chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving her vaccine client states she has tingling in both hands and nausea.  Vital signs BP 100/67, HR 67 O2Sat 96%.  Client states she feels better.  Client d/c home by EMS.
Narrative: 97yo male patient on 08/20/21 was admitted to hospital (non-agency hospital) after ED self presented for Cholecystitis . Pt had a TURBT on 9/1/21 and continuous bladder irrigation post procedure. On 9/7/21 pt's daughter called his agency PCC to inquire about hospice care for her father. Two days later pt died on 9/9/21 at hospital, likely from complication of this illness & procedure given pt's advanced age. Pt had received covid vaccinations on 1/11/21 & 2/8/21. This death is likely not related to the vaccinations due to comorbidities, age and length of time from vaccine administration.
Patient is a 41 year old male  With history of WPW with ablation who presented today at 3:45 p.m. before his 1st COVID-19 vaccination.  He received the Johnson and Johnson  Vaccine and reports that within an hour and a half he began having chest pain /tightness, throat tightness and a headache.    No prior history of allergic reaction.  He was assessed in triage and found to have stable vital signs with a heart rate of 58 beats per minute, a blood pressure of 125/ 67 and a O2 sat of 95% on room air.  He was immediately given Solu-Medrol 125 mg IM and 325 mg of aspirin.   EMS was called and arrived with a stretcher to take him to emergency department.   The patient reported that he began feeling better with less chest tightness and throat tightness after the Solu-Medrol. He declined EMS transport and ER evaluation and reported that he would like to leave AMA.  He was counseled on the potential consequences of this decision and given strict instructions to call 911 should he again began having symptoms.
First noticed 10/05/2005 35 x 40 right deltoid mm induration, Pain, hardness, warm, redness.
pt rcvd vax; pt devel severe headache; pain & left-sided facial numbness; face was droopy next day; taken to MD ;
sore arm; This is a spontaneous report from a non-contactable healthcare professional. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 20Apr2021 at 09:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced sore arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event sore arm was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Dizziness, Headache, Myalgia, Arthralgia,  c/o sweating,chills,fingers swollen,fatigue, eyes burning. Told to follow up with primary care physician if promblem persists.  Narrative:
Faint feeling; Numb sensation in arm; The following information was received from a nurse on 05 Aug 2019.  A vaccinee (no further identifiers provided) received first dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) on an unknown date.  The vaccinee experienced numb sensation in arm and faint feeling which subsided in approximately five minutes.  ---  Follow up 1 received on 12 Aug 2019.  Relevant vaccinee information included initials and date of birth.   Batch number of IXIARO (JEV18G84E) was provided.; Sender's Comments: Though information is scant, causality is assessed as possibly related, given the nature of the events reported, known for IXIARO.
I had the vaccine about 10:00 A.M.  I was fine until about 11:3 PM  I woke up experiencing a lot of pain and was chilling. I took my temperature and was running about 99.5.My normal temperature is 97 degrees. I took tylonel pm. But was never able to sleep longer at night. On Thursday and today (Friday). I have continued with those symptoms with my temperature getting as high as 102. I have had a few more asthma symptoms but ok.
1/24/22: 14 days after dose 1 of Pfizer COVID-19 vaccine (1/10/22) child had first (one-time) seizure (unresponsive, shaking for 1 minute) followed by lethargy/postictal period of 12 hours.  Question if febrile in nature in ED as temperature not taken at home.  Non-febrile in ED with NBNB emesis x1.  CT  had 3 mm lef-to-right mid line shift (non-specific, given no mass/bleed/edema) and asymmetric enlargement of the left ventricle.  If preparing for CT, patient tested positive for COVID-19 on 1/24/22.  Father also tested positive for COVID-19 to transfer patient as did remainder of family over the next few days.  Patient tested negative (required by local law) on 2/4/22.  Ultimate diagnosis by primary physician was  febrile seizure.  2 week follow up was unremakable neurologically.  Plan to re-image in 3-6 months, unless second seizure occurs.
Vaccination site erythema; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus). On 26-Feb-2021, VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (That was miserable).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR060424   Additional Information: GSK receipt date:22-APR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she was sick after each dose of Shingrix shot but, he/she would take that over than having shingles again. He had a miserable experience before. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR060424:Dose 2
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 18-AUG-2016, the patient received a dose of improperly stored VARIVAX (strength, dose, and frequency were unknown; lot number and expiration date were M004662 and 28-JAN-2018). No adverse reactions reported. This is one of several reports received from the same source. Additional information has been requested.
On Feb. 23 or 24 I noticed that the site of the injection itched.  Then on the morning of Feb. 25 I rubbed it to re leave the itching and shortly after it felt warm.  I looked and an area about 2 1/2" in diameter was red.
Difficulty breathing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown.            concomitant medicines was not reported by reporter  treatment information was not provided
Headache, Myalgia, Fever, chills, injection site pain Narrative:  Other Relevant History:
On 3/20/2021 I was awakened from sleep with a rapid and pounding heart beat. No chest pain, no shortness of breath. I finally called 911 about 5:30 AM and was transported to the ED at Hospital. After 8 hours of observation and no arrythmias other than tachycardia I was discharged and referred to a Cardiologist and my primary care Dr. I asked if this could be Vaccine related in the ED, Cardiologist's office and Primary care's office. I was told no because it was 10 days since I had the 2nd dose. The subsequent work up was negative except for the heart monitoring.(ssee below) MRI of heart 5/25/2021 normal
10x10cm erythema at injection site. 3x3cm induration at injection site. Urticaria back/arms mld to interior.
16mins post vacciantion pt c/o dizziness and that everything sounded muffled.  Pt had waited in line for 2hrs before vaccination. Vitals: @13:51 99/52, 67-- > @13:53 99/55, 61 -- > @13:55 96/52, 67 -- > @13:58 100/59, 69, RR 17 -- > @14:00 98/53, 73, 16 -- > 14:04 93/61, 70, 16 -- > @14:08 99/60, 71, 16 -- > @14:13 100/56, 61, 16 -- > @14:20 101/59, 71, 16 -- > @14:30 100/61, 72, 16. Pt states he is asymptomatic @14:35.  Pt stable and released from the vaccination site.
metallic taste in my mouth, chest pain, nausea, throat closed up. went to the ER via ambulance. migraines, brain fog , fatigue
Fatigue, muscle aches, fever, nausea, and swollen lymph nodes in left arm
Patient was vaccinated with a a dose of improperly stored GARDASIL 9; No adverse effects reported; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #R032766, expiration date on for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-US-009507513-1907USA007468: US-US-009507513-1907USA007439: US-US-009507513-1907USA005368: US-US-009507513-1907USA005362: US-US-009507513-1907USA010551: US-US-009507513-1907USA010552: US-US-009507513-1907USA010553: US-US-009507513-1907USA010554: US-US-009507513-1907USA010555: US-US-009507513-1907USA010556: US-US-009507513-1907USA010557: US-US-009507513-1907USA010558:
Patient reported hive-like rash on back of neck on 4/27/2018. She presented to pharmacy on 5/10/2018 with a half-dollar sized lump on her forehead that was tender to the touch. Patient said that the lump had reduced in size since earlier in the morning. Patient was instructed to take diphenhydramine if lump began to itch and to see doctor if the rash spread or if systemic symptoms began.
Burning pain in foot, swelling and heat at injection site followed with a Zoster like vesicular rash and itching by 07/06/15.
Pt. noted on 5/7/19, left arm "heaviness", warmth and pink elevated bump at the vaccine injection site while getting dressed the following day after vaccine administered. Pt. denied any itching or vesicular rash at injection site. Denies any fevers or chills, pain or tenderness. On exam a 5x 6cm oval wheal noted to left posterior upper arm where injection given on 5/6/19, warm to touch. No lymphadenopathy, no fevers, chills, streaking, drainage. VSS. Pt. given cold ice packs, OTC Hydrocortisone cream to site and area outlined to monitor. Pt. has follow up scheduled for 5/10/19.
Vomiting, severe headache, muscle pain in extremities - lasted x 2 days. Began 1 day after vax.
Initial report received on 21 August 2013 from a non-healthcare provider. A four month old male patient was immunized on 20 August 2013 with PENTACEL, Batch # C4486AA into the right thigh and PREVNAR (Wyeth), batch # H04467 into the right thigh. Route and site for PENTACEL was also reported as 10/10/2014 and PREVNAR 03/01/2015 (to be clarified). It was reported that the patient had no illness at the time of vaccination or pre-existing physician diagnosed allergies or medical conditions. At an unspecified time on 20 August 2013, after giving PENTACEL and then PREVNAR, the baby began crying and having breath holding spells. After he stopped crying, he went limp, eyes rolled back, body got stiff, and his arms were shaking. He was sent to the hospital for observation and was discharged on an unreported date. He was doing well at the time of discharge with no further incidents reported. It was reported that he was first given PENTACEL and then given PREVNAR, times not reported. It was unknown if diagnostic tests and laboratory tests were performed. The patient outcome was reported as recovered on an unreported date. No further details were available at the time of this report. Documents held by sender: None.
rash started day p/vax-rash consistent w/hives face, arms, legs, sl runny nose, nl CBC probably secondary to vax;
Case number PHEH2014US025084, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 81-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
It caused me to have rash, My feet is swollen, Allergic reactions in my abdominal area.; It caused me to have rash, My feet is swollen, Allergic reactions in my abdominal area.; It caused me to have rash, My feet is swollen, Allergic reactions in my abdominal area.; I have irregular heart beat, My heart is slow.; This is a spontaneous report from a contactable consumer or other non hcp.  A 42 years old male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 10Sep2021 as dose 1, single for covid-19 immunisation. Medical history included thyroid hormone replacement therapy, Thyroid, blood pressure measurement. Concomitant medication(s) included metformin; levothyroxine (LEVOTHYROXINE). It was reported that, the patient experienced it caused me to have rash, my feet is swollen, allergic reactions in my abdominal area, it caused me to have rash, my feet is swollen, allergic reactions in my abdominal area on an unspecified date with outcome of unknown, it caused me to have rash, my feet is swollen, allergic reactions in my abdominal area, have irregular heartbeat, my heart is slow on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: increased heart rate: irregular.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (25Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
22 y/o male AD, Specialist, is referred to medical center from Allergy for c/o diplopia after Rabies vaccine dose # 1. Received Flu vaccine some 25 days prior to the Rabies vaccine. Receiving rabies vaccine due to dog bite prophylaxis.
First dose /injected after /finished 6th month /second dose in 8th month/reminding/booster dose should be injected; This case was reported by a consumer via media and described the occurrence of inappropriate age at vaccine administration in a female patient who received Men B NVS (Bexsero) 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, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided are as follows: The case was reported by patient's parent. The reporter reported that, she had problem with Bexsero vaccination for her children. The patient received 1st dose after she finished 6th month and then 2nd dose in 8th month, which led to inappropriate age at vaccine administration. The reporter reported that from the card they could now read that 3rd dose which was reminding/booster dose should be injected.
Individual reports hives starting at elbows and traveling to wrists, bilaterally. Concerned about a co-wokers reaction to smallpox, his supervisor advised him to seek care so he went to Hosp. ED and was dx with urticaria and given Rx for Prednisone and ZYRTEC which he did not fill, allowing to resolve on its own. Improved as of 3 Jan 11, but not completely resolved.
Information has been received for the pregnancy registry for GARDASIL from a nurse practitioner concerning a 16 year old female with no drug reactions/allergies, reflux, migraine and a history of cardiac surgery who on 07-MAR-2007 was vaccinated with the first dose of GARDASIL IM (Lot# 654885/1424F).  Concomitant therapy included rizatriptan benzoate (MSD), propranolol HCl and ranitidine.  The patient was pregnant when she was vaccinated with GARDASIL.  The patient had a positive pregnancy test.  As of 01-MAY-2007, she was noted to be 2.5 months gestation.  Follow-up phone call information was received from the nurse practitioner who reported that the patient delivered a healthy, normal, baby that is now 7 months old and not experiencing any problems.  During the pregnancy, the patient did have some symptoms of pre-term labor, but went on to deliver full-term, vaginally.  No additional information is expected.
Right Upper Arm Erythema, Swelling, Warmth and Tenderness.
Significant left upper extremity pain, 5 cm raised area warm, firm, tender lasted about 7 days.
I woke up in the middle  of the night, with a pain in my left shoulder. This is the injection sight of the vaccine.  When I looked at the area around the sight it  was extremely red an noticeably swollen. This approximately 10 hours after I received the injection  I was unable to left the arm above elbow level without incurring  additional pain.  I took an Aleve and just rested the remainder of the day. Things returned to normal about 1500 hours  on the 28th.
After the normal 3 days of a sore arm at the injection site, my arm continued to hurt quite a lot  and when I would move it in a particular position, I had and now still have acute pain. I have limited range of motion and experience acute pain daily now 5 months later. It seemed the administrator did not inject in an inappropriate part of my arm?.in other words seemingly not the bursa.
Fever 101F, chills, HA, Body Aches, fatigue - stayed in Bed - after 24 hours fever resolved  felt better.  Missed one day of work.
Decrease in hand grasp, change in hand grip and ability to squeeze, decrease in right hand fine motor skills; Arm weakness increased over 72 hours; This case was reported by a other health professional via sales rep and described the occurrence of fine motor skill dysfunction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included nerve damage (In 2020 right-sided or right upper extremity nerve damage).   On an unknown date, the patient received Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced fine motor skill dysfunction and weakness of arms. On an unknown date, the outcome of the fine motor skill dysfunction was not recovered/not resolved and the outcome of the weakness of arms was unknown.   It was unknown if the reporter considered the fine motor skill dysfunction and weakness of arms to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: The physician assistant reported that he recently gave a Shingrix vaccine to the patient into left deltoid. The patient stated that approximately 4 hours after injection her right arm she noted a decrease in her hand grasp.  The patient stated that the right arm weakness increased over 72 hours where she noted a change in her hand grip and her ability to squeeze. At the time of reporting, the patient had a decrease in right hand fine motor skills. The patient was questioning whether this was related to her an injection she received on Friday while in office. The reporter was not able to find this was some sort of a side effect but reporter reaching out to GlaxoSmithKline to see if this was a possibility and also ruling out that this was some form of a stroke.  The reporter had placed her in occupational therapy, but reporter did not feel this was a reaction unless GlaxoSmithKline tell reporter some other information that reporter need to know. The reporter agreed to follow up from GlaxoSmithKline.