chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a nurse on 09 Nov 2016. This case involves a 63-year-old female patient who was vaccinated with a dose of FLUZONE MULIT-DOSE VIAL QIV (batch number: U1678AB, expiry date: 30 Jun 2017, route, site and dose not reported) on 31 Oct 2016. Patient had previous history of coagulation disorder. Concomitant medications were not provided. On an unspecified date, post vaccination, the patient had DIC (Disseminated Intravascular Coagulation). On 03 Nov 2016, patient went to emergency room. Lab data includes full vitals, blood planel review and blood was drawn on 18 Oct 2016. Corrective treatment was not reported. On 04 Nov 2016, the patient passed away. List of documents held by sender: none.; Sender's Comments: This is a poorly documented death case where patient passed away from DIC (Disseminated Intravascular Coagulation) after administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was to be noted that the patient had previous history of coagulation disorder of unknown etiology. The detailed autopsy report, detailed past medical history, concomitant medication and immune status at the time of vaccination would be helpful to assess this case further.; Reported Cause(s) of Death: Disseminated Intravascular Coagulation.
Client noted reddness & swelling (about 4"x5")at injection site mid-morning 10/26/08. No tenderness at site. Went to ER On 10/26/08 at 2pm. BP 198/71; Dx:Cellulitis & HTN. Client saw her primary care physician, on 10/27/08. Redness/swelling still remained.  Given Medrol dose pack. Client states redness/swelling gone by 10/29/08.
Significant sleep disturbance and considerable increase hyperactivity and uncontrolled motor movement.  Decreased eye contact and trouble self regulating persists.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUL-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L046896, expiration date: 23-FEB-2017 (exact dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 60 degrees Fahrenheit for 6 hours. There were no previous excursions reported. Additional information has been requested.
Patient skipped metoprolol and benazepril. BP 200/57, pulse 63, O2 sat 100%; BP 191/77, pulse 61. Complained of dizziness. Patient deemed stable and was discharged.
headache; dizziness; This is a spontaneous report from a contactable consumer (patient). This 70-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 07May2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization and had no adverse effects (AEs). On 08May2021, the patient experienced a headache and dizziness. The symptoms had continued but for a few days it got a little better. The dizziness was worse this morning (19May2021). The patient asked if it was normal for symptoms to last this long. The outcome of headache was recovering. The outcome of dizziness was unknown.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 01-SEP-2015, 02-SEP-2015, 03-SEP-2015, 04-SEP-2015, 08-SEP-2015, 09-SEP-2015, 10-SEP-2015, 11-SEP-2015, 15-SEP-2015, 16-SEP-2016, 17-SEP-2015, 18-SEP-2015, 21-SEP-2015, 22-SEP-2015, 23-SEP-2015, 24-SEP-2015, 25-SEP-2015, 28-SEP-2015, 30-SEP-2015, the patients were vaccinated with a dose of improperly stored MMR II, (dose, route and anatomical location were not reported), lot number J016233, expiration date 19-DEC-2015, 30 and also on 04-SEP-2015 and 15-SEP-2015, lot number K002816, expiration date 25-FEB-2016, 18 doses. No adverse effects were reported. There was no concomitant medication reported. This is one of two reports from the same reporter (case # 1512USA011935). Additional information has been requested.
pt recvd vax; 29jul95 devel first chicken pox & subsequently devel 25-30 more which were concentrated on the torso & lt arm;
psoriasis seems to be healing and clearing up; This is a spontaneous report received from a contactable consumer (patient) via Pfizer's Corporate.  A patient of unspecified age and gender started to receive bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received the COVID-19 vaccine and psoriasis seems to be healing and clearing up. Patient had it on every part of my body and thought it might help in research. Not sure if it's a cure or a medicine. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
This spontaneous report was received from other health professional and refers to a 1 year old female patient. The patient concomitant therapies included PREVNAR 13, ACTHIB, DAPTACEL, HAVRIX and M-M-R II. On 07-APR-2017 09:30 hrs, the patient was vaccinated with improperly stored VARIVAX (lot # M028553, expiration date: 07-JUN-2018) dose 1, subcutaneously in the left thigh for prophylaxis (incorrect product storage). No adverse effects were reported. The doses of VARIVAX were stored in the temperatures from 15 Fahrenheit degrees (F) to 46 F (23.2 F) for 96 hours (dates were not reported). There were no previous temperature excursions. The digital data logger was not involved. No Product Quality Complaint (PQC) was involved. This case is cross-referenced with 1704USA006422, 1706USA000217, 1706USA000221 and 1706USA001751 (Same reporter link). Additional information has been requested.; Sender's Comments: US-009507513-1704USA006422: US-009507513-1706USA000217: US-009507513-1706USA000221: US-009507513-1706USA001751:
Tachycardia - has gotten worse as the time has progressed started on day 1 after 2nd Vaccine  HTN- has gotten worse as the time has progressed started on day 1 after 2nd vaccine  Gerd - all the time  Fatigue - all the time Low grade Fevers (99-100)  at least once a day Angina (had EKG done) came back NSR - I have angina now. It?s just awful! I want to feel better!
(R) upper arm & shoulder area swollen, moderate to severe, within 24 hours, with erythema BENADRYL, ice, KEFLEX.
Patient had shortness of breath, increased heart rate, redness, warmth, pain in arm less than 12 hrs after SHINGRIX injection. Patient went to emergency dpt and was treated with prednisone and BENADRYL.
I had the second booster. My left upper arm is sore, I have a headache, light fever, and I feel tired.
Headaches: Initially had what could be described as Migraines (though had never had migraines before so not sure)?severe pain, difficulty with noise, light, had short term memory issues, could not think. Mostly resolved after a few months. Still have daily mild pain at the base of the skull that is ongoing. Pain helped with OTC pain reliever.  Sinus pressure: very thick feeling, pressure it the head and face, now improved-Had clear Sinus CT scan, tried nasal antihistamine, no help  Brain fog: Initially very bad?could not think, felt like I was swimming though water for over month?resolved  Malaise: tired all the time, hard time doing anything, felt flu like and sick?have mostly improved, can push through these times now though still have recurrences. Tried antibiotics initially, no help  Chills: Daily chills, feeling like I am getting sick every day, now some days do not have chills, is improving, was not helped by OTC fever reducer. Feel worse chills when have to go to the bathroom.  Intolerance to cold.  Heat or hot flashes with all exercise and intermittent (maybe caused by hormone shifts?):  started day 1-2 after vax, still have daily. Intolerance to heat?feels like a fever breaking every time I exercise and them sometimes all day. Was not helped by OTC fever reducer, Temperature always normal.  Nerve tingling in arms, hands, face: Face has improved, arms remain?like a heaviness or buzzing, parethesias?daily and ongoing.   Heart racing and palpitations: Better some days and them some get worse again.  Feels like anxiety? Heart pounding, adrenaline surges  GI reflux/indigestion: some days have trouble eating most foods?when have heart pounding, makes stomach hurt. Giving up coffee helped the loose stools.
Patient presented vomits, fever and malaise 10 hrs after administration of immunizations for Meningitis, and Hepatits A.
***I tested Positive for Covid 19 Monday 3/29/21 after receiving Pfizer vaccines (Dec 19 , 2020 and Jan 13, 2021) I am an Acute Care RN.  My exposure was at home (community acquired) - My son tested positive Tuesday Mar 23, 2021 after returning home from University; he is no longer symptomatic.  My husband tested Postive for Covid Sunday Mar 28, 2020.  I began having recognizable symptoms Monday Mar 29;  Upper respiratory; sneezing and runny nose, intermittent headache.  Please feel free to contact me.   I must admit - I was over-confident after receiving vaccine.  I plan to quarantine in home.  However, I am truly concerned that vaccinated people, like me may mistakenly feel that "90% protection rate" means you are highly unlikely to be able to contract Covid, therefore being a vector for viral spread.  If I did not work with vulnerable patients - I may not have been as proactive in retesting.    Please follow up with your V-Safe patients who have been vaccinated.
One hour after vaccine, her tongue and throat was itchy. She took Benadryl and it resolved.
Expired Pediarix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old patient who received DTPa-HBV-IPV (Pediarix) (batch number AZ472, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 2nd December 2022, unknown after receiving Pediarix and Pediarix 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: 5-DEC-2022. Reporter's Comment: The reporter stated that a dose of Pediarix that had expired on 28th November 2022 had been administered to a patient. The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up. Additional Supportive Information: The patient received a dose of Pediarix that had already expired, which lead to expire vaccine used.
Developed rash on arm that received injection. Rash progressed into hives all over the body. Parent took child to urgent care on Sunday night 10/13/13. Benadryl and Methylprednisone was prescribed. Child is on day 2 of 4 day course of medications as of 10/15/13. Per parent report the child had an increase in symptoms the morning of 10/15/13. Dr. was contacted by PHN at 9:10am on 10/15/13 and was advised to tell the parent to take the child back to the doctor for evaluation due to the fact the symptoms were worsening while taking medication.
A week after receiving the vaccine, the pain in my left arm started again after going away 48 after the shot. The pain causes tingling up my arm to my neck and down to my finger tips. There was a lump there that is no gone.
Sudden onset of dizziness; flushing; red streaks down neck and arms lasting about 10 minutes; several more episodes during night and over next couple of days; same as first episode.
PATIENT REPORTS HIVES ON NECK AND CHEST AT AROUND 2:30PM. PATIENT TOOK SOME BENADRYL AND SHOWER AND THE HIVES SEEMED TO IMPROVE.
It was reported, that a female pt received a Fluzone SV '99-'00 vaccination on 10/18/99. Reportedly, on 10/19/99, the pt experienced general body aches and felt hot, no temperature recorded. The pt treated herself with Motrin and Tylenol and was not evaluated by a physician. Reportedly, the pt recovered from this experience. From additional information received on 12/8/99, it was reported, "The pt had generalized achiness for 5-6 days, whereby it was difficult to function."
nausea, temp elevated, extreme dizziness, totally incapacitated-transferred from ER to hosp for 11 days;therapy for 5wk following discharge from hosp;
Patient reports a constant runny nose that began immediately after her vaccine and has continued until now. She is also experiencing shooting pains in her neck/ back of head as well as burning and tingling in hands and feet. She reports an injury to her hamstring that occurred during running  prior to her vaccine(she is not sure of the exact time frame). She has been treated with physical therapy for lower back pain related to that injury. Her physician scheduled a  MRI on her back on 7-14-21. During  one of her office visits her physician told her that her blood pressure was elevated and she has never had this before
Patient experienced syncope. She did fall down but immediately regained consciousness. She was hot and light headedness for a few minutes after and then was ok.
This spontaneous report was received from a physician referring to a 15-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 07-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
pt exp tightness airway & mild difficulty breathing;took DPH twice that evening;was told snored all noc (i.e. obstructed airway); sxs dissipated p/20 hrs
Headache, fatigue, nausea, muscular ache, injection site pain beginning 18 hours after injection.  Continued for 1 week.
Got menstrual cycle like almost two and a half weeks early; Abdominal pain radiating to upper and middle back; Abdominal pain radiating to upper and middle back; Stomach cramps; Nausea; Fatigue; Headache; Sinus infection; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (04Jan2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left deltoid on 15Dec2020 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included irritable bowel syndrome.  Concomitant medications included fexofenadine hydrochloride (ALLEGRA), famotidine (PEPCID), ethinylestradiol, norgestimate (CILIQUE) for birth control and multivitamin. It was stated that the patient got the vaccine on 15Dec2020. On 17Dec2020, she developed severe abdominal pain radiating to her upper and her middle back with pretty bad nausea, fatigue and headache. It was also mentioned that the patient had stomach cramps. These continued all the way until like Christmas. And then on the 19Dec2020, she actually got her menstrual cycle though she was not due to start that till that week. So, it came like almost two and a half weeks early (which was super weird as for her). The patient took ondansetron (ZOFRAN) for the nausea; aluminium hydroxide, magnesium hydroxide (MAALOX); famotidine and hyoscyamine for like stomach cramping. She also took that as well, acetaminophen (TYLENOL) and ibuprofen (MOTRIN). It was mentioned that the symptoms stopped on 26Dec2020 then she sinus infection right after in Dec 2020. Outcome of the event of sinus infection was unknown while the remaining events recovered on 26Dec2020. The patient stated that the she don't think that sinus infection was correlated at all but all other symptoms were happening right after the vaccine (reported as related).  Information on the lot/batch number has been requested.; Sender's Comments: The event sinus infection is likely intercurrent and is unrelated to suspect drug BNT162B2. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Arm was sore and painful; Index finger/fingers tingly; Elbow area is fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore and painful), PARAESTHESIA (Index finger/fingers tingly) and MUSCLE FATIGUE (Elbow area is fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Arm was sore and painful), PARAESTHESIA (Index finger/fingers tingly) and MUSCLE FATIGUE (Elbow area is fatigue). At the time of the report, PAIN IN EXTREMITY (Arm was sore and painful), PARAESTHESIA (Index finger/fingers tingly) and MUSCLE FATIGUE (Elbow area is fatigue) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Reported by husband who had same reaction that I saw: red, swollen lower bicep/tricep extending to just below elbow.
Left Arm reddness and hot to touch, red circle 5 inches wide - Approx 4 hr following injection (5:30PM 1/21/21) Fever 102 at 10PM  :  Aleve  2 gelcaps for fever and arm discomfort ,  also used heating  pad on Left arm discomfort Woke at 5 AM  TEMP 102.2 , arm much better, vertigo  significant, took mezcalin  anti vertigo RX (had from from weeks virus) took 1 Aleve gelcap Temp assessed at 2PM -  99.2 Temp assessed at 5PM - 98     No anti pyretic taken after5am
dry cough, headache, fatigue, ear pain, sinus pain, sinus congestion, nasal congestion, diarrhea-2 times/no blood in stool, chest pain.starting 10/9/21
Headache and nausea, vomiting. Treatment: acetaminophen 325 mg once, diphenhydramine 50 mg once.
presents with wife today.  Patient received covid19 vaccine on 06/11/21. he lost consciousness 24 hours after he received vaccine, lying on bed for 2 days, not understand wife's call, lost control of bladder, wet his pant, he did not know he wet the pants and did not felt his wife changing pants for him, needs wife to feed him during those 2 days.  gradually recovered 2 days later. now he back to his previous condition.
New onset Atrial Fibrillation, fainted, continuous Atrial Fibrillation for 9 days. Treated with Amiodarone and Eliquis
Parent stated that right arm was swelling, warm, red and firm to touch. States child c/o hurting and swelling seemed to be increasing. Parent took child to ER was given antibiotics and MOTRIN. Was told it was cellulitis. Child at school today, doing better.
S/P Covid Vaccine 1st dose, pt alert/oriented, calm, answering Covid questions appropriately. Prior to vaccine. pt reports she doesn't really like vaccines. Vaccine administered at approx 2:34 pm.  Pt reports she doesn't feel well, reports she did not eat or drink today.  This nurse gave her water to drink.  Pt unable to drink, briefly passed out in chair approx 2:36pm.  Myself and RN lowered pt from chair to floor. Site Director called EMS. RN assisted by raising pt's legs above heart level. RN checked b/p 70 palp, pts airway maintained, rechecked b/p 80 palp. As pt returned to consciousness reports she is about to vomit, assisted pt to (R) side >vomited small amount clear liquid x2 into bag provided, pt reports she feels better. EMS arrived, transported pt to ED via stretcher @ 2/40 pm, pt's coat, eye glasses, and purse placed on stretcher with pt.  Phamacist contacted pt's husband at 2:40 pm. Site Director notified.
Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; A spontaneous report was received from Pharmacist concerning a 58-years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial that went through a temperature excursion/product storage error.  The patient's medical history was not provided. Concomitant medications were not provided.  On an unknown date, the patient received their first of the two planned doses of mRNA-1273 (lot number: 027L20A) intramuscularly for the prophylaxis of COVID-19 infection.  It was reported that patient received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion.  Treatment medication included none.  No lab tests were mentioned.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the event received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion was considered resolved.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 027L20A with no associated Adverse Events.
Patient is a 16-year-old male patient admitted with seizure like activity.  One day prior to admission patient received his second COVID vaccine, Pfizer brand.  On the day of admission Patient woke at 0200 with pain in the left side of the chest, mid-axillary per patient's description it was cramp-like pain and he was able to go back to sleep.  At 0500 he got up to use the restroom and went into the kitchen.  He told his mom he didn't feel well and fell forward making a gurgling sound, arms rigid, was unresponsive, and this lasted 1.5minutes according to mom. Mom called EMS and when he awoke he stated he was nauseous.  After EMS arrived it was 2-3 minutes and he did not feel well again, he stood up and head fell back, eyes open, he was shaking, and making a gurgling noise again, this episode lasted 30 seconds.  Upon awaking he was disorientated for a few minutes then back to baseline, he was nauseous again and very tired.     He came to the ED where EKG (pending), CBC (normal), PT/PTT/INR (slight elevation), CMP (normal), TSH (normal), Ethanol (None), Troponin (normal), Head CT (normal), and chest xray (normal) were done.  He received a NS bolus was given.  He was admitted to the pediatric hospitalist for further evaluation and management.  This is where he had a 24hour Video EEG with normal EEG he was discharged home.