chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient felt faint and dizzy after receiving first dose of Pfizer vaccine.  EMS treated the patient and extended their observation time to 30 mins.
Diarrhea; Patient was administered only the liquid portion of the vaccine; Inappropriate dose of vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix. On 22nd October 2019, less than a day after receiving Shingrix, the patient experienced diarrhea, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the diarrhea, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional case details were reported as follows: The patient was administered only the liquid portion of the vaccine, which led to drug reconstitution and inappropriate dose of vaccine administered. The patient experienced diarrhea later that evening.  This case has been linked with case US2019193758, reported by the same reporter.
Elevated blood pressure 161/90, dizziness, paleness, slight swelling of throat, burning, returned to doctor's office for observation.
Patient says she developed swelling and a rash at about 7 PM the day of vaccine. The next day it started to itch all around the area. She applied ice and took Benadryl.
Redness of face, cheek, ears (red hot), Upper chest/neck and back was red and blotchy Took Benadryl at 8pm and then 4hr later took a second dose with resolution of symptoms States her eczema on hands which continues to increase a week later when this was in remission for a long time
Pt began to experience blood in urine day after vaccination. Continues to occur intermittently with urination since that time. Occ has blood spotting in underwear. No pain with urination. No other complaints.
Swelling of shoulder/neck. Trouble breathing. Rash that forms when swelling and breathing get worse. Red rash usually covers neck, shoulders and chest and is accompanied by bumps on the shoulder and down the arm. This has been occurring since I got my first and second shots. I have been to the emergency room multiple occasions when my symptoms and breathing got really bad. I was continually told that it wasn't anything to worry about and to go home and take Benadryl.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided. Vaccine refrigeration date was 07-May-2021.
headache; This is a spontaneous report from a contactable physician (patient). An adult female patient received the first dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose and almost immediately experienced head, ears and headache (as reported).  She followed up with her health care provider and wanted her to take Medrol dose pack and ibuprofen. The patient was looking for the duration and reporting information following each dose, specifically headaches. The patient asked for contraindications or recommendations for the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Immediately following vax, the pt experienced immediate swelling surrounded by small blisters. MD diagnosed as a local reaction. Ice pack applied to injection site. Blood pressure and pulse monitored for 15 minutes, both remained stable. Pt denied symptoms of pain or itching. No respiratory distress observed.
mom called-stated pt had been screaming all noc; could hear pt crying/screaming in the background; pt also teething by hx of mom
got really sick; discomfort in stomach; little bit sore; Feverish; Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got really sick), ABDOMINAL DISCOMFORT (discomfort in stomach), MYALGIA (little bit sore), PYREXIA (Feverish) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION COMPLICATION (got really sick), ABDOMINAL DISCOMFORT (discomfort in stomach), MYALGIA (little bit sore), PYREXIA (Feverish), FATIGUE (Fatigue) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (got really sick), ABDOMINAL DISCOMFORT (discomfort in stomach), MYALGIA (little bit sore), PYREXIA (Feverish) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
3 days p/vax noticed inject arm to be reddened fr shoulder to elbow & a 4-5 in hot hand area around inject site; very uncomfortable; taking meds; seen by MD; dx as moderate rxn to Td;
Moderna COVID-19 vaccine was drawn up and administered 5 days after the use by date.
Patient started with symptoms on Friday 8/6/21. They decided to test him on Tues 8/10/21 and he came back positive on Wed 8/11/21. Patient has a history of COPD, CHF, Diabetes, Prostate Cancer, CVA. He started with SOB, cough, loss of taste and smell and now is very fatigued, has a loss of appetite and has low O2 saturation. Employee of clinic denied that he has any stomach concerns (no vomiting or diarrhea). His O2 sat has been in the high 70's and they are concerned about him. They may look into if he has pneumonia, as he has not had a chest xray, however they have already prescribed antibiotics, steroids, ivermectin, and vitamins C, D, and Zinc
I started having intense migraines; I felt off balance, like when I 1st get out of bed, I would fall against the wall.; I felt nauseous; I felt horrible for the 1st 5 days./ felt so heavy, like liquid cement/felt like water in my head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt horrible for the 1st 5 days./ felt so heavy, like liquid cement/felt like water in my head), MIGRAINE (I started having intense migraines), BALANCE DISORDER (I felt off balance, like when I 1st get out of bed, I would fall against the wall.) and NAUSEA (I felt nauseous) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced FEELING ABNORMAL (I felt horrible for the 1st 5 days./ felt so heavy, like liquid cement/felt like water in my head). On 11-Aug-2021, the patient experienced MIGRAINE (I started having intense migraines), BALANCE DISORDER (I felt off balance, like when I 1st get out of bed, I would fall against the wall.) and NAUSEA (I felt nauseous). At the time of the report, FEELING ABNORMAL (I felt horrible for the 1st 5 days./ felt so heavy, like liquid cement/felt like water in my head), MIGRAINE (I started having intense migraines), BALANCE DISORDER (I felt off balance, like when I 1st get out of bed, I would fall against the wall.) and NAUSEA (I felt nauseous) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication provided   This case was linked to MOD-2021-326700 (Patient Link).
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/31/21 (EN6205) Pfizer Dose 2 4/21/21 (EM9809) COVID Positive 11/5/21  11/5/21: Patient is a 66-year-old female who presented to the emergency department today with complaints of dyspnea x1 week.  Reports that she went to urgent care today, and was then referred to the emergency department for hypoxia. Patient reports productive cough, shortness of breath at rest, dyspnea on exertion, fatigue, and decreased appetite over the last 1 week.  Her symptoms have been worse over the last 1-2 days.  She denies any fever, chills, nausea, vomiting, diarrhea.  She has retched a few times when she has coughed hard.  She received the Pfizer COVID vaccine 2-dose series March/April 2021.   On arrival to ED, the patient's SpO2 was 82% on room air. She required 4L of supplemental oxygen to keep her SpO2 greater than 90%.  CXR showed patchy bilateral infiltrates compatible with pneumonia.  Her labs were significant for sodium 129, glucose 183, BUN 29, creatinine 1.36, hemoglobin A1c 6.9%, hemoglobin 8.9, COVID screening positive.  In the ED she received 40 mg IV Lasix, 750 mg Levaquin, and albuterol nebulizer.   On arrival to the floor, the patient has been quite dyspneic.  Cannot quit coughing.  Has had significant stress incontinence.  Cough has been made worse due to frequent bed changes due to incontinence.  I have ordered a Foley catheter at this time.  We will remove it as soon as the patient is stable.  11/11/21: Patient is a 66 y/o female from home. She has a past medical history which includes type 2 DM, HTN, Obesity, OSA, CHF, and CKD stage 3. She was admitted in the hospital on 11/05/21 and treated for covid 19 pneumonia, hypoxia, AKI on CKD , hyperglycemia, and transaminitis secondary to covid pneumonia. The patient was given, neb treatment, IV Lasix and 750 mg IV Levaquin in the ER. She was transfered to the medical unit and  treated with Remdesivir, dexamethasone, IV antibiotic and supplemental O2. Her Sputum culture finalized with MSSA, which was susceptible to Levaquin.   The patient completed her Remdesivir treatment and was able to maintain her oxygen saturation 89/90% on room air. She stated that she just completed a sleep study and has a f/u appointment in a few days. Today she denies shortness of breath. Patient is agreeable to go home.
pt recv comvax & hep B vax instead of peds HIB & hep B;there was product confusion;pt sought unspecified medical tx;
Pt sat for about 15 min. Felt a hot flash, "felt fine", she stated stood up looked pale. Asked her how are you stated couldn't see saw black spots passed out. Recovered quickly - drank water, spoke fine.
L th red swollen, fever (RN's on call - suggested taking pt to ER - they gave pt Keflex 125/5 one tsp PO BID - follow up with Dr in 2 days.
Around 1 and a half hour after my 2nd dose of the vaccination, 8 started feeling chest pain a fast heartbeat. My friend and her husband were about to take me to the emergency room, but I told them if I could just rest first at their house. The chest pa8n and heartbeat lasted for about 2 hours. I was not able to sleep well that night due to headache, on and off fever, muscle/body aches, feeling nauseated  and a general feeling of being unwell. I was absent from work for two days because of these  adverse reactions/side effects.
Patient age of 17 yrs 8 months. No adverse effects. Patients age out of criteria. Event reviewed by Dr.
skin itching; skin hive; Red big pimple over my body; Skin peeled; Red big pimple over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Sep2021 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. The following information was reported: ACNE (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Red big pimple over my body"; SKIN EXFOLIATION (non-serious) with onset 2021, outcome "not recovered", described as "Skin peeled"; URTICARIA (non-serious) with onset 2021, outcome "not recovered", described as "skin hive"; PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "skin itching". The events "skin itching", "skin hive", "red big pimple over my body" and "skin peeled" required physician office visit. Therapeutic measures were taken as a result of pruritus, urticaria, acne, skin exfoliation, erythema.  Additional info: Reporter stated, I visited many doctors and they gave me many kind of drags none of them works and get worst now, also one of the problem I am having it's those doctors can't prove if it's because vaccine shot or not.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
coworkers' daughter became pregnant after receiving Moderna; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (coworkers' daughter became pregnant after receiving Moderna) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (coworkers' daughter became pregnant after receiving Moderna). At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (coworkers' daughter became pregnant after receiving Moderna) 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.   concomitant medications list was not provided. Treatment information was not provided.  Med Info Agent Crosslinked to cases MOD21-MOD21-167090 and MOD21-167131. Caller stated that one of her coworkers' daughter had been trying to get pregnant for a while. She finally became pregnant after receiving the Moderna vaccine. Consent for Safety follow-up was not obtained for this case.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced Vaccine exposure before pregnancy. The patient received the dose of the vaccine (dose number unknown) at an unknown date before pregnancy. Very limited information is available at this moment. The benefit-risk relationship of mRNA- 1273 vaccine Moderna Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced Vaccine exposure before pregnancy. The patient received the dose of the vaccine (dose number unknown) at an unknown date before pregnancy. Very limited information is available at this moment. The benefit-risk relationship of mRNA- 1273 vaccine Moderna Vaccine is not affected by this report.
This spontaneous report as received from a healthcare worker refers to an unspecified group of the patients (demographics unknown). Information about patients' medical histories was not provided. On an unknown date, the patients were vaccinated with doses of ROTAETQ (dose, frequency and indication were not specified, route of administration default to oral) (lot # K013661, expiration date: 26-MAY-2016) which were exposed to temperatures outside of the recommended range. Concomitant medication was not reported. No adverse effect has been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Large asymmetrical rash on enter outer side of bicep.  Very red on edges, less red in the middle.  Initially smaller and more red, gradually becoming very itchy and spreading while the center is less red than before.   Unsure if headaches and fatigue are related.
3 hours non-stop crying, then 3 weeks low tone low energy poor sleep. See attached sheets. Irritable and arching for 3 weeks staring at times.
it caused SO much PAIN; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2008).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he /she received Shingles vaccine but it caused so much pain.
Exactly 2 weeks after the first shot I experienced 4 2-3 day long migraines back to back over a 2 week period. These were very intense migraines, and prescription medicine did not work to get rid of them, I have had my chronic migraines under control for years with medication, this is highly unusual and abnormal, especially on my course of medication. After the 2 weeks of migraines, my ankylosing spondylitis flared up and from June 5 to the present I am still suffering from pain that should be under control of my medicine. I have a pain on the side of my right thigh and pain throughout my hips/lower back that comes and goes. The most noteable side effect so far though has been my period changes. I have been regular for years and now I am getting intense cramps and migraine with each period, and they are occurring every 3 weeks, which is very early. One even came as early as 13 days early. That period lasted 2 days of heavy bleeding, large blood clots, then stopped all of a sudden. This is highly unusual and I track all of they symptoms and have them recorded in apps. This all started after the first shot on May 18, 2021 and is still ongoing.
Pfizer-BioNTech COVID- 19 Vaccine EUA: Paramedic noticed vaccine recipient's eyes roll back, and mild brief tonic (arms) preceding syncopal x1 activity, patient was pale, clammy. Paramedic held patient up in chair to avoid fall. Patient taken to OBS medic tent for observation for syncopal event. Observed, water offered, orthostatic positioning, rest. Patient walked out after recovery.
Patient came in 2 days later on 9/15/17 with a prescription from ER for Doxycycline 100mg. Patient stated she had skin reaction to the vaccination she was given two days ago and and went to Emergency room. Patient was given antibiotic for cellulitis to be treated for 7 days. Her arm had erythema around the upper arm area.
Unresponsive shaking, trembling x 1 minute child to ER - mom stated R side of mouth started to quiver & then her eyes wandered a bit and then she became quite tonic when event stopped she couldn't use her R arm for a few moments she did not respond for a moment.
Area of injection started size of 50 cent piece as day progressed nose running, lymph nodes in neck swelled, area on left deltoid grew to 9 centimeters, hot to touch, core area 6cm, hard, looked pus like, low grade temp 99.6-99.8, chills, in bed shaking. Called in sick for work on Saturday (NICU nurse). Symptoms gone by Tuesday.
Patient received Rotarix oral vaccine on 08/20/09. Taken to ER on 08/24/09 with vomiting. Diagnosed with intussusception.  9/3/09 Received hospital records of 8/24-8/26/2009. FINAL DX: cecal intussusception, surgically reduced Records reveal patient experienced vomiting & fever x 1 day.  Had bloody stool in ER w/abdominal distention & hypoactive bowel sounds.  Tx w/IV antibiotics.  Surg consult done when BE unable to reduce IS.  Progressed well post op & d/c to home. ICD9 codes: 560.0
Cutaneous hyperesthesia (skin hypersensitivity) in right abdomen area, right lower back/lumbar area, outer right thigh area. Small rash-like spots on right side of abdomen.
Blood clot in my bowel movement; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 05Mar2021 15:45 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that when the patient had a bowel movement, the patient had a blood clot in the bowel movement on an unspecified date. The patient was asking if it was a normal side effect or should that be something to be concerned about. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.
pt states that arm swelled for couple days immed p/receiving flu vax; the following wk pt exp itchy & puffy eyes on 5NOV93 exp rash around neck area;
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported an itchy/tingling sensation on her tongue.  Gave her water and 50mg of Benadryl and monitored for 30 minutes.  She reported that it may have been nerves and "hyperchondriac" feeling. Patient was fine a few minutes later and for the duration of observation
Rash starting out as "water filled" bumps, then becoming papules. Itchy. No fever, no other sx.  Exam: scattered excoriated erythematous papules with central openings, one on back may be a tiny vescicle vs papule on erythematous background, no obvious vescicles, no crusted over papules. Treatment - supportive care. No testing done. Warning to avoid pregnant/immunocompromised people.
At 1 PM this patient complained of numbness and tingling of upper and lower extremities, with slight dizziness. BP 140/100 P 104. At 1:15 PM, signs and symptoms subsiding. BP 138/96, P 86. At 1:30 PM, no further complaints, the patient states she has history of high blood pressure. Advised to see her physician. At 2:15 PM, BP 120/88.