chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 07-NOV-2012 14:35, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient reported exhaustion, joint pain, chest tightness, bronchospasm, cough, rash, dull aching headache, and injection site soreness Treatment: prednisone 20 mg for 5 days, Benadryl 25 mg every 6 hours as needed, atenolol discontinued, and EpiPen given for emergent symptoms Outcome: As of 7/31, patient reported that chest tightness and shortness of breath remain but spasms have resolved
Numbing in arm, progress to back, legs, shoulder, neck.  Numbing lasting for 5 months. Numbing continues. Loss of strength in left side. Problem continues, but seems to be lessening.
Hives on forehead, no obstruction to airway. Benadryl given to patient
patient experienced dizziness and she could not open her eyes due to her vision kept on spinning; tingling lips and tongue; This is a spontaneous report from a contactable consumer (patient). A female patient of an age 76 (units not provided) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 10:00, as single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Mar2021 at 10:15, 15 minutes later after vaccination, the patient experienced tingling lips and tongue and was able to manage while in the facility. On the same day, at 7 pm (at 19:00), the patient experienced dizziness and she could not open her eyes due to her vision kept on spinning. She wanted to know if it was safe for her to get the 2nd shot. The outcome of events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
This spontaneous report as received from a Certificate medical assistant refers to a 8 week old patient. On 11-DEC-2013 the patient was vaccinated with the first dose of oral ROTATEQ (lot # unspecified) (dosage information and routed unspecified). On approximately 11-DEC-2013, the patient experienced vomiting immediately after vaccination. It was unknown if the patient had sought medical attention. The outcome of vomiting was unknown. The relatedness between the therapy and the event was unspecified. This is one of several reports received from same source. Additional information has been requested.
Patient came in for his 2nd Moderna shot today 4/26/21. I administered the vaccine and asked him to remain in the store for a 15-minute observation period (just like the 1st dose). After 2-3 minutes he walked to the pharmacy window to let my technician know he was starting to feel dizzy. At the same time my technician was informing me about his complaint, he lost consciousness and fell, hitting the side of his head on the consultation wall. I immediately asked technician to call 911 and rushed to get EpiPen to patient. He immediately regained consciousness. I did not administer any EpiPen doses. I stayed with him and monitored him until paramedics arrived. When paramedics arrived, they asked me which vaccine I administered and started asking patient questions. They measured his blood pressure. Patient was responsive and he called his wife to let her know he was going to the ER. Paramedic informed us that his blood pressure was low. On his way to the hospital he looked at us and said thank you. I will call him tomorrow to check on him.
noticed arm swelling  and itching that was getting worse following shot on 8/19 and called pharmacy on 8/27. told her to call her primary care physician for followup
pt devel angioedema w/in 8hr p/vax;pt reportedly PCN allergic;
Patient admitted to hospital for progressive bilateral lower extremity weakness, sensory changes and inability to ambulate. Neuroimaging with significant degenerative disc disease with disc protrusions throughout the lumbar spine, greatest L3-L4, and with severe central stenosis. Question of radiculopathy vs peripheral neuropathy at admission, but no acute findings such as cauda equina syndrome. EMG consistent with atypical variant of GBS--acute motor sensory axonal neuropathy.
On 11/5 the patient's right arm became sore. It continued to become sorer until today 11/8 her arm was so sore she couldn't lift it. She has a green bruise from where the vaccine was given. The pain is radiating up to her neck as of 11/8. Her arm is not warm or red or swollen.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was experiencing leg pain for which he wanted surgery to alleviate. He received clearance from cardiology that he was low risk for procedure, and his cardiac history included atrial flutter s/p ablation on Eliquis. He had history of pulmonary embolism and his ejection fraction was 45-50%. On 4/2/21 he suffered a severe stroke and was brought to hospital where he was eventually placed on life support and passed away on 4/3/21. Patient also had a PMH significant for CKD, HTN, AAA, ventricular tachycardia.
sick after she took both Moderna COVID-19 vaccinations.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick after she took both Moderna COVID-19 vaccinations.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to arthropod bite (bees and mosquitos).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick after she took both Moderna COVID-19 vaccinations.). At the time of the report, ILLNESS (sick after she took both Moderna COVID-19 vaccinations.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included neomycin-polymyxin, B-dexamethasone ophthalmic ointment.   This case was linked to US-MODERNATX, INC.-MOD-2021-036583 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-036583:
A non-serious spontaneous report of "administration of expired product" was received from a non healthcare professional concerning a 37-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Woke the next morning with pain in joints and chills. Took Tylenol 600 mg in am then again in late afternoon.  Next morning all gone.
Extremely dizzy and lightheaded, unstable when walking, felt loopy. This lasted over 24 hours. No medical treatment sought.
Blisters on mouth (2/23/15). Blisters in vaginal area (10/29/15).
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 75-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced feeling unwell, tiredness and pain. On an unknown date, the outcome of the feeling unwell, tiredness and pain were recovered/resolved. It was unknown if the reporter considered the feeling unwell, tiredness and pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient had SHINGRIX into left deltoid. The reporter stated that, (probably by) nightfall the patient started generally not feeling well, had achiness, and was tired for a couple of days after the vaccine. The reporter gave permission to contact their physician.
PT C/O METALLIC TASTE . PT STATES THIS HAS NEVER HAPPENED TO HER BEFORE WITH ANY PREVIOUS VACCINES OR MEDICATIONS.  NO VITAL SIGNS TAKEN PT WAS HYDRATED WITH GATORADE AND STABLE AT D/C FROM THE OBSERVATION SITE.
This spontaneous report has been received from a registered nurse via a field representative referring to a 11 or 12 years old female patient. Information about concomitant medication, pertinent medical history and drug reactions/allergies was unknown. It was also unknown if the patient received any other concomitant vaccines. On 29-AUG-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, dose detail, route, batch/lot #, and expiration date were not reported). On the same day (reported as 6 hours after vaccination), the patient began to experience nausea and vomiting. On an unknown date, the patient had been taken to unspecified emergency room due to the adverse events. The patient had been seen back in a pediatric office and consulted with an unspecified gastroenterologist. The patient had tried unspecified anti-nausea medications. As it reported, the symptoms persisted until the time of this report (not recovered). The causality assessment was not provided.
C/O  localized redness, itching, swelling which spread down R arm with progressive worsening.  No shortness of breath.  Given 50 mg IM BENADRYL per Dr.
I had a sore throat and cough. I took a home test and it was positive for COVID-19. I also went to the ER to get tested and it came back positive for COVID-19. The ER prescribed me Paxlovid.
11-9-13 back and leg pain over all weakness. Tingling and 7AM numbness feet and hands shortness of breath 11-19-13 admitted low sodium and facial weakness 6 PM 12 -19-13 admitted after spinal tap 5 PM with Guillain Barre Syndrome, given 5 days of IVIG 12-24-13 Inpat. Rehab 5 PM sent home 12-31-13 noon to continue w/ therapy.
Terrible taste immediately following injection.  My tongue  and lips felt weird and tingle sensation in my head and body.  Tiered, nausea, chest pain, indigestion and a burning sensation in my stomach.
5/19/2021 Large lump on posterior of head at neck base appeared on left side followed by an additional lump on right side. That night, small, red, papular rash appeared on face and has spread to cover torso, arms, and hands.
I received the Moderna shot and immediately had site pain in my right upper arm.  Site pain increased in my right upper arm and the width and severity of the site pain increased as well.  I lost range of motion in my right arm almost immediately after the injection and began experiencing pain in my shoulder within 2 months after the injection.  It is the end of August and the pain has persisted and I have loss of range of motion in my arm.  The pain ranges daily from  severe.   To more moderate but more recently has been severe.  The pain has now spread to my upper middle back and neck area.  I have daily headaches multiple times per day.
I had redness and warm ness and some swelling at injection site about 7 to 8 hours after vaccine. That is when I first noticed it. I thought it would go away in a few days, but there is still a red area and itchiness where the vaccine was administered 2 weeks later. I have let a health care provider at a walk in clinic look at it and he said it was just a histamine reaction and that it was odd to have lasted so long, but he thought it was okay and just take time to go away. I have taken Claritin and Benadryl once a day. I am breastfeeding so I do not want to take a lot of an anti-histamine.
Developed severe vertigo starting 36hr after vaccine administration.  Could not rise from seated position.  Took meclizine 25mg q6h x 3 days. Was most severe for about 36 hours. Resolved after approximately 3 days.
CLIENT RECEIVED VACCINES TDAP, HEPATITIS A, MMR, AND POLIO. 10 OR 15 MIN AFTER VACCINATION CLIENT'S MOTHER COMES BACK FROM ANOTHER AREA INTO THE LOBBY AND SEES HER DAUGHTER'S WAS UNRESPONSIVE, EYES CLOSED, BODY SHAKING ALL OVER.  CALLED FOR A NURSE AND NURSE ARRIVED.  CLIENT STILL UNRESPONSIVE WITH EYES CLOSED SITTING IN A CHAIR AND BODY STILL SHAKING EVERYWHERE.  ONE MIN LATER CLIENT STARTED TO GRADUALLY OPEN EYES AND BREATHING RESUMING BACK TO NORMAL.  VITAL SIGNS TAKEN AND STABLE.  PATIENT PALE IN COLOR AND HEAVILY PERSPIRING AND STATED SHE WAS VERY HOT.  WAS PLACED IN WHEEL CHAIR BY NURSE FOR SUPPORT AND MOVED TO ANOTHER ROOM AWAITING THE AMBULANCE TO GO TO MEDICAL CENTER.
12/13/86 - received spv, yellow fever, typhoid, and flu vaccines. On that day after the vaccinations, gradually started to feel "exhausted and weak" - had the onset of progressive n/v, inability to swallow, and fever (temp not taken) - also developed rapid onset of swelling to the left upper arm (where the spv was given) along with rash (initially noticed on chest, pt. does not remember if pruritic) - rashes spread to bilat arms (majority on chest) - "looked like mosquito bites" - above sxs worsened. 12/14/86 - went to ER - was initially dx'ed with "cellulitis from the site of immunization" - was admitted (r/o sepsis) for the following 4 wks - positive staph and increased cold agglutinins titer (doubled from 1:32 to 1:512) - above successfully treated with IV antibiotics - dx at clc "bacteremia secondary to staph secondary to possible Inoculation Immunization" - echo "no evidence of vegetation".  6/23/09 Medical records received DOS 12/13/86 to 2/4/05. Assessment: Sepsis with diffused rash temporally associated with receipt of vaccines. Patient presented feeling exhaused and weak. Nausea, vomiting, inability to swallow, fever, swelling of left upper arm (site of smallpox vaccine), rash on chest and arms. Cellulitis from site of immunization. Bacteremia staph secondary to possible innoculation immunization. IV antibiotics. ICD-9 codes: 401.9, 780.7, 782.1, 790.7
Swelling erythemia injection site deltoid region. Vesicular rash dermatomal.
10/19/05: Mom called PCP re swelling on L leg the size of a quarter at site of vaccines had increased to double that size.  Instructed to use ice and tylenol.  10/27/05: Mom called PCP child's tummy not feeling well. 11/7/05: 2PM PCP office visit. Both of child's thighs have large blisters with welts on L thigh.  PCP states contact dermatitis inner groin due to new diaper wipes.  Instructed to stop using new diaper wipes. 11/7/05: 7:30 PM Mom called stating rash spreading to eyes, face and going down neck, child fussy.  Instructed to go to ED. 11/7/05: ED physical exam states vital signs stable. afebrile. Does not appear ill. ENT: Oropharnynx: Clear. TMs and throat clear. Neck supple. Lungs: clear.Cardiac: regular rate and rhythm. Skin: diaper area-type rash, but well peripheral to this there are also some separate and distinct-appearing urticarial plaques out on the lateral thighs. Similar urticarial plaques can be noticed on the back of the neck. No vesicles, pustules or drainage or discharge.  No petechiae, prpura.  Assessment Urticaria.  Given Benadryl x 1 in ER Resume old wipes and eliminate the new wipes. Benadryl as recommended at home.  FU with doctor.
Minutes after receiving  vaccines, the child vomited, stated she  feels funny in her legs and c/o body aches.  School personnel called her mother.  The mother picked up child and stated she would take her to the ER.
Hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JAN-2023 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter had asked that if he/she could get a reaction or hives two weeks after the first shot. Additional supportive information: Follow-up would not possible, as no contact, details were available.
feverish; chills; neck pain; Bad headache; patient had not been feeling great; sick; This is a spontaneous report from a contactable consumer (patient's Mother). A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included headache. The patient's concomitant medications were not reported. It was reported that patient took the first dose of the Pfizer Covid vaccine and developed feverish and chills, and neck pain are these symptoms, should he take the second dose our doctor told us his opinion, but reporter want to know about company. Caller reported that her youngest son, the patient, had the Pfizer Covid-19 vaccine last week. Caller reported that the patient had not been feeling great and that the patient had been sick with something a few weeks prior. Caller reported that she thought that the patient called his doctor and the patient's doctor informed him that he was ok to receive the Covid-19 vaccine. Caller reported that after the patient had the Covid-19 vaccine, he woke up the following morning with chills and a bad headache. Caller reported that the patient gets headaches but said that the headache he got after the Covid-19 vaccine was the worst. Caller reported that the patient's headache went away and then went into his neck. Caller reported that the patient became feverish. Caller reported that the patient would get up, go to work, and then come home. Caller reported that the patient experienced side effects for 2 days in a row after he received the Covid-19 vaccine. Caller reported that the patient played basketball after he got the Covid-19 vaccine, which he normally did not do, and that her son physically exerted himself. Caller reported she does not know if the patient had Covid-19 when the patient was sick a few weeks ago or what might have caused his illness. Caller reported that the patient received his first dose of the Covid-19 vaccine and now he was going to need the second dose. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Extreme weakness - had to go down the stairs on my bottom, resting every other step.  Dizziness Frequent urination - every 20 minutes throughout the night Intense lower back pain throughout the night that stopped in the morning.  Hypersensitivity Regular flu like symptoms - chills, aches, hot/cold, tired, no appetite Extreme symptoms were better by the morning. Flue like symptoms remained throughout the next day
13 yo male developed pain, redness, and swelling in right arm the morning after receiving a varicella vaccine. Seen in office 9-14-07 with 4 1/2 x 4 1/4 in red, warm, swollen upper arm. Apply cool compresses and give Ibuprofen.
All the info that I have is that he tested + for covid 1- 12- 2022 and deceased on   2-  11  2022.
Received spray vaccine 10/8/09-Reaction 10/15/09. Rash on face, ears, neck, stomach,arms, legs. Hands, feet face and lips were very swollen. Became horse, constantly clearing throat. Two days later immediately after rash cleared came down with flu!
HCP office to report a temperature excursion for GARDASIL 9/ One GARDASIL 9 vaccine was administered to a patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.       On 07-JAN-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637651 was confirmed to be valid, expiration date 09-JUN-2022, 0.5 milliliter (vaccine schedule, route of administration and anatomical location were not provided) for prophylaxis.   The temperature excursion was 14.99 Celsius degrees (C) for 2 hours and 15 minutes. There were no previous excursions reported. The digital data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received form an RN concerning a 63 year old white female with allergies to codeine and Amoxil who on 23OCT2003 at an unknown time, was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. On 24OCT2003 the pt developed right arm redness and pain. The pt recovered form right arm redness and pain on 26OCT2003. There were no lab or diagnostic tests performed.  The pt was not ill at the time of vaccination. It was noted that the pt did not have adverse events following prior vaccination. No additional information is expected. The RN also mentioned that three other pts who had similar experiences following vaccinations with dose of pneumococcal 23v polysaccharide vaccine.
After getting the booster I was a bit fatigue on Friday night, Saturday night I went to sleep at 10pm and woke up at 12noon. Around that same night and noticed my arm was hot, and hard.
I have a history of fever blisters and have infrequent  flare ups during or after illness or in times of stress or too much sun. I got a fever blister on my lip on Friday following my vaccine the Tues before. Not sure if they are connected but wanted to report.
17 year and 11 month old patient was just given menactra, previous dose was 07 jul 2018, and the first dose was in 2013; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 17 years 11 months old patient (unknown gender) who received three doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Menactra] (route and site of administration, dosing details, lot number, exp date not reported) in 2013, on 07-Jul-2018 and on an unknown date (just given) respectively.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was as an actual medication error case due to extra dose administered.   It was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested  List of documents held by sender: none.
pt recv vax & devel swelling @ the inj site;the swelling was described as a wheal which extended down the arm;pt exp chills & nausea;