chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received second dose outside the 42 day window; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose outside the 42 day window) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose outside the 42 day window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose outside the 42 day window) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment medication details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up was received on 03-MAY-2021. The reporter provided the Batch Lot number for the first dose # 013M20A.
This spontaneous report as received from the nurse refers unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On 04-MAY-2015, the patients were vaccinated with GARDASIL (lot number: K023432 and expiry date: 18-JUN-2016) (dose, frequency and route of administration was not reported) which was exposed to temperatures outside of the recommended range (incorrect product storage). No adverse effects have been reported. The outcome of the reported event was unknown. The causality of the suspect product was considered to be not related to the event. No product quality complaint (PQC) was filed. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
A non-serious spontaneous report of FLUMIST accidentally squirted in eye, which became red, itchy, and oozing eye has been received from a health professional concerning herself, 54-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Nov-2010, the patient was administering the vaccine which squirted in her eye. The patient did not receive FLUMIST herself. On 30-Nov-2010, the FLUMIST squirted in her eye. The medication came out from the plunger and hit the patient's eye. The eye became red, itchy and oozing. The outcome of the event FLUMIST accidentally squirted in eye was recovered while the outcome of the events red eye, itchy eye and oozing eye was not recovered.
25APR91 noon, c/o screaming, lethargic, dilated pupils, fever given APAP; c/o inc fever t104.8, & fussy; Taken to MD tx for ear infect w/Ceclor;
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments:  US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
COVID-19; Aching joints; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and ARTHRALGIA (Aching joints) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF, UNK. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF, UNK. On an unknown date, the patient experienced COVID-19 (COVID-19) and ARTHRALGIA (Aching joints). At the time of the report, COVID-19 (COVID-19) outcome was unknown and ARTHRALGIA (Aching joints) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event Aching joints with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
limp, pale, shallow resp lasting 30 mins 3 hrs post vax; observed in ER & discharged;
Janssen first dose and Moderna Booster Pt reported Respiratory distress including wheezing, coughing. Vitals: 156/82, 83, 26, 100% -- > 155/80, 67, 20, 100%.  Pt given 25mg PO benadryl @09:21.  Pt also took her own Norvasc 10mg. Pt stable and released from the vaccination site.  Pt was able to stand and ambulate w/ no distress.  Recommended f/u w/ PCP.
Sore arm and a just a little bit tired after both doses of vaccine.  However, after the second dose the volume of my tinnitus increased that evening and is still at the increased level 1 week later.  Contacted ENT office, no treatments available.
Information has been received from a physician concerning a child who was vaccinated with a 1st dose MMR. Six to eight hours, post vax, the pt developed a rash and fever. Unspecified medical attention was sought. It was reported that the physician is administering the 2nd dose. Additional information has been requested.
Became fatigued and achy soon after at the grocery store. Went home. Slept in Lazy Boy Chair for 3 hours. Whole right side of my body ached from neck to feet, including arm and fingers. Started limping when I stood up. Took two Aspirin. Body continued to ache through Sunday, Monday and was sleep disturbed. By Thursday only leg ached and I continued to limp. Woke Friday morning in a lot of pain (cleaned house the day before), had trouble sleeping in the night. Applied sports cream at midnight. Continued to take aspirin. Went to urgent care to make sure nothing more serious was going on. Dr. electrolyte scan and checked for a muscle enzyme. He said the tests were normal (October 10).Leg is still hurting including knee. Hard to carry on normal movement and hard to drive a car.
Employee received .2 cc of covid vaccine instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with agency and HCP, decided to offer the employee an additional COVID-19 vaccine dose. Thanks.
Patient reported reaction to vaccine today, 11/10/21 via pharmacy phone call. Patient started to feel ill a few hours after vaccine was given on 11/6/21. Vaccine was given around 11am and she started feeling ill around 3pm. She reports that she started to feel really tired, over the next day, she started to experience nausea and headaches, with continuing tiredness. She also reports intermittent fevers throughout the 5 days post vaccine. She notified her doctor of illness and he recommended that she notify pharmacy.
Sore throat low-grade fever cough shortness of breath nausea all beginning seven days after vaccine and lasting over two weeks at present. Covid testing negative. Flu testing negative. Initial vaccine reaction was sore arm and shoulder on the left being the only symptoms
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: After 15 minutes he was walking out and his arm started itching. He said he already had a little bit of a sunburn. We gave him 25mg benadryl and got him to wait another 30 minutes.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 9:10 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:10 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 58.67 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion with temperature 34 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. 20 vial was moved to clinic, Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Injection site with a goose egg sized knot the day following the injection.  On day three,  the pain and swelling worsened spreading around my arm about 10 to 12 inches in diameter area with extreme hardness, redness, heat, pain, throbbing and orange peel like dimpling.  Extreme itching noted and pain extending down to elbow and forearm.  Tylenol taken and ice packs placed overnight.  Continued with zyrtec, ice, elevation, and tylenol
10 minutes post vaccine administration at 13:15 patient began to exhibit the following symptoms: dizziness, paleness, weakness, blurred/loss of vision, ringing in the ears, and diaphoresis.  Cold pack was placed on patient's forehead and patient's feet were elevated. BP, pulse, & temperature unable to assess, pulse was faint and weak. Patient experienced loss consciousness for 1 minute, 34 seconds. During this time paramedics were called. Vitals at 13:20 were: BP=98/76, P=62, temp= unable to register with machine on hand. Patient able to follow commands and asked to lie down.  Cold pack was placed on the back of his neck. Paramedics arrived and assessed patient's blood glucose = 56. Patient given orange juice. Vitals at 13:30 were: BP = 107/69, P = 70, Temp = 97.6., pulse ox: 99%. Patient asked to sit up and vitals were: BP = 114/73, P: 71. Patient declined to go be transported in ambulance with paramedics to the hospital at that time. Blood glucose assessed again = 127. Patient given chips and salsa from what facility had on hand. Patient stayed 10 minutes to eat the snack. Patient instructed to go to the hospital or urgent care for further follow-up and assessment. Patient verbalized understanding and agreed to instruction. Stated he will go to nearest Urgent Care facility. Patient left this facility alert and oriented.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 48-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
On the morning of September 12, I began to notice pain in my left calf.   It came and went over the following week feeling like a tight muscle and like it was about to cramp but didn't .  I also had some joint pain in my hip, knee, ankle, and throughout my foot.   On September 20 at approximately 11:45AM , I began to experience numbness and "pins and needles" from my knee down and throughout my foot right to the tips of my toes.   I reported to my PCP, went to Urgent Care.  They referred me to local Hospital  where I received an ultrasound for blood clots and told I had none and was released.  As of 9:30PM on September 20th I am still experiencing the symptoms.
after second dose, arm was a little itchy but nothing major; Dose Interval between 1st dose and 2nd dose is beyond 25-35 days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (after second dose, arm was a little itchy but nothing major) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Interval between 1st dose and 2nd dose is beyond 25-35 days) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for Blood pressure, ROSUVASTATIN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (after second dose, arm was a little itchy but nothing major) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Interval between 1st dose and 2nd dose is beyond 25-35 days). The patient was treated with CORTISONE at a dose of 10. On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Interval between 1st dose and 2nd dose is beyond 25-35 days) had resolved. At the time of the report, PRURITUS (after second dose, arm was a little itchy but nothing major) outcome was unknown.            Concomitant includes rovastatin 10mg for statin.   This case was linked to MOD-2022-458708, MOD-2022-458784 (Patient Link).
soreness at injection site; low grade fever; nausea; body aches; chills; pain in the hips; brain fog; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 09Feb2021 (Lot number: EL3247) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 19Jan2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: INJECTION SITE PAIN (non-serious) with onset Feb2021, outcome "recovered", described as "soreness at injection site"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered", described as "low grade fever"; NAUSEA (non-serious) with onset Feb2021, outcome "recovered", described as "nausea"; PAIN (non-serious) with onset Feb2021, outcome "recovered", described as "body aches"; CHILLS (non-serious) with onset Feb2021, outcome "recovered", described as "chills"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "recovered", described as "pain in the hips"; FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "recovered", described as "brain fog"; FATIGUE (non-serious) with onset Feb2021, outcome "recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
On 11/12 with brief intermittent left chest pain.   Seen at Urgent Care on 11/15 - normal EKG Seen at hospital on 11/16.  Exam consistent with left costochondritis ~ left 5/6th rib.  EKG repeated and normal.  Discussed screening labs (CBC, ESR, CRP and Troponins), but deferred.  Advised NSAIDS bid x 3-5 days.  Recheck if symptoms persist.
Swelling of right arm 4 x 3 cm with warmth and erythema.
Patient was seen for swollen (L) arm at site of injection. It was an oval 4 x 5 cm red macular rash, hot to touch, induration and tender. Rash was progressing towards shoulder jt - Temp 100.1 child appeared well, full range of motion - Explained to mom this was cellulitis - AUGMENTIN x 10d. Follow up if rash progressed up/any other signs.