chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (certified medical assistant) and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On 21 January 2013 the subject received 1st dose of KINRIX (.5 ml, unknown route, right thigh) and experienced vaccine administered at inappropriate site. The dose of KINRIX was administered in the right thigh when the preferred site of administration for KINRIX is the deltoid of the upper arm. In January 2013, within days of vaccination with KINRIX (up to and including 23 January 2013), the subject experienced swelling injection site. The certified medical assistant reported that the subject "swelled up at the injection site to mid knee cap." The subject was treated with prednisone. At the time of reporting the events were improved. Per the certified medical assistant, "the swelling is better but not resolved." The healthcare professional considered the events were probably related to vaccination with KINRIX. Follow up was received from the healthcare professional (certified medical assistant - CMA) on 21 May 2013. The CMA documented that on 22 January 2013, 1 day after vaccination with KINRIX, the subject experienced swelling injection site and injection edema (described as "edema, localized NOS"). The CMA reported these events resolved on 23 January 2013 and identified KINRIX as the suspect product. The CMA did not consider these events to be serious. The CMA also considered that the site of administration of KINRIX, right thigh, was appropriate for a 5 year old subject. The CMA documented that the vaccination series was not delayed or discontinued and that symptoms did not recur following subsequent administration. It was unknown if the subject experienced adverse events following previous vaccinations.
Broken hips; runny nose every morning; sound like a lot of cold a lot of times; sneezing; exhausted, tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Broken hips) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drug).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced RHINORRHOEA (runny nose every morning), NASOPHARYNGITIS (sound like a lot of cold a lot of times), SNEEZING (sneezing) and FATIGUE (exhausted, tiredness). On an unknown date, the patient experienced HIP FRACTURE (Broken hips) (seriousness criterion medically significant). At the time of the report, HIP FRACTURE (Broken hips), RHINORRHOEA (runny nose every morning), NASOPHARYNGITIS (sound like a lot of cold a lot of times), SNEEZING (sneezing) and FATIGUE (exhausted, tiredness) outcome was unknown.            Concomitant medication were not reported. Treatment medications were not reported.  company comment:Based on the current available information and temporal association between the use of the product and the start date of the events (rhinorrhoea, nasopharyngitis, sneezing, fatigue), a causal relationship cannot be excluded.   Very limited information regarding the event hip fracture has been provided at this time.Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (rhinorrhoea, nasopharyngitis, sneezing, fatigue), a causal relationship cannot be excluded.   Very limited information regarding the event hip fracture has been provided at this time.Further information has been requested.
HEART PALPITATIONS AND ARRYTHMIAS LASTING 1 WEEK AFTER BOTH DOSES 1 AND 2 OF PFIZER COVID VACCINATION
RASH; Could Not Breath; This spontaneous case was reported by a consumer and describes the occurrence of RASH (RASH) and DYSPNOEA (Could Not Breath) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A12A) for COVID-19 vaccination.     The patient's past medical history included Angioedema and Asthma.    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 RASH (RASH) and DYSPNOEA (Could Not Breath). On 11-Mar-2021, RASH (RASH) and DYSPNOEA (Could Not Breath) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included, Asthma Inhaler. List of concomitant medication include, Asthma Inhaler.
False smell of smoke that happens periodically throughout the day, lasting 3-5 minutes.  I had a web-call with doctor and he asked that I report my symptoms.  I have a follow-up in one week and if the smell doesn't improve, he will refer me to an ENT specialist.
On 4/4/2022, I developed COVID-19 symptoms. I took an at-home test, which yielded a positive result. Since I had previously been vaccinated and boosted, I had a breakthrough case. I contacted my physician, who prescribed me Paxlovid. My last symptoms took place on 4/7/2022. At the time of this writing, I am still in isolation, am I am due to come out on 4/13/2022.
pt devel cellulitis @ the site of inject w/t104; CBC, blood C&S all neg;
pt given MMR #1-20 mins later ER calls pt arrives w/wheezing, dusky color, dyspneic; tx w/ SQ epi, Solu-medrol Iv & DPH;
SYMPTOMS STARTED SHORTLY AFTER LUNCH--APPROXIMATELY 1PM.  PATIENT REPORTED TO PHARMACIST AT 3:30PM.  SHORTNESS OF BREATH, RED, SWELLING, TINGLING AT SITE OF INJECTION, RADIATING TO ENTIRE ARM AND SHOULDER.  FELT CHEST TIGHTNESS/PRESSURE; HEAD CONGESTION, THROAT SWOLLEN.  ADVISED TO ICE INJECTION SITE, TAKE TYLENOL AND DIPHENHYDRAMINE TO ALLEVIATE SYMPTOMS.  USE ALBUTEROL NEBULIZER TO MANAGE SHORTNESS OF BREATH.  FOLLOWED UP THAT EVENING: BREATHING BETTER, STILL TIRED AND FATIGUED, FLU LIKE SYMPTOMS; FOLLOWED UP WITH PATIENT NEXT DAY.  WASN'T ABLE TO SLEEP WELL.  TOOK A TRAMADOL 50MG TABLET TO EASE PAIN.  TOOK A DAY OFF FROM WORK.  FOLLOW UP WITH PATIENT MONDAY, 08/31/2020, FEELING BETTER.
26APR94 1 day p/vax pt devel numbness in rt arm  & weakness in rt thumb & index finger (unable to hold objects); rt partial motor sz; 430PM convuls; also exp aphasia; dx secondary tonic clonic sz; had pain & numbness @ inject site;
This is a spontaneous report received from a non-contactable pharmacist via a Pfizer sales representative. The pharmacist reported similar events for 3 patients. This is the 1st of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, in left arm, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced pain when administering PREVNAR 13 on an unspecified date, with unknown outcome. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017420663 Same reporter/drug/event, different patient; US-PFIZER INC-2017420666 Same reporter/drug/event, different patient.
diarrhea at 3pm same day of vaccine till Saturday night. Friday night  Pain to arm/injection site around 10pm. Took Tylenol. Had slight pain to forehead around 8pm started to bruise. Saturday woke up with slight pain to arm/left side of neck. Bruise larger today. Saturday evening swollen. Lots of pain and trouble turn head. Left side neck/shoulder area pain. Applied ice/took Advil. At times hard to move arm, neck. bone pain by injection site.  Now had pain from elbow to neck area, and shoulder on left arm for about 5 days now. At times pain feels like my bones hurt in those areas. Still swollen with bruising.  Using pain meds ever 4 hours. And placing hot/cold packs with little relief.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 15-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot 3 L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
606 doses were given after expiration date; Vaccine is placed in refrigerator on 29 sep 2021, expired product date on 3rd OCT 2021, administration date on 08 Oct 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29 sep 2021, expired product date on 3rd OCT 2021, administration date on 08 Oct 2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29 sep 2021, expired product date on 3rd OCT 2021, administration date on 08 Oct 2021). On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29 sep 2021, expired product date on 3rd OCT 2021, administration date on 08 Oct 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Patient didn't reported any adverse events. The vials didn't undergo any temperature excursion. The vaccine was kept in the refrigerator on 21/09/2021.
Pain and soreness at injection site beginning 5 hours post injection. At 3am on Jan 5th intense chills/sensitivity to temperature,  coughing, waves of nausea, headache, and significant joint paint in arms, hands, and knees. Symptoms persisted until roughly 3pm that same day.
After midnight the day of my shot I got up to use the bathroom. When I got up I felt really lightheaded and I had to grab the wall to keep from falling. I had to sit down with my back against the wall and try to stop room from spinning. I tried to get back up and it happened again. I felt like I was going to pass out. I told my mom to call EMS.  When  EMT came, my BP was 195/101. They asked if I wanted to go to hospital but I wanted to call my PCP. They said that was ok.  I called my PCP and I went to get a BP check and it was still high so my PCP recommended I call my cardiologist. My NP prescribed a trial of Losartan. It helped but then I had another episode. Every so often I would feel really light-headed. I wasn't myself and felt sluggish. I ended up in the hospital 07/21/2021 and stayed for two days and they doubled up the Bystolic dose.  Prior to this, I was on the same dosage for years and my BP never went over  systolic BP has always been around 140 and never went over 150. The increased dosage of Bystolic did help my BP. I also had a catheter in my heart done 07/23/2021. They couldn't determine at hospital why my BP was high. I had CT scans due to my history of stroke. Discharged 07/23/2021.
In the Patients words "THE LEGS BEGAN TO BURN IN BOTH THIGHS AT FIRST. I FELT HEAT WHEN I PUT MY HAND ON THEM. AFTER FALLING ASLEEP, I WOKE UP AT 4 AM AND MY LEGS FELT LIKE A DEAD WEIGHT. I FELT TINGLING IN MY FEET. IT SCARED ME. I ALSO BEGAN TO HAVE AN INCREASE HEART RATE, AS I FELT MY HEART BEAT FASTER. THE PAIN FROM ALL THE SHOTS WAS STILL IN MY ARMS, BUT I NOTICED MORE TINGLING IN MY HANDS THAN IN MY ARMS. "
Localized swelling from injection site down to pt's elbow on inside of upper arm 6" wide x 7 1/4" long.
I started feeling sick with a bunch of symptoms; 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), administration date 11Oct2021 (Lot number: 30155DA) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 20Oct2021, outcome "unknown", described as "I started feeling sick with a bunch of symptoms".  Additional Information: Dates for I started feeling sick with a bunch of symptoms was unspecified. Reporter seriousness for I started feeling sick with a bunch of symptoms was Unspecified. Consumer stated, "I don't know what that is 30155DA." When probed for the concern, consumer stated, I got the first shot on the Monday 11Oct I felt fine until 19Oct and then I started feeling sick with a bunch of symptoms or whatever. I didn't know if it was just from the shot or maybe it should be from the Covid vaccine shot or not. I received the Pfizer first vaccination and since then seen some symptoms.consumer stated, I just want to ensure that if it is like side effect of this shot (vaccine) or not, or actually some other thing.  Follow-up attempts are completed. No further information is expected.
fatigue; arm pain; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PAIN IN EXTREMITY (arm soreness) and FATIGUE (fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PYRIDOSTIGMINE BROMIDE and SALBUTAMOL SULFATE (INHALERIN) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and PAIN IN EXTREMITY (arm soreness). On 04-Mar-2021, the patient experienced FATIGUE (fatigue). On 05-Mar-2021, PAIN IN EXTREMITY (arm pain), PAIN IN EXTREMITY (arm soreness) and FATIGUE (fatigue) 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.   The consumer reports to having underlying health conditions. The medical condition was unknown. the treatment medication was also unknown.
Intermittent twitching of left eye lower eyelid. a few times a day, 10 seconds to 5 minutes at a time. It has not disappeared as of 5/31, getting a bit better than 2 weeks ago.
Cellulitis; Red spot is hard and hot to touch; Hard spot near Vaccination site; Red spot is also itchy; Painful red spot near the injection site; Painful red spot near the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis), INJECTION SITE WARMTH (Red spot is hard and hot to touch), VACCINATION SITE INDURATION (Hard spot near Vaccination site), INJECTION SITE PRURITUS (Red spot is also itchy) and INJECTION SITE PAIN (Painful red spot near the injection site) in a 46-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.     Concurrent medical conditions included Allergy (Allergic to contrast dye and soy.). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC R), METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN and PROGESTERONE for an unknown indication.    On 28-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis), INJECTION SITE WARMTH (Red spot is hard and hot to touch), VACCINATION SITE INDURATION (Hard spot near Vaccination site), INJECTION SITE PRURITUS (Red spot is also itchy), INJECTION SITE PAIN (Painful red spot near the injection site) and INJECTION SITE ERYTHEMA (Painful red spot near the injection site). At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis), INJECTION SITE WARMTH (Red spot is hard and hot to touch), VACCINATION SITE INDURATION (Hard spot near Vaccination site), INJECTION SITE PRURITUS (Red spot is also itchy), INJECTION SITE PAIN (Painful red spot near the injection site) and INJECTION SITE ERYTHEMA (Painful red spot near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
Fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced HEART RATE INCREASED (Fast heart rate). At the time of the report, HEART RATE INCREASED (Fast heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up received on 16-APR-2021, and no new information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
vial punctured 7May2021 and given 13May2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial punctured 7May2021 and given 13May2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vial punctured 7May2021 and given 13May2021). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (vial punctured 7May2021 and given 13May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received reporters demographics was updated On 19-Jul-2021: Follow up was received Patient's demographics (weight) was added, administration site was  added of dose 2, batch number was added
I noticed my feet swelling on the 14th of October 2021. I called the doctor on the 15th of October and describe my symptoms and she gave me an appointment on oct 18th, 2021. I went for my appointment with the doctor and the doctor checked my vitals and everything was normal, a blood panel, and ultrasound on my right left. My vitals were normal, the blood panel showed that I had a blood clot and so did the ultrasound. The doctor prescribed me blood thinners. So, the doctor scheduled me for a CT scan for my lungs on October 19th, 2021. The CT scan results came back normal. This Monday, Oct 26, 2021, the doctor orders an ultrasound on my heart and the results showed slight fluids on my heart. I have a follow-up appointment on November 17, 2021. The doctor believes that I got the blood clot from my stage 4 cancer.
This child had a temperature of 100 - 103 with nausea. One week after Hep B # 3 on 08/29/01. Per mom similar symptoms occurred after Hep B #1 09/23/93, # 2 12/16/93. Parents very anxious, they feel this is an adverse reaction. The physician feel illness is concurrent with viral illness in community.
Patient is fully vaccinated. COVID + on admission 12/29/2021. Admitted for abdominal pain however that resolved and CT abdomen showed no active issues. Acute respiratory failure with hypoxemia, the patient on a 3 L oxygen supplement.  Treatment: no remdesivir, no baricitinib.  Decadron IV given.  Discharged with homes oxygen.
A Ring of small scabs about 1/4" from injection site, then itching. On 1/4 in evening, a small rash which was examined by physician on 1/6. Rash now approximately 2"x3" in diameter and radiating down arm and toward armpit. MD will be treat as cellulitis.
Symptoms started as a cold chill, shaking, and weakness. This started a little after I breastfed my baby. I felt as if my blood sugar levels dropped. I have eaten very light meals earlier.   Symptoms lasted for about 40 - 60 min. By 9 pm and after dinner I was back to normal.
Approximately 38 hours after receipt of a booster dose of bivalent COVID-19 vaccine (the fourth vaccine dose received over a span 18 months), this 50 year-old female presented to the hospital emergency department with complaints of shortness of breath, fatigue, and body aches.  On admission her heart rate was 134 bpm, increasing to 140 with ambulation.  A chest X-ray revealed no acute cardiopulmonary abnormality.  Urinalysis, complete blood count, basic metabolic panel, high-sensitivity troponins, d-dimer, and electrocardiogram were all within normal limits.  Following administration of 2L of IV fluids she improved symptomatically with resolution of tachycardia.  Her presumptive diagnosis was post-vaccine cytokine response leading to dehydration due to poor oral intake.   She was monitored overnight and subsequently discharged in medically stable condition with anticipatory guidance and follow-up plans in place.
temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving VARIVAX states that there have been administered doses; This spontaneous report has been received from a registered nurse (RN) concerning to a patient of an unknown age, gender and ethnicity. Information concerning patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.   It was reported that since 28-JUL-2020, the following lot # T002843, expiration date 23-JAN-2022; and lot# S032357, expiration date 14-OCT-2021 of varicella virus vaccine live (oka/merck) (VARIVAX) had a intermittent temperature excursion, but was not previously reported. Then, on 11-AUG-2020, the patient was vaccinated with a improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (dosage regimen and route of administration were not provided), lot # T002843, expiration date 23-JAN-2022, as prophylaxis.  The improperly stored doses experienced a temperature of -14 degrees Celsius (°C) to -10 °C (maximum average temperature was -9.5 °C), for 38 hours and 30 minutes. The call was due to a digital data logger. There was not previous temperature excursions. No additional information was provided.
Noticed a red rash with minor itching covering my torso and back. The rash was first noticed about 34 hours after the vaccination.