chrisvoncsefalvay/vaers-outcomes huggingface dataset:
YF-VAX was administered to a patient through the intramuscular route instead of the subcutaneous route, with no reported adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 66 years old female patient who was administered Yellow Fever Vaccine [YF-VAX] through the intramuscular route instead of the subcutaneous route, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Tetanus Vaccine Toxoid (Adacel) and Hepatitis A Vaccine (Hepatitis A) for prophylactic vaccination (Immunisation).  On 14-Jul-2022, the patient received a 0.5 ml dose of suspect Yellow Fever Vaccine (Solution for injection) (lot: UJ602AA; expiry date: 13-Jul-2023) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation).  On 14-Jul-2022 the patient was administered Yellow Fever Vaccine [YF-VAX] through the intramuscular route instead of the subcutaneous route, with no reported adverse event (incorrect route of product administration) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Reports myalgia, fatigue, fever, nasal congestion. sore throat, fatigue, cough
Patent was present in the clinic on 6/27/2022 for his 1st dose of Moderna (6 months ? 5yrs formulation, lot number AS1414B). However, the client received the 6 month to 4-year-old formulation of Pfizer (lot number FT9142) to his RD. This is an appropriate vaccination for this client?s age; however, it was not the vaccine the client?s guardian requested. The client and the guardian were made aware and verbalized understanding with no concerns. The client?s guardian reported that she was fine to continue with Pfizer for her child.    Upon investigation, this writer believes that the client received a non-preferred type of vaccination due to a miscommunication: the vaccinator, RN and the scribe, RN did not verbally confirm the type of vaccine that was being administered, although other safety measures (the set-up of the clinic, confirming the age of the client, etc) ensured that the client did receive a vaccine that appropriate, if not the preferred one.    To ensure that clients receive their preferred vaccine, the Clinical Site Supervisor, RN PHSS, reiterated closed-loop communication best practices with the staff (staff will verbally confirm which vaccine the client is presenting for, verbally confirm which vaccine is selected in the computer, and verbally confirm which vaccine has been drawn and is to be delivered with the client and any other staff present). Staff were also observed for competency.
Chills, flu like symptoms. pounding headache, sore eyes, nausea lasting approximately 36 hours.  Hydrated, bed rest and slept most of the time.
This case was reported by a physician and described the occurrence of rash all over body in a 1-month-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 4 July 1994 the subject received 1st dose of ENGERIX B (unknown route, left arm). The lot number was reported as B59AL. On 4 July 1994, within 8 hours after vaccination with ENGERIX B, the subject experienced rash all over body and hives all over body. The events occurred all over, including corporal, except for palms of hands and soles of feet. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with antihistamine. At the time of reporting the events were unresolved. After the next vaccination with ENGERIX B the events recurred (see case ID A0924086B for more details). The physician considered the events were probably related to vaccination with ENGERIX B. Follow-up Information received on 22 April 2011 confirmed the lot numbers to have been reported as above.
I was very tired, and went to bed. I had a low grade fever and no appetite. I started coughing. The fever went away for a day but then came back and then I went to the urgent care. I had a chest x-ray, and I still had very bad coughing. The doctor put me on CPAP but told to not take it until needed. I took it about 2 days later, and coughing medicine over the counter. I was so tired, all I wanted to do was sleep. I had no appetite. I was diagnosed with influenza type A, which was odd because I had taken the flu shot about 2 weeks after taking the COVID vaccine. I also had lightheadedness, but no aches and pains. 2 weeks later I still have a cough and my fatigue is still lingering. It is not as bad but it is still pretty strong.
Severe migraines, loss of body temperature, poor/circulation (I?m fucking freezing cold), pin point body sores from head to toe. Feels like I?m laying on a bed of needles. Vomiting, nausea.
4x8 cm red, hot area, better by PM 4/21/06 upper left arm DTaP.
I began feeling cramping and bloating similar to period cramping. I then had light vaginal bleeding for a full two weeks. My periods usually last 3-5 days.  People keep saying the vaccine doesn?t affect fertility, but if it messes with menstruation can that be true?
Atrial fibrillation; Flutter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown"; ATRIAL FLUTTER (non-serious), outcome "unknown", described as "Flutter".  Clinical course: Customer verbatim: Pfizer BioNTech Covid Vaccine and Atrial fibrillation/flutter - a phase IV clinical study of CDC and FDA data Summary: Atrial fibrillation/flutter is found among people who get Pfizer BioNTech Covid Vaccine, especially for people who are male, 60plus old. Reporters husband developed this and they reported it but have not heard from them. Requested to be contacted to discuss this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Only MenCYW-135 Liquid was given, it was NOT combined with the MenA Lyophilized powder. No adverse reaction, signs or symptoms.
Left leg hurts badly; Left leg hurts so badly that she couldn't walk or exercise.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left leg hurts badly) and GAIT DISTURBANCE (Left leg hurts so badly that she couldn't walk or exercise.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 PAIN IN EXTREMITY (Left leg hurts badly) and GAIT DISTURBANCE (Left leg hurts so badly that she couldn't walk or exercise.). At the time of the report, PAIN IN EXTREMITY (Left leg hurts badly) and GAIT DISTURBANCE (Left leg hurts so badly that she couldn't walk or exercise.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported. No concomitant medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non significant F/UP: (Email obtained)
Moderate Left Arm pain started 12/29/20 (the day of receiving the vaccine). Especially painful when not moving the extremity of the injection site (for example, while sleeping). This lasted about 3 days. On 1/6/2021, I started experiencing cold symptoms (cough, runny nose, sore throat, and headache). On 1/7/2021, I tested POSITIVE for COVID even after receiving the first does of the vaccine. On 1/11/2021 I lost my sense of smell.
PATIENT CAME INTO THE PHARMACY ON 10/07/18 COMPLAINING OF RED, SWOLLEN ARM THAT IS WARM TO TOUCH. SHE SAID IT WAS PAINFUL AND STARTED ON 10/06/2018. SHE BELIEVED IT WAS FROM A VACCINATION.  SHE WAS SENT TO THE MD PER THE PHARMACIST. THE MD PRESCRIBED HER KEFLEX AND SAID IT WAS NOT A REACTION FROM A VACCINE BUT INSTEAD WAS CELLULITIS.
Migraine, swollen lymph nodes in neck, clavical, and arm pit, nausea, abdominal pain, fatigue, lymphatic pain.
HAD RECEIVED 2ND MODERNA VACCINE ON 03/20/2022, NURSE ADMINISTER THESE AS 1ST BOOSTER DOSE AT 10 WEEKS INSTEAD OF 5 MONTHS ON 05/31/2022. NO NOTED REPORTED SIGNS OR SYMPTOMS OR TREATMENT REQUIRED FROM RECEIVING TO EARLY. UNDERSTAND DO NOT NEED TO REPEAT DOSE
Vaccine was running down her arm; Vaccine was running down her arm; 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 UNDERDOSE (Vaccine was running down her arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine was running down her arm) 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 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced UNDERDOSE (Vaccine was running down her arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine was running down her arm). On 11-May-2021, UNDERDOSE (Vaccine was running down her arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine was running down her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Diagnosed with DVT (peroneal vein thrombosis) 14 days after booster. Symptom onset 10 days after booster.
The following day after vaccination, my daughter would cry and whimper from when she had woken up until she had fallen asleep.  With minimal periods through out the day where she would calm down. She refused to eat all day, only drink fluids. The second day post vaccination, still fussy through out the day however a bit easier to calm. Not much eaten. Odd eye movements and neck arching throughout the day. Times where she would just "blank out", for almost a minute. Awaking multiple times throughout the night. Third day, she is doing better with being put down and playing, though still having small, random bursts of fussiness. Doing better with eating but not like she was. Still doing the same odd eye movements and neck arching throughout the day and the periods of blanking out.
Pt exhibited vasovagal s/s immediately after COVID injection. Stated he felt "light headed", was excessivel ydiaphoretic, and pale. Was sitting in the chair. Limbs were limp, but was able to move them. Remained conscious and able to answer questions, but stated he remained ligh theaded. Given water and able to drink. BP low-80/60. Pt assisted to cot to supine position. Stated he felt better and color returned. BP increased to what pt stated is baseline-92/44. After about 10 minutes, pt stated s/s resolved and able to sit up and then stand without difficulty or any s/s. Ambulated to waiting area where he remained for the rest of his 30 minute observation period.
pt recv vax 1 1/2min post vax & exp a hypotensive episode;blood pressure dec to 95/60;p/resting in the office, sx resolved in ten min;
After withdrawal of FLUARIX QUAD syringe patient bled. Would not stop. Had to apply pressure with cotton ball for 30 seconds. Arm looked bruised. Told patient to ice it.
Expired dose of Heplisav-B given; Initial Report Received on 14-Jun-2019  A medical assistant reported that patient SC, a 44-year-old female patient (race not provided), received an expired dose of Heplisav-B (hepatitis B vaccine) for hepatitis B immunization.   Relevant medical history included obesity, chronic bilateral low back pain with sciatica, and vitamin D deficiency. The patient has allergies to cyclobenzaprine.   Concomitant medications were not reported. The reporter stated that the patient takes some medications for numbness and tingling, but did not disclose medication description.   On 14-Jun-2019, the patient received an expired dose of Heplisav-B (lot #1034864, expiration date: 13-Jun-2019, NDC # unknown). The injection was administered by the medical assistant at a clinic. It was reported that the patient was unaware of the expired dose given.   At the time of the report, there were no adverse events reported.   The reporter did not provide a seriousness assessment for this event.   Company comment: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
Employee felt like her throat was swelling shut.  Voice was high pitched and squeaky. Gasping respirations. Was given PO Benadryl and Epinephrine 0.3 ml IM.
Initial unsolicited report received from other non-health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits. On 06 Feb 2017, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Patient required emergency visit. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
The patient has multiple health issues, so exact time of onset and symptoms are hard to diagnose, but patient presents with respiratory distress, fever (may be due to sepsis)
Menstrual cycle began 9 days earlier than normal and extremely painful.   Also weekly acupuncture was extremely painful when it is normally very comfortable.
No additional AEs; VARIVAX was administered to a patient on 01/03/2023 after a temperature excursion.; This spontaneous report was received from an office manager referring to a 6-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 03-JAN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), for prophylaxis (lot #W017551 had been verified to be a valid number; the expiration date was reported as 01-JUN-2024 and upon internal validation established as the same date) (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection date were not reported). The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) up to 14°degrees Fahrenheit (F), during a time frame of 10 minutes, as recorded by a digital data logger, then 14°degrees Fahrenheit (F) up to 46 degrees Fahrenheit (F) during a time frame of 40 minutes, as recorded by a digital data logger.  There was no previous temperature excursion reported. There was no adverse effect reported.
Week post flu vaccination the patient developed bilateral lower extremity weakness. Nerve conduction study was compatible with the diagnosis of GBS> Bilateral weakness was present with absence of deep tendon reflexes. Patient was admitted to ICU; given 5 doses of IVIG and transferred to rehab.
Received 1st dose of Pfizer COVID vaccine on 1/4/2021.    On 1/11/2021 developed body aches, diarrhea, congestion, sore throat.   Tested positive for COVID.
Received Tdap on 1/14/08. Pt. c/o swelling to site, rash on leg and chest pain on 1/17/08. Pt. ref. to ER. Msg Rec. from pt.on 1/18/08 stating allergic reaction to Tdap. Pt. stated swelling to site began 01/16/08.
Patient received the first dose of the Moderna vaccine on 01/21/21 at a different location and I missed that. The patient did not tell me this was his second dose. Somehow, he had an appointment to receive the vaccine on 02/9/21. I did not know that he had gotten the first dose on 01/21/21. I missed the information on the consent form and administered the vaccine 19 days after the first dose (9 days earlier than the recommended 28 days). Patient did not have any significant adverse reactions other than sore arm, chills, and body aches (which are common with the second dose of the Moderna COVID-19 vaccine). The patient received the vaccine earlier than recommended by guidelines.  Patient came in today because they received a call that their appointment had been cancelled due to shortage of vaccine. Patient's wife comes in confused since the patient had already received both doses. I apologized to the patient's wife, asked if he had any serious reaction and the wife said, "no significant reactions".  Advised patient that I would report this mistake.
Patient received vaccine on March 13 and visited the pharmacy on March 15 with a arm cellulitis.
ANAPHYLAXIS Narrative:  Did not receive at facility. Last received in 2012 outside facility.
Arm sore at site of injection for around 2 days Low grade temp 1 day some body aches 1 day flushed feeling 1 day
pt recv vax & to MD w/erythema of rt deltoid & resp diff p/vax;hives noted on chest pt given epi & DPH for anaphylaxis protocol sx resolved w/in 20min;
mom states patient developed rash on her arms, legs and back two days after the first dose of the Coronavirus vaccine.
Tested positive for covid after the first dose of the vaccine; Tested positive for covid after the first dose of the vaccine; This is a spontaneous report from a contactable Pharmacist.   A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on 18Dec2020 at single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced Tested positive for covid after the 1st dose of the vaccine on an unspecified date. The outcome of unknown. Reporter wanted to know if the patient should receive the 2nd dose.   Information on the lot/batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recv vax 8JUL97 & 23JUL97 pt presented to MD office w/scattered pox lesions;had a total of eight lesions, two on scalp, one on face, one on nape of neck, three on back, & 1 one buttocks;
Next day after receiving vaccine noticed a red swollen quarter sized bump over right thigh - injection site.  Given Motrin.
Patient developed low grade fever and extreme fussiness within one hour of receiving vaccines. He cried non-stop until 8 P.M., when he fell asleep until 3 A.M. He continued crying with low grade fever into the next day - Mother gave infant Tylenol as directed. He was seen by M.D. on 5/27/05. He ordered DT instead of DTaP.
Immediately post vax, the patient let out a sob, "had no breath left", seemed to turn blue for 5-6 seconds and then started breathing again. The patient was very drowsy afterward and slept about 15 minutes in the clinic and then 1 1/2 hours at home.
Patient had Covid; Patient had Covid; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL; IBUPROFEN; FOLIC ACID; LEVOTHYROXINE; LORATADINE; METHOTREXATE; OMEPRAZOLE; VITAMIN C ACID; VITAMIN D3; TIZANIDINE; TYLENOL. Past drug history included: Morphine, reaction(s): "Known allergies: morphine". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2022, outcome "recovering" and all described as "Patient had Covid". Clinical course: In Aug2022 (3 weeks ago) patient had COVID. Symptoms are Cough, upper respiratory symptoms, fatigue, headache, brain fog, difficulty with smelling and cramps. brain fog, fatigue and cough persist (covid). The reporter did not considered that event caused by suspect product. The reporter stated that adverse event was not serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product cannot be fully excluded.
I woke up at 330AM Saturday 1/16/2020 with severe cough, fever (max of 101.4), headache,  body aches.  Knowing I had the vaccination and also tested positive for Covid in March of 2020, I treated with DaQuil Cold/Flu.  Body aches lasted through today, 1/17/2020 were gone by noon.
Headache, "spinning" within my head - aggravating brain thoughts, dizziness, imbalance. Lying down promoted headaches - rising to sitting position caused almost blackouts - better after 8 days.
This case was reported by a physician, via a GSK representative, and described the occurrence of hepatitis B positive in a child subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included elevated liver enzymes and sexually transmitted disease. On unspecified dates, as an infant, the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (details unknown). At an unknown time after vaccination with Hepatitis B vaccine, the subject experienced hepatitis B positive. The physician reported that four subject's, all children from the same family, were vaccinated with the hepatitis B vaccine series (unknown manufacturer) as infants, and as the children are now older (unknown ages) two of the children have tested positive for hepatitis B, and two of the other children were tested as having no immunity/no protection. This is case 1 of 4 (see case IDs A0939314A, A0939315A, A0939316A for details of the other reports).