chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Supraclavicular lymph node swelling on left side starting second day after vaccine and still present at 4th day post vaccine. Pain in the sternocleidomastoid muscle that is mild. Lymph node is tender. Did have fever 12 hours post shot of 102.3 max but none since.  No other lymph nodes swollen.
achey eyeballs; tiredness; low grade headache; chills; bone pain; muscle pain; mild swelling at injection site; mild occasional nausea; welts; light headedness; joint point; Possible fever; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191, Expiration date was not reported), via an unspecified route of administration on 01Jul2021 13:15 (age at vaccination 58 years) as dose number unknown, single for covid-19 immunisation. Medical history not reported. Concomitant medication(s) included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. COVID-19 vaccine was administered at workplace clinic. On 02Jul2021 06:00 the patient experienced achey eyeballs, tiredness, low grade headache, chills, bone pain, muscle pain, mild swelling at injection site, mild occasional nausea, welts, light headedness, joint point, possible fever, persisting 5 days as of report submission. The patient had not received any treatment for events. The outcome of events was recovering.
My heart rate was measured at 194 beat per minute/woke up from a very strong and fast heartbeat; My whole body was shaking; shortness of breath; general weakness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46 years old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 02May2021 at 16:00 (at age of 45 years old, no pregnant, Lot Number: ER8736) as a single dose for covid-19 immunization. Medical history included Penicillin Allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Apr2021 at 13:00 (at age of 45 years old, no pregnant, Lot Number: EW0150) as a single dose for covid-19 immunization. The night of 15May2021 at 3:00, the patient woke up from a very strong and fast heartbeat. Her whole body was shaking, she had experienced shortness of breath and general weakness. After realizing that something was wrong she went to an Emergency room. The patient heart rate was measured at 194 beat per minute. Events resulted in Emergency room/department or urgent care. The patient received treatment (Valsalva Maneuver). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
39 yo female w/ hx of anxiety, depression, GERD, MVP, ETOH abuse, suicidal ideation who presented to ED secondary to drug overdose. Pt reported insomnia and was taking unprescribed medications from a friend, including Ambien, fentanyl. Upon arrival to ED, BP 90/62, HR 114, afebrile. WBC 18.9, Hgb 12.9, plts 384. Na 142, Cr 0.97, AST 36. LA 3.1. Trops 0.25, 0.48. EKG w/ sinus tachy. +COVID. UDS + fentanyl. ETOH <10. UA w/o infx. IVFs given. Hep gtt initiated. Placed on CIWA protocol. Pt admitted for further care. Psych consulted. Pt denies suicidal ideations. Suicide precautions lifted. Cleared for dc home.
Blurring of vision of the right eye few hours after receiving the vaccine described as brown threads or webs floating, initially coming form the temporal side gradually moving and spreading to the nasal half then total blocking her vision.
Patient is a 17-year-old who received a booster with the Moderna vaccine (0.25mL) when Moderna is currently only approved for 18 years and older. Patient was made aware of the event and reported having no adverse effects from the vaccine at the time of the call.
Tingling in face especially cheeks about 5 minutes after I took the vaccine. Lasted about 15 minutes.  Tingling in left arm started about one hour after and lasted about 2 hours.  Swelling in left upper arm with pain started about 5-6 hours after and is still there about 24 hours later.  Aching under arm vaccine side (left) lymph nodes and ache going  down to the left breast.  Fatigue.  Nausea.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210616782.
PATIENT STATES SHOULDER PAIN LASTING ALMOST 2 MONTHS AFTER VACCINATION.
Pt had Pneumonia vaccine 10/23/10 returned to pharmacy on Monday 10/25/10 complaining of redness in arm. It was red 6 inches below immunization area called 10/26 patient said resolved no further reaction.
Became COVID symptomatic on 29Jul2021,  Had positive PCR on 30Jul2021; Became COVID symptomatic on 29Jul2021,  Had positive PCR on 30Jul2021; This is a spontaneous report from a contactable physician (patient).   A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6207) as dose 2, and first dose via an unspecified route of administration in left arm on 19Feb2021 (Batch/Lot Number: EN6207) as dose 1, single for COVID-19 immunization (at the age of 48-year-old). Medical history included hypertension. Concomitant medication(s) (in two weeks) included nadolol and verapamil hydrochloride taken for an unspecified indication. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced became covid symptomatic on 29Jul2021, had positive pcr on 30Jul2021 (vaccination failure) (medically significant), nausea, congestion, fever, cough, malaise, headache on 29Jul2021. It was reported that patient received both vaccines. Became COVID symptomatic on 29Jul2021, Had positive PCR on 30Jul2021. Have had moderate symptoms, including congestion, fever, cough, malaise, headache, nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Hospitalization was not prolonged. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 29Jul2021 Nasal Swab, SARS CoV2 RNA NAAT. Patient received symptomatic COVID treatment for the events. The outcome of the events was recovering at the time of last observation.; Sender's Comments: Based on the information currently available the lack of efficacy of the vaccine BNT162B2 cannot be excluded.
Pt had Zostervax vaccination along w/Pneumovax vaccination in 11/06.  Pt presented yesterday w/outbreak of shingles on lower jaw.
Approximately 1-2 hours post vax, pt developed a temperature of 101; extreme fussiness; took catnaps only. Episode lasted 3-4 days.
Significant redness, itching, with swelling on left deltoid 10x5cm.
Difficult IM vaccine injection resulted in immediate (L) deltoid pain w/radiation to (L) hand. Severe for 4 days, persistent to present (5 mos.) orthopedic consult -> local injection of triamcinolone and Bup/vacaine, followed by 3 wks of arm exercises. Symptoms worsened PT referral-> unable to provide beneficial treatment; Referred back to orthopedics for follow-up care.
Injection soreness followed by the next day of slight fever and very lethargic compounded on top of a headache
Nurse administered second dose 19 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (Nurse administered second dose 19 days after first dose) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced OFF LABEL USE (Nurse administered second dose 19 days after first dose). On 18-Apr-2021, OFF LABEL USE (Nurse administered second dose 19 days after first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable
At 3 months of age (week of 12/23/13), I noticed eye rolling incidents when patient was lying in complete supine. I also noticed she did not make good/much direct eye contact and moved her body/extremities more than "normal."
Patient has been waking during the night, crying inconsolably and unable to fall back to sleep. He is also very clingy during the day, needing to be held and becoming upset very easily.
patient may have received a portion or a small bit of the vaccine/no AE; After I squirted it in to him, i checked the needle and it was on tightly/no AE; there was a hole near the hub and that is what caused the leak.The syringe and needle/no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 89 years old male patient who received partial dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immunodeficiency and Leukaemia.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) for Immunisation.  On 14-Oct-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1912 via unknown route in unknown administration site.  It was of actual medication error due to Vaccine underdose and Exposure via skin contact. It was also a case of Product quality issue. The syringe needle was injected into the patient and then when pharmacist pushed the plunger, the vaccine liquid squirted out from the hub to where it narrows down- the gap between the hub and the syringe- it squirted out there between the glass and the hub of the syringe. The liquid fell out on the chair. The pharmacist stated "it felt like it might not be sterile. There was a hole. The liquid vaccine looked clear and was not cloudy. After pharmacist squirted it in to him, pharmacist checked the needle and it was on tightly. It is not an issue with the needle, but there appears that there was a hole near the hub and that is what caused the leak. The syringe and needle are in the sharps container and are not available for return. The patient may have received a portion or a small bit of the vaccine. The pharmacist gave the patient another dose of the Flublok Quad vaccine of the same lot as the one that leaked. The second syringe was fine. The patient is already immunocompromised. He has leukemia. The pharmacist stated that she is concerned that the vaccine that she gave was not sterile and worries about what could happen as a result to this immunocompromised patient.  It was unknown whether any adverse event was noted or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After vaccine, I felt weak and low energy. On Mar 19th morning, I passed out, fell and hit my head and coffee burnt my feet.  I didn't know how long I was passed out. I went to the ER.
Extreme red splotches that ran together.  Extreme pain and became giant splotches covered from head to toes.  Groin area very swollen, face swollen, fungal infection in mouth & on mouth.  Extreme irritability, close to combative, face some swollen, confusion.  ETC, fever 103.9 first day 11/27/08. 12/3/08-records received-11/27/08-admitted with diffuse rash all over after taking Bactrim and hypoglycemic episode.  DX: Stevens-Johnson syndrome due to mostly likely Bactrim. 1/13/09-Discharge summary received for DOS 11/27-12/6/08-DC DX: Primary Cause of Death-Toxic epidermal necrolysis secondary to either Bactrim or Dilantin. Other diagnoses: Acute renal failure/chronic renal failure. Diabetes mellitus. Coronary artery disease. Atrial fibirllation.  Patient expired 12/6/08.  3/10/09-death certificate received-COD-toxic epidermal necrolysis. Exposure to either Bactrim or Dilantin. other significant conditions:Acute and chronic renal failure, CAD, A fibrillation. Diabetes Mellitus.
Hard to sleep; Experiencing pretty intense headache; Pretty nauseous; Arm was just sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard to sleep), PAIN IN EXTREMITY (Arm was just sore), HEADACHE (Experiencing pretty intense headache) and NAUSEA (Pretty nauseous) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A1 and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm was just sore). On 19-May-2021, the patient experienced INSOMNIA (Hard to sleep), HEADACHE (Experiencing pretty intense headache) and NAUSEA (Pretty nauseous). At the time of the report, INSOMNIA (Hard to sleep), PAIN IN EXTREMITY (Arm was just sore), HEADACHE (Experiencing pretty intense headache) and NAUSEA (Pretty nauseous) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-147945 (Patient Link).
is now 8 years old and has not receive the second dose of MMR II and VARIVAX as recommended; No additional AE reported.; This spontaneous report was received from a nurse and refers to an 8-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 ml; and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, both administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) as per prescribing information. However, the patient was currently 8 years old, and had not received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) as recommended. No additional adverse events were reported.
Sore Arm; felt week; no appetite for 6 days; sick; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ASTHENIA (felt week), DECREASED APPETITE (no appetite for 6 days), ILLNESS (sick) and CHILLS (chills) in a 78-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 information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm), ASTHENIA (felt week), DECREASED APPETITE (no appetite for 6 days), ILLNESS (sick), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Sore Arm), ASTHENIA (felt week), DECREASED APPETITE (no appetite for 6 days), ILLNESS (sick), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant and treatment medications were reported.   This case was linked to MOD-2021-025303 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Followup was received. Reporter's address was added.
Patient received 1st dose of COVID vaccine on 1.15.21, called clinic on 1.28.21 complaining of bruise on left forearm. Patient reports that there is another similar bruise that has developed on his right forearm as well. Patient states that the left forearm has improved. Told the patient to monitor the bruise closely and contact their PCP with new, worsening, or bothersome symptoms. Patient is on warfarin and has agreed to be seen early for an INR check on 2.2.21. Patient presented to visit on 2.2.21. INR was within range at 2.5. Bruising on the top of both forearms healing well, but did appear large in nature.
Low grade fever (99.3), chills, malaise, redness and swelling on the arm where vaccine administered for 5 days.
PATIENT STARTED HAVING A BLOTCHY RASH ON LEFT SIDE OF BODY WITH WELTS AROUND THE INJECTION SITE ABOUT 2 HOURS AFTER INJECTION. TOOK BENADRYL 50MG, NO RELIEF. RECEIVED A STERIOD PRESCRIPTION FROM HER PROVIDER BUT STILL NO RELIEF. THEN ENDED UP RECEIVING AN EPINEPHRINE SHOT ABOUT 3  1/2 HOURS AFTER VACCINATION DUE TO NO RELIEF AND LIPS STARTING TO SWELL.
Chills/ Body ache / Low grade fever ~ 100.4 - fatigue - Lasted about 24 hours
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patients were vaccinated with doses of PROQUAD (Merck) (lot# not reported, 0.5 ml, subcutaneous), which were exposed to temperatures above 5 degrees F but below 19 degrees F for a total time of 9 hours above 5 degrees F. No adverse effect reported. The vaccines were not administered at the time of the 09-OCT-2014 call. Later it was reported that improperly stored vaccines administered was made known on 21-OCT-2014. This is one of several reports received from the same source. Follow up information has been received from the registered nurse on 29-OCT-2014. The registered nurse stated that she had no additional information to share with at this time. Follow up information has been received from the registered nurse on 04-NOV-2014. Nurse stated that clients were vaccinated with improperly stored PROQUAD (Merck) that had again been improperly stored. No adverse effect was reported. Additional information is not expected as the reporter did not want to be contacted about this report. The narrative has been updated.
Dizziness, chills, fever (103 F), neck stiffness, back pain, epigastric pain, mild tachycardia (110), severe headache with photophobia. HA was unresponsive to 100mg of sumatriptan. Back and neck pain worsening over 24 hours, fever slowly decreasing to 101F over 24 hours. Severe head pain with coughing.
Started w a fever of 103.7. The fever continued for 5 days. She also developed a rash on her face and swollen face. She was also very lethargic and had no appetite.
Complained of erythema, slight heat, edema to area just medial to puncture site - left upper leg.
I had a good immune response to to all three of my vaccines. My arm was really sore, my skin was hyper sensitive and I had fatigue. In January 2022, I developed hives in the trunk area of my body. It started to spread from my head to my toes and is still going on. I take antihistamines morning and night. I'm also taking Xolair for my symptoms which is helping.
Numbness developed 15 minutes after administration. Extends from site of injection to fingertips.  Currently lasting 2 weeks and 1 day and ongoing.
No reactions.  Patient was under age of requirement for the Moderna Vaccine at the time of first dose vaccination.  Administered 2nd dose with parent's approval.
90% LOSS OF VISION IN ONE EYE; BURNING EYE; FOGGY VISION; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced 90% loss of vision in one eye, burning eye, and foggy vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning eye, foggy vision and 90% loss of vision in one eye was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to. Sender's Comments: V0.- Covid-19 vaccine ad26.cov2- 90% loss of vision in one eye. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Moderna vaccine (NDC--80777-0273-99, lot # 048C21A) was received at store on 7/16/2021 and placed under refrigerated temperature.  3 vials were transferred to store where 20 doses were administered beyond use date.
Pt developed rash within a few hours of receiving the vaccine; it has spread over his body and persists after 20 days; it is pruritic but not painful, it is blanchable and no systemic symptoms