from a clinic administrator concerning a 45 month-old female subsequent to the administration of FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. On 24-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
cold sweats; diarrhea; feel very weak; fever; nauseous; Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), DIARRHOEA (diarrhea), ASTHENIA (feel very weak), PYREXIA (fever) and NAUSEA (nauseous) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 infection in October 2020.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HEADACHE (headache). On 25-Feb-2021, the patient experienced COLD SWEAT (cold sweats), DIARRHOEA (diarrhea), ASTHENIA (feel very weak), PYREXIA (fever), NAUSEA (nauseous) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 27-Feb-2021, COLD SWEAT (cold sweats), DIARRHOEA (diarrhea), ASTHENIA (feel very weak), PYREXIA (fever), NAUSEA (nauseous), CHILLS (Chills) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 100f (Inconclusive) fever of 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Rash is a little bit itchy; Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is a little bit itchy) and RASH (Rash all over the body) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Sensitive skin (Medical history reported as Sensitive skin/Fair skin.).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH PRURITIC (Rash is a little bit itchy) and RASH (Rash all over the body). At the time of the report, RASH PRURITIC (Rash is a little bit itchy) and RASH (Rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: ADR form contains NNI
This case was reported by a healthcare professional and described the occurrence of shortness of breath in a female subject aged between 40 and 49 years old who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 5 October 2007 at 16:00 the subject received 1st dose of Flulaval (.05 ml, unknown).  Within one hour after vaccination with Flulaval, on 05 October 2007, the subject experienced shortness of breath, tongue numbness and injection site tenderness.  The subject was seen in the emergency room but was not admitted to the hospital.  The reporter did not believe that the patient had received any previous influenza vaccinations.  The reporter also noted that she considered this to be a pharmaceutical product complaint.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.
Couldn't get the second dose/2nd Dose more than  35 days after 1st Dose; out of protocol; Patient was scheduled to receive 2nd Dose; missed appointment.; was hurt; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Couldn't get the second dose/2nd Dose more than  35 days after 1st Dose; out of protocol), PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive 2nd Dose; missed appointment.) and PAIN (was hurt) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TETANUS VACCINE (received a tetanus shot) on 25-Mar-2021.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (was hurt). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Couldn't get the second dose/2nd Dose more than  35 days after 1st Dose; out of protocol) and PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive 2nd Dose; missed appointment.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Couldn't get the second dose/2nd Dose more than  35 days after 1st Dose; out of protocol), PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive 2nd Dose; missed appointment.) and PAIN (was hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: NNI
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case is linked to case 2019SA077259 (same reporter). This case involves a 24 months old female patient who was vaccinated with a 0.5 ml dose of ACT-HIB with diluent (lot number: U6001AA and expiry date: 21-Feb-2019, dose in series and route of administration were not reported) in the right deltoid on 14-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD; PREVNAR 13; PEDIARIX and HAVRIX on an unknown date. It was a case of actual medication error due to expired vaccine used as ACTHIB after 2 doses were given on 14-Mar-2019 to 2 related patients with the Diluent exp date of 21 Feb 2019 and the Lyophilized powder exp date of 14 Nov 2019. No side effects reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by the sender: none.
Client attended the flu shot clinic.  She received a 0.5cc flu injection, Sanofi, Lot # UH734AC, Expiration date 6/30/13, in the left deltoid muscle at 1630 hours by RN.  After receiving the injection the client reported she felt like she was going to faint.  RN instructed the client to remain seated and allowed her to lean forward with her head between her knees.  RN then put a wrapped cold pack to the back of the client's neck and retrieved this nurse to assist.  This nurse retrieved the emergency kit and a mat for the client to lie down on.  When this nurse got to the client with the mat, the client refused to lie down and stated she was feeling better.  This nurse assessed vital signs at 1640 hours: Blood pressure 108/62, pulse 74, respirations 16.  The client was allowed to stand and walk to the bleachers with her mother for further observation.  The client remained on the bleachers without further problems for another 15 minutes.  Client was released with her mother at 1655 hours.  This nurse spoke with the client's mother today (11/14/12) at 0854 hours.  Her mother reports no further concerns and stated the client is doing well.  This nurse then called the client's physician's office at 0903 hours and reported the incident to an office nurse.
The vaccine was received in the left deltoid.  For 22 hours following the injection I had severe, debilitating pain in my left arm from the shoulder down to the hand, across the left clavicle to the sternum, across the entire left side of my chest from the clavicle down to the left breast, between my shoulder blades, across the entire left scapula and midline and left side of my neck up to the base of my skull and ear