chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One of the ones I believed I had mixed had not been mixed (top was still on vial and powder was still inside); I had already given 2 of the injections. I am not sure if one got just the sterile water and not the vaccine.; Case reference number US-BN-2021-002171 is a spontaneous case report initially received from a pharmacist via Agency (reference number: USBAV21-0402) on 10-Aug-2021 and concerns an adult female patient, reported in her 40s.   The patient's medical history and concomitant medication details were not provided.  On 09-Aug-2021, reporter prepared vaccines for a family of six, she personally drew four doses and the intern finished them. On the same date, the reporter administered two doses. The patient was vaccinated with the booster dose of RabAvert (inactivated rabies virus; batch number was not provided), at dose of 1 milliliter, administered intramuscularly, for pre-exposure immunisation.   On the same date, after vaccination, the intern noticed that one of the doses, that reporter believes she had mixed, had not been mixed as the top was still on vial and powder was still inside. The reporter stated that she had already given 2 of the injections, and was not sure if one got just the sterile water and not the vaccine (explicitly coded as Product not dissolved before administration' and 'Product administration error').  The reporter wanted to make sure that there is not a major issue for the patient if they only got sterile water and, since she doesn't know whether the patient got the vaccine, when can the patient have another booster dose.  The reporter gave consent for follow up.  This case is linked to case US-BN-2021-002170 (same reporter)  No further information was provided.; Reporter's Comments: Product preparation error and  product administration error are listed by convention. Reportedly, two doses of RabAvert vaccine were prepared and the patient was vaccinated with one of them. On the same day, it was noticed that one of the doses had not been mixed and since both doses had been administrated, it was possible that the injection given given to the patient contained just sterile water and not the vaccine, which is considered product preparation error and product administration error. Product preparation error and product administration error are not related to RabAvert, but to human action.; Sender's Comments: Product preparation error and  product administration error are listed by convention. Reportedly, two doses of RabAvert vaccine were prepared and the patient was vaccinated with one of them. On the same day, it was noticed that one of the doses had not been mixed and since both doses had been administrated, it was possible that the injection given given to the patient contained just sterile water and not the vaccine, which is considered product preparation error and product administration error. Product preparation error and product administration error are not related to RabAvert, but to human action.
This spontaneous report as received from a 79 year old male pharmacist refers to himself. He stated that on 23-MAY-2013 while drawing ZOSTAVAX up in a syringe to administer a consumer, he felt something wet went into his eye, vaccine's lot # was not reported. Pharmacist's historical drugs and vaccines includes ZOSTAVAX (received on an unknown date). On 23-MAY-2013, reported as several hours later, his affected eye began to sting and burn and at the time of reporting was really red. He believed it was some of ZOSTAVAX that splashed in his eye and he was very worried that he might got 'shingles in his eye'. Pharmacist did not specify whether he performed an eye wash on his eye. No treatment was given for the events. The patient did not seek medical attention. There was no intervention to prevent serious criteria. The outcome of adverse events was unknown. The relatedness between ZOSTAVAX and adverse events was unknown. Additional information has been requested.
severe headache; sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 14 year-old female patient received bnt162b2 (COMIRNATY), administration date 03Apr2022 (Batch/Lot number: unknown) at the age of 14 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 16Dec2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 01, Tested positive for COVID 19 on December 16, 2021.), administration date: 13May2021, for Covid-19 Immunization, reaction(s): "COVID-19"; Comirnaty (Dose: 02, Tested positive for COVID 19 on December 16, 2021.), administration date: 03Jun2021, for Covid-19 Immunization, reaction(s): "COVID-19". The following information was reported: HEADACHE (non-serious) with onset 04Apr2022, outcome "unknown", described as "severe headache"; OROPHARYNGEAL PAIN (non-serious) with onset 04Apr2022, outcome "unknown", described as "sore throat"; FATIGUE (non-serious) with onset 04Apr2022, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
bruising yellowish spot on opposite left arm and two bruising fingers on left arm; bruising fingers on left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (bruising yellowish spot on opposite left arm and two bruising fingers on left arm) and CONTUSION (bruising fingers on left arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Immune thrombocytopenia. Concomitant products included LOSARTAN, SIMVASTATIN and STEROIDS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SKIN DISCOLOURATION (bruising yellowish spot on opposite left arm and two bruising fingers on left arm) and CONTUSION (bruising fingers on left arm). At the time of the report, SKIN DISCOLOURATION (bruising yellowish spot on opposite left arm and two bruising fingers on left arm) and CONTUSION (bruising fingers on left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information related to the events was not provided
About 24 hours after the vaccine, arm became red and swollen at the injection site. Eyes became red and swollen. Experienced coughing if laying flat, had to sleep upright. Symptoms resolved around 12 hours later.
approx 5 minutes after vaccine injection, pt reported feeling hot and itchy. After a few more minutes of observation, he continued to feel hot and itchy and reported some chest tightness. Sent to ED for further evaluation  Narrative:  Pt given first dose of Moderna COVID vaccine in clinic. Approx 5 minutes after administration, pt reported itching on arms, chest and torso as well as feeling warm. VS checked and stable, pt monitored for an additional 5-10 minutes. He continued to feel itchy and warm, then reported feeling chest tightness and was quite anxious. ED physician was called and pt transported to ED for additional evaluation and treatment. In the ED was evaluated for possible allergy vs anxiety response. Due to symptoms was worked up for ACS, PE, pneumonia, or other acute intrathoracic processes. Labs notable for mild leukocytosis. Negative troponin and EKG with normal sinus rhythm and no ST segment or interval changes to suggest ischemia. CXR without acute cardiopulmonary process. He was observed for 3 hours in the ED, treated with diphenhydramine for itching, Zofran for nausea, gabapentin (scheduled for mood/sleep) and hydroxyzine for anxiety. He was discharged home in good condition. Unclear if this was a true allergy or more of an anxiety response and ED provider recommended that he discuss with his PCP whether to receive the second dose of the vaccine.
Light headedness and slightly lethargic with mild headache the following morning. Went away in a few hours.
Arm muscle is hard; arm muscle is hot; Very sick along with flu- like symptoms; Had to stay in bed at all; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Very sick along with flu- like symptoms), MALAISE (Had to stay in bed at all), MUSCLE TIGHTNESS (Arm muscle is hard), FEELING HOT (arm muscle is hot) and PAIN IN EXTREMITY (Arm sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event .  Concomitant products included AMLODIPINE, DIPHENHYDRAMINE HYDROCHLORIDE (NYTOL 1-A-NIGHT), EZETIMIBE, ESOMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), COLECALCIFEROL (VIT D [COLECALCIFEROL]), PROBIOTIC 10 and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 28-Jan-2021, the patient experienced INFLUENZA (Very sick along with flu- like symptoms) and MALAISE (Had to stay in bed at all). On 29-Jan-2021, the patient experienced MUSCLE TIGHTNESS (Arm muscle is hard) and FEELING HOT (arm muscle is hot). At the time of the report, INFLUENZA (Very sick along with flu- like symptoms), MALAISE (Had to stay in bed at all), MUSCLE TIGHTNESS (Arm muscle is hard), FEELING HOT (arm muscle is hot) and PAIN IN EXTREMITY (Arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided
No other AE or PQC identified. No other information available.; Caller reports administration of expired dose of GARDASIL 9; This spontaneous report was received from a 24-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 05-JAN-2021, the patient was vaccinated with expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot# R009614 was confirmed to be valid, expiration date 30-NOV-2020 (route and site of administration were not provided) for prophylaxis. No additional adverse event was reported.
2nd dose delayed beyond 42 days; Sick after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 42 days) and ILLNESS (Sick after the 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 42 days) and ILLNESS (Sick after the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 42 days) and ILLNESS (Sick after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.
This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.
no adverse effect; the patient was 24 years old and received the first dose of GARDASIL 9 and will receive the second dose of GARDASIL 9 22-OCT-2019,; the patient was 24 years old and received the first dose of GARDASIL 9 and will receive the second dose of GARDASIL 9 22-OCT-2019,; received fisrt dose of gardasil on 17/5/2016 and second dose will recived on 22/10/2019; This spontaneous report as received from a nurse refers to a 24-year-old patient.     No information was provided regarding the patient's medical history, concomitant therapies and concurrent conditions.  On 17-MAY-2016, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 (lot# and expiry date was not reported) for prophylaxis.  The nurse reported that on 22-OCT-2019, the patient was in the office and would receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration, circumstance or information capable of leading to medication error, product administered to patient of inappropriate age). No adverse effect reported. No further information was reported.
Can't walk for more than 10 steps without sever unbalance, blood pressure escalates to about 185/100, heart rate 125,  dizziness, falling down. hard to breath,  can;t make it far, can't go upstairs , has hard time functioning.   Legs extremley weak  Can only lay in the sofa.  Thank you .  I wish this  on them.  Sounds like Guillain Barre~
Symptoms started on a Friday evening as pruritus and redness on approximately 2/3 of the upper right arm.  On Saturday pruritus continued and the redness was warm, tender to the touch, and hardening (like a muscle knot) underneath.  This continued through Sunday.  Monday morning (today) the area of redness is smaller, tenderness has improved, and it is no longer like a hard knot underneath.  Some pruritus remains but has improved as well.  This was self limiting adverse reaction no requiring any treatments other than damp rags to the area to help relieve the pruritus
Client received pneumonia vaccine on 12/03/2001 around 11:30 in the morning. Approximately three hours later, she started experiencing chills and a fever. The latter reached 102 and lasted for twenty-four hours. A swollen area of redness was noted about two inches below the injection site. The underside of the left arm was also tender to the touch. This tenderness lasted for two days after the vaccination.
Woke up at 4am dripping in sweat, body shaking, heart rate likely near 200.  I felt like I would literally die if I spent the effort to get out of bed to dial 911.  This happened the third and fourth nights after the second dose.  I have had absolutely no history of any similar events in my lifetime.
Gardasil shot was given to my daughter on June 5, 2008 at 3:00pm by 8:00 pm the same evening she informed me she could not breath. Her chest and throat felt tight. She was taken to the emergency room on June 6, 2008 at 2:00pm. She was given an EKG which came out normal, the dorctor there found no signs of sickness, (eg. cold, flu, asthma, or bronchitis) She was given a nebulizer treatment at about 4:00pm which didn't help her at all. She was sent home with a prescription of Albuterol which has not helped her. She contined to experience difficulty breathing through the weekend and was taken back to her Primary Physician on Monday June 9, 2008. Her Doctor gave her a breathing test which she said was abnormal, and listened to her breathing. Again, there was no sign of a cold,cough or flu or bronchitis. Her doctor gave her a perscription for Methylpred  which did not help her and ordered a blood panel and chest x-ray. The blood panel was determined to be normal, but her doctor claims based on the x-ray she would be diagnosed with Bronchitis. Which did not make sense to me since she had no signs of Bronchitis. She had no cough, fever or phlem. Her Dr prescribed Zithromax Z pak. When I went to get the prescription filled I asked the Pharmacist if it was possible to have Bronchitis without any  coughing, wheezing or phlem. The Pharmacist said NO. She advised me to get a second opinion. I took my daughter to an Alergist on Wed. June 11, 2008. Once he checked her he said that it is a possibility her condition was an adverse reaction to the Gardasil shot. He said the treatment he would prescribe would treat both an adverse reaction to the Gardasil shot and bronchitis. My mother who works for a Physicians office described to two physicians the situation my daughter was experiencing and both concluded that without any signs of cough, wheezing and phlem it was probably an adverse reaction to the Gardasil shot. It has been 7 days since my daughter took the shot and she is still have extreme difficulty breathing.
fluzone high dose qiv was administered to at 15 year old patient instead of the prescribed fluzone qiv on 04oct2022 with no reported adverse event; Initial information received on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 years old female patient who stated that influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] was administered instead of the prescribed fluzone qiv on 04oct2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Oct-2022, the patient received a dose of suspect influenza quadrival A-B high dose hv vaccine at a dose of 0.7 ml once (lot UJ918AA, expiry date - 30-Jun-2023) (with an unknown strength, form) via intramuscular route in the right arm for Immunization.  On 04-Oct-2022 the 15 years old female patient who was administered influenza quadrival A-B high dose hv vaccine instead of the prescribed fluzone qiv with no reported adverse event (wrong product administered) (latency: same day) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
c/o Headache, Nausea, malaise and fatigue for 1 day prior to eval on 7Sept05. Vital signs stable, afebrile. Tx Motrin and rest.
About 3 minutes after yellow fever and typhoid vaccinations patient complained to nurse that she was dizzy and room spinning. Patient assisted to supine position, vital signs taken and normal. Patient A&O. Patient did not have syncopal episode and remained alert and answered questions correctly. Patient able to see up close but after observation of about 30 minutes she complained that her vision was blurry. Recommended patient to follow up in ER for evaluation or at least have a family member or friend pick her up. She refused both. Patient insisted on going home and ambulated without assistance out of the office.
inject within 4 week of live vaccine  pt received mmr on 3/4 pt verbally confirmed no vaccine or tb test within 4 weeks but remember incorrectly and when printing out confirmation of vaccine discovered  pt was too soon
Patient got vaccinated for Smallpox on 02JUL2019 and had check up on 08JUL2019. On the day of check up, Patient had no any other symptoms or adverse reaction. Patient stated that he started to have rashes spreading out all over the body from 11JUL2019 with feeling of fever and chills , and he went to ER in off-post hospital. Patient had lab work, chest x-ray and got emergency care and was discharged on the same day and there was not sick at that point. Patient had follow up on 16JUL2019 with his one provider from this clinic. Patient still has rashes all over the body and has only one pustule on right forearm. Patient states he has itching with rashes. Patient currently is not sick, no fever. Patient was prescribed PREDNISONE 20mg . We discussed about this case with doctor.
suppose to start my menstruation cycle on 14Mar2022 but I have not started my cycle; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2022 10:00 (Lot number: FM0698) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known Allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: FEMARA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch: EW0217, Location: Arm Left, Time: 12:00 PM, Route: Intramuscular), administration date: 02Sep2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch: EW0181, Location: Arm Right, Time: 10:00 AM, Route: Intramuscular), administration date: 09Aug2021, when the patient was 33 years old, for Covid-19 Immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 01Mar2022 11:00, outcome "recovering", described as "suppose to start my menstruation cycle on 14Mar2022 but I have not started my cycle". The event "suppose to start my menstruation cycle on 14mar2022 but i have not started my cycle" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of menstruation delayed.  Additional information: Patient was prescribed Provera to induce her period. She had her cycle regular for 20 years. She never been late. Until the covid booster vaccine. She do not had any cysts as that was checked today too. Also her doctor said a "Bunch" of girls was called their clinic and told they was late and had received there booster or finished the series for the vaccine this month. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination: covid test type post vaccination, nasal swab, covid test name post vaccination pcr.  Follow-up attempts are completed. No further information is expected.
Hospitalized (11.20.21);  COVID-19 positive (11.20.21);  fully vaccinated Admission Date: 11/20/2021 Discharge Date: 11/23/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: Patient is an 86-year-old female who presented to the emergency department with chief complaint of overall malaise.  Patient has been vaccinated.  In the emergency department, patient was found to be hypoxemic with ambulation.  Chest x-ray was negative.  She was admitted.  She did require supplemental oxygen and Decadron and remdesivir were started. She was found to have a PE and was started on therapeutic lovenox and transitioned to eliquis on discharge. Symptoms overall improved. She was evaluated by Pulmonary rehab and 2L NC with activity was arranged for home. She was evaluated by PT/OT. She will complete decadron course as an outpatient. She was recommended to follow up with her PCP outpatient.