chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BORDERLINE HALLUCINATIONS; WEIRD DREAMS; LETHARGIC/WEARING OUT; SWEATING ORANGE/RUST; BODY ACHES/HURT TO GET AROUND; MUSCLE PAIN; HIGH FEVER/HOT TO TOUCH/ HOTTEST AS EVER BEEN; NAUSEA; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 18-JUL-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-JUL-2021, the patient woke up and felt lethargic and then felt worse as the day went on. Had high fever. He slept ate and drank. He had sweat all discolored, stained orange where he was laying. He felt like he had a feverish day yesterday, just recuperating. He was able to go to work today. Wearing out as the day goes on. Hot to the touch. He had Borderline hallucinations. He was hottest as ever been. He had weird dreams. Muscle and body aches. Hurt to get around yesterday. He was slightly nauseated. On 20-JUL-2021, he was feeling little lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating orange/rust, high fever/hot to touch/ hottest as ever been, and nausea on 20-JUL-2021, was recovering from lethargic/wearing out, weird dreams, muscle pain, and body aches/hurt to get around, and the outcome of borderline hallucinations was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210743423- Covid-19 vaccine ad26.cov2.s-Borderline Hallucinations. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date; No adverse event; received doses from the same lot number #015h22a administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date).    No concomitant medications were reported.   The vial size reported was 2.5 milliliter. The vial was initially stored in refrigerator on 01-Nov-2022. The vial did not undergo any temperature excursion.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-693246, US-MODERNATX, INC.-MOD-2022-693247, US-MODERNATX, INC.-MOD-2022-693248, US-MODERNATX, INC.-MOD-2022-693249, US-MODERNATX, INC.-MOD-2022-693250 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-693249:Original Case : MOD-2022-692559 US-MODERNATX, INC.-MOD-2022-693248:Original Case : MOD-2022-692559 US-MODERNATX, INC.-MOD-2022-693247:Original Case : MOD-2022-692559 US-MODERNATX, INC.-MOD-2022-693250:Original Case : MOD-2022-692559 US-MODERNATX, INC.-MOD-2022-693246:Original Case : MOD-2022-692559
Pt received GSK Influenza Quad Inj P Lot# 79XR9 on 10/05/2023 subsequently received an additional dose of the above vaccine at the school flu clinic on 11/02/2023. Parent erred in not notifying the school nurse the pt. had previously received vaccine on 10/05/2023. If that had been done the pt. consent form would have been pulled and this incident would not have happened.
The below narrative include initial information received from a non-healthcare professional on 19 September 2013 plus subsequent follow up: A 5-year-old female patient with no reported medical history had received a dose of FLUZONE intramuscularly (site and batch number, route and site of administration not reported) on 13 September 2013. On 14 September 2013, the patient developed 100.6 degree temperature and a red raised bump under the injection site. The bump was warm to the touch and itched for one week. Laboratory investigations and treatment medications were not reported. At the time of this report, the outcome of the events were not reported. At the time of this report, the outcomes of the events were recovered. List of documents held by sender: none. Additional information received from a non-healthcare professional on 19 September 2013: Dosing information for vaccine, event start and event outcome added. Narrative and relevant field updated.
1 week after vaccination administered, pt reports she noticed pruritus bilateral thighs with erythematous, warm, diffuse raised rash. Lower legs bilaterally with same rash, onset 4-2 - 4-3-14. She applied hydrocortisone cream without relief. She was seen in Health Services 4-14-14. Treated w/ loratadine 10mg and tepid bath with improvement.
Minor splotchy rash on chest and stomach 24hrs after first dose on 3/9/2021. Took Benadryl, resolved within 48 hours. Itchy, bright red rash all over body 24 hours after first dose on 4/6/2021. Took Benadryl for 24 hours then went to the doctor. She prescribed a a steroid to use if it didn?t resolve within the next 24 hours.
Neutrophils count are higher than normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUTROPHIL COUNT INCREASED (non-serious), outcome "unknown", described as "Neutrophils count are higher than normal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took the COVID vaccine and noticed had a blood test few weeks later which resulted neutrophils count were higher than normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Depo and Pneumovax 11/17/2020. A few hours later developed left arm soreness (side that received Pneumovax) and later became erythematous and unableto move left arm. 11/17/2020 developed tachypnea, fever and tachycardia. WBC 15.2, CX WNL, Imaging WNL, Admitted for SIRS and started on empiric ABX while waiting results. Discharged 11/20/2020 and made full recovery.   Number 21 will not let me enter hospital name: She was hospitalized for 2 days at Medical Center She received flu vaccine 10/26/2020. Type and brand unknown. Brand is not letting me enter
Mom noted a lump on leg where shots were given. Also noted lymphadenopathy bilateral groins. Decrease appetite.
fever of 103.5 for 3 night, fatigue, swollen lymph nodes in left axilla.  then HA, body aches and diarrhea.  Seen at Urgent Care prescribed Keflex
The patient presents with shortness of breath. 90 year old presents to ED from other area with concerns over sob. Per EMS, the pt's o2 saturation dropped to 85% PTA and the pt became noticeably exerting herself to breathe. Pt received steroids by EMS, with no significant relief.  The onset was just prior to arrival. Risk factors consist of coronary artery disease, congestive heart failure and hypertension. The patient is a 90-year-old female with a history of Chronic Obstructive Pulmonary Disease, CHF, coronary artery disease, chronic kidney disease that presented to the emergency department with complaints of shortness of breath.  Patient states she has had increased weakness, fatigue and shortness of breath over the past 3 days.  States she began running a fever yesterday and thought she may have COVID-19 so she was sent to the ED by her nursing home.   Notes cough and shortness of breath.  COVID-19 swab was not completed in the ED. currently resting in bed.  In respiratory distress.  On 4 L via nasal cannula with respiratory rate of 30.  She is on chronic home O2 at 2 L. moderate distress.  Unable to complete full sentences.  Respiratory distress
Standard muscle soreness at injection sight then bruises started to appear across my body. I had two appear the day I got the second shot and within 24 hours I had 7 bruises. Wednesday night (48 hours after) I counted 11 bruises. Two on injection (left) arm and most others in the left leg and a few on the right leg. Mostly smaller than a quarter and green in color. One very high on the upper inner thigh started as dark purple about an inch across.
I grew like a little bump on the bottom of the armpit, closer to the side of my heart.; It hurts when  moving; Hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot), MASS (I grew like a little bump on the bottom of the armpit, closer to the side of my heart.) and PAIN (It hurts when  moving) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced FEELING HOT (Hot). On 25-Jul-2021, the patient experienced MASS (I grew like a little bump on the bottom of the armpit, closer to the side of my heart.) and PAIN (It hurts when  moving). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Hot), MASS (I grew like a little bump on the bottom of the armpit, closer to the side of my heart.) and PAIN (It hurts when  moving) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
no adverse effect; patient was administered with improperly stored doses of GARDASIL 9; Information has been received from a physician referring to a 15 year old male patient. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On an unknown dates, the patient was vaccinated with improperly stored (Temperature: 47 Fahrenheit to 77 Fahrenheit; Time frame: 40 minutes) doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # M043731, expiration date: 22-JUN-2019; the dose and route were not reported) for prophylaxis on an unspecified after July 2017. No adverse effect reported. It was reported that there were no previous temperature excursion and there was a data logger involved.  This is one of the multiple reports received from the same reporter.
Developed rash and bubbles similar to poison ivy at sites on my body previously stuck by briars or insect bites. No effect at site of injection. Rash was quite itchy and put cortisone cream on. After about a week it seems to have started to dry up. Vaccine was received at a pharmacy, so no doctors visits were involved.
Initial report was received 12 November 2012 from a health care professional which involved a cluster of two patients. The other patient has been captured in case number 2012-10633. A 94-year-old female patient who had a history of allergy to sulfa and shellfish and no concurrent illness, had received a left deltoid intramuscular injection of FLUZONE, lot number UH752AB on 15 October 2012 and two days later, she developed shingles on her left arm, back, and on her left arm at the vaccination site. Laboratory and diagnostic data was reported as "none". The patient received treatment (not specified) and recovered. Documents held by sender: None.
Menactra, IPOL(unopened), and Tenivac. Caller stated that the temperature was 48.4 degrees Fahrenheit for 15 minutes.; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves three patient (with unknown demographic) who received dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6151AA (Expiry date 16-Mar-2020) and same vaccine  lot U6208AD (Expiry date 08-Jul-2020), DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6021AA (Expiry date 27-Jul-2020) and IPV (VERO) lot P1E701M (Expiry date 09-Nov-2020) via unknown route in unknown administration site. On an unknown date.  It is an actual medication error due to incorrect product storage.   It was reported that Menactra, IPOL(unopened), and Tenivac. Caller stated that the temperature was 48.4 degrees Fahrenheit for 15 minutes. Caller stated that the refrigerator's door had been left open for too long while pulling out vaccines for 3 patients..  It was unknown if any adverse event occurred.  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.  List of documents held by sender: none.
This spontaneous report was received from health care worker and refers to a 2 years old female patient. None known allergies, medical history and concurrent conditions were not reported. The office managers informed that on 23-MAR-2015 at 10:30, the patient was vaccinated with the first dose of MMR II HSA (lot# K020188, expiration date 22-OCT-2016) (strength and dosage were not reported) Subcutaneous, left arm reported as "high", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. The same day at the same time, the patient also received as concomitant vaccination the first dose of VAQTA (lot no. K02387, Expiration date was not reported) intramuscular, left (high). None illness at the time of vaccination was reported. No adverse effects were reported. None relevant diagnostic tests and laboratory data were reported. This is one of several reports from the same reporter. Additional information is not expected because all information required was received.
hives @ site of inj-also hives behind ears & cheeks;pt has had hive rxn from knee to thigh p/all DTP's;
Acute onset of 3-5mm raised red tender nodules with increased redness and swelling L lower leg - approx 6cm area - above ankle.  R lower leg few erythematous papules in same location but no swelling or tenderness.
Patient was due for Menveo vaccine, MA only gave MenCYW-135 Liquid Conjugate Component. Patient was re vaccinated with the full dose of Menveo.
This spontaneous report has been received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On 31-JAN-2017, the patient was inadvertently administered improperly stored ROTATEQ oral liquid, lot # M031807, expiration date 02-APR-2018 (dose was not reported). No adverse effects were reported. The vaccine experienced a temperature excursion of 50 Fahrenheit degrees (F) for 20 minutes, which was detected by a digital data logger. There was no previous temperature excursion. No product quality complaint was involved. Additional information has been requested.
achy, red ring and knot at injection site, chills, dizziness, headache and pressure in the ears and tired
pt recv vax 9DEC96 & 19DEC96 pt devel a rash w/lesions like dots on back, stomach & neck;the lesions were not like blisters or anything;MD determined that the rash was an allerg rxn to amoxicillin & did not mention vax to the pt mother;
Severe  Taste Metallic Smell Ammonia  Fatigue Dizzy Decongestant  Sore Throat
After teen was given the vaccine parent and staff reports that teenager slumped over on bed from sitting position with eyes open and was "shaking" for a few seconds. Mom reports teenager was limp and after the shaking teenager responded and was able to sit up. I immediately entered the room once I heard the screaming and teenager was awake and being held by mother.  Teen did respond to report he felt "tired" after getting the vaccine.  Teenager was sweating and was given water and monitored for 20 minutes after with a recheck of blood pressure which was normal. discussed with mother the information on VIS form including dizziness and fainting. Discussed teen appeared to have had fainting episode but concerns about possible seizure from the "shaking" was a concern of mother.
I woke up with severe pain in my neck and across my shoulder blades(upper back.) Not long after this, my Fit bit signaled a prolonged period of high pulse. My resting heart rate peaked over 135 and stayed about 110 for 6 hours.
Extreme fatigue, tiredness. Don't feel as tired but extremely fatigued since onset when walking for commute and exercising. I am extremely healthy and have been in great shape.
Patient developed a small, bumpy, red rash on her upper abdominal area,  and left neck/collar bone.
Patient developed shooting pains in body along with chills and 101 degree fever.  (no pain at injection site).
My period started on the expected day, April 1st 2021 and it has not stopped (15 days as of now) and is excessively heavy with extremely large clots every day. I have not yet seen a doctor as I do not currently have health insurance.
Fever; Muscle pain; Slight headache; Shivering; Joint discomfort (toes, neck, lower back) / Discomfort in Groin area; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th April 2021, the patient received the 2nd dose of Shingles vaccine. On 6th April 2021, 1 days after receiving Shingles vaccine, the patient experienced fever, muscle pain, headache, shivering and discomfort in joints. On an unknown date, the outcome of the fever, muscle pain, headache and shivering were unknown and the outcome of the discomfort in joints was not recovered/not resolved.   It was unknown if the reporter considered the fever, muscle pain, headache, shivering and discomfort in joints to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After second dose for Shingles vaccine, the patient experienced common side effects including muscle pain, slight headache, shivering and fever. However, the patient also experienced uncommon side effects such as joint discomfort (toes, neck, lower back) and discomfort in groin area. On the day of reporting, the patient was having infrequent joint discomfort while walking.
PATIENT HAD ITCHING AT THE INJECTION SITE FOLLOWING THE FIRST DOSE AND WAS STARTING TO ITCH IMMEDIATELY AFTER ADMINISTRATION OF THE SECOND DOSE (TODAY). NO RASH OBSERVED. OFFERED PATIENT LIQUID BENADRYL AND SHE ACCEPTED. GAVE PATIENT 10ML OF BENADRYL 12.5MG/5ML WHILE SEATED IN THE OBSERVATION CHAIR. PATIENT DRANK WITH NO ISSUES AND DID NOT COMPLAIN OF ITCHING AFTER ADMINISTRATION.
Pt was given RSV vaccine per request for immunocompromising conditions, however is only 59 years of age
administered an adult dose of Havrix to a 4 year old patient; administered an adult dose of Havrix to a 4 year old patient; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 4-year-old female patient who received HAV (Havrix 1440 adult) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were 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 as follows: The medical assistant reported that, she administered an adult dose of Havrix to a 4 year old patient, which led to adult product administered to child and overdose. The reporter consented to follow up via postal address.  No further information was reported.
Describe the event or problem:  Our hospital has been monitoring events related to vaccine administration and syringe failures. Over the last month, we have received 1 vaccine related equipment failure events. This has occurred while the vaccine was being prepared or during administration. Failures note that the syringes appear to have cracks in or around the hub and medication has leaked out. Example of event: "While getting the medication ready to administer the hub cracked and the influenza vaccine leaked out." "There is a faulty connection between the standard influenza vaccination and needle. Vaccination leaked out where needle screws onto the syringe." Our organization is aware that crossed threaded or over tightened Luer locks can leak or become disconnected. Our organization is waiting to hear back from both manufacturers on next steps.  ----------------------------------------- What was the original intended procedure? " Med. administration -------------------------------------------- What problem did the user have (Check all that apply)  :Device failed (e.g. broke, couldn't get it to work or stopped working)  ;