chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered- with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from an other health care professional and non health care professional via Medical Information (MI) number: 00813275.  This case involves a 18 months old male patient who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any additional concomitant disease or risk factor   On 14-Oct-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ405AAA and expiry date:08-OCT-2021 via intramuscular route in the left thigh for prophylactic vaccination.  It was unknown if the patient experienced any additional symptoms/ event  It was unknown if there were lab data/results available.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.   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.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients. The nurse reported that another office was improperly storing M-M-R II during the months of February 2013, March 2013 and April 2013. It was reported that there was a possibility that the vaccine was administered to an unspecified number of patients. No symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
I had allergy like symptoms fever congestion and bronchitis and then experienced 4 days of nausea and cold sweats and chills
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, chills; lymph node swelling Narrative:  Chills, fever 100.2, headache, myalgia, arthralgia, fatigue, nausea;
Chills, fever (100.8), trouble breathing, chest congestion, exhaustion, body/joint aches and inflammation, nausea, brain fog lasting for 24 hours follow the 12 hours after getting the shot. Following day continuing exhaustion, trouble breathing, chest congestion, brain fog. Third day continuing trouble breathing and chest congestion.
I am currently 10 days late following dose 3; I am currently 10 days late following dose 3; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 38-years-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number was not reported), via an unspecified route of administration, administered in left arm on 26Oct2021 12:00 (at age of 38 years-old ) as dose 3 (Booster), single for COVID-19 immunisation. The patient also received first dose of Flu shot (FLU VACCINE VII, formulation: unspecified, Lot/Batch number was not reported) via an unspecified route of administration, administered in right arm on 26Oct2021 as dose 1, Single for unspecified indication.Patient medical history included: ADHD, anxiety disorder, smoker. Known allergies were reported as none. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number was not reported), via an unspecified route of administration, administered in left arm on an unspecified date (at age of 38 years-old )as dose 1, single for COVID-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number was not reported), via an unspecified route of administration, administered in left arm on 21Apr2021 as dose 2, single for COVID-19 immunisation. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; marijuana (MARIJUANA) taken for an unspecified indication, start and stop date were not reported.Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unspecified date in 2021 the patient experienced that she was currently 10 days late following dose 3.The reporter assessed the case as non serious.No treatment was received for the events. The patient underwent lab tests and procedures which included COVID test (nasal swab): results was unknown in 2021. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a medical assistant concerning a 17 year old female with no known allergies and asthma who on 15-NOV--2007 was vaccinated with Gardasil (Lot #657617/0384U) intramuscularly in the left arm. Concomitant therapy included ALLEGRA. The patient was seen by the physician on 04-DEC-2007 because she developed pain in the left shoulder. The patient said that it hurt to lay on her side when sleeping and described it as can be "pinching". No further information is available because the patient has not been seen for a follow up. Additional information has been requested.
Menveo is a two-part vaccine. It has a powder in one vile that is to be reconstituted with a specific liquid from another vile. It was discovered by our vaccine coordinator that there was half of a dose left unused on three separate occasions. This was discovered in the late fall/early winter 2022. This means that there are three patients of our practice who received incomplete Menveo vaccines and we have not yet identified them. Presumably, the powder was reconstituted in a separate diluent.  We had IT run a report of all patients in a certain window of time who received Menveo at our practice. We compared it with our handwritten logs that clinical staff use to track all vaccines.  Unfortunately, the best we could do was to rule down the list to 8 potential patients. I did submit a separate report about one of these patients a few months ago as that was the first patient potentially identified   We have done lots of reeducation with clinical staff since this time. We have also implemented a protocol that all pediatric vaccines must be double checked by a second clinical staff person before being administered. Our vaccine coordinator is also taking a manual inventory weekly to ensure that should a mistake be made, we are aware of it closer to the date or error. We have also discussed with the medical director that for state supplied vaccines we are going to phase out the use of Menveo (two vial dose) and go back to using a (single vial dose.)  The course of action is to place a call to each of the 7 patients who got Menveo in the suspected time frame and explain that while we are not sure they are under vaccinated, it cannot hurt anything to repeat the Menveo vaccine. That would ensure they are fully vaccinated.   Our medical director and CDC rep has advised that a repeat dose is appropriate and should be offered to anyone affected. PCPs have been alerted and agree with the plan for office manager to reach out to patients/guardians
Dizziness after leaving clinic (20 minutes), headache and fatigue, vomiting 8AM the next morning 3/10/2021.  Continuing headache, fatigue, dizziness.  Condition improving as of 7:30PM 3/10/2021
Later in the afternoon my son started experiencing the following Fever, extremely Lethargic, and projectile Vomitting. We called and they told us to take him to the ER, but he was probably just having a reaction to his vaccines from that morning.
Hives/swelling/redness and heat on face - started around 11 and still have them at 810 pm. Took a Benadryl at 750pm
PATIENT REPORTS REDNESS, SWELLING, PAIN WITH MOVEMENT AND WARMTH TO TOUCH TO AREA OF ADMINISTRATION. PATIENT DENIES NUMBNESS OR TINGLING IN LIMBS. PATIENT ALSO STATES SHE FELT DIZZY 24 HOURS AFTER ADMINISTRATION WITH PROLONGED STANDING/WALKING.
After the vaccine he started to feel lightheaded afterwards, and he walked back in to the clinic for drinking water and passed out.  He was pale.  After a couple of minutes of lying down with a wet washcloth on his forehead, he again felt well.  Oxygen saturation was 100%, pulse rate in the 60s, had good color.  He is able to sit up and walk out of building without problems afterwards.
tachycardia, hypoxia, shortness of breath, bilateral pneumonia,  left pulmonary embolism
Nose bleed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 26May2021 17:00 (Batch/Lot Number: UNKNOWN) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 35-year-old) for covid-19 immunisation. Medical history of the patient was reported as none. The patient did not receive any concomitant medications. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had nose bleed on 26May2021 18:15. Therapeutic measures were not taken as a result of this event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of event nose bleed was unknown.  Follow-up attempts completed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient had received anti-viral medication Paxlovid as of COVID-19 treatment. Treatment started on 02Jul2022 and stopped on 06Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I've been having a dull headache for days.  Almost a numbing on the side of my head - both sides. Not sure if this is a side effect of the vaccine, but after seeing all the news reports of possible side effects, I am concerned.
Petechia 12/20, thrombocytopenia 12/21 (platelets 7K). Fever 12/20-12/21. Platelets 12K on 12/23, back to normal on 12/27 (314K).
This statement is solely contingent on the symptoms that i have developed and or aquired after the pfizer booster shot i received on 12/15/2021. I started developing symptoms of imbalance 2 days after (12/19/2021) teh booster was administered. I was experiencing pains in my back, left arm, and under neath my breast. I developed severe twitching and involuntary muscle contractions. By the date of 12/20/2021 i was unable to walk. i have become completely immobile from the waist down. i am somewhat paralyzed.
Shingles; Swelling outside of her ear and behind ear; Noticed spots on neck; Feeling unhappy; Patient did not take the second dose of vaccine; Big and painful rash characterized by patches and spots on her neck; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles), EAR SWELLING (Swelling outside of her ear and behind ear), RASH MACULAR (Noticed spots on neck), FEELING ABNORMAL (Feeling unhappy) and PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O43L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 07-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 HERPES ZOSTER (Shingles), EAR SWELLING (Swelling outside of her ear and behind ear), RASH MACULAR (Noticed spots on neck), FEELING ABNORMAL (Feeling unhappy), PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine), RASH (Big and painful rash characterized by patches and spots on her neck) and FATIGUE (Tired). At the time of the report, HERPES ZOSTER (Shingles), EAR SWELLING (Swelling outside of her ear and behind ear), RASH MACULAR (Noticed spots on neck), FEELING ABNORMAL (Feeling unhappy), RASH (Big and painful rash characterized by patches and spots on her neck) and FATIGUE (Tired) had not resolved and PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant Text: The patient post receiving their first dose of vaccine experienced big and painful rash characterized by patches on their neck and swelling behind and outside of their ear. Patient visited their primary care physician. The doctor said it might be shingles and prescribed Valacyclovir for the event.  The patient also reported that the shingles and the vaccination administered site were on the same side (Left side). The patient's second dose is due on 05 May 2021 which has already passed the 42-day mark.  No Concomitant product use was reported.  Treatment medication prescribed for the event shingles included Valaciclovir.
Three hours after receiving the vaccine my face and neck started swelling and turning red, I went to the emergency room. I contracted pneumonia and have had it twice since the initial episode, I also have two lumps in my left breast that were not there before the vaccine. I have never had an abnormal mammogram. For the pneumonia they gave me antibiotics, steroids and inhaler. My doctor has me taking steroids every time I get a vaccine.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: Administered benadryl with bottle of water, noticed improvement within 5-10 minutes. No additional symptoms. Monitored for additional 20 minutes with no worsening of symptoms.
Mother reported diaphoresis, pallor, nausea & dizziness occurring approximately 3 hrs after receiving typhoid & yellow fever vaccines. The incident occurred in pt's home. No rash, SOB or redness at injection site. Pt recovered spontaneously required no intervention.
non-verbal and could not say he felt weird; He felt weird; Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:. The reporter is the parent. A male patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 06Apr2022, outcome "unknown"; APHASIA (non-serious), outcome "unknown", described as "non-verbal and could not say he felt weird"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "He felt weird". Customer Verbatim: Hi, my son received your vaccine on 05Apr2022 and had a seizure on 06Apr2022, less than 24 hours of taking your vaccine. My son has Autism and has never in his life had a seizure. He is non-verbal and could not say he felt weird. You all need to tell people about this stuff before pushing it out to the public. Now, my son may have to deal with this additional hurdle for the rest of his life. I am going to tell every parent of disabled kids that I know. I regret giving this to my son. Do More Resear  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills, body aches, facial rash, swollen posterior auricular lymph node, headache, malaise, lightheadedness.
Chicken pox like rash on torso, confirmed as chicken pox by physician. Treated with caladryl lotion and oatmeal baths. Had repeated outbreaks 5x during the next four months.
Flu like symptoms, muscle aches, malaise, numbness/tingling in hands and feet and mirgaines. Went to PCP, the did a CT scan. DR said they saw some degeneration in her neck which could cause the mirgraines. RX for prednisone and Medrol. PT is still having weakness in her left foot and numbness/tingling in her hands.
Starting in early June, have severe muscle cramps in both biceps lasting 1 minute. Occurred six different times through now. Also, legs buckled on me, similar to my wife, on Sunday, July 25.
Following the vaccine admin patient felt a wave coming over her and passed out she experienced tunnel vision and was clammy. She was placed on the floor and was then placed on a back board and taken to medical observation, patient wears a continuous glucose monitor and her mom reported that her bld glucose was 129, patients vital signs upon arrival was  120/65, P 71, Ox 98% on room air @ 10:35, at 10:40 her blood presure was 120/78. she was then placed in a sitting position and bp was 119/79 and then standing after 1 minute was 121/74- patient was released from observation via wheelchair she was taken to the exit with her mom and she exited the building.
Immediate and lasting arm pain through day 4 Extreme Fatigue resulting in inability to do job for 3 days after Cold flashes for about 2 hours the day after Headache still lasting Motion sickness/Dizziness/Lightheadedness - comes and goes, still exists
Pt stated she had a lot of pain & swelling the next day and the swelling got increasingly bigger over the week. 2nd day, she woke up to her eye being blood shot (sclera will all bloody contained inside). There was pain on touch; when examined on 12/28/18 the affected area was still hot on touch.
fever; slight cough; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 18May2021 (at the age of 51-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller stated that she received the first dose of the Pfizer COVID-19 vaccine on 18May2021 and on an unspecified date in May2021, had a fever and was experienced slight cough. She was just wondering if having a cough or slight cough one of side effect. She was asking if this was a side effect from the vaccine and was there "Sulfur" in the vaccine. Product details and pharmacy details could not be probed as the consumer hung up abruptly. Hence limited information available over the call. The outcome of the events was unknown.  Response: No information found  Revised: 19May2021  Information about lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
No adverse reactions.  Menactra + Adacel given.  1 month prior to age 11.
loss of taste; This is a spontaneous report from a Pfizer. A contactable male consumer reported. A male patient with unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Not reported) via an unspecified route of administration on 23Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced loss of taste. The patient was tested for covid 6 or 8 weeks ago and came back negative. Clarified noticed loss of taste after vaccine. The patient underwent lab tests and procedures which included SARS-CoV-2 test and resulted negative on unspecified date. The outcome of the event was unknown.  Information of batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Oval, round shape red rash about 3 inches in diameter at injection site 1 week after administration. Smaller size rash was present for days 1 and 2 after administration with soreness, and then went away. Now, 1 week after administration, this larger rash reappeared. It is hot to the touch and itchy, arm is sore again after no soreness for 5 days.
There's a lump in my right arm and it still hurts and if I even move my wrist it hurts all the way up my arm.  I have pain up into my shoulder. I can barely use my arm. I don't sleep on my right side so I am not sure why it is still so swollen with this lump and is painful.
Pt had just left the office and we heard parents call out from the hallway that child had passed out.  When RN responded, dad had lifted child by the waist and she was bent forward and unconscious. Once patient was laid back on the floor, she was immediately responsive.
A poison like rash on hands, feet, and back of neck.  Macular rash hands neck. Sl edema of hands. VS stable (see note).
pt recvd vax;devel hives on face, arms, chest,legs & abd rash 2 days later; 12 days p/ vax sxs worsened & was hosp; rx steroids & atbs; MD dx intermittent urticarial rxn; consulting dermatologist dx: reaction to td;
My joints, my knees, my wrist, my hips etc. started to get stiffer. They seemed to get slowly worse over time. I felt like an old man. I had that same reaction from statins years ago. The doctor prescribed me dexamethasone. I took a tablet every 6 hours. It was a two-day dosage. Within the first 6 hours I started to feel better. I slowly feel it going back to the way it was before.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J006236, expiration date: 25-FEB-2016), dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.