chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9/17/07 At approximately 3:45pm pt. received vaccines and was observed for 15 minutes with no s/s of adverse effects. 9/18/07 Pt. went to school nurse because his left arm muscles between the deltoid and the elbow were constantly twitching. She reported to this office, and when the condition did not improve he was sent home. She and RN. both told family to take him to the doctor. 4:30 pm Family Practice called to tell her he was there and his arm was still twitching. The school nurse and Family Practice did not see any redness or swelling at the injection site, and the pt. did not complain of pain. contacted Sanofi Pasteur, medical division, and asked them to call Dr.at Family Practice. He was given Diazepam and sent home to return 9/19 at 10:30am. 9/19/07 He was seen at Family Practice with his arm still constantly twitching. He was referred to Dr. , a neurologist at Hospital to be seen at 2pm.  9/20/07 Received tel. call from pt's mother reporting that they saw Dr. Blood was drawn and an x-ray was done, and he was given an Rx for Xanax. She said his arm is still twitching this morning, but he can move it, and does not have pain, swelling, numbness or tingling. They are to stay in contact with Dr. to let him know how he is doing. 9/28/07-records received for DOS 9/18-9/19/07-Assessment:adverse reaction to Tdap. twitching to upper left arm site of TD injection.Menactra vaccine in right arm.  L arm hurts from elbow down to writst and a strong twitch that goes down to his hand to makes his arms and fingers lock.  On office visit of 9/19/07-twitching stopped yesterday then started again, Pain in forearm gone. Neurology consult. Able to voluntarily suppress twitiching for a period of time, no pain no loss of sensation no loss of motor function or muscle power. PE: irregulr non-rhythmic jerking of left upper extremity which stops when he is distracted and stops on action as well. Stops when on postural movement such as having him hold his arms outstretched. Impression: abnormal voluntary movements strongly suspect these are probably psychogenic in nature, does not appear to be a vaccine related problem. Benign problem that will probably spontaneously resolve.
SIDS 18NOV98;seen on 6NOV98 had physical exam;had oral thrush put on nystatin;
I experienced a cramp-like pain from my shoulder all the way down to my palm in the arm that received the injection.  This began within a few hours after the injection and primarily lasted for about 14 days.   I'm now 5 weeks out and the pain has mostly gone and away and is more intermittent, but I still experience cramping pain  if I lay on that arm (e.g., when sleeping).
Not Administered in the Deltoid; Itchy Sensation - Near Elbow; Rash - Near Elbow; Redness - Near Elbow; Swelling - Near Elbow; A spontaneous report was received from a consumer concerning a 31-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) at the incorrect injection site and experienced rash, redness, swelling, and an Itchy sensation near her elbow.    The patient's medical history, is not provided by the reporter. Concomitant medications were not reported.   On 21 Jan 2021, the patient received their first of two planned dose of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection.    On 21 Jan 2021, the patient began to experienced rash, redness, a lot of swelling, and an Itchy sensation near her elbow where the vaccine was administered. Treatment for the events included ibuprofen    Action taken with mRNA-1273 in response to the events was unknown.    The outcome of event, incorrect injection site, was considered recovered/resolved on 21 Jan 2021.   The outcome of the events, rash, redness, swelling, and an Itchy sensation, was unknown/not reported.; Reporter's Comments: Based on the 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.  The causality of the event of vaccine administered at inappropriate site is assessed as not applicable.
experienced pruritis over her entire body, even inside her ears; she felt sores on her feet and started to itch; Her eyes were draining; This is a spontaneous report from a contactable Pharmacist. This pharmacist reported for a 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history included excessive histamine response to a variety of modalities- medications/antibiotics, foods, pets/animals, etc. She was also status post craniotomy due to hydrocephalus and had a VP shunt; from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. As per the description, In Jan2021, on her way home from the initial vaccine administration she felt sores on her feet and started to itch. Shortly thereafter, she experienced pruritis over her entire body, even inside her ears. Her eyes were draining. All of this occurred despite using diphenhydramine 25mg q3 hours. Her symptoms finally resolved on 24Jan2021. She was also inquiring of whether she should receive the second dose of vaccine. The outcome of the events was resolved on 24Jan2021.  Follow-up attempts are completed. No further information is expected.
Continued swelling, redness, itching at injection site plus 2" by 2.5" area around injection site 4 days after injection
Indurated rt deltoid. Able to move. The pt shoulder well. No obvious swelling.
Numbness in feet and hands.  Swelling in feet and hands.  Comes and goes through out the day.  Sometimes impairs walking and writing.
pt recvd vax; devel inject site rxn consisting of erythema,tenderness & swelling;recovered
Patient had redness, swelling and painful to touch. (as noted pt stated left elbow swelling 6 hours after TD, seen 48 hours after by me with continued but decreased swelling, olecranon bursa, full range of motion, seen again 12/7/06 resolution of symptoms.
Pt recieve flu vaccine and developed itchy red eyes within 24 hrs of vaccine, same problem occured the year before.  Pt this year treated for allergic conjuctivitis with patonol prn;  if
I had trouble getting up; I had trouble walking; Fatigue; Muscle aches; Chills every now and then; Slight headache; Swelling and red rash around the injection site; Runny nose; Cough; A lot of soreness; Swelling and red rash around the injection site; Swelling and red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), RHINORRHOEA (Runny nose), COUGH (Cough) and VACCINATION SITE PAIN (A lot of soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced RHINORRHOEA (Runny nose), COUGH (Cough), VACCINATION SITE PAIN (A lot of soreness), VACCINATION SITE SWELLING (Swelling and red rash around the injection site), VACCINATION SITE RASH (Swelling and red rash around the injection site), CHILLS (Chills every now and then), HEADACHE (Slight headache) and VACCINATION SITE ERYTHEMA (Swelling and red rash around the injection site). On 03-Jun-2021, the patient experienced HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), FATIGUE (Fatigue) and MYALGIA (Muscle aches). On 07-Jun-2021, HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), FATIGUE (Fatigue) and MYALGIA (Muscle aches) had resolved. At the time of the report, RHINORRHOEA (Runny nose), COUGH (Cough), VACCINATION SITE PAIN (A lot of soreness), VACCINATION SITE SWELLING (Swelling and red rash around the injection site), VACCINATION SITE RASH (Swelling and red rash around the injection site), CHILLS (Chills every now and then), HEADACHE (Slight headache) and VACCINATION SITE ERYTHEMA (Swelling and red rash around the injection site) outcome was unknown.            Treatment information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-116526 (Patient Link).   Reporter did not allow further contact
The morning after the vaccine was given, there was significant swelling and edema in my axilla. The 2nd day it seemed more edematous because it was tender to palpation. The injection site was sore, reddened like it had been the first 2 times I received the vaccine, but was now very itchy. The 3rd day the swelling remained in the axilla, but also was lower on the left side of my chest, including the lateral left breast.  The 4th day seemed the same. Today, the 5th day, it is noticeably less edematous, both the chest wall and axilla. The soreness and redness are gone today, but the deltoid remains itchy, though less than since it started.
Long term difficulty breathing, elevated heart rate, and chest discomfort. Inability to tolerate any exercise for 4 months, followed by 6 more months of frequent relapses.
Mom called at 12:15 PM and said area is red and had a 1 1/2 inch diameter size knot. Mom will do cool compresses and MOTRIN for pain.
about 10 lesions, consisting of red papular vesicles pustules, crater-like lesions & scabbed lesions scattered on the trunk & legs +pruritus;
Local area enduration, erythema & swelling extending area 10cm diameter.  No treatment rendered.
A nurse reported that she experienced a cut to her finger from a broken vial of Hib-Titer vaccine which was inadvertently stored on a shelf. She reported that "no medical attention was necessary".
Patient was complaining of a sore muscle. She was advised to apply ice on the affected area  and if needed take a pain reliever.
Swollen lymph node; Stiffness, soreness and tingling in left arm; Stiffness, soreness and tingling in left arm; Stiffness, soreness and tingling in left arm; Extreme pain and swelling in left arm for a week after each dose; Extreme pain and swelling in left arm for a week after each dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No:  EN6205, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "covid test result=Positive", "Extreme pain and swelling in left arm", "Extreme pain and swelling in left arm", "covid test result=Positive"; BNT162b2 (Dose Number: 1, Batch/Lot No:  EN6205, Location of injection: Arm Left), administration date: 11Mar2021, when the patient was 43-year-old, for COVID-19 immunization, reaction(s): "covid test result=Positive", "Extreme pain and swelling in left arm", "Extreme pain and swelling in left arm", "covid test result=Positive". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Extreme pain and swelling in left arm for a week after each dose"; MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious), PARAESTHESIA (non-serious) all with onset 10Dec2021, outcome "not recovered" and all described as "Stiffness, soreness and tingling in left arm"; LYMPHADENOPATHY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Swollen lymph node". The events "swollen lymph node", "stiffness, soreness and tingling in left arm" and "extreme pain and swelling in left arm for a week after each dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, musculoskeletal stiffness, myalgia, paraesthesia, pain in extremity.  Additional information: No other vaccine in four weeks. Multi vitamins medications was in two weeks. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
102.7 fever began 1/27/21 approx 4pm, along with bad headache.  Headache and Low grade fever continued until 6:30 am ,1/29.
Months later: Weakened immune system, constantly sick . Headaches, nose bleeds, chronic fatigue,  fevers,  allergies, abdominal pain, iron deficiency anemia, vitamin D deficiency,  leg cramps, shortness of breath, rashes, fructose malabsorption, colonoscopy and endoscopy-IBS, SIBO,
heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  .  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening). At the time of the report, HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Heart rate: 110 bpm (High) 110 BPM.         No medical history was provided by reporter.  Other concomitant includes blood pressure pills.  No treatment medication reported.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium
Injection site soreness for 1 or 2 days.  About 8 days later there was rapid onset of soreness in the upper arm, shoulder.  Pain was severe that patient had difficulty raising her arm even to apply underarm deodorant.  She reported this to the pharmacy on Nov. 2nd and had physician treatment on Nov. 4th.  She was prescribed Medrol and Naproxen.  In a follow up call after one week, she said that treatment was working.
After I got the flu shot 3-4 days My right rotator cuff started hurting, I could not lay on it and it was very painful. The pain lasted for 8 weeks. I asked the pharmacist about the pain and asked of this was a symptom of the vaccine and they stated it could be. I'm about 90% recovered.
while sitting at the vaccination  and waiting for mother, patient started to complain of feeling "hot, dizzy and lightheaded." Patient was given gatorade water and hair was pulled into ponytail off of neck to help cool down. Stable vital signs BP 110/64 P84 SpO2 98% room air. Within 5 mins, patient expressed that she was "feeling better." Alert and oriented x3. Patient expressed that she did not eat or drink anything prior to coming in to receive vaccine. Patient assisted to observation area for monitoring. Steady gait noted. Ambulated from facility with mother. No s/sx of distress noted.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated IM with a split dose of MMR II which was given in both arms. Subsequently, the patient had a reaction (arm locking up) in one arm only. The physician stated that the patient received the immunization from another physician's office, (the other physician's name and contact information was not reported). As of 12-APR-2011, the patient had recovered. It was unspecified if the patients sought medical attention. Arm locking up was considered to be disabling by the reporter. This is one of several reports received from the same source. Additional information is not expected.
Pt came back 3 hours after immunization and had a swollen left Eye and itching throughout the body which also included some tingling in the extremeties.  No Anaphylactic shock was noted upon observing the patient.  Pt stated that the eye swelling was beginning to decrease at the time of presentation to the pharmacy.
Arthralgia, Fever teeth hurt, fatigue Narrative:  given ibubrofen chiropractic care  Other Relevant History:
Headache within 10 mins of vaccine admin.  Tachycardia, elevated BP,  and SOB within 30-45  mins.  Headache resolved within 2 hours.  Tachycardia, elevated BP, and SOB last approx 18 hours.   Increased SOB when lying down.
first shot ( given in his left arm) was worse that the second shot ( given in his right arm).; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (first shot ( given in his left arm) was worse that the second shot ( given in his right arm).) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced VACCINATION COMPLICATION (first shot ( given in his left arm) was worse that the second shot ( given in his right arm).). At the time of the report, VACCINATION COMPLICATION (first shot ( given in his left arm) was worse that the second shot ( given in his right arm).) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  No Treatment medications were reported.   This case was linked to MOD-2021-266663 (Patient Link).
After getting vaccine I felt pressure and palpitations- it was uncomfortable and I felt it for 1.5-2 weeks. I checked my blood pressure it was ok but my heart rate was in the  high 90's-100's which was different.; with the second vaccine I felt like I had the flu for 24hrs.
Facial swelling and hives that continued for 2-3 days requiring 2 visits to emergency department and benadryl for symptomatic care.
2 month old female patient administered expired dose of Act-HIB with no reported adverse event; Initial information received on 12-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 month old female patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 11-Mar-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ137AAA and expiry date: 06-Mar-2021) via an intramuscular route in the Vastus Lateralis for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that the ActHIB injection was given and it had expired by 5 days and wants to know if any side effects will be had by patient. The patient has not experienced any adverse event (AE) as a result of this.  Reporter relationship: health care professional (HCP) Product used: used Still using product: no was Device used: yes  At the time of report, no adverse event was reported.   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 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.
On 2/6/02, the vaccinee received his 1st injection of Engerix-B. On 2/11/02, 5 days post vax, he tested positive for Hep-B surface antigen.
Patient not being able to sit up or stand; Chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains) and MOBILITY DECREASED (Patient not being able to sit up or stand) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced CHEST PAIN (Chest pains). On 12-Mar-2021, the patient experienced MOBILITY DECREASED (Patient not being able to sit up or stand). At the time of the report, CHEST PAIN (Chest pains) and MOBILITY DECREASED (Patient not being able to sit up or stand) outcome was unknown.            No relevant concomitant medications were reported.  It was reported that on 12-MAR-2021, patient had chest pain that became unbearable lasting for 20 minutes, restoring to the patient not able to sit or stand. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Patient report that that the same day of the vaccine he had a burning sensation and pinching sense at the time vaccine was given... the back of his left arm from shoulder to elbow is numb....hard to hold thing with his left hand.. also experience headaches and sleep paralysis...he stated that he has always had sleep paralysis but now they are more frequent... His right eye twitches alot
Migraine type headache, severe stiffness of joints and body aches, sensitivity to light, sensitivity to noise, frequent urination, swollen arm,  general malaise.
This spontaneous report has been received from a registered nurse and referred to 2 patients of unknown ages and genders. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, frequency and route of administration were not reported; lot number M035486 with an expiration date 05-JUN-2019 and lot number M041990 with an expiration date 28-JUN-2019) for prophylaxis. The vaccine data logger measured a temperature of 25°C for a total time frame of 23 hours. Previous temperature excursion measured 25°C for a total time frame 57 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015158: US-009507513-1705USA015159: US-009507513-1705USA011313: