chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; administred an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administred an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administred an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administred an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administred an expired vaccine).    It was reported that DOB, Weight and height of the patient were unknown. It was unknown if patient was on any Concomitant medications.  It was unknown if patient had any allergies or ever had COVID positive test or diagnosis. It was unknown if patient had history relating to mentioned AE both Acute and Chronic illnesses at the time of vaccination. It was unknown if patient received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Patient received Monovalent vaccine of individual vial with vial size of 5.5 mL. The vial was initially stored in the refrigerator on 28-Nov-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Patient given second Hepatitis A vaccine prior to recommended due date. Second dose not due until June 2023. Patient parent informed of invalid dose and need for repeated dose.
Patient currently inpatient at (5) days admission.  H & P: PT is a 40 y.o. female who presents today with cough, fever, diarrhea weakness Pt is a 40 yo female s/p renal transplant for AGA nephropathy. Pt has been faithful with her anti-rejection regimen. Pt states started with fever 3 weeks ago. Cough 2 weeks ago and tested positive for COVID. She is fully vaccinated but has not had Booster for COVID. She saw her PCP last week and was started on doxycycline and Augmentin. Nausea and Diarrhea started next day. Today she felt much worse and presented to ED   ASSESSMENT / PLAN: Elevated procalcitonin Assessment & Plan 0.54 - treat with broad spectrum antibiotics    Diarrhea Assessment & Plan Possible secondary to Augmentin as started day after this medication was started. Will watch to see if continues on zosyn - gentle hydration  - supportive care   Renal osteodystrophy Assessment & Plan Continue home Ca and Mag   Hypomagnesemia Assessment & Plan 1.4 pt normally takes BID - will increase to TID for 2 days then return to BID  - monitor daily    Hypertension Assessment & Plan Monitor -hold ACE with current AKI, may restart with improvement in renal function   Hyperglycemia Assessment & Plan Over 200 for first time today - a1c in am   Hyperkalemia Assessment & Plan 5.1 today -gentle hydration - follow closely, repeat at 1am today and daily    Hyponatremia Assessment & Plan 130 today  --gentle hydration - follow closely, repeat at 1am today and daily    AKI (acute kidney injury) (HCC) Assessment & Plan Nephrology felt to be prerenal secondary to dehydration secondary to diarrhea, baseline Cr. 1.5-1.8 over last 2 years. Today 2.66, baseline GFR low 30's last 2 years. Today 20 -gentle hydration - follow closely, repeat at 1am today and daily    S/p cadaver renal transplant Assessment & Plan ED provider contacted on call Nephrology. Comfortable with keeping pt here gentle hydration.  - US renal transplant protocol in am -treat with broad spectrum antibiotic -continue anti rejection regimen      * Acute hypoxemic respiratory failure due to COVID-19 (HCC) Assessment & Plan Admit to HCF. Pt positive for COVID per patient at outpt facility will repeat as pt has had symptoms for 3 weeks. If negative could take out of isolation -O2,  -dexamethasone -renal function precludes use of remdismivir - supportive care
Patient received repeat Pfizer booster to replace the one was stored in the refrigerator 1 day past due date.  Patient developed pain in toe, knees, shoulders, back and wrists.  Patient was later diagnosed with gout that precipitated from receiving the booster so close in time. Patient was treated with steroid injections and tablets.
Few red bumps on arms, muscle pain, lethargic and was sent home from school. Crying and emotional. Lasted less than two weeks  after getting the HPV.
p/shot pt cried lustily;child picked up & turned pale;mom reported eyes rolled up & limped over;heart rate regular @ 100/min;pt seemed to be passing out;kept stimulating (pinching) child & would respond w/a lusty cry;rt ear drain;
Began with fever and muscle aches, escalated to fever over 102, headache, nausea, loss of appetite, muscle weakness, loss of coordination, disorientation, disruptions in short-term memory, disassociation from surroundings, sore joints, insomnia and anxiety. By 48 hours after the vaccine, the symptoms had faded, and he began to recover.
dizziness; chills; loss of appetite; vomiting; retching; fatigue; sweating profusely; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-AUG-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: dizziness), chills (Verbatim: chills), appetite lost (Verbatim: loss of appetite), vomiting (Verbatim: vomiting), retching (Verbatim: retching), fatigue (Verbatim: fatigue) and sweating (Verbatim: sweating profusely).  The outcome of the dizziness, chills, appetite lost, vomiting, retching, fatigue and sweating were resolved (duration 1 week).   It was unknown if the reporter considered the dizziness, chills, appetite lost, vomiting, retching, fatigue and sweating to be related to Shingrix.     It was unknown if the company considered the dizziness, chills, appetite lost, vomiting, retching, fatigue and sweating to be related to Shingrix.   Additional Information: GSK receipt date: 25-Aug-2023 The patient never had a reaction from any vaccine which had been given.  The patient had the first vaccine and this time got the full range of dizziness, chills, loss of appetite, vomiting(retching), fatigue and sweating profusely.  It lasted for one whole week and took a week to recover.  The patient stated did not told him/her about 2 or 3 days side effect.  It was awful and unnecessary.  The patient thought you should try testing this product more and stop advertising it on tv obnoxiously. The patient will not be getting the second dose and the patient did not care.
Patient received Pfizer 5-11 year old COVID vaccine. Patient waited 15 minutes post injection with no adverse reactions. Vaccine administration error was not realized until patient left the office and LPN was documenting vaccine administration. Nurse manager contacted to inform mom of vaccine administration error.  Mom denied adverse reactions at time of phone call. Advised mom to continue to monitor for adverse reactions. Mom verbalized understanding.
Local erythematous macule (5cm x 5 cm) at the site..no significant induration.
Patient with progressive arm pain, back pain.  Progressed to GBS within 3 weeks.
A nurse reported that the patient received Acel-Imune and Hib-Titer vaccines on 7/11/00. On 7/14/00, the patient developed an injection site reaction characterized by redness, swelling and warmth at the site of Acel-Imune administration. He was seen by the physician and recovered. This is 1 of 3 patients from this facility who experienced this event following receipt of Acel-Imune lot 472-251. The reporter indicated that 7 to 8 patients experienced this event; however, only 3 are presently identifiable.
I got the shot in my left arm, noticed my tongue was starting to go numb on the left side almost immediately. Is still numb now, 2.5 hours later.
Rec'd shot @ 4PM-9PM that night, temp 101-103 red area on lt deltoid-in AM lt arm beat red fr shoulder to elbow, area red warm to touch w/moderate amount of swelling; Given APAP q3hrs for pain, ice to area;
Pt was given Pfizer Covid vaccine 3 days following vaccination with Gardasil 9. Had forgotten about previous vaccine when answering screening questions. No immediate adverse effects noted.
0950 pt sitting flushed face, slight wheezing bilaterally anterior/posterior like. B/P 178/98 p 120 R- 28 Treated with albuterol duffs- self admin. wheezing decreased. 0958 BP 180/110 AP - 64 R - 26. Hives left shoulder area noticed at 1000. Epin 1:1000.3 given right arm SQ, wheezes increased bilat. Medical ambulance called 1/20: Spoke with Dr. at hospital ED 11:20. Patient to be D/C'd from ED and doing well.
It has been 6 months since first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been 6 months since first shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been 6 months since first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been 6 months since first shot) had resolved.            Concomitant medications were not reported . Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up was received. Patient demographics- gender ad vaccine first dose date was added
Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022; Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 11 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 11 Apr 2022) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 11 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 11 Apr 2022) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided Treatment medication was not provided by the reporter  It was reported that they thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022 Date the vial was initially stored in refrigerator was 04 Apr 2022. Vial had not undergone any temperature excursion.
Patient came in today for initial dose of COVID-19 Vaccination. Patient has denied exposure to COVID-19 and denies any sign and symptoms of COVID-19 (loss of smell, taste, cough, fever, fatigue and body aches) in last 14 days. After administration of injection patient reported" tightness in the neck area, compromised breathing, numbness and tingling on the face, and high Blood Pressure of 180/100, and Pulse of 110 bpms.  Patient reported allergic reaction has occurred within first 10 minutes of the post vaccination during the observation period. She denies any known allergies to food, drugs, and prior vaccination. Attending Physician and Vaccination Coordinator called the Paramedics (911) immediately. Paramedics has arrived within first 5 minutes at the vaccination site. As per Paramedics the Patient Blood pressure was high (180/110), Oxygen Saturation was dropping fast from 99% to 92%. Paramedics notified Patient that they will be administrating BENADRYL (IV) in route to the hospital. The Follow up call has been made to the Patient Husband name and as per Husband she is doing well and has been discharged from the Hospital. Patient Husband has been advised to make follow up appointment with their personal PCP and discuss precaution to take second shot.
This spontaneous report as received from a physician refers to a 45 year old male patient. The patient had no relevant medical history and past drug history were unknown. On 05-MAR-2014 ("3 days ago") the patient was vaccinated with PNEUMOVAX 23 (route and lot number were not provided). His concomitant medications were unknown. On 07-MAR-2014 the patient started to have symptoms which got progressively worse. On 08-MAR-2014 his left arm looked like it had cellulitis at the injection site and was about 6 inches in diameter. It was unknown if there was any relevant laboratory data. As of 08-MAR-2014 it was unknown if the patient would ever receive a PNEUMOVAX 23 injection again and his left arm continued to look like he had cellulitis that was about 6 inches in diameter. The outcome was reported as not recovered/not resolved. The relatedness was not provided. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to an unspecified multiple patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, multiple doses of improperly stored VARIVAX lot number L035128, expiration date 14-SEP-2017 and lot number M009766, expiration date 23-FEB-2018 (dose and route of administration were not reported) were administered to unspecified patients. It was verified that sterile diluent used to reconstitute vaccines was properly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14 to -10 degrees of Celsius for 105 minutes. It was reported that the vaccines experienced previous temperature excursion (not specified). Data logger was involved.  This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA015034:
Patient brought to the ED via EMS on 7/14 for evaluation of COVID exacerbation. Patient has been unable to walk due to weakness, has been feeling nauseated and has been vomiting. Patient had a positive COVID home test on 7/10. Additional COVID-19 PCR swab taken in the ED on 7/14 was also positive. Patient admitted from 7/14-7/18 with acute  hypoxic operatory failure in the setting of COVID-19 infection and possible pneumonia as well as severe sepsis in the setting of possible pneumonia. Patient has been vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
PT WAS SITTING, RAPIDLY BEGAN TO FEEL LIGHT-HEADEDNESS THEN EXPERIENCED SYNCOPE. PATIENT WAS LOWERED TO THE FLOOR WHERE THE SYMPTOMS PROGRESSED TO ABNORMAL MOTOR ACTIVITY SUCH AS TONIC RIGIDITY, CLONIC RHYTHMIC MOVEMENTS OF LIMBS, FROTHING AT THE MOUTH, AND BITING THE TONGUE AND MOUTH. THIS LAST FOR 1 MINUTE. PATIENT WAS A&O X 2, ELEVEATED BP AND BOUND PULSE. EMS WAS NOTIFIED AND PATIENT WAS IN A WEAKEN STATE. PATIENT WAS TRANSPORTED VIA AMBULANCE TO HOSPITAL FOR FURTHER EVALUATION AND TREATMENT.
HEADACHE(RING AROUND BRAIN); BEHIND BREAST ON BACK IS SUPER SORE; NOT FEELING VERY GOOD; WEAKNESS; MUSCLE SORENESS UP AND DOWN SPINE; TINGLING IN LEFT HAND; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included headache. The patient was previously treated with sumatriptan for headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: not reported) dose was not reported, administered on 07-APR-2021 14:05 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced tingling in left hand. On 08-APR-2021 08:00, the subject experienced behind breast on back is super sore. On 08-APR-2021 08:00, the subject experienced not feeling very good. On 08-APR-2021 08:00, the subject experienced weakness. On 08-APR-2021 08:00, the subject experienced muscle soreness up and down spine. On an unspecified date, the subject experienced headache (ring around brain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in left hand on 07-APR-2021, was recovering from headache(ring around brain), and had not recovered from weakness, behind breast on back is super sore, muscle soreness up and down spine, and not feeling very good. This report was non-serious.
Skin hot - flushed pale, diarrhea, swollen glands, brain on fire.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 16 month old infant patient of unknown gender. On 30-MAY-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
HYPOXIA 4/21/2022 ACUTE & CHRONIC RESPIRATORY FAILURE WITH HYPOXIA
Patient presented to clinic behind immunization schedule. DTaP, HIB given 48 hour later patient developed 3cm x 4cm erythema type area at injection site (right upper arm)
2DEC92 MMR given; 18DEC92 swollen finger rt hand-progressed to wrist advised to come in; MD visit wrist-ankle swelling, t96.5, CBC & SEd rate-Advil; no other meds; hx arthritis rt wrist x 2 yrs;
After 5 minutes I felt warm come over my body, tingling especially in my hands , I just did not feel right , my body felt weak almost like I may faint. My head was very woozy and I was not able to stand up.  I could barely keep my eyes open and I wasn?t sure if I should go to the hospital.
pt recvd vax 11AM came back 5PM c/o episode of hemoptysis, shaking, chills, rapid breathing, t101.1, WBC 19.5 thousand; CXR neg; given APAP & Librium;given Restoril, Keflex;
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 28-JUL-2010 the patient received an expired dose of PNEUMOVAX23 25/0.5 (lot # 662747/1086X, exp date 06-JUN-2010) (route unspecified). Concomitant medications were not reported. No adverse effect reported. This case is linked to case 1307USA013390, 1307USA015840, 1307USA015841, and 1307USA015839 via same reporter link. Additional information has been requested.
Developed a fever of 101.8, night sweats, nausea, fatigue, for two days
I don't sleep a lot but I slept 10 hours last night; Muscle ache; Very tired; unable to even pick my head off the pillow; It went in to stomach situation; terrible diarrhea, uncontrollable; It went in to stomach situation; terrible diarrhea, uncontrollable; I actually also had a shot of the flu vaccine; I actually also had a shot of the flu vaccine; I was my very sick for 2 days; I don't sleep a lot but I slept 10 hours last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose number unknown (booster), single (Lot number: HG4633, Expiration Date: Dec2023) at the age of 79 years for covid-19 immunisation; for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 12Oct2023 as dose number unknown, single (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Oct2023, outcome "unknown" and all described as "I actually also had a shot of the flu vaccine"; ABDOMINAL DISCOMFORT (non-serious), DIARRHOEA (non-serious) all with onset 14Oct2023, outcome "unknown" and all described as "It went in to stomach situation; terrible diarrhea, uncontrollable"; MYALGIA (non-serious) with onset 14Oct2023, outcome "unknown", described as "Muscle ache"; FATIGUE (non-serious) with onset 14Oct2023, outcome "unknown", described as "Very tired; unable to even pick my head off the pillow"; SLEEP DISORDER (non-serious) with onset Oct2023, outcome "unknown", HYPERSOMNIA (non-serious) with onset 16Oct2023, outcome "unknown" and all described as "I don't sleep a lot but I slept 10 hours last night"; ILLNESS (non-serious) with onset Oct2023, outcome "recovered" (Oct2023), described as "I was my very sick for 2 days". Therapeutic measures were taken as a result of myalgia, fatigue, abdominal discomfort, diarrhoea, illness, sleep disorder, hypersomnia.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Rash on both arms. Swollen lips. Swollen, itchy hot ears.
Information has been received from a physician concerning an 11 year old female with no known pertinent medical history or drug reactions/allergies who on 07-JUL-2008 was vaccinated with a first dose of GARDASIL (lot# 660393/0067X) 0.5 mL IM. Concomitant therapy included a dose of ADACEL received on 07-JUL-2008. On 01-SEP-2008 the patient developed a BELL'S palsy. She has facial drooping on her right side. A magnetic resonance imaging was performed with a negative result. The patient was treated with acyclovir and prednisone. The patient was recovering from BELL'S palsy. The patient sought medical attention in the office. Additional information has been requested.
Redness, hot to touch, itchiness at injection site, with a diameter of about 4 inches.  Lasted for about 6 days, went away, and came back 14 days after only not as big of an area.
After projectile vomiting for 4 days coupled with diarrhea, patient taken to ER for dehydration concern where he was given anti-nausea pills and sent home. Vomiting stopped with this, but with diarrhea continuing for another week, patient was taken to Pediatrician where blood work was done showing levels were off. Admitted to hospital overnight for IV fluids and monitoring.