chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temp and upper arm soreness; temp and upper arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 73 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Product name/Manufacturer lot number: Pfizer Lot EN6200), administration date: 27Feb2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness"; BNT162b2 (DOSE 2, SINGLE, Product name / Manufacturer lot number: Pfizer Lot ER8730, Time: 9:25AM), administration date: 23Mar2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Pfizer Lot: FE3590, Expiration: 30Nov2021), administration date: 15Oct2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), BODY TEMPERATURE INCREASED (non-serious), outcome "unknown" and all described as "temp and upper arm soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, body temperature increased. Additional information: Patient reported that the side effects were minor (temp and upper arm soreness). Patient had no medicines other than Tylenol taken day 1, 2 of vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101946 same patient, different vaccine dose/event;US-PFIZER INC-202300259180 same patient, different vaccine dose/event;US-PFIZER INC-202300259177 same patient, different vaccine dose/event;US-PFIZER INC-202300259176 same patient, different vaccine dose/event;US-PFIZER INC-202300259178 same patient, different vaccine dose/event;US-PFIZER INC-PV202300128433 same patient, different vaccine dose/event;
Swelling left arm/left arm was swelling from the elbow all the way down to left hand; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-JUN-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, several days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb (Verbatim: Swelling left arm/left arm was swelling from the elbow all the way down to left hand). The outcome of the extensive swelling of vaccinated limb was not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Shingrix.     It was unknown if the company considered the extensive swelling of vaccinated limb to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUL-2023 The patient self-reported this case. The patient administered first dose of Shingrix and noticed days later that his arm was swelling from the elbow all the way down to his left hand. The swelling continued. Doctor was not aware. The reporter consented to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of VASCULITIS (vasculitis), ASTHMA (flare ups with asthma), LIP SWELLING (swelling in lips), RASH (rash on face) and ERYTHEMA (face is red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The patient's past medical history included Asthma since an unknown date. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VASCULITIS (vasculitis), ASTHMA (flare ups with asthma), LIP SWELLING (swelling in lips), RASH (rash on face) and ERYTHEMA (face is red). At the time of the report, VASCULITIS (vasculitis), ASTHMA (flare ups with asthma), LIP SWELLING (swelling in lips), RASH (rash on face) and ERYTHEMA (face is red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment medications included prednisone and albuterol inhaler.
Chills, fever...aches...arm swollen three times its size with extreme pain and redness.
fever ,swelling of face and throat, red rash all over upper body.  intestines swelled.   epipen, benadryl, prednisone   starting at 4pm.  still taking benadryl and prednisone
AT THE CLINIC DAY, PT 'S AND HIS MOM PRESENTED THE CONSENT FORM WHICH CLEARLY STATED THAT HE IS 16 YO. SO THE VACCINE WAS ADMINISTERED SHORTLY AFTER ON 4.7.21. WHEN GOING BACK TO HOME STORE, RX STAFF ENTERED INFO INTO THE SYSTEM AND GOT ALERT FROM INSURANCE THAT PT WAS NOT REACHING 16 YET SO WOULD NOT PAY. INCIDENT REPORT WAS THEN MADE AND THE VACCINE ADMINSTER  CONTACTED THE PATIENT. SHE TALKED TO PATIENT 'S DAD AND DAD CONFIRMED THAT THEY PUT HIS SON AS 16 WITH THE WISH TO GET HIS SON VACCINATED BEFORE SCHOOL STARTED AGAIN . HEALTH DEPARTMENT WAS THEN TELLING DAD THAT HIS SON WAS NOT SUPPOSED TO GET VACCINE FOR UNDER AGE RECOMMENDED BY CDC AND SO HE WOULD NOT BE ELIGIBLE FOR 2ND SHOT.  TODAY 4.15.21 UPON ASKING HIS SON'S WELLBEING AFTER THE SHOT , DAD SAID HIS SON IS DOING WELL WITH NO SIGNS OF ANY ADVERSE REACTIONS.
Stevens Johnson syndrome; 1 blister on lip looks like outbreak of herpes; horrible outbreak of psoriasis; A spontaneous report was received from a healthcare professional concerning a 73-year-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced steven-johnson syndrome, oral herpes(blister on the lip which looks like an outbreak of herpes), psoriasis (bolus lesion on right arm, two bolus lesions on back, and legs).  The patient's medical history included bad psoriasis.  Products known to have been used by the patient, within two weeks prior to the event, included secukinumab for psoriasis, which the patient took on 21 JAN 2021 as per the reporter.  No other relevant concomitant medications  was reported.   On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 04-Feb-2021, it was reported that the patient had blister on the lip which looked like an outbreak of herpes. It was also reported that the patient had a bolus lesion on right arm, two bolus lesions on back, and legs, had a horrible outbreak of psoriasis. The physician mentioned that it appeared as Stevens Johnsons syndrome. Treatment included secukinumab for psoriasis.   Action taken with mRNA-1273 was unknown.  The outcome of the events, steven-johnson syndrome, oral herpes (blister on the lip which looks like an outbreak of herpes), psoriasis (bolus lesion on right arm, two bolus lesions on back, and legs), were unknown.; Reporter's Comments: This case concerns a 73-year-old  patient, who experienced Stevens-Johnson syndrome, oral herpes outbreak and outbreak of psoriasis. The patient's medical history included bad psoriasis and patient is on cosentyx for psoriasis. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
my arm was itching / my arm was itchy; my arm was hot; about the size of an orange; it was really really blood red; my arm was hard / my arm was sore to touch; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (my arm was itching / my arm was itchy), VACCINATION SITE WARMTH (my arm was hot), VACCINATION SITE REACTION (about the size of an orange), VACCINATION SITE ERYTHEMA (it was really really blood red) and VACCINATION SITE PAIN (my arm was hard / my arm was sore to touch) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71625) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced VACCINATION SITE PRURITUS (my arm was itching / my arm was itchy), VACCINATION SITE WARMTH (my arm was hot), VACCINATION SITE REACTION (about the size of an orange), VACCINATION SITE ERYTHEMA (it was really really blood red) and VACCINATION SITE PAIN (my arm was hard / my arm was sore to touch). On 26-Sep-2022, VACCINATION SITE PRURITUS (my arm was itching / my arm was itchy), VACCINATION SITE WARMTH (my arm was hot) and VACCINATION SITE ERYTHEMA (it was really really blood red) had resolved. At the time of the report, VACCINATION SITE REACTION (about the size of an orange) and VACCINATION SITE PAIN (my arm was hard / my arm was sore to touch) outcome was unknown.            Patient got the Moderna Covid-19 Vaccine, Bivalent booster. No concomitant products were reported. No treatment drugs were reported  It was reported that, It's from patient upper shoulder where patient got the shot, to the middle of left forearm.  It was mentioned as Lot: AS71625 ("the last number might be an 8).    This case was linked to MOD-2022-650778.
Almost fainted twice about 23 hours after receiving the vaccine. Dizzy and nausea for 1.5 hrs. Also experienced sore muscles, fatigue and chills within 12hrs. Fatigue continued for 48hrs. All resolved.
My son spiked a fever with no other symptoms 7 days after vaccinations and 2 weeks after the vaccination he stopped sleeping and became irritable.  He then woke up  unable to walk and was diagnosed with toxic synovitis after x-rays and blood tests at the hospital.
Within 5 minutes of administration vaccine, the patient complained of itching, tingling, and rash on throat. It progressed to dizziness, sweating, and lightheadedness. Patient was given 1 dose of EPIPEN 0.3mg in right outer thigh. Pt is ok.
Developed small rash on neck, side that vaccination was administered.  Last one hour, no other symptoms
One day post vax, it was reported that the pt developed left hip to knee swelling, erythema, heat (injection site), and tenderness to the touch (injection site). MD visits on 3/24/00 and 3/25/00 were required, and the pt was found to have cellulitis. No crepitus was noted, no drainage, no fever, and no cultures were obtained. He was treated with Rocephin on 3/24/00. Decadron on 3/25/00 and then Cephalexin for 10 days. The most recent information received on 4/4/00 reports that the pt is lost to follow-up.
Patient started itching around 8:30 pm last night (2/24/15). Mother gave MOTRIN and child went to sleep. Then today after school mom noticed redness and swelling, warm to touch. Also area where vaccine given was hard. Measured 30 x 35mm. Left deltoid.
w/in a few hrs pt was cold, wet, & clammy & was crying more than usual; 11OCT92 pt had high pitched cry, difficulty breathing, was arching back & had generally uncharacteristic behavior cold like sxs; 12OCT pt DPT reaction was confirmed;
pfizer vaccine was in fridge beyond 30 days at time of administration. pharmacist did not know of this until after administration. discussed with pt. pt reported no adverse effects. advised pt to revaccinate.
fever, chills and headache, which progressed to shortness of breath and chest pain-- 2 separate episodes that lasted  20-30 minutes each.  Cardiology consult.  Patient initially treated with aspirin 325mg, metoprolol succinate 12.5 mg daily and colchicine 0.6mg bid for 6-12 weeks.  Patient to follow up with cardiology.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Approximately an unknown date in 2013 the patients were vaccinated with GARDASIL (lot#, expiration date and route not reported) that was improperly store approximately on an unknown date in March 2013 (reported as over the last month). No adverse effects reported. The medical assistant was unable to confirm the exact number or identities of the patients at the time of this report. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Chills Fever Headache  Tiredness Arm soreness  Nauseous
Swelling in the glands between my neck and left shoulder; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0169) via an unspecified route of administration, in the left arm on 21Apr2021 at 09:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included high triglycerides and low good cholesterol. The patient had known allergies to MSG (monosodium glutamate) chocolate, nuts artificial color, artificial sweetener, sulfur based drugs, penicillin and more. Concomitant medications included gemfibrozil (MANUFRATURER UNKNOWN), niacin (MANUFRATURER UNKNOWN), vitamin C (MANUFRATURER UNKNOWN), fish oil (MANUFRATURER UNKNOWN) and antihistamine (MANUFRATURER UNKNOWN) all were from unknown date and for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021, at 22:30 the patient noticed a swelling in the glands between the neck and left shoulder, the arm which was vaccinated.  It has been two weeks since the first shot, the patient know it was possible but want to report it for the data points. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swelling in the glands between the neck and left shoulder was not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended reporter information,Treatment received and narrative was updated.
This case is a part of a cluster of 5 cases and is linked with 2012-10466, 2012-10467, 2012-10468, 2012-10469 (same reporter, same events after administration of FLUZONE ID batch number: UT4468BA). Initial report received from a consumer (healthcare professional) on 06 November 2012. A male patient (age was not reported) whose illness at the time of vaccination and medical conditions were unknown and concomitant medications were not reported, had received an intradermal dose 1 of FLUZONE ID (batch number: UT4468BA) in the deltoid region on an unspecified date of September 2012. On an unspecified date, 3 months after the vaccination, the patient presented stomach upset with fever, diarrhea and vomiting. Corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient had recovered. Follow-up information received from a healthcare professional on 05 April 2013: The patient's age was updated as 42 years. The patient had no illness at the time of vaccination. Documents held by sender: None.
This spontaneous report as received from licensed practical nurse refers to a female patient of unknown age with vaccination. Patient had no drug allergies. On 06-JAN-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J009827 and expiry date 10-AUG-2014, 0.5 m, intramuscular in the left arm. On 07-JAN-2014, patient developed a large red, warm, tender, swollen area at the injection site. It was reported that patient visited office and received BENADRYL for the treatment of events. No laboratory diagnostic study was performed. The outcome of a large, red, warm, tender, swollen area at the injection site was reported as not recovered/not resolved. No further information provided. Additional information has been requested.
PATIENT BROKE OUT IN SHINGLES BLISTERS ON NECK AND LEFT SIDE OF HEAD.
Normal bowel movements 1-3 times daily prior to vaccination. Has not had a bowel movement since the evening after receiving the vaccine on 3/19/2018.
I was not having any congestion, allergies, or asthma during the week leading up to the COVID vaccine. The day after the injection, I had flu-like symptoms but no congestion or asthma. The following morning, I woke up with severe body aches and a pulse-oximeter reading of 85% oxygen, and my regular reading is 95% or higher, even off the ventilator and on room air. I remained on my night ventilator and turned up my oxygen from my usual 2 liters to 5 liters. I used my airway clearance devices and had a breathing treatment, but my pulse-oximeter reading didn't improve at all. I was nauseated and took Odanestron. I had severe body aches and took Acetaminophen. It didn't help. I took my temperature, and it was 103.7 an hour after taking the Acetaminophen. I went to the emergency room and was admitted to the ICU with pneumonia. I have had pneumonia several times in my life, but this was an extremely sudden onset
Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # reported as L014419 with expiration date of 25-JUL-2017; strength, dosage, frequency and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 27-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in 31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815: US-009507513-1804USA003816: US-009507513-1804USA003817: US-009507513-1804USA003818: US-009507513-1804USA003819: US-009507513-1804USA003821: US-009507513-1804USA003822: US-009507513-1804USA003823: US-009507513-1804USA003824: US-009507513-1804USA003769.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (I have Shortness of breath/a hard time breath), PHARYNGEAL SWELLING (My throat was swelling, and the selling went down the same day) and PALPITATIONS (My heart was racing) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Heart disorder and Drug allergy (allergic to some antibiotics.).    On 26-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 DYSPNOEA (I have Shortness of breath/a hard time breath), PHARYNGEAL SWELLING (My throat was swelling, and the selling went down the same day) and PALPITATIONS (My heart was racing). At the time of the report, DYSPNOEA (I have Shortness of breath/a hard time breath), PHARYNGEAL SWELLING (My throat was swelling, and the selling went down the same day) and PALPITATIONS (My heart was racing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: fast (High) heart was beating fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included for high blood pressure, heart and blood thinners. The patient reported that no treatment was given for events.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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, a causal relationship cannot be excluded.
Approximately 8 hrs after the second Moderna vaccination I starting having chills. These continued and increased in intensity along with the onset of fever. I did not have an accurate means of taking my temperature at the time. Over the course of the night on the 17th/18th of February the chills and fever never subsided, even with two doses of Tylenol. The day of the 18th, fever and chills continued along with a feeling of intense malaise. My sternum was very sore and it hurt to breathe as a result of the prolonged shivering. I had no appetite and ate absolutely nothing the day of the 18th. In the early morning hours of the 19th my fever broke as did the chills. However, later in the day, a thermometer was obtained and my fever was 101.4 degrees. When taken at bedtime, it was down the 99 degrees and returned to normal later with no future spikes. On the morning of the 20th when I awoke, I noticed a stinging soreness in my mouth and lip area, followed later in the day with my nostrils and inner nose. This turned out to be an intense outbreak of Herpes. The roof of my mouth, gums, upper surface of my tongue, lips, nostrils, and inner nose ultimately became covered and extremely painful. These lesions were not typical blebs, but were tiny, albeit most painful. After five days they resolved and I have had no further issues. As a possible area to investigate - I had had the second Shingles booster 14 days prior to my first Moderna COVID vaccination. I understand Shingles is also a Herpes family virus.
Patient received DTaP, HIB, IPV and PCV immunizations. Child had all of these before at 2 months without complications. Within 10 minutes of vaccination patient broke out in spotted rash from head to toe. Referred patient to PCP. Mom to notify HD of PCP evaluation.
within 12 hours of receiving the vaccine, both eyelids swelled and her right eye developed puss-filled lesions. Has an appointment with the family physician at 4:40 pm today January 11, 2021