chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got one my lungs filled up with blood clots; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who states that i got one my lungs filled up with blood clots after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (formulation, strength, route, dosage, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization).  On an unknown date the patient developed serious event of i got one my lungs filled up with blood clots (pulmonary embolism) (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got one my lungs filled up with blood clots).  At time of reporting, the outcome was Unknown for the event i got one my lungs filled up with blood clots.  Seriousness Criteria : This event was assessed as medically significant. The patient was hospitalized for this event.; Sender's Comments: Sanofi Company Comment dated 23-Nov-2022: This case involves an unknown age and unknown gender of patient who states that i got one my lungs filled up with blood clots after receiving vaccine influenza vaccine. Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Minimal pain and soreness at the injection site; 10-12 inch rectangle area on stomach is tingly; 10-12 inch rectangle area on stomach is sensitive; small pink spot on the inside of her left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st November 2022, 1 days after receiving Shingrix, the patient experienced spot pigmented. On 2nd November 2022, the patient experienced tingling and irritable stomach. In 2022, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the spot pigmented, tingling and irritable stomach were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, spot pigmented, tingling and irritable stomach to be related to Shingrix.     Additional Information: GSK receipt date: 08-NOV-2022 Reporters comment: The reporter was patient. The patient received the first dose of shingrix in left arm and experienced minimal pain and soreness at the injection site,small pink spot on the inside of her left arm,10 to12 inch rectangle area of her upper left side of her stomach was tingly and sensitive that was felt 2 days. The patient reported that the rectangle area had no rash or discoloration. patient wants to know if this was from the shingrix vaccine and what should she do. The reporter did not consent to follow-up.
ADVERSE REACTIONS; This spontaneous report received from a consumer (company representative) via social media concerned two female patients of an unspecified race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received Covid-19 vaccine (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) frequency time 1 total, dose, therapy start date and therapy end 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, "two women died from adverse reactions after receiving Johnson and Johnson vaccine shot". It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine was not applicable. The patient died from adverse reactions. This report was serious (Death).; Sender's Comments: V0 20211017484-COVID-19 VACCINE-Adverse reactions. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ADVERSE REACTIONS
After 12 hours  of  receiving the vaccine I experienced chills, fever, headache, and body aches. The symptoms lasted for about 24 hours.
1/31/2022 BP sky rocketed from 120 to 166 (systolic) and because of that I was put on a blood pressure medication. I believe I first noticed my lip lesion was in May of 2022 I notice my lower lip had a oval , 1 cm, rough to the touch, 2nd one that developed shortly after was small like a raised pimple and it started turning while also and rough to the touch. On 8/25/2022 the first lesion was removed and sent to pathology with a positive result of deruquis cancer then the 2nd one was removed on 9/15/2022 and sent to pathology with a squamous cell cancer result. The last time I went to see the ENT 10/12/2022 for follow up and now he wants me to come in once a month due the aggressiveness of this type of cancer cell. If it does return the removal will be more radical. Last time I checked my blood pressure was 9/29/2022 137/68 taking losartan for blood pressure control.
Pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient) in a 31-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (outcome unknown). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 17-Feb-2021 and the estimated date of delivery was 02-Dec-2021. On 26-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 26-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
A few hours after I had chills and a really bad body ache. I could barely move without hurting. I couldn't go to work. I had a low grade fever. Tylenol helped. It was better after the second day. For the second dose the symptoms were similar. My arm is still sore.
Pt here for covid19 vaccine #2 (moderna) After receiving Moderna vaccine #2, pt reported experiencing throat irritation, raspy voice, and stated sx experienced were similar to sx of asthma flare up. Pt has hx of asthma; uses albuterol and a controller inh that she takes daily as directed.  Pt stated she used her controller inh today, but did no have her rescue inh with her.  18:03 - 159/93, 89, 93% RA Pt asked whether her throat may be dry and offered water. Pt stated water helped somewhat, but still experiencing throat irritation, feeling like it may close up and is causing her to forcibly  cough.  D/w Dr.  18:15 - Albuterol inh 4 puffs administered with spacer; tolerated well.  Pt monitored for an additional 30 min as precaution.  18:30 - pt stated she was starting to feel much better after Albuterol inh 18:33 - O2 sat 97% RA 18:45 - pt d/c'd in stable condition. VAERS report done.
Pt received high dose flu vaccine at OV on 1/29/16 at 1117am. Pt returned to health center at 440 pm with coughing and red eyes, Pt declined IM SOLU-MEDROL or epinephrine; administered albuterol nebulizer x 1 and 50 mg BENADRYL given; instructions give to seek emergent care if symptoms worsen.
I started feeling ill on June 24, 2022, I could not eat or drink anything. I called to get in to an urgent care but could not get in Monday June 27, 2022 the rapid COVID-19 test came back positive but the also did a PCR COVID-19 test. I got a call on Tuesday June 28, 2022 that confirmed that the rapid test was correct. I have a sore throat and coughing, fever, chills. I have been advised to take vitamin D, C, and zinc to help boost my immune system.
Approx. 5" x 4" swelling, redness and hard. Warm to touch and minor pain. Place cold pack on to reduce swelling. The evening of which seemed to help. Pt. came in Pharmacy 10-16-16 to show arm.
In early April, 1999, the pt received her first treatment with Lymerix at an unspecified dose for prophylaxis. Approximately two weeks later, she found out that she was pregnant. She became pregnant approximately late February or early March 1999, and her last menstrual period was mid to late February, 1999. The pt had an uncomplicated prenatal course. Because of failure to progress to labor and term, the child was delivered by cesarean section on 12/16/1999. The newborn was viable and had no anomalies during the newborn exam. At the childs 2 week check up it was doing quite well. There were no complications during pregnancy and no obvious anomalies to the newborn.
This initial spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on multiple unspecified date, the patients were administered improperly stored VARIVAX (Merck) injection (lot # L020000 with expiration date 02-JUN-2016, lot #L019126 with expiration date 27-MAY-2017, lot# L017142 with expiration date 13-MAY-2017 and lot # L015048 with expiration date 29-APR-2017; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
acute appendicitis; Erythema nodosum/ atypical erythema nodosum; This is a spontaneous report received from a contactable physician. An approximately 40-year-old (reported as middle-aged, 40 something year old) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 at single dose for COVID-19 immunisation at an unknown age. The patient medical history and concomitant medications were not reported. The patient experienced acute appendicitis in Apr2021 with outcome of recovered on an unspecified date in 2021, erythema nodosum/ atypical erythema nodosum in Apr2021 with outcome of recovered with sequelae on an unspecified date in 2021.  Clinical course: Caller was inquiring for their middle-aged, 40 something year old, female patient who received her 1st dose of the vaccine on 08Apr2021. About 24-48 hours she developed Erythema nodosum in Apr2021. About 2 weeks later, she developed acute appendicitis in Apr2021. They mentioned that the symptoms might have already been resolved but the erythema nodosum might have some remnants. They know that there have been reports of appendicitis and would like to know during which dose it specifically occurred and whether or not the patients received the 2nd dose. They would also know for any reports of erythema nodosum. Dermatology resident calling regarding the Pfizer COVID 19 vaccine. Reported he has a patient who developed atypical erythema nodosum. He was calling to report this event and would like to confirm if the patient should take dose two. Stated he was in the middle of a clinic and can't answer questions right now; he would like immediate transfer to ask his question. Seriousness not provided.   Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported appendicitis cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
fever 103.5; Chills; achy; has no energy; This is a spontaneous report from a contactable consumer (patient's wife). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), intramuscular (right deltoid) on 30Dec2020 0900, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has been in bed since 30Dec2020. The patient was achy, has no energy, and has chills on 30Dec2020. Patient also has a fever with temperature of 103.5 on 31Dec2020. Reporter asked if this was normal. Event outcome for achy and chills was recovered on 31Dec2020, not recovered for has no energy and unknown for fever 103.5.
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 02-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
85 Y female, longstanding tobacco use (0.5 pack per week),  with PMHx significant for HTN, HLD, emphysema (PFTs 2009, moderate obstruction), IgG kappa myeloma (dx 12/2010,  currently on Ninarlo) c/b severe peripheral neuropathy (from prior velcade use), vaccinated for COVID-19 3/27/2021 (J&J), who presents with 2-3 days of worsening fatigue and cough, admitted 8/2/21 with sepsis 2/2 COVID Pneumonia +/- COPD Exacerbation.    ACUTE HYPOXEMIC RESPIRATORY FAILURE SEPSIS COVID PNEUMONIA, COPD Pt presented with acute hypoxemic respiratory failure (86% on RA requiring 4LPM NC). Given her hx of COPD, with faint wheezes on exam, she was given Duonebs, solumedrol 125mg IV x 1, azithro, cefepime, and vancomycin in the ED. Started on remdesivir and continued on daily steroids. CTA negative for PE, CT chest on 8/2 noted with subpleural nodule, emphysematous changes, RUL interstitial opacities. Imaging reviewed by panel, recommended repeat CT chest in 6-8 weeks. Continued on supplemental oxygen, remdesivir, and steroids until discharge. By 8/5, she improved clinically, requiring no oxygen, road test demonstrated good saturation on RA. Inflammatory markers down-trending, blood cultures were no growth, clinically improved.    MULTIPLE MYELOMA PERIPHERAL NEUROPATHY H/o IgG kappa myeloma (dx 12/2010, currently on Ninlaro), she receives 16mg Decadron every Saturday. Also with Acyclovir 400mg BID for prophylaxis on Ninlaro. Given current acute COVID infection, will continue 10 day course of steroids but hold her Saturday Decadron and next Ninlaro dose until her acute illness has resolved.    Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  CORONAVIRUS COVID-19 PNEUMONIA
Pt's skin on left upper arm with erythema, warmth, inflammation and vesicles. The area is 3/4 circumflexed around his arm. There is some mild (L) axillary adenopathy. The right arm with small area of 2.3cm in diameter of erythema, mild inflammation but no vesicles. FU recv'd from allergy consultation 11/27/01 states diagnosis of delayed type hypersensitivity reaction to vaccination.
Rash from my injection site and extending to the back of my left shoulder, across my chest, and up the right side of my neck.
After administration of the COVID-19 vaccine, patient began to have redness, itching of arm/chest/neck at 0910.  At 0930, patient  had tightness of chest and throat was scratchy.  At 1015, patient administered benadryl 25 mg.  At 1115, patient stated all symptoms resolved.  Patient instructed to follow up with physician in regards to 2nd dose of COVID-19 vaccine due in 17-21 days.
pt recvd vax;mom reports lt arm swollen;inject site bruised & red;denies induration;states "it's not hot to touch";mom instructed to f/u w/ PCP for eval for reaction
This case was reported by a healthcare professional via a distributor and described the occurrence of flu-like symptoms in a female subject aged between 30 and 39 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (0.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced flu-like symptoms, red and swollen arm. Medical attention was not required. At the time of reporting the outcome of the events was unspecified. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887614A, A0887616A, A0887618A, A0887619A, and A0887620A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial. Follow-up information was received on 29 October 2010. It was reported that the subject was 76 years old and that the subject received FLULAVAL on 01 October 2010. She reported flu-like symptoms on 06 October 2010. The event resolved.
Soreness at the site of shot for the next couple of hours.  Early the next morning my daughter was sleep walking and I heard her scream and I got out of bed and the pain in my right arm and shoulder was so severe that I urinated on myself (which I have never done before due to pain from Fibromyalgia.)  I started walking toward the stairs where she was and was in such pain that I couldn't concentrate and focus and ended up falling down the stairs, hitting my head and back.  The next morning, I could barely move my right arm and was in excruciating pain in my right shoulder, which radiated down my right arm to the fingers of my right arm at times and into my neck.  My normal headaches would increase into migraines more often than they normally would.  The pain has continued to increase and now is in my bicep and tricep and down in my trapezoid and makes it very difficult for me to fall asleep at night and often wakes me up at night.  I am currently receiving treatment for Fibromyalgia which included physical therapy, which was slowly decreasing my pain level from about a 5 out of 10 (10 being worst pain) and the whole upper right side of my body is a constant 8 or 9 out of 10 (10 being worst pain) while continuing with physical therapy.)  I got an MRI after the injection on 1/18/12, which showed tendonitis, and the beginning of frozen shoulder syndrome.  I was used to having sore neck and shoulder muscles due to fibromyalgia, but this was/is different and continues to get worse.  I received a cortisone injection, which helped someone else move my arm a little, but I still cannot move my right arm more than the circumference of my elbow.  My dexterity of my right hand and fingers is better but that is about it.  I'm terrified that the pain is going to get worse and that my range of motion will never return to normal.
Information has been received from a nurse practitioner concerning a 65 year old female with allergies to DEMEROL, codeine, and "DARVIN", and a history of celiac disease who in 1992, received a first and second dose, and in 1993, received a third dose of RECOMBIVAX HB (specific dates not reported).  It was indicated that after the first two doses in 1992 (specific dates not reported) of RECOMBIVAX HB her feet swelled.  After the third dose in 1993 (specific dates not reported), it was indicated that all of her joints swelled and the reaction lasted for 8 months.  The nurse practitioner indicated that the patient was monitored by her health care provider, but no treatment was reported.  On unspecified dates, she recovered from the events.  A product quality complaint was not reported.  Other medical events included: Celiac disease (diagnosed after the vaccine events (date not reported); also reported as medical history).  Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a 4 month old male patient. No pertinent medical hisotry or drug reactions/allergies were provided. The nurse reported that, on 27-AUG-2014, a baby received a dose of PNEUMOVAX 23, 0.5 ml, intramuscular, at too young an age. No adverse effects were reported. Additional information is not expected because there was no consent to follow up.
Sore arm of injection; Sore around shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm of injection) and ARTHRALGIA (Sore around shoulder blade) 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 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm of injection) and ARTHRALGIA (Sore around shoulder blade). At the time of the report, PAIN IN EXTREMITY (Sore arm of injection) and ARTHRALGIA (Sore around shoulder blade) outcome was unknown.            The concomitant medications were not provided. The treatment information was not provided.
Next day post vax, the pt developed an injection site reaction characterized by redness, warmth, and a large hive. The pt recovered. This is one of eight pts from this facility who had an adverse experience following receipt of vax.