chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a whooshing sound on my hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (a whooshing sound on my hot) in a male 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 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 FEELING ABNORMAL (a whooshing sound on my hot). At the time of the report, FEELING ABNORMAL (a whooshing sound on my hot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication information was provided  No treatment product information was provided
really got lousy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "really got lousy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
In 2/99 and in 3/99, the pt received his first and second dose of Lymerix. One month subsequent to the second dose, in 4/99, he developed chronic foot pain with fatigue, which was considered by the reporter to be severely debilitating. A Rheumatology consultation (results not known) and labs (results not known) were obtained. The pt was treated with NSAID's and prednisone.  This case is considered serious as the pt's symptoms are considered to be permanently disabling.   As of 9/21/00, the reporter has difficulty controlling the pt's symptoms. Per follow-up dated 1/17/01, information received from the vaccine provider indicated that the events are ongoing and the pt remains disabled.
Developed tics: head twitching and nose sniffing, started having shoulder rolling, barking, change in personality - aggression, OCD, anxiety, regression as a 2 year old behavior.
The DTAP vaccine was given to the patient for the first time in the left thigh. Immediately following the injection, the leg became reddened down to the knee, and a rash appeared on the patient's stomach. Ice was applied to the leg for 15 minutes. After 40 minutes, the leg became normal and the rash on the stomach disappeared.
expired vaccine administered to patient / no AE; Initial information received on 14-Feb-2020 regarding an unsolicited valid non-serious case received from a non-health professional.  This case involves a 4 years old male patient who was administered with expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number C5366BA Exp. Date 07-Feb-2020 via unknown route in unknown administration site, on 11-Feb-2020 for prophylactic vaccination.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used (Expired product administered).  At a time of reporting no adverse event reported. Reporter did not know which in the series this Daptacel dose was. Reporter stated that the patient had received concomitant vaccines, but declined to provide the names of the other vaccines. Reporter declined to provide any further information.  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.
Redness, swelling, pain (7x6cm) to deltoid. (Part of cluster of pt's with reaction to same vaccine lot).
102 Temp, weakness, unable to bare weight or walk. Headache, abdominal cramps, swelling of hands and feet, blisters in mouth neck pain.
I developed a rash on the front of my neck that was red, itchy and a bit swollen.  It went away briefly and in a week came back.  I still have this rash.
Information has been received from a case in litigation from a consumer concerning her son who on 15-SEP-1998 at the age of 11 year old was vaccinated with the first dose of RECOMBIVAX HB. The patient was also vaccinated with the second dose on 17-NOV-1998. The mother believed that his stamina decreased during the autumn months, which became more pronounced after the second vaccination. He had also developed such classic diabetes symptoms as weight loss and excessive thirst and urination. At the time of reporting the patient's outcome was unknown. The petitioner alleged that the Hep B vaccine had caused type I (juvenile) diabetes. Additional information has been requested.
Adult Pfizer vial diluted with 1.3ml (pediatric dose) of diluent instead of 1.8ml. It was discovered after 2 vials only had 5 doses instead of 6.
dizziness; head spinning; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness) and VERTIGO (head spinning) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and VERTIGO (head spinning). At the time of the report, DIZZINESS (dizziness) had not resolved and VERTIGO (head spinning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received captured event outcome.
This is a spontaneous report from a contactable other healthcare professional. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via intramuscular route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure, knee issues, back problems and bladder issues. The patient was allergic to food, medications, or other products. The patient received unspecified medication within two weeks prior to the vaccination. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via intramuscular route of administration in the right arm on 11Mar2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 15:30, half an hour after vaccination, the patient felt right side of face and throat were swollen up. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the events right side of face and throat were swollen up were resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
The patient received Aventis Influenza vaccine, and developed Bell's Palsy on the following day. The patient developed left facial droop one day after receiving the Influenza vaccine. She had also received Trastuzumab and Paclitaxel on the same day. An MRI and Lumbar Puncture were performed to rule of Leptomeningitis.
Received 1st dose 1/29/2021 which was Moderna. States was notified by electronic system to receive dose on 2/17/21 clinic. That clinic was designated as first dose Pfizer clinic. Client did not present any info regarding first dose until he made a comment that he needed a vaccine card since he didn't get one the first time. Client stated he had received two notices to come to clinic on 2/17 and had registered. Agency evaluation was that client had probably checked more than one category that he qualified for vaccine and was receiving notices that he was to schedule for what was to be a first dose of vaccine. Agency has now implemented the standard that every client is asked if this is his first or second dose prior giving vaccine.
pateint recieved dose went to register to get rung up with his parent and fainted in aisle regained consciousness. no breathing difficulty but said he was very dizzy. at this point we called 911.  TPatient was transported to hospital tried to reach out to patient no response.
Case number PHHY2011US68646 is an initial spontaneous report received from health care professional on 27 Jul 2011. This case refers to 18years old male patient. He was vaccinated with MENVEO (batch number: X10031) 0.5ml intramuscularly on 25 Jul 2011. But, he was given only Men CYW-135 liquid conjugate component without reconstituting it with Men A lyophilized powder component. No adverse reaction had occurred following this drug administration error.
I am one of those who are still uncomfortable and hurting. I have not said anything because I thought that maybe this was normal but then I received an Email yesterday and said oh okay, everyone is experiencing this. My complaints are; I cannot raise my left arm without being in pain and when I wake up in the morning, I cannot move my arm at all for a little while. In fact, I take my other hand and raise my left arm with it to move it around. After a little while I can  move my arm but it still hurts. Even right now at my desk I tried to lift my arm and cannot lift it after a certain point, just wont go, it hurts a lot. I have not seen a doctor since. I really don't have time and especially money to pay for the co payment, and I hope it will go away. Keep me posted as to what to do next. It is really annoying. I have two small children and it is hard to carry them.
I had an injection site pain a moth or two after the injection.  It has grown increasingly annoying-but not yet incapacitating.
felt like she was going to pass out; face started to tingle/tingling returned but this time it was down her chest; lips started going numb; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration, in the right arm, on 27Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 27Jan2021, after getting the vaccine, the patient experienced face started to tingle and felt like she was going to pass out. On 27Jan2021, vitals were taken and showed normal. The patient reported that on her way home on 27Jan2021, lips started going numb and the tingling returned but this time it was down her chest. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL). Outcome of all the events was recovered on unspecified date in Jan2021.
Sore; swollen; Heat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (swollen) and TEMPERATURE INTOLERANCE (Heat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (swollen) and TEMPERATURE INTOLERANCE (Heat). At the time of the report, PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (swollen) and TEMPERATURE INTOLERANCE (Heat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Narrative: Note: Patient is 57 and this was the first flu vaccine in charting listing as moderate as patient did call and may have treated with over the counter benadryl for itching
I simply had a breakthrough case of COVID. The VSafe people told me to report that here for some baffling reason.  I had a scratchy throat on April 30, 2022. I started getting a headache, fever, body aches, chills, cough ,stuffy nose and fatigue on the morning of May 1. I was tested with a rapid PCR  test in the morning of May 1 and was positive. My symptoms got progressively worse throughout the day. By evening, I had a fever of 101.4.  My worst symptoms were the night of May 1 into May 2. Since then, I've gotten progressively better to the point where the only real symptoms now are a slightly stuffy nose and mild fatigue
Severe Pain, both knees... Swelling about LEFT knee... Swelling down to LEFT ankle foot...  Blood Panel Dr Consult Ultrasound LEFT Leg... Checking for DVT. Beginning Prednisone 20mg for 5days, 4/7/2021.
Severe pain in left arm, started within an hour of getting the shot and getting worse with time. Headaches.
PATIENT RECIEVED PFIZER DOSE AFTER ALREADY RECIEVING MODERNA VACCINE
Multiple episodes of dizziness, fainting, headache, throat closing up; still ongoing.  Leg pain, fatigue, stomach pain, hot flashes
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: JOI5SRA), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: Dec2017; MELOXICAM, start date: Dec2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that while taking Paxlovid, horrid taste for entire 5 day course of treatment; experienced horrific headaches in the middle of the night for the last 3 days of the 5 day course. Approximately 2 days after end of 5 day course, sore throat, increased congestion (head and chest), short of breath with exertion, fatigue, brain fog. Treatment start date 04Jul2022, treatment stop date 08Jul2022, indication was treatment of COVID-19. It was reported that none known allergies.  No follow-up attempts are possible. No further information was expected.; Sender's Comments: Based on the available information and the drug's known safety profile, a possible contribution of the drug to the vaccination failure and COVID-19 cannot be excluded.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product information was not provided. It was reported that the vaccines were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 06-Oct-2021 vaccine was moved to fridge. The facility thought that the vials are received frozen from Moderna so they had unpacked them and put them back into the facility freezer. They just recently found out that the vials are received in refrigerated temperatures and not frozen. They have been accidentally administering refrozen vials to their patients. Duration of the excursion Refrigerated temperature for maximum of 4 hours. Vaccine administered post 30 days from the initial storage at 2 degree C to 8 degree C. Treatment information was not provided. This case was linked to MOD-2022-496015 (Patient Link).
Massive Bruising to the left arm. Lower below the elbow to the hand; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 24Apr2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not received any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 24Apr2021 at 15:00, the patient experienced massive bruising to the left arm, lower below the elbow to the hand. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 event massive bruising to the left arm, lower below the elbow to the hand was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Dec 5,2021 got my moderna booster around 6:45pm  December 6,2021 5:30 pm felt hot and thought it was just from my chronic urticaria and took Claritin  Around 6pm after I took a shower my eyes felt heavy and chin started to become thick. It was not my usual symptoms from my chronic urticaria 6:30pm my face became swollen esp around the eyes and lips and decided to go to the ER In the ER they gave me Benadryl and Pepcid and a prescription for an EpiPen
Upper arm swollen, red and itchy with blister within 4-6 hours, post vax.
Patient after third vaccine and then immediately had arrest of respiration with cyanosis and limpness of all 4 extremities with eyes rolling back. After about 3 minutes started crying and seemed sleepy. Was transferred from peds clinic to ER for further workup.
got shingles; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient). This case involved an adult patient of an unknown age and gender who Fax last time I got the flu was when I got the shot (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient  never had a flu shot, but patient got shingles(illness) and patient heard that shot can give you shingles.   No relevant laboratory details were provided. It was not reported if the patient received a corrective treatment.   Outcome of the events were reported as unknown.  There will be no information available on the batch number for this case.
No adverse event to report. Gave Pfizer Bivalent Booster instead of  Pfizer Monovalent