chrisvoncsefalvay/vaers-outcomes huggingface dataset:
quadracel was administered to a three year old patient with no reported adverse reaction; Initial information received  on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient who had quadracel was administered to a three year old patient with no reported adverse reaction after receiving vaccine diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [quadracel].  The patient's has no past vaccination(s). The patient's past medical history, medical treatment(s), and family history were not provided.  On 19-Apr-2023, the patient received a dose 4, 0.5 ml once of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection lot C6002BA, expiration date 18-May-2024 via intramuscular route in unknown administration site for immunization.  On 19-APR-2023 the patient developed a non-serious event quadracel was administered to a three year old patient with no reported adverse reaction (product administered to patient of inappropriate age) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event quadracel was administered to a three year old patient with no reported adverse reaction.  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 guidelines. 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.
Left leg tremor.  Occurs when in a seated position.  Does not occur when walking around or when lying down.  Has never happened before.  No other symptoms noted.  Only effecting the left leg.
Patient came a week early for the 2nd dose Moderna vaccine today. Vaccine given and Patient was observed for 15 minutes for any adverse reactions.  Patient showed no adverse reaction at this time. Patient  was stable when he left facility.
This spontaneous report refers to a 60 year old female patient with drug reactions/allergies to penicillin. The patient had no pertinent medical history. On 30-SEP-2013 the patient was vaccinated with ZOSTAVAX vial, subcutaneous. Dose, lot and expiry date were unknown. Concomitant therapies included LIPITOR and estradiol, ACTIVELLA. On 30-SEP-2013, 1 day after onset of therapy the patient developed chicken pox, itching and raging rash. The patient called in to report that she had been diagnosed with chicken pox ever since getting ZOSTAVAX. She received the vaccine in the morning and by that evening had experienced a raging rash that appeared 3 times in the following weeks and also experienced an outbreak of chicken pox. She was prescribed VALTREX (manufacturer and dosage unspecified) for 7 days and also received an unspecified steroid shot (manufacturer and dosage unspecified). She was given an unspecified steroid cream (manufacturer and dosage unspecified) to use on the rash. She was also advised to take BENADRYL (manufacturer and dosage unspecified) and CLARITIN (manufacturer and dosage unspecified) as needed for relief of the itching. The outcome of events was reported as not recovered/not resolved. The patient had sought medical attention (seen by physician). Additional information has been requested.
This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jul2021 at 10:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Jul2021, the patient experienced painful and large swelling of lymph nodes (especially around neck, underarms and chest), swelling of lips and numbness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events painful and large swelling of lymph nodes (especially around neck, underarms and chest), swelling of lips and numbness were not recovered at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
LEFT ARM HAD AN AREA OF 10X6 MM OF INDURATION AND ERYTHEMA. TENDERNESS AND SLIGHT FEVER LAST NIGHT (6/14/07).
Patient passed out fell out of chair onto floor bumped head after receiving meningococcal and Hep B vaccines.  Regained consciousness within 30 seconds
dose given after vials stored in dry ice box ran out of batteries, thus deemed compromised by CDC
Whole body Joint pain, muscle pain, nerve pain, Ongoing headache, nausea and gagging  Chills,  inability to sleep , thirst, weakness
Ten minutes after - headache for about 10 hours. About 26th, my back and neck - the joints were sore and I couldn't get out of bed. On 27th - felt better; but my foot (right ball, top of foot and big toe and toe right next to big toe) started swelling up. I went to the Dr. - gave me meds for the swelling (Prednisone)(I don't have a history of gout). It went away and I was fatigued for two weeks. That went away and then got my second dose (on January 19th) my toe swelled up again and they tested it this time and it was URIC acid for gout.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 29-year-old male patient who received TWINRIX (batch number 3HG77, expiry date June 2020). Concomitant products included ibuprofen and Clobetasol ointment. On 12th March 2018 17:00, the patient received the 3rd dose of TWINRIX (intramuscular). On 13th March 2018, 1 days after receiving TWINRIX, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site itching were not recovered/not resolved and the outcome of the injection site erythema was unknown. The reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site itching to be almost certainly related to TWINRIX. Additional details were provided as follows: The pharmacist reported that the patient received his 3rd injection for TWINRIX and on the next day he noticed redness and swelling at the injection site. The symptoms had continued to get worse and the area was also itchy and hot to the touch. The pharmacist described the redness as being an area about the size of a baseball.
I had a severe burning of my right eye.   Felt like I had severely torn my cornea. Only lasted from about 5pm day of injection through the next day and when I woke the following morning the pain was gone. I also started feeling minor pain throughout my body at first very minor but pain increased over the next 3 weeks to about a 4/5
It felt like an adrenaline boost to my heart; lightheadedness; 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 patient.  A patient (no qualifiers provided) 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "It felt like an adrenaline boost to my heart"; DIZZINESS (non-serious), outcome "unknown", described as "lightheadedness".  Additional information: Patient was trying to understand the reaction to the COVID Vaccine. It felt like an adrenaline boost to his heart. It happened several times in the first 30 minutes, several times after that. And patient felt like his had times of lightheadedness for 1-2 weeks after the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
local reaction site, redness at injection side, PCP updated, pts guardian will continue to update PCP
7 hours after immunizations, had a seizure for 4 minutes; a temperature of 100.6F ?. He was floppy, lethargic and staring.
Redness/Pink itchy area around immunization site approximately 3x5 per patient's sister.
none, she had received the pfizer after receiving the Johnson and Johnson vaccine 4/5/2021
Rash - noted all over body - mostly trunk, neck, upper arms bilaterally - mostly macular with slight papular component.  Significant itch.
dizziness then severe weakness that lasted more than three days, unable to get out of bed for 60 hours, headache, stomach issues
Patient received ZOSTAVAX on 4/28/08 in left arm.  On 4/29/08, patient developed rash.  Rash first developed in the left inner arm by the elbow bend and later developed on the left abdomen to a lesser degree.  The area on the arm was seeping.  Patient denied pain, but the rash was seeping.  Rash only developed on the left side.  Patient was advised to use calamine lotion to the rash.  Patient stated the calamine did not seem to help, and that the reaction needed to run its course.  States it took several weeks to resolve.  Symptoms: 1. SkinRash
Patient's mother reported that patient had received second dose of Vaxelis on 08/11/2023. That evening, around 8 pm, patient developed a fever of 101.9 F. His parents put him to bed and co-slept with him to monitor him. Patient's mom went to check on him at 0100 and found he was "stiff as a board" and was not responding. She started screaming for help and had her phone ready to call 911 when he finally came to. Per father, patient was not responding for about 1-2 minutes and they were unsure if he was breathing or not. They did not call 911 or bring him to the hospital. The next day he was fussy and somewhat disoriented. Patient's mom spoke with an MD online provider who thought he may have been in REM sleep during the episode. Patient's mother disagrees with that assessment and states after the first dose of Vaxelis he had been very lethargic. Patient's primary care provider is unsure this event was related to the vaccination.
A non-serious spontaneous report of fever has been received from the mother of the patient concerning a seven year-old male, subsequent to FLUMIST. The patient received FLUMIST on 07-Nov-2008. The patient received FLUMIST on a Friday and the mother reported that her son was sick all weekend with a fever up to 103. On 10-Nov-2008 the fever was 101.2. The patietn had not recovered
An expired Covid-19 pfizer vaccine was administered to the patient on 4/27/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Patient came back to get revaccinated on 5/12/22.
she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec); she received Moderna initially but did receive the Pfizer booster; she received Moderna initially but did receive the Pfizer booster; she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec); she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2) (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: Moderna (she received Moderna initially, DOSE 1), for Covid-19 immunization; Moderna (she received Moderna initially, DOSE 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec)"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "she received Moderna initially but did receive the Pfizer booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. The patient son tested positive for Covid with a home test on 24Dec and his wife had now tested positive too last night that was 29Dec and filling another AE report today (that his wife moderna initially but did received the Pfizer booster). Regarding the report for withheld, the patient intended to file his report within 24 hours but candidly with everything happening in his home and with Christmas holiday it inadvertently slipped.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a registered nurse refers to a 27 year old female patient. On 11-MAR-2015 the patient was vaccinate with a standard dose of ZOSTAVAX instead of VARIVAX (Merck). Additional information has been requested.
On June 3rd, 2021 I was admitted to the hospital with multiple pulmonary embolisms in both lungs in  multiple spots. No family history or any other medical history that would cause this.
Initial reaction (same day) sore arm lasting about 3 days, heavy chills lasting about 7 hours, fatigue lasting about 24 hours.  14 days later, full body systemic hives lasting several days. hives erupted 11/14. initially treated with benadryl. Medical treatment sought 11/18. Given an injection of depo-medrol and a prednisone burst, advised to continue benadryl and add pepcid. Hives lasted approximately 1 week.
Skin reaction to KINRIX (IPC and DTAP) (L) deltoid area.
Covid19 Vaccine: Dizziness, and BP persistently elevated though not clearly connected to vaccination Already on extended observation due to epinephrine allergy. Vitals intermittently checked. At 1620 vitals check, BP still elevated and she reported mild dizziness. After 35 minutes from vaccination time, BP had still not improved, and pt was still mildly dizzy and she was advised to go to ER. She refused. Risks of refusal discussed and she still refused - stated she would go home and take her BP meds. PCP and Cardiologist were notified.
Sensation of lump in the throat and metallic taste in mouth approx. 10 minutes post vaccination while still in Vaccine Observation area.  VS normal and stable.  O2Sat 100%. Evaluated by on site physician.  Received diphenhydramine 25mg PO at clinic.  Remained stable and D/C'd home.  F/U telephone call 12/24/2020.  States additional 25mg diphenhydramine at home in "evening" for "Scratchy" throat.  No problems overnight and all sxs resolved in AM of 12/24 2020.
received the vaccine at 3pm, february 10, 2009.  Suddenly became very dizzy at 4:30 pm.  The extreme dizziness slowly subsided and was gone by 9:30 pm that same evening.  I sat quietly, but lying down increased the dizziness.  there were no recurrences and no medical care was needed.
pt recvd vax & 13 days p/vax exp bilat back-pain & midline lumbar pain;sx were perceived as being urinary tract infect;pt was treated w/Cipro & Floxin;pain persists,& the pt has been unable to work;several MD's think Engerix-B caused sx
Reporter is physician. SMA vaccination last week of Jan 03 with significant pustule and erythema. Symptoms within 2 weeks later. Intensity of first episode of chest pain dropped me to my knees and caused me to sit on floor. No radiation of pain. Have never experienced esophageal spasms or UGI symptoms, but have treated it effectively with NTG spray, so treated myself in this way with complete pain relief within several minutes. Had I been a layperson, I would have gone to ER. Had I treated this patient, I would have admitted due to medicolegal concerns. Because of extreme exercise tolerance (60-90 min on cross trainer at highest resistance, 9-13 miles on meter, 160-170 bpm x 50-80 min without chest pain), low risk factors, I did not believe ischemic in origin.  Subsequent episode [date not provided] after awaking, but still lying supine. During subsequent 3 months, less than 7 days without chest pain. Pain pattern consistent with angina--associated with activity, carrying heavy items, walking after eating. Lasting < 5-6 min, the retrosternal ache frequently radiates down L arm, occasionally with greater intensity down both arms with paresthesias and numbness. With intense or prolonged pain, I take a second and rarely a third nitro spray. Mylanta does not abate symptoms. Possible ischemic preconditioning: acceleration intervals of 300 yards: pain only during walking phase after the first acceleration run of a series of 6-10 runs. No pain during or after subsequent runs. Happened each workout.
Day1 Fatigue, shivers, joint pain, muscle aches, fever that progressed until midnight, mild nausea (8 hrs from onset) Restlessness and night sweats during sleeping hours Day 2 Better but still fatigued easily and muscle aches entire day Not advised of potential side effects Known history of auto immune issues/connective tissue disorder heightened by vaccine side effects
Site: Pain at Injection Site-Mild, Additional Details: Complains of pain in left hand with slight swelling near palm closest to pointer finger after second dose. States that she did not feel anything after the first vaccine. Vaccine administration, technique, and volume properly verified.
soreness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-Apr-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) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (swelling) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Increasingly expanding red blotch, itchy and warm to the touch.  Reaction occurred 1 week after vaccination and eventually disappeared after 9 days.
Mins after shot = sore arm at injection site Next Around 3 am = shivering and severe muscle aches, severe headache, very tired, nausea, dizziness, flu-like symptoms through the day and evening  Following morning around 4:30 am = woke up soaked in sweat. Severe headache and nausea persists. Stomach pain.  Dizziness and very tired still. Felt like passing out at one time while out at a store. Ringing in ears.
10 days following the first vaccine I started to break out in large red welts/rash/lesions.  I consulted a Dermatologist who took a biopsy which reported 'psoriasaform dermatitis'.  The diagnosis was still unclear and I was advised to take the second shot.  10 days after Moderna #2 my entire body was covered in lesions.  I was referred by my PCP to her recommended Dermatologist who immediately diagnosed it as Guttate Psoriasis (most likely from vaccine).  I was started on a course of Cyclosporine which I was on for 8 weeks.  Now tapered off with much clearing however, not completely.  Still treating residual with steroid creams.
Immediately following the injection, I felt discomfort shoot down to the top of my right hand. My hand hurt for several days. Site area was sore. I thought this would resolve in a day or two. The injection site remained sore. It is now intermittent, but I have some discomfort every day. My arm is sore and I feel a mild burning discomfort. I cannot comfortably lie on my side to sleep on my right arm. Sometimes I do not notice the pain, it comes and goes, but every day, it hurts a little to a more moderate degree. As I type this it has been uncomfortable for several hours. I am active, use my arms and hands a lot. Activity does not reduce the pain.
2 days post vax the pt developed chickenpox of less than 50 lesions.
pt recv vax 28FEB97 & 1MAR97 pt exp intermittent fever & a gen erythematous, macular papular rash, which initially appeared on face, then spread to back & chest;
I am having extremely watery and itchy eyes.  Watery eyes is so that water is coming down my face and interfering with my vison a little.  I am trying not to scratch my eves so much.  I am using my Olopatadine HCI solution 0.2%  and Visine Red Eye Total Comfort Multi-symptom everyday since Saturday April 3, 2021.  It is begining to get very irritating.
This spontaneous report as received from a registered nurse refers to her son who was also a patient. The patient was 16 years old and male. The patient's pertinent medical history and drug allergies were none. On 21-OCT-2014, the patient was vaccinated with first dose of GARDASIL (Dose/Frequency: Unspecified and lot # not reported) intramuscularly. Concomitant therapies included BENADRYL. Approximately on 30-OCT-2014 (reported as 10 days later), the patient experienced major depressive episode and depressionary anxiety. On an unspecified date, the patient saw an unspecified psychologist in regards to the event. The unspecified psychologist prescribed ATIVAN and CELEXA for treatment. The nurse stated 25 days after starting CELEXA it was no longer working, at which time the patient discontinued using the CELEXA. The nurse reported that the patient saw the unspecified psychologist, on an unspecified date, and was then placed on EFFEXOR for treatment. The nurse stated the patient also discontinued using the ATIVAN on an unspecified date for unspecified reasons. The patient had 2 emergency visits in 2 weeks but was never actually admitted to the hospital. The patient had a Chem 20 and a tox screen both showed everything was normal. The outcome of major depressive episode and depressionary anxiety was reported as under control and the patient has not had any episodes since Thanksgiving. The causality of the events was not reported. No product quality complaint was reported for GARDASIL. Additional information has been requested.
Severe fever, chills - unresponsive to high temperature and multiple heavy blankets. Severe debilitating body ache.
Information has been received from a nurse concerning a male who on 07-MAR-2001 was vaccinated with a first dose of VARIVAX (Merck) 0.5 mL subcutaneously. On 07-JUL-2008, the patient received a second dose of VARIVAX (Merck) 0.5 mL subcutaneously. The nurse stated that in "early October" 2008 the patient was exposed to chickenpox and later, on 15-OCT-2008 was diagnosed with chickenpox. The patient sought unspecified medical attention. This is one of two reports from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA - Fatigue; pain and tenderness due to swelling of lymph nodes in my armpits; the pain in my armpits persists 9 days after my first dose of the Moderna vaccine.