chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash at injection site that was a pinkish circle; Rash at injection site that was a pinkish circle; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE RASH (rash at injection site that was a pinkish circle) and VACCINATION SITE ERYTHEMA (Rash at injection site that was a pinkish circle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for Crohn's disease.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In February 2021, the patient experienced VACCINATION SITE RASH (rash at injection site that was a pinkish circle) and VACCINATION SITE ERYTHEMA (Rash at injection site that was a pinkish circle). At the time of the report, VACCINATION SITE RASH (rash at injection site that was a pinkish circle) and VACCINATION SITE ERYTHEMA (Rash at injection site that was a pinkish circle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Inhibiting antibodies positive: positive (Positive) Positive.         No treatment medication information was reported.
Information has been received from a health professional concerning a 5 year old white female who on 04/17/97 was vaccinated in the arm. On 01/04/02, the patient developed breakthrough varicella on face, arms, trunk and legs with more than 50 lesions. On 01/12/02, the patient recovered. No further information is available.
3 inch long, 3 inch wide circular pink/red lesion at the injection site.  Slightly itchy, but more painful and tender to the touch.
pt recvd vax; devel full blown chicken pox w/in 48 hrs of vax;
Left deltoid pain noted about 36 hours, post vax. Symptoms of malaise, arthralgias, general fatigue. No wheezing, SOB or itching.
3" x 2" lump.  Very warm to touch.  Painful.  Extremely red.
Patient received vaccine 9-21-15. A first report received today 1-13-16. Patient has had arm soreness and has difficulty raising her arm. She advises she has been seeing physician who believes a nerve was hit.
extremely tired; a lot of vomiting; her arm is swollen; Arm is bruised; loss of appetite; feels like she's swallowing rocks/glass in her throat; her ear itches really bad; Stomach aches; Body aches; Headaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her arm is swollen), CONTUSION (Arm is bruised), DECREASED APPETITE (loss of appetite), DYSPHAGIA (feels like she's swallowing rocks/glass in her throat) and PRURITUS (her ear itches really bad) in a 45-year-old female patient who received mRNA-1273 (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021. Concomitant products included HYDROCHLOROTHIAZIDE, AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and GABAPENTIN for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PERIPHERAL SWELLING (her arm is swollen), CONTUSION (Arm is bruised), DECREASED APPETITE (loss of appetite), DYSPHAGIA (feels like she's swallowing rocks/glass in her throat), PRURITUS (her ear itches really bad), ABDOMINAL PAIN UPPER (Stomach aches), MYALGIA (Body aches), HEADACHE (Headaches), CHILLS (Chills) and VOMITING (a lot of vomiting). On an unknown date, the patient experienced FATIGUE (extremely tired). At the time of the report, PERIPHERAL SWELLING (her arm is swollen), CONTUSION (Arm is bruised), DECREASED APPETITE (loss of appetite), DYSPHAGIA (feels like she's swallowing rocks/glass in her throat), PRURITUS (her ear itches really bad), ABDOMINAL PAIN UPPER (Stomach aches), MYALGIA (Body aches), HEADACHE (Headaches), CHILLS (Chills), FATIGUE (extremely tired) and VOMITING (a lot of vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Unknown) was unknown.       Concomitant medication history not provided.  Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on 25-MAY-2021. contain non significant information. NNI document
No adverse effect reported; a patient was inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 18-JUN-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # N014630, expiration date reported as 11-MAY-2019, but upon internal validation established as 11-AUG-2019 (conflicting information), subcutaneously (strength, dose, and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported.
Pt 3 y/o developed fever & slight tremors post 2nd dose of DPT (MFR unk). No further info at time of this rpt.
throwing up/vomiting; stomach is killing me; I've lost 10lbs; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient stated that I had some sort of reaction and can't figure out why I've been throwing up. I received the second dose last Thursday 25Mar2021 and vomiting started since then. I don't mind that I've lost 10lbs, but my stomach is killing me. Patient asked does the vaccine contain capsaicin and what can I take for the vomiting. The patient underwent lab tests and procedures which included weight: lost 10lbs on unknown date in 2021 (I've lost 10lbs). Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a lab technician referring to a 12 month old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were reported as unknown. On 27-MAY-2018, the patient was vaccinated with a dose of VARIVAX injection (strength, lot # and expiry date were not reported) for prophylaxis whose route of administration was reported as unknown. On an unknown date in 2018, after the vaccine administration the patient developed cutaneous lesions also reported as rash on an unspecified location of the body (varicella) for which the patient sought medical attention and was hospitalized on an unspecified date in 2018. On 16-JUN-2018, a lesion sample was collected, tested in the hospital laboratory and the result revealed as positive for varicella zoster virus (VZV+). It was also reported that on an unspecified date, the rash was swabbed and tested positive for varicella and patient was being treated with antiviral Acyclovir (manufacturer unknown). The reporter confirmed that the patient was currently hospitalized. It was reported that patient had no new vesicles to obtain a sample for testing. The outcome of event was not reported. The causality assessment between the event and VARIVAX was not reported. There was no product quality complaint (PQC) reported. The patient was enrolled in the Varicella Zoster Virus Identification Program (VZVIP) to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Shingles approximately 5-6 weeks after vaccine.  Raised welts on back of neck / shoulder, left side only.  Burning / stabbing pain.  Lasted about 4 weeks.
Tiredness after receiving second COVID vaccine was reported.; 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) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness after receiving second COVID vaccine was reported.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen raised red bump below the injection site. About 2 inches in diameter an d slightly warm and sore to the touch.
Hives- around shot site. Ibu & Benadryl given in clinic spoke with Mom @ 3:10pm. Sx have resolved.
Pulmonary Emboli, Shortness of breath started on 4/30/2021, just after arthroscopy of RLE on 4/28/2021.
oral intake reduced; Acute Renal Failure; Thrush in mouth and gums; Bed ridden, barely hold her head up and barely drink; felt tired, not normal tired; Barely hold her head up; weakness; flu like symptoms; Fever; chills; Body aches and soreness; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE KIDNEY INJURY (Acute Renal Failure) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (Fever), CHILLS (chills) and MYALGIA (Body aches and soreness). On 14-Feb-2021, the patient experienced BEDRIDDEN (Bed ridden, barely hold her head up and barely drink), FATIGUE (felt tired, not normal tired) and HEADACHE (Barely hold her head up). On 22-Feb-2021, the patient experienced ORAL CANDIDIASIS (Thrush in mouth and gums). On 25-Feb-2021, the patient experienced ACUTE KIDNEY INJURY (Acute Renal Failure) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOPHAGIA (oral intake reduced). At the time of the report, ACUTE KIDNEY INJURY (Acute Renal Failure), ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (Bed ridden, barely hold her head up and barely drink), ORAL CANDIDIASIS (Thrush in mouth and gums), HYPOPHAGIA (oral intake reduced), PYREXIA (Fever), CHILLS (chills), MYALGIA (Body aches and soreness), FATIGUE (felt tired, not normal tired) and HEADACHE (Barely hold her head up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood creatine: 1 (Inconclusive) 1. On 25-Feb-2021, Blood creatine: 9 (Inconclusive) 9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Prior to getting the 2nd dose of the vaccine, patient had sinus infection and was prescribed antibiotic and steroid on 10-FEB-2021. Patient was prescribed Nasal Spray and Nystatin. Patient is now on dialysis 3 times a week and on 6 different pills a day and on high dose of steroid. The patient was treated with Percocet 325-10 mg, Lyrica 150 mg, Prevacid 40 mg as required for GERD. The patient is also on dialysis 3 times a week and is on six different pills a day and on high dose of steroid.  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
PT REPORTED DIZZINESS TO US AFTER HER IMMUNIZATION. SHE DECLINED OUR OFFER TO CALL 911 FOR HER. WE TOOK HER BP AND PULSE. HER BP WAS 132/88 AND HER PULSE WAS SLIGHTLY LOW AT 57. WE ADVISED PT TO SIT AS LONG AS SHE NEEDS TO AVOID FAINTING, AND TO NOTIFY US IF HER STATUS CHANGES AT ALL. WE PROVIDED HER WITH A BOTTLE OF WATER.  SHE WAS WITH A CAREGIVER OR SPOUSE HERE AS WELL. AFTER ABOUT 5 MINUTES, WE TOOK A SECOND BP AND PULSE READING. BP WAS 142/99 AND PULSE WAS 56. SHE AND HER CAREGIVER OR HUSBAND PROCEEDED TO GO TO EMERGENCY ROOM. THEY PREFERRED TO TAKE THEMSELVES INSTEAD OF CALLING 911 FOR AN AMBULANCE.
This is a spontaneous report from a contactable consumer (patient's parent). A 18-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date at 05:00 PM the patient experienced nausea, dizziness, feeling unwell and did not sleep well. Outcome of the events was unknown.
Patient was 24 weeks 4 days pregnant with mo/di twins on vaccination date, due Christmas day (37 weeks).  Patient had four doctors appointments in September 2021 prior to receiving Covid vaccine.  This included two appointments with a maternal fetal medicine specialist and in-depth heart scans of the twins at Hospital with no complications found as determined by the Director of the Heart Program and Critical Care Delivery Program.   The twins were delivered less than 72 hours later at 25 weeks. Both babies did not survive, Baby A born at 1.5 oz. and Baby B born at 1.6 oz. At time of delivery Baby A was in fetal distress, Baby B had no heartbeat.
Nurse is calling to report the VAXELIS vaccine was given to an 11-year-old, she was given the infant dose.; The VAXELIS is off-label due to the patient's age, she was intended to receive DTaP; This non-serious spontaneous safety report, with reference number 2022SA497140 / Inquiry# 01396040 was received by a partner on 06-DEC-2022 and forwarded to Agency on 07-DEC-2022 from a health care professional.   Due to the nature of the event, the causality between Vaxelis and reported events "Nurse is calling to report the VAXELIS vaccine was given to an 11-year-old, she was given the infant dose", and "The VAXELIS is off-label due to the patient's age, she was intended to receive DTaP" was not applicable.  OFF LABEL classification has been added to the case.  Further information is expected.
Patient completed Moderna COVID vaccine series 5/26/2021 and 6/23/2021. Patient then received Pfizer dose on 7/30/2021 as indicated on this report.
Rash - Information has been received from a licensed practical nurse concerning a 12 month old caucasian male who on 07 Dec 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 633822/1268K o.5 ml intramuscularly on left leg.  Concomitant therapy included amoxicillin trihydrate (+) clavulanate potassium augmentin.  The licensed practical nurse reported that on 15 Dec 2000. the patient developed a rash that covered his whole body and face.  in follow up the licensed practical nurse reported that the patient developed a rash on his stomach, back and face, which started on 15 Dec 2000.  The licensed practical nurse reported that the patient was in the office on 18 Dec 2000 and the rash was all over body.  she reported that the patient subsequently recovered from his experience.  No further information is available.
7/26 eyes swollen, site pain; 7/27 site pain, ear pain, neck pain on side of vaccine radiating from shoulder to base of head, headache; 7/28 site pain, ear pain & tinnntis, neck pain same as previous day, headache; 7/29 site and arm pain; 7/30 site and neck pain; 7/31 site pain; 8/1 site pain, eyes swollen, body itchiness- needed to take several Benadryl to reduce itchiness; 8/2 site and arm pain, neck pain; 8/3 headache, eyes swollen, moderate itchiness, site and arm pain; 8/4 eye swelling, itchiness, arm pain only when using it; 8/5 arm pain only when using it; 8/6 mild itchiness on back, eyes itchy 8/7 mild itchiness on back, eyes, head, arm pain;  8/8 itchy eyes; 8/9 itchy eyes
mo states pt unable to walk on lt leg for several days, broke out in rash around immun site w/some swelling; feverish where had the shot;
Very bad muscle and joint pain in my hips, groins, and knees. My shoulders were much sorer than normal as well as I have had soreness in both shoulders which has been ongoing. My symptoms continue. My walking, sitting, and standing up, all are affected.
Pt returned to PCP on 1/22/10, bad rash on right arm treated with diphenhydramine and hydrocortisone cream. Symptoms: 1. skin rash, 2. chills, pain to left arm, flatulence, redness/swelling arm. Treatment drugs used: 1. diphenhydramine dose: units: freq: route: 2. hydrocortisone dose: units; freq: route:
Information has been received from a physician concerning a female who on 12/29/98 was vaccinated with a 2nd dose of Hep-B vaccine recombinant. On 2/14/99, the pt experienced pain in her left arm muscle (deltoid). Additional information has been requested.
Tdap-local urticarial lesion 3 cm Varicella-local urticarial-9 1/2 cm lesion
This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 08-OCT-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB injection (dose, route and frequency were not provided). Product quality complaint (PQC) was not involved. It was unknown if the patient sought medical attention. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Severe vomiting for approximately 12 hours followed by approximately another 12 hours of sickness.  No consistent fever.
Patient presented to the ED and was subsequently hospitalized for pneumonia related to COVID-19 within  6 weeks of receiving COVID vaccination.
Vomiting multiple times over few hours (3 x 12 hours). Fever (100.6).
Red and blotchy, low grade fever ache, rash/hives all over body.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (29Jun2022) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
red area, warm to touch rt thigh area of shot; treated w/ ATB  & DPH; either allergy to pertussis or cellulitis;
Received injection at 3:30 pm on October 11, 2004.  Apx 3 hours later injection site was red, very swollen, very hard and hot.  Same thing happened last year.  Doctors office told us to give Benadryl every 6 hours.
Patient c/o tickle in throat, SOB, and noted to have flushing. LVN brought patient to RN observation room for further assessment. Patient reported numbness of face/tongue, sensation of throat swelling, and coughing began at 12:47. Patient initial vs reading at BP elevated 195/109, PR 103, Resp 20, O2 sat 98%. Allergist on-call consulted, and patient given epi x1, 2 puffs albuterol, and Diphenhydramine 25mg PO with slight improvement. 911 called for transport to ED and further evaluation and treatment. Requested ED and patient wife requested to go to Hospital. Paramedics informed closest hospital for transport would be ED and patient agreed to transfer to Hospital ED.
muscle aches in neck on left side, and general muscle aches all over.  These were whose on the second day after the shot.  On day 3, all muscle aches were gone.
This spontaneous case was reported by an other and describes the occurrence of PYREXIA (a low fever like like chills) and CHILLS (a low fever like like chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (a low fever like like chills) and CHILLS (a low fever like like chills). At the time of the report, PYREXIA (a low fever like like chills) and CHILLS (a low fever like like chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment medication included Tylenol. 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.
Localized induration at injection site approximately 7 by 13 cm. Zyrtec 5 cc administered and to take 5 cc daily until resolved.
12/18/2021 02:30 am Awoke from sleep and began vomiting. Over the course of the next 10 or so hours I vomiting at least 30 times. I developed a severe headache on 12/18/2021 around noon that lasted about 1.5 hours and was a 10 on the pain scale. Through out 12/18/2021 and 12/19/2021 I experienced abbreviated symptoms of Covid 19....chills, loss of appetite, body aches, cough and tightness in chest. On 12/20/2021 I found it very hard to focus on work and my vison was very blurry. This finally subsided by noon on 12/20/2021
Day 3 I received severe vertigo which cause vomiting due to the motion and was completely down for two days. Now it is day 6 and I still have dizzy so bad that I can?t drive!
Chills, headache, stomach ache, fatigue, fever of 101.8 (ear thermometer)
Rapid pulse and heart rate, problems catching breath, pasty colored skin and headache. Severe pain all over body.  Later developed a fever of 101.
Associate c/o cough, sweating, chills, fatigue, headache, body ache