chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives/urticaria (small welts/skin wheals) appear at random parts of the body. Slowly spread apart throughout the day, then disappear. Skin welts can be aggravated with physical contact and grow larger.
On 8/26/03, patient received Pediarix, HIB, MMR, and Varicella at approximately 10 AM. The next morning he woke up with fever of 194 rectally. Had fever that day and was given Tylenol and Pedialyte. Fever broke that night. On 8/29/03 patient started turning yellow and is still jaundiced today.
Numbness of the tongue began about two hours after administration of the vaccine.  Persisted for 36 hours and resolved on its own.
Redness, soreness, itching, and slight swelling at injection point. Left upper arm with slight warmth.
chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Chills and Fatigue, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            No concomitant medications were reported. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
feeling the chest, like her heart is tired or her chest is tired; tired; arm was sore; The brain felt similar as with this reaction to the booster shot; but was more like a cold, like a blood cold was running in for a little bit; had problems to breathe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Lot number: EW0161) at the age of 39 years as dose 1, single and administration date 05May2021 (Lot number: EW0176) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergic to the weather and pollen and all kinds of stuff" (unspecified if ongoing), notes: Allergic to the weather and pollen and all kinds of stuff; "Allergic to the weather and pollen and all kinds of stuff" (unspecified if ongoing), notes: Allergic to the weather and pollen and all kinds of stuff. Concomitant medication(s) included: CETIRIZINE HCL taken for hypersensitivity, seasonal allergy. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "arm was sore"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "The brain felt similar as with this reaction to the booster shot; but was more like a cold, like a blood cold was running in for a little bit"; DYSPNOEA (non-serious) with onset 2021, outcome "recovered", described as "had problems to breathe"; CHEST DISCOMFORT (non-serious), outcome "recovered", described as "feeling the chest, like her heart is tired or her chest is tired". Additional information: List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. She mentioned with the first and second doses of the Pfizer Covid Vaccine she at first was just and sore, just the . but she is thinking that was normal; but she did feel so, kind of like if she was getting sick and tired like if she had the flu. She also Those reactions to the first and second doses of the Pfizer Covid Vaccine only lasted for about 2 days and after the doses were administered. She reported the reaction with the first dose, but did not report reaction with the second dose, she did not call the doctor to report the reaction with the second dose because she expected that reaction after the first dose reaction.   Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
pt recvd vax;next day w/prolonged screaming,lasting over next couple of wks, no fever; local redness & induration at inject site x 1; pt fully recovered;
Swollen lymph glands, left side of face; swelling extends up to ear level. Mild ear pain, headache.  Began w/in 1 hour after shot.  Spoke w/ pharmacist @ 6:30 pm; took 10 mg loratadine and 400 mg ibuprofen at his suggestion, and applied icepack.  Overnight swelling extended further toward top of ear (front side), reddened, warm and sore.  No temperature, sneezing, or itching.
patient received flu vaccine 10/1/2021 . one week later she called and informed us she felt sore, bruising and pain at injectionsite
This spontaneous report was received from a consumer via social media refers to some female patients of unknown age. There is no information of concomitant medication, medical history and concurrent condition. On an unknown date, the patient was vaccinated with GARDASIL for prophylaxis. On an unknown date, the patients ended up crippled (disability). The outcome of disability was unknown. Causality assessment was not provided. This case has been linked with the MARRS case no. 1612USA004594 as E2B Linked Report. Additional information has been requested. Sender's Comments:  US-009507513-1612USA004594.
During administration MENACTRA to patient, maybe it was not on tight and most of the vaccine came out with no reported adverse event; Patient probably didn't get majority of the vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (Reference number- 00580918) and transmitted to Sanofi on 28-Apr-2021.  This case involves a 11 year old female patient who probably did not got majority of the vaccine as during administration of 0.5 mL first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [lot number and expiry date not reported, via an intramuscular route at the left arm] for prophylactic vaccination, on 28-Apr-2021 to patient, maybe it was not on tight and most of the vaccine came out (underdose and product leakage).   Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9).  It was a case of vaccine underdose and product leakage. (Latency: same day)  Product used: Used   First time product used: Yes  At the time of report, no adverse event was reported.  Event outcome for reported event was not applicable.
Constant runny nose; feeling sluggish; joint stiffness; lungs and chest were tight/sore; weakness; sweat; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported. A male patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on 11Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included triple bypass, carotid artery surgery, a thyroid condition, and diabetes. The patient stated that he was rather active and "not a couch potato". The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on 21Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. After first dose patient had a sore arm and a change to his bowel movements which were daily and softer resulting in diarrhea for the remainder of the month, he had "never been that regular in his life", end of January his BMs changed. The patient also reported having had a "constant runny nose" since the first dose that was ongoing. After receiving the second shot on 11Feb2021 on day 21 as directed and had been "feeling sluggish" since. Last night, 25Feb2021, the patient was sweat so much he "completely soaked the bed", he had joint stiffness and weakness, and his lungs and chest were tight/sore when he took a deep breath. His symptoms have "kind of cleared up" but he was "just don't feel right" today.  At the time of this report the outcome of the event constant runny nose was not recovered and other events were unknown.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
Patient felt, dizzy, anxious and with vomiting, sweaty skin. Paramedic Vitals 90/60 BP, 80P, SpO2 95%, R21. Patient refers after immunization that he had taken Clonazepam, for anxiety. Pt stabilizes in the observation area.
Bell's Palsy starting on 6/19.  No significant change in  activities of daily life.  Continued to work.   Normal MRI and MRA on 6/25.  Significant improvement in symptoms by 7/3.  Minor symptoms which are not concerning now.
Fever that reached 103.2 degrees. Headache, body aches, chili's. Swollen lymph node under right arm appeared this morning 9/5/2021. Fever has reduced to 101 degrees without tylenol, or ibuprofen
Headache; sore throat; shoulder blade pain, upper arm, armpit, wrist and hand joint pain all on the left side same side as injection; earache; jaw pain; collar bone pain (also same side as injection); nausea; chills; pubic bone painful to walk, low grade fever
Second covid shot today. I feel normal per usual. VERY sore arm though. My first shot was very sore too and red. It subsided about 2 weeks.
After receiving the vaccine, I laid down at noon. When I woke up at 6:30 in the evening, I felt tired. Then by 9:15-9:30pm, I started getting chills. Then by 1:15am, I started running a temp of 101.5. When I got up this morning at 7:30am, My temp had gone up to 101.7. I took two tylenol at 8:30am and I have not checked my temp yet. Im just sitting in the chair sweating.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna,Vaccine administration date:07Apr2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), on 12Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; FAMOTIDINE; CETIRIZINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Apr2022, outcome "unknown", described as "Vaccine brand other: Moderna,Vaccine administration date:07Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2023) Negative; (03Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about COVID treatment yes, If vaccine received yes, Other medication in 2weeks yes, Product COVID 19 Treatment start date 24Jan2023, stop date 29Jan2023, Device timestamp 03Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 12/18/00, the patient had an office visit, parent complained of child being cranky, irritable, lethargic with fever on and off since immunizations. Temperature 103 on Saturday. When seen at the office the temperature was 96.5; rash just started on his chest, back and groins. TM's slight redness, Tympanometry R72, L115, right thigh was red. On 12/19 called the patient crying and pulling on ears. On 12/22, the patient was doing better  not on Zithromax, but Claritan.
it was rpt from nurse concerning pt who was vax & subsequently devel diarrhea;
A pharmacist reported that a male, now 75 years old, received an injection of tetanus toxoid and subsequently developed a "severe" reaction. A diagnosis of allergic reaction was made. No further info was available at the date of this report.
Severe hives - saw MD on following Monday prescribed prednisone treatment and BENADRYL. Took 5 days for hives to abate. Subsequent occasional outbreaks. Bruise at injection site one week later.
sensation of numbness of tongue; swelling of tongue; tongue reddened; a red cough drop; This is a spontaneous report from a contactable pharmacist. An 89-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection, lot number: EN5318) via intramuscularly on 23Jan2021 at 11:00 (at age of 89-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included DM (Diabetes Mellitus), hyperlipidemia, HTN (Hypertension), OPA (Pulmonary Adenomatosis) and SOB (short of breath) and history of recent concussion after a fall. Concomitant medication and medications in two weeks included salbutamol (ALBUTEROL HFA) as needed for SOB (short of breath), ascorbic acid (VITAMIN C) at 1000 mg once a day, calcium citrate at 250mg once a day, colecalciferol (VITAMIN D3) at 2000 IU, once a day, glipizide at 5mg once a day, empagliflozin (JARDIANCE) at 10mg every morning, famotidine 20mg once a day, mirabegron at 50mg once a day and levothyroxine 100mcg once a day. Past drug event included muscle pain due to statins, unknown allergy reaction due to sucralfate, pantoprazole and ipratropium. No other vaccine in four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 23Jan2021 at 11:05 (5 minutes after vaccination), patient experienced sensation of numbness and swelling of tongue, tongue reddened to right side, no visible swelling, patient reports recently having a red cough drop. Treatment received at 11:10 (on same day of vaccination) was diphenhydramine hydrochloride (BENADRYL) 12.5mg oral as 1 dose. Patient appears in NAD (no abnormality detected), resides in rehab center. After medication received patient monitored for additional 30 minutes and discharged back to rehab facility. The outcome of all events was resolved in 2021.  No follow-up attempts are possible. No further information was expected.
This case was reported by a healthcare professional and described the occurrence of stool discolored in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included PENTACEL (Sanofi), ENGERIX B (GlaxoSmithKline) and PREVNAR (Wyeth Labs) all given on 17 May 2011. There were no concurrent medications. On 17 May 2011 (in the pm) the subject received 1st dose of ROTARIX (oral). On 23 May 2011, 6 days after vaccination with ROTARIX, the subject experienced stool discolored (black and blue stool). At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with ROTARIX.
wanted to rule out cellulitis; left arm is now the side of the softball; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (wanted to rule out cellulitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (wanted to rule out cellulitis) (seriousness criterion medically significant) and INDURATION (left arm is now the side of the softball). At the time of the report, CELLULITIS (wanted to rule out cellulitis) and INDURATION (left arm is now the side of the softball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed.  No treatment listed.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received Modera booster 10/29. 10/30- Headache woke me up around 8:00 AM. Radiated from the back of the head to both temperoal regions with intensity of pain behind right and in the right ear. Chills T-99.7, nausea, and extreme fatigue. Right lower teeth even ached. 10/31 -Same symptoms, except for chills were less T-98.9. and did have a little more energy. 11/1- Still having a headache, lower right teeth pain, and ear pain. At work, when drinking from a cup, liquid was dribbling out of mouth right-sided facial drooping was noted. BP was 160/102. Went to ER. Upon arrival BP-179/90.  Dx with  Bell's Palsy Upon discharge BP-10/62 with any ut medication treatment for it. Started on Prednisone 60mg. Was given a Rx for Valtrex 1 Gm tid
was in bed most of the day,used to be lot faster; Brutal side effects,side effects put him down; did not have an appetite but did eat a little bit; Nausea; Fatigue; Headache; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (was in bed most of the day,used to be lot faster), VACCINATION COMPLICATION (Brutal side effects,side effects put him down), DECREASED APPETITE (did not have an appetite but did eat a little bit), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 006A21A and 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Had 8 surgeries due to broken left leg even before he received the 1st dose of moderna vaccine.). Concurrent medical conditions included Diabetic.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (was in bed most of the day,used to be lot faster), VACCINATION COMPLICATION (Brutal side effects,side effects put him down), DECREASED APPETITE (did not have an appetite but did eat a little bit), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (was in bed most of the day,used to be lot faster), VACCINATION COMPLICATION (Brutal side effects,side effects put him down), DECREASED APPETITE (did not have an appetite but did eat a little bit), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   This case was linked to MOD-2021-416078 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Follow up document received included Event Added.
pt recv vax & exp onset of sudden of fever & shaking spell (sz) @ approx 10PM 7JUN95; taken to hosp; pt adm-spinal tap, EEg;
Information has been received from a physician concerning a five year old patient who was vaccinated with varicella virus vaccine live (Oka/Merck) on an unknown date, from another physician (Information unknown). The patient developed breakthrough chickenpox. The chickenpox was severe with more than 50 lesions, and was a "full blown case." Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Visit Diagnoses   Exposure to SARS-associated coronavirus  Chest congestion  Fatigue, unspecified type  Symptoms of upper respiratory infection (URI)
Since receiving the vaccine, I have experienced 4 cold sores as of 5/24. I typically experience 1-2 per year and I'm dealing with one about every 3 weeks. This may not seem like an "adverse" event, but this is not normal for me and the only variable is the vaccine.
Received vaccine on 10/26/17, returned to clinic on 10/27/17 for swelling of right hand and arm was advised to elevate, rest, ice and use ibuprofen. Patient presented to ER on 11/3/17 and was admitted for cellulitis, given IV abx and discharged with oral abx three days later. Patient seen in clinic for hospital follow up and was doing remarkably better.
6 people recvd 3 doses of Engerix-B & failed to achieve seroprotection; pt recvd 3 doses of Engerix-B on 21MAR91 & 18APR91 & 17SEP91; 22OCT91 titers were checked & a value of 0.8 was obtained; pt was a non-responder;
A couple months after receiving the Vaccine I noticed memory problems. Seem to be getting worse. Am currently being seen for it.
Initially,  red rash with severe itching at injection site on left arm, spreading down arm with increasing swelling, itching, and discomfort.  Treated with Benadryl cream locally, Benadryl and Tylenol orally for 4 days with improvement. MD visit on 5th day of reaction for evaluation and prescribed Keflex for possible cellulitis.  Swelling remains after 7 days but itching and redness decreased.
Patient states on 4/14/21 to the facility that he the following issues following his second covid vaccine that started around 22:00 on 3/26/21.  Facial swelling, lymphnode swelling, severe malize and weakness, increased sleepiness, unable to urinate or with extreme difficulty.  He called his PCP and was treated in the outpatient office.
Pt received injection.  Shortly thereafter pt started feeling numbness in lip and left arm and light headeded.  Pt then started getting redness on neck and side of body where she received vaccine.  Rph took pt's blood pressure and pulse and both were high.  EMS was called and pt was observed.  Rph was going to give pt epinephrine and EMS arrived.  EMS gave pt diphenhydramine and took pt to hospital.
COVID arm. Red inflamed area above injection site with extreme muscle ache. Rash not itchy but warm to touch.