chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient's second dose was delayed due to insurance issues and the patient traveling; No additional AE/PQC reported; the patient was 46 years old when she received the 2nd dose of the GARDASIL 9 vaccine; This spontaneous report has been received from a pharmacist and refers to a 46-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date in April 2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and received the second dose at 46-year-old on 11-OCT-2023 (product administered to patient of inappropriate age) after being delayed due to patient's insurance issues (insurance issue) and traveling. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No adverse events reported for this patient.
Unable to move; Migraine each day. Incapacitated for one week. Still get migraines out of the blue.; Chills; This is a spontaneous report from a contactable healthcare professional. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 09Mar2021 at 12:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease. Concomitant medications included SYNTHROID, vitamin d nos (MANUFACTURER UNKNOWN) for unknown indication since unknown date. The patient was allergic to milk products. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 16Feb2021 at 12:00 (at the age of 58-year-old) as a single dose for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021, second day the patient felt extremely ill unable to move except to go to the bathroom, chills, migraine each day which incapacitated for one week. Still get migraines out of the blue. Therapeutic measures were taken which included the treatment with eletriptan (MANUFACTURER UNKNOWN). On 23Mar2021, the patient underwent COVID-19 virus test and the result was Negative. On 06Apr2021, the patient underwent COVID-19 virus test and the result was negative. On 13Apr2021, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events extremely ill unable to move except to go to the bathroom, chills, migraine was recovered with sequelae at the time of this report.  No follow-up attempts are needed. No further information is expected.
started to administer the product but fluid leaked onto her gloves and skin with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11-year-old male patient to whom when started to administer the product INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] but fluid leaked onto her gloves and skin with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Oct-2022, to the patient when started to administer suspect INFLUENZA QUADRIVAL A-B VACCINE at dose of 0.25 ml total (strength: standard; formulation: unknown) (lot number: UJ943AA and expiry date: 30-Jun-2023) via intramuscular route in the deltoid nos for Immunization, but fluid leaked onto her gloves and skin with no reported adverse event (accidental exposure to product) (latency: same day).  It was reported, that during the administration of the vaccine and got a lot of spill. Pharmacist was not sure how much of the vaccine the patient got. She would like to know do they need to re-dose the patient or leave it as is? Pharmacist reported that FLUZONE QUADRIVALENT PREFILLED SYRINGE, was used and after removing the air, the caller started to administer the product but there was significant leakage on the sides and bottom of the syringe.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown.  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.
dizzy; This is a spontaneous report from a contactable consumer reporting on behalf of her mother. A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 8982), via an unspecified route of administration on 16Jan2021 at 16:30 (at the age of 90-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Bronchiectasis, osteoporosis, anemia, Pre- Diabetes, Sjogren's, sleep apnea, GERD and SIBO. The patient has known allergies but these were not specified. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a nursing home/senior living facility. 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 vaccination. Concomitant medications included zolpidem (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), pyridoxine hydrochloride (B6 MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), biotin (BIOTIN MANUFACTURER UNKNOWN), colecalciferol (D3 MANUFACTURER UNKNOWN) and cyanocobalamin (B12 MANUFACTURER UNKNOWN), all from unknown dates and for unspecified indications. On 17Jan2021 at 12:00 (also referred to  as "two days after the vaccine"), and for five days, the patient was very dizzy. She says it wasn't vertigo. It was not spinning. just dizzy like she thought she was going to faint and fall on the floor. She tried to be "sure footed" when she walked and did not walk much other than in her Condo. The patient did not receive any treatment for the event. The clinical outcomes of the event dizziness was reported as recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Member reports beginning to feel nauseous 6 hours after receiving vaccine. 18- 24 hours post vaccination member reports nausea and 2 incidents of vomiting. Exam shows a flat,red, lacy rash 15 x 6 cm across chest, and 20 x 5 cm in the center of her back.  The rash itches and is sensitive to the touch.  Will follow up in 24 hours.
SEVERE ANAPHYLACTIC REACTION; This solicited report received from a patient via RRA-4549: PriCara social media Account concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer, and immunocompromised. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 27-MAR-2021, the patient experienced severe anaphylactic reaction and went twice to emergency room by an ambulance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe anaphylactic reaction was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and severe anaphylactic reaction as related. Company causality between covid-19 vaccine ad26.cov2.s, and severe anaphylactic reaction was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: Covid-19 vaccine ad26.cov2.s-Severe anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
inadvertently administered a pediatric dose of Engerix-B; inadvertently administered a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 54-year-old female patient who received HBV (Engerix B pediatric) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis.   On 30-AUG-2023, the patient received the 1st dose of Engerix B pediatric. On 30-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: inadvertently administered a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: inadvertently administered a pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Aug-2023 Nurse reported that at the time of reporting, no additional doses have been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. An adult patient received a pediatric dose of Engerix-B (10 mcg), which led to underdose and adult use of a child product.
Noe should have received the Pediatric Pfizer vaccine for his second dose but he was given the adult Pfizer for 12&up.
A non-serious spontaneous report of "my daughter had sore throat and headache after H1N1 LAIV" has been received from a consumer, concerning a nine-year-old female, subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient received H1N1, Intranasal on 24-Oct-2009 through a company's employee immunization event. On 28-Oct-2009, the patient complained of sore throat and headache. Her temperature was 98.9 degrees F. The outcome of the adverse events was unknown.
Fever,  body ache, headache, exhaustion.  Onset on the evening of the vaccine through next day afternoon. Back to normal within 24 hours of onset.
pain; developed the shingles rash; Developed the shingles rash; still has lesions; This case was reported by a other health professional via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2020, the patient received the 1st dose of Shingrix. In December 2020, less than 2 months after receiving Shingrix, the patient experienced shingles, rash and skin lesion. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the skin lesion and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, skin lesion and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. About a month before the reporting, the patient developed the shingles rash and still had lesions on the day of reporting.  The patient was to receive 2nd dose of Shingrix on the day of reporting. The reporter asked if they can give the vaccine during an active outbreak and how long they should wait after lesions and pain were gone.
Patient was given the shot by Pharmacist. Right after the shot the patient said he was feeling faint, slowly fainted & was assisted slowly to the floor. He woke up less than 45 seconds later & told us he only had a salad & nuts for lunch. We gave him a 2 cups of water and a piece of chocolate & he said he felt fine afterwards.
T103.8 on 19DEC-hives upper body inj arm;hives worsened on 20DEC;tx w/DPH, APAP & Advil alternating;visit to ER on 21DEC to r/o strep negative;sx subsided on 21DEC97 4PM;
Overheating the first day.  Overheating in cycles, compounded by vertigo and severe nausea.  The overheating, vertigo, and nausea has worsened in height and persisted to date (2 months).
Suspected vaccination failure; one of the first thing I got; Painful; I thought i die; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and feeling abnormal. On an unknown date, the outcome of the vaccination failure, shingles, pain and feeling abnormal were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The patient stated that, it was the 1st thing the patient got and the patient thought he or she would die.  It was painful and patient stated that he or she would not want anyone to get it. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Pt was given wrong vaccine - given primary child dose instead of bivalient adult dose - MD , Supervisor, Patient and QA notified immediately patient was advised to return or call clinic if any adverse side effects occured . No reports made by patient
The diluent was administered to the patient instead of the diluted vaccine. The patient did not have any adverse reaction following the administrations. The patient's parent has been notified. The patient is scheduled to receive the vaccine at their 9-month well-child visit. The RN administering the vaccine has been educated.
On X/XX/21, a patient was referred by the medical unit to come to the pharmacy for a flu vaccine. It was discovered that she had received two flu vaccines: one from RPh XXXXXX XXXXXXXX on XX/XX/20 and one from PRh on XX/XX/21. On XX/XX/20, the patient received 3 different vaccines: flu, TDAP, and HPV 9. The error was discovered when the pharmacy technician tried to bill her current insurance. Upon investigation, it was discovered that the flu shot given on 10/28/2020 was not inputted into system. It was discovered that the flu shots were billed to two different insurances on the pharmacy system. The XX/XX/20 flu shot was billed to one insurance and the X/XX/21 flu shot was billed to another. Patient reports no adverse reactions. Her doctor has been made aware of the error.
Almost instantaneously my arm started aching at the injection site, the next day I did my usual routine exercise in the pool my arm was very painful. By evening my body was aching all over. So I went to bed on Wednesday night and got up on Friday morning, with the exception of getting up going to the bathroom and having a snack and refilling my water. ON FRIDAY Nov.5 I got up and had an itchy red rash on my back and buttocks,and chest and right arm.
6/8/12 received immunizations. 6/10/12 developed fever, & hives on hands & feet,. Mom gave child BENADRYL. 6/11/12 called health dept. Symptoms gone 6/10/12.
Angioedema of throat and lips; cough; tachycardic; burning of eyes.
I have continually had headaches and "hazy headed" feeling since my first dose of the vaccine.  More difficulty focusing and experiencing some word loss issues.
Case number PHEH2014US011221, is an initial spontaneous report from a medical assistant received on 02 Jun 2014, with a combined follow up received from medical assistant on 02 Jun 2014 and 03 Jun 2014 respectively. This report refers to a 17-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered MenA powder component of MENVEO (batch number: A13047) reconstituted with sterile water instead of Men-CYW-135, intramuscularly on 28 May 2014. No adverse event was reported following the administration error (wrong solution used in drug reconstitution). Combined follow up received from medical assistant on 02 Jun 2014 and 03 Jun 2014 respectively: Updated reporter comment.
Child was going to get a bath sat on toilet first then became dizzy had hearing loss and could not see passed out for a few seconds and we were able to get her coherent again within 20 minutes.  We were going to call the emergency squad but she came around and within 1/2 hour was back to normal.
Four hours after shot both arms began to ache. Followed by chills and fever. Patient went to bed and heard voices during the night. Felt a bit strange the next day but all symptoms gone.
This infant became unconscious a few hours after the vaccine. Started vomiting. Called a nurse help line for advise. The child was taken to the ER.  Follow up:  Since I have had both my children experience severe allergic reactions to vaccines (which have been reported), I expect a follow up phone call interview.
Severe hip pain on right side; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 23Sep2023 at 18:00, outcome "recovering", described as "Severe hip pain on right side". Therapeutic measures were taken as a result of arthralgia with Tylenol, heating pad.  Additional information: Patient received vaccine from Pharmacy or Drug Store and no other vaccine was administered in four weeks. Patient was not tested for COVID prior vaccination and post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report sa received from a medical assistant refers to multiple unspecified patients of unknown age. On unknown dates, the multiple unspecified patients were vaccinated with VAQTA, (lot#, expiry date, dose, frequency, route and indication not reported). The medical assistant reported that the multiple unspecified patients were administered VAQTA that went through an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
that day @ 9PM had sz; taken to ER per ambulance t104 @ hosp; MD dx'd febrile seizure & ear infect; pt has not had any more sz activity; sent home same day was in ER; MD recommended ped DT for future immun;
SEVERE CHILLS,FEVER,NAUSEA,DRY MOUTH,DROWSINESS,3DAYS DROWSINESS
she feels cranky; Her left arm injection site is a little sore; the local pharmacy gave her a fact sheet which in the title it states Bivalent and the foot note on page 3 states Spikevax original and Omicron; This spontaneous case was reported by a nurse practitioner and describes the occurrence of IRRITABILITY (she feels cranky), INJECTION SITE PAIN (Her left arm injection site is a little sore) and PRODUCT LABEL CONFUSION (the local pharmacy gave her a fact sheet which in the title it states Bivalent and the foot note on page 3 states Spikevax original and Omicron) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030368) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IRRITABILITY (she feels cranky), INJECTION SITE PAIN (Her left arm injection site is a little sore) and PRODUCT LABEL CONFUSION (the local pharmacy gave her a fact sheet which in the title it states Bivalent and the foot note on page 3 states Spikevax original and Omicron). At the time of the report, IRRITABILITY (she feels cranky), INJECTION SITE PAIN (Her left arm injection site is a little sore) and PRODUCT LABEL CONFUSION (the local pharmacy gave her a fact sheet which in the title it states Bivalent and the foot note on page 3 states Spikevax original and Omicron) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient had received monovalent vaccine of Moderna vaccine in 2021.  Patient reported she received Spikevax 3030368 on 20-Sep-2023. Her left arm injection site was a little sore and she feels cranky. She further stated the local pharmacy gave her a fact sheet which in the title it states Bivalent and the foot note on page 3 states Spikevax original and Omicron. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-008609 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2023: Live follow up received on 22-Sep-2023, quality complaint number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-008609:Monovalent case
Pt has been experiencing pain in injection site area for the last month. She was concerning area for the last month. She was concerned and went to her primary MD, who believes that injection was given to high and burst Bursa sack causing inflammation and pain.
10 min after vaccine c/o tightness throat, chest very cold, tingling dryness to lips, palpitations. Treatment Epinephrine x2 doses, Benadryl, O2, Albuterol treatment. Transferred via Ambulance to the ER. Release the same day from the ER on oral Prednisone.
Fully vaccinated with Janseen x1. Tested positive for Covid on 01/26/2022. Admitted to Medical Center on 01/26/2022. Expired on 02/01/2022 while still hospitalized.