chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired vaccine is stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) in a 75-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 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial placed in refrigerator - 29-OCT-2021  No Concomitant Medications were provided by the Reporter      No Treatment Medications were provided by the Reporter
Patient came to observation area stating having slight tightness and tingling sensation around mouth and throat. Mucus membranes were assessed, no swelling or edema noted. Pt was given water, she was able to swallow and talk without difficulty. Vital signs were taken intermittently, stable vital signs, no signs of distress, she was continued to monitor for any reaction. Patient had received the vaccine at 10:37am waited for her sister until 10:54am to come to observation. Patient was observed until 11:45am, patient stated feels fine. Patient stated she was anxious of getting the vaccine, she stated she felt the reaction and it only lasted 3 minutes, and she stated that it is probably due to history of other allergies. Patient was stable. Patient was verbalizing and communicating during observation period.  Patient stated felt fine before leaving, and left with her sister.
- Fever, Tmax 101.16 occurred 12 hours after injection, febrile at least 2 hours.  Afebrile by AM of 12/25, resolved without antipyretics.  - Right arm pain: Onset 12/24,  up to 6/10.  Resolved by 12/26.  - Fatigue: Onset 12/25, resolved by 12/26.
11-12 hours post vax, the pt became pale, limp, diaphoretic and unresponsive for 3-5 minutes. No fever, emesis, clonic movements or redness/swelling noted. The pt subsequently recovered. She had eaten normally that day.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored oral ROTATEQ (lot # L013192 date 19-JAN-2017; lot# was reported as L027070, expiration date 30-APR-2017; Lot# L029615, expiration date 15-MAY-2017 (the nurse could not identify the lot numbers which had been administered to the patients) strength, dose and frequency were unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Muscle and joint aches lasting 24 hrs, fever beginning 6 PM and lasting 12 hrs (100.7 degrees max), chills beginning 7 PM and lasting 3 hrs. Treatment was 1 ibuprofen and bed.
BLOOD CLOT IN LUNGS; This spontaneous report received from a consumer concerned a 5 decade old (around 45 years) White and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included: blood clots from 2016. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-AUG-2021, the patient experienced blood clot in lungs and on the same day, the patient was hospitalized. On 07-AUG-2021, the patient was discharged from hospital. According to the patient it did not have anything to do with the vaccine. The patient was hospitalized for 3 days. The patient was currently receiving unspecified blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in lungs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210820320-covid-19 vaccine ad26.cov2.s-blood clot in lungs. This case concerned to a 5 decade old (around 45 years) White and not Hispanic or Latino male. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Patient complained of sharp, shooting pains, almost like little bites all throughout her body for 24 hours after the shot.
Clear rhinorrhea, wet cough, decreased appetite, and fussiness for four days after vaccination.
a vial with expired vaccine was diluted with 1.8 ml normal saline and administered to the patient
Patient called reporting he was diagnosed with shingles 2.5 weeks after receiving Zoster vaccine
Redness, pain and swelling - soft tissue mass mildly tender well circumscribe.
This spontaneous report as received from a other health professional refers to an unknown number of patients of unknown age and gender. On an unknown date the patient was vaccinated with PEDVAXHIB (lot number and frequency unknown) (dosing regimen and frequency unknown) which under went temperature excursions outside recommended temperatures. No concomitant medications were reported. No adverse event was reported. No product quality issue was reported. This case is related to case numbers 1403USA009542, 1403USA009427 and 1403USA009541 via same reporter link. Additional information has been requested.
Both arms have been red, painful, and warm to the touch since a few minutes after the injections.  3 days later, the sites are still red and painful.
No adverse event. Pt was given vaccine incorrectly. The Rotarix vaccine was not mixed with the diluent. Patient only received the diluent no vaccine.
1st intradermal shot did not create a wheal. 2nd intradermal injection created wheal . Pt left in no distress from injection
devel malaise, gen urticaria, swollen lips, hives all over including scalp;pre-exposure series 13yr prior;
Severe painful rash to both axillary areas. was seen on 1/22/2021 by a nurse practitioner at a clinic. You were put on antibiotic cream- unsure of the name. Still has rash and pain today, 1/25/2021.
THIS PATIENT ALSO HAD A MINOR CHILD IN THE ROOM THAT GOT A COVID SHOT. THE IMMUNIZER GAVE THE MINOR THE SHOT FIRST WITH NO PROBLEMS. THE SAME NEEDLE AND SYRINGE USED ON THE MINOR WAS INSERTED INTO THE MOTHER'S ARM (WITH NO VACCINE INJECTED BECAUSE IT WAS EMPTY SINCE ALREADY GIVEN TO MINOR CHILD). THE MOTHER THEN WANTED TO PROCEED AND WAS GIVEN THE CORRECT COVID VACCINE USING A NEW NEEDLE AND SYRINGE FILLED WITH VACCINE. NO ADVERSE REACTIONS WERE REPORTED. THIS WAS JUST AN IMMUNIZATION ADMINISTRATION ERROR.
Racing heart, headache, dizziness, near syncope, nauseated, weakness, irregular heart rhythm, redness around the injection site, large lump around the site, immediate bruising, blotchy (spider web looking) redness in arms and legs.
Chills, body aches, fever of 99.5, pounding heart, fast heart rate.
Starting a few hours after my vaccination, I?ve experienced The following: chills, fever, headache, muscle soreness all over my body, nausea, nearly uncontrollable shaking last night, extreme dizziness, and my body has felt heavy. It was worst as I was going to bed (midnight), and it woke me up at 5:30 am today. My fever may have broken, but I am still in pain and dizzy.
This patient had a "quarter sized" area of erythema at the injection site 2 days after receiving the injection. The child was taken to the ER on 02/18/01. The child was asymtomatic other than a 8x5 cm erythematous patch on her right thigh. No intervention given. The child was presented to the clinic on 02/19/01 with a 7 x 5 cm erythematous patch. Exam otherwise normal. Afebrile. The child will return in 2 days for a follow up.
No reactions occurred. Vaccine administered on 4-25-22, however due to it being kept in fridge it should have expired on 4-8-22, therefore pt received expired vaccine.
This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Urticarial rash, itching, swelling, pain and redness at injection site
dizziness; nausea; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Mar-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.
A FEW HOURS AFTER THE INJECTION, DEVELOPED TREMENDOUS PAIN, PROGRESSED TO REDNESS, WARMTH, SWELLING- UNABLE TO RAISE ARM ABOVE SHOULDER. NO PARETHESIAS. NO LOSS OF HAND OR FINGER CONTROL. PAIN RADIATED TO BACK AND NECK AND LEG. JAW PAIN WAS WORSE (CHRONIC CONDITION). 2ND DAY- LESS REDNESS AND SWELLING, FROM PASSIVE MOVEMENT.
BRUISING ON FINGERS/ BRUISE MORE EASILY; VERY TIRED; STRANGE BLOOD VESSELS IN FINGERS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced strange blood vessels in fingers, bruising on fingers/ bruise more easily, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very tired, and the outcome of bruising on fingers/ bruise more easily and strange blood vessels in fingers was not reported. This report was non-serious.
Information has been received from a registered nurse concerning a 2-month-old full term otherwise healthy male with gastroesophageal reflux disease and no drug reactions/allergies who on 08-NOV-2007 was vaccinated with a first 2mL PO dose of Rotateq. Concomitant therapy that day included DTaP (unspecified), Prevnar, and HIB (manufacturer unknown). On 14-NOV-2007, 6 days after receiving the first dose of Rotateq, the patient was seen in the emergency room after experiencing "choking" and "turned blue". The patient also had a fever, vomited twice, and "looked a little dry". Bloodwork showed acidosis. The patient was admitted to the hospital, and was also noted to have multiple episodes of foul-smelling, explosive stool. The stool was positive for rotavirus. Subsequently the patient was diagnosed with rotavirus. The patient was hospitalized with respiratory difficulties, choking, and diarrhea. At the time of the report, the patient was still hospitalized. The patient was noted to be "feeling better", with 3-4 subsequent epsidoes of watery stool, and vomited twice. Acidosis has resolved. The patient is breastfed, and not in daycare. It was noted that the mother and sibling were ill 3 weeks prior with a diarrheal illness that lasted 24 hours. Laboratory diagnostic studies performed included: complete blood count, basic metabolic profile with electrolytes, and rotavirus screen. There was no product quality complaint. Additional information has been requested.
RASH RIGHT ARM AND UPPER BACK, GRANDMOTHER ADVISED TO GIVE ORAL BENADRYL AND ORAL IBUPROFEN AS NEEDED FOR PAIN. ADVISED TO GO TO NEAREST ER IF ANY SIGNS OF ANAPHYLACTIC REACTION.
pretty big dark bruise around the site of injection; has water bubbles on top of the area of the bruise and maybe 3 or 4 of them about medium size; Bruising on the injection site and a water bubble; This is a spontaneous report from a contactable consumer (daughter) reported for a 79-year-old male patient (father). A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: unknown), via an unspecified route on 27Jul2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection), on 06Jul2021, as a single dose for covid-19 immunization. Patient took second dose of Pfizer Covid 19 vaccine yesterday (27Jul2021) and he got pretty big dark bruise around the site of injection/ huge dark bruise around where he got his shot and he also have water bubbles on top of the area of the bruise and maybe 3 or 4 of them about medium size. Reporter wanted to know what patient can take. Was this normal, was these symptoms wide known about? The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
sore throat; chills; mild fever; redness; a little pain; body aches; upset stomach; eating very little; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), DECREASED APPETITE (eating very little), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and PYREXIA (mild fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DECREASED APPETITE (eating very little), CHILLS (chills), PYREXIA (mild fever), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (a little pain) and MYALGIA (body aches). On 19-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), DECREASED APPETITE (eating very little), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), PYREXIA (mild fever), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (a little pain) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment included Tylenol.   Reporter did not allow further contact
24 hours later : left-sided facial droop, limb ataxia bilaterally, and mild to moderate dysarthria.
This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 12Mar2021 (Lot number: EN6204) at the age of 46 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6198, Route of administration: Unspecified, Anatomical site: Right arm), administration date: 19Feb2021, when the patient was 46 years old, for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 13Mar2021 at 08:30, outcome "recovered", described as "Severe headache"; DIZZINESS (non-serious) with onset 13Mar2021 at 08:30, outcome "recovered", described as "extreme dizziness"; CONFUSIONAL STATE (non-serious) with onset 13Mar2021 at 08:30, outcome "recovered", described as "confusion"; PAIN (non-serious) with onset 13Mar2021 at 08:30, outcome "recovered", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, dizziness, confusional state and pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient also received bnt162b2 (BNT162B2), administered in right arm, administration date 12Nov2021 (Lot number: 320308) at the age of 47 years as dose 3 (booster), single for COVID-19 immunisation.
PAPULAR RASH ON BILATERAL HANDS, PALMS, FEET, SOLES, ELBOW, BACK, FACE BEGINNING DAY 7 AFTER VACCINATION. AFEBRILE BUT MYALGIAS REPORTED. NO HEADACHE OR NEUROLOGIC SYMPTOMS. MAJOR TAKE AT VACCINATION SITE WITH LYMPHANGITIS AND CELLULITIS. TREATMENT: KEFLEX 250 MG PO QID FOR 7 DAYS, ZYRTEC 10 MG PO QDAY PRN FOR ITCHING, TYLENOL 650 MG PO Q4HRS PRN CHILLS/MYALGIAS.
vomiting, fever, diarrhea, black mark wont do away;went to ER for a day;
pt recv vax & 25min p/vax exp a raised rash around inj site 4cm diameter which was sore to touch;sx cleared up p/3 days;
FELT NUMBNESS RIGHT ON TOP OF BUTTOCKS AND ALL THROUGH THE BACK OF HER LEGS; HEAD PRESSURE; DIZZINESS; CHILLS; PAIN IN LEGS; LEGS WERE NOT STRONG ENOUGH FOR HER TO GET UP; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, and fibromyalgia, and other pre-existing medical conditions included not obese or overweight, not taking medication for high cholesterol or fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced felt numbness right on top of buttocks and all through the back of her legs. On 12-APR-2021, the subject experienced head pressure. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced pain in legs. On 12-APR-2021, the subject experienced legs were not strong enough for her to get up. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 13-APR-2021, and had not recovered from headache, head pressure, dizziness, nausea, felt numbness right on top of buttocks and all through the back of her legs, legs were not strong enough for her to get up, and pain in legs. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
currently has the flu; diagnosed with COVID-19 after Moderna vaccination; Moderna Booster 23Oct2021. Diagnosed with COVID 01Feb2022; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (currently has the flu), COVID-19 (diagnosed with COVID-19 after Moderna vaccination) and DRUG INEFFECTIVE (Moderna Booster 23Oct2021. Diagnosed with COVID 01Feb2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2021. Previously administered products included for Product used for unknown indication: JNJ vaccine (COVID in August 2021.) on 31-Mar-2021. Past adverse reactions to the above products included COVID-19 with JNJ vaccine.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced COVID-19 (diagnosed with COVID-19 after Moderna vaccination) and DRUG INEFFECTIVE (Moderna Booster 23Oct2021. Diagnosed with COVID 01Feb2022). In April 2022, the patient experienced INFLUENZA (currently has the flu). At the time of the report, INFLUENZA (currently has the flu) had not resolved and COVID-19 (diagnosed with COVID-19 after Moderna vaccination) and DRUG INEFFECTIVE (Moderna Booster 23Oct2021. Diagnosed with COVID 01Feb2022) outcome was unknown.            No relevant concomitant medications were reported. The patient stated that currently she had flu and was sicker now than when she had COVID. Treatment information was unknown.  Company comment This is a spontaneous case concerning 59-year-old female patient with no relevant medical history, previously received JNJ COVID-19 vaccine, who experienced the non-serious, unexpected event of COVID-19 (AESI) and influenza. Interchange of vaccine products was considered an additional event. COVID-19 was diagnosed approximately 3 months and 9 days after the 3rd dose of mRNA-1273. Influenza occurred on an unknown date and is ongoing. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning 59-year-old female patient with no relevant medical history, previously received JNJ COVID-19 vaccine, who experienced the non-serious, unexpected event of COVID-19 (AESI) and influenza. Interchange of vaccine products was considered an additional event. COVID-19 was diagnosed approximately 3 months and 9 days after the 3rd dose of mRNA-1273. Influenza occurred on an unknown date and is ongoing. The benefit-risk relationship of mRNA-1273 is not affected by this report.