chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COLITIS      "I'm having a colitis flare up" Symtoms started friday ? Nausea, Vomiting, Diarrhea     Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 33y.o. female with PMH significant for IBD, endometriosis, asthma, and prior DVT not on anticoagulation who presented to the hospital for 5-day history of abdominal pain with diarrhea, nausea, and vomiting. Patient is a poor historian, and history was corroborated with chart review.  Patient was recently at Hospital from 1/20?1/24 for abdominal pain with nausea and vomiting.  At that time she was found to be Covid positive and constipated.  Her symptoms improved with bowel regimen where she was given MiraLAX and Colace.  She states that on discharge she was feeling well until 1/28 when she developed diarrhea followed by abdominal pain.  She describes the abdominal pain as generalized and constant.  Nothing makes it better or worse.  She states that she has had multiple loose bowel movements since Friday and is unable to enumerate how many.  Has had 3 episodes of emesis since Friday as well which she relates to her abdominal pain.  Patient states that this feels more severe than her prior UC flares.  Does note that she gets nauseous from her abdominal pain which then leads to emesis.  Has not had any recent travel anywhere.  Does note that her mom who she lives with also started experiencing diarrhea yesterday.  Denies any fevers or chills.  Most of her diet consists of outside food, she states that she ate chicken the night before she felt ill.  Patient is maintained on mesalamine for her UC, however does not routinely follow with a gastroenterologist.  Her last colonoscopy was in 2018 which demonstrated proctosigmoid UC.  She has previously required a partial colectomy due to both her UC and endometriosis.  Patient denies any melena or hematochezia.  Patient states that she was given an antibiotic while she was at Hospital, however upon chart review no records found.  She is unable to state where she was given.  Patient has routinely good appetite and is able to eat and drink, however states that 30 minutes after she eats she has to have a bowel movement and vomits.  Patient without fevers, chills, chest pain, shortness of breath.   Patient has had an extensive surgical history due to her endometriosis and ulcerative colitis.  Previously patient received a hysterectomy with a right salpingectomy and excision of bladder endometriosis.    Patient currently smokes 2-3 black mild cigars daily, and has had a 10-pack-year smoking history prior.  Denies any alcohol or recreational drug use.  Currently lives at home with her mom.  No pets.   Vitals on presentation to ED: 104/60, 92 HR, 16 RR, 98.1 F, 100%  SpO2 on RA.  EKG showing NSR.  CT abdomen pelvis showing circumferential wall thickening of the rectum with perirectal inflammatory changes.  Patient given 1 L normal saline, ketamine, Protonix, Compazine, and Benadryl.  She did receive fentanyl 25 mcg for pain.  GI consulted.
The pain I?m experiencing is throbbing joint pain in the following areas of my body:  pain in my right knee pain in my right hip pain in my left ring finger  I did not experience this until after I received the J&J vaccine
2 patients received a  0.6 ml was administered instead of 0.3ml of the Pfizer Covid vaccine; This is a spontaneous report from a contactable pharmacist. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3181; Expiration Date: Oct2021), first dose via an unspecified route of administration on left side on an unspecified date in 2021, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that caller stated 2 patients received a 0.6 ml was administered instead of 0.3ml of the Pfizer Covid vaccine. 2 patients were involved one 49 years old male and the other 16 years old male, both were given the Pfizer Covid vaccine inadvertently today. Caller was looking and wanting guidance on how to proceed. Lot number FC3181. The outcome of the event was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Overdose and the administration of the vaccine cannot be excluded.
High blood pressure, tachycardia,  difficulty breathing air, mental confusion, dizziness, nausea, asthenia, numbness arms hands and legs, couldn't move arms, flushing facial on neck and arms, hyporexia.. applied hydrocortisone and medication to reduce blood pressure.. I was hospitalized for 3 hours and they sent me home.. reoccurance 12 hours later but with greater intensity and I was hospitalized again.. I am the patient and I am a medical doctor..
got very very sick; had a hard time with the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very very sick) and DISCOMFORT (had a hard time with the second dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced ILLNESS (got very very sick) and DISCOMFORT (had a hard time with the second dose). At the time of the report, ILLNESS (got very very sick) and DISCOMFORT (had a hard time with the second dose) outcome was unknown. Not Provided          No concomitant medication information provided.  NO treatment information provided.
At approximately 5:15 AM patient found to have temperature of 38.6 degrees C and with supraventricular tachycardia (HR 134-140- documented with EKG). Patient sent to local hospital emergency room via ambulance. (Note prior to event- patient was being for possible UTI with Macrobid and had had low grade fever on and off. The day of the vaccine 12/29/20- patient reported feeling better and desired to proceed with vaccine). Emergency room evaluation revealed clear CXR, normal WBC.   Patient was sent back to facility on 12/30/20 from the Emergency room with recommendation to continue antibiotic for possible urinary tract infection. Patient seen 12/31/20 AM and reports feeling improved.  Temperature at 7AM 12/31/20- 38.3 degrees C, HR 90, BP 124/82. Patient denies shortness of breath or cough. No headache. Patient reports mild tenderness to left upper arm at injection site. No swelling or redness to area noted. Of note urine culture sent on 12/28/20- final result reported 12/30/20- no growth.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 12:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:25 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 67.28.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM temperature was 34 and 37 respectively, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  Vial was stored on cooler 1, on 20-Mar-2021, Excursion duration At 9 AM: 34, 10 AM: 30, 11 AM: 41,  12 AM: 45, 1PM: 44, 2 PM : 44, 3 PM: 44, 4 PM: 44 and 5 PM : 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received form a physician concerning a five-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
Rash that was extremely itchy; flu like symptoms; aching; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 26th September and experienced pain, flu like symptoms, refer case US2019183593).   On 26th September 2019, the patient received the 2nd dose of Shingrix. On 26th September 2019, 20 hrs after receiving Shingrix, the patient experienced influenza-like symptoms and pain. On 1st October 2019, the patient experienced itchy rash. The patient was treated with fexofenadine hydrochloride (Allegra). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms and pain were recovered/resolved and the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain and itchy rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. Approximately 20 hours after receiving Shingrix, the patient experienced aching and flu like symptoms. These symptoms lasted for 24 hours. The patient developed a rash 5 days after receiving the 2nd dose of Shingrix. It was reported that, the rash started on both sides of the chest and spread to the left upper arm and both wrists. The rash was extremely itchy. The patient received Allegra for rash. The reporter consented to follow up.
Fast heart rate, tiredness, headache, loss of appetite. No medical attn sought. Last seen at Dr office on 2/21/18.
Patient states he has had radiating pain from his LUE  at the vaccine site & shoulder area up around his neck since his second shot. His first dose was given in his RUE.  The primary area of pain is his left shoulder.
The day following the vaccine, my arm was very tender at the injection site and I started feeling like I was getting sick.  The second day after the injection, I continued to feel like I was getting sick (sore throat, congestion, and fatigue).  I remembered dreaming that night, while sleeping, that my heart was racing (I'd never had a dream like that before and didn't think much of it).  By the fourth day following, I felt like I was having a severe panic attack as my heart was racing, my chest hurt, I was on the verge of crying all day, and there was no way to resolve any of it.  On the fifth day, my heart has continued to race (140 bpm on average), my chest continues to hurt, my lungs hurt, my stomach hurts, and I have no appetite.
After administration of FLUZONE vaccine, patient developed a hard lump. Patient was concerned so I gave her an ice pack to apply to arm where shot was administered. Lump did not go down so I gave her BENADRYL by mouth. Lump decreased in size a little. After 20-25 minutes, the patient said she felt fine except site of injection was still a little swollen and sore. Patient left store with her mom.
Patient spouse reports to me the following: patient felt normal most of the day, later in the evening he felt extreme fatigue went to bed around 9pm.  She found him deceased around 2am.
Stayed home with fever and body aches first day. Second day radiating pain in arm, back, left shoulder, arm pit and under rib cage. Itching and could not sleep. Can touch, turn or sleep on her left side.
Normal symptoms, the adverse symptom I'm experiencing is an extremely intense sharp pain in my left chest, it happens about 3 times a minute, and only lasts maybe a quarter of a second, but it has been happening since I woke up a couple of hours ago, and hasn't seemed to even become less frequent at all. It is extremely painful as it happens, but since it lasts so briefly each time it's bearable, if it were to happen for longer than it would actually be unbearable.
Approximately 10 hours post vax the pt experienced severe headache, nausea and chills. She took extra strength Tylenol and was then see in the ER. The pt thought she had a cranial bleed. CT-scan was normal. The most recent information received reports the condition of the pt is resolved.
This was my booster shot.  I noticed a severe increase in tinnitus, before the vaccines i had a very slight ringing in the ears.   After the booster it increased significantly.
Shortness of breath Turning blue and  passing out extreme fatigue Feeling of throat closing Extreme hot and cold Extreme soreness
It started in my right thumb in the joint it started swelling and I could bend it. The pad part of my hand was very tender.  My doctor said that it may be trigger thumb caused by Tendonitis.  About two weeks ago I began to have the same pain in the left hand and the same symptoms. I was offer the same treatment but I didn't take it because the first shot hurt so bad. The doctor said that if it is unusual to have the same thing in both hands. He don't think it is related to the Pfizer vaccine but I do. (Participant) I am still having trouble with both hands hurting.
1545 - Patient reported hx of hospitalization after TDaP as a child during screening. Consulted w/ NP and PA on site. Given 1st Pfizer dose (lot #EW0217) to RD. Asked to wait 30 minutes for observation. 1600 - Patient reported 5/10 mid-sternal "chest heaviness". No other symptoms. HR feels regular and in 60s. BP 134/83 and HR 65 on over-the-counter BP monitor on-site. No cardiac history. History of anxiety w/ and w/o panic attacks, but patient reports this is well-controlled and today's symptoms are not consistent with this history. Patient does not want ambulance called, but staff explained that our medical obligation is to call 911 for life-threatening symptoms such as chest pain/tightness/pressure/heaviness. 1605 - Provider on-site called 911. 1615 - Ambulance arrived. HR with SR 60, BP 133/84, and SpO2 99% on their monitor, but EKG print-out has "concerning areas" that warrant evaluation by a hospital given its unclear if they were pre-existing or new and further evaluation is outside ambulance scope. Patient declined transport to a hospital, however, due to financial concerns after having lost his medical insurance when he turned 26 last month. Patient said "I'd rather die than face those medical bills" and "I truly don't care if I die".  1625 - Ambulance and on-site vaccine staff all repeated hospital transfer recommendation. Patient declined again. Ambulance left. 1635 - Given resources for, Marketplace, and several Portland-area low-income, sliding scale medical offices. Additionally recommended messaging his PCP to discuss whether 2nd Pfizer dose is advised, because messaging can still occur at no cost without health insurance. 1645 - Patient escorted to car by staff for continued observation. No change to 5/10 "chest heaviness". Otherwise stable. Patient left in vehicle.
I was vaccinated on Monday August 23, started having shortness of breath midday on Thursday, heart palpitations midday on Friday, and midday Sunday I went to the ER for chest pains, dizziness, nausea, and shortness of breath. Chest xrays came back clean, EKG was normal, bloodwork was normal except for low potassium (3.1) and DDIMER at 657. Doctor ordered a CT scan which showed two small clots in my right lung. Diagnosed with accute pulmonary embolism with unspecified cause. Sent home after 3 hours with Apixaban 5mg (two pills twice daily for the first week) and told to follow up with PCP and Hematology clinic within 10 days.
Following my second shot & booster shot I became very ill with the following symptoms. (Fever, body aches, chills, & extreme fatigue). All shots were done in the morning and onset of symptoms came in the evening and lasted for the entire following day. A little over a week after receiving my booster I began to experience irritated skin. It started in the middle of the night on my scalp keeping me up having to itch it relentlessly. It then moved to my back and entire body. It was a very irritating itch then progressively got worse. Areas on my body would itch and as I scratched them I would begin to swell/redness & develop hives. I finally went to an urgent care on 11/16/21 where they treated me with a steroid shot & steroids/Benadryl to take. The shot helped ease the itching however I was not able to get the prescription started before the shot wore off. Itching & shortness of breath had come on quick as the shot wore off. Luckily I was able to get the medicine stated as symptoms came back.
This case was reported by a healthcare professional and described the occurrence of unspecified event in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (unknown0.  At an unspecified time after vaccination with Flulaval, the subject experienced unspecified event.  The reporter declined to provide any other information.  At the time of reporting the outcome of the event was unspecified.
Developed two symmetrical indentations across both calves. Have seen 4 different specialists, none have found cause or cure.
pt recvd immun on 29JUN93; 30JUN93 @ 130-2PM the following sx nausea, w/o vomiting, lack of appetite, very lethargic, aching muscles, dec temp to 101.6, no diarrhea; 1JUL93 @ 7AM none of the sx were present; inject site was warm-hard to tou
Hematomas on the leg; Blood blisters that run down her legs; Rash all over her body which bleeds; Bad rash all over her body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATOMA (Hematomas on the leg), BLOOD BLISTER (Blood blisters that run down her legs), SKIN HAEMORRHAGE (Rash all over her body which bleeds) and RASH (Bad rash all over her body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced SKIN HAEMORRHAGE (Rash all over her body which bleeds) and RASH (Bad rash all over her body). On an unknown date, the patient experienced HAEMATOMA (Hematomas on the leg) and BLOOD BLISTER (Blood blisters that run down her legs). At the time of the report, HAEMATOMA (Hematomas on the leg), BLOOD BLISTER (Blood blisters that run down her legs), SKIN HAEMORRHAGE (Rash all over her body which bleeds) and RASH (Bad rash all over her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products are being used as per the reporter. Treatment for the events included betamethasone cream and a pill she was prescribed by her doctor, that has already run out, and she couldn't remember the name.
Patient stated that he had received the Pfizer vaccine previously but upon examination he had actually gotten the Moderna for the first dose.   He did not present his vaccine record card at time of administration.
After vaccination patient felt dizzy and then began to continuously vomit. Patient wanted to sit for a little but symptoms continued, and paramedics were called.
Pt recvd Hep B vax in 1987 & exp an inc bilirubin that was sx as Gilbert's synd;
On Day 4 post vaccine I started getting heaving slime drainage in the back of my throat causing gagging and choking,  Day 5 post vaccine I have extreme fatigue, headaches, nausea, severe stomach cramping and muscle pain and on Day 12, I am still experiencing symptoms which affect my ADLs.  At the advice of the Nurse Line I went to the ER on Day 10, which resulted in symptoms consistent with bilateral fluid in ears, sinus drainage, severe stomach cramping, nausea, and extreme fatigue. Zofran was given, mucinex, and diagnosis of Lymes - which later test was negative.  No definitive Diagnosis at this time.