chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has had a mass of varying size under the injection site that causes him pain. Within 24 hourse of the vaccine his leg that received the DTaP vaccine was extremely swollen ( especially in the thigh area) After the swelling reduced he had a mass approximately the size of a small Brussels sprout. His parents understood that this occurs in ~1/500 cases and that it should resolve in ~2 weeks. A month after the vaccine patient still had a mass the size of a large pea and they brought him to the Medical Unit for an Ultrasound. They were advised that the mass should dissipate but it has not over three months post vaccination.
diarrhea, abdominal cramping. Feels like a viral gastroenteritis. So far it has lasted 5 days.
He tested positive for COVID-19 on 10/09/22. He was also diagnosed with Croup Cough too. He had a high fever and a cough. We took him to Urgent Care, and they thought he had something else going on and sent us to the emergency Room. It turned out that he just had Croup Cough and they prescribed Dexamethasone. We gave Tylenol and Motrin for his fever. He got well and then on 12/24/22 he developed a cough again with a fever and we took him to the emergency Room, and they gave him Dexamethasone again. Then on 1/21/23 he had a fever, diarrhea, and some ear pain. He was diagnosed with a double ear infection. He was prescribed Amoxicillin. No other medications were prescribed.
Upper arm almost down to her elbow became swollen; Typical soreness at site; Upper arm almost down to her elbow became swollen / very uncomfortable; Indurated nodule that protruded from the site; Injection site nodule; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA86AZ, expiry date 31st January 2022) for prophylaxis.   On 10th July 2020, the patient received the 1st dose of Bexsero (intramuscular). In July 2020, less than a week after receiving Bexsero, the patient experienced extensive swelling of vaccinated limb, injection site pain, arm discomfort, injection site induration and injection site nodule. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown and the outcome of the injection site pain was recovered/resolved and the outcome of the arm discomfort, injection site induration and injection site nodule were recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, arm discomfort, injection site induration and injection site nodule to be related to Bexsero.  Additional details were provided as follows: After receiving Bexsero, the patient developed typical soreness at site for next couple days that was painful for the first 48 hours.  Then her upper arm almost down to her elbow became swollen, no erythema and no pallor but very uncomfortable.  The patient developed a 25-cent size indurated nodule that protruded from the site. It was firm.  The arm was still considered uncomfortable when she used it but it did decrease.  The reporter was consented to follow up. The batch number of Bexsero was reported as ABXAH6AZ, which was corrected to ABXA86AZ as per sales data sheet.
This spontaneous prospective pregnancy report was received from a physician and refers to a 22 year old female patient. The patient did not have any pertinent medical history, drug reactions, allergies and concomitant therapies. On 18-MAY-2016, the patient, who was at four to six weeks of gestation, was inadvertently vaccinated with M-M-R II (lot #, expiration date, exact dose and route of administration were not reported). No adverse effects were reported. The patient sought medical attention and was seen in the physician's office. No lab diagnostic studies were performed. The last menstrual period (LMP) and estimated delivery date (EDD) were not specified. The pregnancy outcome was pending. Additional information has been requested.
pain like she's getting stuck with needles in her eye; eye pain; severe I'll pain; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (pain like she's getting stuck with needles in her eye), EYE PAIN (eye pain) and MYALGIA (severe I'll pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (pain like she's getting stuck with needles in her eye), EYE PAIN (eye pain) and MYALGIA (severe I'll pain). At the time of the report, OCULAR DISCOMFORT (pain like she's getting stuck with needles in her eye), EYE PAIN (eye pain) and MYALGIA (severe I'll pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment medication was not reported.
About 3-5 min after vaccination patient felt unwell, hot, dizzy, feeling of passing out, had his head down between hands.  Pharmacist and patients mom got patient down on the ground flat with legs elevated on chair, a cold pack and water.  Pharmacist did not witness loss of conscientious.  Patient was nervous about getting vaccine.  We called 911, emergency services came, did a work up.  It appeared to be a vagal response, possibly from fear of needles.  When emergency services got patient up he seemed a little nauseous.  They took him to hospital.
Swelling of lymph node on same side as injection, fatigue, sweating, fever, chills and body aches.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # J005713, expiration date 25-OCT-2015) (strength, route and dose were not provided). Concomitant medication was not reported. Additional information has been requested.
I had recently travelled on 06/30/2022 to vacation with some family members. On 07/02/2022, I began feeling really fatigued. The next day, I was still feeling abnormally tired and had a feeling of dryness and thickness in my throat so I stayed at the hotel rather than going with my family for the scheduled events that day. I was able to find an at home COVID-19 test that my son was able to pick up for me. I took the test that night, 07/03/2022, and the results were negative. I still felt tired but was feeling better after resting so I continued on with our scheduled activities. On 07/06/2022, I returned home and was still feeling tired, but attributed it to travel. On 07/07/2022, I slept late and took another at home COVID-19 test and the results were positive. I called my doctor's office who prescribed Paxlovid and advised that I needed to start the medication right away. I began taking it that night. On Saturday 07/09 I took a PCR COVID-19 test at a drive thru clinic and the results were also positive. I continued feeling congestion and head cold like symptoms but my symptoms have gotten better overall. I actually woke up on 07/09/2022 feeling rested and quite a bit better.
Note: Patient (me) reports similar adverse reaction to BOTH 1st & 2nd Moderna vaccinations.   Chills and general body/joint aches started approx 26-30 hrs post injection.  Fever (101.2F) peaked ~ 36 hrs after 1st injection.  Mild but obvious headache ceased after 48 hrs.  No injection site rash, just soreness of the arm (like all of my previous flu vaccinations).   Second vaccination was followed with chills and peak fever of 101.4F along same time interval.  Current 02/25/21 at 2:30 pm pacific fever has ?broke? with some sweating.  Feeling much better.  I know these symptoms are positive evidence that body is geared up building the protection system for which we are vaccinated. Self-medicated with acetaminophen (500 mg) to relieve aches. Thank you!!
Fever 101.8; Fatigue- 40 hours; Nausea- 24 hours; arm swelling and redness and pain and hot to touch- went to PMD. Diagnosed with cellulitis-placed on Keflex.
12/29 7:20 AM During injection, developed scratchy, itchy throat x15 min. Resolved without treatment one hour later. -Severe headache x 4days - Took Tylenol.
The patient called  Clinic and reported that he got a flu shot with us a couple of days ago and has since been experiencing redness, swelling and warmth down the arm at a site that is below where the vaccine was administered. The  cliinic called the pharmacy and told the pharmacist on duty about adverse reaction. Pharmacist said that the reaction doesn't sound normal as skin should not be warm to the touch and the arm should not be red/swollen at a site where the injection didnt occur. Patient will be advised to go to Clinic and get an evaluation to make sure reaction hasnt progressed to being cellulitis and the pharmacy will report the adverse reaction to VAERS and follow up with patient to see how he's feeling.
headache, aleve and tylenol, right side of face felt like sinus infection, right side of mouth not closing correctly, back pain, lethargic, cheek swollen
The patient experienced erythema, swelling, and warmth of the entire right arm within 24 hours after receiving the vaccine. This was consistent with cellulitis. The patient was treated with Clindamycin and Benadryl.
10/23/21 ~1pm Patient received the flu shot on left deltoid and had slight bleeding after I drew out the needle out. As I was drawing out the needle, a bump was developing visibly under her skin.  After I wiped the blood (~1 drop) away and put on an bandage, a big bump with diameter slightly bigger than a quarter coin and height slightly more than 1/2'' developed under her skin and as I finished applying the bandage.  I confirmed again with patient to make sure she was not allergic to flu shot, which she's not and had it before.  I asked if pt had breathing issues and pt did not.  I asked if patient felt any pain and patient said no. I pointed out the bump to her and her daughter who was accompanying her during the flu shot, and told them it's not normal, the bump is most likely hematoma (blood accumulating under the skin).  I explained that they should go seek medical attention to make sure everything is okay, but asked them to wait for 10 minutes first to make sure she's not having an allergic reaction.  Patient waited around for 10min and did not develop rash/shortness of breath/throat swelling.  Patient still did not feel any pain, the bump stayed around the same size, and I asked the patient and the daughter (who was taking care of her mom) to go see a doctor immediately to rule out any clotting issues.  The daughter, brought mom back to pharmacy at 6pm and told me that patient was seen by a doctor and suspected the bump was blood accumulating from muscular blood vessel broken (hematoma) and told them to keep an eye on it and follow up on Monday 10/25/21.
"on and off dizziness"; Has a dull headache that throbs constantly at back of head; Experienced tiredness; Inappropriate schedule of vaccine administered; 3rd dose of Moderna vaccine administered by accident instead of flu vaccine was on 14Aug2021; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS ("on and off dizziness"), HEADACHE (Has a dull headache that throbs constantly at back of head), FATIGUE (Experienced tiredness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXTRA DOSE ADMINISTERED (3rd dose of Moderna vaccine administered by accident instead of flu vaccine was on 14Aug2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer on 26-Feb-2021 and Pfizer on 26-Mar-2021.    On 14-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXTRA DOSE ADMINISTERED (3rd dose of Moderna vaccine administered by accident instead of flu vaccine was on 14Aug2021). On an unknown date, the patient experienced DIZZINESS ("on and off dizziness"), HEADACHE (Has a dull headache that throbs constantly at back of head) and FATIGUE (Experienced tiredness). On 14-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXTRA DOSE ADMINISTERED (3rd dose of Moderna vaccine administered by accident instead of flu vaccine was on 14Aug2021) had resolved. At the time of the report, DIZZINESS ("on and off dizziness"), HEADACHE (Has a dull headache that throbs constantly at back of head) and FATIGUE (Experienced tiredness) outcome was unknown.            Concomitant medication were not given.  Treatment information was not provided.
pt seen 1sx w/pericarditis, pruritus & costochondritis;ER visit x 2 10/21/99;MD visit 10/22/99;
Pt had large local reaction following AVA #5. Edema at injection site >120 mm not beyond elbow. Start: 5/25/04 . End: 5/31/04. Erythema start: 5/25/04. End: 6/15/04. Comment: Faded but still visible.
3RD DOSE MODERNA COVID GIVEN 11/4/21, LOT #045C21A; 4TH DOSE MODERNA COVID GIVEN 5/20/22, LOT #002M21A; pt to ED with seizure-like activity; positive for COVID; chest xray showed right sided lobe pneumonia; O2 supplementation; CCU; hypotensive; difficulty breathing; pt's condition worsened; increase in confusion; on vasopressors; comfort care measures; pt passed away in the hospital
Ipsilateral left side clavicular lymphadenopathy; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 09:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and hypothyroidism. The patient had known allergies to sulfa. Concomitant medications included escitalopram oxalate (LEXAPRO) and levothyroxine sodium (SYNTHROID); both taken for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Apr2021 at 09:00, the patient experienced ipsilateral left side clavicular lymphadenopathy. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ipsilateral left side clavicular lymphadenopathy was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Very violent and irritable onset few hours after DTaP given. Lasted several days until treated for a vaccine reaction.
Approximately 24h after vaccination the site was noted to be raised, red, hot and tender to touch about 2" diameter. By the following morning the dark red area encompassed almost the entire upper arm. The child exhibited no systemic sxs. As of today the area is about 3" diameter, light pink, tender but not hot.
Dx: varicella; Rx: Acyclovir 200/5 3tsp PO qid x 5 days.
Patient was given vaccine and asked to wait 15 minutes.  While waiting patient slumped over in chair. We aroused him and helped him onto the floor, his breathing seemed ok but we called 911.  While waiting we kept him talking and he seemed alert.  When paramedics arrived they took over.  He began to loose consciousness again and they took him in.
Migraine after 2 days, 1/2in welt on arm at injection site, exhaustion lasting 4 day
I am now 65 years old.  After vaccine, I have had ringing in the ears.  I have never had ringing in the ears until after  vaccine.  I had my physical two weeks before vaccine with a new doctor.  I had a list of things to talk to doctor about and ringing in the ears was not on my list.  It has been hard to sleep and I always hear ringing in the ears.  I wanted to report this information.
I?m having pain in my arm pit, with a little swelling. It?s getting worse, and it?s making my arm hurt underneath
I tested positive for COVID-19 on 12/30/2022. I had mild symptoms and took a dose of Paxlovid. Within fourteen days after testing positive again, I started to develop hives. It started on my abdomen and spread going up towards my chest and neck. I've been seen by a dermatologist where he treated me with topical creams and tested me for contact allergens. He gave me a round of cortisone which only helped temporarily. I consulted with an allergist who suggested taking antihistamines; it helps with the itching, but the hives are still active. It's still very spreading, and I'm scheduled to get a second opinion from another allergist soon.
About 9 p.m. both feet were very cold and cramped up, both hands cramped also. By 10 p.m. felt like "getting a cold" - headache, sore throat. 1/23 left arm sore and puffy. By 3 p.m. sleepy and couldn't use left arm to drink. Went to bed 7 p.m., 1/24 achy all over, headache, left arm bruised. Stayed in bed all day. 1/25 felt better. 1/27 returned to work - she felt fine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 01Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: RA1570), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course:  Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Covid-19 treatment Paxlovid was given form 13Aug2022 to 18Aug2022.
Vaccine administration error. Patient had a Meningococcal ACWY vaccine 10/19/2021.  Another dose was inadvertently administered on 12/2/2021. No adverse reaction to vaccine was reported.
Face felt hot, appeared reddened.  Diphenhydramine 25 mg given at Employee Health Center.
This spontaneous report was received from a healthcare professional refers to a male patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 21-SEP-2015 the patient was vaccinated into his anterolateral thigh with a dose of (Merck) VARIVAX (Lot # reported as L018000, expiration date: 19-MAY-2017), 0.5 ml, subcutaneous in the leg. Concomitant medications were not reported. It was reported that the patient moved while the (Merck) VARIVAX was being administered and some of the (Merck) VARIVAX leaked out of the plastic syringe onto his thigh. No further information was provided. Additional information has been requested.
left facial droop with left cheek numbness/Left-sided Bell's palsy (primary; Partial paralysis; left facial droop with left cheek numbness; Forehead sparing; visual disturbance; facial asymmetry; This case was reported by a lawyer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for product used for prophylaxis.  The initial information was received on 13 May 2020 via medical records (case is now medically confirmed). As per the pharmacy record, the patient had Shingrix vial kit on 30 April 2018 and 10 August 2018.On 31 August 2018, the patient presents with Left-sided Bell's palsy (primary), complaint of left facial droop with left cheek numbness symptoms were of acute onset, constant, moderate in severity, and without alleviating or exacerbating factors. The patient had partial paralysis ((total or near total paralysis of lower face) and forehead sparing was noted. The patient had  facial asymmetry and visual disturbance.
Nausea and fever for 3 hours, pain at injection site for 5 days
stomach pains; loss of appetite; vomiting; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pains"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; LETHARGY (non-serious), outcome "unknown", described as "lethargy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
+ ITCHING AND SIGNIFICANT TENDERNESS LIKE SOMEONE "PUNCHED ME IN THE ARM" ON 12/30/2020; + FATIGUE ON 1/4; +SORE THROAT  Narrative: USED BENADRYL FOR ITCHING X 3 DAYS 1/4/2021-1/6/2021. LOW GRADE TEMP OF 99.1. WAS TESTED FOR COVID ON 1/8/2021 WHICH WAS NEGATIVE. AREA OF TENDERNESS AND ITCHING BEGAIN WITHIN 2 HOURS IF THE INJECTION.