chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Baby having problems going to the bathroom-moving her stools; Baby also having problems with acid reflux; vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL FAECES (Baby having problems going to the bathroom-moving her stools), GASTROOESOPHAGEAL REFLUX DISEASE (Baby also having problems with acid reflux) and EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) in a 1-month-old female infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the infant was diagnosed with ABNORMAL FAECES (Baby having problems going to the bathroom-moving her stools), GASTROOESOPHAGEAL REFLUX DISEASE (Baby also having problems with acid reflux) and EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred  on 30-Nov-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, ABNORMAL FAECES (Baby having problems going to the bathroom-moving her stools) and GASTROOESOPHAGEAL REFLUX DISEASE (Baby also having problems with acid reflux) outcome was unknown and EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported. Treatment information was not provided   This case was linked to MOD-2022-464894 (Patient Link).
Anaphylaxis, blurred vision, fever, cough, swelling of lips and eyes, myalgias symptoms lasted from 3 pm until 8 am 12/6/05. Recovered fully.
This spontaneous report was received from a nurse referring to a patient of unknown age. On 08-AUG-2017, the patient was vaccinated with M-M-R II lot # M017346, expiration date 06-ABR-2018, intramuscularly, rather than the subcutaneous route, for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT).
Extreme aching in left arm at injection site; Bruising; Sore throat; Chest tightness; Ache in both legs and down left side of body; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 17:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Patient had no drug history. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 17:00 (at the age of 39-year-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 01May2021 at 08:00, the patient experienced extreme aching in left arm at injection site, extreme ache in down left side of body and both legs, bruising, sore throat and chest tightness. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event extreme aching in left arm at injection site, extreme ache in down left side of body and both legs, bruising, sore throat and chest tightness was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient details (initials). Updated Vaccine start time (17:00), treatment received for events was no. updated narrative (Administration time for 1st and 2nd dose updated from 05:00 to 17:00 (05:00 PM), "No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had no allergies to medications, food, or other products" added).
Complex febrile seizure (15-20 min of generalized T-C seizure but with eye deviation to the right). Fever 39. Hoarseness. RSV antigen positive. Rec'd 0.75 mg Lorazepam in ER. Hospitalized for observation overnight.  4/13/09 MR received for DOS 3/22/09 with final dx:  Complex febrile seizure.  RSV infection. Pt presented to ER following an episode of seizure and fever.  Recently pt had some hoarseness, loose stools, 1 episode of vomiting and irritability.  Pt found unresponsive with jerking extremities, eye deviation to the right and gurgling. Still seizing on arrival to ED for a totoal of 15-20 minutes. Somnolent after. Tx with lorazepam with improvement and d/c same day.
Fever of 4+ degrees F, body aches, 10lbs+ water weight gained in one day, severe left arm pain to the point of tears if arm needed to be moved (carried in a sling for 24 hours). Extreme fatigue, unable to attempt normal ADLs, dizziness, brain fog, joint pain (worst in wrists, ankles, knees, hips and neck). 2nd shot was more severe, hit harder and more quickly, was unable to do anything by lie still with eyes closed for nearly 24 hours. 2 hours of sleep, woke up covered in sweat, mild shaking, dizziness, nausea, difficulty eating, migraine headache (with light/smell/sound sensitivity, but no aura). Symptoms lasted for 48 hours round two.
Patient received Covid vaccine at age 15, not approved for use in this age. No current reported adverse events.
Large swollen, hot arm, itchy, no signs of hypotonic.  Seen 2-9-08 by doctor.
Upper left arm inflamed and sore. Pt experienced nausea and went to hospital and received BENADRYL and a shot. Came to pharmacy today to report.
Body pain, back, joints, arms and ankles. Skin itching in all body. When I sweat, some blisters appear at both arms skin.
Resident became hypoxic and possibly aspiration transported to the ER. Resident passed away on the 1/16/2023
It was reported that a 22 year old female received the Fluzone SB '99-'00 vaccine on 11/24/99. Reportedly, 6 hours, post vax, the pt started vomiting and vomited at least 6 times between 20:00 on 11/24/99 and 07:00 on 11/25/99. On the morning of 11/25/99, both sides of the pt's jaw started to ache, especially when opening her mouth or chewing. The pain was still present on 11/29/99. From correspondence received on 2/3/00, additional vaccine information was provided.
Information was received from a nurse practitioner concerning a 2 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.  On 16-AUG-2016, the patient was vaccinated with a first dose of VARIVAX (lot#, expiration date, dose and route were not reported)  and on 15-DEC-2016, the patient was vaccinated with an inadvertent dose of ZOSTAVAX (lot#, expiration date, dose and route were not reported) for prophylaxis. No adverse symptoms were reported.No product quality complaint was involved. Additional information is not expected, as all scheduled correspondence was returned.
According to MD, patient complained of loss of sensation and tingling of fingers/arm. Patient's caretaker noticed some swelling when patient had pain in arm 48 hrs after shot was given and no relief from TYLENOL.
Redness, swelling of arm, great pain, slept in chair for 2 nights.  Doctor ordered ultrasound of arm after seeing it on second day.  Very Very sore and inflamed.  Said it was a very bad reaction.
Headache (7 days) Tingling sensation on bottom lip  (1 day) Pain/Soreness at injection site (5 days) Pain/discomfort from injection site down to my hand (3-5 days) Fatigue (3-5 days) Slight body aches (3-5 days) Elevated heart rate (1-2 days)
Narrative: 89yo male patient who receives most of his care outside clinic died on 10/31/2021. No info given on cause of pt's death. No info on events leading up to pt's death. Last note from 5/2021. See pt's clinic problem list below: 8 Active Problems PROBLEM LAST MOD PROVIDER Bilateral arthritis of knees (SCT 03/20/2019 1074871000119108) (ICD-10-CM M17.9) Cognitive disorder (SCT 443265004) (ICD-10-CM 08/19/2016 G31.09) Constipation (SCT 14760008) (ICD-9-CM 564.00) 08/19/2015 Personal History of Venus Thrombosis and 5/12/2014 Embolism (ICD-9-CM V12.51) Long term (current) use of Anticoagulants 10/21/2013 (ICD-9-CM V58.61) (ICD-10-CM E78.5); Hyperlipidemia (SNOMED CT 02/19/2016 55822004) (ICD-10-CM I10.); Benign essential hypertension 02/19/2016 (SNOMED CT 1201005) Cerebrovascular accident (SCT 230690007) 11/12/2013 (ICD-9-CM 436.) Mri 10-2013, r parietal, occipital Pt had received covid vaccines on 3/19/21 & 4/9/21 from outside provider. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
4/7/2021 patient had a normal cbc with differential. on 4/8/2021 she received the J&J vaccine. On 5/6 and 5/25 she was hospitalized with GIB secondary to AVMs. However, from a hematology perspective she has  bicytopenia. Further workup as outpatient determines she has continued bleeding issues, clumped platelets, elevated platelet factor analysis. We are going to do a bone marrow biopsy.
Transverse myelitis with hemiparesis truncal weakness, MRI changes in spinal cord from C4 to T 11   Onset of transverse myelitis 2/20/2008 Vaccine given 11/19/2007  IVIG, Steroids given for transverse myelitis given during hospitalization at Hospital.  Patient now in Rehab hospital.  3/11/08 Reviewed D/C summary from hospital for 2/23-3/07/2008 admission. FINAL DX: Transverse myelitis. Patient experienced progressive ascending paralysis x 2 days, back pain, balance difficulty w/falls & fever.  On admission, was unable to walk, had to crawl.  Patient transferred from outlying ER to PICU. Neuro consult done.  Tx w/IVIG x 4, IV steroids & pain meds.  Transferred to ped floor, improved  to be able to walk w/walker & d/c to inpatient rehab on tapering steroids.   3/11/08 Received additional hospital  med records which reveal patient also experienced right foot pain & weakness which quickly progressed to paraplegia w/urinary incontinence, areflexia & absence of pain sensation.  Optho exam WNL.
Patient reports (not witnessed) extreme swelling at injection site. Flu like symptoms-stiff neck-sore joints-(shoulders/elbows/back). Duration at 48hrs.
This spontaneous report was received from a healthcare Worker and refers to a patient of unknown age and gender. No pertinent medical history,  or drug reactions / allergies were reported. On unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (which had a lot # of R006753 and an expiration date of 06-MAR-2020; however, dosage number and route of administration were not reported), for prophylaxis. The diluent used to reconstitute the vaccine was properly stored. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 6 F degrees to 14 F degrees (9.5 F degrees) for 1 hour and 6 F degrees to 14 F degrees (6.4 F degrees) multiple excursion for 50 minutes. Reportedly, there had been previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved.
vaccine had been put into the syringe the night before and thus it was considered null and void; first dose not guaranteed as valid; Got administered with total 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine had been put into the syringe the night before and thus it was considered null and void), PRODUCT PREPARATION ISSUE (first dose not guaranteed as valid) and OFF LABEL USE (Got administered with total 3 doses) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine had been put into the syringe the night before and thus it was considered null and void), PRODUCT PREPARATION ISSUE (first dose not guaranteed as valid) and OFF LABEL USE (Got administered with total 3 doses). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine had been put into the syringe the night before and thus it was considered null and void), PRODUCT PREPARATION ISSUE (first dose not guaranteed as valid) and OFF LABEL USE (Got administered with total 3 doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment details were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: No specific follow-up information recorded. On 28-Jun-2021: Patient height and weight updated and mentioned second dose received after 1 month
Growing redness and tenderness in the place of shot. Doesn't hurt too much, but growing in size. Was advised to report and contact the provider to take a look.
Pain and redness at injection site (within 12 hrs of administration Extreme myalgia, fatigue, fever (began within 18 hrs of administration and lasted 24 hours)
The client was transferred to this hospital from another hospital.  The hospital did not have documentation of prior COVID-19 vaccination.  The client received a Moderna COVID-19 vaccination at the facility on 9/8/21 at 4:43 pm in the right deltoid.  Upon Database entry of immunization it was discovered that the client had already received 2 prior Moderna COVID-19 vaccinations on 12/31/20 and 1/28/21.  The client, nurse, and provider were notified. The client was monitored for any adverse reactions to the 3rd Moderna COVID-19 vaccination received.  Vitals remained at baseline with no fever documented.  The client was administered one dose of acetaminophen 650 mg on 9/8 at 6:11 pm, 2 doses 9/9-9/12 and 1 dose on 9/13 for pain.  No other treatment was necessary.
Patient fainted after the shot. She would come in out though 911 was called and they checked her sugar (blood sugar) it registered as 67. Mom said that they didn't go to the ER and patient recovered and is now well.
Receiving a "Cortizone" shot on her foot.; This is a spontaneous report from an agency. This is a spontaneous report from an agency. A 77-year-old consumer female received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number -not reported) via unspecified route of administration as dose 2, single and first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number -not reported) via unspecified route of administration (age at vaccination 77 years) for covid 19 immunization. The patient medical history and concomitant's medications were not reported. Patient was scheduled to take her booster shot on Monday 01Nov2021 as well as receiving a Cortizone shot on her foot. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.  Reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/13/21pfizer,Lot#EL3248 2nd dose: 02/03/21Pfizer,Lot# EL9264 Diagnosed covid positive:04/19/21 Exposure:Unknown Symptoms:loss of smell,taste,ABD pain,runnny nose,sneezing.
Arm became red, swollen , hot and extremely itchy,  Lasted about 5 days.
Dizziness like when you're drunk; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness like when you're drunk) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fall (History of falls). Concurrent medical conditions included Dementia (Which varies in severity daily).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness like when you're drunk). At the time of the report, DIZZINESS (Dizziness like when you're drunk) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.  Patient reports the occurring of dizziness when  woke up the morning after receiving the dose.  Action taken with mRNA-1273 in response to the events was not applicable.
Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4289030-00 (Agency).  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis, psoriasis, colitis ulcerative; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: 04Feb2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "Mycoplasma infection". The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 25Feb2021, outcome "recovered" (01Mar2021), described as "Rheumatoid arthritis flare up". The action taken for upadacitinib and adalimumab was unknown. Clinical course:The reporter causality for the event of rheumatoid arthritis flare up was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: based on a positive temporal relationship, causal relationship between the reported event rheumatoid arthritis and the suspect BNT162B2 cannot be excluded.  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.
Got notice that expiration date is 9/30/22 even though we received it and placed it in the fridge 8/26/22 and should have been good for 10 weeks
This spontaneous report as received from a pharmacy technician concerning an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date, the patients were vaccinated with an unspecified number of improperly stored ROTATEQ (dosing details were not reported) lot # L042216, expiry: 13-JUN-2017 lot#L035510, expiry: 13-MAY-2017 and lot#L029615, expiry:15-MAY-2017. There were no product quality complaints (PQC) involved. No adverse reactions were reported. Additional information has been requested.
Injection PNEUMOVAX 23 right deltoid 8/7/14. 8/9/14 pt call concerning nausea. 8/10/14 pt to ER with cellulitis Rt arm (see picture). ED physician started on IV antibiotics admitted to hospital.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        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 concomitant medications were provided.  No treatment medications were provided.
Inject site reaction on left arm triceps region. Red and warm to touch. Measured 2 in wide by 4 in. long. Instructed patient to take 50mg Benadryl and to follow up with physician on next day to determine if any additional action will be necessary.
Nausea Vomiting  Vaccine site red and warm X 24 hours  Narrative:
Patient developed fever up to 103.2 F rectally on 3/26/2009 - and an erythematous papular rash - descendant - started on face on 3/27/09. Fever resolved on 3/28/09. Rash is less prominent but still present today, on trunk/limb. Child also has small retruauricular adenopathies, soft, nontender.