chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 82 year old female patient with renal insufficiency, hypertension, coronary artery disease, a history of "diabetes", asthma, and a previous myocardial infarction (MI) who on 09-DEC-2008 was vaccinated subcutaneously in the right arm with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 662860/1617X, expiration date 14-MAY-2010). The physician reported that the patient's husband had shingles and the patient inquired about the vaccine. The physician confirmed that the patient's husband was not vaccinated with ZOSTAVAX (Merck) prior to developing shingles. Shortly after vaccination within 1 week to 1 month the patient developed an illness. The patient experienced shingles after receiving ZOSTAVAX (Merck). The patient was admitted to the hospital on 09-JAN-2009. She was in the ICU and then transferred to the long term unit prior to passing away. The physician explained that the hospital records mention varicella encephalitis, chickenpox complicated with encephalitis. He indicated that shingles was mentioned in the chart once. The physician did not provide a definitive diagnosis or cause of death. Shingles and pass away due to complication from the shingles were considered to be disabling and immediately life-threatening. Upon international review, the patient's varicella encephalitis was considered to be other important medical event. A lot check has been requested. Additional information has been requested.
Per the CDC definition, patient is not severely immunocompromised. Patient received a third Moderna COVID vaccine dose of 0.5 mL, instead of the standard 0.25 mL.  Patient contacted PCP on 1/28/2022; no adverse reactions were reported.
09/19/22 admitted to Oncology for "CLL, inpatient chemo". PMHx of "A-fib, Arrhythmia, Arthritis, AS, bilateral lower extremity edema, bleeding tendency, chronic renal failure, CLL, Congestive heart failure"
I got a bad headache within 10 minutes of injection and also got transient pain that moved throughout my body within 10 minutes. The pain started in my upper left neck, moved to my right arm, then to my right thigh, then to my hand, then both ankles and heels of feet. Dizziness for first few hours of vaccine. I've had joint pain, racing/thumping heart for 6-7 hours day of vaccine, felt a bit better Friday afternoon but then racing/thumping heart returned that night. It's more evident at night. Skin crawling sensation occurred Saturday night and also felt pins/needles on my skin. Some blurred vision within 24 hours of vaccine and now have sore throat, congestion and runny nose. Also both forearms broke out into a rash Saturday night but seems to have resolved itself. The racing/thumping heart has felt very scary and I can physically feel it.
Pt. states that after receiving the 1st dose of J&J 10/16/2021, started experiencing symptoms immediately of headache (continuous), loss of sleep (due to headaches), shortness of breath, fatigue, and increased heart rate. Pre-Surgery appt. *Hysterectomy scheduled for 11/16/2021, mentioned headaches with no recommendations.
Developed papular rash on body. Question of vesicles (hard bumps) versus papules on the trunk.
Pneumonia Vaccine given around 11:00am, 09/25/09. Pt reports nausea and vomiting, diarrhea, temp. 103 beginning around 6:00pm on the same day. Small amount of redness at site (Left arm). Symptoms progressively worsened, and admitted to Hospital on 9/27/09, which by this time Left arm was red, swollen and diagnosed with Cellulitis. Dismissed from hospital on 9/30/09. 10/5/09 DC summary and hospital records received from dates, 9/28/09 to 9/30/09. DC DX: Cellulitis of LUE. Systemic inflammatory response syndrome. Intravascular depletion with hypovolemic hyponatremia. Marked bandemia. Acute normocytic anemia probably r/t sepsis. Hypoalbuminemia, hypokalemia secondary to diarrhea. Presenting symptoms: Arriving to ER with high fever, systemic inflammatory response syndrome with severe diarrhea, dehydration, hypokalemia. 2 days prior received pneumovax in LUE with subsequent nausea/vomiting, pain, induration, erythema of entire left deltoid spreading to bicep region site of injection. Recieved steriod tx in ER with relief. After 24-36 hours localized symptoms returned. TX: IV Abx, after 24 hours bandemia resolved overall pt improvement.
Pt reports redness/pain/swelling at injection site. Pt has been icing area and taking ibuprofen. Informed pt some pts report this reaction and may be typical, not to be alarmed. Pt to continue to monitor and treat, should resolve on its own in 2-3 days. Pt will report back and/or seek medical attention if worsens or does not resolve.
Blotchy, erythematous patches over scalp and trunk.  Began about 5 minutes after shot was administered.  Lasted about 15 minutes with complete resolution.  No airway compromise.  No localized swelling or erythema at site of injection.
had a temperature of 100.4; pain in his shoulders and neck/has joint pain across his neck; he has joint pain across his shoulders and neck and that he cannot turn his head/ pain in his shoulders and neck; he has joint pain across his shoulders and neck and that he cannot turn his head; This is a spontaneous report from a contactable consumer. This 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 05Feb2021 (at age 78-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, Caller stated that he had his first Pfizer shot Friday 05Feb2021. Stated that he had a temperature of 100.4 that went back to normal. Stated that he had pain in shoulders and neck since he got the shot. Clarified that it was for Pfizer Covid 19 shot. Stated that it may be normal or if others felt this way. Clarified that he had joint pain across his shoulders and neck and that he couldn't't turn his head. Wanted to know if this was serious. Patient underwent lab test includes body temperature for which result 100.4 was reported. The outcome of event was resolved for body temperature increased, whereas unknown for all other events.  Information on lot/ batch number has been requested.
During the 15 minute waiting period, patient stiffened up and lost conciousness. He bit his tongue, sat to the floor and shook for approximately 4 minutes according to his wife. His spouse called for help because her husband was not feeling good. Patient was found lying on the floor, vital signs assessed all within normal ranges, rescue (911) was called to the scene then patient was taken to Emergency Department. Patient was awake, alert and oriented to self, place and time upon awakening.  11/13/2009 Hospital records received for dates of service 10/29/2009 -10/31/2009. Discharge Diagnosis: Seizure versus possible reaction to H1N1 vaccine    Patient received H1N1 vaccination and shortly thereafter the wife reported that the patient stiffened up while sitting in a chair and lost consciousness. He bit his tongue and shook for approximately four minutes. The patient reported that he could hear other people and knew where he was. The patient had no prior history of seizure. On admission, the patient was alert and orientated times 3 with no focal neuro defects, normal cognitive function and normal gait. Neurology consultation recommended that no indication for an antiepileptic drug even if we think that this does represent a new-onset seizure and he is okay for discharge home with follow-up with primary care physician./REM
reports headache, body aches, feeling "feverish" in the evening of 8/25/2022- tested negative for covid on home rapid antigen test 8/25/2022, symptoms continued 8/26/22- tested positive on home rapid antigen test morning of 8/26/22
Shingrix vaccine was reconstituted with sterile water for injections diluent (used for Merck live vaccines such as Zostavax) instead of the diluent provided in the Shingrix box.  Patient has not experienced any adverse effects.  Patient will return for a correctly reconstituted vaccination.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient presented to emergency department on 11/30/21 with fatigue and shortness of breath patient was admitted for further management of pneumonia due to covid-19 patient was found to be covid-19 on 11/30/21 patient did require treatment for symptoms associated with covid-19 - treatment included dexamethasone and remdesivir patient was discharged to rehab facility on 12/15/21
Red rash at injection site spread across chest and up neck. Hot to the touch. Gave 25 mg liquid Benadryl at 1:00pm and another 25mg at 2:00pm.
Started with Fatigue at 6:00pm, then headache started, around midnight got a fever of 101 degrees, took Tylenol, fever broke a couple hours later. Chills, headache, lightheadedness throughout the following day. Started feeling better at 6pm or so. I have been uncomfortably warm for the following 24 hours, but headache has subsided. No fever since the day after the vaccine.
Fever, chills for approximately 6 hours;  fatigue for 24 hours, headache  for 4 days following vaccination.
Dr. Office called pharmacy on 7/06/2017 to say patient came in on 7/1 with shoulder pain and limited mobility in the left arm. Nurse said patient was given prednisone and was coming back later that day for a follow up appointment.
patient indicates that at 4:00 am in the morning he had a paralysis in the whole body. At 6:00 am the ambulance went to pick her up steroids by vein every 4 hours. They sent her home at 7:00 pm at night and the treatment they gave her was methrylprednisoloned for 5 days
dosing done with the fluzone quadrivalent prefilled syringe for a 14-month-old patient, he states that two dosages were administered but not in the appropriate time frame with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 months old and unknown gender patient for whom dosing done with the Influenza Quadrival A-B Vaccine [Fluzone QIV] prefilled syringe but not in the appropriate time frame with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct and 27-Oct both in unknown year, the patient received a dose of suspect Influenza Quadrival A-B Vaccine suspension for injection (lot U8192AA for date 11-Oct and for 27-Oct the lot is U8192BA with unknown strength, dose, expiry date) via unknown route in unknown administration site as immunization not in the appropriate time frame with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  It was reported "the first dose was given on 11OctxxXX and the second dose was given 27OctxxXX so the dose was administered two weeks before it should have been administered and he is looking for some clinical guidance on how to proceed with the patient."   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.
Patient vomited about 2 hours after vaccines were administered.   I made follow up call to mother one hour after she reported patient vomiting.  He has not vomited again and is resting quietly.He is afebrile- axillary temperature of 97.7 and has no other symptoms.  I will call patient's mother tomorrow to follow up again.  The clinic is now closed so I advised Mother to take patient to the ER if she has any further concerns that arise.
So the patient complained of weird vision and  her lower lip felt a bit numb.  She said her normal vision came back after a couple minutes and her lips no longer numb after about  ~10mins.  I asked if she experienced any other symptoms or her symptoms got worsen.  She answered no.  Right after a few minutes of reporting the symptoms, I asked patient's mom if  it's ok for me to call the paramedic.  Her symptoms went away before the paramedic came.  They checked on her pulse and said she's ok but still took her to monitor for further evaluation.
Information has been received from a pharmacist concerning a patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently the patient developed a generalized rash.  Unspecified medical attention was sought.  The pharmacist also described the experience of another patient while on therapy with measles virus vaccine lie (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(WAES#0207USA01697).  Additional information has been requested.
Delayed cutaneous hypersensitivity, beginning as red blotches around injection site 8 days after injection and worsening to large red circle surrounding injection site throughout day 9
On second day after vaccination, Patient began to notice cutaneous lesions on bilateral dorsa of feet and both palms. The dorsa of his feet had a slightly raised, pruritic erythematous rash that, over the course of the day, extended in places near to the ankle. Though not warm to the touch, Patient explained that they felt hot and painful. There was slight swelling. By 1/24/21, there was less swelling, and discomfort and the erythematous rash had become eczematous in places and thicker than the previous day.  The palms didn't have an appreciable rash. However, Patient felt much discomfort there (not exactly painful) and some paresthesia. He felt that his fingers were swollen. By 1/24/21, the discomfort in both palms was worse.
the evening of the vaccine started having tongue swelling, difficulty breathing, itching, and tachycardia.  lasted 3 days
feel sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing), notes: Had Afib and takes a blood thinner and heart pill to slow the heart down. Takes something else for the heart. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6201, Expiration date: Unknown), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "positive for Covid after one dose vaccine", "positive for Covid after one dose vaccine", "sick"; BNT162b2 (DOSE 1, SINGLE, Lot number: EN6201, Expiration date: Unknown), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 immunisation, reaction(s): "Then went and got the shot for it. Afterwards, went back to the doctor because she was falling down"; BNT162b2 (DOSE 2, SINGLE, Lot number: EN9581, Expiration date: Unknown), administration date: 08Mar2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "With the previous doses of Covid-19 vaccine, she felt sick after receiving them"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FC3183, Expiration date: Unknown), administration date: 27Sep2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "feel sick". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feel sick".  Additional information: It was reported that, that caller previously tested positive for Covid. Had it really bad, a long time there, she was really sick. Didn't want it again. Actually had Covid before, twice. The first time, was down for 6 weeks, probably. Then went and got the shot for it. Afterwards, went back to the doctor because she was falling down. Tested again positive and it wasn't as bad as the firs time, because she had the shot. Clarified further that caller had not had any Covid vaccines prior to first time testing positive for Covid. When she was positive for Covid the second time, she had received just one dose of the Covid vaccine, prior. Concomitant Products/Medical Conditions: Had Afib and took a blood thinner and heart pill to slow the heart down. Took something else for the heart. Prior to vaccination (within 4 weeks), the patient was not diagnosed with Covid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210413 same patient, different vaccine dose/AE;
I had a very bad reaction after the vaccine PPSV23 was given to me on June 4 at around 11:00 am. A couple hrs afterwards I noticed there was a slight headache and I felt the left upper arm where the injection was given was getting heavier and heavier. This did not both me too much thinking it was a normal reaction after vaccines. The injection was given at the muscle at the top of my left arm close to my left shoulder. At around 4 pm, 5 hours after the vaccine, I had the most excruciating pain at my left shoulder joint caused by the vaccine injection for at least 12 hours. The pain was 10 in a scale of 1 to 10. Tylenol and NSAIDs and ice offered to help. I wanted to die. The pain went to my neck, not only did I not able to lift my left arm, I could not even move my left hand. The throbbing pain travelled to the palm of my hand. I had fever. I felt better the next day and there was still pain but the pain was bearable even though I still could not move my left arm. It took a week for the pain to be gone and for me to be able to lift my left arm. Even today, 20 days after the vaccine, my left shoulder joint still feel stiff. I never have problem with my shoulders before. The adverse reaction was reported to the doctor thru email the next day and she told me to report to CDC myself. She advised to apply ice on the area for a few days.
Significant swelling of lymph node in clavicle  Swelling of face, ear, left eye and throat.
Starting 4 days after vaccination, baby experienced a high fever that precipitated a doctor visit.  Doctor reported that immune system may have been suppressed by vaccination.  Baby experienced high fever again, with emergency room visits, five days, then seven days from immunization.  emergency room physician prescribed cefprozil.  9 days from immunization, baby experienced high fever again, 104.4, and was taken back to administrating pediatrician, who took her off of the cefprozil, and told parents that per white blood count baby should be better in 2 days.
Since receiving my first dose of the COVID vaccine, I experience a heavy feeling in the chest and tightness in the heart at least once per day, ranging from 15 minutes to 3 hours. The pain is not excruciating, but is worrisome as I've never experienced the symptoms before.
Felt ill after second dose. Onset of headaches, face "burning" and tingling in hands and feet starting 3 weeks after second shot. BP higher. Symptoms persisted with BP control. Slowing improving with less headache and improving sensation in hands and feet and face by early August.
Moderna COVID-19 Vaccine EUA.  Starting about 10 or 11 hours after the shot, my temperature started to go up and hovered around 101.8 for at least 7 hours until it hit 102 and I took some Advil.  The body aches were intense and like nothing I have ever experienced so between that and the fever, I just had to take something.  I was woozy all day but again, starting in the first evening, any time I stood up, I thought I was going to pass out.  I got nauseous after taking the Advil and haven't taken any other fever/ache reducers since last night  because I don't want to feel nauseous anymore.  I could not eat anything yesterday after about lunch time.  Now, the next morning at 9:30am, I could only eat a little fruit smoothie and nothing else (except a ton of water all day yesterday, and all night, etc).  When I first "woke up" (I didn't sleep much last night since I was so uncomfortable), my fever was down to 99.6 but now it is back up to 100.8 (I am usually slightly sub-normal temp).  I am not a wimp, I have been sick before and gone through child birth.  The way I feel now is crappy enough that I thought you should know and even though I am extremely uncomfortable right now, I am taking the time to file this report FYI.
This spontaneous report as received from a physician refers to unspecified number of patients. On an unknown dates, the patients were vaccinated with their second and third doses of GARDASIL (Lot # not reported) off schedule. No adverse symptoms were reported. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Eve of shots (within 5 hrs) chill - deep bruised feeling of shot site - body aches - joints - headache - stuffy and runny nose - eyes dry and burning. Next day cough and some sneezing - chills gone - still have fever - soreness - tired.
3rd Hep A vaccine given - 2nd dose was not 'chirped" - error discovered after the fact.
I had a sore throat, sensitivity to light. I had lost of taste and smell by September 3rd. I had a cough, sneezing, nasal drainage. I had brain fog, I couldn't think right. I lost my appetite and my throat was really raw and it hurt to eat. I had a low grade fever between 99-100. I went to ER twice, my oxygen was dancing around 95-96. My oxygen dropped around 94 and I had really unbearable migraine not typical to my migraines. I had shortness of breath. I went back to ER, They did a D dimer test, chest X-ray, EKG, IV fluids and gave me Ibuprofen and Tylenol. I still have fatigue and shortness of breath. The doctor recommended I use steroid.
Immediately after the injection I felt a warm sensation flowing through my body and my head felt warm but I did not have a temperature.  This subsided within 20 minutes.    Prior to the vaccination I had slight Tinnitus on a scale of 1-10 I would say it was a 2.  I had no trouble sleeping at night and did not use any sound machines to mask the tinnitus. I would characterize myself as a great sleeper.   About 48 hours after the vaccination in my left ear my Tinnitus went from a 2 to a 5.  Now to sleep I must run a fan or noise machine to mask the tinnitus and sometimes have to take benadryl or Tylenol PM to sleep.
Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to (Patient Link).