chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported     This case was linked to MOD21-068786, MOD21-068785, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068784, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711, MOD21-068713, MOD21-068716, MOD21-068783, MOD21-068717, MOD21-068718, MOD21-068721, MOD21-068722, MOD21-068723, MOD21-068724, MOD21-068727, MOD21-068729, MOD21-068731, MOD21-068732, MOD21-068733, MOD21-068734, MOD21-068735, MOD21-068736, MOD21-068738, MOD21-068782, MOD21-068739, MOD21-068768, MOD21-068769, MOD21-068770, MOD21-068771, MOD21-068772, MOD21-068774, MOD21-068775, MOD21-068776, MOD21-068778, MOD21-068780, MOD21-068781 (E2B Linked Report).; Sender's Comments:  MOD21-068786: MOD21-068785: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068784: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068783: MOD21-068717: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068782: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781:
Cutaneous pruritic maculopaular rash initially to injection site.  progressed to bilateral upper extremities and upper torso.  Few scattered vesicles to extremities.  Treated with prednisone 40mg/day for 5 days.  Much improved at this time, 3 days into course.
When she received the vaccine shot on Wednesday, the 15th of September of 2021 she experienced the usual symptoms typical of a vaccine. However, each day her symptoms became more unusual and of concern. She was experiencing  severe diarrhea, chronic coughing up of mucous, and dehydration. Then by the 18th she was experiencing the loss of control over her bowels and urine.  Then it escalated to paralysis and was rushed to the hospital.
Pt. developed a rash below injection site about "4x2" with fever approximate 100.
This spontaneous report was received from a supervisor, referring to a currently 4 year old female patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 25-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000684.
Body aches, slight fever, nausea, headache, tachycardia, fatigue.
Patient complained of feeling dizzy after receiving the vaccine.  He states he got nervous after seeing the syringe. He states this has happened in the past when he sees any syringe. His blood pressure was checked at 9:14 am 105/50 pulse 50 and after giving him fluids, laid and down and had lower extremities elevated it was rechecked  at 9:35 119/79 pulse 58. Patient confirmed that he was feeling better.
Information has been received from a RN concerning a 9 yr old twin female pt who on 03Jun98 and 15Apr99 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. On 09May05 the pt broke out with varicella lesions on her abdomen. She had approx 16 lesions. There was no product quality complaint reported. Additionally, the nurse reported that another child in the class may also have varicella. The pt sought unspecified medical attention. The reporter mentioned that the pt's twin sister broke out with lesions following vaccination with varicella virus vaccine live (WAES0505USA03284). Additional information has been requested.
After administering vaccine patient asked to stay in chair for a few minutes. When his mother came over to him he was seated on the floor. After laying down for a few minutes and drinking some gatorade the patient said he would like to get up and leave. While standing at the counter the patient is believed to have fainted and fallen to the ground hitting his head. He was awake and alert but stated "I don't know where I am". I called 911 and while waiting for EMS to arrive the patient laid down with an ice pack on the back of his neck. He was able to sit up and drink some orange juice. EMS took vitals and his blood glucose. They believe since the patient had not eaten anything today that that could be the cause. After being released by EMS and refusing to go to the hospital the patient left the pharmacy. EMS later came in to inform me that they were contacted again by the patients mother while in the parking lot. The patient again refused to be taken to the hospital.
97.1 temp-131/82=BP, 80=R, localized redness, slight swelling-c/o itching upper L arm from flu shot.
Broke out with itchy bumps 2/18/13. Received VARIVAX 1/31/13 no fever, no malaise. Scabbed over found out, 2/10 she was pregnant did not know at time of injection.
Patient tested positive for Covid-19 on 19JUN2022 after receiving her primary series of vaccine and her first booster dose of the Moderna Covid-19 vaccine.; stayed in bed for a day; higher temperature of 101 degrees Farenheight after her first Moderna Covid-19 booster dose; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (stayed in bed for a day), PYREXIA (higher temperature of 101 degrees Farenheight after her first Moderna Covid-19 booster dose) and COVID-19 (Patient tested positive for Covid-19 on 19JUN2022 after receiving her primary series of vaccine and her first booster dose of the Moderna Covid-19 vaccine.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced BEDRIDDEN (stayed in bed for a day) and PYREXIA (higher temperature of 101 degrees Farenheight after her first Moderna Covid-19 booster dose). On 19-Jun-2022, the patient experienced COVID-19 (Patient tested positive for Covid-19 on 19JUN2022 after receiving her primary series of vaccine and her first booster dose of the Moderna Covid-19 vaccine.). On 20-Nov-2021, BEDRIDDEN (stayed in bed for a day) had resolved. At the time of the report, PYREXIA (higher temperature of 101 degrees Farenheight after her first Moderna Covid-19 booster dose) and COVID-19 (Patient tested positive for Covid-19 on 19JUN2022 after receiving her primary series of vaccine and her first booster dose of the Moderna Covid-19 vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 101 higher temperature of 101 degrees Farenheight. On 19-Jun-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant information was reported. No treatment information was reported.  Company Comment: This is a spontaneous case concerning a 67-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately 7 months after receiving the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-609295 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately 7 months after receiving the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Received ZOSTAVAX injection in our office. Patient reported within 2 hrs had a bad episode of vertigo. No report of how long it lasted. She took DRAMAMINE and this relieved symptoms.
rash appeared on my chest/ spread first to my back, then my arms, and eventually my legs/ rash on my body; face turned red and inflamed; face turned red and inflamed; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 02Mar2021 09:00 (at the age of 72-year-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient did not have covid prior to vaccination. The patient was not pregnant at the time of vaccination. The patient was taking an unspecified concomitant medication. The patient previously took bnt162b2 for covid-19 immunization and patient experienced headache in the evening after the first shot. It was reported that headache in the event went away with Tylenol and another headache in the morning that also went away with Tylenol. The patient also previously took Tylenol for headache and erythromycin and experienced drug allergy. It was reported that on 02Mar2021 at 15:00 reported as about six hours after the second shot, her face turned red and inflamed. About 4 hours later a rash appeared on her chest which took about 12 hours to spread first to her back, then her arms, and eventually her legs. Now, 48 hours later, her face was a little better, but the rash on her body remained. It does not itch. No treatment was given in response to the event. Patient was not tested for covid post vaccination. The patient was not recovered from rash while recovering from face turned red and inflamed.    No follow-up attempts are possible. No further information is expected.
PATIENT WAS GIVEN A MODERNA BOOSTER SHOT AND HE IS NOT 18 YEARS OR OLDER. THIS WAS ADMINISTERED BY ACCIDENT . HIS MOTHER DID SIGN AND AUTHRORIZE THE PHARMACY TO ADMNISTER THE BOOSTER SHOT. PHARMACY FOLLOWED UP WITH THE PATIENT THE NEXT DAY AND HE DID NOT HAVE ANY SIDE EFFECTS/ADVERSE EVENTS AND FELT FINE.
Cold sores on lips Itchy rashes or varying sizes with papules in random locations on body. In order or appearance: face-especially left side including around eyes, left forearm, right forearm, neck, behind ears, inner right thigh, right knee, outer right calf
13mar90,had a macular rash,adenitis & achy legs & rt elbow;on 18mar90, had paresthesia & wrist pain;had persistent polyarthralgia,fatigue & depression;on 21mar91, ANA, Anti-Ro and anti-LA were detected;
Beginning approximately the middle of October I started to significant hair loss. My hair is now visibly thinner on the top of my scalp.
Pt reported that her arm started to swell up on 1/25/13. She also has redness and itching to the area. Pt came in the office on 1/31/13, swelling & redness has gone down. PCP evaluated her. No acute distress at this time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Report about covid treatment. Return of symptoms and retesting positive 5 days after ending Paxlovid. Anti-viral treatment for Covid-19, start date: 03Jun2022 and stop date 08Jun2022. Device timestamp was 15Jun2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1/26-1/30/21 -  hard swelling, red, raised and itchy started 1/26/21.  Called Dr. on 1/27 to report the reaction and the increasing side effect of the 2x2 raised hard, red, swelling, and extremely ITCHY.  Instructed to use Benadryl or Zyrtec along with cold compress to assist in decreasing the itchiness.  After starting Zyrtec on 1/27/21 evening, before reaction started to subside, the redness and itchiness had increased to cover my bicep and around to my tricep.  As of this reporting (7:00pm) 1/30/21, reaction area is still slightly red and itchy.  The swelling and hardness has gone.    I'm still taking zyrtec because the itchiness still remains.  Moderna fact sheet and side effects did not list itchiness.  Thought that data collectors should add this to the side effects.
My blood sugar was 176 right before I received vaccine, within 5 minutes it dropped to 70, took 3 glucose tablets. That did not reverse the fall,it went as low as 55, took another 3 glucose tablets.  It took about an 1 1/2 he to get blood sugar into a normal range.
Within 1 week of 3rd BIOTHRAX, patient could hardly stand due to the pain in all of his joints and rib cage. He barely got out of bed and could not sleep more than a short while due to the joint pains. He sought evaluation and was given NSAIDS with no improvement. He was tested for RA, which was negative, but he did have an elevated ESR. He had radiologic studies completed that were negative. He also had an MRI that was negative. Around the same time, he noted psoriasis on his scalp, elbows and knees. (He had no previous history of psoriatic lesions, but did have a history of eczema with small patches, usually only on one area of his forearms.) In July 2000, patient was placed on a short steroid burst for an allergic reaction where he broke out in hives. While on the prednisone, his joint pain was completely relieved. He was seen again in late 2000 and polymyalgia rheumatica was suspected, and again, he was placed on Prednisone 30 mg per day. The prednisone was effective in relieving his joint pains, as well as helping to clear his psoriasis.   6/23/09 Medical/Hospital records received DOS 8/16/00 to 9/22/2006. Assessment: Psoriatric arthritis with temporal association to receipt of anthrax vaccine. Patient presented with pain in most joints and rib cage. Fatigue, unable to sleep. Psoriasis - lesions covered 60% of body. Psoriatric arthritis. Hives. Treated with prenisone. Continued low back and L knee pain. Trapezius muscle spasm. Myalgia. Pleurisy, osteopenia, obesity. Hearing diminished.  ICD-9 Code: Psoriatric Arthritis 716.59 Follow-up Information 02-FEB-2007: Psoriatic arthritis. Patient's medical disability evaluation is currently pending.
Patient received 3rd dose of Moderna vaccine. When the patient arrived in the observation staging area, the patient complained of dizziness and ?light headed?, and felt like vomiting. Patient was assessed. Vitals were Heart rate-75, Respirations-14, SpO2-93% on room air. BP-120/60. Patient then stated that she had a reaction with the two previous does, and it required transport by ambulance to the hospital. Patient appeared to have facial swelling. Patient denied difficulty breathing and hives. Patient has a history of Neuropathy.  Patient stated that she did not want an ambulance called, nor want further treatment by us and left the premises by vehicle.
Swollen Lymph node in left arm pit. Sensitive to touch, sore. Development was about 24 hours after receiving the 2nd dose. Other side effects were headaches and fatigue. Took Tylenol for that twice.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. When the patient was at the clinic to receive the 2nd dose, it was reported that, after the 1st dose, the patient experienced pain and swelling at the site of injection for three weeks. The reporter did not agree for follow up.
pos.test; pos.test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "pos.test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Pos. Therapeutic measures taken as a result of drug ineffective, covid-19 included administration of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300124971 different patient, same drug and event;
Child developed redness and swelling about 24 hours after vaccine. Swelling and redness increased and became warm after 48 hours. Treated for cellulitis.
Received the covid vaccine on 1/12/21 started having symptoms evening of 1/15 including stomach upset, chills, muscle and joint pains headache and overall feeling Blah........on Saturday afternoon started feeling much better.  Over all symptoms lasted less than 24 hours slight headache after that but relieved with medication.
Warm and solid bump appeared 8 days after vaccination at the vaccination site. Bump was about the size of a cutie orange, approximately 2.5 by 2.5 inches. Went to urgent care and was told that I had what the nurse practitioner called COVID arm. I was given a topical steroid cream to apply three times a day for seven days. After a couple days, the bump reduced in size and disappeared within five days. The arm is still warm in that area.
24 hours post vax, the pt developed cyanosis in hands and feet, worse in right lower leg. 48 hours post vax, the pt's color changed, swelling on right lower leg and foot, increased fussiness, and decreased sleep. The 60 day follow up states 1/17/03 leg swelling related to vaccine reaction. Increased calcium not related to vaccine and is resolving. Follow-up: Vaccine injected in R quadriceps. 24 hours later - cyanosis hands and feet, worse in R lower leg; intermittently. 48 hours hours later - color changes, swelling of R lower leg and foot. Increase fussiness decrease sleep.
Was not required to wait 15 minutes, left facility, then just about passed out while driving. Sweating, dizziness, confusion, tingling hands & feet,  not able to stand up. Additionally, approximately 6 hrs post shot fever, headache, body aches for 24 hours
broke his hips; This is a spontaneous report from a contactable consumer (reported from himself) from a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 15Mar2021 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitantly, the patient was taking unspecified blood thinners. The patient called in because he was scheduled to get his 2nd dose on Monday, 05Apr2021 He got his 1st dose on 15Mar2021 and 10 days ago from the time of the report (Mar2021) he said he broke his hips and had surgery. He said he was on blood thinners and asking if it is ok for him to take the 2nd dose on the scheduled date. The outcome of the event was unknown.   Information on lot/batch number has been requested.
0.5 ml dose given for booster dose of Moderna instead of the 0.25 ml dose prescribed
Patient received dose of monovalent Pfizer after 4/18 when the FDA stopped use of the monovalent vaccines.    Patient seen for q12 month WCC and decided to wait til next visit for the BIVALENT>
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (On an unknown date 1st dose received). On an unknown date, the patient received the 2nd dose of SHINGRIX and the 3rd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and intercepted drug administration error. On an unknown date, the outcome of the injection site pain and intercepted drug administration error were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated the patient was given dose of SHINGRIX and complained that the vaccine hurt when it was administered. The reporter also stated that the patient did not believe she got 2 doses of SHINGRIX (even though MD had documentation of 2 doses being given to patient) and the patient wanted the reporter to get a 3rd dose of SHINGRIX. The reporter said she was not going to give the patient a 3rd dose of SHINGRIX since they already had documentation of 2 doses being given to this patient. This led to intercepted (averted) drug administration error. The reporter did not consent to follow-up.
One hour after immunizations pt developed increased temp and fussiness. Pt also developed redness, swelling and rash to left half of head. Mother advised to take pt directly to ER. All attempts to follow up with parent failed.