chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On day 3 of menstrual cycle. Menses abruptly ended within 12 hours of receiving vaccine. Normal cycle length 7 days. Subsequently, all menstrual cycles have included mid-cycle bleeding, severe uterine pain, ovarian cyst formation with no prior history of these events.
Sore at the injection site, headache, nausea, dizziness, full arm swelling including hand/fingers, arm numbness over 24 hours. Symptoms started 10 minutes after injection.
Information has been received from a Certified Medical Assistant concerning a female patient between 70 to 79 years old with chronic obstructive pulmonary disease (COPD) who in March 2012 was SC vaccinated with 0.5 ml of one dose of VARIVAX (Merck) (lot # was not reported). The patient was on a lot of other (unspecified) medications. Sometime in March 2012, a few days after receiving VARIVAX (Merck) therapy, the patient experienced rash and lump at the injection site. No treatment was given for the adverse event. The patient did not seek medical attention. Subsequently, on an unspecified date, about a week after administration, the patient recovered from rash at the injection site and lump at the injection site. Additional information has been requested.
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who all received flu vaccine. This case deals with fourteenth of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns 15-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 21-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (number: 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case correction received on 10-Aug-2017: Narrative was corrected.
We received the following information via our legal contractor on 15 OCT 2009: A female patient was vaccinated with influenza vaccine (manufacturer or batch no. unknown) on an unspecified date. The patient complained about swollen glands in her throat and soreness in her neck. She was transported by ambulance to the hospital. Interval between vaccination and onset of the symptoms or outcome is unknown. Claim no.: 30090950992-0001.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-OCT-2015 11:50, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.0 and 0.5 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
2.6cm x 16.2cm erythema and warmth over left thigh.
I forgot to get my 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in mid April 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10 NOV 2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received 1st dose of Shingrix in mid April. The patient reported that forgotten to take 2nd dose of vaccine at 6th months. It had been 7 months since 1st Shingrix dose, the reporter asked it was ok to get second dose now or it was problematic to have the 2nd dose now Additional supportive information: Till the time of reporting the patient did not received the second dose of Shingrix which led to incomplete course of vaccination.
Patient received a small area of erythema at site of varicella vaccination.  This is the 3rd patient that has had this reaction in the past week to the Merk Varivax, different lots.
Very itchy for a day an a half.  Huge painful welt about the size of the palm of my hand at the injection site.
sore arm where it was put into the muscle of her right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm where it was put into the muscle of her right arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm where it was put into the muscle of her right arm). At the time of the report, VACCINATION SITE PAIN (sore arm where it was put into the muscle of her right arm) 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.   Reporter did not allow further contact
CLINICAL IMPRESSION: Altered mental status, COVID Hypoxia,  Chronic atrial fibrillation, Chronic kidney disease, unspecified CKD stage Came to ED for evaluation of altered mental status. Patient's wife died yesterday morning as well. Heart rate is elevated and variable, hx atrial fibrillation. Scattered rhonchi. Patient in the emergency department last night for epistaxis. Anticoagulated on Eliquis due to history of atrial fibrillation. A nasal packing was placed in the right nostril which remains in place currently.  Baseline use of O2- 1 to 2 L. Here he is requiring 3 to 4 L. On oxy mask rather than nasal cannula due to the presence of nasal packing.  Patient given dose of dexamethasone due to hypoxia in the presence of COVID. He was also given a dose of diltiazem due to elevated heart rate.  ASSESSMENT & PLAN: COVID c/b Hypoxia - Unclear day of symptom onset; PCR+ 5/9 - CXR - diffuse bilateral pulmonary infiltrates (but unchanged from 4/11) - Recently started wearing 2L O2 with activity - up to 5L in ED - wean as able - IV Decadron 10 mg x 3 days, then 6 mg x 7 days - Not a candidate for Remdesivir d/t borderline renal function, unclear onset - Mucinex BID - Isolation precautions Mon May 15 2023 Date of hospital admission: 5/9/2023 Date of death: 5/15/2023  Cause of death Interval 1. Acute hypoxic respiratory failure - 3 days 2. COVID-19 - 1 week  Admitted with: Altered Mental Status, COVID-19 pneumonia, metabolic encephalopathy, mild AKI. Hospital Course: Patient on nightly oxygen as he cannot tolerate CPAP. Patient lost his wife just day before admission. Patient started on remdesivir and dexamethasone for COVID-19. Patient is high aspiration risk and speech therapy evaluated on admission. Despite optimal treatment, patient started worsening and oxygenation got worse and he was transferred to ICU on 15 L / 90% Vapotherm. Patient started becoming more confused. Patient was started on high-dose steroids, low-dose Precedex drip. Patient continued to worsen. He removed his own oxygen and was noted to have severe bradycardia. Family was notified and worsening status was related. Patient was transitioned to hospice care on the night of 5/14/2023. Patient expired soon after at 0220 on 5/15 /2023. Family at bedside.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital:
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 07-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
received Rotarix intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of wrong route of administration in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7H9CH, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th May 2022, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 4th May 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of 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: 04-May-2022 Reporter's comment: The reporter reported that the patient received a dose of Rotarix  inadvertently administered via intramuscular instead of oral. No symptoms were reported. The reporter consented to follow-up by email. Additional Supportive Information: The patient received a dose of Roatrix intramuscularly, which led to wrong route of administration. This case was identified as duplicate of US2022073859. The case US2022073859 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Patient got vaccine and then felt tingling in her legs. Paramedics were called. BG 75. Cleared by paramedics. Patient stay at the pharmacy for 2 hours drank lots of water and ate a turkey sandwich. After, patient felt better and was able to walk and leave store.
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. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache. This report was non-serious.
Pt recvd 1st Engerix-B on 9JUL91, 2nd on 19AUG91 & 1 wk post 2nd vax lt deltoid hurt & continued to hurt for 3 wks; 16SEP91 exp weakness in both legs & knees gave out; weakness lasted 7-10 days; 3OCT91 exp skin eruptions that were itchy;
Low-grade, subjective fever Body aches Listlessness  No energy  Fatigue  Muscle soreness at injection site
Had routine DTp/HIB @ clinic & mom called next AM to report t105 & took pt to MD; MD could find nothing significant poss vax related; inject site warm;
Client states about 4-6 hrs after her first Pfizer covid vaccine on her L arm , she developed raised red welts and then small blisters began to develope, which spread down her arm.  She also added a few days later her vision became very blurred, her vision did come back to normal.  She states on 02/14/2021, she returned to receive her second Pfizer Covid vaccine.  She states she did tell the nurse and showed the rash on the L arm.  The nurse consulted with other nurses at the clinic and it was decided to provide the vaccine on the other arm, which the client agreed to.  She states a few hours later the red raised welts appeared on the her right arm and begin to spread down her arm.  She states the red raised welts began to spread over her body including  her legs, feet, and buttocks.  The blistery rash then began to spred over her breasts, stomach and back.  She did consult Dr. and was placed on prednisone.  She states she has received the treatment for about 4 weeks
Patient tested positive for Covid after more than 15 days of receiving second dose of Moderna COVID-19 vaccine; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION FAILURE (Patient tested positive for Covid after more than 15 days of receiving second dose of Moderna COVID-19 vaccine) and COVID-19 (COVID-19) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 047B21A and 003821A) for COVID-19 prophylaxis.     Patent had no acute illnesses at the time of vaccination and upto one month before. It was unknown if patient had any chronic long-standing health conditions at the time of vaccination or not.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION FAILURE (Patient tested positive for Covid after more than 15 days of receiving second dose of Moderna COVID-19 vaccine) and COVID-19 (COVID-19). At the time of the report, VACCINATION FAILURE (Patient tested positive for Covid after more than 15 days of receiving second dose of Moderna COVID-19 vaccine) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, SARS-CoV-2 test: (Positive) test done in hospital.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient's race was reported as North American Indian/Inuit/Meitis.  No treatment medications were reported. Company comment- This vaccination failure spontaneous case concerns a 40-year-old male patient with no medical history reported, who experienced the non-serious unexpected event COVID-19 approximately 6 months after receiving a second dose of mRNA-1273 vaccine. First and second doses of mRNA-1273 vaccine were administered in an appropriate schedule of vaccination. Patient tested positive for COVID-19 test. No further clinical information was provided for medical reviewing. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-730391 (Patient Link).
Yesterday, Day 1 post-vaccination, had localized soreness in left arm all day (as expected). Today, Day 2 post-vaccination, soreness has resolved. Upon waking, I noticed that I was unable to smell things that I typically smell in the morning (bathroom smells, coffee brewing). Could smell things up close and perfume wafting up from my chest. Hyposmia is most apparent in relation to diffusive scents in a room.
Pt experienced extreme body pain (feet and spine). Her fingers aren't working well. Sound hurts, painful hearing along with a headache. She also experienced emotional lability and crying. this lasted for about 24 hours.
I started to see bruising on my sons body and two days later, he woke suddenly from his nap crying that he hurt. He hurt in several places on his body that he can identify (joints). The bruising was present in different locations but continued. A scratch would turn into a bruise and things like what they call his "stork bite" turned very red. At this exact time of him waking from his nap upset, his vaccine injection site had a dime size red mark that had previously not shown up and he had a fever of 101-102 that day. This turned to him crying uncontrollably that evening to where we would hyperventilate almost as well as very lethargic. He kept complaining that he was in pain.
Left arm red and swollen with massive headache, eyes bulged temp 100.0 and 101.0 with sweating and difficult to move left arm due to pain.  Every bone in body hurt.  Literally slept 11:00 am Friday til 6 am Monday continuously.
Information has been received from a physician and registered nurse concerning a 30 yr old male who on 10Dec05 was vaccinated with the first dose of hep A virus vaccine inactivated. According to the nurse, approx three weeks following the vaccination a hep antibody test was performed. She was not sure why the test was performed at this early date. It revealed that the pt failed to seroconvert. On approx 18Jan06, the pt saw a different physician at an outpt clinic and at that visit was vaccinated with the second dose of hep A vaccine (mfr unk) as well as with hep B vaccine (mfr unk). Later that day the pt experienced an unspecified reaction. The nurse felt that the reaction was due to having both vaccinations on the same day. She had no further details on the reaction type and severity. The outcome was unk. She did report that the pt was not hospitalized since the first vaccination with hep A virus vaccine inactivated on 10Dec05 (initially reported as hospitalized for unrelated health issue). Additional information has been requested.
local reaction-lg swelling, red. Tender to touch  irritable x 24 hours, crying  fever 100.4
15 days after vaccine was administered at the clinic, patient presented for appointment and the physician that saw the patient was informed by patient that she was pregnant. As of 7/7/2023, patient's EDD is 10/1/2023, and the only known complications currently are well-controlled HIV and thrombocytopenia [suspect gestational thrombocytopenia]. PCP: no PCP
Chills night of vaccine; COVID-19; Lost sense of smell; Severe Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ANOSMIA (Lost sense of smell), HEADACHE (Severe Headache), FATIGUE (Fatigue) and CHILLS (Chills night of vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced CHILLS (Chills night of vaccine). In January 2021, the patient experienced COVID-19 (COVID-19), ANOSMIA (Lost sense of smell), HEADACHE (Severe Headache) and FATIGUE (Fatigue). At the time of the report, COVID-19 (COVID-19), HEADACHE (Severe Headache), FATIGUE (Fatigue) and CHILLS (Chills night of vaccine) had resolved and ANOSMIA (Lost sense of smell) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) positive for Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Shortness of breath; She is hurting right now; Hydrocortisone for arthritis/ Methylprednisolone for arthritis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose number, single dose for COVID -19 immunisation; hydrocortisone, route of administration, start and stop date, batch/lot number and dose were not reported for arthritis; methylprednisolone, route of administration, start and stop date, batch/lot number and dose were not reported for arthritis; adalimumab (HUMIRA), via an unspecified route of administration, from an unspecified date (batch/lot number not reported) to an unspecified  date at 2 DF (dosage form) (2 doses) for an unspecified indication; and leflunomide, route of administration, start and stop date, batch/lot number and dose were not reported for arthritis. The patient's medical history and concomitant medications were not reported.  The patient experienced shortness of breath and hurting on an unspecified date. Patient reported that she used to be on Humira but stopped it because it gave her shortness of breath. She takes Methylprednisolone, Leflunomide, and Hydrocortisone for her arthritis.  Patient was wondering if these medications interfere with the COVID shot.  She has already reported the Humira incident. She only took two doses of it. She had to stop because it gave her shortness of breath. Patient was wondering if any of her medications will interfere with the COVID vaccine. The family doctor told the patient to wait a week before the shot, but the Rheumatologist said okay to get the vaccine with her medications. The patient was hurting right now. She was trying to find some cream in the pharmacy. The action taken in response to the events for hydrocortisone, methylprednisolone and leflunomide was unknown; and for adalimumab was permanently withdrawn on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.