chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment given on the paitent. No Concomitant medication were reported. Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
As I was driving home after having my flu shot, I noticed I was having trouble hearing my car radio. I did not pay much attention to this.  After entering my house approximately 30-45 minutes after getting the shot, I had a severe dizzy spell. I had to sit down to keep from falling. After approximately five minutes, the dizziness went away.  I went outside and cut my lawn. About an hour later I came into the house, turned on the TV and had severe trouble hearing the sound.  This continued throughout the day. By evening all I could hear was squeaks and crackling sounds. It sounded like a cell phone breaking up. This remained the same at any volume. I could no longer distinguish words or music. When I woke up the next morning, conditions had not changed.  My wife made an appointment to see an ear, nose, throat doctor at Hospital. My ears were examined and tested. They could find no reason for my hearing loss and had no knowledge of this being a possible reaction to the flu shot. I contacted Dr.'s office and reported my problem.  He got back to us later in the day and left a message stating that he knew of nobody having this type of reaction from the shot, but if it was a reaction it would probably clear up within 24-48 hours. Condition did not change throughout the rest of the day and evening (Friday). On Saturday morning upon waking, my hearing was returning, but I had loud ringing in my ears. As the day wore on, my hearing continued to improve. As of now, Sunday evening, my hearing seems to have returned completely and may even have improved some.
Chest pain, rapid heart rate increase, mental and physical discomfort from the heart/chest pain, heart rate would increase rapidly. Inability to drink coffee or anything with caffeine for 3 weeks after. Chat pains began around day 4/5 after 2nd vax and lasted up to 3 weeks. Still sometimes irregular heart. My guess is a form of  myocarditis.
Baby is extremely sleepy (slept nonstop except for waking up to eat) for about a day after the vaccination.
Diagnosed with COVID-19 virus as positive after the 1st dose of vaccine.; I was not feeling good.; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored Program.   A 58-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EP7533; Expiration Date: 31Jul2021), via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 02Apr2021 the patient got a COVID test as she was not feeling good and the patient diagnosed with COVID-19 (03Apr2021). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Apr2021. The clinical outcome of the events was unknown.  Follow-up (22Jun2021): Follow-up attempts completed. No further information expected.
pt recv vax 16MAY95 & exp swelling of the hands & a measles-type rash covering the body, hands & feet; No further details were provided
01/27/2015 9:30am 0.5 mL MMR Lot # k003806 vaccination administered in Upper Left Leg using 25G x 5/8" Jelco Hypodermic Needle. Grandmother 30 year veteran nurse present as patient's guardian on that day has administered many shots in her career. Stated shock at witnessing how the shot was administered 'very roughly'. Patient experienced immediate extreme leg pain at the point where the shot was administered. Doctor was phoned within a few days to request advice regards pain. Doctor stated pain was normal and would subside in few days to weeks. Leg pain continued at the area of the shot without resolution. Patient taken to see Doctor one month to six weeks later, extreme pain still present causing patient immobility. Dr. prescribed therapy. Therapy course completed, minimal to no improvement. Through the duration of aprox one year pain continues to arise particularly after moderate activity, patient is unable to walk or even stand due to extreme pain starting at the point of the shot and radiating through her leg. Doctor Visit Jan 19th, 2015 discussed continuing pain from vaccination. Was advised to file VAERS report. In contradiction to the clear onset of symptoms tracing their direct roots to the moment of administration of vaccination the Doctor advised to follow a course of testing to determine if some underlying systemic pre-existing condition existed that never manifested itself previously even though patient had multiple previous vaccinations and other normal childhood injuries that never resulted in any long term symptoms such as she has experienced directly upon adminstration of the MMR vaccination. To explore another route beside the highly unlikely idea of a possible pre-existing condition diagnosis Doctor consulted a Rheumatologist who advised an X-ray be taken to examine the possibility of injury due to trauma from the injection. X-ray results for Myositis ossificans were negative. As of the day of this report patient continues to experience debilitating leg pain on a regular basis causing her to have to refrain from anything more than minimum physical activities. She is unable to make it through a day of normal childhood activities, nor participate in sports, nor even bike a few blocks to school without experiencing pain at the spot of the vaccination that makes her have to stop all activity for at least a day before she can walk again.
Erythema, tenderness, edema R arm 20x22.5cm. Pt given Benadryl and Motrin sx resolved by 6/9.
Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from Physician via other company (under the reference number-2019051602). This case involves a patient of unknown demographics who experienced high fever and allergy to Tetanus-Diphtheria Toxoid, while he/she received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced high fever (pyrexia) and allergy to vaccine. (Other relevant tests included no lab data). Final diagnosis was fever and allergy to vaccine. An unknown corrective treatment was received. The outcome of the events were unknown. List of documents held by sender: none.
Joint pain, muscle aches, flatulence, hands (only) faded or appeared light brown, head ache (nail hammered into the skull pain), back pain, check tightness, and upset stomach.
Headache, malaise, urticaria within 24h of BEXSERO and second MENVEO. Denies previous MENVEO reaction.
have been suffering adverse effects from the Moderna vaccine/injured by your product; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (have been suffering adverse effects from the Moderna vaccine/injured by your product) in a  patient of an unknown age and gender 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 IMMUNISATION REACTION (have been suffering adverse effects from the Moderna vaccine/injured by your product). At the time of the report, IMMUNISATION REACTION (have been suffering adverse effects from the Moderna vaccine/injured by your product) had not resolved.            No concomitant products reported. No treatment products reported.
Information was received on 20-FEB-2017 from a pharmacist who reported that a patient of unknown age and gender received a dose of VARIVAX (lot M039317, expires 20-SEP-2018) subcutaneously, on an unknown date after a temperature excursion of 14-46 degrees F for 48 hours (noted on a data logger).  No medical history or concomitant medications were reported for the patient. No adverse effect reported in the patient. No other information is available. Additional information has been requested.
First dose of Shingrix was given at 4:49 pm on 8/3/2019. Patient stayed in the area for about 15 minutes and as she was leaving, she said the sides of the tongue were tingling. However, since the symptoms did not get worse, she left for home. She was called about 2 hours later and the tingling was gone, but she had developed a headache that lasted a couple of hours. She returned to the pharmacy on 8/9/2019 stating that her arm was still red and hot to the touch. The first couple of days she said the area was hot to the touch and painful. A call was made to the doctor alerting the office to the reaction. Patient said she was taking Fexofenadine 1 qd to help counteract the reaction.  It is unknown what the outcome with the doctor is.
patient was treated by a healthcare provider for shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 19-FEB-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a pharmacy for for the long-term prevention of shingles and zoster-related conditions.  Subsequent to the patient's vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's vaccination, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).  The outcome of shingles was unknown.
10 minutes after child received DTAP, COMVAX, IPV and Prevnar and Rotateq po, petechiae noted on neck and face. No symptoms of dizziness. Doctor made aware.
SHAKES; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to follow-up batch number/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced shakes, and chills. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and shakes was not reported. This report was non-serious.
1st dose at almost 6 months old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number K33EZ, expiry date 15-JUL-2023) for prophylaxis.   On 08-FEB-2023, the patient received Rotarix lyophilized formulation. On 08-FEB-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: 1st dose at almost 6 months old). The outcome of the inappropriate age at vaccine administration was 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: 21-Mar-2023 Practice Manager called to inquire how to proceed with the Rotarix. Manager reported a patient received Rotarix first dose at almost 6 months of age administered. The patient only received Hep B at Birth. Did not consent to follow-up. The patient received Rotarix vaccine at almost 6 months of age, which led to inappropriate age at vaccine administration.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (lymph nodes feel like bee stings), VACCINATION SITE DISCOLOURATION (injection arm is yellow) and FATIGUE (tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (injection arm is yellow). On an unknown date, the patient experienced LYMPH NODE PAIN (lymph nodes feel like bee stings) and FATIGUE (tired). At the time of the report, LYMPH NODE PAIN (lymph nodes feel like bee stings), VACCINATION SITE DISCOLOURATION (injection arm is yellow) and FATIGUE (tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported.
Pain and red at inject. site, flu-like aches and pains. Severe pain, spasms neck, shoulder, arm and hand. Pain down both legs. Loss of function and weakness left arm and hand-fingers. Severe cramping in hands, fingers, leg and feet. Left hand muscle wasting and denervation. Headaches.
Muscle aches; Tired for a day or two/spent time in bed; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches) and FATIGUE (Tired for a day or two/spent time in bed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle aches) and FATIGUE (Tired for a day or two/spent time in bed). At the time of the report, MYALGIA (Muscle aches) and FATIGUE (Tired for a day or two/spent time in bed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Slight elevated temperature.         Patient had bed bound, its not necessarily bed bound but tired for a day or two and spent some time in bed.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Patient states had pain, redness, swelling next day after vaccine.  Four weeks later, patient still has pain and redness in the arm and cannot raise arm over her head. Patient recently consulted with doctor who recommended possible physical therapy.
Information has been received from a physician concerning an "around 12 to 14 years old" female who had been vaccinated with the series of GARDASIL (LOT#s not reported, third dose was 0.5 mL). After the series, she had her PAP tests done and came back positive for HPV (type unspecified for now). Unspecified medical attention was sought. It was reported that on an unspecified date the patient recovered. This is the third of three cases received from same source. Additional information has been requested.
On Apr 17, 2021 I had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what I thought may be allergies, but not feeling good. I continued to cough, but thought it was attributed to GERD. I wasn't thinking it could be COVID because I had been vaccinated. By May 18, I was having trouble breathing as it was painful to inhale. I thought I might be having a heart attack so went into the emergency room at Hospital. I tested positive in ER. No heart problem.  There were also at least 5 blood clots found in my lungs. It felt like what I imagine it would feel like if my ribs were broken and I was trying to take a deep breath. I continued to have difficulty inhaling because of the pain of doing so into the next day (19th) and part of the 20th. I was administered oxygen and pain meds for the first day. I was put on Eliquis, which I am ordered to take for 6 more months. I was released from ICU on the 20th, which appeared to be a quick turnaround. I still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, I had no fever. The only time I think I did was on April 19th when I had the chills and cough.
second vaccine dose which she got at the beginning of March she had arm soreness; skin abnormality on her left shin disappeared/skin abnormality on her right wrist cleared up and disappeared; This is a spontaneous report received from a contactable physician via Pfizer sales representative. A elderly female patient received 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine,Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as Dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported. The patient experienced after receiving second vaccine dose which she got at the beginning of march she had arm soreness on an unspecified date and skin abnormality on her left shin disappeared/skin abnormality on her right wrist cleared up and disappeared on an unspecified date.The outcome of the event was unknown.The case was accessed as non serious by the reporter.Reporter described about therapeutic benefits after receiving 2nd dose of Pfizer covid19 vaccine. Pfizer sales Rep reports that reporter said she got her first Pfizer COVID-19 vaccine dose in February and had zero adverse events.Sales representative reported that after the patient second vaccine dose which she got at the beginning of March she had arm soreness. Rep reports she said she had a couple of abnormalities on her skin that her dermatologist wanted to cut out and biopsy prior to having the vaccine shots, and after getting both shots the skin abnormality on her left shin disappeared and the other one on her right wrist cleared up and disappeared within a couple months. No further details captured, reported, or documented at this time. Product strength and count size dispensed: not provided, two doses.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021900915 similar report from same reporter
5YO FEMALE DEP BROUGHT INTO CLINIC BY MOTHER FOR RIGHT ARM SWELLING. PT RECIEVED VACCINE (SEASONAL INFLUENZA) DAY PRIOR AT OFF SITE INFLUENZA VACCINATION AT SCHOOL. NKA OR NKDA. MOTHER STATED EDEMA STARTED YESTERDAY EVENING BUT NOTICED IT WAS WORSE THIS MORNING AND GETTING BIGGER. PT HAS SEVERE SWELLING ABOUT 13CM IN LENGTH, STARTING 2 INCHES ABOVE ELBOW PROCEEDING OVER BICEP IN SHOULDER. SWOLLEN TISSUE WAS WARM TO TOUCH AND TENDER. MOM STATES NO MEDICATIONS WERE GIVEN. PT DID HAVE DECREASED RANGE OF MOTION. M.D. DID EVALUATE PATIENT. BORDER NEAR ELBOW WAS MARKED. MOTHER WAS INSTRUCTED THAT IF SWELLING PROCEEDED PAST MARKED BORDER SHE NEEDS TO BRING HER SON BACK INTO CLINIC.
Palpitation; Her heartbeat is 20 bpm higher than usual.generally at 60 bpm but has increased to 80 to 90 bpm; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation) and HEART RATE INCREASED (Her heartbeat is 20 bpm higher than usual.generally at 60 bpm but has increased to 80 to 90 bpm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PALPITATIONS (Palpitation) and HEART RATE INCREASED (Her heartbeat is 20 bpm higher than usual.generally at 60 bpm but has increased to 80 to 90 bpm). At the time of the report, PALPITATIONS (Palpitation) and HEART RATE INCREASED (Her heartbeat is 20 bpm higher than usual.generally at 60 bpm but has increased to 80 to 90 bpm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate abnormal (60-60): increased 80-90 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Lab data : Heart beat increased by 20 bpm. Normal is 60 bpm, increased to 80-90 bpm.  No concomitant medication information provided.  Treatment information provided.
Flublok Quad is administerd to the 9 month old patient, no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA309992 (same reporter).  This case involves a 9 months old patient who was vaccinated with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number not reported via unknown route in unknown administration site), on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  The physician stated that the standard packaging for both the Flublok Quad and the Fluzone Quad look the same.  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 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.  Information on batch number is requested.
Abnormal involuntary movements- being referred to neurology; chest pain, shortness of breath (possible anxiety