chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant referring to a currently 12 days old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA, lot number N017094 and expiration date of 31-AUG-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1709USA011980: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported) via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included DiGeorge's syndrome. The patient's concomitant medications not reported. Historical vaccines included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose; and the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunisation. Patient stated after the third COVID-19 shot, "I was sick for 2 days." The outcome of sickness recovered on unspecified date. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 64-year-old male patient who received FLUARIX Quadrivalent (batch number 7A54E, expiry date 30th June 2016). The patient's past medical history included heart disease, unspecified. Previously administered products included BOOSTRIX (one dose, 0.5 ml received on 24th February 2015 in left deltoid intramuscularly, lot number: FB942, expiry date: 3rd December 2017) and ZOSTAVAX (one dose, 0.5 ml received on 6th October 2009 in right deltoid subcutaneously, lot number: L035286, expiry date: 15th December 2016). On 7th August 2015, the patient received FLUARIX Quadrivalent (intramuscular) .5 ml. On 29th December 2015, 144 days after receiving FLUARIX Quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FLUARIX Quadrivalent. Additional details provided were as follows: This case was reported by a pharmacy via a pharmacy claims management company.
My 1st shot was at the Walmart on 8/12/21. The minor side effects I experienced were soreness at the injection site for a couple days as well as exhaustion for a couple days.  On August 20th I came down with Covid symptoms. Dry cough, congestion, head ache, sore throat, exhaustion, wheezing, I drove out and took a rapid test and was negative. I would have gone for a PCR test but they are pretty hard to come by in our area. Pharmacy was booked 5 days out at the time. 4 days later, while I was on the mend, my 16 year old daughter came down with symptoms and we were able to borrow a Binax test from a friend and test very and she was positive, so I am quite certain what I had was Covid and I had given it to her. My symptoms gradually improved and I was able to resume normal activity but my resting heart rate stayed elevated by 6-10 beats per mintute, started on a downward tend 8 days out from onset of symptoms, and then began to rise back to an elevation of 8 bpm. I researched Fitbit data at this time and found out that this is a common heart trend for health activity tracker wearers.   I got my second shot on 9/10. I went home and began to work on a Spanish course I am taken and had to take a nap. 8 hours later I was stuck in bed with a fever of 102.5, shakes, chills, body aches, and a heart rate that was stuck at 125. Ibuprofren and Tylenol helped some, We were able to get the fever to break, and my resting heart rate over night was 90 bpm. Heart rate is still elevated in the 90s.
The patient sent an e-mail and stated a few days after my flu shot on 10/15/09 I began to have an inflamed area around the shot. There was some swelling but not that painful. It was a red ring with a yellow ring in the center. Went to the doctor and said that the needles may have moved & bruised it but that there was a small CA was there row and I am being treated for that.
Information has been received from an aunt of a female consumer who on an unspecified date was vaccinated with hepatitis A virus vaccine inactivated. Subsequently, the pt vomited for 2 days straight and experienced a fever of 102F. The child was treated with promethazine hydrochloride (Phenergan) which stopped the vomiting. On 11/2/01, the pt experienced a seizure. The child was hospitalized for the events. It was reported that the child had "several more" seizures while in the hospital. The events were considered to be immediately life-threatening. At the time of this report, the outcome of the fever and seizure was unknown. Additional information has been requested.
I am short of breath; I am in severe pain all over my body; I require more oxygen; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSPNOEA (I am short of breath), MYALGIA (I am in severe pain all over my body) and OXYGEN CONSUMPTION INCREASED (I require more oxygen) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung disease. Concomitant products included OXYCODONE, PREGABALIN (LYRICA), MORPHINE, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), LOSARTAN, AMBRISENTAN (LETAIRIS), DOMPERIDONE, FUROSEMIDE and APIXABAN (ELIQUIS) for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (I am short of breath) (seriousness criterion medically significant), MYALGIA (I am in severe pain all over my body) (seriousness criterion medically significant) and OXYGEN CONSUMPTION INCREASED (I require more oxygen) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (I am short of breath), MYALGIA (I am in severe pain all over my body) and OXYGEN CONSUMPTION INCREASED (I require more oxygen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.   Patient stated that she had lung disease and she find that after her first vaccination that she require more Oxygen and she is short of breath. The pain is so severe that she went to see her Doctor.  Company comment Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Less than 5 minutes after the vaccine injection patient's eyes rolled back, patient went limp, then patient began to seize. Seizure lasted only 2-3 seconds and patient was conscious and responding within 2-3 minutes of her reaction. Called the doctor from the clinic. Patient was taken to the urgent care to be checked out.
Felt cold wave on whole left side of body starting at the head and very quickly going down all the ways to toes. It happened as I was still in the car about 5 minutes after receiving shot. Immediately after felt numbness in left side of the face, left arm, and left leg (all mild).  Numbness on the arm and leg stayed for about 4 hours, and numbness on the left side of the face stayed until the next morning. The numbness on the face was similar to when anesthetized by a dentist and also the tip of my tongue was numb. I could smile and close my eyes without a problem, and both right and left sides looked the same when doing so.
Patient has a past medical history of Ataxia Telangiectasia. Live vaccines are contraindicated when a patient has this diagnosis. No adverse reaction to vaccines as of this report.
Information has been received from a physician concerning a 11 year old female with asthma who on 18-JUL-2007 was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 657753/0781U) in the right quadricep. On 20-JUL-2007 the patient experienced a local injection site reaction that was hard, swollen, red and feverish to the touch. The reaction as being "softball-sized." Medical attention was sought. The physician suggested that the patient treat the reaction with Benadryl. No product complaint was involved. Additional information has been requested.
pt recv vax & same day of vax pt exp dizziness & nausea;tx w/antivert;nausea resolved;dizziness has cont for 1 1/2wk;event was reported to be disabling as the pt still is not able to work d/t dizziness;
Received 1st injection on lunch break around noon.   Went back to work and a few hours later I felt light pressure on left side beneath left breast.  The pressure became worse and felt tight.  It became hard to breathe. I kept trying to take breaths but could not get enough air. It was frightening so I went and told one of the doctors I work with what I was feeling.  He told another doctor.  They both told me I may be experiencing anxiety as I wouldn?t be able to feel reactions from the vaccination so soon.   I can?t tell you exactly how long this tight/pressure hard-to-breathe feeling lasted but it was enough to make me lightheaded.  It was enough to make me call the number on the Pfizer booklet they gave me but the number took me to a hotline and it was confusing and there wasn?t a clear option to talk to someone to tell them what I was experiencing.  I also had to continue working.    I was so happy when my chest started to gradually feel less pressure.  Then breathing became easier.   I was tired after I went home and experienced soreness at the site of injection after approXimately 5 pm.  This was serious and now that I had a abnormal EKG and am scheduled for an echocardiogram, makes me wonder if what I felt was due to the vaccination.
When the individual returned to the pharmacy on 5/19/21 he reported that he had a numb arm from the elbow bend to the shoulder starting the morning after the injection. He went to work and was unable to move his arm and had to leave work early and took the next day off as well. He said this continued for three days after the vaccine. He reported that he did contact his physician who told him to give it some time and if it  got worse to make an appointment to be seen, stating that all they would do is give him an anti-inflammatory to reduce swelling. The patient told the physician that he already had some for another condition and would just use that and did not go in to see her. He said that it was still not 100% on 5/19/21 but wanted to proceed with the shot in the same arm.  He was able to make circles with his arms over his head after the immunization was given a little lower that where the first one was administered.  He said he had looked up the symptoms that it might be a frozen shoulder/nerve issue.
6 yr old pt came in for 1st covid booster vaccine and was given Moderna 6-11y (purple border) and should have been given Pfizer 5-11yr (orange top), the later is the only things approved for Covid boosters for the pts age range. Called and LMOM for pt on 7/21/22 @1745. On 7/22/22 made contact with pts parent @0847 and notified parent. Parent had no report of adverse side effects at this time. Advised parent to watch for side effects lasting more than a few days and to contact PCP for further followup. Parent expressed understanding. Rendering physician notified.
Severe muscle arm and body aches. Half of left side of the body is numb and colder than another half. Still having numbness in left limbs (left arm, fingers, and left leg) is still continuing since the first dose.
received the "3rd dose" (stated by the patient) on 29Oct2021 but when she entered the lot number 026C21A into lot look up tool, it turned out that it was expired on 24Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the "3rd dose" (stated by the patient) on 29Oct2021 but when she entered the lot number 026C21A into lot look up tool, it turned out that it was expired on 24Oct2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid disorder. Concomitant products included LISINOPRIL for Blood pressure high, DILTIAZEM HYDROCHLORIDE (CARTIA [DILTIAZEM HYDROCHLORIDE]) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received the "3rd dose" (stated by the patient) on 29Oct2021 but when she entered the lot number 026C21A into lot look up tool, it turned out that it was expired on 24Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received the "3rd dose" (stated by the patient) on 29Oct2021 but when she entered the lot number 026C21A into lot look up tool, it turned out that it was expired on 24Oct2021) had resolved.            Concomitant medications also included Thyroid medications.  No treatment information was provided.    This case was linked to MOD-2021-384436 (Patient Link).
Patient reported back to the vaccinating pharmacy that he is still having pain and trouble moving vaccinated arm one week after the injection. He is calling his physician.
COVID vaccine breakthrough case. Moderna 3/10/21 002B21A, 4/7/21 040B21A and boosted Pfizer 12/4/21 FJ1620 and 5/19/22 FP4554
Child developed abdominal pain 07/23/10. Subsequently she was admitted at Med. Ctr., where she underwent appendectomy 07/26/10.
significant myositis; difficulty standing creatine kinase 1,597 (Nl < 144)
Headache FATIGUE, DISCOMFORT IN THE RIGHT SIDE OF NECK & RIGHT INNER EAR. Narrative:
09/17/03: mother said child was lethargic. Weird cry. Legs shaky. No fever. Told to go to ER. 9/18/03: mother stated he is fine. Didn't go to ER. Gave Tylenol then he was fine.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and VACCINATION SITE PAIN (Arm is a little achy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and VACCINATION SITE PAIN (Arm is a little achy). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and VACCINATION SITE PAIN (Arm is a little achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  No concomitant medications were provided.
Caller received vaccine on Sat next day had really really red eyes; still don't feel good and is shaky; still don't feel good and is shaky; This is a spontaneous report received from a Pfizer Sponsored Program via a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received vaccine on Saturday-next day had really really red eyes-still don't feel good and is shaky-wants to know if she should still be feeling like this. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from an office manager and refers to an 19 month old child patient of an unknown gender. On 24-FEB-2015, the patient was simultaneously vaccinated with the first dose of PROQUAD lot # K008185 with the expiration date of 05-DEC-2015, 0.5 ml, subcutaneous and with the first dose of VARIVAX (lot# J003704 with the expiration date of 27-MAR-2015, 0.5 ml, first dose, subcutaneous). No adverse effect was reported. No product quality complaint was involved. Follow up has been received from a physician on 09-APR-2015 regarding 19 month old child (also reported as 20 month old child). It was reported that there was no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions. On an unknown date, reported as one week later, the physician followed up with the patient and the child was fine without any adverse event after shots. No adverse effect was reported. Additional information is not expected because there is no follow up required. Reporter tab, product tab, event tab and narrative were updated.
Sudden onset Paresthesia (tingling, crawling feeling, pins and needles, itching, prickling) of skin all over the body. Startle reflex upon sleeping. Went to ER, no treatment. Feeling has continued for 20 hours.
Eruption of Herpes Simplex; cold sores; This case was reported by a pharmacist via call center representative and described the occurrence of herpes simplex in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (are usually brought on by sun exposure or a fever).   On 22nd August 2019, the patient received Shingrix. On 26th August 2019, 4 days after receiving Shingrix, the patient experienced herpes simplex and cold sores. On an unknown date, the outcome of the herpes simplex and cold sores were unknown.   It was unknown if the reporter considered the herpes simplex and cold sores to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that the patient experienced an eruption of herpes simplex four days after Shingrix vaccine.  The reporter stated that cold sores are usually brought on by sun exposure or a fever but patient experienced followed Shingrix vaccination. The reporter consented to follow up.  Clarification has been raised for event onset date for eruption of herpes simplex whether it is 28th August 2019 or 26th August 2019.
Fever of 102; Severe nausea; Vomiting; Extreme chills every time I stand up; Muscle aches; Fatigue; Extreme stiffness pain; Extreme stiffness pain; Swelling in joints especially my knees; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 15:45 (Lot number: 30135ba) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis in knees and back" (unspecified if ongoing); "Military related PTSD" (unspecified if ongoing), notes: Post-traumatic stress disorder. Concomitant medication(s) included: NAPROXEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Rw0172, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 10May2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 19Apr2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Fever of 102"; NAUSEA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Severe nausea"; VOMITING (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Vomiting"; CHILLS (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Extreme chills every time I stand up"; MYALGIA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Muscle aches"; FATIGUE (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Fatigue"; MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious) all with onset 18Nov2021 08:30, outcome "recovering" and all described as "Extreme stiffness pain"; JOINT SWELLING (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Swelling in joints especially my knees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, nausea, vomiting, chills, myalgia, fatigue, musculoskeletal stiffness, pain, joint swelling.  Follow-up attempts are completed. No further information is expected.
On 5/12/01, father reported, child developed 30-35 chickenpox lesions on trunk, face and extremities. Afebrile.
I received the 3rd Pfizer COVID vaccine on 9/28/21 and later that day became extremely fatigued with fevers starting that evening.  Injection site pain and redness noted the same evening.  Intermittent fevers, fatigue and injection site pain/redness continued until Friday, 10/1/21.
She has a hard red bump where the shot was given in her rt leg. It was hot to touch and she had diarrhea as well. She also started to run a fever 2 days later and have a cough and runny nose.
CDC reports: 3 mo infant developed fever 103, local rxn, wheezing & screaming episode within 6 hrs p/DTP/OPV immuization, duration of illness 1 day.
SIGNIFIGANT SWELLING AT VACCINE SITE, SWOLLEN LYMPH NODES UNDERARM AND UP NECK ON RIGHT SIDE, FATIGUE, LOW FEVER, ACHES & CHILLS, HEADACHE
Case number PHEH2015US021581, is an initial spontaneous report from a nurse received on 21 Oct 2015. This report refers to a 54 years old female patient. Medical history and concomitant medications were not reported. On 21 Oct 2015 the patient received FLUVIRIN (batch number: 1517401) intramuscularly at a dose of 1 ml in error. The case was assessed as non-serious. No adverse event was reported.