chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented with +SARS-CoV2 in the setting of generalized weakness, difficulty ambulating, fever/chills, occasional dry cough, diarrhea, poor PO intake, He was treated with dexamethasone 6 mg PO once daily x 10 days and remdesivir 200 mg x 1 then 100 mg q24h x 1 day. He was weaned off of oxygen  by day 4 of hospitalization and discharged in good condition.
Injection site was itchy and mildly sore 7 days after the injection .  This lasted for about 7 days
Patient presented with swollen left upper arm, red & itchy. I instructed patient to monitor & I left message with pcp.
Did not realize I had a reaction until I came home from the hospital...  started with a grey out that progressed to a functioning black out... shortly after the black out I passed out... it had effected my heart and pacemaker...  I went into a functioning grey out...
Allergic reaction 20 mins after receiving vaccine. Feeling hot, rash on face and neck, swollen and itchy throat, numb lips, and light headed. Most symptoms subsided after 10 minutes. Swollen and itchy throat did not subside until  30 minutes after taking 50mg of Benadryl.
One week after receiving shots, patient "got warm", got a rash, 2 lesions in mouth and some behind knees. Papules are clear liquid filled. Diagnosed with chickenpox. Treatment: Push fluids, treat fever, keep him out of daycare until lesions are crusted over.
Pimple-like rash on entire body per patient's description - Benadryl administered over weekend - Medrol Dosepak prescribed on 06/09/2015.
COVID swab test on Sunday, 21Mar2021, and results came back as positive today; sick; fever inside; sometimes I have tears and vomiting; sometimes I have tears and vomiting; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration was not provided), via an unspecified route of administration on 13Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was scheduled for second dose of Pfizer-Biontech Covid-19 vaccine on 01Apr2021. It was reported that I got my first dose on 13Mar2021 of the Pfizer Biontech Covid 19 vaccine; second dose scheduled on 01Apr2021. One week after first dose, I got sick and developed the following symptoms: "fever inside, sometimes I have tears and vomiting". I took a COVID swab test on Sunday, 21Mar2021, and results came back as positive today, 24Mar2021. She planned to follow-up with her primary care provider regarding the second dose. The patient underwent lab tests and procedures which included COVID swab test on Sunday, 21Mar2021 and results came back as positive today, on 24Mar2021. The outcome of the events was unknown.
Individual received 1st dose of anthrax vaccine on 5Feb11 - left arm. He then rec'd HepA & Typhoid in his right arm on 6Feb11. On 8Feb11 individual noticed "red spots warm to touch on arm, leg, ankle". No fever, no swelling. Raised dime sized bumps multiple.
Information has been received from a medical assistant concerning her 16 year old sister, who on 13-JUL-2007 was vaccinated intramuscularly on the lateral portion of the arm (unspecified arm) with a 0.5mL dose of Gardasil. There was no concomitant medication. On 14-JUL-2007 the patient developed a fever and vomited four times. She continued to experience nausea through 16-JUL-2007. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Very acute onset of Fever, Chills, Severe Nausea, Dizziness - lasted for 6 hours, then suddenly disappeared
Approximately 1 hour after vaccines given pt. returned to school and noted increased resp. difficulty-"throat felt tight". Taken to ER. Seen by Dr. Epinephrine given-pt. responded positively.
swelling and tenderness in breast on side of injection site; swelling and tenderness in breast on side of injection site; Swollen lymph nodes in neck and underarm; Intense arm pain and underarm pain; Intense arm pain and underarm pain; Swollen injection site; Rash on arm and neck near injection area; This is a spontaneous report from a non-contactable consumer (patient). This 24-year-old female patient reported for herself.  A 24-years-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, on an unspecified date (24-year-old at the time of vaccination) as dose number unknown, single for COVID-19 immunization. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medications included ethinylestradiol, desogestrel (ENSKYCE) and daily vitamins (UNSPECIFIED DRUG), received within 2 weeks of vaccination for unknown indication. The patient took Doxycycline on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 the patient experienced Swollen injection site, rash on arm and neck near injection area, swollen lymph nodes in neck and underarm, intense arm pain and underarm pain, swelling and tenderness in breast on side of injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events swollen injection site, rash on arm and neck near injection area, swollen lymph nodes in neck and underarm, intense arm pain and underarm pain, swelling and tenderness in breast on side of injection site were resolving at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.
Llittle bit of cough; Arm still hurts a little bit; I feel like I have sinus infection kind of; Fuzzy headed; Body ache; Swollen a little bit at the site, when touches it hurts; Swollen a little bit at the site, when touches it hurts; Bad chills (2nd dose); Real bad headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Llittle bit of cough), PAIN IN EXTREMITY (Arm still hurts a little bit), SINUSITIS (I feel like I have sinus infection kind of), FEELING ABNORMAL (Fuzzy headed) and MYALGIA (Body ache) in a female patient of an unknown age 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, 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 experienced COUGH (Llittle bit of cough), PAIN IN EXTREMITY (Arm still hurts a little bit), SINUSITIS (I feel like I have sinus infection kind of), FEELING ABNORMAL (Fuzzy headed), MYALGIA (Body ache), VACCINATION SITE SWELLING (Swollen a little bit at the site, when touches it hurts), VACCINATION SITE PAIN (Swollen a little bit at the site, when touches it hurts), CHILLS (Bad chills (2nd dose)) and HEADACHE (Real bad headache). At the time of the report, COUGH (Llittle bit of cough), PAIN IN EXTREMITY (Arm still hurts a little bit), SINUSITIS (I feel like I have sinus infection kind of), FEELING ABNORMAL (Fuzzy headed), MYALGIA (Body ache), VACCINATION SITE SWELLING (Swollen a little bit at the site, when touches it hurts), VACCINATION SITE PAIN (Swollen a little bit at the site, when touches it hurts) and CHILLS (Bad chills (2nd dose)) outcome was unknown and HEADACHE (Real bad headache) had resolved.            The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-395585, MOD-2021-395755 (Patient Link).
Significant redness and induration x 3. DTaP: 4 cm induration, 1 cm erythema; HIB: 2 cm induration & erythema (linear); Prevnar: 1 cm erythema, 1.5 cm induration.
This spontaneous report as received from a clinical assistant (healthcare worker) refers to a patient of unknown age. On 18-JUL-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 0363AE, exp date as 16-MAR-2013) for prophylaxis. No symptoms reported. The outcome was unknown. Additional information has been requested.
The first week he started getting sore, affected hand and arm, can't raise right arm completely, soreness and brown spot at injection site
Severe tingling in arm down to the hand, severe pain in upper arm, loss of grip in hand. Doctor said give it a few months. No help.
No wheal formed on 1st dose; 2nd doses given; wheal formed on 2nd attempt.
Fever; Chills; Dry GERD; Headaches; Body Aches; Nausea; This case was reported by a physician via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th July 2019, less than a day after receiving Shingrix, the patient experienced fever, chills, gastroesophageal reflux disease, headache, general body pain and nausea. On an unknown date, the outcome of the fever, chills, gastroesophageal reflux disease, headache, general body pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, gastroesophageal reflux disease, headache, general body pain and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The physician reported that, the patient experienced fever, chills, dry GERD, headaches, body aches, nausea after 1st dose and it was not abating. The patient experienced adverse events in the same day the injection was given. No further details provided regarding dry GERD. Permission for follow up not queried. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Bedridden for 11 days with pain, headache, chills, loss of appetite, Extreme fatigue,  Raynaud?s. Blood test on 12th day revealed high sed rate and abnormally high platelets ( twice normal)
I had a period that lasted from May 3rd to June 5th. I was concerned and talked to friends who had also had a similar reaction after receiving the vaccine, so I went to the doctor.  I feel that this is not being taken seriously enough or investigated thoroughly because of the amount of misinformation about the vaccine. I don't want this to dissuade anyone from getting the vaccine, but I also feel like this is a side effect that is being underreported because it is effecting women and it is difficult to track. I just want to be listened to and taken seriously. Hopefully this will help other women in the future.
Left Arm Numbness, Tingling, and Weakness from shoulder to 5th digit of hand. Onset approximately 72 hours post vaccination. Ibuprofen and cold compress only partially relieves symptoms.
Initial reaction of a golf ball sized lymph node in left axilla. Then hives started 2 weeks after vaccination. They were diffuse, intensely itchy, and dermatographia is present. They are much improved 2 weeks later, but daily antihistamine is still required to keep them at bay.
Got the shot at 10:45 am and about 6:00 the injection site began to hurt very badly. The next day at 4:00 PM other body parts began to ache, chills, overall sick feeling.
nerve on top of her left foot was disturbed; swollen feet and veins on legs (between knees and ankles; painful veins on her legs (between knees and ankles); nerve on top of left foot was disturbed which gives constant pain; Cannot walk as much as she needs to; Swollen veins; stomach issues and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) (seriousness criterion medically significant), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort). At the time of the report, NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested
Redness & swelling to (R) thigh - 7cm x 10cm redness with 2cm x 2cm knot to area - area warm to touch & tender.
Patient experienced diaphoresis and syncope. 911 was called. patient recovered on his own without intervention. was taken to the hospital as a safety precaution.
Swelling and pain at the base of left side of the neck.  Very tender to the touch.  Swelling diminishing on day 3 but still very sore.
UNKNOWN SIDE EFFECT; This spontaneous report received from a consumer 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced unknown side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unknown side effect was not reported. This report was non-serious. This case, from the same reporter was linked to 20220112564 and 20220112185.
c/o arm hurting @ inj site;no redness-no pustules;pt c/o pain in lt shoulder;physical exam reveals a frozen shoulder w/abduction restricted to 80 degrees;tender area over the posterior part of rotator cuff
Migraine for 6 days, body aches, chills, sore throat, earache, anorexia, dizzy.
Patient received vaccine at approximately 9:30am. Around 9:40am patient stood up and complained of feeling nauseous and very hot. Patient asked to step outside to get some fresh, cool area. Patient stayed outside for approximately 5 minutes, returned inside and said she was feeling better. Out of precaution, during the remaining minutes on her 15 minute timer, we administered 25mg po liquid diphenhydramine. Patient remained seated for about 5 minutes and then complained of feeling even more nauseated and faint than before. We laid the patient down into the recovery position. No improvement in symptoms. Then administered 10mg IM of dexamethasone. Patient showed no signs of improvement nor worsening of symptoms. Administed 1 epipen into left outer thigh. Patient within 3 minutes began to feel better but chose to remain laying on the ground. EMS was called at 9:50am and were on scene to further evaluate patient at 9:58am. Patient was alert, responding, and reported feeling better. Moved to sitting position. Vitals were taken, Pulse of 77bmp, O2 Saturation of 100%, BP of 113/72. Vital signs were within normal limits. Patient had regained color in her face and her response to stimuli was back to normal when EMS were on scene.
Only the liquid diluent portion of Menveo used.; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA722Z, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reported that a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The reporter reported that a possible 7 patients having received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140222:Same reporter- Patient 2 US-GSK-US2022140223:Same reporter- Patient 3 US-GSK-US2022140225:Same reporter- Patient 4 US-GSK-US2022140231:Same reporter- Patient 5 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140243:Same reporter- Patient 7
Initial misuse report received from a healthcare professional on 21 October 2013 and on 21 March 2014 at agency. A patient over 65 years of age of unknown gender had received FLUZONE ID on an unknown date. The patient received FLUZONE ID at incorrect age. No adverse event was reported. The list of documents held by sender: None.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 20-AUG-2014 the patient was vaccinated with a dose of expired PNEUMOVAX 23 (dose and route not reported), lot # J009827, expiration date: 10-AUG-2014. Additional information is not expected because there was no consent to contact the reporter.
1540 Pt complaint of feeling nauseous, states feels this was when anxious.  Pt at POD with girlfriend. Squad was called for girlfriend earlier after girlfriend fell to ground.  States anxious watching all that happen.  Denies any other symptoms.  Drank juice.  1551  BP 118/60, RR 18, OSat 99%, HR 87.  States feeling much better.  States ready to go home.  Advised pt to seek medical care if experiencing symptoms.  Pt verbalized understanding.  1553 Pt left with girlfriend at his side.
Breakthrough COVID infection. Patient fully vaccinated 02/09/2021. Patient tested positive for COVID on 7/14/2021.
Fever 105, local rxn rt thigh, screaming > 3 hrs; c/o fever several days, diarrhea, rhinorrhea x 1 day;
body aches; headaches; left deltoid soreness; left axillary swelling; developed a mild non-pruritic maculopapular rash to bilateral anterior flanks and under breast; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 11:30 (Lot number: FF2590) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Well Controlled Asthma" (unspecified if ongoing); "Acne" (unspecified if ongoing). Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; VIT D [COLECALCIFEROL]; VIT C. Vaccination history included: Bnt162b2 (Dose number 1, Lot number E19262, Dose administration time 7:00 PM), administration date: 29Jan2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose number 2, Lot number EM9809, Dose administration time 15:30 PM), administration date: 19Feb2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 22Oct2021 19:30, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset 22Oct2021 19:30, outcome "unknown", described as "headaches"; MYALGIA (non-serious) with onset 22Oct2021 19:30, outcome "unknown", described as "left deltoid soreness"; SWELLING (non-serious) with onset 22Oct2021 19:30, outcome "unknown", described as "left axillary swelling"; RASH MACULO-PAPULAR (non-serious) with onset 22Oct2021 19:30, outcome "unknown", described as "developed a mild non-pruritic maculopapular rash to bilateral anterior flanks and under breast". Therapeutic measures were not taken as a result of pain, headache, myalgia, swelling, rash maculo-papular.  Additional information: No other vaccine in four weeks. Other medications in two weeks: Prenatal Vitamin, Vit D, Vit C 1 tablet PO QD each. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Adverse event included in addition to expected reactions including body aches, headaches, left deltoid sore-ness and left axillary swelling I also developed a mild non-pruritic maculopapular rash to bilateral ante-rior flanks and under breast. No treatment ae.  Follow-up attempts are completed. No further information is expected.
Pt states swelling within 2 hrs after admin at office 14 hours later red, swelling, heat, pain from deltoid to elbow right. Pneumovax site.
patient described severe flu like symptoms for 2 days.  Also injection site swelling, redness and hot to the touch.
Mild hand swelling Pt not sure if vaccine gave him the  hand swelling or if it was from before vaccine
Patient was leaving clinic and felt faint, slid down but did not fall on floor, her mother caught her. Was conscious the whole time, no sign of seizure activity. Possible vaso vagal response.