chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; HCP advised that her office administered 3 vaccinations with expired vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered 3 vaccinations with expired vaccines) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknown.     On 12-Jul-2023, 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 12-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered 3 vaccinations with expired vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered 3 vaccinations with expired vaccines) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered 3 vaccinations with expired vaccines).    It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine or not. Concomitant medication details not reported by the reporter. Suspect product dosage text was reported as unknown. The expiry date was reported as 18-JUN-2023. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733038 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733038:Same reporter
R upper arm very red from shoulder to elbow & swollen low grade fever/treated with Medrol Dose Pak
Redness, increased warmth, swelling, severe pain at right deltoid injection site with small area of central ecchymosis (6.5x3.5cm outer diameter, with approximately 6x8mm ecchymotic center).
Initial information received on 30-Aug-2018 regarding an unsolicited valid non-serious case received from Other health professional. This case involves a 13 years old female patient who was inadvertently administered FLUBLOK QIV. The patients past medical history, concomitant medication and family history were not provided. On 29-Aug-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAAA103, expiry date 31 May 2019 via unknown route and unknown site of administration. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that patient was female patient who was inadvertently administered vaccine FLUBLOK QIV. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender - none.
About 30 minutes after the shot got an episode of lightheadedness and nausea that lasted a few minutes.  It came in waves, but was bad enough that he was afraid to drive home.  These 'episodes' continued to happen for the next two days at least once per day for about 30 seconds.   On Friday, 8/30/19, patient had 3 'episodes' with the last one lasting about 30 minutes in which time his wife drove him to the ER.  He had another 'episode' at the ER waiting room.  Many tests were run at the ER of which I am not privy to, but the patient said labs were drawn, an x-ray was done, and a Cat Scan.  All tests came back normal and ruled out any issues.  He had a follow up appointment with Dr. today, 9/5/19, of which not much was mentioned.  He is feeling back to his self now.
by history died of SIDS;was off the monitor which was discharged home with;on the floor having fallen asleep w/mom on couch;
i had headaches minutes after first shot; extreme pain; vomiting; dizziness; This is a spontaneous report from a contactable consumer or other non hcp.     A 40-year-old (non-pregnant) female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 40 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing, cilians (drug hypersensitivity) from an unknown date and unknown if ongoing (known allergies: cilians). Concomitant medication(s) included acetylsalicylic acid, caffeine (BC [ACETYLSALICYLIC ACID;CAFFEINE]) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid, caffeine, ergotamine tartrate, homatropine methylbromide (MIGRANE) taken for an unspecified indication, start and stop date were not reported. Patient was not Pregnant at Time of Vaccination. No other vaccine in four weeks. Patient had covid prior vaccination. covid was tested post vaccination.On 28Feb2021 at 10:30 the patient had headaches minutes after first shot, extreme pain, vomiting and dizziness. It was reported that patient had headaches minutes after first shot that then progressed in coming weeks to migranes which needed to go on medicine due to extreme pain and vomiting and dizziness. Upon second shot the headaches worsened and dizziness. Still on medicine and now receiving an MRI. Brain fogginess had increased. Getting through the day to complete work or even basic tasks was very difficult.Therapeutic measures were taken with BC, migrane medicine as a result of  had headaches minutes after first shot, extreme pain, vomiting, dizziness. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on unspecified date, sars-cov-2 test: negative on 24Mar2021.The outcome of events was not recovered.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, vertigo, facial numbness. Er visit ... full stroke work up, mri, ct scan
dose of the Shingrix in 2018 / the second dose in 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose in 2021, later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter inquired if a third dose of Shingrix was recommended. The reporter did not consent to follow up.
Fever and tiredness hours after the short that lasted for approx 12-18 hours; Very Hot Arm Around the Injection Site for over 5 days post shot
First day - sore arm The second day - swollen lymph nodes in the armpit of right arm
This is a spontaneous report from a contactable reporter (a manager). This is the 2nd case out of the 2 cases. A 66-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot# R12276, Exp date Feb2018, NDC 0051971-02) via an unspecified route of administration at 0.5ml, single at right deltoid on 07Feb2017 for immunisation. The patient medical history and concomitant medications were not reported. The next morning, on 08Feb2017, the patient experienced redness and intensive swelling with outcome of unknown. The patient actually ended up going to the emergency room for the reaction to the shot.
Redness! Major swelling, rash, fatigue, pain in arm and shoulders, itching, sharp pains, light sensitivity - all symptoms have lasted over a week.
Had walking pneumonia in army; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer reporting for him/herself.  A patient of unknown age and gender received on an unknown date a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization. Medical history and concomitant medications were not reported. The patient had 3 pneumonia shots including pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on unspecified dates. Additionally, it was reported that the patient received a flu shot on 01Oct2019 for immunization and got Type A influenza on 07Feb2020 that lasted 10 days. On an unknown date, the patient had walking pneumonia. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
On the evening of about 1/12/2023, I began to feel more tired than usual. On 1/13/2023, I developed flu-like symptoms, like runny nose, cough, and fatigue. I took a COVID-19 test and got a positive result on 1/14/2023. On 1/14/2023, I went to an urgent care clinic. I told them about the test result. They took my vitals, and my blood oxygen level was 99 and my BP was okay. I took a PCR test. Later that night, I because nauseous and threw up. On 1/15/2023, I felt better sometimes, but then I would intermittently have dizziness and nausea. I learned from the urgent care clinic that my PCR test result was positive. On 1/16/2023, I contacted my PCR and was prescribed PAXLOVID. I took the PAXLOVID for five days, and by 1/21/2023, I tested negative for COVID-19 and felt better. Over the period between 1/14/2023 and 1/16/2023, my sense of taste was off. It wasn't gone, but it was altered.
Patient received flu shot on 10/02/2007. Patient came to pharmacy today (10/05/2007) to show pharmacy intern her left upper arm where flu shot was administered.  Patient's upper left arm was noted by pharmacy intern to be substantially bruised being purple and black in color.  The bruising was noted to be circular and estimated to be about 3 inches in diameter and located towards the distal part of the deltoid muscle.  Apparently the bruising has lessened, but was more extensive starting that night that she received the flu shot, extending from where it is now to all the way to where the flu shot was administered.  Patient stated that her upper left arm was painful to move that night, but experienced no other symptoms.  Today patient did not complain of any symptoms, nor pain associated with the current bruising.  Patient stated that this never happened with previous flu shots.  Patient stated that she is not on Coumadin, but is taking aspirin.  Patient was advised that bruising is seen in some patients and that she should monitor the bruised area and seek medical attention if bruising gets worse or does not go away.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2013 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 05-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
I got a rash all over my body on my first shot; 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 RASH (I got a rash all over my body on my first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    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 RASH (I got a rash all over my body on my first shot). At the time of the report, RASH (I got a rash all over my body on my first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 29Jan2021 at 15:30 as DOSE 1, SINGLE (lot number: EL9264), in the arm; on 24Feb2021 at 14:30 as DOSE 2, SINGLE (lot number: EN6198), in the arm; and on 17Nov2021 at 14:00 as DOSE 3 (BOOSTER), SINGLE (lot number: FF8839), in the arm, all intramuscular for COVID-19 immunization. The patient's relevant medical history included: "Anxiety", start date: 1998 (unspecified if ongoing); "BPPV", start date: 2005 (unspecified if ongoing); "CAD", start date: 2012 (ongoing); "Prediabetic", start date: 2012 (unspecified if ongoing); "GERD", start date: 2012 (unspecified if ongoing); "Diverticulitis", start date: 2017 (unspecified if ongoing); "Dysautonomia", start date: 2019 (ongoing). The patient's concomitant medications were not reported. Patient had no prior vaccination (within 4 weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "COVID-19." The patient underwent the following laboratory tests and procedures: Echocardiogram: (unspecified date) Ok, notes: Heart checked okay, Date: Mar/Jul; Physiotherapy: (Jun2022) Unknown results, notes: Assessed nerve muscle function; (Jul2022) Unknown results, notes: Assessed nerve muscle function; COVID-19 (SARS-CoV-2 antibody test): (12Jan2022) Unknown, notes: COVID-19 onset date: 12Jan2022; did receive antibody transfusion 13Jan2022; Lumbar X-ray (Spinal X-ray): (Jul2022) Some narrow WA LS/S1/PT; Ultrasound/Circulatory (Ultrasound scan): (Jul2022) No blockage/ No blood clots in legs; Chest X-ray: (2022) Ok, notes: Lung checked okay. Therapeutic measures were taken as a result of Vaccination failure, Covid-19; patient received antibody transfusion 13Jan2022.  Additional information: Patient age at the time of vaccination (dose number series unknown) was reported as "65 years." The patient received the 4th dose on 20May2022 (batch/lot Number: FM7553) at 15:00 via intramuscular route, administered in the arm for COVID-19 immunization. The subsequent booster doses were administered due to a weakened immune system (medical history). Specific relevant test: for thromboembolic events with thrombocytopenia was reported as "unknown."; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092813 same reporter/patient/vaccine; different dose number and events;US-PFIZER INC-202201225349 same reporter/patient/vaccine; different dose number and events;
Patient received Pfizer Booster shot at vaccination shot on day above. In observation line, she reported feeling anxious, high heart rate and lightheaded. Vital signs at 12:45 pm were as followed, 144/82 blood pressure, 76 heart rate, 18 respirations and 96% SPO2. Patient was independently talking, no chest pain or shortness of breath reported. Monitored by paramedics. At 12:50 pm vital signs were: 151/80 blood pressure, heart rate 74, respirations 18 and 100% SPO2. At this time, patient reported feeling much better and stated she had gone for a walk that morning but had not eaten anything. Advised patient to get some lunch, drink water and rest for afternoon. Left site with no further symptoms.
?Vaccine arm ?as described in the clinic, Delayed Large Local Reactions to mRNA-1273 Vaccine against SARS-CoV-2 April 1, 2021 N Engl J Med 2021; 384:1273-1277 DOI: 10.1056/NEJMc2102131  Red rash at vaccine site, itching, swelling,  hot to the touch .
Allergy to the vaccine; Eruptions and lumps on his chest, stomach area and wrist and hands; Swollen tongue; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE, HYPERSENSITIVITY, and RASH in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy. Concomitant products included ASPIRIN for an unknown indication.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE, HYPERSENSITIVITY, and RASH. At the time of the report, SWOLLEN TONGUE and RASH had resolved and HYPERSENSITIVITY outcome was unknown. recovered with allergy pills.           It was reported that the patient was deemed to have allergies to the vaccine (having visited an allergist). He had swollen tongue (twice), eruptions and lumps on his chest, stomach area, wrist, and hands. It disappeared the next day (with intake of allergy pills).  Treatment medication included allergy pills (unspecified).   Reporter did not allow further contact.
This is a spontaneous report from a contactable consumer (patient).  A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN5318, via an unspecified route of administration in the left arm, on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history included hereditary haemorrhagic telangiectasia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included benazepril, folic acid, torsemide, tamsulosin and iron. This patient has a history of Hereditary Hemorrhagic Talengiectasia, a bleeding disorder causing very brittle veins in my nose. He gets injections every 6 months to partially control the extreme nosebleeds. Starting the next day after getting the vaccination (30Jan2021, 04:00), there was an increase in the number and intensity of them. It has been the third day and they are getting more frequent. Outcome of events was not recovered. Events are considered non-serious.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Pt's wife reported that he got mini stroke shortly after getting Covid 19 vaccines and got admitted to the hospital right after.
12/01/2021 I started having heavy menstrual type bleeding with extremely large clots. It happened suddenly, not slowly like a normal period. It did not stop. I had to wear overnight pads all the time and had bleeding through my clothes. I had horrible cramping and back pain. This did not stop until I had a hysterectomy on March 23, 2022.
A non-serious spontaneous report of gave pregnant woman H1N1 was received from a nurse practitioner concerning a 32-year-old female. No relevant medical history and concomitant medications was reported for the patient. The patient's obstetrical history was unknown and estimated date of delivery was 07-Dec-2009. The patient was in her third trimester at 35 weeks gestation. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments was not applicable and the event vaccine exposure during pregnancy was considered resolved. The outcome of the pregnancy in mid of Dec-2009 was birth to a beautiful, healthy and normal baby girl and both mother and child are doing very well. Additional information was received on 11-Nov-2009 and incorporated into the narrative: obstetrical history, medical history, concomitant medication and estimated date of delivery. Additional information was received on 23-Dec-2009 and incorporated into the narrative: outcome of pregnancy.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 12/30/21 (EL0340) Pfizer Dose 2 1/20/21 (EL0140) COVID Positive 10/16/21  10/16/21: Patient is a 57-year-old male who presents from his nursing home with some reported hypoxia with the patient having a room air saturation of 79% earlier today. Patient was subsequently placed on 2 L of supplemental nasal cannula oxygen and transferred to the emergency room for further treatment and evaluation.  Patient himself did not necessarily feel any increasing shortness of breath or dyspnea but does note some increased generalized weakness recently.  For the past 4 days prior to arrival the patient had some decreased appetite and decreased fluid intake recently.  Patient has not voided in roughly 36 hours and has refused a Foley catheter, patient has also refused hospice previously.  Patient has an extensive medical history which was discussed reviewed today as well as reviewing the patient's current medications.  Patient's previous hospitalizations and acute rehabilitative courses have been reviewed.  Laboratory studies, imaging studies, vital signs, current medications and emergency room records were personally reviewed.  Patient has been vaccinated for COVID and did ultimately end up testing positive for COVID while in the emergency room.  10/20/21: 1. Bilateral COVID-19 pneumonia-patient was vaccinated fully for COVID-19 but has tested positive, was significantly hypoxic at the nursing home and is now on 2-3 L via nasal cannula. Completed a 5 day course of , Ascorbic acid, vitamin-D and zinc along with dexamethasone.   2. Acute hypoxia-patient maintaining normal oxygenation on 2-3 L via nasal cannula. Can continue at LTC.   3. Supratherapeutic INR-INR upon arrival is 7.3 with no obvious signs of bleeding, INR improved today at 5.6.  At therapeutic levels on discharge.   4. Hypomagnesemia-magnesium level is noted to be 1.6 today started the patient oral Mg++ at 400mg Po Bid   5. Elevated troponin-patient has an elevated troponin x2 at 0.05 and 0.04 with no complaints of chest pain.  Two EKG tracings have been reviewed which were negative x2 with no acute changes.  No events on telemetry with the patient having no chest pain, monitor for now.   6. Essential hypertension-patient was hypotensive upon arrival to the emergency room and is known to have a history of autonomic dysfunction and orthostatic hypotension.  At his baseline the patient is on midodrine at 10 mg p.o. t.i.d. which will be continued.   7. Type 2 diabetes-blood sugars have been reviewed which are overall stable, make no changes or adjustments but continue close monitoring.
pt started feeling bad w/in 1hr of vax; nauseated; diarrhea; vomiting; temp 100f about 7pm; dizziness; vomiting lasted about 1:30am; still little diarrhea; has cramping upper abd; 7/27 feels better today except hasn't eaten/or had liquids