chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT C/O SORTNESS OF BREATH AND WHEEZING. SWOLLEN, SORE, RED AND WARM TO THE TOUCH VACCINATION SITE. PATIENT CALLED THE DR. ON CALL FOR ADVICE. SHE WAS INSTRUCTED TO FOLLOW UP WITH THE IMMUNIZATION CLINIC THE FOLLOWING MORNING.
She says some people didn't have any problems but others had more reactions than they did with their first 2 doses.; the full dose instead of the half dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She says some people didn't have any problems but others had more reactions than they did with their first 2 doses.) and ACCIDENTAL OVERDOSE (the full dose instead of the half dose) 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 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (the full dose instead of the half dose). On an unknown date, the patient experienced VACCINATION COMPLICATION (She says some people didn't have any problems but others had more reactions than they did with their first 2 doses.). On 22-Oct-2021, ACCIDENTAL OVERDOSE (the full dose instead of the half dose) had resolved. At the time of the report, VACCINATION COMPLICATION (She says some people didn't have any problems but others had more reactions than they did with their first 2 doses.) outcome was unknown.            Concomitant medication were not reported. No treatment details were provided.   This case was linked to MOD-2021-366021 (Patient Link).
Patient received vaccine at 11:02 am. During her observation period, her husband notified me at 11:14 am  that the patient "felt like she was going to pass out". Upon assessment patient was diaphoretic. Denied any shortness of breath or difficulty breathing. Initial vitals at 11:15 showed blood pressure 110/70, Heart rate 70, spO2 87%. At 11:20 the pulse oximeter showed spO2 70% and HR 150 bpm. Ambulance was called. The pulse ox was moved to other hand and showed a reading of 81% and HR 140 bpm. Patient was still diaphoretic and described tingling in to fingers and toes. Fingers were very cold to the touch.  Patient still denied chest pain and shortness of breath or difficulty breathing. Patient was awake and communication throughout event and when trying to sit up described her head as feeling "woozy". Additional reading on pulse oximeter at 11:26 showed HR 155 bpm and spO2 62%. Blood pressure 130/70. Ambulance arrived at 11: 30. Upon their initial assessment her spo2 was 100%, HR 76 bpm- sinus rhythm, and blood pressure 136/76. Patient declined ambulance ride to hospital and was driven by her husband in personal vehicle. Patient was alert and described symptom improvement at time of departure. Patient also stated that she "hadn't been feeling right for a while". I do not believe that this was a true reaction to the moderna vaccine.
Waxing/waning BL hand paresthesias (entire hand) and left lateral thigh. Lasted 10-15 minutes before resolving, occurred 4-5 times since onset. Asymptomatic during ER visit on 10/6/2015 at 10:06.
Myalgia, Fever, rigors, fatigue, deltoid soreness Narrative:  Temp is 100.5, feels like she got hit by a truck. Taking Motrin OTC. Fever continues to spike after OTC.
A non-serious report of "six patients received expired FLUMIST" was received from a nurse concerning a 24-month-old patient (gender unknown). The patient's medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow up received 05/21/2009. Based on the result of the investigation, the root cause for the medication errors were caused by  1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occured shortly after the product expired.
her husband's cousin got pericarditis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERICARDITIS (her husband's cousin got pericarditis) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (her husband's cousin got pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (her husband's cousin got pericarditis) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  It was unknown whether patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication information was not reported.   Reporter did not allow further contact; Reporter's Comments: Company comment: This spontaneous case concerns an adult male patient with no reported medical history who experienced the expected serious (medically significant) AESI of Pericarditis which occurred unknown days after administration of a dose of mRNA-1273.222 bivalent vaccine. Other details have not been reported. The benefit-risk relationship of mRNA-1273.222 bivalent is not affected by this report.
Fever, loss of acquired speech, loss of eye contact, loss of normal interest in her environment. Later diagnosed autistic. Believe mercury damaged. 60 day follow up states pt has not recovered. Autism-severe.
The pt became very irritable and had an elevated temp. Mom stated that the pt had seizures on 5/22 and through the night. The pt also experienced a high shrill cry.
Death; A spontaneous report was received from a consumer concerning a 57 years old male patient who received mRNA-1273 for prophylaxis of COVID-19 infection and had died (death).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 2 Mar 2021, approximately three hours prior to the onset of the symptoms, the patient received hia second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   It was reported that  the patient died three hours after receiving the 2nd dose in the ER. Treatment information was not provided. The cause of death was unknown. Plans for an autopsy were unknown.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event of death  was considered as fatal.; Reporter's Comments: This is a case of sudden concerning a 57 year old male who died three hours after receiving the second dose of the vaccine. Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: unknown cause of Death
This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 31-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Medicaid-VFC (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
rash NOS on 2022-02-18, Other complications following immunization, not elsewhere classified, initial encounter on 2022-03-07.
vasovagal type reaction- pale, clammy. Gave pretzels and apple juice. Recovered and returned to class, notified school nurse as was at clinic without parent/guardian.
Large rash around most of upper left arm. Red ring around upper arm.  Observed  1/28/21.  Skin where shot was administered is tough. Itching on the injection site about a week after the shot. Itching persisted for several days. Contacted my Doctor via patient portal over email and provided her with pictures of the rash on arm. Can provide agency with pictures. Was directed by GP to take Tylenol and Benadryl. Have not taken those at this time.
diarrhea; was very weak; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and ASTHENIA (was very weak) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Stroke, Wheelchair user, Communication disorder NOS and Artificial cardiac pacemaker user. Concurrent medical conditions included Blood pressure abnormal.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and ASTHENIA (was very weak). At the time of the report, DIARRHOEA (diarrhea) and ASTHENIA (was very weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications provided as 13 pills a day (for blood pressure , for everything). Treatment information was not provided
On 3/27/2020, the patient received the second dose of the Pfizer COVID vaccine.  About 3 hours later she started to develop paresthesias in both hands and fingers, as well as pain.  She continued with the same paresthesias and pains; in about a week, she developed  subungual  hemorrhages
Patient had several ED visits within 6 weeks of receiving COVID vaccination. DOS include 3/10/21, 3/18/21, 3/24/21, 4/4/21, 4/7/21. Patient presented to the ED and was subsequently hospitalized on 4/18/21 and 4/20/21. Two more ED visits on 4/21/21 and then was hospitalized on 5/1/21.
Information has been received from a registered nurse concerning a 15 month old male who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently 10 days post vaccination, the pt developed a 103 F fever which resolved in 24 hours. Additional info has been requested.
On 05Mar2021, left arm was itchy and then a red rash approximately 2 in by 2 in  developed at the injection site.  Rash was warm, but not hot.  Rash was mild and I took Benadryl and applied a topical hydrocortisone cream to the rash.  Itchiness was present for about 24-36 hours and rash was present for about 48 hours.  After about 48 hours the rash disappeared and no other side effects were noted.
Patient complained of right hand numbness since Tetanus Diphtheria given 05/13/2005 right deltoid according to patient.  Patient currently seeing neurologist.
Affected individual donated plasma and then received the Twinrix vaccine.  The individual c/o pain with injection and lost consciousness for approx. 10 seconds.  He recovered almost immediately.
Patient started hitting himself in the head and banging his head on the couch after a few hours of being home after the injections.
Employee received .2 cc of Pfizer inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and DOH, decided to offer the employee an additional COVID-19 vaccine dose.  Note: same employee was vaccinated on 1/13/2021 by same vaccinator and .2 cc was incorrectly administered.  Vaccinator was removed from process.  Thanks.
3 miscarriages; Hashimoto's; Arms and legs are burning; I have several swollen lymph nodes that hurt and haven't gone away for over a year and more are appearing; I have several swollen lymph nodes that hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "3 miscarriages"; AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "Hashimoto's"; BURNING SENSATION (non-serious), outcome "unknown", described as "Arms and legs are burning"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "I have several swollen lymph nodes that hurt and haven't gone away for over a year and more are appearing"; PAIN (non-serious), outcome "not recovered", described as "I have several swollen lymph nodes that hurt".  Clinical course: Since receiving 2 COVID-19 Pfizer vaccines and a booster, the patient health has taken a dive, have several swollen lymph nodes that hurt and haven't gone away for over a year and more are appearing. The arms and legs were burning, had 3 miscarriages, and was diagnosed with Hashimoto's. The patient asked is there a way to flush my body of the vaccine? A way to detox from it? A way to reverse all of these negative effects it's been having on my body?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After shingles vaccine got a rash with blisters and pain in arm where injection was given. Took vaccine at pharmacy.
eruption of cold sores on my lip and at the opening of my nostril; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her left arm 02Feb2021 02:30 PM as single dose for Covid-19 immunization. Facility type vaccine: Hospital. The patient's medical history included thyroid condition (being treated) and cold sores. The patient sensitivity to latex, egg, wheat, pollen and evergreen (known allergies). Concomitant medications included levothyroxine, powdered collagen/Goli ACV chews (APPLE CIDER VINEGAR) (other medications in two weeks). It was reported that, on 14Feb2021 12:00 PM, the patient did not have a cold sore in over a year, but had a history of getting cold sores when she was stressed out. But, she did get several 13 days after getting the vaccine. She had an eruption of cold sores on lip and at the opening of nostril (never had them in this location before). Covid was not tested prior or post vaccination. The patient did not take any treatment in response to the events. Outcome of the event was recovering.  Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
No adverse side effects were reported with the administration of the vaccine.; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes) and ROTATEQ (Lot #1968385; Expiration; This spontaneous report was received from an other health professional and referred to a 12-week-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-JUN-2023, the patient was vaccinated with improperly storage pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection through right thigh, strength: 0.5 milliliter, dose: 0.5 milliliter, lot #W039033, expiration date: 01-OCT-2024, administered once for prophylaxis (route of administration was not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1968385, expiration date: 22-MAY-2024, administered once orally for prophylaxis (strength was not provided). It was reported that a temperature excursion (TE) for pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) with current excursion (49.1F) for 34 minutes, with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes; and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (same excursion details) (Product storage error). No adverse side effects were reported with the administration of both vaccines. User of the device was an HCP and product was not available to obtain.  ; Sender's Comments:  US-009507513-2307USA004472:
Had low grade fever (100.9) which continues to now, decreased appetite, pain x 3 days, swelling with hard, raised knot still in place, nausea, diarrhea starting 4/4/2010, vomiting starting 4/6/2010
Nausea, chills, fever, sweats, myalgias, fatigue, red/hot/firm/swollen at immunization site.
Dolor de Pecho  (Chest Pain). Dolor e inflamacion area izquierda del cuello (Neck Pain/ Inflammation).  A small bump is noticeable and palpable at neck (left side).   Visit Emergency Room and received medications for pain ( Ketorolac ) and muscle relaxant  (Orphenadrine).
Quick onset of blurred vision in both eyes. Identification of color noted to be incorrect 4 days later. Loss of color perception a week later. Loss of the ability to smell.
Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 17-Aug-2022; No adverse event; Received expired 2nd dose after 30 day beyond use expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 17-Aug-2022) 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. 051B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose after 30 day beyond use expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 17-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 17-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose after 30 day beyond use expiry date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 17-Aug-2022).    Patient received the second booster dose. Concomitant medications details were not reported by the reporter. Two patients received Moderna COVID-19 Vaccine on 19-AUG-2022. Reportedly 4 doses and 3 vials were initially stored in the refrigerator on 15-Jul-2022. The vials did not undergo any temperature excursions.
NUMBNESS IN RIGHT LEG ABOUT AN INCH OR 2 AWAY FROM THE KNEE CAP; TINGLING IN THE RIGHT LEG; RADIATING PAIN UP THE LEG TO THE HIP AND AROUND LOWER PART OF BACK; BACK PAIN (WITH RADIATION); CAN HARDLY MOVE; PAIN IN THE RIGHT LEG; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 165 pounds, and height was 60 inches. The patient's concurrent conditions included non-smoker, non-alcoholic, peptic ulcer disease, high blood pressure, and spice allergy, and other pre-existing medical conditions included patient have numerous allergies to medication, food and additives. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included cimetidine for peptic ulcer disease, and levothyroxine sodium. On APR-2021, the subject experienced numbness in right leg about an inch or 2 away from the knee cap. On APR-2021, the subject experienced tingling in the right leg. On APR-2021, the subject experienced radiating pain up the leg to the hip and around lower part of back. On APR-2021, the subject experienced back pain (with radiation). On APR-2021, the subject experienced can hardly move. On APR-2021, the subject experienced pain in the right leg. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) Pain 1/10, Raised to 5/10, 10/10, It went up to a 15/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in right leg about an inch or 2 away from the knee cap, tingling in the right leg, radiating pain up the leg to the hip and around lower part of back, back pain (with radiation), can hardly move, and pain in the right leg. This report was non-serious.
Approximately 20 minutes after vaccination, patient began having tremors in her chin which spread to her legs within 2-3 minutes. She declined epinephrine but did receive an oral dose of liquid diphenhydramine before her husband took her to the hospital. Once there, she was given IV steroids, famotidine, lorazepam, and diphenhydramine to control her reaction. She was discharged the same day with a prescription for a prednisone taper and famotidine. Over the next two days she experienced confusion, continued tremors, leg weakness, nausea, chest pain, stomach pain, neck pain, swollen tongue, poor balance, and pain in joints.
On 3/15/2010, pt was given the Dtap & Ipv vax. His leg was swollen right afterwards. That same day pt. had non-stop crying for 48 hours. Later that night pt. developed a 101.5 fever. The next morning pt. was complaining that his head, neck, and back was hurting. After giving MOTRIN, pt. go better.