chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient inadvertently administering extra dose of FLUZONE HIGH DOSE QIV in one flu season with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 74 years old female patient who inadvertently administered extra dose of  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in one flu season with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Sep-2023, the patient received 0.7 mL dose 1 of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UT8157CA and expiry date: 30-Jun-2024) (Frequency = ONCE), (Strength = FLUZONE HIGH DOSE) via intramuscular route in the left deltoid and On 26-Oct-2023 she also received 0.7 mL dose 2 of the same vaccine.  On 26-Oct-2023, the patient inadvertently administering extra dose of  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE in one flu season with no reported adverse event (extra dose administered) (latency: 28 days).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
1/5 vaccination 1/8 started with pain lower R back, near waist. I could not turn.  extreme sharp pain. I could hardly stand. Went to physiotherapist for 2-3 weeks. Cardiologist for ultra sound. Blood panel. Urine.  on and off with symptoms. frequency has subsided.
Patient mom called in regards to daughter, she stated her daughter got the vaccine on Monday 5/17 around 6pm and the next day in the afternoon she started to itch and notice a rash on her shoulders and then under bra, cheeks, around mask, neck and even on legs. She states the rash is all over body and looks like little bumps. Patient is extremely itchy. Mom applied cortisone on the patients arms and she states it might have helped a little and also gave her Allegra which she states it didn't work. Patient's mother gave her daughter Benadryl on 5/25/21 at round 10:30pm and it helped.
Patient was turning around to look at their brother, then suddenly fainted and fell on the floor. Patient got up soon after.
about five minutes post shot, I began experiencing throat swelling and tongue tingling with a feeling of faint. That along with headache and fatigue continued for a few days. About six days postshot, I experienced facial parasthesis for several days that warranted an ER trip.
Information has been received from a health professional concerning a 5 year old female pt who was vaccinated on 05/10/1999 with a dose of varicella virus vaccine, live. Subsequently, on approximately 02/19/1999, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that "there was not a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough  cases of chicken pox (WAES # 0405USA02615, 0405USA00572, 0405USA00573, 0405USA00574, 0405USA00575, 0405USA00576, 0405USA00577, 0405USA00578, 0405USA00579, 0405USA00580,  0405USA00581,  0405USA00582,  0405USA00583,  0405USA00584,  0405USA00585,  0405USA00586,  0405USA00587,  0405USA00588, 0405USA00589,  0405USA00590, 0405USA00591, 0405USA00592, 0405USA00593, 0405USA00594, 0405USA00595, 0405USA00596, 0405USA00597, 0405USA00598, 0405USA00599, 0405USA00600, 0405USA00601, 0405USA00602, 0405USA00603, 0405USA00604, 0405USA00605, 0405USA00606, 0405USA00607, 0405USA00608, 0405USA00609, 0405USA00610, 0405USA00611, 0405USA00612, 0405USA00613, 0405USA00614, 0405USA00615, 0405USA00616, 0405USA00617, 0405USA00618, and 0405USA00619).  No additional information is expected.
Patient received vaccine on 11/19/2020 from the reporter who is the organization's Employee Health Nurse, no initial sign of adverse reaction at time of injection. Patient reported her arm felt "itchy" when going to bed that night. Received a call this morning at 11:15am from the employee and supervisor reporting that there was about a nickel sized area of redness at the insertion site on her left arm and then about 2 cm below the insertion site there was a roughly 5 cm x 3 cm area of erythema that was hot, raised, and itchy.
administered an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Received only 1 Pfizer vaccine in April. Pt tested positive for covid on November 2, 2021, pt had cough, SOB was admitted on 11/16 and was discharged on 11/20
Had vaccine on Wednesday woke up Sunday morning with Vertigo.  I have never had or experienced naything like this.  Came home and went to Doctor on Monday.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot# L033693, expiration date 31-MAY-2017, dose was not reported, orally). On the same day, the patient was also vaccinated with an improperly stored dose of PEDVAXHIB (lot# L035880, expiration date 11-AUG-2018; dose, anatomical location and route of administration were not reported). No adverse events were reported and there was no previous temperature excursion. The data logger was involved. Temperature was 21.1 degrees Fahrenheit for 2 hours and 5 minutes, 33.4 degrees Fahrenheit for 6 hours and 5 minutes and 31 degrees Fahrenheit for 3 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax 8DEC93 5PM & that evening upper arm was sore & hot; the following evening 25 hrs later, itching & swelling & redness was first noticed, dorsal surface upper arm from shoulder to elbow;
Expired vial was moved from the freezer to the fridge on 29-Apr-2022; Vaccine expired on 05-May-2022 which got administered on 06-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 which got administered on 06-May-2022) and PRODUCT STORAGE ERROR (Expired vial was moved from the freezer to the fridge on 29-Apr-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 which got administered on 06-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was moved from the freezer to the fridge on 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 which got administered on 06-May-2022) and PRODUCT STORAGE ERROR (Expired vial was moved from the freezer to the fridge on 29-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not undergo any temperature excursions.  Less than a month ago vial was initially stored in the refrigerator (HCP believes it was last Friday).  Concomitant drugs were not reported.  Treatment details were not given.  It was reported that they have vaccinated only nine people with Moderna on 06-May-2022. They originally thought it was 10. Of those, all were boosters except one who had their second dose.  Expired vial was moved from the freezer to the fridge on 29-Apr-2022   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Live Follow received contains non-significant information-Number of patients who received expired vaccine was reconfirmed. On 11-May-2022: Live Follow up received contains significant information: Date of refrigeration was added.
Patient presented approximately 25 minutes following vaccine dose with swelling of her upper lip and tingling to the roof of her mouth, tongue, and upper lip.  Vital signs with mildly elevated blood pressure at 132/80, oxygen saturation 99%, and pulse 72.  She was given diphenhydramine (Benadryl) 50 mg by mouth as a single dose and water to drink.  She was observed for 30 minutes and symptoms gradually improved.  Vital signs after 30 minutes of observation with blood pressure 120/78, oxygen saturation 100%, and pulse 61.  She had her husband come to drive her home due to receiving a dose of Benadryl and due to the potential for drowsiness with this medication.   She was instructed to take another dose of Benadryl in 6-8 hours if her symptoms continue to persist.  She states that her husband will be home with her for the remainder of the day and will observe her and seek medical attention if needed.  She was also instructed to follow up with her primary care provider if symptoms persist beyond the next few hours today and certainly if they persist following a second dose of Benadryl in 6-8 hours.  She expressed understanding.  She stated that she was comfortable going home and continuing to monitor her symptoms.
Information has been received from a physician concerning a 15 year old female who on 14-NOV-2007 was vaccinated with her first dose of Gardasil. There was no concomitant medication. On 14-NOV-2007, the patient's arm hurt and then she fainted. On 14-NOV-2007, the patient recovered from fainting and her arm hurting. The patient sought unspecified medical attention. Additional information has been requested.
Arm was itching; Arm was hard; Arm was swollen; Arm became red / Sunday her arm was much redder; She received her 2nd dose 28Jan2021 (lot was accidentally deleted) and her 3rd dose 27Aug2021 Lot 088D21A; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 2nd dose 28Jan2021 (lot was accidentally deleted) and her 3rd dose 27Aug2021 Lot 088D21A), VACCINATION SITE PRURITUS (Arm was itching), VACCINATION SITE INDURATION (Arm was hard), VACCINATION SITE ERYTHEMA (Arm became red / Sunday her arm was much redder) and VACCINATION SITE SWELLING (Arm was swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 2nd dose 28Jan2021 (lot was accidentally deleted) and her 3rd dose 27Aug2021 Lot 088D21A). On 27-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm became red / Sunday her arm was much redder). On 29-Aug-2021, the patient experienced VACCINATION SITE INDURATION (Arm was hard) and VACCINATION SITE SWELLING (Arm was swollen). On 30-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Arm was itching). On 27-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 2nd dose 28Jan2021 (lot was accidentally deleted) and her 3rd dose 27Aug2021 Lot 088D21A) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm was itching), VACCINATION SITE INDURATION (Arm was hard), VACCINATION SITE ERYTHEMA (Arm became red / Sunday her arm was much redder) and VACCINATION SITE SWELLING (Arm was swollen) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
MEDICAL ASSISTANT GAVE 1ML INSTEAD OF 0.5 ML. SHE DID NOT NOTIFY US UNTIL AFTER THE LAST PATIENT WAS GIVEN THE SHOT. SHE OPENED A NEW VIAL TO COMPLETE THE PATIENTS. EMPLOYEE WAS TERMINATED AND WE CONTACTED PATIENTS TO SEE IF THEY WERE FIND AND TO ADVISE THEM ABOUT GOING TO E.R. IF CONDITION WORSENED.  CALLED DAILY TO VERIFY WELL-BEING.
Covid vaccine dose for 6 mos to 4 yr child given to a 2 month old child.
Pain and swelling at injection site beginning 24 hours after injection. Injection site remains swollen and occasional soreness at injection site. When palpated, injection site feels hardened in a dime-sized area around injection site.
rash at the site of injection; her arm started to itch; excessive sweat across stomach area; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash at the site of injection), PRURITUS (her arm started to itch) and HYPERHIDROSIS (excessive sweat across stomach area) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (rash at the site of injection), PRURITUS (her arm started to itch) and HYPERHIDROSIS (excessive sweat across stomach area). At the time of the report, INJECTION SITE RASH (rash at the site of injection), PRURITUS (her arm started to itch) and HYPERHIDROSIS (excessive sweat across stomach area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
pt had a positive COVID test at home; to ED with c/o fever, malaise; COVID test positive; CXR showed left basilar atelectasis; pt O2 saturation 94% on RA; given Vitamins C, D, and zinc; DNR/DNI; pt had rapid response due to hypoxia; O2 supplementation; pt deteriorated and transitioned to comfort measures; he passed away in the hospital
Patient received Hep B #3 and PPD on 7/30/07 Lot# Hep B AHBVB443AA, he has a rash all over body, he denies taking any other meds.
My menstrual cycle, which had been very regular, ceased.  I expected it on 10/12, but did not occur again until 11/5.  It then returned on 11/15.  I am older, however, I have not had irregular cycles until taking the two COVID shots.  My second shot was on 10/18/21 and was Pfizer lot FE3590 at the Pharmacy.  I want to report this because I am concerned about the vaccine in younger women and children.  It is widely know that the vaccine changes menstruation, yet is understudied.
Child crying for 5 hrs. from 2130 pm 12/20/11 until seen by oncall doctor in clinic at 0230am 12/21/11. Nonstop crying, difficult console. Treated with TYLENOL and Ibuprofen alternating - each given every 6 hrs offset 3 hrs.
DTap vaccine given to patient over the age of 7 years old.  Reviewed with provider who stated that the vaccine was ordered because the fourth dose of DTap on record was given before the child was 4 years old.
A couple hours after the vaccine my body got achy all over again resulting in me taking Tylenol for about 2 days or so but finally went away. The injections site got a little sore and puffy for a few days also, but went away on its own as well.
Quarter sized lump to injection site with itching.  Redness 9cm by 5cm to right arm where injection given. Benadryl 50mg given and hydrocortisone 1% ointment applied to site for itching.
Information has been received from a Licensed Practical Nurse concerning a 25 year old female who on 29-JUN-2007 was vaccinated in the right deltoid with a first dose of Gardasil (Lot #0469U) while nursing.  On approximately 13-JUL-2007, the baby developed a cold.  Subsequently, the baby recovered.  Subsequently the infant developed otitis media (OM).  The infant was treated with amoxicillin for OM.  On approximately 07-AUG-2007, the baby developed a cold.  At the time of the report the infant's outcomes was unknown.
Numbness and a tingling sensation to the left side of face.  Started to left jaw and moved to left ear and eye.  No treatment.
Stomach Pain; Diarrhea; 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 ABDOMINAL PAIN UPPER (Stomach Pain) and DIARRHOEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MACROGOL 3350 (MIRALAX) for an unknown indication.    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 ABDOMINAL PAIN UPPER (Stomach Pain) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Pain) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not provided   Reporter did not allow further contact
Broke out in hives on my midsection, hands and legs and my lower lip was swollen. I also have a tingling sensation from my knee to my ankle on the left leg.
I had a Stroke .  After all of the testing my arteries were crystal clean and all of the tests could not find a reason other than the covid vaccine .    The Vaccine gave me a stroke .
Patient called with complaint: 2in by 2in red painful at injection site. Not hot, not swollen, but very painful. Moderna vaccine administered 12/29 (10 days prior)
After 1st shot had severe back pain. Experienced again briefly after second. More concerning was on 4/26/2021 I developed tinnitus and vertigo lasting about a week. Still experience some back pain and ear pressure. Never had issues prior to vaccine.
Hives on wrist; Swollen / painful lymph nodes (backof neck); Swollen / painful lymph nodes (back of neck); This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 15Apr2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medications within two weeks of the COVID-19 vaccine. On 15Apr2021, after 25 mins of getting the first vaccination the patient experienced hives on wrist, swollen/painful lymph nodes; back of neck. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives on wrist, swollen/painful lymph nodes; back of neck was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
BODYACHES; TIRED; CHILLS; This spontaneous report received from a patient concerned a 44 year old adult  of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced bodyaches. On 07-APR-2021, the subject experienced tired. On 07-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, tired, and chills on 08-APR-2021. This report was non-serious.
SHARP PAIN NEXT DAY IN FINGER, HURT TO PUSH SHOPPING CART, TO PICK UP A PLATE OR A SPOON, SHARP PAIN IN ANKLES FROM TIME TO TIME, ONE TIME IT HURT TO WRITE WITH A PEN,TO TYPE ON A KEYBOARD HAVE PAINS IN  MY BODY TO THIS DAY, FEET HURT ALL THE TIME  DURING NOV AND DEC I NEVER HAD ANY PAIN AT ALL EVER I STILL HAVE PROBLEMS TO THIS DAY!
I am immediately  felt something when the second shot  was injected into me I was told by the pharmacist that I will feel something and take two Tylenol and it will go away I did that I got immediately sick went to sleep that same evening because I had to because of how I felt the two Tylenol helped but then the feeling that coming back and now it?s consistent gonna take to Tylenols it does help but it comes back
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 2 months old infant patient of unknown gender. On 09-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.