chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Swelling at Injection Site-Medium, Systemic: Other- patient felt tightness in trachea; nurse practitioner ordered for administration of epipen
Fever (101.5), chills, aches, light headed, nausea, dizzy, elevated heart rate (over 20bpm higher than normal resting average.
Pt developed confirmed pericarditis with initial symptoms of chest pain/tightness, shortness of breath on exertion, radiation of pain down the left arm, getting dizzy with any significant exertion.  Initial date of evaluation in ED was 2/4/22 after having had symptoms for the few days prior.  Initially diagnosed as costochondritis and treated with a course of ibuprofen and methylprednisolone.  Returned to ED and ECG noted to show global changes consistent with pericarditis.  Given more prolonged course of ibuprofen 600mg TID and symptoms improved somewhat.  Went back to ED in April, 2022, with confirmation of diagnosis and recurrence, placed on colchicine 0.6mg once daily x 3 months at that time and symptoms went into remission.  Now, 1 week after completion of that course, symptoms have returned of chest pain/pressure radiating into the left arm/axilla.
Large local reaction at immunization site - first noted <24 hours after injection, increasing in size.  At ~48 hours - ~6cm erythematous, warm patch with ~2cm tender, underlying nodule.   Red: BENADRYL, cool compresses.
I received the vaccine the 9th of June the 2nd dose during the night my whole left side of my face became inflamed, my ear hurt a lot and tonsils became swollen in my throat and all of my mouth became inflamed even my gums had a strong pain and a lot of headache but what scared me the most was the inflammation in all the left side of my face.
My adverse event started on 12/10/2022 in the evening. On left upper forearm  it was swelling over the next few days it got bigger. it had no pain. I went to my doctor on 12/23/2022 she diagnosed as  localized soft tissue swelling ( cellulitis). She prescribed  Cephalexin for 5 days. As of today 01/04/2023 it decreased in size but still there. The doctor said if any changes occur on the swelling to contact her right away. If  the swelling decreases to let my doctor know as well.
Petechiae starting on the left side of mouth, then spread around my whole mouth and by my right eye  by the next day, then to the forehead the following day. This was a 3 day period of the petechiae spreading before going to urgent care.
Patient complains of an itchy "bump" on his left shoulder which he feels developed 2-3 weeks after he received his seasonal influenza vaccine. He notes it has progressively grown in size. He denies adverse reactions to prior vaccines. He denies generalized cutaneous and systemic symptoms. He denies fever/chills.
Patient had mild dementia before vaccination and now after vaccination, he has total dementia. Wife believes it bc of the moderna vaccine.
Pt stated tingling on the back of her throat. Upon assessment lips appeared normal and no swelling was noticed. No respiratory distress and vitals signs were within normal range. Pt stated stated she was really anxious upon arrival to the clinic. She was alert and oriented and able to keep a normal conversation. Pt requested water and no issues noticed with swallowing . Benadryl 25mg was administered at 1550.  Pt stated improvement and was discharged home at 1625 with all symptoms resolved and feeling comfortable going home. Observation total time was 55 minutes
Presented with shortness of breath and tested + for Covid. Treated with Remdesivir and dexametasone. Once stable pt discharged home.
Infarct; Double vision; Dizziness; A spontaneous report (United States) was received from a consumer concerning a 77-years-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an infarct that effected the left thalamus of his brain (Thalamic infarction), double vision (Diplopia) and dizzinesss (Dizziness).   The patient's medical history was not provided. Concomitant medication included amlodipine for unknown indication.  On 02 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number004M20A) intramuscularly in the left ( non-dominant) arm and  on 02 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number- 001A21A) intramuscularly on the left (non-dominant) arm for prophylaxis of COVID-19 infection.    On 17Feb2021, patient states that he had an infarct that effected the left thalamus of his brain. On the same day around 8pm he was driving not far from his house and developed double vision and dizziness. Once reached home he went to bed, upon waking up in the morning symptoms were still present, at this time he went to the emergency room. Patient was hospitalized for 2 nights and 2 days.  While hospitalized he had several blood test done and a CAT scan done and also had an MRI on 24Feb2021, report details were not reported.  Treatment for the event included are plavix, Catapres, rosuvastatin and doxazosin.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable  The events double vision and dizziness were as recovered on 19-feb-2021. The outcome of the event, Infarct was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Information has been received from a male dentist with a history of being given 2 doses of pneumococcal 23v polysaccharide vaccine close together (WAES# 0805USA04877) who reported that on 08-APR-2008 he was vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) due to human error. No adverse effects reported. The patient's lady friend also received VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) due to human error. (WAES#: 0805USA04876). Additional information has been requested.
pt brought to hosp via EMS due to extreme weakness and dyspnea; per wife, pt had a recent hospitalization  (Hospital)from 1/5/22 - 1/14/22 and was treated for COVID and fluid around the lung; was dc'd to home on O2 3L via NC; 2 days ago she learned the fluid had grown pseudomonas, and pt started taking Levaquin; pt now requiring 100# NRB FM; pt tested positive again for COVID; pt's condition worsened; he decided to only be intubated if he had to go to surgery, otherwise DNR/DNI if respiratory failure; pt suffered PEA arrest, comfort measures performed and he passed away in the hospital
Sick to their stomach; breaking up in a sweat; body rash on their trunk, mainly on their stomach and the top of their legs; nausea and fever; Weird headache; nausea; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to their stomach), HYPERHIDROSIS (breaking up in a sweat), RASH (body rash on their trunk, mainly on their stomach and the top of their legs), PYREXIA (nausea and fever) and HEADACHE (Weird headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 048A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced PYREXIA (nausea and fever), HEADACHE (Weird headache) and NAUSEA (nausea). On 03-Dec-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to their stomach), HYPERHIDROSIS (breaking up in a sweat) and RASH (body rash on their trunk, mainly on their stomach and the top of their legs). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Sick to their stomach), HYPERHIDROSIS (breaking up in a sweat) and RASH (body rash on their trunk, mainly on their stomach and the top of their legs) had not resolved and PYREXIA (nausea and fever), HEADACHE (Weird headache) and NAUSEA (nausea) outcome was unknown.
pt had temp & didn't sleep well that noc; had several episodes of shaking & staring in the morning; eyes rolled back in head; MD referred pt to MD & was adm to hosp; sz, fever, abn EEG:
Dehydration, vomiting, dizziness (flu-like illness) Patient was hospitalized.
Beginning approx. 8 days post-vaccination and continuing through present I began feeling itchy, rash-like sensations on various parts of my body - waistline, upper chest, forearms - areas I previously never had those sensations. In the following days the itchy patches spread, and read splotches began to appear (notably, around waistline and on R torso, and on upper, backside of L arm). The itching is intermittent and mostly a minor distraction - it's not intense and/or constant. The splotchy areas don't always itch, but are pronounced and have appeared on just about every body part.
Within minutes of receiving the vaccine, the patient stated her face was itching and lips were swelling. Redness noted on her cheeks and neck. Epinephrine 0.3 mg administered in right thigh; rapid response team called. Responding provider ordered a second dose of epi (0.3 mg) which was also administered in her right thigh. A dose of Benadryl 50 mg was given orally. Transported via ambulance to Emergency Room
Approximately 4-5 hours post first dose of hepatitis B recombinant vax, this pt experienced loss of appetite, nausea, vomiting, and cramps. Another pt reported with a similar experience following vax. No further information is available.
Five days after 1st Moderna Booster (dose 3), I started having hives, itching all over and they would come and go on 4-25-2022. On 4-26, I noticed they were spreading more and the itching increased in severity. I was taking Benadryl as needed. On the morning of 4-27, I went to the emergency room at a local health center due to elevated heart rate, hives, and itching. They treated me with epinephrine and hydroxyzine. They also performed an EKG. They sent me home with antihistamines (Banophen). On the morning of 4-29, I went to an urgent care due to hives returning along with boils to my scalp, behind my ears and back of my neck. They did not prescribe any medication. They cut hair extensions from my head thinking it was a reaction to my hair extensions. I then went to a dermatologist clinic on 5-11 and 5-25 due to the hives. I was given a tapering dose of prednisone on the 1st visit. The skin issue had not cleared up after the steroids so I went back to the dermatology clinic on 5-25 and she suggested I use only Vanicream products for 1 week. I am scheduled for a biopsy next week on 6-1-2022.
Chills with shaking, nausea, entire body joint aches, severe headache, fatigue, dizziness, extremith numbness.
Patient experiences strong pain which starts from the arm pit and extends through his arm to his fingers. He also reports that he cannot raise his arm because of it. The pain started 2-3 days after the administration of the vaccine. Patient is planning to visit his physical therapist and consult with him in regard to this issue.
It was reported that a 36 year old female pt received TD ADS adult, lot number U1015AA, administered IM on 12/22/03. The next morning, the pt developed a fever, right arm swelling, redness, soreness and muscle spasms. On 12/30/03, the pt developed spasms and tremors of the right lower extremity, which progressed to the bilateral lower extremities and eventually the entire body. The pt was reportedly hospitalized for 20 days, which resulted in her being out of work. The pt's recovery status is currently unknown. Follow up on 03/22/04 states: "From additional information received on 03/05/04, the middle initial of the pt's identity was provided. She received Tetanus vaccine for a laceration involving her dog's leash.  No other information was reported."
One hour after receiving injection I developed a pruritic generalized rash and burning sensation on face. I took 20mg pepcid, 10mg claritin, and 25mg atarax. Symptoms resolved until 3am the next am when I repeated the dose. On 12/31/2020 I have a minor pruritic rash on my abdomen, bilateral legs, and back with lacy blanching rash on my legs.
Fever/ "screamed for 2 hours".  Taken to ED.  Reports also had "ear infection" at same time.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or about October 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. In or about February 2017, the patient was treated for zoster-related pneumonia. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, 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. Upon internal review, zoster-related pneumonia was determined to be medically significant. Additional information has been requested.
High fever - I gave him Tylenol. For two days, and the second day I gave him Advil. He was very tired. I let him sleep. I gave him a lot of water. Urgent Care -  For the shot broke his skin and caused him an infection, he had Prescription punicic  acid ointment - 2% . The ointment worked to help the infection.
PATIENT 15 MINUTES LATER HAD DIZZINESS AND TREMBLING HANDS.
Slight dizziness on 12/26/2018 and 12/27/2018. Extreme dizziness 12/28/2018 and right chest pain. Noticeable red areas on right upper back on 12/30/2018 with itching which are still present. Persistent  discomfort under right breast which is still present. Lack of energy since 12/30/2018 is still noticeable.
FELT LIKE ASTHMA ATTACK; COUGH; HEADACHE; TIREDNESS; SHORTNESS OF BREATH; LOW O2 SAT ABOUT 92 % FOR A WEEK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and 1802072 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced low o2 sat about 92 % for a week. On 09-MAR-2021, the subject experienced cough. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced tiredness. On 15-MAR-2021, the subject experienced felt like asthma attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, low o2 sat about 92 % for a week, headache, felt like asthma attack, and cough, and had not recovered from tiredness. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Patient presented with rash on left arm that extended roughly from injection site down to above elbow. was red and itchy. Patient put Benadryl cream on it and took half of a Benadryl tablet. She is watching rash to see if gets bigger or starts to go away. Patient was going to try hydrocortisone cream on the area.
Massive headache, dizziness, nausea, throat pain, swelling and bruising around injection site,  body aches.
macular papular rash over whole body 24hr p/vax given;no tx rash lasted x 24hr;
Patient was vaccinated. After vaccination was complete healthcare professional quickly noticed the change in the patient. Reacted quickly & with the assistance of another professional lowered her to the floor. Patient was pale at the time. I went to get the bag, along with an ice pack and bottle watered. Patient slowly started to respond to her surrondings. Slightly confused and started to regain color. Did state she was nausea and started to dry heave. After taking a few sips of water and having the ice pack applied to the back of neck patientregained her color and alertness. EMT was called. Mom was called and in route with an estimated time of arrival of 25 minutes. At 5:42 patient is full alert and stable.
fever; upper arm injection site pain; patient experienced extreme diarrhoea for a long time/she experienced diarrhea 15x; she has difficulty sleeping deep; injection site is bruise in left upper arm; This non-valid spontaneous report was received from an unspecified reporter via company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot#, expiration date, route, dosing details were unknown) for prophylaxis.   On an unknown date, the patient experienced extreme diarrhea for a long time. The outcome of the event diarrhea was unknown.   The causal relationship between the suspect therapy and the event was not provided.  Follow-up was received on 23-OCT-2019 from the initial reporter, who was an  acupuncturist. Upon receive of follow up information, patient identifiers were provided and the case is now considered valid. This report refers to a 70-year-old female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided. It was reported that the patient had never had any adverse event prior to this vaccine.  On 20-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S012245, expiration date 09-FEB-2021; route of administration, exact dose and frequency were not provided) in the left upper arm for prophylaxis at clinic. On the same day, the patient was vaccinated with influenza virus vaccine (unspecified) (lot # 3L32N, expiration date 30-JUN-2020; route of administration, exact dose, indication and frequency were not provided).  On 20-SEP-2019 (also reported as on Friday and on 21-SEP-2019) at the night, after vaccination with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced diarrhea with intensity of 15 times and upper arm injection site pain. She also had fever on 21-SEP-2019 (reported as on the next day). On 25-SEP-2019, when she went for acupuncture, the injection site was still bruise on left upper arm. The patient also complained of having difficulty sleeping deep. The reporter stated that according to Traditional Chinese Medicine, the explanation was that lung and large intestine pain could appeared when the vaccine for lung was administered and the patient might have "LI st". The reporter informed the patient's primary care physician (PCP) about the events. The outcome of the events was not reported.     The relatedness between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), influenza virus vaccine (unspecified) and the events was not provided.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015205:
pt recv vax & devel flu-like sx characterized by fever,malaise,deep body/muscle aches,h/a,& nausea;this is one of three patients who exp above rxn @ this site;
rash at the base of her neck to her shoulder; turned red; thermometer registered a fever; felt like she had the flu and all this mess; allergic reaction; had muscle aches; felt flushed; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing, covid-19 from Jan2021 and was hospitalized. The patient's concomitant medications were not reported. On Jul2021, patient turned red and the thermometer registered a fever when placed near the redness. She felt flushed. She had a rash at the base of her neck to her shoulder on Jul2021. She did take Benadryl for symptoms. She stayed there for a while and then she was starting to feel okay. She took it last Friday (from date of report) and Friday wasn't too bad but Saturday was horrible. She felt like she had the flu and all this mess. She never ran a fever but then on Saturday evening she had looked in the mirror and her face was like on fire, and she knew that's an allergic reaction. She has an EpiPen and she has been using Benadryl. She had muscle aches that she was taking Aleve for and Tylenol for a fever. She has a temperature scanner that you can just hold up to your forehead but not touch it and when she did it against her forehead she had no temperature, no fever, but if she did it on her cheek it was a fever. It was just really weird. She really felt more scared of the delta variant than of COVID that had put her in the hospital. Patient was asking if taking antihistamines before the COVID vaccine and all during it make it ineffective because she really would like to be vaccinated. She was just hoping that maybe she can take antihistamines before she gets the COVID vaccine and during the time while she was feeling symptoms because she was not a typical person who typically reacts to severely. But in 15 minutes she was sitting in the store and she did react fairly quickly by the flushing and she had to take Benadryl and they took her blood pressure and then finally let her go. She was there longer than most people but she just doesn't know if antihistamines will render it ineffective, like if she takes Benadryl on the day she gets her 2nd COVID vaccine, before she even shows up, and then Benadryl all the way through the time she was having symptoms. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt c/o numbness and tingling X 4 days on the L side of her body. Pt states it sometimes is one part like her leg and other times it is several parts of her L body at the same time. Pt describes the tingling like 'when you sleep on your arm and it goes to sleep; and when you start to move it, it starts to have the needle feeling.' Pt states unable to perform simple finger exercises at times during these episodes.
Shot administered ~ 11 AM Upper outer (L) thigh cried immediately. Parents called within 2 hrs (L) thigh red swollen warm to touch pt. still crying anytime thigh touched.