chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine squirted out; Caller believes it was faulty needle; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (vaccine squirted out), NEEDLE ISSUE (Caller believes it was faulty needle) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced UNDERDOSE (vaccine squirted out), NEEDLE ISSUE (Caller believes it was faulty needle) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (vaccine squirted out), NEEDLE ISSUE (Caller believes it was faulty needle) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No Concomitant medications were provided.  It was reported that patient received Moderna Covid Bivalent booster the new one and when they entered the needle into the patients arm the vaccine squirted out.   No treatment medications were provided.
Pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Uterine dilation and curettage on 04-Nov-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 20-Jan-2021 to an unknown date for an unknown indication.    On 02-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 13-Oct-2021. On 02-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 02-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The pregnancy history of the patient included  a terminated pregnancy on 15 Oct 2020. The patient doesn't have any complications or acute illness during the pregnancy. No prenatal care has been established. The patient doesn't have any chronic or long standing health conditions.The patient doesn't have any record of substance abuse. On 03 Feb 2021, the patient had a positive pregnancy test and the estimated date of conception was on 17 Jan 2021. No treatment information was provided.
Information has been received from a third party claims administrator on behalf of a pharmacy concerning a male patient, who on an unspecified date was vaccinated with PNEUMOVAX (lot # K007772, expiration date 01-MAY-2015 and also reported as lot # K0077773) on the right deltoid muscle. On 17-SEP-2014, the patient sustained on the right arm swelling of the area, itchy, redness, warmth to touch and fever. Treatment and outcome of the adverse event were not reported.  Information has been received from a claims representative via an email who reported an anonymous male patient of unspecified age was injected 1 PNEUMOVAX (lot # K007773, expiration date 01-MAY-2015) (also reported as lot # "K0077773') on the right deltoid  muscle. Claimant sustained on the right arm swelling of the area, itchy, redness and warmth to the touch and fever. On 10-OCT-2014, a call was made to the claims representative to verify the lot number as two different lot numbers that had been reported in the case of "Lot # K007773 with an expiration date of 01-MAy-2015" and "lot # K0077773, expiration date 01-MAY-2015 has been accepted as a valid lot #). Neither of the lot numbers which had been originally reported in the claim were correct (conflicting information has noted above: lot # K007773, expiration date 01-MAY-2015 has been accepted as a valid lot #). No further AE information was provided. Additional information has been requested.
Child received Tdap and Flu vaccine on Left deltoid and then MCV4 on Right deltoid. Student suddenly turned pale, lightheadedness (Child fainted and was not verbally responsive for a few seconds), noted slight bilateral upper extremity stiffening. Child began to have slight breathing difficultly. Child was positioned in Trandelenburg and provided a comfortable and safe environment.  Vital signs indicated BP 100/60 at 11:05 am, pulse of 100, RR 14. At that time Epinephrine and Benadryl were administered per protocol.  EMS was called.  School Administrators were notified of situation.  School personelle notified parents. Paramedics arrived and took over care.  Medical Director and District Nursing Services were notified of event.
Burning upon injection, soreness at injection site several hours later, pain awakened pt in the night, mental confusion and dizziness in the night continuing into the next day, redness and swelling and continued pain at injection site.
Chills and headache; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills and headache) and HEADACHE (headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced CHILLS (Chills and headache) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form every eight hours; ACETAMINOPHEN at a dose of 1 dosage form every eight hours and DEXAMETHASONE at a dose of 1 dosage form. At the time of the report, CHILLS (Chills and headache) and HEADACHE (headache) outcome was unknown.            Reporter did not allow further contact
Severe injection site pain, severe body aches lasting greater than 24 hours,  tachycardia, severe chills and blue nail beds followed by temperature of 101.7. I was unable to work the next day due to fever and severe body pain that limited my movement.  Ibuprofen was taken twice with little impact.
A red ball swollen, it's warm on the site; Red ball swollen, it's warm on the site; Tingling; Numb; Tingling on the arm; Pain in the arm; Red spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (A red ball swollen, it's warm on the site), PARAESTHESIA (Tingling), HYPOAESTHESIA (Numb), PARAESTHESIA (Tingling on the arm) and PAIN IN EXTREMITY (Pain in the arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced PARAESTHESIA (Tingling). On an unknown date, the patient experienced VACCINATION SITE WARMTH (A red ball swollen, it's warm on the site), HYPOAESTHESIA (Numb), PARAESTHESIA (Tingling on the arm), PAIN IN EXTREMITY (Pain in the arm), RASH MACULAR (Red spot) and VACCINATION SITE SWELLING (Red ball swollen, it's warm on the site). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (A red ball swollen, it's warm on the site), PARAESTHESIA (Tingling) and VACCINATION SITE SWELLING (Red ball swollen, it's warm on the site) outcome was unknown and HYPOAESTHESIA (Numb), PARAESTHESIA (Tingling on the arm), PAIN IN EXTREMITY (Pain in the arm) and RASH MACULAR (Red spot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Initial unsolicited misuse report received from a nurse on 21-Sep-2016. This case involves a five-year-old male patient who was vaccinated with first dose of FLUZONE QIV (batch number: U5309AA, expiry date: 30-Jun-2016, dose, dose in series was not reported) via intramuscular route in the right deltoid on 16-Sep-2016. Previously the patient had no known allergy and had medical history of asthma and ectopic dermatitis. Previous medications included albuterol inhaler and topical hydrocortisone. Illness at the time of vaccination was reported as none. Patient's concomitant medication was not reported. On 19 September 2016, three days following the vaccination the patient's right arm became swollen all the way down arm, sore to touch, and warm to touch. The patient was seen in emergency room. It was a case of expired product administered. Lab data was not reported. Patient received benadryl and oral steroids as corrective treatment. The outcome for the events was reported as not recovered. List of documents held by sender: none.
pt recvd vax 4APR94 & exp low grade temp, irritability, shaking per mom, wouldn't eat; no URI sxs present;
Pain in left arm, and headache. Pain in back on 11/13/21 and then 11/14, dull and sharp pain shooting from left hip to left knee and back to hip.  Pulsing and constant regardless of position.  Morning of 11/15, Monday, continuing and for the entire day.  With activity, more intense pain.  Pain still in the LEFT. She started texting me to let me know the pain was intense.  Notified clinic via email about the adverse reaction.  Spoke with Nurse about the situation on 11/15 but no clinic visit.  Pain subsided on the 16th and 17th of November it was gone.
Patient developed hives within 5 hours of administration on bilateral arms and chest and then developed a feeling of shortness of breath and tachycardia rate of 108.  Patient was given 40 mg Solumedrol IM in the office. Given 0.3 mg IM epinephrine by EMS and taken to the ED for further evaluation, where she was given oral Benadryl and Pepcid for full anaphylaxis prevention treatment and monitored for approximately 2 hours and then discharged to home in stable and improved condition.
horribly sick w flu; double ear infections; major sinus infection strep throat; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to case 2020SA306302, 2020SA306301, 2020SA306304, 2020SA306305, 2020SA306306, 2020SA306276, 2020SA306293, 2020SA306294, 2020SA306295, 2020SA306296, 2020SA306297, 2020SA306298, 2020SA306299, 2020SA306300 and 2020SA306303.  This case involves a patient of an unknown age who was horribly sick w flu (illness), double ear infections (ear infection) and major sinus infection strep throat (sinusitis), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient was horribly sick w flu (illness), double ear infections (ear infection) and major sinus infection strep throat (sinusitis).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
never came back for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose was received 2.5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never came back for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 Pharmacist reported a patient received her first Shingrix dose and never came back for the 2nd dose. The Vaccine Administration Facility was the same as Primary Reporter. Healthcare professional did not have date of birth for patient and did not ask about follow-up but pharmacy address was in healthcare professional details. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details provided corresponding to the 1st dose.
expired dose of Daptacel was administered to a 15 months old girl with no AE; Initial information was received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received a 0.5 mL dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number- C5254AA, Expiration date- 18-SEP-2019) via intramuscular route in the right thigh on 11-Feb-2020 for prophylactic vaccination.  Past vaccination included a dose of PEDIARIX at 2, 4, and 6 months of age.  Medical history, past medical treatment and family history were not provided.  Concomitant medications included HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) for prophylactic vaccination on 11-Feb-2020.  It was a case of actual medication error case due to expired vaccine used.  Nurse reported that an expired dose of Daptacel was administered to a 15 months old girl this morning. She states that she drew vaccine up into a syringe, another nurse administered it. They did not notice the expiration date until after administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
A couple of days after my third Moderna vaccine I developed a painful area and tingling on my skin on my left lower stomach area and left lower and mid back area.  I then developed red spots that became very itchy and painful.  By Friday October 15 tiny blisters appeared.  I sent photos to my doctor on Saturday and on Sunday he called in a 7 day course of antivirals called Valacyclovir, 1000 mg 3 times day.
Pt recvd measles vax/DTP/OPV/PPD & 15 to 20 min following vax pt devel stuffy nose, watery eyes & felt very uncomfortable; pt to ER & tx unspecified nasal spray & adrenalin; pt recovered;
p/vax pt devel large hive over the site. pt felt fine. area red & warm. treated w/ice the swelling went down
Diffuse complaints of joint and muscle pain and stiffness. Onset 2 days after receiving Gardasil.
This spontaneous report was received from a physician via field representative refers to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date a couple of years ago, the patient was vaccinated with ZOSTAVAX (dosing details not provided). Physician reported that an unspecified time after vaccination, the patient developed a small rash on an unspecified location of the body, which might had been shingles. It was reported that the patient healed from the small rash. Outcome of the event was reported as recovering. Reporting physician had not assessed the causality of the event with respect to ZOSTAVAX. Additional information has been requested.
35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant product use was reported. Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. It was unknown if patient experienced any symptoms after getting the vaccine. Treatment information was unknown.
Vaccine was administered SQ instead of IM patient sis report pain and redness at the injection site the following day.
Day 1: 2 fleeting headaches Day 2: Vertigo for24 hours, fatigue, loss of appetite, body aches, had to lay down most of the day Day 3: all teeth ached Day 4: eyesight distorted Day 5: eyesight distorted, loss of hair when washed Day 6: 2 headaches, not terrible but tylenol did not stop either, smell distortion Day 7: one headache, not terrible Day 8: back to normal Note:I had covid and experienced few symptoms: minor fatique, loss of smell and taste, hair loss, and 4 terrible headaches the likes of which I never have had. I was tested in January and had them
expired diluent of the vaccine was administered to a patient with no reported adverse event; Initial information received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who experienced expired diluent of the vaccine was administered with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Apr-2023, the patient received a 0.5 ml (total) (dose 2) dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of lot UJ667ABA (diluent expiry: 07-Apr-2023) via intramuscular route in unknown administration site as immunization.  On 20-Apr-2023, the patient developed a non-serious event expired diluent of the vaccine was administered to a patient with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired diluent of the vaccine was administered to a patient with no reported adverse event.   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 the 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.
Tightness in throat, dizziness, Neck pain, Headache and high blood pressure.  She states she has continuing HTN  146/80 "Never had before", nausea, ,headache and neck pain; working with Dr., PCP in a state who is listed as a contact on prior page.
Narrative:  Patient received two doses of covid vaccine. Died approx. one month later. Unclear cause of death and no further reports of death documented. Patient with PMH of HFrEF, NSTEMI, COPD,CKD, AMS, HTN.
pt recvd vax 2SEP93 & 3SEP93 devel redness @ the inject site which measured 4" in diameter & was warm to touch; c/o of being sore;
Fever; swollen and painful joints (knees;  wrists; fingers). Nausea. Headache
Patient called on 8/17/17 reporting raised red itchy area at vaccine site in the diameter of a "fifty cent piece". She reported that the itching was much more severe earlier in the day but had since lessened. Patient was instructed to apply ice to the affected area and potentially take tylenol of appropriate symptoms presented.
03/30/2021 @ vaccine drive though safe room site-pt received 2nd dose Moderna vaccine in left deltoid. Approx. 5 minutes after vaccination @ 10:15am, pt reported tightness in throat, chest pressure heart and palpitations. EMT assessed pt obtained v/s -b/p 144/78, P 64 o2sat 96% Pt was observed for 15 minutes after given Benadryl25mg po nurse  Pt stated that she felt " a little better" left side. Pt stated she had a history of hypothyroidism and A-Fib
vaccine administered to 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 15 year old). On 14-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 15 year old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown.
Patient administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2022 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Feb-2022 at 8:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine). On 08-Feb-2022 at 8:45 AM, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No Treatment medications were reported.