chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in an 18-month-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    Concomitant medications were not reported.  This case was created for patient 11 out of 17 patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live significant follow-up received contains Patient demographics updated On 28-Feb-2023: Follow-up received contains no new information On 28-Feb-2023: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
This initial spontaneous report was received from a nurse referring to three unspecified patients of unknown age and genders. Pertinent medical history, rug reactions/allergies and concomitant medications were not reported. The reporter stated that on unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L038501 with expiration date 16-AUG-2018 or lot # L051122 with expiration date 12-OCT-2018; the dose, route and anatomical location were not reported (the nurse was unable to tell which lot # was administered). The vaccines underwent a temperature of 8.8C during 40 minutes with an "outcome" reported as "supported". No adverse effect was reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. Additional information is not expected as the reporter did not wish further contact.
Immediately after receiving her vaccination, she developed lightheadedness, nausea, and felt like she was having a recurrence of a panic attack. She does have a history of aversion to needles. She was taken to a private section and monitored. Her vital signs are within normal limits. She also developed tingling in bilateral hands. She was monitored and her symptoms resolved.
Pain at injection site (4-36 hours following injection) - subsided after 36 hours Dizziness (7 hours following injection) - subsided within a few hours Found lump above my right collarbone, accompanied by muscle pain on right side of neck, beginning 6 days after vaccine and continuing through today - saw primary doctor regarding lump & pain the day after it began (4/16/21) - ordered ultra sound but couldn't schedule until 5/4/21 - as of today, 4/24/21, the muscle pain has intensified and a cord-like structure is prominent at the surface, also with pain, in addition to a headache and fatigue
Rt. arm shows swelling from the superior aspect of the deltoid down to her elbow with erythema spreading in the same area and half way around her arm as well. Antibiotics were started.
sore arms; rash on neck; nauseated; dizzy; This is a spontaneous report from a contactable consumer (patient) received through reporting system. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history was, and concomitant medications were not reported. On an unspecified date in 2021, After the first dose the patient experienced sore arms, after a few days she got a rash on the neck, feeling nauseated and dizzy intermittently. The event outcome was Unknown.  The second dose scheduled on 10Apr2021.  Medical Information:  Were any unaddressed medical questions referred or forwarded to Medical Information? No
Patient given a pediatric strength and dose of the Pfizer COVID 19 vaccine. Due to her age she should have received the adult strength and dose. No adverse effects noted after injection. No treatment done.
Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The patient was administered with booster dose.
Pt reported upset stomach, nausea, and diarrhea that developed 10/16/19 after vaccine administration. Starting 10/17/19, patient developed swelling/redness that "looked like bruises" extending from her shoulder to elbow. On 10/28, patient reported a new rash developing on her chest area.
After 3 weeks of getting the vaccine, I developed a blood clot in my arm and severe swelling.
severe pain at the injection site; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.       On an unknown date the patient experienced injection site pain.    The outcome of injection site pain is unknown.        This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA006344: US-009507513-1912USA006286:
I had a heavy minstrel cycle and I felt very fatigue and had chills and a high fever. My body was aching  from 2am-10pm.
Pt reported Hives to vaccine on 5/24 while in ER for abdominal pain.  Timeframe for the development of hives post vaccination is unclear.  First dose of Moderna 4/16.  Pt was in ER for gallstones on 5/6.  Second dose of Moderna on 5/14.  Pt returned to ER on 5/24 for recurrent abdominal pain.
This is a spontaneous report from a contactable Consumer via Pfizer sales representative. This Consumer reported for an 18-year-old male patient (Consumer's Son). It was reported that a 18 year-old male patient received TRUMENBA intramuscularly in the arm on an unknown date at single dose for immunization. Patient medical history and concomitant medications were not reported. The reporter saw the photo of arm it was just redness from pretty much shoulder, biceps all the way down to elbow. It was not swollen or bumpy. The information on the batch number has been requested.
No adverse reactions. Patient received pfizer booster bivalent on 1/3/23, 3rd dose, however it was beyond use date. Placed in fridge on 10/17/22, beyond use on 12/26/22.
sense of taste changed/taste awful; sense of smell changed/smells like onion powder/urine has started to smell like onion powder too; sniffles; soreness in his shoulder; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (sense of taste changed/taste awful), PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too), RHINORRHOEA (sniffles), ARTHRALGIA (soreness in his shoulder) and MYALGIA (muscle aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had symptoms for 3 days with a continuing whole body soreness for 2 months. He feels his lungs were worse with this, but day by day his breathing improved. He also lost sense of smell and taste) in February 2021.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced TASTE DISORDER (sense of taste changed/taste awful) and PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too). 23-Apr-2021, the patient experienced RHINORRHOEA (sniffles), ARTHRALGIA (soreness in his shoulder) and MYALGIA (muscle aches). In April 2021, RHINORRHOEA (sniffles) and MYALGIA (muscle aches) had resolved. In June 2021, ARTHRALGIA (soreness in his shoulder) had resolved. At the time of the report, TASTE DISORDER (sense of taste changed/taste awful) and PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided. After the first dose patient had soreness in his shoulder which lasted for 2 months. After both the second and the first dose, he experienced sniffles and muscle aches which lasted less than a day for both doses. Within 3 hours of receiving his first dose of the vaccine he noticed his sense of smell and taste had changed. All things except for Dr. Pepper tasted awful. He also noticed that everything he can smell, smells like onion powder. This included his coffee, his truck and the smell of cars at a traffic light. More recently his urine has also started to smell like onion powder.   This case was linked to MOD-2022-465250 (Patient Link).
Hearing loss; Peripheral neuropathy; Epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest; Epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest; Eyelid edema; Tinnitus / Ringing ears; Consisting of pain and swelling of his eyes and eyelids; Consisting of pain and swelling of his eyes and eyelids; Consisting of pain and swelling of his eyes and eyelids; Information has been received from a lawyer, referring to a patient (pt) of unknown age and gender. Information regrading the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or around 10-DEC-2013, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date,  the pt was diagnosed with peripheral neuropathy and epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest. Furthermore, was additionally diagnosed with tinnitus, consisting of hearing loss and ringing in the ears, as well as eyelid edema, consisting of pain and swelling of his eyes and eyelid. As a direct and proximate result of a defective zoster vaccine live(ZOSTAVAX), the patient had resulted in physical limitation not presented prior vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of the patient's conditions, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the outcome of deafness, eyelid pain, eye swelling, eye pain, tinnitus, eyelid oedema, perivascular dermatitis, eczema and neuropathy peripheral was unknown.     The lawyer considered deafness, eyelid pain, eye swelling, eye pain, tinnitus, eyelid oedema, perivascular dermatitis, eczema and neuropathy peripheral to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the events deafness and neuropathy peripheral were determined to be medically significant and serious due to disabling criteria. The events tinnitus, eyelid oedema, perivascular dermatitis, eyelid pain, eye swelling, eye pain and eczema were determined to be serious due to disability.
2 hrs intense pain from shoulder, paralysis, 10 of 10 pain ER visit pain Meds, muscles relaxer.
This case was reported by a pharmacist via call center representative and described the occurrence of taste loss in a 65-year-old male patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 29th January 2019 10:40, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th January 2019, less than an hour after receiving SHINGRIX, the patient experienced taste loss. On an unknown date, the outcome of the taste loss was not recovered/not resolved. It was unknown if the reporter considered the taste loss to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right deltoid. Within one hour of receiving the SHINGRIX, the patient reported losing his sense of taste. The reporter did not consent to follow up. This case has been linked to case US2019016635, reported by same reporter.
My arm  beginning to hurt; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: FF8841) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient reported "I didn't expected to get the Pfizer booster shot today, I was calling to make appointment for us to get it and they said oh we have an opening so I went in and I got it and they came with a yellow paper and it said something about don't take Tylenol or something before and I don't know if I get but now it's been some hours after my arm beginning to hurt but I didn't know whether you can take Tylenol after for a day because (voice incomprehensive)  that's what I wanna know". The event outcome was unknown.  No follow-up attempts are possible. No further information is expected.
2 weeks post vax, the pt developed a 2 cm induration with small vesicles. Temperature of 98.1.
opened Ipol was at 1.0 C for about 1 hour 15 minutes/there may be one child that received a dose; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who received vaccine IPV (VERO) [IPOL] (lot number not reported via unknown route in unknown administration site) that was opened at 1 degree C for about 1 hour 15 minutes.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.   It was of actual medication error case due to incorrect product storage. Nurse stated they had an issue with the refrigerator during restocking and the refrigerator was cycling to keep up and got too cold.  It was unknown whether adverse event was experienced..  Information on the batch number was requested.  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 from a pharmacist refers to a patient of unknown age. The pharmacist reported on 11-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 lot # K019386, expiration 09-JUN-2016.  No adverse effects. No additional information provided. Additional information is not expected.
Had fever 4 days after 12 (up to 102.5) which lasted for 4 days.  Broke out with red rash "dots" with fever, cranky.
Miscarriage at 9 weeks, embryo appeared to have stopped developing two weeks before, right around the time I received the vaccination. My six week ultrasound revealed a healthy embryo with a heartbeat.  12/07/09 ED received for DOS 12/01/09 DX: Recurrent and missed abortion  Pt presented to hospital with miscarriage. Fetal demise by week 7. Pt went to OR for evacuation. Curettage and suction performed. Samples of conception and placental tissues were taken. Pt discharged home.
Patient received vaccination on Sunday and called the pharmacy Wednesday morning reporting severe pain and difficulty lifting arm. Site was red/swollen and hot. Patient had to have assistance getting dressed as the pain was too severe to do on her own. She stated the pain began Tuesday evening and woke her from sleep due to severity.
Pt had vomiting at about 1 am the night she received vaccines and had a low grade fever and 3 days later pt's mouth and gums are swollen and has sores in the mouth.
27DEC95 pt ran temp of 104 which lasted 5hrs;had red rash all over body had thick nasal discharge, sore throat & reddened eyes;rash lasted 3 days;
11 days after shot, fatigue of face muscles began. Within one more week, arms and legs also fatigue. Undiagnosed at this time. Flu-like episodes at onset with night sweats; no fever. Seen by local doctors (neurologist/rheumatologists/infectious disease). Athletic and healthy prior to onset.  Nurse follow up on 07/15/04 states: "Per review of emergency room record and hospital d/c summary, Final diagnosis was stated as "muscle weakness and shaking chills" ER report stated additional symptoms of nausea, myalgias, and headache.  Hospital D/C summary stated additional symptoms of blurred vision, muscle twitching, general weakness.  Per annual report-Pt. has difficult time trying to walk due to muscle pressure/fatigue in legs (quads).  Internal vibration, muscle fatigue, ringing/buzzing/humming in ears, pressure in face and legs slight muscle twitching all over esp. around eyes.  Pt. has been left in a condition that does not allow pt. to work (a teacher).
Syringe malfunctioned/exploded during vaccine administration and patient received less than or equal to half the dose. Per clinic MD, patient was given another half dose (0.25ml) of Moderna Bivalent Booster. Patient was informed and agreed to receive.
This non-serious medically confirmed report (initial receipt 10-Sep-2014) concerns a female patient. On an unspecified date, 6 years ago, the patient received a flu shot (manufacturer and batch number not reported). On an unspecified date after receiving the vaccine, the patient developed hives. Outcome was not reported.
on 5/5/08, patient seen in the ER with worsening intermittent abdominal pain for 1 day.  Child would bring knees to his chest and cry inconsolably for up to 20 minutes.  AXR showed intussuception, and patient was seen by surgery who successfully performed an air-contrast enema.  Patient was admitted to the hospital.  6/3/08 Reviewed hospital medical records for 5/5-5/7/2008. FINAL DX: intussusception, enema reduced. Records reveal patient experiencec worsening abdominal pain, crying inconsolably, vomiting, reduced oral intake, lethargy, irritability.  Admitted for observation s/p enema reduction of IS.  Improved & d/c to home.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 05-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). NO adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
11/7/12 - Vaccine given. 11/19/12 - Pt called stated since injection she had felt dizzy, headaches, vomiting, body aches, possible seizure, depression and anxiety, and nightmares. 12/26/12 Pt seen in ER 3 times. Pain, muscle spasms. Also seen by endo and has inflammation in thyroid and elevated T3 & T4. 2/21/13 - Diagnosed per pt with Lupus and myopathy.
S&S of "runny nose", afternoon naps were longer than usual 5 days prior-5AM check by mom & was breathing, not breathing @ 815AM;
4/14/05 PC from child's mother with c/o left arm red, swollen and tender x 2 days, gave child Tylenol, and ice to site, at injection site. 4/15/05 PC to child's mother for f/u on reaction, mother states resolved except for little redness at injection site.
Patient with history of partial retinal vein occlusion and macular edema in the left eye and pre-existing glaucoma. Conditions had been stable without edema until OCT examination on 25 August, one day after administration of vaccine, macular edema noted and intravitreal Eyelea administered,
Patient developed a generalized rash on her body starting Monday 3/28/22. The doctor described this is as pityriasis rosea and prescribed  that she takes otc benadryl. Pt states she has a red itchy rash over her entire body.
Fever of 104 degrees. Extreme pain in joints, burning sensation that felt bone-deep. Chills to the point of chattering teeth. Profuse sweating. Extreme sensitivity to touch.
Fever chills shivers extreme fatigue shortness of breath sweats body aches headaches.
Patient developed severe ITP and was hospitalized on 8/26/22 through 8/27/22
On audit it was found that client had gotten the pediatric, 10 mcg dose, for her 2nd dose, instead of the adult 30 mcg dose.  Per the vaccinator, the client was so small, it didn't click that she was 12 years old, and qualified for the adult dose.  The upstate Medical Director, was contacted, and advised that a 12 y/o who received the second dose of vaccine as a 10 microgram pediatric dose is not required to have the dose repeated per the CDC guidance. It is not known if the child will be as protected with the slightly lower dose since that was not studied, but I don?t think giving another dose at this time would be recommended unless there were special circumstances.  If the child is immunosuppressed in the moderate to severe category, his or her guardian can talk to their doctor about it. The clients father was made aware of all of the included information.