chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; sore arm; This is a spontaneous report received from a contactable reporter other HCP.  A 21 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Oct2021 (Batch/Lot number: unknown) at the age of 21 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 30Oct2021, outcome "recovered" (2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 30Oct2021, outcome "recovered" (2021), described as "sore arm".   Additional information:-Vaccination facility type was Physician's office/Urgent care.Specific Relevant Test for thromboembolic events with thrombocytopenia was none.Comment and Narrative including that (Name) received his second dose of Pfizer on 30Oct2021.Today 15Nov2021 patient report no issues or concerns. He reports having a sore arm and headache for week after his vaccination 30Oct2021. He has no concerned or issues at this time & is considered fully vaccinated.the patient did not provide information to regarding the reported adverse event(s) with the use of the product   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
first Moderna COVID-19 vaccine on 03Mar2021 and the second on 23Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 03Mar2021 and the second on 23Mar2021) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0211321A and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 03Mar2021 and the second on 23Mar2021). On 23-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 03Mar2021 and the second on 23Mar2021) had resolved.            Concomitant products included a lot of unspecified pills for unknown indication. No treatment medications were reported.   This case was linked to MOD-2021-032507, MOD-2021-400008 (Patient Link).
sore injection site arms; felt slightly fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued). At the time of the report, VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) had resolved.            No concomitant medications were reported.   It was reported that, the patient received Moderna vaccination and had no side effects to the Moderna vaccine except sore injection site arms and felt slightly fatigued. "Just like with a Flu shot". Arm was sore for a day.   No treatment details were reported.  This case contains information for the 4th of 05 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710705.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710705:1 out of 5 siblings
In March, April and September 1995, a 1st, 2nd and 3rd dose of Engerix-B were given. During the summer of 1995 (not known whether after the 2nd or the 3rd dose), this female pt gradually developed fatigue and malaise and was found to have a newly elevated erythrocyte sedimentation rate (Westergren) of 49mm/h in the absence of back pain or other symptoms of active ankylosing spondylitis from which she suffers since 1991. In 10/95, she developed severe headaches and was found to have blood pressure of 220/110 mmHg. She had never before has had hypertension and her blood pressure in 8/95 had been 116/70 mmHg. After starting Enalapril (Enalapril Maleate), she developed acute renal failure, prompting her admission to the hospital. Her exam was remarkable for hypertension, a left-side abdominal bruit and normal pulses in her extremities. Enalapril was discontinued upon hospital admission. Her renal recovery following emergent aortorenal sephenous vein grafts and pulse methylprednisolone has been reported. In 10/97, 90% stenosis of the right renal artery vein graft was treated successfully with angioplasty. At that time a slight stenosis of the mid portion of the right subclavian artery was noted. An MRI in 8/99 showed no further narrowing of the involved arteries. It is mentioned that the dx of Takayasu's arteritis fits well, as she was a young woman with angiographic abnormalties of the subclavian, celiac, superior mesenteria and renal arteries that are characteristic of Takayasu's. It was also mentioned that it is not possible to determine whether the large artery vasculitis in this pt was caused by the vaccination or simply temporally associated. The number of cases of vasculitis that have been reported following vaccination at least raises the possibility of a causal relationship. The underlying rheumatic diseases of both pts described in this article (ankylosing spondylitis for the present case and polymyalgia rheumation for the 2nd pt) suggests the possibility that the pt with immunologic dysfunction may be more susceptible to developing vasculitis following vaccination.
Information has been received from a consumer, for ZOSTAVAX, a Pregnancy Registry product, concerning her friend, an approximately 33 year old female patient. On 01-JUL-2013 the patient was vaccinated with ZOSTAVAX, 1 single standard dose, subcutaneously. Soon after that the patient discovered pregnant. At the time of the report, the patient was 5 weeks and 2 days pregnant. No adverse event was reported. The LMP was approximately on 18-JUN-2013 and EDD is 25-MAR-2014. Additional information is not expected.
At approximately 345 PM patient complained of itchiness on his body, hives, swelling and tightness in throat. Consulted with provider and administered 2 tabs BENADRYL monitored vitals. Provider re-evaluated and nurse administered hydroxyzine HCI 25 mg/ml. Patients vitals and symptoms were evaluated by provider and released to go home.
The first shot hurt; my arm "burned"; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and burning sensation. On an unknown date, the outcome of the pain and burning sensation were recovered/resolved.   It was unknown if the reporter considered the pain and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient received Shingles vaccine and his/her arm hurt and burned for a week or more then was fine. The patient had no issue since, about 5 years. For the tolerance of 2nd dose, refer case US2021AMR190661.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190661:same reporter
Actually, I am having quite a few reactions that are abnormal for me that I did not have before the shots.  I went to the doctor on Friday for a yearly physical and she found a supraclavicular lymph node swelling on the right clavicle that I now have to get ultra-sounded on June 26th.  The vaccines kicked my butt, especially the one given in the right arm.  The night of and the couple of days after I have been sick with malaise, arm tingling and numbness, slight chest pain and exertion breathing issues/ stomach pain and having issues thermoregulating at night.  I have had like almost cold flashes and then will get really hot and have been having issues sleeping.  I had a slight fever the day of, but haven't had any since, but the arm numbness, stomach pain and swollen node are not abating and it is now Saturday.   I feel like I need to report this and I don't know how to go about it.  My doctor was really worried about the clavicle node until I told her I just had a vaccine a day and a half before but she  said it is soft, moveable and tender which is a good sign it's vaccine related, but still needs me to be seen for it.  I looked up side effects and adverse reactions on the web and these are all part of the B vaccine affects, but I'm wondering if I should be seen in ER, because some of them are kind of freaking me out obviously because you don't mess around with supraclavicular node issues.
approximately 1-1.5 hours after receiving vaccination, child returned to school based clinic crying, stated " I am shaking all over and have the worst headache I have ever had in my life".  Nurse seated child in chair, noted child was pale and visibly trembling all over her entire body.  Child was not exhbiting any signs of allergic reaction (hives, rash, swelling in face, nose, tongue, or throat) and denied difficulty breathing.  Blood pressure taken, 140/100.  Nurse made decision to call 911.  Cool cloths placed on child's forehead and neck.  Squad arrived at approximately 12:00pm.  Blood pressure 136/78, heart rate 87, blood sugar 124.  Child taken to nearest emergency room by squad, parents notified.
2:30PM NOTIFIED Nurse THAT PT HAS GOTTEN DOSE #2 ONE WEEK EARLY. NO NEED TO REPEAT DOSE #2. 2:50PM PT NOTIFIED BY PHONE -VVERBALIZED UNDERSTANDING TO Nurse.
Pt felt like she was getting hot flashes. Temp was 99.1. Air conditioning turned on at tent site and pt monitored for 30 mins by paramedics and medical provider. Pt felt better, temp was 97.5 orally when pt left vaccine site.
Had injection on 9/26/2021, on 9/27/2021 he stated he was watching football on television, Client stated at home and felt like torso was being crushed, foreboding feeling, took Tylenol and rested, by 5 PM he decided to go to ER, stated was taken by priority after 3 people were taken ahead of him in the crowded waiting room of ER, heart attack described as silent widowmaker, had balloon angioplasty and 2 cardiac stents placed, was admitted to the hospital as inpatient from 9/27-10/1/2021
Pt developed hives approximately 1hr after receiving her vaccine. Hives present to both arms. No difficulty breathing. Breath sounds CTA (B). Slight itching noted. 25 mg Benadryl po given per RN (school nurse) & parent notified.
Initial unsolicited report received from nurse via other company (Pfizer) (manufacturer report number -2016273237) on 30 May 2016. This case involves a 16-year-old female patient who was vaccinated with a dose of MENACTRA (batch number, expiry date, dose, route of administration not reported) in the right arm and TRUMENBA (batch number, expiry date, dose, route of administration not reported) in the left arm on unspecified date. The patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced seizure and loss of color. Lab data and corrective treatment were not reported. The outcome of events was not reported. Upon internal review, the case was considered as serious due to important medical event: seizure. List of documents held by sender: none. Sender's Comments: A 16-year-old female patient developed seizure with loss of color following vaccination with TRUMENBA and MENACTRA. The exact date of vaccination and date of event are unknown and also patient had two vaccines on the same day. Further information on patient's medical history, family history, investigation results ruling out a concurrent infection, etc. are needed to further assess the case. However, as two vaccines were administered concomitantly, the role of each component cannot be assessed.
First night got a little dizzy and real tired then Rash on upper arm where shot was given and  second day just the rash getting bigger
Headache, muscle ache, fatigue, nausea, redness and swelling at injection site.
Pt. had flu shot and within a few days developed (R) lat. lower leg pain and weakness. Ascending and involving (R) ant. thigh and hip flexors, compromising gait. Next, (L) lower extrem. developed weakness. Pt. lost appetite and began losing wt. 11-16-13, pt came to ER b/c (R) sided facial weakness -> Bell's palsy. 11-17-13, pt. admitted to hospital b/c progressive weakness, (R) sided facial droop, difficulty eating and drinking. As an outpt., pt saw orthopedic spine doctor, int. med. primary doc. Inpatient, he saw neurology. (+) P.T./O.T. He was hospitalized x9 days. He has ongoing PT/OT to develop gait. Uses wheelchair now.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
The patient noted red patch (R) inguinal fold 6 days after injection on 8/28/14. He has had several episodes of emesis intermittent headache as well.
At 12 noon  I was working at the front yard of my sisters area and I mentioned to her I was feeling sleepy and I insistently felt like I was going to faint and I told her I had to go home and go to bed. I felt a pain  in my kidney I asked my niece if she knew the adverse events of the vaccine. She said no. I felt pain everyday in the kidney area until the 19th yesterday I  instantly felt paralyzed my sister provided first aid with an ice pack with applied pressure my kidney and a pack on my forehead and felt some relief.  I was assisted to a Epson salt bath and given 200 mg  times 4 of ibprophen.
PATIENT COMPLAINED OF HEADACHE & HAVING DIZZINESS; I CALLED FOR EMERGENCY SERVICE; I PASSED THE CARE ONTO THE PARAMEDICS
Period delayed by 4-5 days every cycle since second and last covid vaccine shot; Also began spotting mid-cycle, which is abnormal and a new development since vaccine shot; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamin, on an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021, the patient's period delayed by 4-5 days every cycle since second and last covid vaccine shot. Also began spotting mid-cycle, which was abnormal and a new development since vaccine shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event period delayed by 4-5 days every cycle since second and last covid vaccine shot and also began spotting mid-cycle, which was abnormal and a new development since vaccine shot was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
32 y/o male with history of allergic rhinitis here for first COVID vaccine (Pfizer).  Within 20 minutes or so of being vaccinated (the patient was observed for 15 minutes and then left as per normal procedure, went upstairs to get medications at the pharmacy when started to have symptoms) - throat tightness/fullness/feeling of constriction but no inability to swallow or breathe.  Walked back to the vaccination area for evaluation.  No prior reactions to medications or vaccines.  No rash, itching, dyspnea, lightheadedness.   Symptoms coincident to vaccination with COVID-19 Pfizer vaccine - throat tightness, sinus fullness and chest heaviness.  No abnormalities on physical exam or vitals other than slight elevation in BP.  Due to progression of symptoms, lack of resolution treated with antihistamine and epinephrine 0.3mg IM left thigh.  Called 911 to transport patient for observation in the ED.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # reported as L036851, expiration date 23-SEP-2017, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 9.6 Celsius degrees for 1 hour before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Redness and swelling of right arm during first 24 hours post vax, resolving slowly during next 24 hours. Swelling mostly in upper arm around site of DTaP vax.
This spontaneous report was received from a pharmacist and refers to a 86 year old male patient. The patient's pertinent medical history and concurrent conditions were not reported. The patient had no known drug reactions and allergies. On 14-NOV-2014, the patient was subcutaneously vaccinated with ZOSTAVAX (lot # K010647, exp. date 30-OCT-2015, dose: 0.65ml, anatomical location was not reported). Concomitant therapies included allopurinol and enalapril maleate (manufacturer unknown). On approximately 22-NOV-2014 (it was reported that the adverse reaction started "3 to 4 days ago") the patient experienced burning at the injection site, redness approximately 2 to 3 inches in radius around the injection site, a blister about the size of a pencil eraser around the site of injection and a lump under the skin at the site of injection. It was also reported, by a pharmacy student that, on an unknown date, approximately in 2014, the patient was officially diagnosed with shingles. The patient did not seek care from his unspecified primary healthcare provider, he reported the events to the pharmacist. No treatment was given for the adverse events, no laboratory tests were performed. The patient did not recover from the adverse events. The relatedness between vaccination with ZOSTAVAX and the events was not reported. Additional information has been requested.
SHORTNESS OF BREATH, STUFFY NOSE, HOARSENESS VOICE AND HIP PAIN.
01AUG90 pt vax hepta B. pt devel flu-like sx like myalgia, cough, nausea, and malaise.  sx grew worse for 7 days then disappeared after 16 days.  pt did not continue series
This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 Lot# reported 1013428, expiration date: 03-FEB-2017 for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009044: US-009507513-1702USA009042: US-009507513-1702USA009043: US-009507513-1702USA009040: US-009507513-1702USA006132.
fever; body ache; flu; swollen lymph node; really bad pain in the chest; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program.  A female patient of an unspecified age received second dose of BNT162B2 (PIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 14Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 immunization. The patient experienced fever, body ache, flu, swollen lymph node and really bad pain in the chest on an unspecified date in Apr2021. The consumer was asking if these are related to the side effect of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.