chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; feeling nauseous; soreness at the site of the injection; she felt like she was having a frozen shoulder again; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (soreness progressed, felt like she was having a frozen shoulder again), DIARRHOEA (diarrhea), NAUSEA (feeling nauseous) and VACCINATION SITE PAIN (soreness at the site of the injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Frozen shoulder.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PERIARTHRITIS (soreness progressed, felt like she was having a frozen shoulder again) and VACCINATION SITE PAIN (soreness at the site of the injection). On 11-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and NAUSEA (feeling nauseous). On 11-Feb-2021, PERIARTHRITIS (soreness progressed, felt like she was having a frozen shoulder again) and VACCINATION SITE PAIN (soreness at the site of the injection) had resolved. On 13-Feb-2021, DIARRHOEA (diarrhea) had resolved. On 15-Feb-2021, NAUSEA (feeling nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.
PFIZER-BIONTECH COVID-19 VACCINE EUA.  Administration error:  Individual vaccinated on 4/6/21 with consent form stating no prior dose of vaccine received.  Later, it was discovered that the individual had received first dose of Pfizer COVID-19 vaccine on 1/12/21 and second dose on 2/2/21. Patient has no adverse reactions reported to date.
Arm was sore at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 11:00 (Lot number: EL3247) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Mar2021 14:00, outcome "recovering", described as "Arm was sore at injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Patient became dizzy and hypotensive 70's systolic after receiving his 1st PFIZER COVID-19 MRNA VACCINATION. Patient was taken to the ER.
Became diaphoretic within 2-3 minutes one episode of vomiting. Nausea, vomiting, diaphoresis resolved in approximately 5 min. Elevated BP and HR -> 150/70 HR 100 128/68 HR 95. Resolved with rest and hydration approximately 20 min.
Rash all over the body, very bad Itchy.  It started 1/12/21.
After about a week the right side of my jaw began to hurt at the TMJ.  It was bothering me enough that I went to dentist on 3/10/21 to have him look at it.  He gave me some massage exercises and recommended I not open jaw so wide when taking bites.  Discomfort continued but didn't seem as intense.  The week of June 7th my jaw became more painful making it difficult to chew.   I went back and saw dentist on June 16th.  He felt around in and outside my mouth in indicating problem was at TMJ, surrounding muscles and tendons.  He gave me stretches and exercises, prescribed 600mg Ibuprofen every 8 hrs for two days.  He also worked on my night bite to see if that was issue, told me to make sure and wear it every night and told me to call him with update in 2 weeks.  Since him discomfort has worsened.
The patient was seen in the ED on 5/27/23 for shortness of breath. During this visit, she reported testing positive for COVID-19 the week prior and has since had worsening shortness of breath, along with chills, productive cough, and bloody nose.  A repeat COVID-19 PCR test performed in the ED resulted positive. She was admitted 5/27/23 - 5/29/23 with severe COVID-19, acute hypoxemic respiratory failure, and right lower lung bacterial pneumonia, among other diagnoses. During admission, the patient had resting room air SPO2 87%, which improved above 90% after being placed on 2-4L nasal cannula. The patient did not receive systemic steroids during admission. Of note, the patient has received the primary COVID vaccine series and three boosters, including the Bivalent vaccine.
Redness to left upper arm. 50 x 55 mm warm to touch. Stated on 3/2/04 approx. 2 hours after injection. Instructed to give Motirn 200 mgT orally three times daily & apply ice pack to site three times daily.
Received immunizations x 4. Stayed 20-30 minutes - no problem.  Patient was home and 30-110 minutes after vaccines, started itching and scratching.  Developed whelps and when arrived in ER was having respiratory difficulty.  Treatment in ER are with an IV, Cortisone, and Benadryl.  Discharged 2 hours after indicent.  Benadryl every 6 hours, prednisone for 3 days.  Mom notified CIS 07/18/2003 at about 12 noon of the problems. A follow up report received 8/26/2003 adds: Made phone call to the pt's residence, spoke with pt's father to inquire as to how many days the rash lasted. He stated the rash lasted only one day. And his son is doing just fine. I told father to please check with their doctor about the next dose of Hep A, as to whether or not to take it.
My first dose in 12/2019 I got ulcers in my mouth. I had to go to a urgent care due to Christmas holidays. Valtrex prescribed. It helped. I received the second dose in March 2020. About 1 week later I started with lip pustules. After 2-3 days I had upper lip edema and itching to my lips. No difficulty breathing. I had a virtual visit due to the weekend and Covid. Prescribed Medtol dose pack. It did help .
Since my first vaccine shot, I have had noticeable, high-pitched ringing in both ears (tinnitus). I have had it in the past, but had not had for many years before my vaccination. It does not feel life-threatening in any way, but I am a musician, so it does add to my stress and detracts from my quality of life.
About one week after my 2nd dose, I started having symptoms such as heart racing, insomnia, hyperactivity. I went in for my regular yearly labs in May 2020 to find out my TSH was extremely low and my dosage of synthroid had to be decreased for the first time since my diagnosis 5 years ago
I felt like I got run over by a truck; My arm was hard; trouble walking; My arm was swollen; Muscle pain; Next day I had joint pain; headache; chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt like I got run over by a truck), VACCINATION SITE INDURATION (My arm was hard), GAIT DISTURBANCE (trouble walking), VACCINATION SITE SWELLING (My arm was swollen) and MYALGIA (Muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026DZ1A, 032MZCA and 024MZCA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, IRBESARTAN, DILTIAZEM, PRAVASTATIN and EZETIMIBE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I felt like I got run over by a truck), VACCINATION SITE INDURATION (My arm was hard), GAIT DISTURBANCE (trouble walking), VACCINATION SITE SWELLING (My arm was swollen), MYALGIA (Muscle pain), ARTHRALGIA (Next day I had joint pain), HEADACHE (headache), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (I felt like I got run over by a truck), VACCINATION SITE INDURATION (My arm was hard), VACCINATION SITE SWELLING (My arm was swollen) and ARTHRALGIA (Next day I had joint pain) outcome was unknown and GAIT DISTURBANCE (trouble walking), MYALGIA (Muscle pain), HEADACHE (headache), CHILLS (chills) and FATIGUE (Fatigue) was resolving.            No treatment medications were provided.
skin lesion - Information has been received from a registered nurse concerning a 16 month old caucasian female patient who on 07 apr 2000 was vaccinated with a dose of varicella virus vaccine live sc in the right arm.  concomitant vaccinations that same day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation msd sc in the left arm and a second dose of hoemophilum m conjugate vaccine lot number 412353a im in the right arm.  On 17 apr 2000 the patient developed pustules secondary to varicella vaccine less than 60 lesions.  The patient did not experience itching or a fever.  The patient sought unspecified medial attention.  Follow up information from a registered nurse indicated that the patient subsequently recovered.
Severe arthritic issues developed Sept. 29, 2022 in both hands and wrists, including swelling, numbness, and pain that ibuprofen, ice, heat, and massage could not manage. I had mild arthritis in my fingers prior to that. The same symptoms would stop after 3-4 days, and reappear in another joint...ankle, knee, toes, or  jaw. Dr. prescribed  Prednisone on Oct. 26, 2022 and sent a referral for an EMG.
Fatigue (24 hours),  excessive thirst (14 hours), low grade fever (exact time unknown but less than 24 hours), chills (8 hours), sweating/hot (2 hours), light arm stiffness.
high fever started 14 hours after injection with exhaustion and confusion. fever started at 99.4 and rose to 100.7 while taking acetaminophen every 4 to 5 hours.  Fever lasted 60 hours (Friday 11 - Sunday overnight). Nausea and chills started 16 hours after injection and lasted 48 hours Arm swelling, redness and hard nodule at injection site - extremely sore and tender to light brushing swelling to 4 inches around and solid - swelling beginning to reduce on day 4.
Onset of pain and soreness of hip joints. Patient returned today to get Hep B accel. He inquired if any of the vaccines he received 4/25 could make for soreness in hip joints. States he noticed yesterday a soreness in both hip joints (very isolated areas), but particularly in left hip. States he has not done any sports or anything that would make him sore like this, but only traveled on airplane for work etc. I inquired if he would rather wait and not do 2nd Hep B today and he said "no, he was fine to proceed, that he wasn't even sure it was the vaccines". We reviewed common side effects of each of the vaccines he received 4/25, and none appear to cause joint soreness. I encouraged him to let me know if symptoms worsened and informed him I would report to VAERS.
Both legs red and swollen. Cellulitis - given antibiotics. Went to urgent care - Then follow up and office 6/23/08.
New onset of ringing in the ears - bilaterally.  Has continued through the date of this report. Just now associated the onset with the administration of the COVID vaccination.
She is been so ill ever since. She has been in emergency room like 5 times; This is a Spontaneous report from a contactable consumer. This consumer reported for a female patient (Daughter). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experienced flu like symptoms, arm pain, and She is really sick. Reporter stated, she was calling about her daughter, that she had the Pfizer vaccine and she is really sick. She has had both doses and the 1st time she had flu like symptoms. Afterwards she had some arm pain but then it seemed to go away and then she asked the pharmacist before she the 2nd one if she should get it or if that was normal. He said yeah that was normal, no problem and then she got the 2nd one and she is been so ill ever since. She has been in emergency room like 5 times. The outcome of the events was unknown.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEELING LIKE EAR INFECTION; This spontaneous report received from a patient concerned a 52 year old female of an unspecified ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, dose number in series was 1, 1 total administered on 26-MAY-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 29-DEC-2021 in morning, the patient started having symptoms of cold, headache, fever and sore throat (suspected covid-19 infection) and feeling like ear infection. On an unspecified date, the patient had suspected clinical vaccination failure (dose number in series was 1). Laboratory data (dates unspecified) included: EE home kit test (COVID-19 virus test) (NR: not provided) Negative. The patient had not taken any other tests. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and feeling like ear infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209648.; Sender's Comments: V0: 20211266394 -Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
INJECTION SITE IS RED, INFLAMMED AND ITCHY. TOLD PATIENT TO APPLY ICE FOR 15 MINUTES 3 TO 4 TIMES A DAY AND TO TAKE AN ANTIHISTAMINE.
Patient is having a 4x4 patch of redness around the injection site with heat and pain radiating off of it.
Cellulitis and abscess of right leg except foot (from hip to knee) (1.5 size of left leg). Tender, Epsom salt, warm compresses, Motrin. Follow up for 1 day, decreased redness and swelling, pt has full range of motion, no fever.
Fever; She woke up before 6 in the morning feeling bad; when she stand up she felt weak; She woke up before 6 in the morning feeling bad; when she stand up she felt weak; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 07Jun2021 14:45 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received other products. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 17May2021 for COVID-19 immunization. Reporter stated, Exactly 3 weeks before second dose patient took 1st dose of vaccine. Reporter stated that, On 08Jun2021 patient woke up before 6 in the morning feeling bad and she had a fever and so they gave her Ibuprofen an hour ago and currently she still had the fever over 101 and she still feeling pretty badly like she did not like when she stand up she felt weak. Reporter was just wondering at what point they should get an alarmed the sheet said that a fever was a side effect but like at what point for a fever should be they worried; she enquired. Reporter further added, 'The sheet she received says that if experience severe reaction Call 911 but it's hard to know what is severe reaction is, you know. Reporter was informed about Pfizer Medical information department and was provided with the number. Therapeutic measures were taken as a result of fever, she woke up before 6 in the morning feeling bad; when she stand up she felt weak, she woke up before 6 in the morning feeling bad; when she stand up she felt weak as Ibuprofen was given to patient. The outcome of all events was unknown.  Information on Lot/Batch number has been requested.
left axilla swelling and tenderness; left axilla swelling and tenderness; pain at the injection site; throat closing; This is a spontaneous report from a contactable physician (Patient, Self-reported). A 47-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an intramuscular, administered in left arm on 06Jan2021 12:00 as 1st dose, single and  dose 2, (Batch/Lot number was not reported), in Arm Left, on 27Jan2021 for covid-19 immunisation. Medical history included patient was infected with covid back in April2020, neoplasm malignant (patient scared I might have had breast cancer at the time, as there is family hx of cancer). The patient previously took acetylsalicylic acid and experienced hypersensitivity, lactose and experienced hypersensitivity, lactose and experienced reaction to excipient. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination and did not receive Other medications in two weeks of vaccinations. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination.Reportedly, left axilla swelling and tenderness 4 days after the 1st injection with pain at the injection site. (she scared might have had breast cancer at the time, as there was family history of cancer). Repeatedly swelling and pain to the left arm occurred less than 1 day after the 2nd injection. Concerned of the hot flashes and disturbed sleep consistent to the time when she was infected with covid back in April 2020. One more thing, slight feeling of throat closing both times with the injections. With the first injection occurred 3-4 days afterwards with no SOB. With the second injection it occurred the within 24 hrs. On 10Jan2021 22:00, the patient experienced left axilla swelling and tenderness, pain at the injection site and throat closing. Treatment was not received for the adverse events. The patient underwent lab tests and procedures which included COVID-19 (sars-cov-2) test was negative on 08Jan2021. Outcome of the events was recovering.  Information about Batch/Lot number has been requested  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report was received from the patient's mother referring to a 21 year old female patient. The patient had no medical history, concurrent conditions, drug reactions, allergies nor concomitant medication. On 03-OCT-2018, the patient was vaccinated with 1 injection of GARDASIL 9 in the upper arm, lot number R008163 and expiration date of 18-NOV-2020 for prophylaxis (dose and route of administration were not reported). In approximately November 2018, (reported as "a month after vaccination") the patient experienced injection site hardness under the skin (injection site induration), swelling, and discomfort that lasted for a little more than a week and it went away on its own without treatment. The patient called the clinician, nevertheless there were no laboratory diagnostics or studies performed. The reporter did not provide causality assessment between the events and vaccination with injection of GARDASIL 9.
She received the vaccination on 10/30 at 1 pm. Around Wednesday she had a swollen and red upper left arm. She came in to the pharmacy on Thursday and the swelling had moved down her arm to her elbow area. The swelling covers around 8 inches down her arm. She does not state any pain/itchiness.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male.  Neither medical history nor concomitant medications were reported.  On 26-Jan-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic.  Additional information was received on 12-May-2009 and incorporated into the narrative:  Product complaint investigation results.
01/15/22 presents to EC ED for "cough" "shortness of breath". PMHx of "asthma, CHF (reports EF 20-25%, has life vest), HLD"
Upon waking up, complained of severe leg pain, and weakness. Went to school but had to get picked up because of feeling faint. Three days later, still in pain, called doctor and left message on 10/5/11 about what is going on but doctor has not returned call yet. Called doctor again twice today, but calls have still not been returned. Want to know if we need to be seen again.  No fever or vomiting so we are waiting before a trip to ER because ER visits cost 200 up front.
Client received her booster dose 4 days early, vaccine card date looked like 5/2/2021, and it was actually 7/2/2021.  The system did not alert to dose being given too soon. Client observed for over 15 minutes no reactions noted