chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash, itching, redness left deltoid area 30-40 minutes after injections. As reported by patient on 1/28/13 1600.
I had a mild fever and minor headache and had mild chills when I went to bed. I feel fine this morning with no issues.
child recv vax & had not rxn; had not been in contact w/any child that has had chickenpox then sibling broke out w/chickenpox x 3-4 days;was febrile, fussy;
Severe pain in joints  Shoulders, elbows, knees, ankles, wrists and fingers
Patient developed nasal congestion with clear drainage then he was tested positive COVID on 01/03.  Today he had of dizziness and lightheadedness.   He received bamlanivimab and etesevimab on 1/3. Given concerning findings of on CXR and also his immunocompromised state, he was started on ceftriaxone/azithromycin from ER and had symptomatic improvement. He was then transitioned to PO on discharge to complete 5-day course and recheck CXR in 6-8 weeks for resolution. - Continue supportive therapy + Airborne/Contact Isolations + N95/Eye shield use. - Not a candidate for Dexamethasone/Remdesivir. - Encourage incentive spirometry. - Supplemental O2 NC or HF and titrate as needed to keep O2 sat >93%.  - MDI Spacer w/ Neb PRN per RT  Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Patient fainted, pharmacist laid him down on the floor gently, 911 was called, EMTs checked him out and said he was OK;patient was dizzy/disoriented for 5-10 minutes after the initial syncope.
No further information is available; patient received an expired GARDASIL 9; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 10-MAY-2021,  the patient was vaccinated with an expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), prefilled syringe , dose :0 .5 milliliter/once, lot # R027946, expiration date reported as  27-APR-2021 for prophylaxis (dose number, and route of administration were not reported). . No further information is available combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Raised, red skin splotches of different sizes and shapes, covering an area of 3 1/2? x 2? (inches) at and around the injection site (upper right arm).  The soreness has returned to the tissue and muscles directly under this area and is similar to the soreness felt two days after the injection was given.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "prediabetes" (unspecified if ongoing); "intermittent asthma" (unspecified if ongoing), notes: intermittent; "ADHD" (unspecified if ongoing). No known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment with paxlovid from 25Jul2022 to 31Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information causal association between the reported event cannot be totally excluded, the case will be reassessed once new information becomes available.
No adverse event; On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.  It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.  On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml).  This case corresponds to 21st patient out of 27 patients as described by the reporter.  The age of the patient was reported as over 65 years.  Concomitant medication of the patient was not reported as it was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  It was reported that on 10-May-2023, 27 patients had received 0.25 ml of bivalent booster instead of 0.5 ml. On 11-May-2023, the patients were contacted and on 12-May-2023, 18 patients received additional 0.25 ml. Vaccine body site was reported as deltoid.  The reporter did not report any other adverse reactions.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Patient 21
gastrointestinal motility; nausea; abdominal cramps; sweating; presyncopy; tired; feeling moderate to severe myalgia and and it woke him up; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 69 years old male patient who experienced feeling moderate to severe myalgia (myalgia), presyncopy (presyncope), abdominal cramps (abdominal pain), sweating (hyperhidrosis), nausea and tired (fatigue) and gastrointestinal motility (gastrointestinal motility disorder) while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Past vaccination included Fluzone High Dose (every year for the last 10 years).  Medical history, medical treatment and family history were not provided.  Concomitant medication was not reported  On 31-Aug-2020 18:00, the patient received a 0.7 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number and expiry date not reported) via an unknown route in the left arm for prophylactic vaccination.  On 01-Sep-2020 01:00, the patient developed a non-serious feeling moderate to severe myalgia (myalgia) 7 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On 01-Sep-2020 01:00, the patient developed a non-serious sweating (hyperhidrosis), abdominal cramps (abdominal pain), gastrointestinal motility (gastrointestinal motility disorder), nausea, tired (fatigue) and presyncopy (presyncope) 10 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also reported that he didn't feel like himself but his breathing was ok. States he laid down on the floor and tried to ride it out but if he needed to he could call his wife who was in another room. States he tried to stay awake and felt it wasn't Corona Virus Disease (COVID), has a pulse oximeter but didn't use it and it took him 10-15 minutes to get over it.  Details of laboratory data not reported.    The patient was treated with DICLOFENAC SODIUM (THERMACARE SCHMERZGEL [DICLOFENAC SODIUM]), took 2 PARACETAMOL (TYLENOL) (1000 mg) and IBUPROFEN (ADVIL [IBUPROFEN]) (1000 mg).  On an unknown date, the patient was recovered from the nausea, gastrointestinal motility disorder and abdominal pain. The patient was recovering from the all other events (reported was this morning he feels 60-70 % like himself).  There will be no information available on the batch number for this case.
Grouped vesicular lesion patch on (L) post lower back, patch in vertical orientation along anterolateral (L) thigh, & patch (L).
losing appetite; This is a spontaneous report from a contactable consumer or other non health care professional. A male patient 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 immunization. Medical history included diabetes mellitus from an unknown date. Prior to vaccination patient diagnosed with COVID-19. Patient had no known allergies. The patient's 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: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient reported losing appetite on an unspecified date after second dose. It was unknown if the patient received vaccine in four weeks. It was unknown if the patient was tested post vaccination. No treatment received for the event. The outcome of event was recovered.  Follow-up attempts have been completed and no further information is expected.
Fatigue, fogginess, chills and inflammation of shoulder on day 1. 36-48 hours post-vaccine ~1.5in by 1in bruise surrounded by a red slightly raised mark. Red area approximately 3in by 2in. Soreness mostly resolved by 72 hours. Redness and brushing persist.
Large red wheal, tender to touch, and hard in center 3" in diameter at injection site.
Extreme stiffness that was from shoulder up into neck. Extreme nausea dizziness  chills extreme headache and fatigue. for 7 days. Would never go completly go away and would intensify and start again severely making it impossible to  leave the house. On day 7 and 8 still nausea with diarhea. The heaasche dizziness and brain fog were from days 4-7 Shaking and delayed movement of legs  numbness around lips and tongue on day7   Was told noone knew what to do and just drink water.  Awful to be this sick for one week.
10/6 and 10/7 sudden weakness of all finger both hands with fingers extended and unable to bend finger. Pain in hands when fingers bent. Numbness tips of all finger. When "shook out hands" then could bend fingers and numbness left. Pain in right shoulder extending to right shoulder blade and right neck if turned head. 10/10 sudden weakness with projectile vomiting and involuntary BM.
Administered COVID  vaccine to patient on the  right arm, vaccine was expired on 07/11/22.  Patient waited in office for 20 minutes, no adverse reaction noted. Provider informed parent of expired vaccine and advised patient to call our office if there is   a reaction.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 24-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Knot in the arm/Lump in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Knot in the arm/Lump in the arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sickle cell anemia.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced SKIN MASS (Knot in the arm/Lump in the arm). At the time of the report, SKIN MASS (Knot in the arm/Lump in the arm) had resolved.            Relevant concomitant medications were not provided.  Treatment information was not provided.  The patient stated that she should be taking medications but she does not.     This case was linked to MOD-2021-290615 (Patient Link).
Tachycardia- 150bpm at rest for 36 hours after vaccination. Spontaneously resolved after 48 hours. Slight fever of 100 F. degrees.
Upon receiving the vaccination, the pt got nauseated and dizzy. He vomited and became pale. He reported feeling hot and was sweaty. He reported visual disturbances and feeling weak. He sat for 30 minutes or more before he felt well enough to stand. EMS was not called the patient was given water and ice packs.
mom reports pt recvd vax 24MAR92 @ 915AM & pt was given APAP & 1 hr later sitter called about crying/screaming upset pt; mom took pt to MD 1130AM; site ok as per nurse; t101.6; No other illness found;
Woken with worst headache imaginable, unable to sip water, intense nausea, frequent stool x 7-8 that morning, body aches, chills, then feeling hot. Unable to keep eyes open due to the headache severity.  Extreme malaise.    This lasted in a severe form for over 14 hours. Then, able to sit up and take some sips of water without the nausea.  By the next day, felt very weak with milder headache but able to take in applesauce and crackers.  Continued to feel overall shaky and weak for 4 more days.  Watery diarrhea started on 4/26 x 1 day.  Also: Arm soreness (expected) at injection site.
Information has been received from a physician referring to an unspecified number of 11-18 years old female patients, 1 in 30 who were enrolled in a patient support program. There was no information about medical history, concurrent condition and concomitant medication. On unknown dates the patients were vaccinated with first dose of GARDASIL (strength, dosage, frequency and route unspecified). Patients fainted when they received GARDASIL. Pediatrician would then have them elevate legs, recovered, and watch the patients for 15-20 mins before letting them go. The physician reminded patients to eat before vaccine and had them sit in office for 15(unit unspecified). The physician did not prevent administration of 2, 3 doses due to event. The outcome of syncope was reported as recovering/resolving. The causality was not reported. This is one of two cases received from the same reported. Additional information is not expected as there was no consent to follow up.
Patient stated that approximately 2.5 hours after getting vaccine that she experience arm pain. The pain intensified over the next few hours. By 4pm the day the vaccine was given she was not able to move her arm at all. The pain radiated from her shoulder/neck area all the way down through her elbow and even slightly to her wrist. Patient has had other medical issues in the past that caused her pain and she said she has never experienced pain this bad. She could not drive for several days, as her arm almost had a numb feeling and she could not move it fast enough to steer or operate a vehicle safely. After about a week, the pain has subsided but patient wanted us to report because of the severity.
Pins/Needles; Paralysis; Full body weakness; Numbness; This is a spontaneous report from a contactable consumer (patient)   A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 07Apr2021 15:15 as single dose, for covid-19 immunisation. Medical history included Raynaud's phenomenon, cystitis interstitial, motion sickness, allergy to sulfa and macrobid. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced paralysis on 07Apr2021 15:15, full body weakness on 07Apr2021 15:15, numbness on 07Apr2021 15:15, pins/needles  on an unspecified date. The patient was hospitalized for the events for 4 days (start date not reported). No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 17Apr2021, sars-cov-2 test: negative on 29Apr2021. The events outcome was not recovered.  Information on the lot/batch number has been requested
Fever; chills; body aches; nausea; This is a spontaneous report from a contactable consumer (patient's parent). A 19-year old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EP6955) via unspecified route of administration in arm left on 10Apr2021 10:45 AM at age of 19-year old at single dose for COVID-19 immunization. Medical history included autism spectrum disorder-Asperger's, no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EP6955) on 20Mar2021 11:00 AM in left arm for Covid-19 immunization. Patient experienced adverse event: fever, chills, body aches, nausea on 10Apr2021 10:30 PM. Patient did not received treatment for the adverse event. Patients mother became aware of these symptoms the morning after patient received the vaccine on April 11th. Since the vaccination, the patient had not been tested for COVID-19. Patient was recovered from events.     No follow-up attempts are needed. No further information is expected.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Diarrhea-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Received 2 nd dose of Moderna shot on Sunday.  Sunday night and Monday, patient states he had vomting and diarrhea.   Vomiting and diarrhea stop on Monday.  Monday night and Tuesday, bodyache.  Tuesday night and Wednesday, patient has asthmatic symptoms.
Evening after vaccination had lightheadedness. Next day 10/10/2014, patient felt weak, tingly. Headache started 10/11/2014 along with chills, sweats and fever. 10/17 reports temp 100.4. On and off vomiting, headache and body aches.
NauseaVomiting Throat irritation Narrative:  The employee felt throat irritation and nausea after receiving the  vaccine after a couple of hours. She stated, " feeling sick with nausea and throat  irritation for four days. The employee did not seek care for her symptoms. After four days, her nausea and throat irritation resolved without taking any OTC  medication or home remedies. She wants to consult with her primary care doctor  before getting her second dose.
High fever that lasted two days (even with acetaminophen and ibuprofen), extreme chills with uncontrollable shaking, face and neck rash.
States she has had pain in entire R arm for several months ever since flu vaccine. Pain is worse at night. Has improved w time. No prior hx of this type of reaction to flu vaccine. No swelling. Has been having paresthesias in R hand since then as well. Heat helps. Tried Advil which helps.
49 yr/o female with a history of HTN, obesity, Graves' disease, asthma, T2DM, HLD, heroin abuse, hep C, MRSA, IVDU, COPD pancreatitis who presents to the emergency department complaining of abdominal pain with associated symptoms of nausea and vomiting.  She was very flat affect and not very forthcoming with information at this time.   She endorses a history of pancreatitis.  She endorses a history of IVDU, and states she last used heroin this morning. Patient stated " I just feel crappy". Limited HPI due to patients unwillingness to provide detail information.  She reported to the triage nurse that she recently tested positive for Covid 19. Pt denies headache, chest pain, shortness of breath. Review of Systems  Constitutional: Negative for chills, diaphoresis, fatigue and fever.  HENT: Negative for facial swelling.   Eyes: Negative for redness.  Respiratory: Positive for shortness of breath. Negative for cough.   Cardiovascular: Positive for chest pain. Negative for leg swelling.  Gastrointestinal: Positive for abdominal pain, nausea and vomiting. Negative for constipation and diarrhea.  Genitourinary: Negative for dysuria and flank pain.  Musculoskeletal: Negative for back pain and arthralgias.  Skin: Negative for pallor and rash.  Neurological: Negative for speech difficulty.  Hematological: Negative for adenopathy.  Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.   History of Present Illness:  49 year old F with history of tobacco/substance abuse, HTN, grave's disease with severe exopthalmos, NIDDM, hep C, chronic pancreatitis. She presented to Er with complaints of abdominal pain, n/v, with recent coid + test. ER evaluation revealed wbc 10.58, BNP 7.91, troponin <0.01, BP 210/86. - CTA chest: No obvious source for the acute abdominal discomfort. The preliminary report by the VRad radiologist described "significant gastritis." However, these findings are felt to be artifactual due to suboptimal distention of the stomach, and are grossly stable when compared to multiple prior exams over the past 3 years. 2. Groundglass nodular infiltrates involving the right middle and lower lobes, indicating an atypical pneumonia. - CXR; Rounded airspace opacity in the right lower lung likely representing pneumonia or residual pneumonitis as seen on prior chest CT dated 12/12/2021   Onset: several days Location: abd pain Duration: constant Characteristics: sharp Radiation: none Alleviating factors: none Aggravating factors: none Severity: moderate Associated symptoms: n/v, headache, chest pain, soa   Patient admitted for further evaluation and treatment.  1/31/22Discharge Diagnoses:  Covid 19 pneumonia, acute resp failure with hypoxia Abdominal pain with intractable nausea and vomiting Hypertensive urgency IVDU Diabetes melliuts Grave's disease