chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hot to the touch; Injection site is hard; Swollen as a delayed reaction; Right arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was very sore), INJECTION SITE WARMTH (Hot to the touch), INJECTION SITE INDURATION (Injection site is hard) and INJECTION SITE SWELLING (Swollen as a delayed reaction) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm was very sore). On an unknown date, the patient experienced INJECTION SITE WARMTH (Hot to the touch), INJECTION SITE INDURATION (Injection site is hard) and INJECTION SITE SWELLING (Swollen as a delayed reaction). At the time of the report, PAIN IN EXTREMITY (Right arm was very sore), INJECTION SITE WARMTH (Hot to the touch), INJECTION SITE INDURATION (Injection site is hard) and INJECTION SITE SWELLING (Swollen as a delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-131962 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up document received on 14-May-2021 contains significant information of second dose details and reported event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-131962:Dose 2
Rash, initial presentation bilateral anterior thighs. Painful to touch. Pain in soles of feet. Joint pain, left knee.  1/7/21  Spread of rash to posterior hands and anterior fingers. 1/8/21
Information has been received from a physician concerning a 16 month old white female child with no medical history who on 23-MAY-2005 was vaccinated subcutaneously in the right thigh with her first dose of varicella virus vaccine live )Oka/Merck) (lot #648552/0113R). Concomitant vaccination given on the same day included a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot# 648664/0992P) given subcutaneously in the right thigh. There was no illness at the time of vaccination. On 16-OCT-2005, while on vacation, the patient developed a solitary right thigh rash. The patient returned home on 17-)CT-2005 without pain or discomfort but blistered patch still present a week later without improvement. The patient was seen in the pediatrician's office and a viral culture was sent on 20-OCT-2005. There was no information regarding the recovery status of the patient. Follow-up information has been received from a registered nurse (RN) stating that a follow up phone call was placed to the patient's mother on 17-NOV-2005. The mother reported the patient had not recovered, the area has improved but it's more flared out. The patient has been itching at it for a week. The patient's mother was not convinced that it is varicella. The RN also noted that the cultures send could not be tested and the test had been cancelled. A follow-up appointment was then scheduled for 21-NOV-2005. Additional follow-up information has been received from a RN reported that the date of onset was 26-OCT-2005 (previously reported as 16-OCT-2005 when a fine papular rash surfaced on a patch of skin on the right thigh. One thigh lesion had a vesicular top, no fluid. It was reported that the patient was diagnosed with varicella zoster status post vaccine. The patient had a follow up appointment on 21-NOV-2005 and was considered recovered at that time. Additional information is not expected.
Patient was given Vaccine one week early.  First Vaccination was on June 06, 2021. Second Vaccination Was given June 20, 2021.
Had the booster vaccine on the 13th of this month; Had the booster vaccine on the 13th of this month; Got fever for four days, low grade fever; Got a black and blue mark that came out on arm; Rash on arm; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 3 via an unspecified route of administration on 13Sep2021 (Batch/Lot number was not reported and stated that do not have anything, had it done on 13 and had nothing; Expiry date: Unknown) as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2 single and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1 single for covid-19 immunization. On 13 Sep2021, the patient reported off label use and immunization.In Sep2021, got fever for four days, low grade fever and a rash on arm, after the rash patient got a black and blue mark that came out. Patient was concerned about the black and blue mark, mean patient did not bang itself or anything it just came out on arm. The patient underwent lab tests and procedures which included body temperature: low grade fever in Sep 2021. The outcome of the events was reported as unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Pt feels injection too high on arm (near shoulder joint) constant pain, redness and swelling.
Mother into clinic with daughter states pt had grand mal seizures on 1/19/03. Was seen at hospital, no temp run.
Patient was tested positive for Covid; Initial information received on 27-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer (patient).  This case involves a male patient of unknown age who was tested positive for COVID (COVID-19), while he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was tested positive for COVID (COVID-19), a week following the administration of INFLUENZA VACCINE. The patient was hospitalized for 3 weeks due to this event.  Other relevant laboratory data were not reported.  It was reported that the patient was back home taking treatments (not specified) and was on oxygen for COVID-19.   At the time of reporting, the patient was recovering from the event. He also reported that some of those folks that were in the Hospital did not make it.  Information on the batch number was requested.; Sender's Comments: This case involves a male patient of unknown age who was tested positive for COVID-19 after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was compatible. However, patient's medical condition at time of vaccination was not reported. Based upon the reported information and considering the infectious nature of the event, the role of suspect vaccine cannot be assessed.
Five weeks between doses; A spontaneous report was received from a consumer who was a 73 year-old, male patient who received Moderna's COVID -19 Vaccine, which the vaccine doses had been scheduled five weeks between doses.  The patient's medical history included idiopathic pulmonary fibrosis, hypothyroidism, cholesterol, and diabetes. Concomitant medications included an unspecified calcium carbonate, nintedanib esilate, levothyroxine sodium, metformin, and an unspecified medication for cholesterol.     The patient received his first of two planned doses of mRNA-1273 (Batch number 011L20A) on 30 Dec 2020 intramuscularly in his upper arm for prophylaxis of COVID-19 infection.  On 07 Jan 2021, the patient scheduled his second of the two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID -19 infection for 13 Feb 2021 (45 days post first dose). The subject was advised that the COVID -19 vaccine series should be given one month apart for the vaccine to work and help protect against COVID -19.  Treatment for the event included not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.   The outcome of the event was considered resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 73-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot 011L20A), reporting Inappropriate schedule of product administration without any associated adverse events.
Patient was given the Moderna Bivalent instead of the Moderna primary dose for their first covid dose.
Information has been received from a company representative concerning a patient who in approximately 1997 was vaccinated with varicella virus vaccine live. Subsequently, the patient experienced breakthrough chickenpox.  It was also reported that 4 children at the patient's daycare had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. Follow up information from the RN indicated the adverse experience occurred in the daycare nearby the office, and she had no additional information on this adverse experience. The physician's office did not administer any of the vaccines. No further information is expected.
Seasonal Influenza vaccine administered 3/4/2011. Personal risk-healthcare worker. Reported 3/15/2011 to Infection prevention and central nurse that she began experiencing numbness and tingling of her hands and feet on 3/8/2011. Referred to MD for evaluation.
p/vax pt exp chickenpox w/approx 15-20 lesions located on the torso & buttocks;pt sought unspecified medical treatment;
swelling, redness, itching @ inj site;rash on opposite arm, itching of ears & arms;
Information has been received from a male consumer of unknown age referring to himself. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 10-NOV-2015 the patient was vaccinated with a dose of ZOSTAVAX (frequency reported as one time vaccine; lot # and dose unspecified). on the same day, the patient's arm was hurt after getting vaccine for 2-3 hours where the vaccine was given. The outcome of the event was unknown. The causality of the event and ZOSTAVAX was not provided. Additional information is not expected as contact details were not provided.
Dad states the eve. of shots, child had hand print size red rash on side of left thigh. States at first child said it itched. No fever, no other complaint. Since 1st day, dad states his wife said "they were like tiny pin-heads now they are brown". PHN referred father to child's PCP.
Patients reports about 30 hours after receiving vaccines she started running a fever, had a headache, nausea and diarrhea.  She states this lasted for 3 days.
First shot on 5/23/2021.  No adverse reactions following the first shot. Second shot on 6/13/2021.  All reactions/side effects described below followed the second shot.  06/14/21 ? 06/16/21: Fever, fatigue, headache, dizziness, chest pressure, arm soreness at injection site 6/17/21 ? 06/23/21: fatigue, headache, dizziness, intermittent chest pressure, abnormal sinus pressure (no stuffy nose, no drainage or feeling of having clogged sinuses, just pressure) 6/24/21 ? 7/6/21: severe ear pressure/fullness to the point of being painful, severe tinnitus, sinus pressure, daily headaches 7/7/21 ? Present: intermittent mild to severe ear pressure/fullness, mild to severe tinnitus (directly related to how much pressure/fullness is present at any given moment), sinus pressure, frequent headaches (3-4 times per week).   These symptoms persist with no end in sight.  Before the second vaccine shot, my average headache frequency was once every month or two.  Ears have been abnormally sensitive to loud noises since the pressure/fullness started.  Treatments: Flonase and saline sprays twice daily since 7/12/21.  Ibuprofin when headaches get bad, but it doesn't help much. Changed diet to an anti-inflammatory diet (more fruits/veggies, no red meat, less cheese, less carbohydrates, less sugar); this has helped some, but any deviation and symptoms get worse within 24 hours.  Additional dietary supplements (vitamin C, vitamin D, tumeric).
Rash on head/face and (B) arms immediately following PEDIARIX, HIB, PREVNAR 13, ROTATEQ.
Severe nausea, lethargy, and fever between 101 and 102 Fahrenheit for approximately 18 hours, beginning 24 hours after the vaccine was administered.
Lymph node swollen since 19May; This is a spontaneous report from a contactable consumer (Patient).   A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 18May2021 17:15 (Batch/Lot Number: EW0162; 12-years-old age at time of vaccination) as single dose for covid-19 immunisation. Medical history included asthma and seasonal allergies. Concomitant medications included montelukast and cetirizine hydrochloride (ZYRTEC) and Smarty Pants Vitamins. The patient previously took Tamiflu and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19May2021 at 07:30 PM, patient had lymph node swelling. No treatment was received for event. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not resolved.
Extreme fatigue; Ongoing chills; This is a spontaneous report from a contactable physician. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an intramuscular route of administration in the left arm on 12Apr2021 at 10:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included nicotine dependence and anxiety. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included fluoxetine hydrochloride (PROZAC), alprazolam (XANAX) and paracetamol (TYLENOL); all for unknown indication from unknown date and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an intramuscular route of administration in the left arm on 22Mar2021 at 10:00 as a single dose for COVID-19 immunisation and received sulfamethoxazole/trimethoprim (BACTRIM) and sertraline hydrochloride (ZOLOFT); both for unknown indication on unknown date and experienced drug allergy. On 13Apr2021, the patient experienced extreme fatigue and ongoing chills. On 06May2021, the patient underwent Nasal swab and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with azithromycin (Z-PAK). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events extreme fatigue and ongoing chills was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
I have had terrible migraines, pain in my left skull, left side of my neck, and base of my skull every single day since my booster shot (Pfizer) on November 8th 2021. I notified my doctor's office of this and was told to take NSAIDs. I am a person who gets migraines and this pain is unlike my usual migraines and in very different places. It is draining and painful to have this pain every single day.
Post vax, the pt developed pain, swelling, and redness in right upper arm for 10 days at injection site. Also, complained of fever and chills.
Rash on arms, abdomen, and back; This is a spontaneous report from a contactable other HCP. A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular in left arm on 15Jan2021 16:00 at a single dose for covid-19 immunization. There were no relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin d nos (VITAMIN D NOS), ascorbic acid (VITAMIN C), and fish oil (FISH OIL). The patient previously received the first dose of bnt162b2 on 26Dec2020, lot number: EH9899, in left arm for COVID-19 immunization. The patient experienced rash on arms, abdomen, and back on 17Jan2021 08:00. The outcome of the event was unknown. The event was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
When she tries to left arm, patient has pain and can barely lift. When wakes up it takes a while for her to get it moving. Not sure if how she is sleeping on arm. Hurts in the generally area in the joint. Patient has been rubbing with green alcohol and taking Tylenol. Patient will rotate shoulder from front to back to see if any relief.
01/27/2021 Presenting Problem/History of Present Illness/Reason for Admission Shortness of breath [R06.02] Pneumonia due to COVID-19 virus [U07.1, J12.82]     Hospital Course   Is a 63-year-old male with type 2 diabetes obesity BMI 33 presents with shortness of breath secondary to COVID-19 pneumonia he received plasma remdesivir and 8 of his 10 days of dexamethasone is being discharged home on oxygen therapy he will finish out his dexamethasone at home follow-up with primary care provider for diabetes optimization given he has an elevated hemoglobin A1c
Initial misuse report received from a healthcare professional on 03 FEBRUARY 2014. An 11-year-old patient had received a dose of MENACTRA and a dose of ADACEL, both on 14 JANUARY 2014. The patient had received a dose of MENACTRA and a dose of ADACEL, both on 13 AUGUST 2013. No adverse event was reported. List of documents held by sender: none
Approximately 24 hours after getting immunization she had a reticular rash on the entirety of her left thigh and pain in the inguinal lymph nodes.  Nearly resolved 24 hours later.
After about 10 min after receiving the vaccine, patient reports symptoms of difficulty breathing, wheezing and throat tightness. RN observed audible wheezing and shortness of breath. Was taken immediately to ER via w/c and treated with Epi, Benadryl, Pepcid, and Solu-Medrol. Was able to be DC home.
coughs it is like a bronchitis type thing; coughs it is like a bronchitis type thing; full of phlegm; back started to hurt; tingling to the bottom of her feet; tired; severely sick; she couldn't walk or talk; she couldn't walk or talk; She shrunk; This is a spontaneous report from a contactable consumer (reported for herself). This 76-year-old female BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown), via intramuscular route on left arm as a single dose on 06Feb2021 12:15pm, for covid-19 immunization. Medical history included minimal (borderline high blood pressure (since 6 years prior to this report). Concomitant medication included Lisinopril 10 mg once a day orally. On 06Feb2021 About 4 hours later after she got the shot, the patient experienced some tingling to the bottom of her feet with and without walking and felt like needles, then it went away some but not totally, and her back started to hurt. On 10Feb2021, she was coughing and full of phlegm. On an unknown date, since getting the first dose of the covid vaccine she had been severely sick, she could not walk or talk, felt really tired, and she shrunk (weight about 130 pounds). The patient did not have any history of previous immunization with the Pfizer vaccine. She was not administered any additional vaccines on Same Date of the Pfizer Suspect. The events did not require emergency room/ Physician office visit. She did not receive any prior Vaccinations within 4 weeks. There were no relevant tests performed. The patient recovered from the event of tingling on 07Feb2021. The outcome of the event of was event of phlegm was recovering. The outcome of the events of coughing, severely sick, she could not walk or talk, felt really tired, and she shrunk was not reported. She had not recovered from the event of back started to hurt and it had worsened.    Information about Batch/Lot number has been requested.
Area of red, hard, nontender, hot, on left deltoid almost to elbow.
She has high blood pressure; she developed Afib; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received bnt162b2 (BNT162B2; Lot # EN5318) vaccine, via an unspecified route of administration on  25Jan2021 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient  developed atrial fibrillation on 29Jan2021 with outcome of unknown , she has high blood pressure  on an unspecified date with outcome of unknown.  The patient  laid down and she could feel her heart beating real fast. She has high blood pressure so she went to taking her blood pressure and her heart rate was like 100. On Sunday night of that week it got worse and her blood pressure got higher so she called 911 and they took to the ER. She says this was her first ever episode with Afib she never had it before this. The patient was treated with metoprolol and rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood pressure measurement: high   and  heart rate: heart rate was like 100. Both the reported events were considered serious because Important Medical Events.  Follow up information has been requested.
Received moderna vaccine on 4/1/21 and 4/29/21. COVID positive on 2/11/22. Presented to ER on 2/14/22 and was admitted. presented to the ED today with complaints of worsening shortness of breath and cough.  Patient reports symptoms started on 02/09/22 but began worsening today. She, her husband and son were diagnosed with COVID on 02/11/22.  Patient has been using her home breathing treatments and albuterol inhaler without much improvement.  Notes she is short of breath at rest and with exertion. She notes a productive cough, chills, subjective fever, palpitations, back pain and nausea without emesis. Denies any headache, weight changes, chest pain, abdominal pain, diarrhea, constipation, dysuria, syncope or weakness. Patient is overdue for her COVID booster. She was seen in the ED on 1/17/22 for similar complaints and at that time was being actively treated for a bibasilar pneumonia. Patient was started on a dexamethasone per COVID-19 treatment protocol; asthma exacerbation. Respiratory therapy with bronchodilators was also offered. Antitussive agents and analgesics offered as needed - add tylenol #3. ABG obtained today showed hypoxemia; a 6 minute-walk test was performed and the patient qualified for 2L/min supplemental oxygen with exertion. Pulmonology consult/evaluation was obtained and recommendation was for outpatient follow up. The patient was ultimately discharged home in stable condition and will follow up with Pulmonology and PCP within 2 weeks or as scheduled. Discharged on 2/18/22. Passed away on 2/24/22
Shot given at 8 am.  Myalgias & arthralgias, chills, & low grade fever by late afternoon.  Slight headache by 8 pm.  By 9 pm, began vomiting until 3 pm the following day (18 hours).  Felt weak, sweaty, chilled.  Fever up to 101.9 (baseline is 96.8).