chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 30 year old female pharmacist who is also the patient regarding on herself. On 20-AUG-2014 one drop of ZOSTAVAX (lot # reported as K007548; expiration date: 23-AUG-2015) splashed in her left eye and she ws 35 weeks pregnant. Pharmacist stated she was wearing her contacts and gloves at the time of administration. Pharmacist stated she flushed her ye with water after incident. She was not experiencing any symptoms and her eye was not red. The patient was 35 weeks pregnant on 21-AUG-2014 with last menstrual period (LMP) of 19 DEC-2013 and Estimated Date of Delivery (EDD) of 25-SEP-2014. The pregnancy outcome was pending.  The outcome of one drop of ZOSTAVAX splashed in her left eye when she was administering the vaccine to the patient, she was not experiencing any symptoms and she was 35 weeks pregnant and drop of ZOSTAVAX splashed in her eye was unknown. This case was related to the patient who also experienced adverse events MARRS1408USA013266. Additional information has been requested.
began 9JUL98 w/few vesicles on torso, face, & legs;afeb;very irritable;
Patient present with mother for second dose of covid pfizer vaccine. Patient has allergies to peanuts and tree nuts - was waiting 30 minutes.   Vaccine administered at 1054.  At 1115 patient called RN over to bedside for itchiness and hives developing on chest. Denies difficulty breathing at this time. Dr. called to bedside and put orders for 5ml of benadryl.  1120 Benadryl administered. Mother decided to stay additional 10 minutes for observation.  1127 patient stated she was having minimal difficulty swallowing her saliva. Denied difficulty breathing at this time. Vital signs were taken with continuous o2 sats. Dr. notified and additional orders placed. Benadryl 37.5mg (15ml) given to patient.   Dr. prescribed prednisone 60mg at 1211. Patient took medication in office and observed for 30 additional minutes.
Pt thinks he developed a rash after receiving yellow fever vaccine approx 3 weeks ago. Not sure, but he might have had the rash before this shot. Rash is more notable on tops of feet, knees, and right hip. Rash is itchy. Denies fever, cough nose bleeds. Cream 0.05% applied to affected areas bid given topical.
The patient was gave a Meningococcal Group B , instead of Meningococcal Conjugate (MCV4).. There has been no treatment, the parent has been notified along wit a vaccine administration error report has been  submitted.
Patient received Pneumococcal 23 in her left arm at clinic.  Lot # S002640 exp 9/19/20.  Then she went to Pharmacy that same day and received the Shingrix vaccine.   She developed the following symptoms:  Bad Headache, chills (didn't take temperature), nausea, abdominal cramping, body aches, joint aches.
At 5AM a 17 year old female accompanied by her sister which is her legal guardian, received first dose of Pfizer. While patient was in observation she became dizzy, passed out, and fell on the floor and hit her forehead. Patient was immediately attended to by clinical staff. Within less then a minute patient was alert and oriented X3 but could not recall what happened. Ambulance was called, and site lead was made aware. Vital signs at the time were BP: 90/45, O2 100%, HR: 55. Ambulance arrived on scene and assessed patient. Vital signs upon transfer to hospital 111/56 HR78. Patient was transfer to hospital.
The pt reported that he received his 1st injection of Lymerix in 5/99; exact date of IZ was not provided. On 6/23/99, a dx of "sensory motor hearing loss" was reportedly made. The pt stated that he underwent "several" unidentified procedures to correct the hearing loss, but "it has reverted back to the way it was in the beginning". The pt stated that he received the second injection of Lymerix 3 to 6 months following the 1st injection. The Lymerix IZ series was then discontinued. The hearing loss in this report is considered to be an "Other Important Medical Event".
welts in small patches; itching at arm; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of  Pain in extremity (arm was sore), Urticaria (welts in small patches) and Urticaria (welts in small patches)  in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milligram.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) administered intramuscularly, the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter.
After H1N1 injection right arm ached when raised above head until now. No redness, or bruising, or hives. (2/4/10)
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No medical history was reported.    On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 28-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 28-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
. Pt was vaccinated with Moderna on 3/12 and 4/9/21 and pt was admitted on 6/15/21 with an acute stroke and L carotid thrombus despite being on eliquiss.  CTA head and neck showed a non occlusive thrombus of the Left internal carotid artery. Pt admitted for acute L frontal lobe stroke. Was not given TPA in the ER as was out of the window and is on eliquis chronically for past hx of RLE Dvt and partially occluded IVC as a resulted of a complication she suffered from a kyphoplasty procedure in 2017. She has no hx of atrial fibrillation or clotting disorder and has been compliant with her eliquis per the pt and spouse. She does not smoke, her aic is 5.2 and her ldl is 101. Her echo showed no ventricular thrombus and was a neg bubble study with nl EF. she was transferred to a higher level of care for possible neurovascular intervention. She did not ultimately require neurovascular intervention and Her acute ischemia was presumably due to artery to artery embolus causing left ICA thrombus and was not felt to be an eliquiss failure and she was discharged home on 6/17. she was also found to have a klebsiella uti and was sent home on oral antibiotics.    covid 19 neg
Date of Admission: 10/20/2022   Date of Discharge: 10/24/2022   Admission Diagnosis: Altered mental status, unspecified altered mental status type      Hospital Principal Problem (Discharge Diagnoses): COVID
Swollen lymph node in left armpit for the past 3 days. Somewhat sore.
sore arm (at site of injection); achy muscles; achy knees; general fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 09:15 (Lot number: EL0217) at the age of 34 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Sep2021 19:00, outcome "recovering", described as "sore arm (at site of injection)"; MYALGIA (non-serious) with onset 29Sep2021 19:00, outcome "recovering", described as "achy muscles"; ARTHRALGIA (non-serious) with onset 29Sep2021 19:00, outcome "recovering", described as "achy knees"; FATIGUE (non-serious) with onset 29Sep2021 19:00, outcome "recovering", described as "general fatigue". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, arthralgia, fatigue.  Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been not tested for COVID-19. Yes, the patient had been taking other vaccine in four weeks. Other vaccine 4 weeks details other vaccine 4 weeks product: Flu. The report was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021 at 2:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 2:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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. The age of patient was reported as 83.43. Concomitant product use was not provided by the reporter. Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature 29 and 32 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 29-Sep-2021 and 05-Oct-2021, beyond use date for the vial was reported as 29-Oct-2021 and 04-Nov-2021. Product moved to clinic on 27-Oct-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 Fisherbrand traceable temperature monitor at every hour. Treatment information was not provided. This case was linked to MOD-2022-566976 (Patient Link).
chronic cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (chronic cough) in a patient of an unknown age and gender 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (chronic cough). At the time of the report, COUGH (chronic cough) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine product; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 64 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Lot number: 046A21A), in right arm, on 23Apr2021 as dose 2, single (Lot number: 027B21A), in right arm and on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "glaucoma" (ongoing), notes: Only take two RX and those are eye drops for glaucoma and dry eye disease; "dry eye disease" (ongoing), notes: Only take two RX and those are eye drops for glaucoma and dry eye disease. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine product"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Negative, notes: Tested three times negative within two days; (May2023) Negative, notes: Tested three times negative within two days; (May2023) Negative, notes: Tested three times negative within two days; (May2023) Positive, notes: Took the test again three times showing positive to the virus; (May2023) Positive, notes: Took the test again three times showing positive to the virus; (May2023) Positive, notes: Took the test again three times showing positive to the virus. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid for COVID 19 Treatment from 11May2023 to 16May2023 (Lot number: 00069-0345-30). The patient had no known allergies.
Employee seen two days after administration. Site red (appx 2" diameter) and warm to touch. Ice packs and Tylenol ordered by physician. Personal physician contacted.
This 8 yr old female was vaccinated with Varivax, on 6/12/07. She was seen with Dehydration on 7/19/07. Admitted on 7/29 and Dx with Guillain Barre by neurologist.  08/13/2007 MR received for DOS 7/29 to 8/2/2007.   Child presented to the ED with worseninglower extremity weakness and difficulty walking.  Child had a 2 day hx of nausea/vomiting attributed to viral infection. She recovered and LE weakness began several days later with more N&V. % lb weight loss due to decreased po intake.  PE (+) for elevated BP, tachycardia, LE proximal muscle weakness, unsteady gait. LE reflexes absent.  Child remained hypertensive with BPs 130-140s /100s initially but dropped with antihypertensives. Critical care note on DoD/C  with following Assessment:  1)Guillain Barre Syndrome 2) Hypertension 3)  Tachycardia resolved  4) Mild LVH. 09/04/2007 D/C summary received for DOS 7/29-8/02/2007 for admitting DX of lower extremity weakness as above. Bilateral lower extremity paresthesias and proximal muscle weakness present upon exam. Discharge PE with no neurologic focal deficits and grossly intact cranial nerves. D/C DX:  Guillain-Barre Syndrome . 02/02/2010 Child still experiences weakeness in the lower extremities. However she is off the walker.
Much swelling in multiple sites below injection site, swelling, heat and pain lasted til 12/3 4 attack attack of Afib 24 hours later (11/30) that took me to emergency room, treated, kept overnight and released  on 12/1.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had one temperature excursion of 96 hours with a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Localized erythema, induration.  Complaints of pain/ itching.  Not a systemic reaction.
Rash at injection site along with chest and back pain on left side which traveled to his right side
Patient reported her mouth was dry, her throat closed up and it was difficult to breathe 30 minutes after getting the Moderna vaccine.  Her husband drove her to the fire station near her home where she was monitored for a couple hours.  They told her to drink lots of water and breathe through her nose.  They monitored her vitals.  She reported increased blood pressure and heart rate and low oxygen.
My right ear developed a progresssive pressure/muffling similar to getting water in the ear over a 2 hour period. By 5:00 PM I felt almost 90% deaf in the right ear. Over the next two days the pressure and sensation reduced and went away, but leaving a high pitched tone in right ear, continues to present. Went to ENT 11/5/09 and evaluated with Audiology testing. Recommend to follow-up in one month to assess.
Headache, Myalgia, Fever, NauseaVomiting, CHILLS Narrative:  Other Relevant History:
Information has been received from a registered nurse concerning a 14 year old female with no medical history and no allergies who on 30-APR-2007 was vaccinated with a second 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 657193/0363U)in the left arm. There were no concomitant medications. There was no illness at the time of vaccination. On 01-MAY-2007, in the morning, the patient experienced a baseball sized red, hot, swollen and painful area of the arm at the injection site that was warm to touch. No treatment was required. There were no laboratory or diagnostic tests performed. The patient recovered on 03-MAY-2007. No additional information was available. No product quality complaint was involved. This is one of several reports received from the same source. Follow-up information received from a registered nurse stated that the patient's symptoms were self-limiting and went away in approximately 72 hours. There was no treatment necessary. There were no other visits nor was any follow-up needed. No further information is expected.
Cotton mouth Felt like mouth/throat were closing Trouble breathing Sore all over - burning sore
Patient stated that she felt fine until 3 to 4am the day after she felt sick went to the bathroom thinks she fainted at least 3 times. Her husband saw her and take her emergency room about 10am. Her blood pressure at emergency room was low about 65 to 69. He was discharged to go home at 130pm on the same day. After 48 hours her pain level was at 3 out of 10.
Arm was very sore; Two patients receive doses diluted with 0.8ml rather than 1.8ml; Two patients receive doses diluted with 0.8ml rather than 1.8ml; This is a spontaneous report from a contactable pharmacist via medical information team.   A 17-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot number: EW0179) via intramuscular route of administration, administered in deltoid left on 20Jul2021 at 11:30 (at the age of 17 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. Prior vaccination was none. Vaccination facility type was Doctor's office/Urgent care. Vaccine was not administered at facility. It was reported that they didn't dilute appropriately, and they gave a more concentrated dose. They were wondering if there was any literature or anything available on instructing and what to tell patients. Two patients were affected and received the vaccine which happened about an hour ago. The reporter does not have any patient identifiers or any details to complete report. It was clarified that it was 2 patients who had received the vaccine. It had been reconstituted with 0.8 ml of diluent rather than 1.8 ml. On 21Jul2021, the patient experienced arm was very sore. Therapeutic measure was taken as a result of arm was very sore. The reporter reported that, during preparation of COVID vaccine 0.8 ml of saline was used to dilute instead of 1.8 ml. This resulted in an overdose that was given to the patient. Patient stated arm was very sore the next day and was using Ibuprofen to help. No further issues. On 22Jul2021, the event arm was very sore resolved.   Information on lot/batch number has been requested.  Follow-up (02Sep2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (07Sep2021): This is a Follow-up spontaneous report received from a contactable pharmacist. This pharmacist reported for a 17-years-old patient in response to HCP letter sent which included: Patient's age, Age group, Age at vaccination, New event of arm was very sore, Onset time of events (overdose and product preparation issue) updated, Suspect dose details, Route of administration, Vaccination time, Batch/Lot number, Location of vaccination, Medical history and concomitant medications (unknown), Clinical course of events and additional information (Prior vaccination was none, Vaccination facility type was Doctor's office/Urgent care. Vaccine was not administered at  facility).  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 23-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L034724 expiration date: 09-DEC-2016) for prophylaxis (dose and route of administration were not provided). No side effects reported. Additional information has been requested.
Breakthrough COVID Hospital. Pt vaccinated on 2/5/21 and 2/24/21, did not receive a booster. Patient arrived to ED on 1/25/22 with c/o cough with green sputum, wheezing, chest congestion and decreased appetite. Denies other symptoms. ED workup included normal chest XR, positive COVID test, IV steroids and inhalers. Admitted for COPD exacerbation and covid.
Pt was given PPV-23 in (R) deltoid on 11-6/07. She reports area swelling that night with fever and chills. Today (11-8-07) returned to health unit for evaluation. (R) deltoid area to elbow area red and swollen, warm to touch. Pt reports is little better than it was. Plans to call PMD to let him know.
After getting the first dose, two weeks later on July 27 I started getting a light period (two weeks early.). My periods are very regular and come on time every month and I keep track of them. My period lasted 7 days. I went in on August 3rd to get my second shot and on August 4th in the afternoon (today). I started to bleed very heavy and have really really bad cramping. This is not normal for me.
Altered smell and taste on certain foods and items. Has a rotten smell/taste to certain items. Including lemon Gatorade, chocolate, coffee, gasoline, Gain laundry detergent powder, etc. Treatment as an allergy by doctor including antibiotics and nasal spray. Effects still the same with no change.
c/o back pain started in PM p/recv vax approx 5 1/2hr p/vax;