chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US026884, is an initial spontaneous report received from a nurse on 22 Dec 2015, This report refers to a female patient of unknown age. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number 1514501 and expiry date: May 2016) into left deltoid on 08 Oct 2015 which was stored out of recommended temperature range. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day, the temperature was fine. It was a new refrigerator and there had not been any problems since the temperature excursion. No adverse event was reported following this medication errors. No further information provided. Follow up information received from the nurse on 26 Jun 2016: Reporter's comment updated.
Apparent breakthrough varicella rash about 1 1/2 years after vaccination. About 10 lesions total.
Client given child dose of 5mcg. vs. adult dose of 20mcg.  gave. adult dose while client still in clinic in rt. arm
expired dose of Menactra administered; Initial information received on 22-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old male patient who was vaccinated with 0.5 ml second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5917AA via intramuscular route in the left deltoid, on 23-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used. It was reported that expired dose of Menactra administered.  At a time of reporting no adverse reaction reported  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 party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
t104.2 R; local rxn site sml red spot @ inject site; wheezing somewhat for about 5 mins in PM; called MD said had ear infect & sinus;
This spontaneous report was received from a nurse concerning a 4 months old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 09-JAN-2017, the patient was vaccinated with improperly stored dose of ROTATEQ orally from lot number M031650 with expiration date of 16-MAR-2018 (strenght, dosage schedule, anatomical location and route of administration were not provided) for prophylaxis. The administered doses were exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA009503: US-009507513-1701USA009504: US-009507513-1701USA008111:
Erythema (blanching) of bilateral lower extremities with swelling of feet and soles. Crying inconsolably. Reaction within 20 minutes post vax administration. Responded to Benadryl.
The day after I received the vaccin I experienced an extreme tension in my two eyes that I still have now but not as intense. My left eye is the most affected - The blood flows really fast in the eye and it is pulsing. I don't have the sensation every day now but still on and off. Both of my eyes feel tension not as much as it was at the beginning but still experiencing symptoms of pressure and pulsions. It feels like I am going to have an ophthalmic migraine. My eyes doesn't feel right either. Overall, I felt weak, highlighted and it felt like if I was experiencing  feeling of "dissociation" - caused I think by my sight being affected.  I couldn't do a lot as my energy was very low and it felt that my oxygen wasn't at its maximum. Every small activity required a lot of energy and I could barely walk around my block. It affected my work and I couldn't teach at the end of that first week. I wasn't feeling good. I went to my doctor on Monday, April 12th as I was concerned about blood clot or other neurological and pulmonary issues. My Doctor examined me and listened to me and concluded that the sides effects were taking longer than the average to go away. The following day I woke up reading about the blood clots due to J&J vaccin. I called back my doctor and we did a blood test. It came back negative and I got my eyes checked by my ophthalmologist too, and he didn't see anything.
Swelling of right arm at injection site. Similar reaction in past two shingles and pneumonia shots. HR 81, O2 96%, BP 130/73. Given Benadryl 25mg IM w reduction in swelling.
Information has been received from a parent concerning his 6 year old son who was vaccinated with MMR II (Lot# not reported). The patient was on the autism spectrum. Upon internal review autism spectrum was determined to be an other important medical event. No further information is available.
Chills; 102 degrees F Fever; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 72-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9266 and expiry date: unknown), via an unspecified route of administration, in arm left on 04Mar2021 at 11:30 AM as second dose, single for COVID-19 immunisation. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265 and expiry date: unknown), via an unspecified route of administration on 10Feb20211 2:30 PM on left arm as single dose for COVID-19 immunisation. The patient medical history and allergies was not reported. Concomitant medication included 100 mcg levothyroxine (LEVOTHYROXINE), medication in two weeks. The patient experienced chills and 102 degrees f fever on 04Mar2021 21:00. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit. Facility type vaccine. The patient did not receive other vaccine in four weeks. The patient did not receive any treatment for the adverse event. No covid prior vaccination and did not tested covid post vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
A 42 year old female received an injection of TD Toxoids Adsorbed, Purogenated for a leg laceration on 3/28/00 and that same day, reportedly developed left arm pain and difficulty moving her arm. The pt indicated that immunization was administered 3" or 4" from the top of her left shoulder and that her arm pain has been worse in the morning, "throbbing and hurts in shoulder". She stated that during the day, her pain has been a deep aching, "feels like the muscle is damaged". She also stated that she has no strength in her arm and has difficulty lifting objects. Several weeks ago, the pt experienced numbness of her left wrist and fingers. As of 5/16/00, the numbness had resolved. She was seen by a physician who indicated that "the bone may have" been "nicked during the injection" and "it may take 6-8 weeks to heal". As of 5/16/00, her injection site reaction, deep aching and throbbing of her left arm, decreased left arm strength and difficulty moving her left arm, persisted.
As patient was outside checking in our site manager caught that the patient received Moderna as their first dose on 03/21/2021. Patient is 17 years old and was returning today for their second dose. Site Manager alerted myself Nurse Co-Lead. Nurse Co-Lead elevated the situation to Clinical Operations Coordinator, whom verified and approved for patient to receive the second dose of Moderna according to CDC interim considerations. Nurse Co-Lead verified that patient received the first dose of Moderna on the patient's immunization record. First 0.5 ML IM dose of Moderna lot #046A21A administered on 03/21/2021. Second 0.5 ML IM dose of Moderna lot #042B21A administered on 04/18/2021. Patient denied adverse reaction to both doses of Moderna, only slight soreness at vaccination site for first dose on 03/21/2021. Nurse Co-Lead then spoke to all Moderna vaccinators and ancillary staff assigned for 04/18/2021, I reiterated the correct age groups for both Moderna and Pfizer. Our vaccination sites have today's date for allowing to vaccinate to which age group and for which vaccine on the walls of each nursing station within the vaccinator's view. In addition, our reception desk inside the building and now outside check in table have these daily reminders visibly in front of them. Nurse Co-Lead spoke to the nurse specifically that administered the first dose of Moderna on 03/21/2021 and re-educated the medication rights and agreed to the methods in preventing this error in the future. Nurse Co-Lead spoke to Lead Ancillary to re-educate and reiterate her ancillary staff each day as well. Nurse Lead produced a new nurse station safety checklist that includes medication rights, correct age group for each vaccine, and verbal consent from patient, and the 3 contraindication questions for the vaccinator/nurse to hold the vaccine. Nurse Co-Lead spoke to lead registration table ancillary lead as well as the site manager that oversees the ancillary staff outside the building as initial check in staff. Nurse Co-Lead and Nurse Lead agreed to have end of day huddle to re-iterate today's captured vaccination error and methods to prevent in the future. Both patient and mother gave verbal consent and were in agreement in completed the 2 dose series of Moderna.
A large itchy rash below the injection site. There is some pain associated with it.; A large itchy rash below the injection site. There is some pain associated with it.; A large itchy rash below the injection site. There is some pain associated with it.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 15:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. The patient had taken other medications (unspecified) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 12:00, the patient experienced a large itchy rash below the injection site. There was some pain associated with it. Therapeutic measures were not taken as a result of the events. The events did not result  in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event a large itchy rash below the injection site; there was some pain associated with it was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
roughly 24 hours after the shot I had a mild fever followed by a mild headache in the morning. Nothing too serious but notable since I rarely get headaches.
Information has been received from a registered nurse concerning an approximate 10-year-old female who on 06-OCT-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality compliant was not involved. This is one of several reports from the same source. Additional information has been requested.
That same evening I began to feel chills, woke up sweating the next day and progressively got worse the closer I got to the 24 hour mark. Jitters, joint pain, abdominal pain, nausea, metal taste, even felt numbness near joints on my thighs. Fatigue of course. About 48 hours later those symptoms started to subside.
pt w/erythematous indurated 2" lesion lt thigh, warm to touch nonfluctuant recv vax 8OCT97;
Narrative: 90 yo male with history of Type 2 DM, CAD, PVD, HTN presents to the Emergency department on 8/7/21 with a chief complaint of intermittent CP with chest and sinus congestion for a week, worsening SOB with exertion, decrease appetite, dizziness, syncope and productive yellow cough also for a week. He also had lower extremity swelling that is worse. Patient was taking 20mg of lasix for lower extremity edema but no history of CHF. EKG with Normal Sinus rhythm with PVC, rate 88, PR 258, QRS 126. In the ED he had desaturating event to the mid 90s on RA (saturating well on room air when stationary, but requiring 2L NC to reach mid 90s sats when mobile). He had elevated BNP to 159, so was diuresed with 40 IV Lasix. Creatinine 1.82 (BL ~1.5, but unsure), troponins negative, UA with trace blood. CT head w no acute intracranial abnormality, mild abnormal hypoattenuation in the subcortical and periventricular white matter of the bilateral cerebral hemispheres, which can be seen with chronic ischemic small vessel gliosis, prior inflammation/infection, vasculopathy, or other etiologies. He was found to be COVID positive with CXR c/f mild/early PNA in left lung base. He was transferred to the floor and started on CAP coverage with ceftriaxone and Azithromycin and started on 6 mg dexamethasone daily. While on the floor he had recurring episodes of bradycardia into the 40s and tachycardia into the 140s, he remained asymptomatic. No known history of arrhythmia on file. TTE with EF of 56% and mildly dilated RV and moderately enlarged RA, otherwise unremarkable. His O2 needs continued to rise, and patient was unable to remain in prone position. ABG on 8/9 with pH 7.43/pCO2 33.5/pO2 59. On 8/10 he was transitioned to 8L oximyzer. Repeat CXR showed worsening patchy and groundglass midlung and lower lung opacification consistent with worsening COVID pneumonia-most extensive in the left lung base. On 8/10 procal was elevated to 5.44 and antibiotics were escalated to cefepime 2g q24h IV. Patient was started on remdesivir (received 200mg the first day, 100mg for 4 days thereafter) and completed a 7-day course of bacterial pneumonia coverage. Over the next days, oxygen requirements started to decrease (patient did not require oxygen supplementation on 8/14), and on 8/14 walk test showed: resting SPO2 on room air 92; patient ambulating for 1 minute on room air with lowest SPO2% 91, patient unable to fully ambulate in the room for 1 minute due to weakness. Patient received 8 doses of dexamethasone (8/8 through 8/15) due to concerns for weakness when ambulating as well as hyperglycemia events. Ultimately, patient was discharged to home on 8/16.
Really bad headache; Really itchy/itching in her upper body and in legs, like a  rash; Rash/itching in her upper body and in legs, like a  rash; Mottled skin; This is a spontaneous report from a contactable  nurse reporting for herself  A 41-years-old female patient  received bnt162b2 (BNT162B2; Lot #EL3249) vaccine , in the left arm  on 11Jan2021 13:00 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced really bad headache  on 12Jan2021 with outcome of unknown , really itchy/itching in her upper body and in legs, like a  rash  on 12Jan2021 with outcome of unknown , mottled skin on 12Jan2021 with outcome of unknown.  Unknown treatment was given for really bad headache  The reported events were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events headache, pruritus, rash and livedo reticularis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Hives noted (L) upper arm. Advised to give BENADRYL & go to ER if any facial swelling or itchy throat.
Shingle-like rash various areas; itching, redness. No treatment as yet. Moderna COVID?19 Vaccine EUA
Two Pfizer doses given at pharmacy 2142 on 5/12/21 and 6/3/21 after patient had already received J&J on 4/3/21. Database was not checked prior to administer Pfizer vaccination.
A patient was being administered the Moderna vaccine, however, the needle was not attached securely to the syringe. This caused the vaccine to leak during administration. The patient was a retired RN who verbalized she could feel the liquid running down her arm immediately and does not believe she received any of the vaccine. The patient stated she had 3 drops on her sleeve.  Patient was questioned how many ml she would estimate the 3 drops were? and she stated 2 ml. Considering we only give 0.5 ml, most likely conclusion is she indeed the patient did not receive the vaccine.  Per CDC If less than a full recommended dose of a vaccine is administered because of syringe, applicator, or needle leakage, the dose should be repeated. The patient has been rescheduled to return to the clinic this Wednesday February 3, 2021 to receive her first dose of Moderna as recommended.
severe pain in arm and left side chills flueish feeling could knot sleep aches and pain throout entire body
Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; There were also 10 underage recipients; Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) outcome was unknown.        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.
A pediatrician reported via a company representative that a 4 year old male received a subcutaneous injection of Prevnar on 01/29/2002. The following day, the child developed soreness at the injection site. No further information was available at the date of this report. The recommended route of administration for Prevnar is intramuscular.
Nausea/diarrhea - headache for 2 wks. Chills/low grade fever. Muscle aches muscle spasms (legs) chronic fatigue saw PCP 10/21 (VALTREX - Blisters chest legs) (prednisone severe reaction red/swollen face).
Chest pain which got worse over a few days, reached a maximum around one week after, and gradually subsided. For several weeks the pain got more intense when lying down, elevating limbs, or doing any activity. 13 weeks after, still get occasional slight pain with high exertion or elevating limbs.
Chronic spontaneous urticaria. About eight days after my booster dose, I developed a full body rash. Splotchy, raised hives covered the front of my hips, across my torso, chest, and back, and down my arms. My face was also very sensitive, and would develop hives if touched.  The hives were incredibly itchy. I took 10mg loratadine on the second day after symptom onset to relieve the itching. It slightly reduced the itching and relieved some of the swelling and hives. I continued to take 10mg loratadine every 24 hours to manage the discomfort. If I waited even two hours after the 24, the itching would again become extremely uncomfortable. After perhaps 10 days of severe symptoms, the rash began to fade. Now, hives can be easily triggered on my arms, torso, back, and face. Gently rub the skin, and a hive will form without fail in a minute or two. I continue to take loratadine daily, which helps reduce the size and itchiness of the hives, but has not relieved my symptoms entirely.