chrisvoncsefalvay/vaers-outcomes huggingface dataset:
due to multiple reasons (sometimes refrigerator was left opened, maintenance and cleaning, power outage) temp reached was 32.5f;temp: 35fduration: 356 minutes or around 6 hours with no reported adverse event; ipol that after a series of excursions. ipol was opened and administered with no reported adverse event; Initial information received on 10-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves temperature excursion, due to multiple reasons (sometimes refrigerator was left opened, maintenance and cleaning, power outage) temp reached was 32.5 f;temp: 35f duration: 356 minutes or around 6 hours and IPV (VERO) [IPOL] that after a series of excursions. IPOL was opened and administered to a 7 years old male patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, due to multiple reasons (sometimes refrigerator was left opened, maintenance and cleaning, power outage) temp reached was 32.5f;temp: 35fduration: 356 minutes or around 6 hours with no reported adverse event (product storage error) (unknown latency).  On 24-Jul-2023, the patient received a dose of 0.5 ml 1x (Frequency = once) dose 4 of suspect IPV (VERO) of standard strength suspension for injection (lot: W1A191M, Expiry date: 16-Feb-2025) via intramuscular route in the right thigh for Immunization, that after a series of excursions. IPOL was opened and administered with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Acute respiratory infection, hypoxia, respiratory distress. Possible seizure activity. Normal EEG. Respiratory support provided, oxygen and transfer to PICU x 36 hours.
~36 hours after vaccine had expected reaction (site reaction, pain, fatigue, fever).  One week later experienced repeated site inflammation and pain; new muscle pain across back, and sore, tender to the touch skin around breast and up to collar bone, body aches and fatigue. Resolved and arm pain restarted again 1 week later(4/22/21) (took 2000 mg of Tylenol without effect). when speaking with patient on 4/23/21 arm pain currently the only symptom.
Migrain. Excessive exhaustion. Brain shock. Weakness. Stomach sick. Shaking excessive pain in my arm where shot was givin.
Date of Admission: 1/19/2022   Chief Complaint:  Abdominal pain   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 88y.o. female with past medical history as indicated below who initially presented to the emergency department secondary to abdominal pain. Patient states that she developed sudden onset diffuse abdominal pain earlier this morning. Denies any fever, chills, nausea, vomiting. Patient states most recent bowel movement was 2 days ago and was normal in caliber with no evidence of blood/mucus. Denies any hematuria, dysuria or difficulties with voiding.Patient denies ever having a colonoscopy or EGD performed. Denies any history of colon cancer or inflammatory bowel disease. Patient denies taking any daily prescription medications, however does take baby aspirin BID, as well as tylenol and a multivitamin. Does report history of a previous open cholecystectomy. Denies any smoking or alcohol history. CT of the abdomen and pelvis was obtained in the emergency department which was significant for scattered pneumoperitoneum with diffuse inflammatory changes and small gas Ladish fluid collections within the abdomen and pelvis centered around the jejunal loop in the mid abdomen. There was noted to be trace free fluid within the pelvis, left pericolic gutter as well as around the spleen. Patient is currently hemodynamically stable and afebrile. Pertinent labs include WBC 18.0, lactic acid 3.9, creatinine 1.56.  Past Medical History:
This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (circular rash at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.  No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (circular rash at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (circular rash at injection site) 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 medications were provided.
Pt reports experiencing symptoms about 30 minutes after injections: abdominal cramps, nausea, excess sputum production but no dyspnea, anxiety, desperation, and stress. She reports loose stools towards the end of the night. She also report nausea for the last few days. She also reports pruritis over scalp "I feel like I have ants and spiders crawling over my body:" She reports induration, redness and tenderness over left deltoid- she states " it feels like I got hit on the arm, a sting to my arm".
Burning sensation on the bottom of their feet; Body aches; Joint pain (elbows, knees, and ankles); Low grade fever; Could hardly walk; Both knees were swollen; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could hardly walk), JOINT SWELLING (Both knees were swollen), BURNING SENSATION (Burning sensation on the bottom of their feet), MYALGIA (Body aches) and ARTHRALGIA (Joint pain (elbows, knees, and ankles)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A and 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Blood pressure high and Hypercholesteremia. Concomitant products included AMLODIPINE for Blood pressure high, PRAVASTATIN for Hypercholesteraemia, HYDROXYCHLOROQUINE for Rheumatoid arthritis, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), VITAMIN D [VITAMIN D NOS], VITAMIN K3 [MENADIONE] and FOLIC ACID for an unknown indication.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2021, the patient experienced GAIT DISTURBANCE (Could hardly walk), JOINT SWELLING (Both knees were swollen), MYALGIA (Body aches), ARTHRALGIA (Joint pain (elbows, knees, and ankles)) and PYREXIA (Low grade fever). On 20-Jul-2021, the patient experienced BURNING SENSATION (Burning sensation on the bottom of their feet). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Jul-2021, JOINT SWELLING (Both knees were swollen) and PYREXIA (Low grade fever) had resolved. At the time of the report, GAIT DISTURBANCE (Could hardly walk), BURNING SENSATION (Burning sensation on the bottom of their feet), MYALGIA (Body aches) and ARTHRALGIA (Joint pain (elbows, knees, and ankles)) outcome was unknown.
No adverse event; incorrect product storage; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 01-NOV-2019, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660935, expiration date 06-OCT-2020 (dose was not reported). The vaccine underwent a temperature excursion at 51.28 degrees Fahrenheit for 2 hours and 16 minutes. No adverse event occurred.
1 of 6 pts exp inject site react , erythema, tenderness & itching w/in 24 hrs following vax; maximum size of react approx 7 cm long;
Pt reported on 10/31/08 that she received Influenza injection on 10/30/08 at aprox 1:00pm. Pt reports that aprox 5:30pm she felt the following symptoms:eyes felt dry,vision blurry, coughing,throat felt enlarged, fever of 101 and had body aches. She took Ibuprofen and nyquill at 10:30pm on 10/30/08.  On 10/31/08 at aprox 4:00pm she took Benadryl 25mg and aprox 30 minutes later her swollen throat felt better.
Small red circle around shot. Now white circle, swollen arm, 6 inches across red circle.
LITTLE TO NO NEGATIVE REACTION; SUSPECTED CLINICAL VACCINATION FAILURE; DIAGNOSED WITH COVID; This spontaneous report received from a patient via a company representative concerned a 74 year old of unspecified sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported and batch number: unknown, expiry: unknown) dose was not reported, 01 total was administered on 15-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant therapy includes chemotherapy for breast cancer.  On 23-DEC-2021, two days before Christmas, the patient was diagnosed with Covid (suspected covid 19 infection) thus had suspected clinical vaccination failure. The patient had Covid-19 test resulted positive. The patient's physician sent the patient for monoclonal antibodies treatment. The treatment and vaccine worked. On an unspecified date, the patient had little to no negative reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diagnosed with covid, little to no negative reaction and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC): 90000222783.; Sender's Comments: V0: 20220344946-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related. 20220344946-COVID-19 VACCINE AD26.COV2.S- diagnosed with covid. 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). Therefore, this event(s) is considered unassessable.
headache presenting behind the ear and going down her neck; This is a spontaneous report via a contactable consumer (Patient herself). A 55-year-old female received first dose of BNT162b2 (BNT162B2 Formulation: Solution for injection, Lot/Batch number: Unknown, Expiration date: Unknown) an unspecified route of administration on 12Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache presenting behind her ears and going down her neck on an unspecified date. The reporter assessed the events as non-serious. She has since been experiencing a headache presenting behind her ears and going down her neck, that she has been treating with Advil. She wants to know how long this may last. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Raised rash on torso, groin, legs, chest, neck and back.; Burning & itching on skin but not at injection site; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hereditary high blood pressure and COVID-19. The patient had unspecified allergies. Concomitant medications included salbutamol (ALBUTEROL) inhaler and losartan (MANUFACTURER UNKNOWN), both taken for asthma and high blood pressure respectively from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Mar2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 18:00, the patient experienced raised rash on torso, groin, legs, chest, neck and back and burning and itching on the skin but not at injection site. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with Benadryl and if not improved the patient planned to see the doctor. The clinical outcome of the events raised rash on torso, groin, legs, chest, neck and back and burning and itching on skin were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Leg became swollen hard and red around where the shot was given. He said it hurt when I touched it and was affecting his running and seemed tired. The size of the wound was a total of 6-7" in diameter.
Requested only MMR and TB test. Patient received dose of MMR-V, hep A hep B, TB test.Prior to this, we spaced out all vaccines and did only one at a time. Day of vaccination child was cold,clammy, sleepy--Doctor was called. Seven days later child coughing, nine days after a high fever and cough was reported to Doctor. No treatment. Doctor apologized for mix up with new vaccine process. Child did not eat or sleep well for about 12 days.
He has mild chonnic cough and diarrhea which has not changed. No other infectious symptoms. started 10/13/21 comes in for a COVID test after his son was tested positive for COVID 2 days ago.
About 10 hours after vaccine, I began feeling lethargic and running a low grade fever.  At 19 hours I developed intense pain in the upper right abdomen radiating to the back.  Minimally responsive to OTC pain medication
Event occurred after third vaccine; breakthrough case admission; patient received third vaccine on 11/3/21 Moderna but no lot# available
So basically I'm like very bad at telling stories, I got the vaccine and I was originally told not to because I have a lot of allergies and sensitivities. I got the vaccine and started walking to like the holing area and I felt weird. I sat down and was feeling weird, I started coughing and clearing my throat. My friend was with me and kept an eye on me. SO Basically I am in this place, people are looking at me and my eye are watering and my nose was running and I was super thirsty but it was minor, nothing crazy. They called me up to check on me and told me to stay hydrated and let me go. I got in the car, and it started getting really bad. I got really watery eyes and runny nose and my throat hurt. I went back to my friend's house and she gave me some Benadryl. The reaction calmed down and then after a few hours my throat got itchy and tight, so I took Benadryl 2-3 times through the day. I kept waking up in the middle of the night. I also was having my menstrual cycle and I was mid cycle and it just like stopped, which is weird. I had three days left of my period and it just stopped like I said. SO that was another weird symptom. The next day, the 29th, my arm hurt more than before; I had fatigue and a headache and all my joints just like hurt really bad. Day 3, my arm was still sore, sore throat, fatigue, Covid arm. So the stiffness and joint pain never really went away, I still have that today. Basically, one of these days, I woke up and I had a super stiff neck - it was so so so so bad to where it was locked in place. I was looking to my left and down, I could not go to work and I tried muscle relaxers and pain killers and nothing helped. I had to go to the DR and they gave me a neck brace which I wore for two days. I went to a Chiropractor and her taped my neck and it slowly went away at the end of the week. Also, I have this injection site nodule that is like not going away.
Fever, chills, joint & body aches, headache, fatigue.  Arm was extremely painful.  All symptoms severe for two days.  But fatigue and achy, off and on sore throat, headaches have continued to present day.  Plus the weak, sore arm where shot administered.
pt devel redness, warmth, swelling & tenderness @ vax site (c/w cellulitis) w/in 6hr of inj;
Severe pain, tighening, cramps, spasms in upper and lower back. Pain began 24 hours after shot (flu).
Pt started with redness and swollen upper arm on 7/22/04. Advised to use ice compress and Motrin at home.
4 inch diameter expanding induration at injection site, hot, with fevers/chills and significant TTP progressive over next 4 days. Concerning for cellulitis.
Rash; This is a spontaneous report from a contactable physician (patient herself). A 38-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on left arm on 05Jan2021 08:15 at single dose for covid-19 immunization, administered at hospital. Medical history included asthma. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced rash within 12 hours on 05Jan2021. The reported event was non-serious. The patient underwent lab tests and procedures which included nasal swab-PCR on 07Jan2021 with pending result. Therapeutic measures were taken as a result of rash with steroid cream and antihistamine. The outcome of the event was not recovered.  No follow-up attempts are possible; Information on the lot/batch number cannot be obtained.
mom describes rt thigh, red, swollen, hot to the touch;looks like a heat rash;pt aso c/o h/a & nausea;parents took child to an immed care facility 6AUG98;
As soon as vaccine was injected, I saw stars and was dizzy for about 1 minute.  After the stars disappeared, I then started to feel like I had the flu.  I waited at pharmacy for 15 minutes.  I was drove to facility and drove home.  After arriving at home 5 minutes after the 15 minutes, I had to lie down and started to feel the aches and pains.  After approximately 1 hour my palse increased to 100.  I couldn't raise my left arm, the site of the injection.  After 3 hours, I was in excruciating pain and my blood pressure increased to 148/103.  I was breathing radically.  After 5 hours I was advised to go to ER.  I had to be helped by two people to do anything.  Complete assist.  At ER, I was evaluated and monitored.  I never got a fever.  I was given pain medication via IV and medicine to get my heart rate down.  After about two hours of observation, I was released.  No medications were given to me.  The next day, I was still in pain, and had aches all over and was exhausted.  By 4pm on Sunday, I started to vomit.  I was sick for 4 hours and got a headache and was very dizzy.  Mon-Tues I remained dizzy, in pain, aches and exhaustion and my blood pressue was still high.  The dizziness stopped by Wed but all other symptoms remain.  The pain ranges from 8-10.  Today, Thursday, my blood pressure is still high: 130/101.  Wed it was 138/103.  I still have pain and aches all over and in muscles and joints and exhausted.  I have been advised by my primary care Doctor to be seen again and have blood labs taken.
Psoriasis went away/disappeared; Psoriasis went away/disappeared; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot Number: EW0173; Expiration Date: Aug2021) via intramuscular route of administration, administered in Arm Right (around the shoulder area) on 05May2021 at 10:13 (at the age of 63-year-old), as dose 1, single for covid-19 immunisation. Medical history included aorta valve replacement from an unknown date and unknown if ongoing . The patient's concomitant medications were not reported. He has not been received any vaccination prior. The patient previously took Baby aspirin 81mg, Metoprolol 25mg, Glipizide 5mg, Levothyroxine 88mcg, Atorvastatin 40mg, Losartan 100mg, Hydrochlorothiazide 25mg for 20 years. On 10May2021, The patient experienced psoriasis went away/disappeared. he had psoriasis for the last 26 years. 5 days after receiving the shot, his psoriasis went away. He confirms his psoriasis disappeared. he had psoriasis on his knees, elbows and upper arms. 5 days later after receiving the vaccine, clarified as 10 May 2021, he was watching his body for symptoms like a rash, and he noticed something was strange but he couldn't figure out what it was  He then realized all of his psoriasis was completely gone. He mentions he has spoken to the pharmacists and was told its a life time sentence with psoriasis so when his psoriasis went away after the vaccine, he was blown away. He hasn't done anything out of the unusual either. He walks every day but that's it. Relevant test has not been performed. His next dose is scheduled for Wednesday, 26May2021. The outcome of the events were unknown.   Information on Lot/Batch number was available. Additional information has been requested
Tinnitus, pain at injection site, chills, fever, body aches, fatigue, headache, stomach pain
Swelling and Pain in lymph nodes under left arm. Pain radiates down past my elbow. Unable to stretch it out fully.