chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RECEIVED HALF DOSE (0.25 ML); This spontaneous report received from a health care professional concerned a 64 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 18-FEB-2023) 0.25 ml, 1 total, administered on 14-DEC-2021 for covid-19 prophylaxis. On 14-DEC-2021, the patient received half dose (0.25 ml) of vaccine (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 18-FEB-2023) 0.25 ml, 1 total, administered on 24-JUN-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 64 years old. No concomitant medications were reported.  On 24-JUN-2022, the patient received half dose (0.25 ml) of vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received half dose (0.25 ml) was not reported. This report was non-serious. This case, involving the same patient is linked to 20230426062. This case, from the same reporter is linked to 20230426106.
Disorientation; Off Balance; Emotionally Off; Shaking; Swollen Injection Site; Fever (Low grade); This spontaneous case was reported by a nurse and describes the occurrence of DISORIENTATION (Disorientation), BALANCE DISORDER (Off Balance), EMOTIONAL DISORDER (Emotionally Off), TREMOR (Shaking) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) 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 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) at an unspecified dose. On 03-Feb-2021, the patient experienced DISORIENTATION (Disorientation), BALANCE DISORDER (Off Balance), EMOTIONAL DISORDER (Emotionally Off), TREMOR (Shaking), VACCINATION SITE SWELLING (Swollen Injection Site) and PYREXIA (Fever (Low grade)). In February 2021, DISORIENTATION (Disorientation), BALANCE DISORDER (Off Balance), EMOTIONAL DISORDER (Emotionally Off), TREMOR (Shaking), VACCINATION SITE SWELLING (Swollen Injection Site) and PYREXIA (Fever (Low grade)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication information provided.  No treatment medication information provided.
No additional AE/PQC.; patient received an expired dose of PROQUAD; This spontaneous report was received from a office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 03-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter (ml) once (lot number S003868 which has been verified to be valid, expiration date reported and validated as 08-AUG-2020) (vaccination scheme, route of administration, and anatomical site of injection were not reported) as prophylaxis (expired product administered). No additional adverse events were reported in the patient.
approximately 4 x 3 inch welt at injection site, area is warm with redness
Abnormal head shaking w/out change in level of consciousness w/in 1 hr after 6m vaccines. (PENTACEL, PREVNAR, Hep B, Rota). 02/23/2017-Both parents are here due to concerns about movements. Patient had immunizations 2/14/17 and mother states that 1hr after apt he started shaking his head "back and forth" Looking right to left, and would do it for a few seconds and stop. No LOC, No perioral cyanosis, no uprolling of eyes, foaming at mouth or abn movements of limbs associated with this rocking head movement. No fever and mother noted that he is otherwise eating and drinking well with no labored breathing, inconsolable, irritability. Since that first day - this head rocking activity has been occurring Daily 2-3 times per day and up to 5-6 times lasting about 1 min but mom says his name and stops. Last episode was just prior ot arrival and parents have a video him doing this. No previous history of stereotypic movements. Reviewed history - developmentally appropriate for age. Bhx - noncontributory. Viewed phone video of and movements - for 3 seconds he had symm rocking of his head back and forth without eye movements that is associated with movement of b/l lower extremities symmetric movements. 05/11/2017- Pt is here with mom. Dad is sick with head cold mom would like patient checked - showing no sx bruise on left wrist x2 (mom states its not going away). Mother unsure about future vaccines. Had abnormal head shaking without change in level of consciousness starting within 1 hr after 6 m vaccines were administered on 2/14/17 (rec'd PENTACEL, PREVNAR, Hep B, Rota). Pt seen here by Dr on 2/23/17 for this complaint, inc video of the head movements which were felt to be benign purposeful movements. Mother has read online about other children experiencing similar head movements after vaccines and feels strongly that they are related due to the timing. Head movements have gradually decreased in pat 2 mos and now has not had any for few days. Also was more fussy after the vaccines for weeks, has finally resolved.
Constant muscle twitching starting under both eyes and then lower legs (shin, calves, feet)
"allergic to egg got flu shot with egg" Team member was accidently given the wrong flu vaccine by administrator. TM developed throat swelling and hives. Needed IM Benadryl, EPI pen. Sent to ED for monitoring
Temperature of 101.7 degrees Fahrenheit for 24 hours. Temperature ranging between 99.0-99.6 Farhrenheit following fever break, and has been consistent and is continuing. Headache consistent and persistent within 24 hours of vaccination and has continued without end.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccines were stored in freezer and took out one to two vials and place in fridge each day as needed. No concomitant medications were reported. No treatment given.
Welts appeared around waist and up back. The welts itched. Noticed them the day after.
Tingling sensation that went up her neck and onto her cheek; tingling sensation that was itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling sensation that went up her neck and onto her cheek) and PRURITUS (tingling sensation that was itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and VITAMINS NOS for an unknown indication.    On 21-Jan-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021 at 8:00 PM, the patient experienced PARAESTHESIA (Tingling sensation that went up her neck and onto her cheek) and PRURITUS (tingling sensation that was itchy). At the time of the report, PARAESTHESIA (Tingling sensation that went up her neck and onto her cheek) and PRURITUS (tingling sensation that was itchy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment details provided for the patient were-on 21Jan2021 patient took loratadine and on 22Jan2021- patient took diphenhydramine.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer or other non HCP. This consumer (patient) reported for himself that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced tested positive for covid-19. The event was serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Event took place after use of product. The clinical outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This started with a bad sore throat, cough, congestion, and headache.  Tested positive with an At Home COVID-19 Test and then continued having slight fever, 99, sinus pain and pressure. Then on 8/22 I reached out to doctor who proscribed an antiviral.  Felt better by 8/24.
Patient seen on 1/8, 1/9 and 1/11 in ER at Hospital for Chest pain.  Work up negative for acute coronary syndrome.  This started hours after 2nd dose of COVID 19 vaccine.  Pleuritic type pain.  She was sent with aspirin and monitored.  On her 3rd ER visit was given medication for anxiety and to aid in sleep (ativan).   Symptoms continued and she was off work the week of 1/11 because of this.  Seen in Clinic on 1/18 and symptoms had stopped on 1/17.
arm was all red underneath of where the injection was given, between injection site and elbow it was red, inflamed and warm to the touch; arm was all red underneath of where the injection was given, between injection site and elbow it was red, inflamed and warm to the touch; arm was all red underneath of where the injection was given, between injection site and elbow it was red, inflamed and warm to the touch; received a Fluzone QD in the lateral aspect of her arm and not the deltoid muscle; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 8 years old female patient who experienced arm was all red underneath of where the injection was given, between injection site and elbow it was red, inflamed and warm to the touch (vaccination site inflammation), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  On 15-Oct-2019, the patient received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UJ256AA, exp date Jun 30, 2020) in the lateral aspect of her arm and not the deltoid muscle via unknown route.  On an unknown date (unknown latency), the patient experienced arm was all red underneath of where the injection was given, between injection site and elbow it was red, inflamed and warm to the touch (vaccination site inflammation with vaccination site warmth and vaccination site erythema).  It was an actual medication error due to Vaccine administered at inappropriate site. It was reported that the patient received a Fluzone QD in the lateral aspect of her arm and not the deltoid muscle.  On an unknown date, it was reported that the reporter was concerned that the child will not have enough protection, as it was not given correctly by nurse.   It was not reported if the patient received a corrective treatment.  The outcome of the events were reported as unknown.  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 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.
Almost died; Passed out; Headache problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "Almost died"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Passed out"; HEADACHE (non-serious), outcome "unknown", described as "Headache problems". Clinical course: Reporter stated that her grandma passed out and almost died. She said that her grandma had headache problems and started passing out randomly.  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-PV202300108339 same reporter/drug, different patient/event;
Client reported dizziness, "feeling lump in throat" and sleepiness within 30 mins of receiving 2nd dose Pfizer vaccine. Client reported allergy to benadryl. Vitals at 1447: BP 136/84, pulse 83, oxygen 100%. Client alert and oriented x 4, speaking in full sentences, no swelling noted. EMT called 911. Client denied headache,  chest pain, blurry vision. Vitals at 1452: bp 136/86, pulse 85, oxygen 98%. EMS arrived at 1453 and assumed care. Client signed AMA and left home. Client left facility with steady gait. PHN gave client ER precautions and advised to follow up with provider.
She experienced achy-ness in the injection arm; Booster shot on 30Dec2021; Experienced  immediate pain in the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, did not experience any side effects with her first two Pfizer Covid vaccine shots.), for COVID-19 immunization, reaction(s): "did not experience any side effects"; Bnt162b2 (Dose: 2, did not experience any side effects with her first two Pfizer Covid vaccine shots.), for COVID-19 immunization, reaction(s): "did not experience any side effects". The following information was reported: Immunisation(non-serious) with onset 30Dec2021, outcome "unknown", described as "Booster shot on 30Dec2021"; Vaccination site pain(non-serious) with onset 30Dec2021, outcome "unknown", described as "Experienced  immediate pain in the injection site"; Pain in extremity (non-serious) with onset 31Dec2021, outcome "unknown", described as "She experienced achy-ness in the injection arm".  Additional information: Event took place after use of product. Experienced immediate pain in the injection site.Patient said that the following day, experienced achy-ness in the injection arm. withheld said that did not experience any side effects with her first two Pfizer Covid vaccine shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After 1st pill rapid heart beat (100 per minute) for 4 hours.  After 2nd pill rapid heart beat (100 per minute) for 24 hours - Doctor advice discontinue pills.
On March 16, 2021, I had flu like symptoms.  On March 17, 2021, I noted some tingling in my right hand that would not go away.  Like my fingers had started to go to sleep.  On March 18, 2021, I noted back pain with the persistent tingling in my right hand.  On Saturday March 20, 2021, I went to Urgent care for my symptoms. Diagnosed with Complex Regional Pain Syndrome Dec 16,2021
10 minutes After receiving the vaccine; Pt looked pale and his Blood pressure was going down. pulse rate were normal he felt little dizzy. He mentioned about having anxiety issues. we monitored him and the called 911 EMTcame and monitored him but he felt fine after eating lunch
My vision had 5-7 water bubbles that appeared with blood-stained edges. They would move as I looked at things for about 10 minutes. Was on a walk and went home and sat in a chair. 4 hours after injection my neck and upper back was killing me. I have had a previous injury from a car wreck 40 hears ago. I slept in the chair that night and the next days on a heating pad. My back felt like a horse kicked me. The next day my eyelids were too heavy to lift for about the duration of a movie. I could not fall a sleep, but could not lift my eyelids. I had vaccination on Friday night. I could not stand any sunlight until Sunday. My sinuses were killing me and the back of the head. On Sunday afternoon I could eat chicken broth and drank lots of water. By Sunday night, I felt fine and ran 5 miles on the treadmill. Feel great now.
uncontrollable chills, fever, headache, fatigue, lack of appetite, foggy head
RIGHT ARM, SWOLLEN, WARM, RED FROM SHOULDER TO ELBOW; PT WITH LOW GRADE FEVER.
"22 y/o F presented to clinic complaining of rash that is spreading over her entire body. PT describes the rash as feeling tight on the skin, itchy, and stinging. PT states that she received her vaccines for Hep A and HPV yesterday and attributes the rash to a reaction to on of those shots. PT denies any difficulty breathing, SOB, or wheezing. PT does not appear to be in any acute distress."  Once seen by medical professional her skin condition was described as such: "erythematous papules noted spread diffusely across entire body. No weeping, lesions, or open sores"
It began with joint pain in the knees moving to other major joints and then followed by headache, chills and sweats. As well as; dizziness, arm soreness, back pain and fatigue. For the second dose of the vaccine. for the first does of the vaccine it dizziness and arm soreness.
Fever 99.7 max fatigue aches; diarrhea started Saturday stomach upset.
Patient received her second dose of her vaccine and during her 15 minute observation period the patient passed out and struck her head on the floor. She did take a minute to respond to the nurse at her side and has no recollection of the event or hitting her head. She was moved in to an observation area and she reported feeling dizzy and lightheaded prior to her syncopal episode.  Because she struck her head directly on the floor EMS was called to the clinic. She refused EMS transportation to the hospital.  Her husband arrived to the clinic and reported he would be transporting her for further evaluation.
I felt dizzy and had a bad headache about an hour after my vaccine. I started running a high  fever, very nauseous , and I developed itchy hives all over my body. I also started to feel my tongue swell. I immediately took Benedryl  knew I was hving an allergic reaction>because I I called  New Madrid Pharmacy that morning when they opened. I had a tele med doctors appointment and the doctor prescribed and steriod. My docors office was closed because of a snow and ice storm. I started having a bad cough,runny nose, and continued to run fever so they also called me in an antibiotic.
Took Hep. B this morning.  Felt faint, light-headed, laid 20 min an went back to work.  1-1.5 hours later experienced throbbing headache and heavy neck.  Post Hep B injection questionable reaction.
pt recv vax & exp a varicella-type rash which crusted over & cont to itch;MD stated that he was not pt attending physician;
Pain swelling warmth at injection site , pain in fingers , rashes appearing around . Size is growing . Feels like golf ball under skin . Also now itchy
Saturday 10/15/2016 upon standing from chair right leg not working, basically stand realize leg not working hold on to chair, shake leg wait for motor return. Sunday night Monday - right Thoracic/Rib pain excruciating - continued intermittently with Right leg weakness.
Dose that was administered to the patient had been left in the syringe at room temperature for 17 hours (11 hours past the expiration). Vaccine was administered with no adverse event noted by the patient.
Pilonidal cyst; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have any allergies to medications, food, or other products. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C) and vitamin d nos (VITAMIN D); taken for an unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19.  On 12Apr2021, the patient experienced pilonidal cyst. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse event and included cyst drained and wound left open to heal. Since the vaccination, the patient had been tested for COVID-19. On unknown date in Mar2021, the patient underwent color test and the result was negative and on an unknown date in Apr2021, May2021, Jun2021 and Jul2021, the patient underwent color test and the result was unknown. The clinical outcome of the event pilonidal cyst was recovered on unknown date in 2021 at this time of this report.
Patient is a 49 year old male with a form of mental handicap. The patient's mother informed us of a possible reaction to the vaccine today. The first time any reaction was noticed was on August 19th, 2021- the reaction was described as "muscle jerking" by the mother. Over the next 4 days the patient became lethargic, sleeping more than usual. As the mother describes, by the 6th day post vaccine, the patient had lost the ability to stand. She described that the patient could move all but his left arm on command. On that day, severe diarrhea had started, leading to bowel incontinence.