chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced more bleeding than usual.; 2nd dose of vaccine was administered 21 days after first dose; Excessive sweat; Sneezing; Runny nose; Back pain around the kidney area; Joint pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Experienced more bleeding than usual.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003RB1A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hemorrhage. Concurrent medical conditions included Anemia.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced HAEMORRHAGE (Experienced more bleeding than usual.) (seriousness criterion medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine was administered 21 days after first dose), HYPERHIDROSIS (Excessive sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), BACK PAIN (Back pain around the kidney area), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue). The patient was treated with NORETHINDRONE ACETATE for Hemorrhage, at an unspecified dose and frequency; CARVEDILOL at an unspecified dose and frequency; SPIRONOLACTONE at an unspecified dose and frequency and ERGOCALCIFEROL at an unspecified dose and frequency. On 05-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine was administered 21 days after first dose) had resolved. At the time of the report, HAEMORRHAGE (Experienced more bleeding than usual.), HYPERHIDROSIS (Excessive sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), BACK PAIN (Back pain around the kidney area), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue) outcome was unknown.            There was no concomitant medication reported. Patient was treated with zitrone C  for unknown indication.  Very limited information regarding this event (hemorrhage) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the all other events, a causal relationship cannot be excluded.  This report also refers to a case of (Inappropriate schedule of product administration) for mRNA-1273, lot # 003RB1A with no associated AEs. Details regarding the type of hemorrhage is required for further assessment.; Sender's Comments: Very limited information regarding this event (hemorrhage) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the all other events, a causal relationship cannot be excluded.  This report also refers to a case of (Inappropriate schedule of product administration) for mRNA-1273, lot # 003RB1A with no associated AEs. Details regarding the type of hemorrhage is required for further assessment.
Information has been received from a registered nurse concerning a 9 year old female with no allergies or medical history who on 01-DEC-1998 was vaccinated SC with a 0.5 mL dose of Varivax (lot # "613881/1257A"). There was no concomitant medication. On 22-JAN-2007, the patient had approximately 30 lesions and a low grade fever. It was noted that the patient had break through varicella. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. It was also reported that the patient's brother had a similar experience after therapy with Varivax (WAES # 0701USA04042).
Pt reports having a baseball-sized bruise appear approx 2 days after given 2 shots in the left arm. Became hard to the touch and intermittent deep pain during the day. Was hard for several days, and is deep blue/black in appearance.
I have been as sick as I was with covid; I have been as sick as I was with covid; I am having adverse effects after my first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I have been as sick as I was with covid), COVID-19 (I have been as sick as I was with covid) and IMMUNISATION REACTION (I am having adverse effects after my first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 ILLNESS (I have been as sick as I was with covid), COVID-19 (I have been as sick as I was with covid) and IMMUNISATION REACTION (I am having adverse effects after my first dose). At the time of the report, ILLNESS (I have been as sick as I was with covid), COVID-19 (I have been as sick as I was with covid) and IMMUNISATION REACTION (I am having adverse effects after my first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
States she started having spotting the day after her 1st moderna vaccine and it continued for 10 more days. She stated that she has not had a period in several years. She states her gynecologist will see her at her regularly scheduled next appointment.
pt after receiving vaccine, felt tight chest, difficulty breathing. 25mg Benadryl po. pt hypertensive 160/100.  pt remained hypertensive and with chest tightness and CP. EMS called. EKG done. EMS found no need to go to ER at this time. Pt remained in observation then d/c home with friend.
Patient was given the influenza vaccine in right arm. She  leaned over after being given the shot so I asked if she was ok. She said that she was lightheaded, and that she thought the vaccine might have gone into a nerve. She said that she has never passed out after receiving a vaccine, but that she did when giving blood. She was given water and she continued to keep her head on her knees. She then dropped the water and slumped. I caught her and her husband helped keep her from falling out of the chair. She woke up and took about 10 minutes before we helped her to lie down on a bench  for about 5-10 minutes after which she felt better and color returned to her face and she was able to continue with her shopping.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot# reported as L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Felt feverish, extremely tired, legs ached, stomach ached, legs ached, very thirsty.  Throat felt raw, skin felt very dry. Not hungry at all. Later in the week, diarhea, one 1/2 day. Really took 3 weeks before I felt like myself. I usually have a good amount of energy, but had to rest a few times a day.
Extreme muscle tightness in chest and neck.  swollen glands, muscle tightness in arms and hands.  Sinus attack like symptoms, runny nose, sore throat, and post nasal drainage that is yellow.  Chest congestion. fever, and chills
Day 1: Woke up at 5:30 am achy and tired. Hungry. Obtained food. Was going okay. Arm was expectedly sore. A couple hours later chills set in, aching, joint pain, and fatigue increased. Occasionally had a running nose, pain in abdomen when bending over like knife being drawn in a line across my hips. by 4:00 pm, so achy, tired, and nauseous. Terrible chills, followed by occasional hot flashes. No fever anytime it was taken. Could not do more than lay on floor and turn a quart of the way over. By 8:00 pm, symptoms start to ease. Am able to walk again. Back to chills/hot flashes, aches, joint pain, fatigue, runny nose, and shortness of breath. Day 2: Wake at 6 am feeling achy like my whole body had been tensed for a day, was awake off and on during the night with hot flashes/chills and body pain. Went through the day achy and fatigued, with no temperature control. Started feeling worse around 5 pm, but tolerable. Still short of breath. Day 3: Wake at 3:50 am with horrible aching in lymph nodes from armpits up through neck. Still rapidly rotating from chills to hot flashes. Do not sleep until 6 am. Get up at 7:30. Go through day mostly fatigued and a little achy. Had chills/hot flashes till approximately 11 am. Around 2 am aching in neck started to set in and increased throughout evening to the time of this report. Neck is so still and sore I can barely turn my head.
Patient lost consciousness,  EpiPen was administered, and 911 was called. EMT came and checked vitals
Dose 1 Pfizer 03/11/2021 Lot EN6208  Pt currently has covid 19 8/18/2021
Rebound infection after Paxlovid; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Rebound infection after Paxlovid) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Rebound infection after Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 30-Apr-2022 to 05-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound infection after Paxlovid) was resolving.            No concomitant medication information was reported.  The device date was reported as 11-May-2022.  Company Comment: This is a spontaneous case concerning  a patient of unknown age and gender with no reported medical history, who experienced the unexpected AESI non-serious event of Covid-19. The event occurred on an unknown date after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on an unknown date. Patient was treated with Nirmatrelvir/ritonavir at an unspecified dose and frequency. The event were reported as resolving at time of event. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a patient of unknown age and gender with no reported medical history, who experienced the unexpected AESI non-serious event of Covid-19. The event occurred on an unknown date after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on an unknown date. Patient was treated with Nirmatrelvir/ritonavir at an unspecified dose and frequency. The event were reported as resolving at time of event. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (inflamed all over body from psoriasis/psoriasis symptoms worsened) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.      No concomitant drug information was provided.  Moderna daily dose was reported as one in once.    The reporter's causality with Skyrizi for the events of Humira did not stop the spread after six years of taking it, inflamed all over body from psoriasis/psoriasis symptoms worsened and symptoms of psoriasis affected ability to work and perform daily activities was not provided.   It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2022: Follow-up received, added patient medical history, co-suspect drug, new events and updated narrative.
I got severe chills (tremors) first that lasted a good 10-15 minutes first.  Later that day I got a fever and chills continued off and on throughout the day. I also had body aches and a headache.  My left arm was also very sore. All symptoms went away on the third day except for the soreness in my arm. That lasted about four days from the time I got the shot.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR, start date: Mar2008, stop date: 03Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Rebound 5 days after completion of last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was treated with Paxlovid from 04Jul2022 to 08Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arrived to the emergency department via EMS and was in respiratory distress, initial ABG showed a pCO2 of 88, admitted to the ICU for acute hypoxemic respiratory failure, found to have COVID-19 and COVID pneumonia. Tx w/remdesivir, abx, steroids, O2, zinc. Discharged to SNF on O2.
Breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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, reaction(s): "lymph nodes swelled in her arm pit". The following information was reported: BREAST CANCER (medically significant) with onset Sep2022, outcome "unknown".  Clinical information: While reporting on her son, the caller mentioned that she has cancer. She stated that she also had the the same Pfizer Covid-19 Vaccine. Her cancer was diagnosed after her Pfizer doses and she believes that the vaccine showed them that she had cancer. She thinks the vaccine sped up her cancer. After her first vaccination, her lymph nodes swelled in her arm pit. She did not want to get a second dose, but was getting a new job and did not want to lie on the application so she got fully vaccinated. She was diagnosed with a very aggressive breast cancer in Sep2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201374752 Same product, patient, different AEs, different dose;
Very itchy; Fiery red; Pink most of the week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pink most of the week), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Fiery red) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink most of the week). On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Fiery red). At the time of the report, VACCINATION SITE DISCOLOURATION (Pink most of the week) outcome was unknown and VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Fiery red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient said lips, tongue, and nose began to tingle about 10 minutes after injection. After 40 minutes patient had no change and left.
Information has been received from a physician's assistant concerning a 14-year-old female who was vaccinated SC with a 0.5mL dose of Varivax. In approximately 2005 the patient developed a rash and was diagnosed with shingles. Unspecified medical attention was sought. Subsequently, in approximately 2005, the patient recovered. There was no product quality complaint. No additional information is expected.
Pt received Hep A vaccine on 8/25/09.  Mother reported generalized red itchy rash first noticied 8/25/09 in the evening, and swollen eyes 8/26/09 in AM.  Pt stated rash was itchy.  Denies any other symptoms.
Fever; skin lesion- Information has been received from a physician concerning a her 15 month old son who on 14 Mar 2000 was vaccinated with one dose of varicella virus vaccine live lot 631467 /16823.  On 21 Mar 2000 the patient experienced a fever of 104-105 degrees F and an eruption of 25 pimple-like lesions on the anterior trunkal area and on the back of the arms.  The reporter indicated this was the sickest she had seen her child.  There was no exposure to natual chickenpox.  The pediatrician indicated the patient was healthy with no known problems, meeting all developmental milestones and up to date with his vaccination.  He was not on any steroids.  Medical attention was sought.  No further information is available.
Swollen L arm where it was injected, warm to the touch, red golfball sized mark where injected, very swollen lymph node under left armpit, low grade fever (99.3), migraine (started last night around 8 and ongoing) with no relief from my medication), mental fog (trouble processing/comprehending information or my thoughts to express), no sleep last night,. I can not touch my left arm from my shoulder to elbow without pain and I can?t lay on it/provide pressure at all.
Date and time of symptom onset: 12/17/20 at 4:15 PM Symptoms: 12/17 during 30 minute observation window, patient reports the following symptoms:  felt dizzy, heart palpitations, shortness of breath and difficulty breathing.  Patient reports, ?I didn?t tell anyone because I didn?t know who the monitors were.  I tried to get eye contact with someone, but I wasn?t able to.  I didn?t want to stand up because I was afraid I would pass out and would be really embarrassed for causing a scene.?  Patient was tearful on phone when describing account.  Patient verbalized concerns with being unable to determine who was assigned to be monitoring employees after vaccination administration.  Patient reports she did not notify anyone of her symptoms/what she experienced and remained at designated ?monitoring? location for 40 minutes before she drove home.  Patient endorses, ?I probably shouldn?t have driven, but I did anyway.?  Patient reports she struggles with anxiety and wondered if what she was feeling was a result of hx of anxiety.  Patient reports resolution of SOB approx. 1 hour she got home.   Patient endorses hx of ADHD, depression, thyroid issues and hypoglycemia.  Patient reports compliance of prescribed medications.  Patient reports the following timeline for symptoms listed: Dizziness:  Patient reports continued intermittent dizziness (denied at time of call) and feelings of ?cloudiness/spaciness?, currently experiencing today Headache:  began with severe headache on night of 12/17 and continued with headaches, pt denies headaches today (12/23).  Patient with hx of migraines Heart palpitations:  continued with heart palpitations through evening of 12/17, intermittent palpitations on 12/18 and 12/19, denies palpitations today. Fever:  low-grade fever on 12/17 (pm) and 12/21 (am), denies fever since 12/21 and has not taken antipyretics since 12/21 at approx. 9:30 pm. At time of call:  Patient endorses continued ?cloudiness and feeling spacy.?  Patient reports feelings of fatigue.  Last day of work and shift: 12/23, working from home  Home remedies: Rotated Tylenol and motrin, last dose of motrin at 9:30 PM on 12/21  Patient scheduled PTO on 12/18 and 12/21 due to concerns of not feeling well after vaccine.
Pt recvd vax & c/o extreme burning/stinging sensation during & immed p/inject;
On the evening of the vaccine day, recipient woke up with Fever, Chills, Body aches, and Fatigue. Called off of work.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Date the vial was initially stored in the refrigerator was unknown. The vial didn't undergo any temperature excursions. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant follow up received
Patient is past the 35 day mark from the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is past the 35 day mark from the first dose) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is past the 35 day mark from the first dose). On 09-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Patient is past the 35 day mark from the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided