chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (wistar ra 27-3) M-M-R II (lot #, expiration date, dose and route not reported. The doses of vaccine were improperly stored at 8.5 degree Celsius for 1 hour. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
a dose that was reconstituted with a sterile solution; a dose that was reconstituted with a sterile solution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA908A) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: a dose that was reconstituted with a sterile solution) and inappropriate dose of vaccine administered (Verbatim: a dose that was reconstituted with a sterile solution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt Date: 16-AUG-2023 The reporter reported that there was a possibility that 1 in 5 patients received a Menveo dose that was reconstituted with a sterile solution and wished to know how to proceed.  The basic information was collected but there was partial information available. The reporter consented to follow up. The patient received a dose that was reconstituted with a sterile solution, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Pt became febrile on 9/5/2022; Rash diagnose as erythema multiforme; Rash diagnosed as erythema multiforme vs urticaria vs vasculitis; Rash diagnosed as erythema multiforme vs urticaria vs vasculitis; The patient developed a rash at the site of the injection; The patient developed a rash at the site of the injection. The rash continue to spread to all extremities and chest/back/abdomen.; Blood culture; Culture urine; Urine Analysis normal; Full blood count normal; Influenza virus test negative; Respiratory Syncytial virus test negative; SARS-COV-2 TEST NEGATIVE; winter viral studies; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2428990-1. The original narrative from the sender is the following:  Pt received standard 2-month immunizations on 9/2/2022. The next day, the patient developed a rash at the site of injection - the rash continued to spread to all extremities & chest/back/abdomen. Rash diagnosed as erythema multiforme vs urticaria multiforme vs vasculitis. Pt became febrile on 9/5/2022 and re-presented to the emergency department. Unknown if immunizations vs fever/viral illness are the cause of the rash; doubt immunizations are cause of fever  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "The patient developed a rash at the site of the injection", "The rash continue to spread to all extremities and chest/back/abdomen", "Rash diagnosed as erythema multiforme vs urticaria vs vasculitis", and "Pt became febrile on 9/5/2022".  Due to the nature of the event, the causality between the events "Blood culture", "Culture urine", "Urine Analysis normal", "Full blood count normal", "Influenza virus test negative", "Respiratory Syncytial virus test negative", "SARS-COV-2 TEST NEGATIVE", and "winter viral studies" and Vaxelis was not applicable.   No further information is expected.
Unvaccinated patient presented for a well child check. It was determined that he had never received the pneumoccocal vaccine. Parents wished to start the patient on catch up vaccine schedule and it was determined that he would receive one dose of PCV-13 as he is 10 years old and never been vaccinated.
Woke at 3:00am with strong pounding in my heart. I have a EKG device and took an EKG which showed tachycardia 120 pulse but no A Fib.   Took my BP which was 139/92.  Stayed awake for 2hrs until the heart rate slowed down. Did not realize this was a potential vaccine side effect until today.
Patient's mother called on 11/7/2020 to report an adverse event for her daughter. She states that her daughter has been experiencing a rash on her forearm near her wrist and numbness/tingling on her forearm which started on Thursday after receiving her flu shot. Her mother stated that she does not have a primary care doctor, but will continue to monitor the condition and seek medical attention if her condition continues or worsens.
First and second night rigors, full body cramps.  At 30 hrs ageusia following an exercise run with severe knee pain.  Dry mouth starting at 48 hours.  Chills continue 3 days later.  No resp symptoms. Afebrile.  Going on 4 days and symptoms continue
Patient had pain in the shoulder muscles the same evening as getting the flu shot. It was getting better, but then it was aggravated again. The patient went in to see the doctor who believed the flu shot was given into the joint. The doctor recommended resting the arm and it should get better. The patient is still having some pain at the time of the report.
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851, 2016SA191730, 2016SA191735, 2016SA191739, 2016SA191741, 2016SA191743, 2016SA191744 (same source and same vaccine). This case involves a male patient (age unknown) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient had got flu. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. The reporter assessed the events as minor. List of documents held by sender: none.
Pain at injection site worsening later in the day.  Overnight, more pain in arm, forearm & neck.  Redness & swelling the following day, 12/22. All symptoms worsened by 12/23.  Physician diagnosed cellulitis in ER, prescribed antibiotics.
Vaccine given in thigh area red and swollen. No pain noted. Pt was seen in our office for visit and no adverse reaction noted.
Doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that the doses were stored in the freezer before administration. One dose was administered on 05-Mar-2022. Treatment information was not provided.
Limp & quiet pale face, blue lips, stuffiness later, wheezing, temp measured highest 104.6 21NOV; given inject Epi by MD; devel ear infect 28NOV91;
Hard lump about 4 inches round at the injection site; Body aches; lymph nodes on left side of my neck swelled; lymph nodes in my left arm pit swelled; Fever; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Hard lump about 4 inches round at the injection site), PAIN (Body aches), LYMPHADENOPATHY (lymph nodes on left side of my neck swelled), LYMPHADENOPATHY (lymph nodes in my left arm pit swelled) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Mar-2021, the patient experienced INJECTION SITE MASS (Hard lump about 4 inches round at the injection site), PAIN (Body aches), LYMPHADENOPATHY (lymph nodes on left side of my neck swelled), LYMPHADENOPATHY (lymph nodes in my left arm pit swelled), PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache). On 27-Mar-2021, PYREXIA (Fever) and NAUSEA (Nausea) had resolved. On 31-Mar-2021, INJECTION SITE MASS (Hard lump about 4 inches round at the injection site), PAIN (Body aches), LYMPHADENOPATHY (lymph nodes on left side of my neck swelled), LYMPHADENOPATHY (lymph nodes in my left arm pit swelled), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Information has been received from a Registered Nurse (R.N) concerning a 13 year old female patient who "a few months ago" was vaccinated with a dose of GARDASIL (Lot # was not reported). It was reported that "a few months ago" the patient  experienced syncope after receiving GARDASIL. The patient sought medical attention with the nurse. It was reported that on an unspecified date the patient had recovered. Follow-up information was received on 26-AUG-2009, from a nurse, who reported that this event occurred "a few years ago when GARDASIL first came out". The nurse did not know who the patient was or the doctor was. Subsequently, the patient had fully recovered. Additional information has been requested.
Memory loss; Vaccine injured following two moderna vaccines; Cognitive issues; Nerve pain throughout her body; Racing heart palpitations; Headaches; Lost weight; Trouble sleeping; Can no loger drive; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss), VACCINATION COMPLICATION (Vaccine injured following two moderna vaccines), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body) and PALPITATIONS (Racing heart palpitations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced AMNESIA (Memory loss), VACCINATION COMPLICATION (Vaccine injured following two moderna vaccines), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart palpitations) and HEADACHE (Headaches). In 2021, the patient experienced WEIGHT DECREASED (Lost weight), INSOMNIA (Trouble sleeping) and IMPAIRED DRIVING ABILITY (Can no loger drive). At the time of the report, AMNESIA (Memory loss), VACCINATION COMPLICATION (Vaccine injured following two moderna vaccines), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart palpitations), WEIGHT DECREASED (Lost weight) and HEADACHE (Headaches) outcome was unknown and INSOMNIA (Trouble sleeping) and IMPAIRED DRIVING ABILITY (Can no loger drive) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient had 17 doctors' visits (neurologist, virologists, infectious disease, ENT, cardiologist, functional rheumatologist, primary care) and multiple tests (MRIs, CT scan, blood tests) which determined that the patient was vaccine injured following their two Moderna vaccine.
Patient is a 66 y.o. female with a history of RA on chronic prednisone recently found to be positive for COVID 19 on 8/29/23 with multiple ED visits for worsening dyspnea sent home on steroids and antibiotics who presented to RMH 9/13/2023 with persistent shortness of breath, hemoptysis, fever. CTPA on admit showed no PE, mild bilateral lower lobe infiltrates vs atelectasis. Improved with supportive care.    1. COVID 19 pneumonia: positive on 8/29/23. Vaccinated. Patient immunocompromised on chronic prednisone. Has had persistent fevers, dyspnea since. Did not want paxlovid at the time. Was prescribed prednisone taper and antibiotics as OP. Given 2 weeks since diagnosis, no benefit of starting any antivirals per ID. Isolation to end 9/18/23 as immunocompromised. Received IV Rocephin with limited improvement, doubt bacterial superinfection. Symptoms improved at discharge, expectant resolution. 2. Hemoptysis: likely due to above pneumonia with coughing. CTPA negative for PE. Management as above, resolved.  3. Diarrhea: due to above, resolved.  4. RA: h/o. On chronic prednisone. Follows rheumatology as OP. Refused to be on azathioprine, hydroxychloroquine. Continued prednisone.
Patient was admitted to Hospital  on 1/17/22 for COVID pneumonia. This is considered a breakthrough case.
Side effects after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after second dose). At the time of the report, VACCINATION COMPLICATION (Side effects after second dose) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The patient wanted to know what were the side effects of the second dose within an hour of receiving it .
Sore throat and runny nose in pm; sore throat, runny nose, body aches in am of 11/08/2009.
Acute Vomiting, Nausea, feels Faint, dizzy, high BP, sick to stomach w sit, unable to safely stand, arm sore, HA on 9/15-16 +dehydration w muscle cramping at home.  I gave mom sips of water, Gatorade prn till paramedics arrived. Onset Chest discomforts 9/17
Hospitalization; This spontaneous case was reported by an other health care professional and describes the occurrence of HOSPITALISATION (Hospitalization) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Hospitalization) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not provided. Very limited information regarding the event has been provided at this time.; Sender's Comments: Very limited information regarding the event has been provided at this time.
Note: I AM reporting this because I strongly believe that patient's death was caused by his second COvid-19 vaccine. The exact date of the vaccine is unknown. His girlfriend told me he got his second Vaccine at the end of February. I also don't know what vaccine (Moderna or Pfizer) he got, so the Pfizer is just a guess. Patient started feeling bad and looking bad after his second vaccine. He complained that he wasn't feeling well and missed appointments saying he wasn't feeling well during the two weeks or so between the time of his second vaccine and his death.
Information has been received from a physician concerning a 15 month old female with no pertinent medical history and no drug reactions/allergies who on 15 Mar 2006 was vaccinated SC in the right thigh with a first dose of Varivax (lot #647523/0633R). Concomitant therapy that day included a dose of MMR II vaccine. There was no illness at the time of vaccination. On 22 Mar 2006, one week post vaccination, the patient developed a papule rash, also reported as 19 pox mostly on her lower abdomen. The pox were reported to be small and drying, with some others scattered over her body. The patient was reported to be bright and alert. Unspecified medial attention was sought. There was no lab diagnostic studies performed. On 01 Apr 2006 the patient recovered. The patient had no adverse events following prior vaccination. There was no product quality complaint. Additional information is not expected.
chest pain- P 79, BP 131/98, 99% SPO2, Throat itching, Taken to ED  Left sided pain Sinus tacky- troponin normal- EKG normal Benadryl 50 mg IV and Zofran administered  In ED 3 hours
Pulmonary embolism; This is a spontaneous report from a contactable physician via the company representative. This physician reported same events for two male patients (one was 25 years old, another one was 27 year old), this report was for the patient who was not hospitalized due to the event. This is the 2nd of two reports. An adult male patient (unknown 25 year old or 27 year old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced pulmonary embolism after the vaccination (not hospitalized due to the event). Outcome of the event was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of pulmonary embolism  due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021711391 Same reporter/ drug/ event for different patients
This literature marketed report has been received from authors in a published literature article titled as above.  This literature referred to 3 children patients of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown date(s), the patients was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, frequency, route and lot # were not reported) for prophylaxis. On unknown date(s), the patients were diagnosed measles within 30 days of vaccine administration, which are most likely measles vaccine-associated adverse events. The outcome of the event was unknown. The causality was related.  A copy of the published article is attached as further documentation of the patient's experience.
No additional AE; PROQUAD that underwent a temperature excursion was administered; This spontaneous report has been received from a registered nurse referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 08-NOV-2022, the patient was vaccinated with an improperly stored dose of measles (+) mumps (+) rubella and varicella (oka-merck) virus vaccine live (PROQUAD), subcutaneous Injection, lot number W023865 with expiration date 29-OCT-2023 (product storage error).  The administered dose of the vaccine experienced a temperature excursion of -10 grades celsius (C) up to 8 grades celsius (C) (2.5C) for 1 hour 42 minutes and 0 seconds. No previous temperature excursion happened and there was no additional adverse event reported.
COVID-19 Breakthrough. Last Saturday night I got a sore throat. On Sunday in the morning, I woke up with congestion and runny nose. Then that afternoon I had fatigue, muscle soreness, lost of taste (I couldn't taste anything sweet), and headache. By Monday afternoon, pretty much everything was gone except for congestion and a little cough.
At onset: Nausea, headache, fever, chills, fatigue, injection site red, sore and warm.  At 24 hours from onset: headache, mild nausea, injection site sore, red and warm and arm pain when moving.
patient was administered expired TENIVAC with no reported adverse event; Initial information received on 06-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 50 years old female patient who stated patient was administered expired tenivac with no reported adverse event after receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine; varicella zoster vaccine RGE (CHO) (Shingrix); and influenza vaccine for prophylactic vaccination.  On 05-Dec-2022, the patient received a 0.5 ml dose (1 x) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult suspension for injection (lot U6831AA, expiry date 08-Aug-2022, strength not reported) via unknown route in unknown administration site for Immunization.  On 05-Dec-2022 the patient was administered expired tenivac with no reported adverse event (expired product administered) (latency: same day)  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient was administered expired tenivac 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.
12 yr old received VARIVAX and TDAP and MENACTRA on 7/9/09 - developed Zoster lesions 7/11/09