chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner concerning a 24 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. Approximately in 2007, 2008 and 2013 (reported as "at age 15 years, 16 years and 21 years"), the patient received a complete series of properly stored GARDASIL injection (dose, route and site of administration, lot # and expiration date were not provided) as vaccination against papillomavirus. In approximately 2014, reported as "2 and 1/2 years ago", the patient experienced myeloblastic lymphocytic leukemia. On an unknown date, she developed two genital warts and had a Papanicolaou (Pap) test that showed human papillomavirus (HPV), which was "not the type of high risk for neoplasm". The patient sought medical attention and received unspecified "chemotherapy type" treatment for myeloblastic lymphocytic leukemia. Product quality complaint was not involved. At the time of reporting, the patient's myeloblastic lymphocytic leukemia was in remission since an unknown date. The outcome of the event of HPV infection was not reported. The relatedness between the events of myeloblastic lymphocytic leukemia and HPV infection and the vaccination with GARDASIL was not reported. Upon internal review, myeloblastic lymphocytic leukemia was considered to be medically significant.  Follow-up information has been received from the reporting nurse practitioner on 06-JAN-2017. The patient's concurrent conditions included seizure disorder. Concomitant medications included unspecified anti-seizure medication. The patient recovered from genital warts (on an unknown date) without treatment and had no recurrence. The nurse practitioner was not able to provide any further information as she was not in her office at the time of the call. The reporter also stated that she did not think that myeloblastic leukemia or lymphocytic leukemia was related to GARDASIL. Additional information is not expected. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL and the reported events cannot be established. Is pending important information about the patient's pertinent medical history,concurrent conditions and concomitant medications. also is important that the patient recovered from genital warts  without treatment and had no recurrence. Company Comment- No changes to the GARDASIL safety information are warranted at this time.  Merck and Co., Inc., known as MSD, continues to monitor the safety profile of the GARDASIL.; Sender's Comments: MERCK 1611USA013477:Mfr number.
administered vaccine as per store protocol and safety policies. the evening of the injections patient's right arm became red and with fever. The redness was from the site of injection, above and below to the elbow. Pt ran low grade fever and was not feeling well. Headache and body ache. He also experienced heaviness of chest. Pt lost appetite and didn't really eat anything for around 4 days. Pt had to take a day off of work because he wasn't feeling well.
Day 11 post-vaccine - intense, itchy rash on bilateral palms. Temporarily relieved by diphenhydramine + prednisone. Rash periodically recurred on skin folds (elbows, knees), always bilateral, always intensely itchy, relieved by diphenhydramine + prednisone for total duration of 5 days. Skin sensitivity on areas of rash persisted for about 7 days after rash.  Day 18 post-vaccine - few small bruises in areas unlikely to be associated with trauma, resolved spontaneously (possibly unrelated) Day 19 post-vaccine - leg stiffness/soreness/weakness (possibly unrelated)
1.  Mild ataxia  postural imbalance/lag in coordination  2. Rising BP (from hypotension to hypertensive) 3.  Rise in TROPONIN.  60, 96 4.  Change in heart imaging from 7/14 echocardiogram (pre vax) to 7/19 limited echo. Interventricular delay to incomplete LBBB on  ekgs Overnight ER to Observation admission.  Hospital
Very shortly after receiving initial vaccine dose recipient felt weak and slightly nauseated without rash, shortness of breath or sense of tissue swelling or itching.  He had no chest pain He endorsed a history of well controlled hypertension and hypercholesterolemia. He had no history of adverse experiences with injections He became sweaty and had a somewhat weak pulse so was moved to the medical area where his initial blood pressure was 88/47 with a pulse of 71. He was encourgaed to lie down and his symptoms improved. He had an intravenous line established and an ambulance arrived promptly to transport him for emergency evaluation.
Got the shot last night. Starting sometime before lunch (mid morning) I?ve been having a ton of hot flashes. Been going from hot to cold really fast.  Not uncommon right before my period, but it only happens once or twice then. Probably over 30 times today.  Also sore throat and loss of taste. Maybe I just have covid? Dunno - will figure it out tomorrow.  This is ongoing.
Fell asleep 2 minutes after shot. C/O headache, dizziness. No treatment.
Erythema over the entire left anterior thigh, 1cm x 3cm edema around injection site. Immunization reaction verus cellulitis. Treated with Duricef 500 MG, BID x 10 days.
a few hr p/vax pt had diffuse pain, swelling w/o redness (local rxn);
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. An adult male patient between the ages of 19-24 experienced OTHER ANAPHYLACTIC SHOCK, NEC from 18-Jan-2012 to 19-Jan-2012. The patient was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) batch: 34600017 on 13-Jan-2012. The event occurred on 18-Jan-2012. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Event outcome was resolved on 19-Jan-2012. Treatment medication included: Prednisone 50mg PO, Epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg INH, and SOLU-MEDROL 125mg IV. Lab tests 12-JAN-2012, Hepatitis B Virus AB: negative; 12-Jan-2012, Hepatitis A Virus AB: negative IU/L; 12-Jan-2012, ABO Group: O positive; 12-Jan-2012, varicella zoster AB: Immune; 12-Jan-2012, rubella virus AB: Immune; 12-Jan-2012, rubeola AB: Immune; 12-Jan-2012, G6 PD: 15.2 Unknown U/g; 12-Jan-2012, sickle cell screen: negative; 25-Jan-2012, glucose: 80 mg/dL; 25-Jan-2012, hemoglobin: 15.2 g/dL; 25-Jan-2012, hematocrit: 44.7%; 25-Jan-2012, cholesterol/HDL cholesterol: 3.6; 25-Jan-2012, cholesterol: 157 mg/dL; 25-Jan-2012, HDL: 44 mg/dL; 25-Jan-2012, LDL: 89 mg/dL; 25-Jan-2012, triglycerides: 119 mg/dL; 25-Jan-2012, hemolysis index: no hemolysis; 25-Jan-2012, Icterus index: 0; 25-Jan-2012, lipemia index: 47; 25-Jan-2012, urinalysis: negative, yellow, clear; 25-Jan-2012, Urobilinogen: 0.2 EU/dL; 25-Jan-2012, nitrate: negative; 25-Jan-2012, leukocyte esterase: negative; 25-Jan-2012, specific gravity: 1.020; 25-Jan-2012, pH: 6.5. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: Not applicable. The patient's medical history was not reported. The patient's concomitant medication included INFLUENZA VACCINE (since 13-Jan-2012); TDAP (since 13-Jan-2012); IPV (since 13-Jan-2012); MENINGOCOCCAL POLYSACCHARIDE (since 18-Jan-2012); HEPATITIS A VACCINE W/HEPATITIS B VACCINE (since 18-Jan-2012); RANITIDINE (Oral, since 18-Jan-2012); PARACETAMOL (Oral, since 20-Jan-2012, until 19-Jan-2013; since 08-Feb-2012, until 18-Feb-2012, for PAIN); Ibuprofen (Oral, since 08-Feb-2012, until 09-Mar-2012, for PAIN). The patient's past medication were unspecified. The medical monitor's causality assessment: The medical monitor assessed the causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE as possible. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)).
Three doses were given outside the 12-hour window; dose was given outside the 12-hour window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window) and PRODUCT STORAGE ERROR (Three doses were given outside the 12-hour window) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Three doses were given outside the 12-hour window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window) and PRODUCT STORAGE ERROR (Three doses were given outside the 12-hour window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the vaccine was stored in the fridge at night of 22-Mar-2022 and left in the fridge for overnight. It was also reported that the vial was first punctured on 23-Mar-2022 around 10:15 am and was administered on 24-Mar-2022.  The vial did not underwent any temperature excursions and was exposed to room temperature for maybe 5 minutes.   This case was linked to MOD-2022-523279, MOD-2022-523314 (Patient Link).
ongoing nosebleeds; tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (ongoing nosebleeds), FATIGUE (tired) and PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.    Co-suspect product included non-company product IBUPROFEN for an unknown indication.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) at an unspecified dose. On 06-Mar-2021, the patient experienced EPISTAXIS (ongoing nosebleeds), FATIGUE (tired) and PAIN IN EXTREMITY (sore arm). On 07-Mar-2021, FATIGUE (tired) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, EPISTAXIS (ongoing nosebleeds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
A non-serious spontaneous report of administered FLUMIST to a patient over 49-years-old, nasal congestion, sore throat and muscle aches has been received from a consumer concerning herself, a 56-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 13-Oct-2009. On 15-Oct-2009, the patient developed nasal congestion, sore throat and muscle aches. The treatment for the events was not provided. The outcome of the events is unknown.
Patient received PREVNAR and BOOSTRIX vaccines on her right arm on 5/13/17. She came to the pharmacy on 5/17/2017 with a new prescription for KEFLEX and Prednisone after being told by her physician that the redness and warmth felt on her right arm where do to infections caused by the vaccines she received.
This spontaneous report as received from a 61 year old female patient regarding herself. The patient's current condition included allergy to penicillin. Patient's medical history was none. On 01-OCT-2013, the patient was vaccinated with a single dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported) injection. Concomitant medications were none. On 02-OCT-2013, about 24 hours after the injection, at the site of the shot, there was a long elliptical shaped redness that sort of was whiter in the middle and came to a point at the end with three small white pimples in the middle that itched mildly. Approximately on 03-OCT-2013 (also reproted as on Thursday and Friday), the area of redness and puffiness expanded until it was about 4 inches long and 1.5 inches wide at the widest part, and a couple of more small white pimples formed that were also itchy. A couple of those still existed. It stabilized at that point, and very slowly began to recede. This was day 6 after receiving the vaccine, and then it took another five days to totally dissipate, and even now the patient had a couple of the little pimples that were left, all the redness and swelling were going, no pain, just mild itching and puffiness and expansion. The patient sought medical attention (saw the doctor). No treatment was given. Lab Diagnostics Studies Performed was none. The outcome of all the reported events was recovering/resolving. Additional information is not expected.
Dizzy/lightheaded at 8pm 12/28, nauseous.  12/29 6:30am dizzy, lightheaded, fainted in shower
Headache, Myalgia, Arthralgia, NauseaVomiting, fatigue, chills, lymph node tenderness Narrative:
This spontaneous case was reported by another health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported. On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again). No concomitant medication was reported. Nurse reported that 100 bivalent boosters were given a day before reporting from vials that were put in the fridge and after that refrozen and thawed again. No treatment information was provided. This case contains information for the 80 of 100 adult male patients described by the reporter. This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2023-697752:Master case
I lost my little brother to a Pfizer heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "I lost my little brother to a Pfizer heart attack". The patient date of death was unknown. Reported cause of death: "I lost my little brother to a Pfizer heart attack". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: I lost my little brother to a Pfizer heart attack
Weakness, neck pain/stiffness, burning in face, abdominal pain, confusion, chills, *SX prior to imm - sinus/nasal infection.
Under my arm and shoulder is sore; Under my arm and shoulder is sore; Pain; This is a spontaneous report received from contactable consumer (patient). A patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number/ NDC number/ UPC number and Expiry Date: unknown), via an unknown route of administration on 17Apr2021 (Saturday) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 18Apr2021, next day of vaccination, the patient experienced under my arm and shoulder was sore and pain. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever 102-102.6F for 48 hours. 10/18/2013 developed rash on torso and face. Continue to check in with Dr office, they're saying it's normal or he caught something else. We have a nanny for our son and no one in his vicinity has been sick.
I starting having chest pain, tachycardia, bradycardia, dizziness and SOB. The dizziness was a big problem. Then, my heart rate would be evaluated then goes straight down. These symptoms are still ongoing. I went to a cardiologist specialist. They did a heart stress test, EKG, and blood work.
Patient started complaining of difficulty breathing, no s/s distress, vomited x 2. Symptoms resolved immediately after vomiting.
NAUSEA BEGAN WITHIN 5 HRS & LASTED THROUGHOUT FOLLOWING DAY; MINIMAL PAIN AT SITE OF INJECTION THE NEXT MORNING
vision is distorted; eyes are swollen; after receiving vaccine her arm is sore and red; after receiving vaccine her arm is sore and red; This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (vision is distorted), EYE SWELLING (eyes are swollen), VACCINATION SITE PAIN (after receiving vaccine her arm is sore and red) and VACCINATION SITE ERYTHEMA (after receiving vaccine her arm is sore and red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced METAMORPHOPSIA (vision is distorted), EYE SWELLING (eyes are swollen), VACCINATION SITE PAIN (after receiving vaccine her arm is sore and red) and VACCINATION SITE ERYTHEMA (after receiving vaccine her arm is sore and red). At the time of the report, METAMORPHOPSIA (vision is distorted), EYE SWELLING (eyes are swollen), VACCINATION SITE PAIN (after receiving vaccine her arm is sore and red) and VACCINATION SITE ERYTHEMA (after receiving vaccine her arm is sore and red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Child developed a mild case of chicken pox. One near nose became infected and developed impetigo. Child also had diarrhea. Child was seen by the nurse practitioner on 05/24/02 and was prescribed Amoxicillin for the impetigo and Nystatin external cream for diaper rash caused by diarrhea.
Balance affected with dizziness, tired, joints achy, all sx still exist today 2/16/05.
Pt received vaccination and developed severe swelling which was warm to the touch in vaccinated arm which resolved without MD intervention.
Lightheadednsss immediately after vaccination. Slight nausea that resolved within a minute, hot feeling, and slightly elevated blood pressure of 142/92.
Case number PHEH2015US022086, is an initial spontaneous report from a consumer received on 27 Oct 2015. This report refers to a 56 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 26 Oct 2015. Shortly after vaccination she had a itching in the back of her throat and 2 to 3 hours later she had an asthma attack. She treated itchy throat with BENADRYL and had 2 to 3 cups of coffee and then had asthma attack treated with rescue inhaler. Events recovered on the same day (26 Oct 2015). Seriousness and causality of the events were not reported. Seriousness assessment of asthma attack was upgraded based on information in the source document.
Mild fever on 12/14/2009 after receiving H1N1 vaccine; Developed sore throat on 12/16/2009 along with cold-like symptoms: Sneezing, some coughing, dripping nose; Starting becoming hoarse on 12/19/2009 PM; Awoke stuffed up and hoarse on 12/20/2009, unable to speak properly due to extreme hoarseness of throat; Went to Urgent Care center at Hospital on 12/20/2009 AM and told non-related to vaccine and to take Claritin-D; Obtained Claritin-D and self-administered on 12/20/2009 which did absolutely no good for condition!! I believe it was related to the vaccine and I was misdiagnosed at the Urgent Care center!!
8 days after MMR/Pox shot patient developed high fever, runny nose.  Fever broke, but she has had 5 days now red bump rash all over body with Kopliks in throat.
pt c/o extremities feeling funny; attempted to get into exam room pt passed out; immed seizured; tremors of legs; breathing  no SOB, no cyanosis; face flushed some dry coughing, pulse strong tachy; clenched teeth, crying;
Unexplained bruising on both legs (inner thighs above knees). Bruises are various sizes from nickle size to over quarter size.  20-30 +.   No known previous health issues or history of bruising. Very healthy diet (eats salads, fruits on regular basis). Perfect health entire life with no major issues or abnormal blood test histories. Healthy, perfect weight, active.
Subsequent to receiving one dose of varicella virus vaccine live the pt was diagnosed with chickenpox.
Redness, itching, burning and very sore to touch. Scaly/bump.
Allergic reaction to flu shot was given 25 mg BENADRYL. Allergic reaction included watery eyes blurred vision, lump in throat coughing, mucus to eyes and chills.
Fever began elevating between 5pm and 7pm on 4/09/21.  Severe chills and headache followed fever.  Fever was above 102F.  By 9pm I began experiencing dizziness and heart rate increased.  At this time I called for someone to come home and assist with my children.  Throughout the night and into the morning I experienced sweating. Symptoms persisted through the weekend with improvement until 4/11/21.
This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was not feeling really good, had got a really bad headache, had 101 temperature, arm was red; really swollen, and just felt really tired and achy. Outcome of the events was unknown. Information on the batch number has been requested.