chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness; Redness; Rashes all over body; Muscle pain; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness), RASH (Rashes all over body), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (Fever). 30-Jun-2021, the patient experienced RASH (Rashes all over body). At the time of the report, PRURITUS (Itchiness) had not resolved and ERYTHEMA (Redness), RASH (Rashes all over body), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (Fever) had resolved.            No Concomitant medications were reported.  No Treatment information was reported.
I lost consciousness at least 3 times.  I had no warning signs of feeling faint.  I was disoriented and I do not remember all of the details.  It was not a normal fainting spell.  It was a complete loss of consciousness and I would "come to" on the ground.  After the third time I realized that i was not dreaming and that is when i realized that I was having a serious adverse reaction to the CoVid Vaccine booster and needed to seek medical attention.
I got aborted after getting two-shot; Vaginal Bleeding/ continuedly bleeding; 20 times blood works; I was emotional damaged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 30-year-old female patient (pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD TEST ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "20 times blood works"; EMOTIONAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I was emotional damaged"; VAGINAL HAEMORRHAGE (non-serious) with onset 2021, outcome "unknown", described as "Vaginal Bleeding/ continuedly bleeding"; ABORTION (hospitalization, medically significant) with onset Nov2021, outcome "unknown", described as "I got aborted after getting two-shot". The event "i got aborted after getting two-shot" required emergency room visit. The patient underwent the following laboratory tests and procedures: 20 times blood work: Unknown, notes: abnormal.  Clinical Course: Admission to hospital was required due to the event. Patient not sure, Still Experiencing and affect next pregnancy. Vaginal Bleeding complete abortion at the hospital's Emergency dept. Patient finished covid Pfizer vaccination on 28Jun2021 and patient was pregnant on Nov2021 Doctor asked her if Patient had gynaecological diseases. None, she just gave a birth and her first baby born 1 years. She was healthy never had any problems. she was so observed 3 weeks 20 times blood work. Stayed in the bed. Continuedly bleeding. Finally her doctor said she cant save this baby and she was sent to emergency room for abortion. This year march patient saw the news about Pfizer side effects cause gynaecological diseases' was emotional damaged. Patient got recovery check and asked her doctor if its because of Pfizer and she said yes. Patient need Pfizer pay for it because her baby was innocent.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received unauthorize dose of Moderna Bivalent. Mother reported fever and fatigue for 24 hours following however within 48 hours symptoms resolved. Mother denied any further complaints.
Excruciating back pain, severe nausea, vomiting, abdominal pain, and fatigue.
12 hours after the vaccine, his arm became swollen, hot, hard and red from the shoulder to the elbow. His Mom took him to Urgent care and they told her to give him CLARITIN. We spoke on 10/24/17 and the arm was no longer hard but was still warm and red. Mom is to consult with her pediatrician about next year's flu vaccine. I sent her the package insert.
Sore shoulder and neck, continued to get worse each day and travel from shoulder to neck upper back and down arm of side vaccination was on, it is 7 days later and I had to intermittently lay on ice or heating pad all night last night to get any sleep, my lymph nodes feel swollen on that side under my arm and in my neck  I am trying to reach my Dr about it.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-DEC-2012, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
She claimed that 24 hours, post vax, she developed chills, body malaise, nausea, redness and tenderness at injection site. She was bed-ridden on the following day and noted swelling and increased pain at injection site. All symptoms resolved on 2/12/01, 5 days, post vax.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
A couple days after receiving the vaccine, I broke out in severe hives. My whole body began to itch & the hives has been coming and going for the past month. I took Benadryl & used hydrocortisone to help alleviate the itch. However, it is only temporary relief. I went to see my doctor about a week after, and my doctor informed me to take Zyrtec & Benadryl. As of today I am still breaking out in hives, and broke out again yesterday (1/16/22).
Dizzy; Fatigued; worsened; Arm was still aching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose 1, single (Batch/Lot number: unknown), in right deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Oct2023, outcome "recovered", described as "Arm was still aching"; DIZZINESS (non-serious) with onset 19Oct2023, outcome "recovered", described as "Dizzy"; FATIGUE (non-serious) with onset 19Oct2023, outcome "recovered", described as "Fatigued"; CONDITION AGGRAVATED (non-serious) with onset 19Oct2023, outcome "recovered", described as "worsened". Therapeutic measures were taken as a result of dizziness, fatigue, condition aggravated, pain in extremity.  Additional information: patient started feeling very dizzy and fatigued after a 3 mile walk which worsened. Took Tylenol went to bed and woke up after sleeping 5 hours. She took more Tylenol since her arm was still aching. 48 hours after she woke up feeling better. By Sunday she was back to normal. Covid prior vaccination: no. Covid tested post vaccination: no.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
7/22/21 Meningitis Vaccine.   8/1/21 Small welts began on bilateral elbows (started oral bendryl), progressed to red rash and large welts on bilateral arms (worst on underside of forearms) and severe bilateral hand swelling on 8/2/21.   Steroid injection and steroid cream started on 8/2/21 with little improvement and new target lesions on palms of bilateral hands in the evening.    8/4/21 mild improvement in swelling and rash.  8/5/21 hand lesions began to improve with continued improvement in rash and swelling over next several days.    8/6/21 right shoulder and knee became very painful in evening and unable to lift arm; shoulder pain, weakness, decreased ROM much more severe on 8/7/21.  (continued...)8/8/21 continued with severe pain, weakness, and decreased right shoulder ROM.    8/9/21 Doctor appointment with PCP, ordered lab work and x-ray of right shoulder.    8/10/21 Awoke with new left shoulder severe pain, weakness, and decreased ROM; unable to lift left arm. By this time he has weakness throughout Bilateral UEs, unable to lift either arms, and now required maximal assist with dressing, reaching head / face for grooming, preparing / cutting food, opening doors, etc..., he was no longer able to drive.    8/11/21 recheck with physician: lab work WNL except CRP elevated to 13.64mg/L, Normal right arm x-ray. PCP sent referral to orthopedic surgeon.     8/12/21 appointment with Ortho: left shoulder and cervical spine x-rays orders, results normal; MRI of bilateral shoulders and cervical spine ordered, also normal. Ortho sent referral to neurologist.    8/13/21 appointment with Neurologist: diagnosed with pain and weakness from inflammation due to meningitis vaccine. Oral steroid ordered x8 days. Gradual improvement in symptoms over next 3 weeks with minor residual weakness of bilateral shoulders with external rotation.
I HAD THE PFIZER VACCINE ADMINITERED AT FACILITY ON 3/31/21. THIS WAS THE FIRST DOSAGE. ON DAY 5 I HAD PAIN IN MY LEFT LEG FROM GROIN TO CALF. BY DAY 5, I BEGIN TO LIMP, MY LEG WAS BURNING, INCREASED PAIN AND I COULD FEEL WHAT I BELIEVE TO BE BLOOD CLOTS AND MY LYMP NODE IN MY LEFT GROIN FELT SWOLLEN. OVER THE COURSE OF 2 DAYS, THE PAIN BECAME WORSE. I CONTACTED MY DOCTOR AT FACILITY FOR A TELEPHONE INTERVIEW IN REGARDS TO WHAT I STATED ABOUT THE PAIN. CLOTS, SWOLLEN LYMP NODES ETC.. AND EXPLAINED THAT THIS OCCURED AFTER OBTAINING THE COVID-19 VACCINE. I WAS ADVISED TO HAVE A DOPPLER PERFORMED AT THE ER. I WENT TO THE ER LATER THAT EVENING AND WAS TOLD THAT DOPPLERS WERE NOT COMPLETED AFTER 4 P.M. BLOOD WORK WAS PERFORMED BY HOSPITAL. MY LAB WORK WAS NORMAL AND I WAS ADVISED THAT I WOULD BE CONTACTED THE NEXT MORNING FOR AN APPOINTMENT FOR THE DOPPLER. ON 4/8@1:00 PM, I HAD THE DOPPLER PERFORMED AT HOSPITAL. I WAS TAKEN BACK TO THE ER AND WAS INFORMED THAT I HAVE DVT AND THIS WAS POSSIBLY LIFE THREATING. I HAD NO PRIOR HISTORY OF CLOTS. I'M CURRENTLY TAKING ELIQUIS FOR THE BLOOD CLOTS, WEARING A COMPRESSION GARMENT AND TYLENOL FOR PAIN. I WAS ADVISED TO HAVE ANOTHER DOPPLER COMPLETED IN 6 MONTHS
Whole left side of face is numb. No feeling in lips, ears, jaw line, cheek area on left side.
Erythema and swelling at injection site approx. 6 cm x 2.5 cm with induration but no flucuation.
Left upper arm, at site of injection, has become red, hot, and swollen but with minimal pain reported.
pt recv vax 14OCT97 & returned to clinic c/o arm stinging & burning;area redness size 1/2 dollar noted;no other complaints;arm still red & swollen on 15OCT97;some sl redness still present 17OCT97;
Pt. was given a flu vaccine (pt previously received 3 doses in life). After discharged, pt was brought back by family d/t pt. was unresponsive, foaming in the mouth and in a postictal state. Pt. was taken to ED then followed up in the clinic the following day.
LITTLE DISCOMFORT; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced phenergan allergy when treated with promethazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: 23-AUG-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced little discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little discomfort. This report was non-serious.
Two days after my second Covid shot I developed serious chest pains that radiated into my left arm. I went to the ER and was told my troponin levels were severely elevated and I needed to be admitted to the hospital. I was told I had developed myocarditis and pericarditis as a side effect of my vaccine. I spent two nights in the hospital before my troponin levels began decreasing.
Febrile seizures with temp 103.1 per ER. TYL/MOTRIN given at ER.
patient had first lifetime seizure (loss of consciousness, loss of urine, with post ictal period afterwards)
Initial physician report received on 13 Aug 2010: This patient was vaccinated with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error.
This spontaneous report has been received from a health commissioner also reported as administrator who was referring to a 4 year and 10 months old female patient. Information on medical history was not reported. On 19-NOV-2009, the patient was vaccinated with the first dose of (Merck) VARIVAX. 0.5ml subcutaneously (lot# and exp not reported). It was reported that on 27-JUN-2013 the patient was vaccinated with an extra dose of varicella vaccine; single dose of both (Merck) VARIVAX (lot# expiry date not reported) 0.5 ml, subcutaneously, and (Merck) PROQUAD (lot# expiry date not reported) (dose, strength, frequency, route, indication not reported) were administered on the same day. No adverse effect was reported. Additional information has been requested.
After the vaccine was given patient only had a sore arm. Then 2 days later, developed right facial weakness and clinically diagnosed with Right Bell's Palsy. Patient was given 5 day course of Prednisone. Symptoms slowly improved over the next 3 weeks. Was evaluated by Head and Neck Surgery on 8/31/2021 and symptoms had almost completely resolved. Per the exam note "On maximal effort there is minimal noticed weakness of the right orbicularis oris for complete eye closure.  There is mildly decreased right oral commissure excursion with smiling, there is symmetric movement of the forehead and lower face." Patient did receive her second dose of COVID vaccine on 8/31/2021.
Information has been received from a health professional concerning a 53 year old female who in 1998 was vaccinated with a three dose series of hepatitis B virus vaccine rHBsAg (yeast).  "Now" when her titer was checked it was negative.  After the first dose the pt experienced redness and swelling at the injection site.  No additional information was available at this time.  Unspecified medical attention was sought.  Additional information has been requested.
During observation period following patient's first dose of Pfizer COVID-19 vaccination, patient began to experience some difficulty swallowing and became nervous and flagged down observation team. Staff noted angioedema on the patient and assessed she had a strong heart rate of 98 bpm, 16 RR, 99 O2, 138/88 BP. Was given 50 mg of Benadryl and symptoms began to improve. Patient began to recover quickly. EMS arrived on the scene, patient declined transport by EMS and seemed to recover from event.
we elected to have our 11 year old twins vaccinated; we elected to have our 11 year old twins vaccinated; Their resistance to allergens was better; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 11 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "we elected to have our 11 year old twins vaccinated"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Their resistance to allergens was better".  Additional information: Reporter stated that when announced the vaccine safe for 1216-year-olds, reporter elected to have 11 year old twins vaccinated. Reporter only had to give verbal approval, parental signature etc, so advised they were of age to receive the vaccine. Technically, they'll be 12 this year, reporter didn't want them to be restricted for summer camps/events planned. Reporter wanted to share information and the fact they have not had any adverse effects, not even a sniffle, and if anything noticed their resistance to allergens was better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198669 same reporter/drug/AE, different patient
approx 10 days p/vax pt devel rash w/blistered lesions on left shoulder w/secondary cellulitis
Experienced "tingling" feeling in inner thighs; Later her right ankle "swelled up"; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "Experienced "tingling" feeling in inner thighs"; JOINT SWELLING (non-serious), outcome "unknown", described as "Later her right ankle "swelled up"".  Additional information: Swap reported 16 year old patient received first dose last weekend, experienced "tingling" feeling in inner thighs, later her right ankle "swelled up," asked if they can provide any medical advice on whether it is safe to provide second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The following morning I was fatigued but also started receiving an acute pain in my left hip that I have never experienced before taking the Covid shot. My experience of the pain felt like an electrical shot wave, short pain but sharp that was on going sporadically. The pain started to lessen before going to bed around 11:00 pm. By morning it had almost disappeared and the following days ahead I only felt it a few times until Sunday morning May 22, it started to resurface.  I had hope it was the end of this new occurrence.        I know how important it is to get vaccine, but with this strange occurrence and pain, I am now apprehensive about my next shot if this doesn't go away.
PATIENT PRESENTED TO HOSPITAL WITH COMPLAINTS OF DYSPNEA, COUGH, WHEEZING X 1 WEEK.
feel bad; Her hip, knees, arms hurt; Her hip, knees, arms hurt; hardly walk; dizziness; vomiting; has no strength; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 01Jul2021 at night, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jul2021, 1 day after the administration of first dose of vaccine, the patient felt bad and continued even at the time of reporting. On an unspecified date in Jul2021, after the administration of first dose of vaccine, the patient's hip, knees, and arms hurt. Patient had no strength and can hardly walk. Patient enquired whether this was normal. Patient also mentioned that, about 8 days ago she had a lot of dizziness and vomiting. Patient enquired whether she should get the second dose. The clinical outcome of the event feel bad was not resolved, and the clinical outcome of all other events was unknown.  Information on the lot/batch number has been requested.
Pt. reports she developed a burnt taste and smell as well as a loss of taste and smell one week after having the second Covid 19 virus vaccine. She states she did have Covid 19 virus back in February of this year and had lost her taste and smell during period of illness but symptoms had resolved.
expired dose of PENTACEL was administered with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00674627) and transmitted to Sanofi on 08-Jul-2021.   This case involves a 2-month-old male patient who administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB (PRP/T) VACCINE [PENTACEL (VERO)] vaccine.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE.  On 08-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ336AAA and expiry date: 05-Jul-2021] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired product administered [Latency: on the same day].  No adverse effects have been reported.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
10/14/2019 Grandmother noticed redness, swelling, and warmth to touch at injection site around 10:00 PM.  Grandmother applied ice pack to injection site and surrounding swollen area.  Grandmother and patient arrived in clinic again 8/16/19 to have arm observed.   On 8/16/19 at 10:27 AM, I observed upper left arm was swollen about 10 inch diameter area, redness, pain, and warm to touch at the site.