chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achy; flu like symptoms; bumpy rash across chest and shoulders; injection site is red; injection site is swollen; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (bumpy rash across chest and shoulders), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen) in a female patient of an unknown age 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 information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN (Achy), INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (bumpy rash across chest and shoulders), VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE SWELLING (injection site is swollen) and CHILLS (Chills). At the time of the report, PAIN (Achy), INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (bumpy rash across chest and shoulders), VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE SWELLING (injection site is swollen) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
This case was reported by a sales representative via a physician and described the occurrence of screaming in a 2-month-old male subject who was vaccinated with Pediarix for prophylaxis. On 17 August 2007 the subject received 1st dose of Pediarix (.5 ml, unknown). On 17 August 2007, less than one day after vaccination with Pediarix, the subject experienced screaming to the point of exhaustion, crying and sleep interruption. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with Pediarix.
Headache late in the day- motrin cured Swollen arm, painful to touch- motrin, movement, and cold compresses have NOT worked as of today red, knot size lump still present on day 4
2:00 Am headache, achy body, back pain, shoulder ache, no apatite,  feels like he had the flu.
He received the vaccines above in the morning and, later that evening, he developed a rash consisting of 1 mm blanching red macules over anterior and posterior trunk and proximal thighs.  He also breast fed less than usual and had less urine output and fewer bowel movements than usual.
edema in his left arm where he got the shot in.; It is a soft mass/rather large/frightening/it is shrinking but it is still not gone after a month.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (edema in his left arm where he got the shot in.) and VACCINATION SITE MASS (It is a soft mass/rather large/frightening/it is shrinking but it is still not gone after a month.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004PL1A and 040C21A) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus in 2000 and Enlarged prostate in 1999. Concurrent medical conditions included Allergy to antibiotic and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, DOXAZOSIN MESYLATE for Enlarged prostate, CANAGLIFLOZIN HEMIHYDRATE, METFORMIN HYDROCHLORIDE (INVOKANA DUO) and METFORMIN for Type 2 diabetes mellitus.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced VACCINATION SITE OEDEMA (edema in his left arm where he got the shot in.) and VACCINATION SITE MASS (It is a soft mass/rather large/frightening/it is shrinking but it is still not gone after a month.). At the time of the report, VACCINATION SITE OEDEMA (edema in his left arm where he got the shot in.) and VACCINATION SITE MASS (It is a soft mass/rather large/frightening/it is shrinking but it is still not gone after a month.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Patient stated that Soft mass in Left Arm Tricep, not painful.  It has been 30 plus days. The lump has reduced in size but has not gone away.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Added patient demographics, other relevant history and concomitant medications, updated dose details.
pt recv vax 10NOV98 & later that day pt became diaphoretic & c/o that was hot, ached all over, was dizzy;mom also noticed that sx dec in about an hour but remained very tired for the rest of the day;
Shot 1 - February 26, 2021 - The next morning woke up with fever, muscle aches, swollen and red itchy eyes (above and below eyelids) Saw doctor and treated with Benadryl and Pepcid.  Took about 4 days for eyes to look normal.  Doctor stated this was her immune response to vaccine.  Shot 2 - March 21, 2021 - No facial swelling.  Fever, Muscle aches for two days.   Shot 3 (booster) - December 26, 2021 - Initial Reaction (headache, body aches) for 24 hours after shot.  On Wednesday, December 29 started to have itching and red eyes.  On Thursday, December 30 - Eyes swollen shut and entire face red and burning.  Cheeks swollen.  Burning sensation.  Called Primary Care Doctor on Thursday and started Benadryl.  Friday, Dec. 31 started to have hives on face, more swelling and whelps.  Continued Benadryl and went to Urgent Care.  Urgent Care Doctor gave steroid shot.  During this entire time having severe congestion and sinus pain.  Urgent Care Doctor also prescribed Antibiotic Amoxicillin and Steroid Dose Pack.  January 2, 2022 - continue to have redness and skin is swollen and drying out.  Peeling of skin around eyes.  Swelling in cheeks.  Very dehydrated.  Returning to follow up at Urgent Care on Monday, January 3.
Felt like a baseball in my arm, could not move my arm to the side for three days, then still tender to touch for another 3 days. I could move my arm forward, just not side or backwards.
24 hrs p/vax pt devel red, hardened area immed below inject site approx 1 1/2 circum; central reddened area is approx 1/2 x 3/4"; area not hot to touch lt leg;
Left arm at injection site red, swollen, painful, warm and very tender. Treated with OTC Benadryl, ice pack, and Decadron 8mg LGM.
Patient was feeling light headed like she was going to pass out. She also vomited multiple times.
Fever, Arthralgia, Conjunctivitis - Information has been received from a physician concerning a 60 year old female who on approximately 29 Nov 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine lie (+) rubella virus vaccine live (second generation since she had no prior immunity.  On 08 Dec 2000, the patient presented to the physician with a 101.3 degree fahrenhelt fever.  Arthrialgia and conjunctivitis.  She did not have a rash or encephalitis.  Additional information has been requested.
Client reported feeling itchy on his arm and felt that his throat was itchy to EMT in observation.  EMT did assessment.  ABC's intact.  No rash noted by EMT on assessment. Patient stated he had a history of anaphylaxis but doesn't feel the same as it did when that happened. 50 mg of benadryl administered to client.
Presented to ED on 9/17 with signs of stroke. Had recently been at a local hospital after a MVA on 9/9 with bilateral leg hematomas and had started xarelto the evening before presentation to the ED.  Labs showed anemia, elevated creatinine which is at baseline, mild hyponatremia and elvated toponins but normal CK-MB, covid +.  Overnight developed worsening hypoxia and increased O2 requirments up to 15 L. Family confirmed wanting only conservative measures.Cardiology and Neurology consulted. Sudden decline on 9/20 with worening labs and chest xray.  Family requested comfort care.
The patient is a 13 y.o. female presents to the office for influenza vaccination.     Vaccine Information Sheet given to patient.  Vaccine screening questionnaire completed and reviewed   Patient had emesis episode about 30-60 seconds post vaccine with pallor, no diaphoresis, no rash, no urticaria, no facial swelling or angioedema, no respiratory distress. Updated Dr. on patient's condition. No previous issues with vaccines and no known allergies. Patient's symptoms resolved with no continual emesis- waited in clinic for observation period. Patient stable on discharge with no complaints.
TheJ&J /Janssen vaccine was administered into the patient's left arm. Patient went pale and said he was feeling woozy and he would like to sit for a while and when he felt fine he would go shopping. I told him I would get him an ice pack and for him to take deep breaths and I would be right back. I went to go grab the ice pack and I heard the chair move and I ran to look for him and he was on the floor. This was a minute after I gave the vaccine. I asked another technician to call 911. When I got to him he was passed out maybe for 10 or 15 seconds. He woke back up and I helped him up off the floor and he was uneasy on his feet. He was pale and I had him sit down until EMS got to him. EMS got there maybe 5 minutes after and took his vitals. Blood pressure was low.  112/60 Pulse ox was 97. They laid him down and  took his blood sugar and it was 106.  He was able to sit down and regain his composure and his blood pressure came back up. He had to get a ride back to his house from his father but he was able to go shopping with him before he left the store. In total probably waited 45 minutes after the incident.
pt called clinic 5MAY95 @ 1020AM stated 7-8 hr p/receiving vax had thick tongue, dizziness, body felt real warm (no fever); still weak today; pt stated had typhoid fever 2-2 1/2 yr ago when lived in haiti; told call immun hot line
Swollen arm, large red patch and hard knot at the injection site. Extremely painful to touch. Some pain is relieved with TYLENOL or Ibuprofen but never completely goes away.
hyperthyroidism; heart rate began to go up; This case was reported by a consumer via call center representative and described the occurrence of hyperthyroidism in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced hyperthyroidism (serious criteria GSK medically significant) and heart rate increased. On an unknown date, the outcome of the hyperthyroidism and heart rate increased were unknown.   It was unknown if the reporter considered the hyperthyroidism and heart rate increased to be related to Shingrix.  Additional case details were provided as follows: In 2019, within a couple days after Shingrix vaccination, the patient's heart rate began to go up significantly and was diagnosed with hyperthyroidism. The patient asked whether this injection could damage the thyroid gland.
pt devel fever 104 24hr p/vax had intermittent fever 101-105 x 3 days;irritable x 2 noc 2MAY & 3MAY;motrin given PRN w/elevated temp;
Pt recvd vax & the next day pt donated blood & was informed that blood was Hep B surface antigen pos; liver enzyme were performed & the results are pending;
This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in.  On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club.  Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.
Moderna COVID-19 Vaccine  Approximately 11 hours after vaccination, woke up to a 101.4 fever, chills, fatigue, sweats, nausea, and severe headache. In addition, swelling and severe pain at the injection site. Took ibuprofen to address fever. The fever lasted about 24 hours.  Headache and fatigue lasted about 36 hours.
having pain at the injection site; redness at the injection site; A rash is moving down the arm; red pumps that are very itchy the / redness then started to get itchy; red pumps that are very itchy; rash is like urticaria; scratched; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluocinolone acetonide (Fluocinolone Cream).   On 11th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema, rash, pruritus, erythema, urticaria and scratch. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the rash and pruritus were not recovered/not resolved and the outcome of the erythema, urticaria and scratch were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, rash, pruritus, erythema, urticaria and scratch to be related to Shingrix.  Additional details were provided as follows: The patient reported initially having pain and redness at the injection site but the vaccine site is good now. A rash was moving down the arm.  The reporter asked was this normal or not normal the rash was like urticaria with red pumps that are very itchy.  The patient reported, the redness then started to get itchy and scratched, and it had been moving down to the forearm area. It had been almost 2 months later and the rash with urticaria was still happening.  It has moved to the inside of the forearm area. It was like  the patient chasing it. This was my new normal.  The patient do not know if want to get the 2nd vaccine. The reporter consented to follow up.
I was ok, I drove home, I ate soup. 1 hour later I felt dizzy. I sat on the couch and i was so dizzy I couldnt get up. I stayed there all night. I was vomitting. My arm also swelled up really big. It is still a little swollen and red today (9/20/23). This all lasted about 24 hours and then it subsided. I dont feel great but I feel some better. Today is the 3rd day.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot number N028444 with expiration date on 09-APR-2019 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between negative 14°C to negative 10°C for 30 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effects reported. No product quality complaint was involved.
2 minutes after received 1st dose of Moderna COVID vaccine, patient stated unilateral headache, advised to drink water. 3 minutes after receiving vaccine, patient stated " I feel funny, I can't breathe" and lost consciousness x 5-10 seconds. Patient airway clear and breathing monitored. Patient regained consciousness, diaphoretic, oriented. Patient A&O x 4 after sternal rub. HR: 52, SPO2: 97% RA. Provided breath coaching, held patient in upright position, monitored breathing, had patient orally drink water. Manual B/P: 95/60, HR: 64. Patient became more coherent and stated prior to loss of consciousness he felt chest pain, denied any current chest pain, SOB, dizziness, headache, confusion, itching, rash, swelling.   Consulted with MD on site who advised EMS called and to monitor patient vitals. Patient declined EMS. Patient placed in wheelchair and taken to private room to lay supine and orally drink fluids. 15 minutes later supine vitals: B/P: 117/77 HR: 68, SPO2: 99% RA. Patient rested for additional 15 minutes, sat upright for 5 minutes. Vitals sitting: B/P 117/79, HR: 69, SPO2: 99% RA. Per MD, patient approved to return home but advised not to drive. Patient stated had not eaten or been drinking water and driven 2 hours prior to vaccination. Patient stated all symptoms resolved except feeling fatigued. Advised patient's wife to drive, to eat/drink prior to leaving, if develops chest pain, SOB, facial swelling, hives, loss of consciousness, lethargy, confusion to go to ER or call 911. Patient and wife verbalized understanding. Patient monitored for 1 hour after loss of consciousness.   Telephone call to patient 4 hours after vaccination. Patient stated "feeling much better," ate and drank water after leaving clinic, and resting. Patient denied SOB, chest pain, loss of consciousness, confusion, lethargy, HA, dizziness, lightheadedness. Patient advised to inform PCP of symptoms/reaction and discuss plan for when/if 2nd dose. Explained may have been vasovagal response. Patient stated several years ago having similar episode at ER when seeing blood, stated at vaccine clinic today, watched wife receive vaccine, then saw small drop of blood on his arm before loss of consciousness. Patient stated he will discuss with his PCP.
ITP, Platelet transfusion +. Information received from Discharge summry states thrombocytopenia. 60 Day Follow-up Information 12-May-2006: Lost contact.
1 cm mass; inflamed supraclavicular lymph node on left side/nodule; This is a spontaneous case received from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 19Mar2021 at 11:30 (at the age of 16-years-old) as a single dose on the left side for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient did not have any allergies to medications, food, or other products. On 25Mar2021, the patient experienced an inflamed supraclavicular lymph node on left side (same side as vaccine administration). On 26Mar2021, the patient visited her primary care physician (PCP) as a result of the event. The physician documented a 1 cm mass. The patient was referred to another doctor for follow-up. On 07Apr2021 the patient saw another doctor who reviewed the case. The patient underwent lab tests and procedures which included a COVID-19 nasal swab on 25Mar2021 with result of negative, chest X-ray on 26Mar2021 with results of "clear" and lab work on 07Apr2021 with results of "clear." The patient did not receive any treatment for the events. The patient was told to follow-up in six weeks if the nodule was not gone. The outcome of inflamed supraclavicular node was not recovered. The outcome of 1cm mass was unknown. The patient received dose 2 of BNT162B2 on 09Apr2021 at 13:30 and was told to contact the doctor with any changes in the lymph node (smaller, larger, etc.).   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
fever x 2 days p/vax temp up to 101.6 oral;OTC ibuprofen;pt notified clinic of this rxn on 5MAY97; no prior hx to Td in pt;
injection site started swelling; sweating; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site started swelling), HYPERHIDROSIS (sweating) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site started swelling), HYPERHIDROSIS (sweating) and HEADACHE (headache). At the time of the report, VACCINATION SITE SWELLING (injection site started swelling), HYPERHIDROSIS (sweating) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Indentation on R thigh, turned into morphea and panniculitis. Over the course of the first year more dents appeared on R thigh, over the second year I had bilateral symptoms.