chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administering ACTHIB on  saline diluent for ACTHIB was not used for reconstitution; diluent from MMR was used with no adverse event; Initial information regarding an unsolicited non-valid non serious case was received from other health professional via Medical Information (MI) (Reference number: 00838515) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 7-month-old female patient administering HIB (PRP/T) VACCINE [ACT-HIB] on  saline diluent for HIB (PRP/T) VACCINE [ACT-HIB]  was not used for reconstitution; diluent from MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR VACCINE] with the use of medical device FLUZONE QUADRIVALENT PRE-FILLED SYRINGE (Product preparation error).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT).  On 01-Nov-2021, the patient received a fourth dose of 0.5 mL total dose of suspect HIB (PRP/T) VACCINE [lot UJ579AA, expiry date 09-Oct-2021] via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient started using MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  This was actual medication error case due to wrong solution used in drug reconstitution (latency same day).  It was reporter "Caller reports administering ACTHIB on 01Nov2021; saline diluent for ACTHIB was not used for reconstitution; diluent from  MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE was used."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this FLUZONE QUADRIVALENT.
approximately 2 hours after DTaP, Pt c/o redness, ithiness, from 3-6AM left arm became increasing red, warm to touch and hard. No fever noted. Tylenol given or ice applied. Saw PMD 06/07 for PE, noted rxn. This arm L has oversized area with multiple small blisters in center of redness. Advised Tylenol per age. Ice [ack to area. to consult with PMD re; blisters continues to be afebrile.
fever(6 hours), chills(6 hours), severe body-wide achiness(12 hours), skin sensitivity(12 hours), migrating sharp body pains (12 hours), extreme fatigue(1.5 weeks)
Pain, redness & swelling of rt arm from elbow to shoulders; stiff neck; inability to move w/o pain; sx began 9AUG91; tx APAP & warm soaks;
Painful Swelling of lymph nodes in left armpit and side. Tenderness to touch. Swelling and tenderness lasted for about a week.
silver dollar size red induration, redness spreading down & around arm;vaccine given below deltoid muscle;itching around inj site;
This spontaneous report as received from a 82 year old female consumer refers to herself. On 09-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number not reported) in the back of her upper right arm. The patient reported that she believed that ZOSTAVAX was administered in the wrong area and improperly, not subcutaneous. No adverse effects reported. The patient did not seek medical attention. Additional information has been requested.
Patient had become extremely paleness, sweating, coldness of the hands, light headed, dizziness, weakness,  shaky like trembling sign of minor seizures.
Lightheaded; Dizzy; Tired; Arm Ache; Light Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm Ache), DIZZINESS (Lightheaded), DIZZINESS (Dizzy), HEADACHE (Light Headache) and FATIGUE (Tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Ache) and HEADACHE (Light Headache). On 27-Feb-2021, the patient experienced DIZZINESS (Lightheaded), DIZZINESS (Dizzy) and FATIGUE (Tired). The patient was treated with MECLIZINE [MECLOZINE] at an unspecified dose and frequency. On 27-Feb-2021, PAIN IN EXTREMITY (Arm Ache) and HEADACHE (Light Headache) had resolved. At the time of the report, DIZZINESS (Lightheaded), DIZZINESS (Dizzy) and FATIGUE (Tired) had not resolved.             No concomitant medications reported.   Patient used ginger oil, serenity essential oil, and meclizine but none of those resolved the adverse events.  Action taken with mRNA-1273 in response to events was not applicable.
Information has been received from a 32 year old female physician assistant who in February 2008, reported as "a little less than 2 months ago," was vaccinated intramuscularly into the left arm with the first dose of GARDASIL.  Subsequently, she experienced pain at the injection site since being vaccinated around 2 months ago.  She also reported that she has slight swelling at the injection site or a ball that was visible at the injection site on her left arm.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Given Varivax 8/22/01 without problems. 03/29/05 zoster rash began. Pt never had chicken pox/Varicella Dz.
passed out; no energy; Tired/exhausted; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 09:00 (Lot Number: RW0150) as SINGLE DOSE for COVID-19 immunization. The patient previously took BNT162B2 (lot number: EN6207) dose 1 in the right arm on 24Mar2021 for COVID-19 immunization. Medical history included ongoing hormones are low. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hormone from an unspecified start date and ongoing; hydrocortisone taken for hormone from an unspecified start date and ongoing. The patient took the second dose of the COVID-19 vaccine, the next day he was tired on  15Apr2021.  The patient had never been tired in his life like that. The patient was completely passed out.  His wife wanted to call an ambulance and the caller told her no ambulance please. He knew the tiredness would eventually go away. The patient had no energy, zero, for 4 days or so. He has blurred vision for some reason on 15Apr2021. He thinks that the vaccine was no good. The patient has never had blurred vision before that that he is still experiencing some blurred vision.  The blurred vision is what concerns him. His vision is not right and his side effects were severe. The tired disappeared, but the blurred vision is still there at time of call on 23Apr2021. The patient was wearing his reading glasses but that something has happened with his vision.  He had 20/20 vision and now something is not right. The patient was exhausted, passing out, and not polite. The patient has to go to the doctor for the doctor to check his eyes. The outcome of tired was recovering. The outcome of the event blurred vision was not recovered and the outcome of the rest of the events was unknown.
Headache, shortness of breath, leg pain, sore throat. Positive Covid test.
The patient received the vaccine in the left deltoid muscle and developed a fever at home after the vaccine.  She felt very achy and was unable to get out of bed for a while.  "She was down and out for a week."  She noted congestion and shortness of breath.  She notes a cough. The symptoms continued for a month and she did not feel back to her normal self for 8 months.  She denies itching or redness.
Sore injection site for a few days. Pain went deeper over the course of several months. Diagnosed with bursitis recently. Unsure if related to injection, or elbow fracture from June 2020. Combo of both?
Patient complains of initial soreness which persisted. Three days then eased for 3 days on 7th day. Pain in shoulder awakened patient. Pain has persisted days 7-8-9-10 post vaccination. Is using Advil with positive effect.
Discharge Provider: Primary Care Provider:  Admission Date: 5/7/2022 Discharge Date: May 11, 2022  Discharge Diagnoses Patient was seen at 0930   1. COVID 19 without hypoxia 2. Acute metabolic encephalopathy due to COVID on baseline cognitive impairment 3. Urinary incontinence/OAB/BPH/bladder diverticulum 4. History of recurrent UTI 5. Malignant melanoma with mets to lungs and brain 6. History of DVT due to cancer 7. Cognitive impairment due to brain mets and whole brain radiation  Hospital course:   1. COVID - patient presented to the ED with fatigue and lethargy with audible cough and crackles in bilateral lungs. The patient initially saturated 96% on room air, and had a positive COVID 19 PCR test. Patient was admitted to the hospital for monitoring and was given a five day course of IV Remdesivir. The patient was monitored for liver and renal toxicity with no concerning lab abnormalities noted. The patient did not require steroids or supplemental oxygen during his stay. CRP was 53 > 79 > 54 and D-Dimer was 860 > 400 > 420. The patient demonstrated improved mobility and decreased fatigue/lethargy during the hospital course.   2. Acute metabolic encephalopathy - Patient presented to the ED with confusion and was oriented to person only. After admission to the hospital patient initially did not remember why he was in the hospital or his specific location. As the hospital course progressed patient gradually became more aware of his surroundings and was alert and oriented x 3 on 5/11/22 at 0930.
Received injection in the left upper arm. A week or so later, constant discomfort/pain near right collarbone area as if something is pressing against the tendons. The discomfort is worse if the arms and hands are in a relaxed position to where I feel forced to keep my arm in a certain position to reduce the discomfort.
Initial report received on 24 September 2009 from a Healthcare Professional.  An unidentified female patient, whose medical history were unknown, received a dose of ADACEL (lot number unknown) on an unspecified date (dosage, route and number of previous doses unknown).  Concomitant medications and illness at the time of vaccination were unknown.  On an unspecified date, the patient developed an 8 cm local reaction at the injection site, fever for 48 hours, malaise, and bone pain for 48 hours.  The patient's outcome was unknown.  The reporter declined to provide further information.
Information has been received from a physician concerning an 18 week old female who on 07-DEC-2007 was vaccinated (does not reported) with COMVAX (lot # 657380/0377U). The patient's mother called the office to inform them that on 10-DEC-2007 her daughter had developed redness at the injection site which was reported to be the size of a dime or nickel and hard at the injection site. The mother reported that the child did not seem to be in any pain. The mother was instructed to put a warm compress on the area and gently massage the area. At the the time of this report the mother had not contacted the office again and the physician was not aware of the patient's recovery status. Additional information has been requested.
had two part shot got shingles/suspected vaccination failure; got the shingles; awful pain very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had two part shot got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got the shingles) and pain (Verbatim: awful pain very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 This case was reported by a patient via interactive digital media. The patient had two part shingles shots in 2018. The patient was in his/her third month with this awful pain at the time of reporting. The reporter thought he/she was safe from getting the shingles but he/she got the shingles and it was very painful. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Pt received FLUVIRIN 2011/12 0.5ml IM right deltoid sub-q on 8/4/11. Bleeding at injection site was noted in small amt, several days of local soreness reported. Pt is a football player and he reports that when he takes a "hit" to the right arm, he has recurrent pain which persists for approximately 10 mins each time.
Same round redness spot; Little bit of swelling under the spot; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE ERYTHEMA (Same round redness spot) and INJECTION SITE SWELLING (Little bit of swelling under the spot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced ERYTHEMA (Redness) and SWELLING (Swelling). On 01-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Same round redness spot) and INJECTION SITE SWELLING (Little bit of swelling under the spot). On 23-Jan-2021, ERYTHEMA (Redness) and SWELLING (Swelling) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Same round redness spot) and INJECTION SITE SWELLING (Little bit of swelling under the spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
I've been in bed for 2 and a half days feeling awful, like I have the flu; I've been in bed for 2 and a half days feeling awful, like I have the flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "I've been in bed for 2 and a half days feeling awful, like I have the flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315029 Same reporter/patient, different dose;US-PFIZER INC-202300314661 Same reporter/patient, drug, different dose/event;
pt recv vax 27FEB97 & pt exp chickenpox;9 other pt were reported as well (WAES 97030174, 97030176-97030180, & 97030182-97030184);
Rigors, fever, headache, body aches, nausea, (rigors & fever, nausea duration four hours) malaise, body aches, fatigue continues but more mild. Local pain at administration site two days.
101.4 degree fever, shaking chills, headache, and full body aches began approx. 14 hours after injection and lasted for about 18 hours.
A patient was administrated with adjuvant component of Shingrix; A patient was administrated with adjuvant component of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient was administrated with adjuvant component of Shingrix, which led to Inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, no patient's identifiers, no lot number and expiration date and no vaccination date was provided No adverse event was reported.  The reporter consented to follow up.
Headache and neck pain for 12 days Bloated abdomen for 15 days Fatigue for 15 days Rash on face for days 2-4
This patient's injection site was very red and slightly raised. Peripheral redness to the injection site with pain and numbness experienced in the limb from injection site down to the hand.
On 5/15/21 underarm uncomfortable and swollen, called and talked to on call nurse on 5/16/21, appointment on 5/18/21 to see NP,  after exam ordered mammogram and ultrasound of area. She believed it was reactive axillary adenopathy to Covid 19 vaccine. The testing showed enlarged axillary lymph nodes. Followed up with NP one month later. Basically resolved by then.
Pt to ED 10/16 for AMS, recent COVID+ 10/13. Pt with continuous fever and tachycardic rhythm. 10/17 pt unresponsive, febrile, tachycardic, on ventilator, sedated. 10/19 Vital signs stable, pt on mechanical ventilator, minimal response to pain, non-purposeful opening of eyes. 10/21 pt with Pneumococcal meningitis/pneumonia and is Hypotensive and tachycardic. 10/26 Pt unresponsive, no cough/gag, no response to painful stimuli. Pt intubated, NSR on monitor, VSS. 10/28 Pt is unresponsive, no reaction to pain, pupils are fixed and dilated, NSR on the monitor, and intubated. 10/30 Patient unresponsive to any stimuli upon initial assessment. Pt expired 10/31.
Off label use; Inappropriate Age at Vaccine Administration; Circumstance or information capable of leading to medication error; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 43-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use, inappropriate age at vaccine administration and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the off label use, inappropriate age at vaccine administration and circumstance or information capable of leading to medication error were unknown.  Additional information received were as follows: The age at vaccination was not applicable for this report. The lot number and expiry date was not available. The pharmacist on the line with a patient who was under 50 years old and had a prescription for Shingrix, which may lead to circumstance or information capable of leading to medication error, inappropriate age at vaccine administration and off label use. The reporter consented to follow up.
patient stated he felt light headed about 5 minutes after the inection, then collapsed gently to the floor and rested there. after a few minutes he asked to sit up. with 2 peoples help he sat up. after a few more minutes he was helped to a wheel chair where he passed out for approximately 5 seconds. He had some water after that and was feeling better. He went home with a family member.
Patient stated "I feel like I'm going to pass out" 5 minutes after administration of vaccine, and passed out. Patient was unconscious for 30 seconds, and returned to consciousness w/o medical intervention. No injuries sustained. Pt. left facility under own power 20 minutes after recovering consciousness.
Received Varicella vaccine and MMR vaccine July 27. August 12, client reports a fever of 101. On August 13, noticed bumps on her back, over the next couple more bumps appeared on back and stomach, arms,and face. She went to see the doctor. Doctor diagnosed as Varicella. Now bumps are starting to dry up. Client is afebrile now.
Patient is a 62 y.o. female with a history of HIV on retroviral therapy, CAD status post CABG presenting to the emergency department with generalized fatigue and chest pain.  Patient reports feeling unwell ever since receiving her second dose of the Covid vaccine on May 28.  Describes decreased appetite, burning constant chest pain and shortness of breath worsened with exertion.  Reports that the symptoms are similar to prior heart attack.  Also reports intermittent burning epigastric/right upper quadrant abdominal pain sometimes worsening with eating, denies other exacerbating factors.  Endorses nausea, no vomiting.  Also reports productive cough, loss of taste and smell
49 yo F with PMH of HTN and anxiety began noticing a fast heart rate after waiting 15min from recieving vaccine. Pt was evaluated by medical staff and EMS. Vitals: 130 HR, 137/83 BP, 100% SpO2. Pt denied symptoms. A four lead EKG was placed that showed concerning ST depressions in leads III, aVL, aVF. Decision was made to have pt evaluated at near by ED. Provider was given invoice.
Per mother whole body shaking-? grand mal seizure. Seen at Hospital E.D. - no anti seizure meds given.  plus foaming at the mouth, plus tongue biting - lasted about 4 minutes. 11/02/09 Received ER records for date 10/23/09. 11/3/09 Duplicate records sent. DX: seizure. Presenting c/o seizure stated by parent. Parent states pt had loss of consciousness, unresponsive, shaking all over, confusion, froth from mouth,  approx 3 min. EMS called by parent. Per parent, stated pt. had H1N1 vaccine nasal spray 2 days prior, no seizure since 1/09.  Assessment: tongue abrasion, no seizure activity in ER. Pt recovered and sent home.