chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to ED due to sudden onset of chest pain and dyspnea. Symptoms worsened with exertion and relieved with rest. She received 2nd dose of Moderna Covid-19 vaccine on 4/4/21 and began having left calf pain on 4/5/21. She was mildly hypoxic on room air with ambulation and tachycardic. Prior COVID 19 infection in December 2020.  CTA  showed bilateral moderate burden of disease and was found to have developed bilateral pulmonary emboli.
I had COVID-19 vaccine Sunday morning.  I noticed fecal impaction Tuesday morning when I tried to use the bathroom .  It did not respond to stool softener (Docusate sodium 100mg) 4 pills a day that I self administered Tuesday and Wednesday.  I sought medical treatment with gastroenterologist Thursday morning.  The NP told me to administer fleet enemas at home .  I self-administered two enemas Thursday morning and evening.   Now, I am having normal bowel function Friday morning.   I believe this event is related to the COVID-19 vaccine because nothing else in my habits or diet was different at this time.  For years prior to this event I had no constipation.  I have regular bowel movements every morning after I drink some caffeine.  I am physically active and eat lots of fiber.  I never use laxatives prior to this event.  On Sunday after I got the vaccine I worked in the garden for several hours.  I felt good while I was working.    But it was in the high 80s and I was in the sun.  This could have caused some dehydration, but I felt fine Sunday night.  Monday I was fatigued which I attributed to the vaccine and I took two advil.  I know advil can be constipating but I only took 2 pills Monday and I commonly take more around my period and have normal bowel function.   Tuesday, I felt fine except for the fecal impaction.   I ate normally Sunday and Monday including lots of vegetables.
Seizure: caregiver gave her ODT clonazepam- patient has epilepsy not sure if this was related to the event
Unable to stand or walk; Unable to stand or walk; Pulmonary edema weakness; Temp. 101.7; Vomiting; weakness; This is a spontaneous report received from a contactable consumer (daughter of the patient) reported for in response to HCP follow-up letter sent in cross reference case. A 87-year-old male patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, second dose on 03feb2021 (formulation: Solution for injection, lot number: EIV6202) via intramuscular route of administration at single dose for covid 19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID Immunity on 06Jan2021. On 04Feb2021, the patient was unable to stand or walk. It was reported that the patient had to call all could not get off couch, no strength in his legs. All came could not stand or walk. On an unspecified date, patient had temp. 101.7, vomiting, SOB, chest X-ray showed pulmonary edema weakness. The patient received IV Lasix, one dose IV Antibiotics, physical therapy consult. On 05Feb2021 he could stand again on his own and able to walk on 06Feb2021. Discharged home on 07Feb2021. The outcome of event pulmonary edema was unknown and rest of the events was recovered on 11Feb2021. The reporter assessed the events are related to drug.
Fever developed shortly after receiving vaccine. Mother reports "spacey" behavior following by twitching of the arms.
Severe insomnia. Inability to sleep for more than two hours even with sleep aide. This lasted for three weeks. I saw starting to hallucinate. Within a few days after I began to sleep I started having heart palpitations and tachycardia. This lasted for 8-10 weeks. I may still have some lingering but at a lesser amount.
no adverse effects; patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On 01-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S006022, expiration date 27-FEB-2021 (exact dose, route and site of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # S026376, expiration date 24-MAR-2022). The vaccine experienced a temperature excursion between 6 to 14 degrees Fahrenheit (F) (7.2 F) for 2 hours. There was no previous temperature excursion reported. Digital data logger was involved to capture the temperature excursion. No adverse effect was reported.
Swelling, hot to the touch and a large lump in injection site. Red all around injection site (24h+) (still in effect) Severe muscle pain in legs and arm (13H+) (still in effect) Migraines (still in effect) Trouble sleeping, cold chills, fever (still in effect)
Starting within hours: -Extreme Fatigue, unable to stay awake more 30 minutes at a time, no more then a total of 3 -4 hours a day - lasted 15 days -Extreme Dizziness, unable to walk without holding on to something, constant for 6 days  -Headache, constant for 5-6 days -Extreme nausea, unable to function, constant for 7-8 days  Starting within days: -Extreme Fatigue, frequently unable to function - intermittently (more a problem then not), still continues at 7 1/2 weeks post injection -Extreme Dizziness, frequently unable to function - intermittently (more a problem then not), still continues at 7 1/2 weeks post injection -Headache, Intermittent, still continues at 7 1/2 weeks post injection -Extreme nausea, frequently unable to function - intermittently (more a problem then not), still continues at 7 1/2 weeks post injection Severe abdominal pain - constant, severity changes (between bad and severe) but constant,  still continues at 7 1/2 weeks post injection Vascular issues - tests resulted in diagnosis of PAD, post vaccine, still continues at 7 1/2 weeks post injection (not a problem prior to vaccine) Stroke Symptoms - Tested for Stoke, urgent care said symptoms  but did not diagnosis stroke, still continues at 7 1/2 weeks post injection Blood Pressure Irregularity - Blood Pressure spiking between ranges of approximately 190/110 and 116/72 (average  over several weeks 160/97) and pulse going from normal approximately 80 to in low 100's, still continues at 7 1/2 weeks post injection Muscle Pain - ongoing excessive muscle pain Overall feeling "off", still continues at 7 1/2 weeks post injection Shakiness - intermittent, still continues at 7 1/2 weeks post injection Angry - I'm not an angry person at all and the weeks following the vaccine, I have fought with being very angry   Other more minor changes that may or may not be related
Pericarditis: severe chest pain worse with being supine, lethargy, fatigue, starting day after vaccine, peaked in pain 3 days post-vaccine, lingering chest pain for at least 2 weeks (still present over 2 weeks later) after vaccine.
I had vaccination on 12/03/2021. On 12/25/2021 I started to experience fatigue achiness and cough. I tested COVID-19 positive on 12/28/2021. I was sick for about 5 weeks. I still presently have the cough on 12/05/2022.
Patient was due to DTap booster , Kinrix  ordered instead of Infanrix . No side effects noted or reported.
After second dose in primary series, daughter re-experienced loss of taste and smell, similar as to when she was ill with Covid infection.; After second dose in primary series, daughter re-experienced loss of taste and smell, similar as to when she was ill with Covid infection.; Loss of taste; loss of taste and smell; everything tastes like nickels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid 19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After second dose in primary series, daughter re-experienced loss of taste and smell, similar as to when she was ill with Covid infection."; AGEUSIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Loss of taste"; ANOSMIA (non-serious) with onset Oct2021, outcome "not recovered", described as "loss of taste and smell"; TASTE DISORDER (non-serious) with onset Oct2021, outcome "not recovered", described as "everything tastes like nickels". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) positive.  Clinical course: Reporter is a consumer that said that she was calling on behalf of her daughter. She reported that her daughter had a pretty severe case of Covid in Aug2021 and lost her sense of taste and smell. Reporter said that her daughter got mandated to take the vaccine by the military and after the second dose, she lost her sense of taste and smell and everything tastes like nickels. Reporter said that she is in Law enforcement and declined to provide any further contact details for her or her family. Reporter reports daughter's loss of taste and smell ongoing since October.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
after the 1st dose she felt a little sore in her arm.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2,Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration on 21Jan2021 as FIRST DOSE,SINGLE for covid-19 immunisation.The patient medical history and  concomitant medications were not reported.The patient experienced after the 1st dose she felt a little sore in her arm on an unspecified date. The outcome of the event little sore in her arm was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
From telephone correspondence received at AP on 08/22/2002, it was reported that a 47 year old female received TD ADS vaccine on 08/19/2002.  The pt developed redness and soreness at the site, body aches, stiffness in her neck, pain in her eyes and difficulty walking on 08/21/2002.  The pt went to the ER. Spinal tap for meningitis and CT scan were performed and the results were negative. Test for West Nile virus was negative. The pt was released from the ER.
Mom does fine in the afternoon of shot.  Goes to bed just fine....In the morning she's catatonic.  Cannot stand, no comprehension of anything we're asking of her or telling her.  She cannot speak.  Cannot put 2 words together! She has had a history of Tia's and seizures that affect her ability to speak.  Her previous seizures only last up to an hour.  The reaction to the shots seem to cause a seizure that lasts 24 hours almost.  2 out of the 2 doses we called EMS.
Feeling less energetic; Condition worsened; Minor pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling less energetic), CONDITION AGGRAVATED (Condition worsened) and VACCINATION SITE PAIN (Minor pain at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Energy decreased (history of going through periods of feeling more energetic and less energetic.) and Energy increased (history of going through periods of feeling more energetic and less energetic.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feeling less energetic), CONDITION AGGRAVATED (Condition worsened) and VACCINATION SITE PAIN (Minor pain at injection site). At the time of the report, ASTHENIA (Feeling less energetic), CONDITION AGGRAVATED (Condition worsened) and VACCINATION SITE PAIN (Minor pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; 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.
This non-serious initial spontaneous case, was received from other non-health professional on 25-Jan-2018, concerning a female patient of unspecified age. The patient had allergy to neomycin since an unspecified date. Historical drug included AFLURIA for an unknown indication (dates not reported). On an unspecified date (reported as past 2 season), the patient was vaccinated with AFLURIA (dose, route of administration, anatomical location, batch no and expiry date: not reported) with no reaction which was explicitly coded as contraindicated product administered. Reportedly, the consumer wanted to know if the AFLURIA contains neomycin and she did not received the vaccine this year. The reporter did not provide the seriousness assessment.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: syncope/seizure like activity-Medium, Systemic: Hypotension-Medium, Additional Details: Patient experienced a syncope/fainting/hypotensive event immediately post vaccination that had characteristics of possible seizure activity. Patient regained consciousness after a few minutes and seemed disoriented but stable (still hypotensive). Transported to reading hospital (tower health) emergency room for evaluation
The pt felt a burning pain to the front of the arm 25 minutes post vax which lasted 20 minutes. 12 hours later the pt had feet jitters, then 48 hours later a temp of 99 and body aches and headaches.
pt recv vax 19FEB96 & exp fatigue & muscle weakness;sx appeared to be assoc w/elevated liver enzymes which were detected on 16APR96 blood test;
Ten days, 03-13-2021)) after receiving vaccine I woke up up at l:00 A.M. with pain, itching, redness  and heat at site of vaccination with hard, raised area. I had an hive measuring l7"x5".  Applied ice pack  20min on and off.  I still have heat and itching at site 33 hours later.  Slight pressure at back (right side) of head.
Hospitalization, on ECMO, deteriorating lung function - now on lung transplant list, hx. sarcoidosis.  Question of whether vaccination caused worsening of lung function / sarcoidosis.  Still currently hospitalized.  Transferred to our organization for ECMO.    Hospital Course: Patient is 62y.o. male with PMH of Sarcoidosis who presented to the hospital with worsening shortness of breath. Over the past 2 weeks, patient has had worsening shortness of breath on exertion and also while talking. On 4/23, patient noted intermittent fever, TMax 102F. Patient was seen by his PCP on 4/25 and started on a zpack, and was also seen in our ED on 4/25. He was discharged home with OP pulm follow up. Since then, patient has been feeling progressively worse, He noted 4/27, that his pulse ox was in the 70s with ambulation and that the cough and shortness of breath were worsening.    In ER, patient has been placed on 6 L of oxygen via nasal cannula. He was also febrile with TMax of 101.5 F. POC COVID-19 testing was negative. WBC was slightly elevated at 10.7, Na level was noted to be 129. PCT was negative. CTA PE protocol was negative for PE, there was significant interval progression of nodular and consolidative opacities throughout both lungs when compared to 2017, compatible with interval progression of sarcoidosis. Patient was admitted for further workup and management.   Patient's oxygen requirements gradually increased. He was initially treated with IV antibiotics and antifungals. He underwent extensive testing, including urine histoplasma, cryptococcal, respiratory viral panel which will negative. TB QuantiFERON was indeterminate, along with elevated IgM mycoplasma for which he received azithromycin. Patient was also placed on IV Solu-Medrol initially, transitioned to IV Decadron. Inflammatory markers were elevated. D-dimer was noted to be greater than 10,000, he was placed on therapeutic Lovenox dosing. Patient did have Covid testing which was negative, he was also vaccinated. His oxygen requirements continue to increase, he was eventually placed on BiPAP, although due to lethargy and increased work of breathing patient was eventually intubated and sedated. He was also started on paralytics. Patient was transferred to another hospital for possible need of ECMO or lung transplantation.
Patient received a FLUZONE High Dose (NDC 49281-403-65, lot UJ000AA exp 03/28/19) on 09/05/2018. His wife reports that he began a fever that resulted in an emergency room visit. At its peak the fever was 102 degrees F. In addition, he was lethargic and had no appetite. The fever was controlled with Acetaminophen; however, persisted for 9 days. During the ER visit, he was swabbed and it came back negative for the flu.
Post vax, the pt developed cellulitis at the injection site. The pt sought unspecified medical attention.
Dizziness and High blood pressure 149/110, 159/100, 139/100.
HEART PALPITATIONS; MY BLOOD IS THICKENING; IT IS SHOWING THAT IT IS REGULATING AN IRATE; This spontaneous report received from a patient concerned a patient of unspecified age and sex The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart palpitations, my blood is thickening, and it is showing that it is regulating an irate. Laboratory data (dates unspecified) included: Elevated liver enzyme levels (NR: not provided) Developed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart palpitations, my blood is thickening and it is showing that it is regulating an irate was not reported. This report was non-serious.
pt recvd Hep B vax on 10APR92 & 14APR92 devel a flu-like illness w/achy sensation, chest congestion & t99; instructed to inc fluid intake & monitor temp; 17APR92 upper resp congestion, coughing, chest tightness; t99.2, tired & sluggish;
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with the second 0.5ml dose of GARDASIL, IM. "9 days after the vaccination, the patient experienced joint pain, swelling of the knees, fatigue, headache and a blotchy bright red face. The events lasted for approximately 3 to 4 weeks". The patient did not seek medical attention. At the time of the report, the patient recovered. Follow up information received from a physician concerning a 14 (previously reported as 15 year old) year old female with Coeliac disease and penicillin allergy, who on 15-OCT-2009 at 11:30 am was vaccinated with the second dose of GARDASIL (IM, lot # 663452/0671Y) in the right arm. Subsequently (on 24-OCT-2009, 9 day after the vaccination) the patient experienced joint pain, swelling of the knees, fatigue, headache and a blotchy bright red face following the second dose of vaccination. All pertinent work up was done through the patient's Gastrointestinal (GI) & rheumatology doctors. The reporter did not have notes at labs or imaging studies to back up the health concerns. No further information is available.
symptoms after second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (symptoms after second dose) 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 12-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 an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms after second dose). At the time of the report, VACCINATION COMPLICATION (symptoms after second dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Beginning about 04/25, extreme fatigue, scratchy/ swollen throat, low-grade fever.  Persistent cough with chest congestion. Symptoms still persist today (05/18).  Doctor has had Covid and Strep tests run - negative. Blood work did not reveal anything alarming.
I am suffering ear tinnitus in my both ears. I tried many medications with no success. I have theses signs since three months and no improvements
Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016505985) on 16-Nov-2016. This case involves a male patient (onset age not reported) who was vaccinated with a dose of Tetanus-Diphtheria Toxoids Td (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced allergy to vaccine (allergy to tetanus vaccine) and sign reported as syncope. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Client stated that the redness started shortly following injection and inability to move elbow and worsening redness over the next day. Presented to clinic on 11/08/2011 in the afternoon with a 6cm x 3.5cm of induration at injection site and redness that was hot to touch with slight swelling and warm to touch to mid forearm. Client was encouraged to seek medical attention immediately due to joint involvement.
Redness around the ankles; This is a spontaneous report received from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient received the COVID -19 shot of Pfizer and experienced redness around the ankles on an unspecified date. The event was assessed as non-serious by the reporter. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.