chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Infanrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th December 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Infanrix, which led to expired vaccine used.
The adverse events that occurred after this vaccination include the following: Severe headache, vision issues (i.e., loss of clarity, focus), muscle aches/cramps, chills, stomach/abdominal discomfort, upset stomach, loss of taste, loss of smell, sore throat, swelling of lymph nodes (underarms, groin region, and behind the ears), tiredness / loss of energy, and nasal congestion.  The most adverse event, a headache, led to some dizziness, loss of clarity/focus (vision), and pain behind the eyes.  The only treatment taken to lessen the severity of these events were acetaminophen and ibuprofen.  The adverse events still occurring today are (as of now 04/14) include: stomach discomfort, muscle aches/pains, and discomfort under the arms (armpit area) near lymph nodes.
Nurse stated here were no additional AE's.; Nurse stated that the PNEUMOVAX 23 (prefilled syringes) had been administered to 2 patients since undergoing the temperature excursion.; This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.     On 02-MAR-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number reported as T031820, has been verified to be a valid lot number, expiration date reported and established as 10-MAY-2022) as prophylaxis (product storage error).  The administered dose of the vaccine was stored in a temperature between 2 degrees Celsius (C) to 8 degrees C (9.3 degrees C) for 4 hours, 40 minutes and 0 seconds, and then at -1.6 degrees C for 1 hour, 20 minutes and 0 seconds. There was no previous temperature excursion reported and no digital data logger was involved. No adverse events were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T031820; expirationdate: 10-MAY-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; Sender's Comments:  US-009507513-2103USA001865:
None- vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient was given vaccine 13 days post expiry No treatment medication information was provided   This case was linked to MOD-2021-395985.
FATIGUE, NAUSEA, MUSCLE PAIN, CHILLS, ANS SORENESS IN OTHER BODY PARTS.
Information has been received from a physician concerning a 5 year old female with no known allergies or past medical history who on 21-DEC-2001 was vaccinated in the left thigh with a first 0.5 ml dose of Varivax (lot#638931/1144L). Concomitant vaccination included a first dose of MMR. There was no illness at the time of vaccination. On 30-JUL-2006 the patient developed right chest and back pain. On 31-JUL-2006 the patient developed a painful polyvesicular rash with dermatomal distribution on her anterior and posterior trunk, which was noted to be herpes zoster. The patient rated her pain at 8 on a scale of 0 (LEAST)-10(most). Maximum temperature was 98.3 F. It was reported that the patient has not had a recent exposure to chickenpox or shingles. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the vaccine VZV strain. On 01-AUG-2006 the patient was seen by the physician, specimens were obtained from vesicles on her anterior and posterior torso, and sent for PCR analysis and it was found to be vaccine strain, previously reported as wild type strain. It was reported that VZV DNA was amplified but that B-globin DNA was not amplified. Subsequently, the patient recovered. It was reported that there was no adverse events following prior vaccination with the patient or her siblings. There was no product quality complaint involved. Additional information is not expected.
Inflammation of right eyelid. On the evening of receiving the vaccination, the right eyelid showed minor swelling/inflammation. The inflammation increased on Monday, including the eye producing excess fluid during the night. Monday I visited an outpatient clinic of my GP and was prescribed antibiotic drops for the eye and instructed to apply a warm compress twice a day. During Tuesday/Wednesday the eyelid was inflamed to the point where opening it was difficult and it was not easily possible to see out of it. Thursday the eyelid was back to the level it was at on Monday, and Friday/Saturday it was back to a minor inflammation. As of Tuesday evening (9/13), there is still a minor inflammation of the right eyelid.
office visit 5/16/2021- left leg swelling along with erythema along with increased vascularity, no warmth or tenderness, full ROM office visit 5/19/2021- left leg purple and swollen, basic CBC done in office was normal office visit 5/30/2021- left leg cellulitis, given Augmentin 400mg/ml 2.5ml BID x 10 days, sent for bloodwork (CBC, EBV, CRP ), sent for X-Ray & Ultrasound, refer ortho ; parent informed us they "saw PA, at Dr.'s office,  who  rubbed and massaged leg for 30 seconds and child was screaming whole time" office visit 6/1/2021- leg still swollen, parent advised to take patient to ER for be evaluated.
Initial report was received 20 July 2009 from a consumer in the country, who is also the patient. A 50-year-old female patient with a history of a stray cat bite, had received a left deltoid injection of Tetanus Toxoid (manufacturer, lot number and route not reported) at 15:00 hours on 11 July 2009 for wound management, and at approximately 18:30 hours, she became itchy on her abdomen and under her breast area. She also developed hives, and her face, mouth and hands turned red with a burning and stinging sensation. Her mouth and throat felt swollen and her throat felt like it was locked. The patient was prescribed a Z-PACK antibiotic on the day of the event, which she started taking an unspecified amount of time prior to the event onset. The patient was treated by emergency services and was taken to the hospital at which time she received BENADRYL and steroids. The patient was kept for observation and then discharged. The patient was instructed to continue taking oral BENADRYL and was prescribed a MEDROL PACK which she never had filled. Her diagnosis had been possible acute allergic reaction. The following day, on 12 July 2009, she was seen at a walk-in clinic due to persistent symptoms; no additional treatments were prescribed. On 13 July 2009, she went to the hospital with the same symptoms and left sided muscle pain that extended from her shoulder to her throat. She was given TORADOL and morphine for pain and kept for observation until 14 July 2009. The patient's last tetanus vaccination had been 10 -12 years ago. Per the reporter, she could not remember having this kind of a reaction after receiving a tetanus vaccine in the past. The patient had a past history of seasonal allergies, asthma, sinus problems, cardiac arrythmias and allergies to dust, latex, nickel, penicillin. She had been taking ZYRTEC, TOPROL XL, Albuterol inhaler and CARDIZEM concomitantly. At the time of the report, her recovery status was reported as unknown. Documents held by sender: None
Headache developed 2 months and 9 days following booster dose.  Migraines started for the first time after the first dose in 1/21 and subsided within 5 months.  No significant symptoms following booster except for a migraine 60+ days later.  Went to see a neurologist to discuss medication management and received an MRI due to a new feature of the migraine that included loss of feeling on the left side of my face, which eventually subsided.
Pt recvd 1 doses of Engerix-B & 6 hrs p/inject had hives;
No adverse event; Patient received first Moderna vaccine dose on 05-Jan-2021 and second Moderna vaccine dose on 03-Mar-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine dose on 05-Jan-2021 and second Moderna vaccine dose on 03-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 010M20A and 030H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .25 milliliter. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine dose on 05-Jan-2021 and second Moderna vaccine dose on 03-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine dose on 05-Jan-2021 and second Moderna vaccine dose on 03-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine dose on 05-Jan-2021 and second Moderna vaccine dose on 03-Mar-2021).    No concomitant medications were reported.  On 23-Aug-2023, the patient received Pfizer bivalent Covid-19 vaccine (that was intended for use in patients having ages 12 and above of dose 0.3 ml given via intramuscular route in her left arm in the afternoon) that was 2 days past 10-week allowance in the refrigerator. It was given at 72 days and not at 70 days that was allowed, having it's in refrigerator beyond use date as 21-Aug-2023. Currently, patient had no issues. The patient did not receive the Moderna bivalent dose and was due for a bivalent dose.  No treatment medications were reported.
Pt called to report that she had a pink area about the size of a golf ball about two inches away from where she received the Shingrix vaccination on Friday 5/29.  She said that the area is warm and sore to the touch.  She had some stiffness in the shoulder on Saturday but didn't notice the pink area until today.  She said she was going to ice the area today and come to the pharmacy on Monday.  I informed her to call her Dr or go to the ER if any of the symptoms worsen.
ANXIOUS, RACING HR, TINGLING LIPS, SORENESS LEFT ARM. PT HAS HX ANXIETY AND PANIC ATTACK. HEALTH PERSONNEL AT SITE. PT WAS OFFERED HYDRATION AND FOOD, NOW C/O MUSCLE TWITCHING ON LEGS ARMS AND JAW. STATED HAD THIS SYMTOMS BEFORE, VSS, SYMPTOMS IMPROVED, REFUSED TRANSPORT, WILL GO TO HOSPITAL IF WORSEN.
Covid like symptoms the day after Thursday March 25, 2021, chils , fatigue, body aches , headache , tired.  On Monday March 29,2021 brain bleed led to stroke, woke up at 6 Am went to  ER by 10:30.  I have no health issues that would  be considered a precursor for a stroke
Vaccinator pushing the needle into the arm she was pushing on the plunger at the same time, so part of the medication went on his arm and the subcutaneous tissue into the muscle. with no adverse event, the full dose was not administered; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Regulatory Authority (under the reference 00838646).  This case involves a 47 years old male patient whom vaccinator pushing the needle into the arm, pushing on the plunger at the same time so part of the medication went on his arm and the subcutaneous tissue into the muscle (exposure via skin contact) and the full dose was not administered (underdose) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient had no other concomitant vaccines.  On 01-Nov-2021, the patient received a first dose of suspect FLUZONE QUADRIVALENT (total, once, lot UT7377LA and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid and 2nd dose were administered on unknown dates (lot number and expiration date not provided) via intramuscular route in right deltoid for prophylactic vaccination.  It was an actual medication error due to exposure via skin contact and underside (same day latency).  No adverse event was reported.  It was reported "Caller stated that they had an administration error involving FLUZONE QUAD PFS. the full dose was not administered to the adult patient. the vaccinator plunged the plunger before injecting the vaccine. she repeated the dose, but needs guidance for future reference. Caller states yesterday she was injecting a consumer and as she was pushing the needle into the arm she was pushing on the plunger at the same time so part of the medication went on his arm and the subcutaneous tissue into the muscle. Caller repeated the dose yesterday and called the Communicable Disease Center (CDC) to find out what to do."  At time of reporting, the outcome was Unknown for the reported events.  There would be no information on the batch number for the another dose.
Area around injection site is red, swollen, hot and itchy. It has a circumference of about 4 inches.
There was no relevant medical history. Concurrent conditions and concurrent medications were not specified. On an unspecified date, the vaccinee received an injection of LYMErix in his arm. On 11/30/01, an unspecified time post-vax, he experienced "mild" numbness of the arm. The numbness spread to his chest and down the arm to the fingers. The numbness resolved after "several hrs", w/out treatment. The nurse stated that she "probably hit his nerve to cause this reaction." She also indicated that the event was possibly related to LYMErix. The adverse event "numbness" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter. Comment: The nurse reported that she administered LYMErix lot LY1Y7F9; however, this is not a valid lot #.
after vaccine, patient felt very dizzy, and pale. she was sitting in chair. she was responsive and talking but patient's mother wanted us to call 911/. Paramedics took her vital signs and she was good.
Pt. states she experienced onset of fever, redness, soreness and general malaise. Reported to Clinic on 3/7/2012 with continued redness, soreness, on arm where TDAP was given. Fever was resolved aprox. 24 hrs. after injection.
enlarged lymph node to rt axilla-pt discovered on 4OCT98 recv vax 29OCT98;
Left arm paralysis and neuropathic pain eventually diagnosed as brachial plexus neuritis and treated with physical therapy, to date has not regained strength and range of motion proximal arm.
33 year old female with polycystic ovary syndrome and DM2 who received varicella vaccine 3/16/06 and presents 4/5/06 with complaint of fever, chills and rash on face, chest, back and arms x 3 days. Rash appeared vesicular and varicella like. Fevers/chills had resolved. No respiratory or neurological symptoms.
Client presented for her first COVID vaccine. She has severe allergies to fish, shellfish, tree nuts, Kelfex, Doxycycline, and red dye. These were reviewed. Vaccine given in right deltoid at 0925. Client was asked to wait in the building for 30 min. At 1000 client stated she was feeling light headed and having a, "hard time swallowing." 2nd nurse was then alerted and came to assist myself and the client. Client was taken into exam room and laid down immediately. 1000 Epinephrine 0.5 mg IM given in LD by 2nd nurse. 1002 B.P of client 182/145, pulse120. 1002 Clinic Secretary Called 911 phone given to myself to give report. 1006 Benadryl 1 mg given LD by 2nd nurse. 1010 O2 98% pulse 136. 1010 EMS arrived and report given. EMS left building with client at 1018. 1028 report given to Immunization Coordinator.
Expired Dose administration; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HBV (Engerix B) (batch number MN7XR, expiry date 18th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the Medical assistant. The reporter stated that, the patient received an expired dose of Engerix B, which led to expired vaccine used. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 45 years old female patient who experienced pain that radiated to left side of her back and then developed spine pain and local injection site redness, swelling and, pain, while she received vaccine ADACEL. The patient's no prior back pain history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity (allergies are to NSAIDs and acetaminophen). The patient had no concomitant medication. On 17-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5850AA expiry date: 17-Jan-2020 via intramuscular route in the left deltoid. On an unknown date, patient developed a non-serious pain that radiated to left side of her back and then developed spine pain Unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, patient developed a non-serious local injection site redness, swelling and, pain Unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Lab data was not reported. Final diagnosis was local injection site redness, swelling and, pain and pain that radiated to left side of her back and then developed spine pain. It was not reported if the patient received a corrective treatment. The outcome of event of local injection site redness, swelling and, pain was unknown at the time of reporting but the arm pain had left and event of pain that radiated to left side of her back and then developed spine pain was Not Recovered/Not Resolved at the time of reporting (however duration was reported as 01 month). Documents held by sender: none.
2/3 - 2/5/22 pt admitted to the Hospital with sepsis and COVID pneumonia; pt had a positive COVID test on 2/2/22; was dc'd to home feeling better; pt went back to the hospital on 2/9/22 with worsening dyspnea, dry cough, fatigue; hypoxic (77% O2 sat on RA); O2 given; transported to the medical center for further care; given IV Decadron and ABX; O2 demands increased; pt's condition worsened with hypotension, bradycardia, became unresponsive and pulseless; code blue called and pt passed away in the hospital; DC and med records sent to info@vaers.org per their request
Fever; Soreness at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Myalgia fatigue Narrative:  Employee reported moderate muscle pain 02/03/21, mild fatigue 02/03/21. Resulted in unable to work 02/03/21. Did not seek medical attention for the symptoms.  Other Relevant History:
9 days after vaccine, woke up with pain in left arm, swelling, rash, hot to touch, red.  Lasted 3 days and seemed to subside but then again flared up on 4th day.  By 6th day after symptoms, arm was better.
Pt was achy & feverish morning after and had low blood pressure 90/40. Then her arm became so sore she could not raise above mid body. Ibuprofen & exercise & time helped.
Localized reaction, hot, hard, raised, reddened area (approximately 2" in diameter) at injection site.  Slightly painful and itchy.  Did not occur until 8 days post injection.  No treatment required.