chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a stored improperly dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been received.
pt exp mild fatigue & lt pc adenopathy, w/lower occipital discomfort;rash, viral synd, inc pain in joints,lymph nodes lt & rt side of neck, could hardly eat w/hands, viral exanthem -mild outbreak of disease immunized for;
Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA344670, 2018SA344695, 2018SA344687 and 2018SA344689. This case involves a 70 years old male patient in which 0.5 ml of FLUZONE HIGH DOSE was potentially out of range between 32 F and 47 F for 7 days  and exposed to freezing temperature (lot number: U1994AA, expiry date: 09-Apr-2019) via unknown route in right deltoid on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not following the vaccination. 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 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 sender: none.
Lightheadedness, shortness of breath, chest tightness  Needed to take Ventolin inhaler 2 puffs, Duoneb nebulizer, liquid benadryl  Symptoms improved with medications. Felt very tired rest of day.  Symtoms to relief was probably 1 to 1.5 hours
Had high fever, dehydration 11/30/06, right middle lobe pneumonia, seen at hospital then transferred to another. Gave IV fluids, IV antibiotics. Discharged on 12/03/06. Had Fluzone 0.25ml on 11/28/06. Pt at that time had cough and runny nose, had temp of 97.5. Temp at office was 99. 12/14/06-records received and reviewed. DC DX: for DOS 12/1-12/3/06 Right lower lobe pneumonia HX: 2-3 days fever with cough and increased work to breath.
Headacehs, Chills, Body Aches Day after Inj. Tenderness on Lt Upper Arm Inj Site
Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is complained and alleged that the patient was inoculated with ZOSTAVAX vaccine on or about 10-APR-2012 at a medical facility, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-DEC-2013, the patient was treated by a physician for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient has been prescribed antivirals to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Mother of child requested to staff member administering the COVID-19 vaccine, to give half of the recommended dose for the age. The staff member administered half dose of the vaccine to the child,without consulting first with medical director on site or DOH site supervisor.
Ever since I have got the vaccine I have become insulin, its not working. I am having do double or triple the amount of insulin I am taking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; insulin (INSULIN), (Batch/Lot number: unknown). The patient's relevant medical history included: "I am a type 1 diabetic" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization.  The following information was reported: BLOOD INSULIN ABNORMAL (non-serious), outcome "unknown", described as "Ever since I have got the vaccine I have become insulin, its not working. I am having do double or triple the amount of insulin I am taking". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for insulin was unknown.  Additional information: The patient was also the reporter. Consumer stated that ever since patient have had the COVID vaccine (Manufacture not clarified), had two vaccines and a booster. patient is a type 1 diabetic and have been entire life. Ever since patient have got the vaccine, patient have become insulin, it was not working (Further clarification unknown, hence Insulin captured as suspect conservatively). patient having do double or triple the amount of insulin  patient taking. Is that a side effect of the COVID that patient having.   No follow-up attempts are possible. No further information is expected.
Heart was racing; Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart was racing), MYALGIA (Sore arm) and PYREXIA (Fever) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 039A21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included CLARITHROMYCIN, OMEPRAZOLE and AMOXICILLIN for Helicobacter pylori infection.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced HEART RATE INCREASED (Heart was racing), MYALGIA (Sore arm) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, HEART RATE INCREASED (Heart was racing), MYALGIA (Sore arm) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Body temperature: 103 (High) fever (103F), 100 (High) High and 98 (High) High. On 28-May-2021, Heart rate: 111-113 (High) High heart rate and 85-103 (High) High heart rate.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   Additional information reported include that the patient had to know whether the heart beat was dangerous or not.
Patient was administered an expired dose of vaccine. Expiration date was 9-25-23. Parents were informed and vaccine dose was rescheduled in 5 weeks.
Mother stated child's legs were trembling and she was screaming in pain and would not let anyone touch her legs especially her rt. leg. No redness or swelling of legs.  No fever. She slept the night and was eating and drinking. The morning post inoculations she was using a small shopping cart to walk.  Mother had administered acetominophen with minimal relief. Mother was going to use Motrin which was recommended by physician.
Per patient report "Debilitating pain in right arm half way from elbow to shoulder, could not move arm, could not drive car taken to ER 3 1/2 hrs after vaccine administered. Discharged from ER. Later at 4 am went to hospital, had severe pain that could not be relieved by morphine. 50 cc fluid taken from shoulder."
"Throat was itchy and hives located all over my body the size of dimes. Took Benadryl every 6 hours. Took 3 weeks for the hives to go away"
About 48 hrs after my shot I started to experience symptoms (headache, agitation, chest tightness) that I wrote off for a few days.  Then a few days later i checked my blood pressure and it was very high for me on my blood pressure meds.  The same thing the next day.  I called and my cardiologist's office told me to go to urgent care or the ER to get checked out.  I went to urgent care and was sent on to the ER after and ekg and a physical just to be safe.  I was sent home from the ER after an ekg, blood draw, and chest x-ray and told to follow up with my doctor.  I called my cardiologist and he adjusted my meds saying that he has seen this reaction happen before and it ought to resolve itself with time.  The meds adjustment fixed the headaches, agitation, and chest tightness, but my blood pressure is like a roller coaster still and it's 12 days out from my vaccination.
Sxs started around 2 H post vaccination: fatigue followed by difficulty sleeping.  The next day, fatigue, slight cough,  stomach upset, and severe headache (before noon).  After noon, nausea, diarrhea, cough, SOB, and fever (max 103); in addition to all previous Sxs.  Sxs lasted through 48 H.   In total, 1.5 days was missed from work.  I have never felt this sick before.
12 hours after my second dose I felt paresthesias in my extremities - particularly in my hands and feet - as well as my face. I also had chills and rigors. I felt lightheaded and nearly fainted.  Day 1 post vaccine: I had chills and rigors and the hand/feet paresthesias were persisting. I also felt heavy and weak.  Day 2 post vaccine: the chills had resolved but the hand/feet paresthesias were persisting as well and the generalized weakness got worse. I went to the ER and was sent home with instructions to follow up with neurology. That evening my hands became swollen and tight.  Day 3 post vaccine: the weakness improved but the paresthesias were persisting. I went to work and on my drive home a I felt electric jolts throughout my body but especially my extremities - which caused me to shake. The rigors came back and I also had abdominal pain. Day 4 post vaccine: I still felt similar symptoms but milder than the night before. I got evaluated and tested for covid which was negative. Labwork and U/A were also negative. The symptoms resolved that evening but the paresthesias were persisting and started to become more painful. I had an MRI of my brain and spine which were negative. Day 5 post vaccine: The paresthesias had become more painful. I was started on Lyrica by my neurologist. Day 6 post vaccine: I felt chest pressure and a globus sensation in my chest, weakness, and jolts in my extremities. The dysthesias in my extremities were persisting. I was evaluated by my neurologist had an EMG which was normal and was diagnosed with small fiber neuropathy. I was told to continue Lyrica and titrate the dose up until the symptoms resolve. Day 7 post vaccine:  I have been having heaviness, jolts in my extremities and face, and dysthesias in my hands and feet for most of the day. Lyrica helps a little.  Throughout the entire time I have also had intermittent paresthesias in my face and jolts of pain in my face at times.  I also had paresthesias in my face and intermittent dysthesias in my extremities 7-10 days after my first Moderna dose. Symptoms got a lot worse after the second one. Given the timing I am concerned that these symptoms are vaccine-related.
patient received 1 vaccine, went to sit in waiting area for 15 min, about 3 minutes into it he passed out and fell over. We went out there and he woke up. Sweating alot. called ambulance and they checked him out and let him go.
Swelling Left arm, upper Calves and legs swelling; Bruise/ Lump on the injection Site; Sore Arm; Itching all over the body and injection site; upper Calves and legs swelling; Asthma attack; Anxiety; Stomach Cramps; stomach Bloating; Runny Nose; Weak / Tired eyes; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site) and PERIPHERAL SWELLING (upper Calves and legs swelling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety, Neuropathy, Celiac disease, White blood cell count low and Immunoglobulin therapy (IVIG treatment was recommended two years ago). Concurrent medical conditions included Asthma and Heart disease, unspecified.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site), PERIPHERAL SWELLING (upper Calves and legs swelling), ASTHMA (Asthma attack), ANXIETY (Anxiety), ABDOMINAL PAIN UPPER (Stomach Cramps), ABDOMINAL DISTENSION (stomach Bloating), RHINORRHOEA (Runny Nose), ASTHENOPIA (Weak / Tired eyes), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site), PERIPHERAL SWELLING (upper Calves and legs swelling), ASTHMA (Asthma attack), ANXIETY (Anxiety), ABDOMINAL PAIN UPPER (Stomach Cramps), ABDOMINAL DISTENSION (stomach Bloating), RHINORRHOEA (Runny Nose), ASTHENOPIA (Weak / Tired eyes), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included Xanax and Breathing Treatment
nurse reported that a 60 year old female received an injection  approximately 20 years ago and subsequently experienced an anaphylactic reaction. The reporter stated that the patient was told that the reaction was "related to an allergy to horse serum". She recovered. This event is considered medically important.
Patient with 2 Moderna COVID vaccinations who admitted to hospital with COVID detected PCR upon admission.  Provider d/c note below:  "71 YO-year-old female with h/o rheumatoid arthritis, coronary artery disease, paroxysmal Afib not on anticoagulation, and GERD who presents to the emergency department for altered mental status and aphasia. Initial studies showed: CT head negative, CT perfusion negative, CT angiogram negative.  Positive for COVID at home. Chest x-ray with left base infiltrate.  Labs unremarkable. EKG with normal sinus rhythm heart rate 99, QTC 477 no acute ST changes. She was admitted for further work-up . MRI negative for stroke or bleeding. EEG showedfocal neuronal dysfunction and epileptiform foci. Neurology was consult. She was initiated on Keppra and speech started improving day by day. While on addmision, patient presented with several episodes of paroxsymal atrial fibrillation, initially she was anticoagulated with heparin and then changed to  Xarelto. She also presented with high blood pressure and Lisinopril was initiated and metoprolol dose was adjusted. Patient has improved a lot is salable, but somehow week will sent her home with home therapy. Follow-up with her PCP, cardiology and neurology. "
Initial date the vial was stored in the refrigerator is 20Jan2022, vaccine expired on 16Apr2022 and expired on 18Apr2022; administered with expired vaccine; Hysterical; This spontaneous case was reported by a nurse and describes the occurrence of CONVERSION DISORDER (Hysterical), EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (Initial date the vial was stored in the refrigerator is 20Jan2022, vaccine expired on 16Apr2022 and expired on 18Apr2022) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022 at 10:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. In April 2022, the patient experienced CONVERSION DISORDER (Hysterical). On 18-Apr-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initial date the vial was stored in the refrigerator is 20Jan2022, vaccine expired on 16Apr2022 and expired on 18Apr2022). At the time of the report, CONVERSION DISORDER (Hysterical), EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (Initial date the vial was stored in the refrigerator is 20Jan2022, vaccine expired on 16Apr2022 and expired on 18Apr2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. The reporter reported that the vial did not undergo any temperature excursions. No treatment medication reported.   This case was linked to MOD-2022-543460 (Patient Link).
This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 03-AUGG-2015, the patient was vaccinated wiht improperly stored dose of VAQTA 25/0.5 lot # K012457, expiration date: 04-JUN-2017, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1508USA003819, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA005124, 1508USA005125). Additional information has been requested.
pt seen 18MAR93 @ that time was dx w/OM; given vax & 1 wk later devel rash on stomach & back & fever of 102 to 103 which was reduced to 100 w/APAP; rash had blisters, scabs & itched;
1010AM pt standing in posting room states mom then collapse to floor; but remained oriented to mom & responsive to verbal command; mom pick-up pt off the floor & taken to exam room; placed on exam table w/feet elevated BP 120/80, P100, R10;
Patient got an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HAB (Twinrix) (batch number 4f3yy, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 19th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Erythema (4" square), edema & induration of entire upper arm, increased warmth, bruising (is on Plavix and ASA 325mg daily for multiple stents).  Noticed 12/9 about 18 hours after shot.  Saw MD and put on Keflex for cellulitis and cool soaks.  By 12/11 erythema fading but remained indurated and warm to touch.
Big red hot itchy tender painful rash on arm spot of injection. A bad headache, nausea and vomiting, chills, aches and pains all over. Feels like flu coming on.
Itching all over for 12 hours.  Tired, patient reports feeling funny, tired and tongue felt funny day after shot.  No hives or swelling or tongue noted upon exam.  No egg allergy.  Afebrile.
A constant and persistent ringing in both ears; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) intramuscular, administered in Arm Right on 03May2021 11:00 (at the age of 63 years old) (Batch/Lot Number: ER8736) as dose 2, single for COVID-19 immunisation. No COVID prior vaccination. Patient has no known allergies. Medical history and concomitant medications were none. Relevant tests: None. Specific relevant test for thromboembolic with thrombocytopenia: None. No COVID test post vaccination. No other vaccine in four weeks. No other medications in two weeks. The patient took the first dose of BNT162B2 on 12Apr2021 11:00 (at the age of 63 years old, Batch/Lot No: ER8729 Intramuscular administered to Right Arm for COVID-19 immunization. On 06May2021 06:00, three days after the second shot, patient has had a constant and persistent ringing in both ears. Patient waited for a few months for it to go away but it never did. No treatment was given. The event was reported as serious, Persistent/Significant/Disability/Incapacity. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (did some suffer from vertigo but unsure if its coming back with being dizzy) and DIZZINESS (at night in bed when she turns she gets dizzy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Vertigo. Concomitant products included MELATONIN for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VERTIGO (did some suffer from vertigo but unsure if its coming back with being dizzy) and DIZZINESS (at night in bed when she turns she gets dizzy). At the time of the report, VERTIGO (did some suffer from vertigo but unsure if its coming back with being dizzy) and DIZZINESS (at night in bed when she turns she gets dizzy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Concomitant products includes Afib medication, BP medications too.
01/06/22 presents to ED for "generalized weakness and falls". PMHx of "DM, MI, CAD, HTN"
1 of 3 pts exp an inject site react which included welts, redness & swelling; treated w/DPH
Right upper arm/shoulder is swollen, slightly warm to touch, and sore. Cool compress applied.
Bell's Palsy. Treatment was steroids (PredniSONE). Unknown time course.