chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menactra; expired product was given to a patient with no reported adverse event; Initial information received on 23-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves an unknown age and unknown gender patient who experienced menactra; expired product was given to a patient with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (unknown strength, dosage,formulation,batch number and expiry date) via unknown route in unknown administration site for immunization  On an unknown date (latency: unknown) the patient developed a non-serious event of menactra; expired product was given to a patient with no reported adverse event (expired product administered) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Case number PHEH2013US023320 is an initial spontaneous report received from a nurse on 01 NOV 2013 with the follow-up received on 20 FEB 2014. This report refers to a 34-year-old female patient. Her medical history included depression, intrauterine growth restriction at 31 weeks on 06 JUL 2013 and normal spontaneous vaginal delivery. Concomitant medication included azithromycin for upper respiratory infection and prenatal vitamins during entire pregnancy. She was vaccinated  with 0.5 ml of FLUVIRIN 2013/2014 (batch number: unknown) intramuscularly into left upper arm on 30 OCT 2013 at 9:00 AM when she was pregnant for 28 weeks of gestation. On the same day, she was also vaccinated with TDAP (manufacturer and batch number unknown). One week before prior to this flu vaccination, she was also vaccinated with an intramuscular dose of FLUVIRIN 2013/2014 (batch number: unknown). The patient was already receiving frequent ultrasounds due to intrauterine growth restriction which she also had a history with her prior pregnancy. The patient did not experience any adverse reactions as proven into the continuation of her pregnancy. On an unknown date at her 37 weeks of gestation, she had a precipitous labor (<3 hours) and delivered a normal male baby. Nurse assessed the causality as not suspected. No additional information was available.   Follow-up received from a nurse on 20 FEB 2014: Patients demographics, medical history, concomitant medications and vaccinations details were updated.
Pt developed a fever of 103 F 13 hours after immunizations were given. The fever resolved the next day. Tylenol Given.
SOB, weakness, cough, fever on 09/03/2022, pt was hospitalized. Pt expired at the hospital on 09/15/2022.
Started with single outbreak of hives lasting several days, after second dose started happening with greater frequency and greater outbreaks.  Now, lasting 3 weeks, some go away and new ones appear, feet, arms, legs, face.  No history of hives prior.
Fever, severe headache that caused high blood pressure, small non itchy red spots on arm, stomach, and back
5 days after vaccine swollen lymph node and swollen neck near collar bone.  7 days after vaccine red swollen itchy at injection site.  No signs prior to that except soreness at injection site.
Had a reaction 25 minutes after receiving the vaccine. swelling tongue, hands and feet. Dizzy, nausea, felt like I was going to throw up. Cold sweat. Lasted for about 25 minutes. Felt okay the next two days, then starting Friday 4/9 the dizzy and nausea came back. Tightness in chest and so dizzy having trouble working a full day at work. Some times it would go away and I would feel fine, then it would come back. I haven't had one day where I have felt good the whole day since.
Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a patient who experienced non-responsive titer levels to PREVNAR. The patient received a dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date, the patient received a dose of PREVNAR (date unspecified) and subsequently experienced a non-responsive titer level to PREVNAR (antibody test abnormal). The patient's outcome is unknown. No additional information was available at the time of this report.
I95.9 HYPOTENSION 9/27/2021 HEMORRHOID I95.9 HYPOTENSION 9/27/2021 HEMORRHOID I95.9 HYPOTENSION 9/27/2021 ANEMIA    ULCERATIVE COLITIS OF UNSPECIFIED SITE I95.9 HYPOTENSION 9/27/2021 ANEMIA I95.9 HYPOTENSION 9/27/2021 HEMORRHOID
Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and developed Shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Pt called saying has sore throat/aches since flu shot. Described feeling of "fullness" in throat, but no difficulty breathing.3  days later SZ resolved.
Patient was given the vaccine without incident at or near 0924a.  He previously was diagnosed, through PCR test to have COVID-19 back in December 2019.  Outside of supportive therapy at home, he was not treated and was not hospitalized and he recovered within a few weeks.  At or near 930-10p, on April 9th, approximately 12 hours after the vaccine was given, while out at a restaurant with family, the patient experienced a medical event, (what appears to be an acute coronary event) and died.
This case was reported by a healthcare professional and described the occurrence of throat closed in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. On 15 September 2009, the subject received unspecified dose of FLULAVAL (unknown). on 15 September 2009, less that one day after vaccination with FLULAVAL, the subject experienced throat closure. The subject was seen in the emergency room and the event resolved. The reporter stated that the batch of vaccine for lot number AFLLA261AA might be defective which caused the adverse event. The reporter did not have specific information and is seeking advice on whether to continue giving injection with this lot. The reporter did not have an expiration date.  The reporter stated three additional subjects experienced adverse events; see cases A0807882A, A0807883A, and A0807884A. On 15 September 2009, the events were resolved. Follow-up was received on 18 September 2009, via sales representative, who reported the onset of symptoms were approximately a half hour, the subject was treated in the emergency room and discharged. Subject again visited emergency room that night, symptoms resolved. Subject reported feeling well prior to vaccine, no fever, no allergies to chicken feathers or eggs. Subject reported no previous allergy to flu vaccine, did report muscle aches and general symptoms following previous flu vaccine. No other concurrent medications. The event resolved on 16 September 2009 and was considered possibly related to vaccination with FLULAVAL.
fast heart beat, dizziness, tiredness,muscle pain, chills,nausea, vomitting, feeling unwell, decreased appetite, chest pain, feelings of having a fast beating, fluttering or pounding heart,
Patient began to loose vision and fainted. after about 5 minutes she began to make jerking movements  and fainted again 911 was called  and they took over the situation
I woke up early in am with 3rd toe on left foot painfully swollen and red.  I took ibuprofen for pain and continued to work Thursday, Friday, and Saturday.  I came home Saturday night around 8pm.  I could barely walk the pain  was so bad.  Took my boot off and saw that the redness was spreading to the top of my foot towards my ankle. My wife took me to the ER. I was diagnosed with cellulitis and prescribed Cephalexin 500mg 4 times a day for 10 days. The infection resolved after finishing the antibiotic.
Patient received vaccine at  1:23pm 4/30/21. He came back to the pharmacy at 4:45pm 4/30/21 reporting  that his throat and tongue were burning, itchy, and felt swollen. He had excessive thirst and nausea. His symptoms were getting worse during the 10 minutes he were talking with him. The patient refused Benadryl and  Epipen at the pharmacy as he wasn't sure he needed it. An ambulance was called and he was transported to the hospital.
First shot (on 03/27/2021 at 12:30 PM) resulted in fatigue and pain/soreness at injection site.  Fatigue started within 1 hour of injection but was only on 03/27/2021 and did not return in subsequent days.  Pain/soreness at injection site started within 1 hour of injection but was steadily decreasing until gone on 03/30/2021.  Second shot (on 04/24/2021 at 12:00 PM) resulted in fatigue, pain/soreness at injection site, and moderate flu-like symptoms.  Fatigue started within 1 hour of injection and was gone by 5:00 PM 04/25/2021.  Pain/soreness at injection site started within 1 hour of injection and lasted until 04/28/2021 (steadily decreasing each day since injection).  Flu-like symptoms started in the evening of 04/24/2021 and peaked at 9 AM (wake-up time) on 04/25/2021 until 5 PM 04/25/2021.  Flu-like symptoms included muscle pain, chills, elevated temperature (did not break 100 degrees), headache, fatigue, and general malaise.  These symptoms peaked in intensity around 1PM on 04/25/2021.  1000mg Tylenol taken at 9PM and 3PM seemed to help with symptoms.  Fell asleep at 3:30 PM and woke at 5PM with virtually no feeling of symptoms (other than pain/soreness at injection site).
Rash Rash one week later, initially chills day 1, sore arm day 2-3
I have them and had the shot years ago/ suspected vaccination failure; I have them and had the shot years ago; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient had shingles and had received the shot years ago. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Rash where she had injection; Raised hives where she had injection; Rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash), VACCINATION SITE REACTION (Rash where she had injection) and VACCINATION SITE URTICARIA (Raised hives where she had injection) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced RASH (Rash). On 04-Feb-2021, the patient experienced VACCINATION SITE REACTION (Rash where she had injection) and VACCINATION SITE URTICARIA (Raised hives where she had injection). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. On 05-Feb-2021, RASH (Rash) and VACCINATION SITE REACTION (Rash where she had injection) had resolved. At the time of the report, VACCINATION SITE URTICARIA (Raised hives where she had injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient reported that, about 3 weeks to 1 month after the first injection she broke out a rash with raised hives where she had the injection. This rash lasted about a day after using cortisone lotion.   This case was linked to MOD-2021-339269 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Events start date, new events and outcome was updated. On 01-Oct-2021: Suspect drug start date was updated.
This spontaneous report as received from a health worker (medical assistant) refers to a patient of unknown age and gender. On 17-AUG-2008 the patient was vaccinated with the first dose of GARDASIL (lot#, dose, route not reported). On 20-AUG-2009 the patient was vaccinated with the second dose of GARDASIL  (lot#, dose, route not reported). Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
G45.9 TRANSIENT CEREBRAL ISCHEMIA 5/14/2022 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 5/14/2022 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/23/2022 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY G45.9 TRANSIENT CEREBRAL ISCHEMIA 5/14/2022 ESSENTIAL HTN I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 5/14/2022 ESSENTIAL HTN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/23/2022 ESSENTIAL HTN
t105 oral on 10DEC96;mom sought tx @ ER several sz in ER given Motrin, temp down to 102 & discharged home;no APAP given as instructed until p/temp got to 105;
Pt complained of arm pain 2 weeks post injection. Pt. received FLUVIRIN.
A patient received an expired ActHIB vaccine, NO AE; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2020SA271339 and 2020SA271354 (same reporter).  This case involves a patient (unknown demographics) who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UI959AAA and expiry date: 07-Mar-2020, via an unknown route and at an unknown administration site) (expired product administered) on 23-Jul-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event was reported.  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.
08/01/17 onset 3:00 PM, pain at site, erythema with induration 4x5 in; rash, swollen (L) face, swollen tongue, throat, lymphadenopathy, (L) side chest/side pain. T 99.6 F, SOB, severe headache muscle pain (general). At 8:30 PM 08/01/17 called to after-hours MD; RN responded with comment that s/s were in normal listing. Did not recommend or seek care at ED or walk-in-clinics. Self treated with prednisone tabs and OTC antihistamine-and TYLENOL. Mild neuropathy (L) arm-transient.
Medical Assistant drew and administered the three vaccines. After the received the 3rd vaccination in his right arm, he had a vasovagal reaction. I was still in the room at the time. We saw that he was going to fall to the floor and he had slow controlled fall to the floor face down. He did hit his left cheek on the floor. He was rolled over onto his back. Within 30 seconds he was awake and alert. He has had one other similar vasovagal episodes while watching movies in health class, and his older bother has had vasovagal episodes when receiving vaccinations. He continued to feel nauseated and light headed for about 30 minutes after the episode. His blood sugar was 129. He was given applesauce and apple juice. He did have on episode of emesis after taking a bite of the applesauce, he was later able to tolerate. He was able to tolerate the apple juice. He remained in the office for 60 minutes after the episode, and was allowed to rest. Upon discharge home his VS BP 108/60, P 84, R 16, O2 sat 99%. He was awake and alert, and color pink. He went home with mom. I called mom around 1345, he was doing well. Again called on 1/25/19, he was doing well.
autoimmune diseases; nodules in my lungs; This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a year after receiving Shingrix, the patient experienced autoimmune disorder (serious criteria GSK medically significant) and lung nodule. On an unknown date, the outcome of the autoimmune disorder and lung nodule were unknown.   It was unknown if the reporter considered the autoimmune disorder and lung nodule to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was due for 2nd dose and wanted to make sure whether it was good time or if would have to wait. The specialist advised not take dose.
On morning of 11th, he complained of sore throat and fatigue.  On morning of 12th, his apple watch recorded tachycardia.  Later in the day, he had complained of fatigue, muscle aches, and sore throat with a temperature of 100.2 F.  His apple watch recorded no cardiac activity after 1959 hours.
Next 48 hrs. very painful thru 72 hr, red rash (R) arm spread to under area of arm - recommended for flu and pneumonia given different intervals not together, too debilitating.
Body aches, headache, redness, warmth, induration, tenderness at site. Redness about the size of an orange.
I had an episode of supraventricular tachycardia where my heart rate went up to 187 while stationary for about 5 minutes. I have since had a heart monitor that has captured several more episodes but none as symptomatic as that first episode 2 days after the second vaccine.
Received GARDASIL (1) 8/12/09/ (2) 11/4/09/ (3) 9/14/10.  7/12/11 Reported moderate pain loss x 3 weeks at office visit. 9/15/11 PC mom reported diagnosis alopecia areata by dermatologist. Mom concerned related to GARDASIL.
difficulty breathing that night but it cleared up the next day; sore arm but no rash; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing that night but it cleared up the next day) and PAIN IN EXTREMITY (sore arm but no rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing that night but it cleared up the next day) and PAIN IN EXTREMITY (sore arm but no rash). On 02-Mar-2021, DYSPNOEA (difficulty breathing that night but it cleared up the next day) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm but no rash) 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.
Patient received her vaccination at 0900 on 01/15/2021. By 0905, started complaining of itching and warmth. redness noted to left cheek and swollen some on left side of face. Initial HR 115 and slowed to 86 after sitting down. BP 130/90, RR 20, Pulse OX 100% on room air. Patient was given Benadryl 50 mg PO and Pepcid 20 mg PO. Started to feel better so was released after 30 minute wait time. at 1500 came back and reported that itchiness was back as well as face flushed. Patient was sent to the ER as she complained of some dysphagia and throat soreness. Red streak noted down front of neck about 1.5 inches wide from top of neck about 4 in in length. VS in the ER showed HR 68, BP 155/74  RR 18, Temp 97.0F, O2 98%. patient was hooked to telemetry that showed sinus rhythm, given Epinephrine 0.3mg SQ, Solumedrol 40mg IV, Pepcid 40 mg infusion, NS infusion, and benadryl injection.. Patient remained under close observation for 1.5 hours during which vital signs remained stable. Patient was discharged around 1700 with Epi Pen to have available at home.  Follow-up call today she verbalized no further hives or rash, continued to have a bit of rash.
Left atrium mildy enlarged 02/17/2022 Echo Cardio Left atrial index 35/ml/m2
Rash on stomach; Rash on left side of the body; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on left side of the body) and RASH (Rash on stomach) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced RASH (Rash on left side of the body). On an unknown date, the patient experienced RASH (Rash on stomach). At the time of the report, RASH (Rash on left side of the body) and RASH (Rash on stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD21-061837 (E2B Linked Report).; Sender's Comments:  MOD21-061837:Link to Dose 2 with argus ID MOD-2021-056255