chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 29-JUN-2021, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number T013727, expiration date 21-APR-2022, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263:
None. On 10/7/2011 I was notified that two pediatric patients, ages 8yr and 9yr were given influenza vaccine that was meant for "adult only" administration. I had previously signed off on the orders for these children to be immunized as one child had chronic asthma and the other was for sibling of the first. To date there hasn't been any reported adverse reactions to the vaccination of these children. Apparently, there was vaccine available approved for children 4yrs and up but it had expired 4/2011. I discussed the incident with Dr. and he believes the probability of harm having been done to the children is little to none, due to their age and BMI. He suggested I also call the CDC for their expertise on this. CDC referred me back to another agency. The other agency feels there is no concern for harm related to this event but suggested a "Vaccination Adverse Event" form be filled out and filed for future reference. Corrective action to prevent similar events: 1) Clearly labeling boxes/vials as "Adult Only" or "For Pediatric Pts" and nursing staff to be aware of separate preparations. 2) Establish a written policy of checking medications for expiration dates in a timely manner ie: the first week of each month, check expiration dates, flag those that will expire at the end of the month and order replacement medications at that time. 3) Defer immunizations if appropriate product not available, referring pts to Public Health's immunization clinic. Notified of 3rd incident 10/17/11 - see above for corrective plan.
Pallor, Fatigue, loss of vitality, diarrhea, profuse rectal bleeding, coughing up blood, death 25 days after vaccine
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 20-AUG-2015 the patient was vaccinated with expired dose of PROQUAD (Merck) (lot # K002483, exp. 18-AUG-2015, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several report from the same reporter. Additional information has been requested.
I have the nexplanon implant as birth control, and my body stopped having periods two years ago because of that. After my second dose I experienced spotting for about three weeks and then it turned into a full blown menstrual cycle. It is very weird. It doesn't feel like a big deal but I also think it is important to note considering my BC reacts with my body reliably in such a way that I do not menstrate.
Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster).    Concomitant medication was not provided. HCP stated that they had a situation at the pharmacy where Moderna monovalent vaccine was administered to approximately 20 patients from 11JAN2023 - 21JAN2023, instead of the Moderna bivalent booster. HCP wanted to know if these patients can receive the Moderna bivalent booster shot after this incorrect dose, and how long should they wait to receive it. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704234 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704234:Master
Sore throat, Fever, Headache, Nausea, Loss of appetite and all over body aches for 24 hours.
Pain, redness,extreme itchiness 2nd toe right foot.  I do not remember exact date of occurrence.  Redness remains.  Small area of redness also on 4th toe of right foot.  Remains.    Hair loss/thinning.  Was noticeable by April 2021.  I attempted to report this in May or June, but see that attempt failed.  Itchiness of left arm surrounding area where vaccine was given remains itchy and lumpy.  This area had previously been red, etc., from elbow to almost shoulder.
Patient given Pfizer 5-11yo bivalent COVID vaccine but never completed the primary series.  No adverse effects noted.
Syncope that lasted for seconds. Evaluated by paramedics and advised to contact primary provider. Contacting Primary Care on 11-21.
Pt received an HPV by accident since it looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance. This was an error in administration. No adverse reactions seen yet.
Patient was given Pneumococcal-23 immunization in clinic at 3:53pm. Approximately 10 minutes later, patient reported having difficulty breathing, a racing heart, and possible hives present on chest of patient. Patient vitals were 130/84, 94 bpm, and O2 of 100%. Doctor notified and recommended patient to be brought to ER to be evaluated. Writer transferred patient to ER via shuttle.
11 year old pt came into office at urgent care and received GARDASIL 9 vaccine IM in buttocks. Wrong administration site (e.g. gluteus maximus rather than the deltoid).
Fever and awoke from nap having wet pants, went to bathroom and had seizure activity while in bathroom. Grandparent called 911.
Red, warm, itchy rash around injection site.  Initially, about 2 days after injection, the area was very tender to touch.  Then it became itchy and now it?s warm, red and with a rash.  I believe I have ?Covid arm? from I found on-line.  I sent a message and picture to Dr.
11, body aches and fever begin. 11:30, cold sweats begin, making sleep impossible.  12 AM, the fever has made the patient light-headed. 2 AM, patient tries to drink some water and use the restroom, hoping to relieve the light-headedness. Patient feels weak, and begins to lose color vision. 2:15 AM, Patient's legs buckle on the way back from the restroom, and her vision goes entirely white. She lays on the ground, going in and out of consciousness for approximately one hour. 3 AM (approx) patient awakens, feeling less feverish. Is able to catch some sleep but body aches persist. The chills and body aches return the following night, this time without a fever or any other symptoms. Sore arm lasts two to three days.
Information has been received from a other healthcare professional, author of the abstract. Background: Sepsis was a leading cause of mortality in pediatric SLE with increased susceptibility to Streptococcus pneumoniae infection. We routinely vaccinate with the 23-va lent pneumococcal polysacchride vaccine (PPV) to protect against infection. Response to vaccination may vary due to disease-specific factors and immunosuppressant use. The appropriate time to assess antibody response to PPV is unknown. Our study objectives were to describe the clinical and immunological response to PPV in pediatric systemic lupus erythematosus (SLE) and to determine predictors of decline in immunogenicity after PPV. Methods: the author evaluated 54 pediatric SLE subjects who received the PPV at diagnosis with vaccine titers obtained as varying intervals. Change in disease activity after vaccination was assessed by the SLE Disease Activity Index (SLEDAI). A positive antibody response was defined as 7 of the 14 titers measured having a value > = 1 ug/ml. They used Cox proportional hazards to evaluate factors associated with lack of immunological response to PPV. Results: The majority of the cohorts were female (79) and 52% were another group. Nephritis (74%), cytopenias (57%), and arthritis (50%) were the most common clinical features at baseline presentation. In the month prior to vaccination, 54% of the cohort received pulse methylprednisolone, and 20% received cyclophosphamide or mycophenolate mofetil. There was no change in the median SLEDAI score after vaccination (8 vs. 6, P =0.2). One subject experienced an adverse reaction after initial vaccination, and two subjects developed severe pneumococcal disease despite vaccination. After initial vaccination, 59% of subjects did not achieve protective titers. The median time to inadequate response after initial vaccine was 0.73 years (0.16 to 3.1). In unadjusted models, age (HR + 1.2, P = 0.02, 95% Cl = 1.02 to 1.4) and hydroxychloroquine use (HR = 2.4, P = 0.05, 95% Cl = 1.0 to 5.7) were associated with decreased response. However, after adjustment for age, sex, and ethnicity, disease characteristics and medication use were not associated with lack of immunologic response to PPV. Conclusion:PPV was well tolerated in our cohort, but the majority of subjects failed to demonstrate adequate immunologic response to initial vaccination. Disease characteristics and medication use did not explain the lack of response. Pneumococcal infection may occur despite vaccination. PPV vaccination is recommended for patients with pediatric SLE but future studies in larger cohorts are needed to delineate risk factors for lack of immunogenicity. Relationship between severe pneumococcal disease despite vaccination and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unspecified) therapy was unknown. Additional information is not expected.
From telephone correspondence received at manufacturer on 11/06/02, it was reported that a 7 year old male child was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0930FA). The pt experienced chills, temperature 99.9F, and body aches for a period of 2 days after vaccination.  He had not previously been immunized with Flu vaccine. The pt recovered.
states fever & chills Saturday 1AM 7NOV98;h/a from 7NOV98  11AM-8PM;
This spontaneous report as received from a consumer refers to her daughter, a 15 year old female patient. In April and July 2012 the patient was vaccinated with GARDASIL (lot # not reported). The patient was diagnosed with fibromyalgia. Adverse event onset date was reported as July 2012. It was unspecified whether the patient sought for medical attention. The outcome of fibromyalgia was unknown. Additional information is not expected.
Information has been received from a registered nurse concerning an eight month old "healthy" male patient who on 08-AUG-2005 was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (0.5 ml) (intramuscularly) (lot 647363/0944N), in the left vastus lateralis, instead pneumococcal 4 6B 9v 14 18C 19F conj vaccine.  There was no concomitant medication.  The nurse reported that a follow up call was placed to mother of the child who stated child seemed fine and no adverse event.  However, two days post vaccination a phone conversation with father of the child says there was a mark on the child's leg and child's eyes were swollen.  Father of child told nurse he may take him to the emergency room.  No product quality complaint involved.  Additional follow up information from the registered nurse reported that " no adverse event, client not seen by physician".  No relevant diagnostic laboratory tests performed.  The patient had no prior adverse following vaccination.  No further information is expected.
Arm was little sore; injection site itchy; injection site swelling; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was little sore), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was little sore), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). On 02-Mar-2021, PAIN IN EXTREMITY (Arm was little sore), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. Treatment medication include Baby Benadryl
Nurse dropped open needle on the floor; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Nurse dropped open needle on the floor) in a female 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 DEVICE CONNECTION ISSUE (Nurse dropped open needle on the floor). At the time of the report, DEVICE CONNECTION ISSUE (Nurse dropped open needle on the floor) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
client given vaccine that had expired 12/22/21.  Vaccine given in left deltoid. client tolerated well with no signs or symptoms of adverse reactions.  Medical Director notified and advised that client should not be redosed unless directed by manufacturer. Manufacturer notified and given details of incident. Manufacturer to provide guidance from medical guidance team.
eyes got 25% worse (inc near sighted) p/3rd dose in post exposure rabies series in SEP94;series was d/c;
Swelling, pain, redness in (L) deltoid. Pt has been taking Benadryl every 4 hours and it seemed to be working (per PA chart note). Pt also applying ice.
Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and body felt hot General tired and achy lasting 4 days
Delayed/skipped menstrual cycle. Vaccine was received on 10/14/22, and my next menstrual cycle should have started around 10/23/22 at the latest. Instead, I had no menstrual cycle until 11/28/22, 64 days after my prior cycle. This is the first time I have ever missed a cycle other than during pregnancy and nursing.
*On Saturday, February 20, 2021, I began feeling a slight burning sensation under my left side, under my armpit area. I also noticed small, red blotches.   *By Sunday, February 21, 2021, there were more blotches that had spread across to my back and across my chest on the left side. There was severe burning, zinging pain that traveled across my chest, under my left arm, and across to my back. * Monday, February 22, 2021, I visited the Doctor who confirmed it was shingles.  She prescribed 1 gram of Valacyclovir (Valtrex) 3x daily for 7 days. *The shingles have now covered my entire left breast,  under my entire left arm area with a huge patch on my back. It has become extremely uncomfortable with much burning, stinging, and zinging that travels along the rash area and down my left arm.
PATIENT FEELS HER ARM IS HEAVY AND UNCOMFORTABLE WHEN SHE LIFTS ARM TO REACH SOMETHING.
Patient had vaccine on 3-4-22. She tested positive for covid on 3-8-22.   (We later found out she was exposed on 3-5-22). She had mild symptoms 3-8-22 through 3-10-22. Then for an unknown reason, she had an anaphylactic reaction on 3-12-22. She started with itching and hives and then within 5 minutes had difficulty breathing and stridor.  Epinephrine reversed her symptoms quickly. She had not eaten anything for about 5 hrs prior and cause of anaphylaxis is unknown. Patient saw her pediatrician Dr,  the following week and he felt the vaccine could have been the cause of the reaction. However her allergist, whom she also saw the following week, did not feel it was due to her vaccine but more likely a post viral response from having  covid itself along with some other unknown factor since anaphylaxis is more of an acute reaction and he would not have expected such a delayed reaction.
PATIENT DID NOT HAVE ANY SIDE AFFECTS FROM VACCINE. I NEEDED TO REPORT BECAUSE WRONG VACCINE WAS GIVEN. I HAVE TALKED TO MOTHER OF CHILD MOTHER STATES CHILD IS DOING GOOD.
starting 4/8/21 headage, feeling slighly ill starting 4/9/21 pain in right ear tragus during whole day on 4/10/21 in the afternoon: strong vertigo lasting about one minute, no longer pain in ear that day
Aches and Pains in the muscles, hurt to move, Numbness and tingling of legs, unusual tiredness, headache, drowsiness, general feeling of illness.
patient had J&J 1/18/2022, external admin on 7/8/2022 and Novavax on 10/19/2022  2021: Pfizer admin 3/15/2021, 4/5/2021, 8/15//2021
Initial report received from literature on 11 April 2014. A 6 adult patients of age below 65 years, whose concomitant medications were not reported, had received 2013-14 seasonal Influenza Vaccine (batch number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The department of public health conducts surveillance on severe influenza like illness aged less than 65 years. This case includes the influenza with symptom onset on or after 29 September 2013 of 2013-14 influenza seasons. There were only 6 out of 28 patients whose vaccination status were known had received 2013-14 influenza seasonal vaccine greater than or equal to 2 weeks before symptoms onset. DPH sought the data from autopsy and medical records for fatal cases and reviewed available data for all severe cases for 2013-14 season vaccine. Data review includes patient's demographics, clinical courses and treatment underlying medical conditions, influenza vaccination status and underlying medical conditions. There were 3 fatal influenza cases includes children aged less than 18 years and one fatal case includes a patient less than 5 years old. Of six patients with no known comorbid conditions predisposing them to complications from influenza, as defined by ACIP three were obese with body mass indices of 30-39. The data from 2013-14 influenza vaccination season indicates that the patients aged 41-64 years are at the higher risk of influenza. The antiviral treatment was underutilized by these patients and overreliance on rapid diagnostic test with poor sensitivity. The patient's died on unspecified date. Documents held by sender: none.
Mother gave the wrong age of the patient and a Pfizer was given to an 11 y/o patient.  Mother indicated the patient was 12 years old.  Pt had no adverse reaction to the vaccine
Friday evening, 8 days after my original injection, I developed a headache and  2 inch red, hard, raised, painful and itchy lump at the site of the injection.  The headache is gone and the arm is getting better though the pain and itchiness are still present.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-DEC-2016, the patient was vaccinated with a dose of VARIVAX, intramuscularly rather that subcutaneously, for prophylaxis (dose, anatomical location, lot/batch number and expiration date were not reported). No adverse effects were reported by patient. Additional information has been requested.
Case number PHEH2016US029108, is an initial spontaneous report received from a nurse on 03 Nov 2016. This report refers to a 31 years old female patient. Past medical history and concomitant medications were not reported. This 31 year old breast feeding patient was vaccinated with FLUCELVAX (batch number 187276) at a dose of 0.5 ml intramuscularly on 08 Oct 2016. No adverse event was reported following vaccine exposure via breast milk. The case was lost to follow up at initial.
2 patients received Adacel, Pentacel, Ipol and Quadracel vaccine which were exposed to a temperature of 51 degrees Fahrenheit for a total of 5 to 6 minutes due to human error refrigerator door was left open; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves 2 patients who received doses of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], IPV (VERO) [IPOL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine which were exposed to a temperature of 51 degrees Fahrenheit for a total of 5 to 6 minutes due to human error refrigerator door was left open lot number and expiry date not reported on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.