chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Common cold; Crohn's disease aggravated; Inflammatory marker increased; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4443121-00.  A 16-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from Dec2021 (Lot number: 1160679) to Mar2022 at 40 mg 2x/week (citrate free 40 mg, 2x/week), second regimen from Mar2022 (Lot number: 1160679) to Jun2022 at 40 mg weekly and third regimen since Jun2022 (ongoing) (Lot number: 1160679) at 40 mg weekly, all subcutaneous. The patient's relevant medical history included: "Non Tobaco user" (unspecified if ongoing); "Abstains From Alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Route of administration: Intramuscular), administration date: 2021, for Covid-19 Vaccination; Bnt162b2 (Dose:2, Route of administration: Intramuscular), administration date: 2021, for Covid-19 Vaccination. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Jun2022, outcome "recovered" (17Jun2022), described as "Common cold"; CROHN'S DISEASE (medically significant) with onset 2022, outcome "not recovered", described as "Crohn's disease aggravated"; INFLAMMATORY MARKER INCREASED (non-serious) with onset 2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Drug level: (2022) High; Inflammation level: (2022) High. The action taken for adalimumab was dosage permanently withdrawn.  The reporter considered "crohn's disease aggravated" related to BNT162b2. The reporter's assessment of the causal relationship of "inflammatory marker increased" and "common cold" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported  events.
This case was reported by a healthcare professional and described the occurrence of possible myelitis in a female subject aged between 50 and 59 years old who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 September 2011 the subject received a dose of FLUARIX. In September 2011, a few days after vaccination with FLUARIX, the subject experienced numbness of extremities which within the same time period progressed to difficulty walking. The subject was hospitalised and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). There was a possible diagnosis of unrelated myelitis occurring within the same month of vaccination with FLUARIX. At the time of reporting numbness of extremities and difficulty walking were improving. The outcome of possible myelitis was not specifically reported. No additional details were provided.
No menstruation since vaccine. (Patient should have had 2 menstrual periods and has not.)
lots of chills; lots of dizziness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (lots of dizziness) and CHILLS (lots of chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0391321A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIZZINESS (lots of dizziness). On 26-Apr-2021, the patient experienced CHILLS (lots of chills). At the time of the report, DIZZINESS (lots of dizziness) and CHILLS (lots of chills) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.   No treatment information was provided.
Delayed allergic vaccine reaction including itchy, raised, red, circular area that covered my entire  upper left arm area.
Fever at 101 F overnight after second dose; High Blood Pressure 160/50 on second dose; Chills on both First and Second Doses; This is a spontaneous report from a contactable consumer or other non hcp. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 27Jan2021 23:15 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, hypertension, cardiac pacemaker insertion, aortic stenosis, liver disorder, hip surgery, food allergy, known allergies: pork, food allergy, Shellfish. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 06Jan2021 24:00 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. After first dose, the patient had chills, and high blood pressure at 180/60. Concomitant medication(s) included losartan (LOSARTAN); apixaban (ELIQUIS); montelukast (MONTELUKAST); amlodipine (AMLODIPINE). After second dose, the patient had fever at 101 Fahrenheit overnight and high blood pressure at 160/50. Went away with taking high blood pressure pills. The patient was not covid tested post vaccination. The patient underwent lab tests and procedures which included blood pressure measurement: 160/50 on second dose, body temperature: 101 Fahrenheit. Outcome of events was resolving.
Sore injection site; fatigue; headache; aches/pains; low grade fever
Bumps with blisters were appearing even while child was in the office. Also, itching. Treat with Aveeno oatmeal bath and Benadryl.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 25-AUG-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 72 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Client states she started feeling dizzy or light headed. Progressed to a very bad headache. Chills, fatigue developed. Temperature 105.9*F. Nauseous. Has a very hard time remembering Saturday evening. Took 500mg of Tylenol and went to bed. No fever the following day but still felt achy, fatigued, headache, hot/cold flashes, nauseous, extreme thirsty. Developed an unseen rash all over her body, itched very bad that lasted hours. Mainly scalp, hands, and feet.
Pt c/o severe headache & increased B/P. Seen in ED 10-19-09. Flu shot administered 10-15-09 10 AM. Headache started in afternoon 10-15-09 - progressive worsening of throbbing headache (bitemporal-biparietal location). Acute hypertension to 180/90 simultaneously in non-migrainous, non hypertensive female. No response to LABETALOL 200mg & VICODIN. No neck stiffness. Never had a headache like.  11/5/09:  ED Records for date of service 10/19/09.  Dx:  Vascular HA, Acute Hypertension, adverse reaction to flu vaccine.   Assessment: Presented to the ED with a 4 day history of a throbbing  migraine HA exacerbated by light and noise.  Pain rated 10/10, described as worst pain in life.  BP 167/82.  Treated with labetolol for HTN, Zofran for nausea and Fentanyl and Toradol for pain.    12/08/09 MR received for DOS 10/25/09-10/27/09. Intrautrerine pregnancy 27 weeks with fetal demise.  Pt reported no fetal movement on the 10/24/09.  The next day, Pt presented to hospital and it was confirmed that fetus had no heartbeat.  Delivery performed of dead fetus. Cytotec was used to deliver. Pt discharged in stable condition.
Red eye and mild headache. Distal portion of right eye is red, but not noticeably itchy or with any discharge. No tears or changes in vision. Eye is still red 48 hr later, which is uncommon (unprecedented) for me. Headache was very mild and lasted < 1 day, even without medication.
Information has been received from a pharmacist concerning an approximately 83 year old female with sulfa allergy and no medical history who on 12-DEC-2009 was vaccinated SQ with 0.65 ml ZOSTAVAX (Merck) (lot # 664626/0875Y). Concomitant therapy included timolol (manufacturer unknown) eye drops, omeprazole and LEVOXYL. Subsequently on an unspecified date the patient developed zoster. She first experienced back pain which was similar to a pulled muscle and then developed a zoster rash on her back and side. The patient sought medical attention via office visit. The patient was treated with prescribed VALTREX and prednisone. At the time of reporting, the patient's zoster persisted. Additional information has been requested.
Pt recvd 2nd immun 13FEB91 & w/in 20 hrs, exp severe urticaria & irritability; Babysitter reported pt was shivering & afebrile; Seen in office 14FEB91-eardrum was red; questionable OM; treated w/Septra & DPH; 15FEB hives still present;
was refused to give the second shot in vaccination site; "quick hot flashes" 15 min and 30 min after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH ("quick hot flashes" 15 min and 30 min after vaccination) and PRODUCT DOSE OMISSION ISSUE (was refused to give the second shot in vaccination site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HOT FLUSH ("quick hot flashes" 15 min and 30 min after vaccination). On 12-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (was refused to give the second shot in vaccination site). On 12-Feb-2021, HOT FLUSH ("quick hot flashes" 15 min and 30 min after vaccination) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (was refused to give the second shot in vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender'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.
UNUSUAL THIRST; BRIEF HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified date, the patient was previously treated with covid-19 ad26.cov2.s vaccine for prophylactic vaccination. (Dose number in series: 1)  On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported) (dose number in series: 2), frequency 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient reported shortly after booster approval, booked appointment at site. Initial 24 hours after booster The patient experienced unusual thirst, and brief headache. (Dose number in series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the brief headache and unusual thirst was not reported.  This report was non-serious.
Racing of heart throughout the night after 1st dose; Could not sleep at night after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Racing of heart throughout the night after 1st dose) and INSOMNIA (Could not sleep at night after the 1st dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PALPITATIONS (Racing of heart throughout the night after 1st dose) and INSOMNIA (Could not sleep at night after the 1st dose). On 05-Mar-2021, PALPITATIONS (Racing of heart throughout the night after 1st dose) and INSOMNIA (Could not sleep at night after the 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non-significant follow-up
Adult patient was administered (1-June-2022) a pediatric dose; Adult patient was administered (1-June-2022) a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 58-year-old female patient who received HBV (Engerix B pediatric) (batch number T022566, expiry date 29th December 2022) for prophylaxis.   On 1st June 2022, the patient received the 2nd dose of Engerix B pediatric. On 1st June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's comment: Nurse reported a patient was administered a pediatric dose of the Engerix-b vaccine instead of the adult dose. The reporter consented to follow up. Additional supportive information: The patient received the Engerix-b pediatric instead adult dose which led to underdose and adult use of a child product.
Left leg was swollen, red and warm to touch. Treatment: ice packs to leg, Diphenhydramine and Orapred for 3 days.
13 days after receiving the first Covid-19 vaccine I started experiencing pain in my left leg calf area.  I have not had any recent injuries or have been involved in any events to cause the leg to be in pain.  On Thursday, September 16, 2021, I called my primary care doctor because the pain had increased, and my calf was swollen.  I was seen on Friday, September 17, 2021, by the nurse practitioner and she ordered an ultra-sound.  Friday afternoon the nurse practitioner called with the results to advise I have a blood clot in my left calf.  The nurse practitioner started me on Eliquis 5mg tablets.
I had my  Pfizer covid vaccine shot, 1st dose, on November 24, 2021. Three days later, I  developed a rash on my pelvis and right forearm.  No blisters, but itched. Reported rash, but was told this was a food allergy. Rash did not go away with Benadryl. On December 8th, had massive pain in pelvic area. Went to Urgent Care where they found a 11 centimeter cyst on my left ovary. Had no problems prior. Had to have cyst and left ovary removed surgically on December 21st, 2021.
Developed cyanosis, numbness, pain, tingling of bilateral hands about 24 hours after vaccine administration.
hives on arms w/generalized itching 2 days p/2nd booster dose; On day 3 & 4 post 2nd booster had hives on groins, ankles & flanks;
Side effect: Menstrual bleeding light but consistent. Abnormal with my menstrual cycle as I had my period and it was complete one week prior to vaccine. I am very regular and I knew this was abnormal right away and only have one factor as to why it would have occurred and that would be the vaccine. I also experienced extreme fatigue first day after my shot, but that resolved whereas menstrual bleeding is still continuing. I also had covid 19, six months ago.
Shivers and tremors started that evening, then sharp burning feeling in hands that lasted for hours.  600 mg of Advil did not receive the pain. On 12/24 took one Tramidol, which relieved the hand pain.  The pain did not come back,  but occasionally, hand pain  does present and appeared to be triggered by the Shingrix vaccine, according to the patient.
delayed period, red rash around my body and hives 8 days after vaccine, unknown cause. The rash comes and goes around my body, first time I've ever had this.
The day I had the booster I felt bad and under the weather. I didn't feel good at all. Then when I traveled, I started to have a scratchy throat. Then I head a headache and then a high fever. I was extremely congested and had ear problems. I had a cough that would not stop. I was coughing all night. That lasted for 4 days with fever. I went to the doctor on 10/27/2021. They checked my ear, throat, and heart. They said they did find some fluid behind my ears. They put me on an antibiotic and then 3 days after that I felt bad but got to feeling better.
He had a fever of 102 that stayed all day despite ibuprofen every 4 hours. He also had belly aches and didn?t eat that day.
01/04/22 presents to EC ED for "sore throat, cough, shortness of breath and chest tightness". PMHx of "HTN, and Hypothyroidism"
I had received about 20CC Bellafill 5 Year Facial Filler .  Four days after my first COVID 19 vaccine, I began to notice loss of volume in my face.  That became severe with hollowing, emaciation, and severe asymmetry.  My face is distorted and remains so today.
This spontaneous report was received from a office manager (also reported as healthcare worker) refers to patients of unknown age. On an unknown date between 17-FEB-2014 to 21-MAR-2014, the patients were vaccinated with a dose of GARDASIL, (lot number, expiry date was not reported) which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
R thigh 3x3cm area of sl. tender induration, 4x8cm area of erythema. No fever or limp or injection site discharge.
pt woke up the next morning after vaccination with pain/soreness at the injection site that radiated up into her neck. as the day went on she felt pain radiating down her arm as well. She stated she felt like she "had the flu" and was overall miserable. she reports limited range of motion while moving head side to side and up and down. she is unable to take aspirin products, so no anti-inflammatories have been tried. she has tried tylenol, stretching, and lidocaine patches with little relief. patient states the pain has alleviated some over the past week, but "not as much as she'd like".  She states this has never happened to her in the past with a flu shot and is concerned the pain will not go away in time for her vacation this upcoming weekend. Pt was advised to follow-up with PCP for further evaluation and has been informed that I am reporting this to VAERS
Redness and swelling of left arm, area 4cm x 6cm.  Received a IM dose of rocephin 10-20-05.  Also had vomiting and dehydration, admitted to short stay and rehydrated and given clindamycin IV.  Discharged home after one day with oral antibiotics.  Redness continued to increase, readmitted and received vancomycin IV with improvement of redness and swelling. Term added form Dis Summary rec'd 11/30/2005: Cellulitis
She had swelling of the face; Migraine; Hypersensitivity reaction; She had severe headache for a week; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (She had swelling of the face), MIGRAINE (Migraine), HYPERSENSITIVITY (Hypersensitivity reaction) and HEADACHE (She had severe headache for a week) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever and Hashimoto's disease. Concurrent medical conditions included Asthma and Endometriosis.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (She had swelling of the face), MIGRAINE (Migraine), HYPERSENSITIVITY (Hypersensitivity reaction) and HEADACHE (She had severe headache for a week). The patient was treated with ADRENALINE [EPINEPHRINE] at an unspecified dose and frequency. At the time of the report, SWELLING FACE (She had swelling of the face), MIGRAINE (Migraine), HYPERSENSITIVITY (Hypersensitivity reaction) and HEADACHE (She had severe headache for a week) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Unspecified antihistamines and steroids along with oxygen was use for the treatment of events Patient had to visit emergency 3 times due to events   No concomitant use were reported.   This case was linked to MOD-2021-278924 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Upon follow-up receipt: Medical information and events updated. Suspect dose 2 were deleted. Action taken updated no change from not applicable.
Patient received the shot at approximately 2:00pm. He was visibly anxious while waiting for the shot and receiving it, as he verbalized he was afraid of needles. After giving the shot and sitting for about 5 minutes, he stated he was feeling a little bit light headed and nauseous. At this time, I pulled up next to him and talked about symptoms. There was slight nausea and felt a little "out of sorts." Due to the nausea, gave a dose of benadryl in order to help with the nausea, sweats, and nervousness. 9-1-1 was called during benadryl administration. Within 5 minutes, the patient began to talk about his throat being itchy, and when about to administer epinephrine the paramedics arrived and took over, and left in an ambulance. Ultimately after discharge from the hospital, the patient did not receive Epinephrine either from our clinic or from the hospital.