chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in the brain; Blurred vision; Weakness in the hand; Difficulty walking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN OEDEMA (Swelling in the brain), VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Weakness in the hand) and GAIT DISTURBANCE (Difficulty walking) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced BRAIN OEDEMA (Swelling in the brain) (seriousness criteria hospitalization and medically significant), VISION BLURRED (Blurred vision) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Weakness in the hand) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Difficulty walking) (seriousness criterion hospitalization). At the time of the report, BRAIN OEDEMA (Swelling in the brain), VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Weakness in the hand) and GAIT DISTURBANCE (Difficulty walking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging head: abnormal (abnormal) He had a brain MRI which shows swelling in the brain.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not taken by the patient. Treatment information was not provided.  The patient has weakness in his hand, difficulty walking, blurred vision. The patient started experiencing symptoms 3 days later, and they are ongoing. The patient was hospitalized for these symptoms, and was given steroids to reduce the swelling.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Twelve hours after receiving shot, pt began to experience extreme redness and swelling going down her arm from the injection.  She also experience pain radiating up her arm involving the shoulder and neck.  On 1/21/2020 she consulted a physician who diagnosed cellulitis and administered Rocephin IM and oral Clindamycin.
Large (apple sized), lump at injection site. Lump is also noticeably warmer to the touch than other areas around it.  No itching, no burning.
Nurse administered an expired dose of Bexsero to a patient on 15 Jul 2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comments: Nurse administered an expired dose of Bexsero to the patient on 15 Jul 2022.  The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Ejection fraction rate went from 70 to 50; Stayed in bed for a couple days; Very fatigued/Felt rundown/Felt extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of EJECTION FRACTION DECREASED (Ejection fraction rate went from 70 to 50), BEDRIDDEN (Stayed in bed for a couple days) and FATIGUE (Very fatigued/Felt rundown/Felt extremely tired) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cardiovascular disorder.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EJECTION FRACTION DECREASED (Ejection fraction rate went from 70 to 50), BEDRIDDEN (Stayed in bed for a couple days) and FATIGUE (Very fatigued/Felt rundown/Felt extremely tired). At the time of the report, EJECTION FRACTION DECREASED (Ejection fraction rate went from 70 to 50) and FATIGUE (Very fatigued/Felt rundown/Felt extremely tired) outcome was unknown and BEDRIDDEN (Stayed in bed for a couple days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Laboratory test: results not reported (Inconclusive) Results not reported. On an unknown date, Ejection fraction: 70 (normal) 70 and 50 (abnormal) Ejection fraction rate went from 70 to 50.         No concomitant medications were reported. No treatment medications were reported.  It was reported that doctor did not think it was from the booster. There was no product complaint associated.  Company comment: This is a spontaneous case concerning a 24-year-old male patient with medical history of Cardiovascular disorder, who experienced the non-serious unexpected event of ejection fraction decreased (AESI) and other non-serious events. The event occurred on an unknown date after the booster dose of mRNA-1273. The ejection fraction went from 70 to 50, the outcome was unknown. The mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-464811, MOD-2022-466148, MOD-2022-465239 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 24-year-old male patient with medical history of Cardiovascular disorder, who experienced the non-serious unexpected event of ejection fraction decreased (AESI) and other non-serious events. The event occurred on an unknown date after the booster dose of mRNA-1273. The ejection fraction went from 70 to 50, the outcome was unknown. The mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
had a knot/all at injection site on left deltoid; very sore; all at injection site on left deltoid; redness/all at injection site on left deltoid; warmth/ all at injection site on left deltoid; This case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number F29KK, expiry date October 2021) for prophylaxis.   On 6th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th May 2021, less than a day after receiving Shingrix, the patient experienced injection site lump, injection site pain, injection site erythema and injection site warmth. On 8th May 2021, the outcome of the injection site lump, injection site pain, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site lump, injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received her first Shingrix dose then had a knot with redness, warmth and very sore all at injection site on left deltoid.  All adverse events resolved after 2 days. The reporter did not consent to follow-up and not given permission to contact her HCP (health care provider).
weakness, numbness, paralysis, effacea, can barely speak, loss of all motor skills, guillain varre syndrome
Mother reports child with gagging, swelling to eyes, & lethargy 30 min after vaccine. Mother report via TC. Mother told to get child to Emergency Room.
Difficulty breathing, body hurting head to toe, coughing hard, sore neck, extremely tired, weakness,  headache
01/17/2021 @11:41 am Covid Vax in Left Deltoid @12:03 pm stated tongue was ?tingly? and had a headache 5/10.  She took 1000mg Tylenol.  Given history of allergies, I gave her 50mg oral diphenhydramine ? liquid.  She also took an Ativan 1mg.    She was nervous and upset, but no further reaction except ?tingly tongue?.  No rash, examined arms, torso, face, lips.   12:15pm  BP 152/82, admitted to some anxiety 12:30 ?feels good?,  still some tongue tingling 12:36  BP 140/80  tongue/mouth nothing remarkable I advised her not to drive and sister came to pick her up at 1:30.  No further incidents I advised her to talk to her dr about 2nd vaccine and consider an allergist due to prior allergies.
First night (12/14) Flu symptoms, shaking body aches. Second night (12/15) Tongue swelled up almost to point of closure. swallowed 3  dissolved Benadryls (with difficulty) and stayed upright.
pt recvd vax approx 11AM APAP given; pt refused lunch 1130AM; body felt warm; 235PM noticed twitching & jerking of boy; then went into grand mal seizure w/frothing @ mouth & eyes rolled to side; taken to hosp; 238PM t105 R;
Extreme pain in my left ring finger; injection site arm was swollen; entire left side is swollen from my neck to my toes; Feel like I have a Fever but my body temperature is normal; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Extreme pain in my left ring finger), PERIPHERAL SWELLING (injection site arm was swollen), SWELLING (entire left side is swollen from my neck to my toes) and PYREXIA (Feel like I have a Fever but my body temperature is normal) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C211A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (Extreme pain in my left ring finger), PERIPHERAL SWELLING (injection site arm was swollen), SWELLING (entire left side is swollen from my neck to my toes) and PYREXIA (Feel like I have a Fever but my body temperature is normal). At the time of the report, PAIN IN EXTREMITY (Extreme pain in my left ring finger), PERIPHERAL SWELLING (injection site arm was swollen), SWELLING (entire left side is swollen from my neck to my toes) and PYREXIA (Feel like I have a Fever but my body temperature is normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Body temperature: 98.6 f normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Narrative:  COVID fully vaccinated admitted with incidental positive COVID given remdesivir for 5 days
Patient presented to  emergency department with complaint of left-sided arm pain/numbness that began 6/17/2021, approximately 11 PM.  She reports sleeping on her right side and woke up with new onset of left arm pain.  Patient also noted feeling as though she could not feel her pulse on left arm as much as her right.  This is what prompted her to follow-up to the emergency department for further evaluation.  Upon arrival she noted that left-sided arm tingling/pain had improved. Upon assessment patient states left-sided arm pain has returned and is now radiating towards mid chest region.  Diagnosed with an occlusion in the distal brachial artery and proximal ulnar artery and she was started on heparin and went to surgery for a thrombectomy.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 43-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or known allergies provided. On 11-APR-2018, the patient was vaccinated with an expired dose of PROQUAD lot # M041083, expiry date 04-APR-2018, subcutaneously for prophylaxis. No known adverse effects were reported.
Per patient: "Side effects experienced with the vaccine obtained on Sat 1/2/2021. I had had covid in August 2020 and received the shot then experienced a strong reaction. Fever of 100-101 for two days, extreme arm pain at injection site for 3 days with swelling and redness, body aches for 3 days, joint and fingers swollen for 2 days. Headache continues still at 5 days and time of this report.  Most notably is that my left thigh and gluteus has gone numb. This also happened when sick in August but not to the extreme that it is now. The area of the hip bone is predominately the most numb and sore. This was not the injection site."
Red from inject site to elbow warm to touch & itching; 6NOV91 recvd inject; 11NOV91 noticed little red area; 12NOV91 area inc; 13NOV91 area 20cm x 15cm & itching; 13NOV91 cold compresses, no fever; 14NOV91 compresses relieved itching;
Patient states that he lost consciousness and fell hitting his head within 24 hours of receiving his first covid shot. He was taken to the ER, but ended up leaving before seeing any doctor because they waited for several hours and just monitored him at home.
This spontaneous report as received from a Licensed Practical Nurse refers to a 22 month old patient. On 17-NOV-2006 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, indication, route not reported). On 21-JAN-2009, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date, dose, indication, route not reported). No adverse effects reported. Additional information has been requested.
on the crook of left arm,  on the elbow part of the arm part,  within 30 minutes, it turned a deep purple-red color and developed a bubble on the top. there was no pain associated with it.  it is 4 days later and still visable
This spontaneous report was received from a consumer refers to herself as a 71 year old female patient. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported). On 18-NOV-2015, the patient experienced soreness in the arm and that she cannot raise her arm after receiving PNEUMOVAX 23. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
a big lump of hives or rash that is itchy; a big lump of hives or rash that is itchy; a big lump of hives or rash that is itchy; This is a spontaneous report from a contactable consumer. A 55-Year-old male received first dose of bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number were not reported) via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After getting the 1st dose of the vaccine the reporters husband experienced a big lump of hives or rash that is itchy. Talked to a Pharmacist, advised them not to get the second dose. While his primary care physician asked them to call Pfizer to ask how to remedy this. Reporter said that her husband did not do anything different and that he had this after get-ting the vaccine. The reporter on the line calling about the Pfizer Vaccine, clarified to be the COVID Vaccine. On 19Jul2021 she called to report her husband had a bad reaction to the vaccine. It has been four weeks now and her husband is still having these bad reactions. It has not subsided. The patient requested for medical information. The outcome of the events was not recovered.  Information about Lot/batch number has been requested.
2-3 minuites after receiving VZV and Tdap pt. began to feel faint and c/o dizziness and fainted.Skin cold and clammy, B/P 130/74. Pulse 64/reg. Pt.easily aroused in less than one minute after fainting. Alert and oriented to person, place,date,and situation.C/O generalized weakness and momentary numbness in lips and throat with no c/o shortness of breath..or difficulty breathing. After 10 min.of clinical observation: B/P 130/78, pulse 60/reg. while sitting. C/O soreness afterward in (L) shoulder. No swelling noted. Moves all extremities well.  Left per wheel chair with god-grandmother enroute to Urgent facility for evaluation. Child's father notified of incident and will be meeting child and god-grandmother at the facility. Pt. left in good spirits, no apparent distress and asked god-grandmother to follow-up with Health Dept. as to care rendered at the urgent care facility. Nurses clinical documentation sent with patient to facility.
Same day reaction - red circle from injection site, throbbing, sore to touch, shower spray hurts hitting spot, sore to lay on injection site side. Doxycycline started 2/25 & 1 wk course. Starting BACTRIM DS 3/6/13.
Patient given 1st dose of Gardasil Lot # 14484 on 2/4/08.  Patient became ill with Severe Adominal Pain and Nausea.  Patient given 2nd dose of Gardasil Lot # 17574 on 4/16/08.  Patient because ill with Severe adominal pain, and Nausea and treated at pediatricans office on 5/1/08.  Patient given 3rd dose of Gardasil Lot # 0067X on 8/18/08.  Patient returned to Pediatrician on 9/3/08 with Severe adominal pain, severe nausea, and brain freezes or seizure complaints.  Since September of 2008, patient has been placed on a modified school schedule and is being treated by Hospital with little to no improvement.  Student is unable to attend school except for an average of 2 days per week.  Student has become disabled because of pain, nausea, and seizure effects.  2/19/2009 MR received from PCP which include multiple consults and ER visits.  Seen 2/4/08 for c/o congestion, H/A, fever and abd pain. Assess:  Sinustis.  Vax given. WCC 4/16/08 with normal G&D. PE WNL.  Vax given. Returned 5/1/08 with c/o fever, diarrhea, decreased appetitie and po intake. Assess:  Pharyngitis.  Viral syndrome.  OV 6/4/09 for nausea and migraine. Assess: VGE. OV 9/3/08 for H/a, nausea, stomach pain.  Assess: VGE. Returned 9/15/08 with RUQ pain and diarrhea. Rx:  Prilosec. Similar sx 9/22/08, 9/25/08 with fever. Seen 11/10/08 with for daily "brain freeze' where pt can't think clearly, panics, with H/A after. Missed 20 days of school this yr. Sx continue to present.   Referred to GI 10/6/08 with multiple consults for abd pain with no clear dx-likely functional. Depression noted 1/13/09. Weight gain 2' to eating to lessen pain. IBS dx 2/16/09 2/26/09 Hospital records received for ER visit 9/29/08 and later diagnostic studies with DX:  Abdominal pain. Pt presented with several week hx of RUQ abdominal cramping with nausea. Severity 4-9/10. PE WNL. Referred for out pt tx. Follow-up: I have reported my daughter's adverse effects to GARDASIL and so far, she hasn't shown up in your VAERS database. The # assigned was 339589. Can you let me know if you need anything else from me and/or how long it will take before I can query on her information. I also want to ensure that all 3 of her lots are listed. See below: Below is her lot information and # of VAERS reports of each. Shot 1 - 78 events with Vaccine is 'HPV4' and Lot Number contain '1448U'. Shot 2 - 70 events with Vaccine is 'HPV4' and Lot Number contain '1757U'. Shot 3 - 74 events with Vaccine is 'HPV4' and Lot Number contain '0067X'. All of her lots have had multiple adverse effects listed. Can you make sure this is recorded and let me know when her information will be published for query purposes? Thanks for providing this service.
Axillary lymphadenopathy lasting at least through 4/22/21. Initially LAD was painful, but this has resolved.
This case was reported by a physician via call center representative and described the occurrence of shingles in a 58-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 29th June 2018, the patient received SHINGRIX (intramuscular). On 1st July 2018, 2 days after receiving SHINGRIX, the patient experienced shingles, chills and fever. On 2nd July 2018, the patient experienced back pain. On an unknown date, the outcome of the shingles and back pain were unknown and the outcome of the chills and fever were recovered/resolved. It was unknown if the reporter considered the shingles, chills, back pain and fever to be related to SHINGRIX. Additional details were provided as follows: On Friday, the patient received SHINGRIX. On Sunday, the patient experienced fever and chills. On Monday, 3 days after vaccination, the patient woke up with pain on the right side of her lower back. The patient went to the health care professional office and was diagnosed with shingles.
Headache, Arthralgia & HYPERtension Narrative:  pT REPORTS HAVING HYPOTENSION NORMALLY THAT IS TREATED WITH MEDICATION. Since vaccination, she has had HTN and her PCP has stopped her medication for hypotension. SHe also reports ongoing fatigue and joint pains nearly one month after receiving her second dose. SHe has had head CT and a cardiac stress test due to her ongoing symptoms.  Other Relevant History:
Rash: neck, face, arms, leg. Treated with Benadryl, 24, waited 30 minutes, rash still present, increased redness.  checked airways-open. Tongue itching reported. Contacted 911.  911 assessed. Patient refused to go to the hospital. Patient when home and took additional doses of Benadryl 50... redness, rash nearly disappeared. 5 hours later, rash reappeared, some itching. Patient took 50 Benadryl.   Rash and itching improved.  Symptoms had not appeared within 12 hours of last dose of Benadryl.