chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have administered menquadfi to a patient 6 months earlier with no reported adverse event; Initial information received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who have been administered to meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] 6 months earlier with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and HPV vaccine, both for prophylactic vaccination.  On 15-Nov-2022, the patient was administered with dose 2 of meningococcal A-C-Y-W135 (T CONJ) vaccine of dose 0.5 milliliter (ml) with (lot: U7576AB & expiry date: 28-Feb-2025), 6 months earlier with no reported adverse event (inappropriate schedule of product administration) via intramuscular route in the right deltoid, (formulation, strength: unknown) for immunization.  Action taken was not applicable.  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 guidelines. 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.
8/7/08 received phone call from patient's mother that he had stopped breathing.  She called EMS and he was taken to hospital and he was pronounced dead.
Myalgia, Headache, Backache, sore arm, fatigue Narrative:
About one week after vaccination I began to get small itchy hives on my extremities, my legs, behind my knees and then it would occur up my legs and eventually or within one month it would show up my arms, hands, face and different spots on my body. Over a period of approximately five months this would occur with steroids being the only treatment to make the hives not present, I also contracted the COVID-19 virus on or about the fourth month of this timeline.
POTS; Bad chills; nausea; diarrhea; general weakness; severe neck pain; dizziness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhea), ASTHENIA (general weakness), NECK PAIN (severe neck pain), DIZZINESS (dizziness) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD in 2010. Concurrent medical conditions included Seasonal allergy since 2010. Concomitant products included LORATADINE for Seasonal allergy.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced NECK PAIN (severe neck pain) and DIZZINESS (dizziness). On 08-Jan-2021, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (general weakness), CHILLS (Bad chills) and NAUSEA (nausea). On an unknown date, the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS). On 18-Jan-2021, DIARRHOEA (diarrhea), NECK PAIN (severe neck pain), DIZZINESS (dizziness), CHILLS (Bad chills) and NAUSEA (nausea) had resolved. At the time of the report, ASTHENIA (general weakness) had not resolved and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS) 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: Case is non serious On 19-Mar-2021: Adding completed ADR form received from patient
Narrative:  Patient contacted telephone triage nurse today requesting appt with provider for c/o injection site reaction. Patient had a shingles vaccine in R deltoid one week ago, "I had very bad pain in the arm for a few days, that went away - but now the area is very red and inflamed - also itchy." States redness just started yesterday. No lumps or drainage in area. No fever, chills, nausea or vomiting.
46 yr old Male /vacc. /w MMR c/o rt shoulder & lt elbow pain. Was given cortisone inject. & treated w/antibiotics & steroids.Shoulder pain increase/hospitalized.I&D of lt elbow,@ time of rpt still under treatment. See WORM more detail
Boostrix instead of Infanrix; 15 month old was administered Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 25th July 2022, the patient received Boostrix. On 25th July 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comments: The medical assistant called in to inquired and reported a 15 month old patient was administered Boostrix instead of Infanrix.  The Infanrix would have been the patient's 4th dose.  The reporter unable to provide any additional details regarding patient and vaccines.  The reporter did not consent to follow-up.
Rash ( 2.5?x2.5?) on arm below shot site. Some itching, some heat. Discovered 6:00 pm 02/20/2021. And
Initial case was received from a consumer, who is also the patient's parent, on 13 October 2009. A 13 year old male patient became feverish and complained of dizziness, lethargy, nausea, and muscles weakness after receiving an intramuscular left deltoid injection of Menactra (lot not reported) on 08 October 2009. No medical history was reported, and the patient was not ill at the time of vaccination. Two days post-vaccination, on 10 October 2009, the patient became feverish and complained of dizziness, lethargy, nausea, and muscle weakness, nothing that is knees were buckling. His mother had spoken with the patient's physician 12 October 2009, but the patient had not been seen by a physician at the time of the report. The events remained ongoing. Follow up information received on 02 November 2009 from a health care professional. The lot number administered for Menactra was U2905AA. The patient was seen by a nurse practioner and was felt to have a vital illness. The patient's symptoms lasted for 5 days. No further information was provided.
Several hours later pt. experienced a sudden onset of light-headed, dizziness and nausea. She was sensitive to light. She had not eaten yet that day and was working on her feet. She gradually felt stronger and by 10/15/13 felt normal. May have been AE.
Pt was ill with body aches, cough, diarrhea, fever/chills, chest congestion. Pt receives a split dose vaccine #1 given 11/9/12 #2 on 11/29/12.
Patient had anxiety about getting the second shot and had fainted on the first dose of pfizer.  After the shot the patient thought she might faint,  never did.  Patient was hot, anxious and then vomited.  911 was called
Caregiver (CG) called office at 0802 complaining of unrelenting "nausea and a lump in my throat." CG just left parking lot; advised to return to office for Benadryl administration. CG stated she is allergic to Benadryl; does not have other anti-allergy meds on her except private Epi pen. CG ANA to erythromycin (and other -mycins), penicillin, mushrooms, bee stings, opioids, latex, strawberries, Benadryl. CG advised to head for ED and keep Epi pen on person; had RN on phone. ED alerted. CG met at ED with print out of vaccine administered and package insert; endorsed documents and CG to ED care at 0815. RN to called CG and left voicemail for F/U; also emailed CG. Response pending.
red, blotchy area @ inj site, half dollar in size;also stiffness @ inj site, half dollar size;later red blotchy area became a bruise;stiffness subsided completely;
sudden onset about 14 hours after injection of severe dizziness and vertigo with nausea and vomiting and also diarrhea x 1.  Significant headache.  Some fatigue.  Still symptomatic after 36 hours of symptoms
Right after: Sore arm at site of vaccination A couple of days after -Rash on neck, just below chin-very red, dry, sore and itchy Bumps on hand appearing a week after
Patient said had covid19 last august. He said that he was hospitalized. He said he was followed up for cardiac issues, now they are follow up with his lungs, because he said he is winded. He said after the vaccine he had a rash on his arm that had cleared up. He said he was fatigued and winded. He said that the symptoms are still off and on.
Ringing in my ears. Tinnitus. I have ringing in my ears everyday all day. It's not debilitating but it does not go away.
This spontaneous report as received from a Certified Medical Assistant refers to a female patient of unknown age. Concomitant medications, medical history, drug reactions and allergies were not reported. On unspecified dates between 15-SEP-2014 and 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J013555 expiry date 02-MAY-2015, intramuscular (dose was not reported. On the day, in September 2014 following to the vaccination with PNEUMOVAX 23 injection, the patient experienced hot area, red and painful at the site of injection. The patient sought medical attention went to see the physician. There were no laboratory diagnostic studies performed. On an unknown day, the patient received an unspecified antibiotic. The outcome of painful, red and hot area at the site of injection was reported as recovering. This is one of several reports received from the same reporter. Additional information has been requested.
Elevated liver enzymes discovered in a liver panel done 6/30/2021, subsequent to beginning prescription of atorvastatin. Cause of elevated liver enzymes has not been definitively diagnosed as far as I know, so unsure whether it is related to vaccine or not.
Extra Dose; rceived 2nd dose on 29 Aug 2018 and 3rd dose on 09 Sep 2019; received 1st dose on 30th Aug 2016 and 2nd dose on 29th August 2018; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 43-year-old female patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 30th August 2016).   On 19-SEP-2023, the patient received the 4th dose of Twinrix. On 09-SEP-2019, the patient received the 3rd dose of Twinrix. On 29-AUG-2018, the patient received the 2nd dose of Twinrix. On 29-AUG-2018, not applicable after receiving Twinrix and Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received 1st dose on 30th Aug 2016 and 2nd dose on 29th August 2018). On 09-SEP-2019, the patient experienced drug dose administration interval too long (Verbatim: rceived 2nd dose on 29 Aug 2018 and 3rd dose on 09 Sep 2019). On 19-SEP-2023, the patient experienced extra dose administered (Verbatim: Extra Dose).The outcome of the drug dose administration interval too long, drug dose administration interval too long and extra dose administered were 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: 25-SEP-2023 The reporter was medical assistant. The reporter reported that office had patient that received Twinrix doses outside of the recommended timeframe (they had late doses), so they were administered another dose in September when they were seen in clinic.  The doses prior to the 2023 dose were given at another location. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received 3rd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received 4th dose of Twinrix on 19th September 2023, which led to extra dose administered. The case had been linked to US2023131774, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023131774:2nd report
On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID and they were all asymptomatic). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID and they were all asymptomatic) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, corona test: positive (Positive) Asymptomatic. On 15-Jan-2021, pcr test: positive (Positive) Asymptomatic. On 15-Jan-2021, rapid test: positive (Positive) Asymptomatic.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of COVID-19 positive test in a patient who received mRNA-1273. Causality is not applicable.
Received Moderna 1st dose 1/6/21 only felt fatigue first day. 1/7/21 when I woke up my arm was very sore red at injection site about the size of the palm of my hand and swollen, very itchy. Hurt to raise above my shoulder. This went on till about 1/9/21. Then it went away nothing at my infection site then it came back which is what my concern is same as 1/7/21 itchy, swollen, red and bruised. Why I?m reporting is I?m wondering if I should take my 2nd dose or not from these reactions just at the injection site and only fatigue. This is Day 10. I also took pictures 1/8/21 and 1/15/21
Child had a seasonal flu shot in his L arm at a school flu clinic. The next day he developed swelling (3" x 3") and pain around the injection site. On 11-17-09 the mother noticed a facial rash on his check, jaw, behind his ears and 2 inches below his earlobes. The rash was faint, 1-2 mm in diameter and itchy. The mother brought him to the health department to show the nurse that rash and to report the reaction. She gave her son BENADRYL, 25 mg., every 6 hours: 3:00 PM, 8:30 PM and 3:00 AM. On the morning of 11/18-09, the boy developed a rash over his chest, back, arms and legs, 1-2 mm "bumps". the mother took him to see his PCP at 9:00 AM. The doctor continued the BENADRYL 25 mg, P.O. every 6 hours and also ordered hydrocortisone ointment to be applied 4 times a day to the affected skin. By 11/23/09, the rash was gone except for patches on his check and neck. His 5 year old sister, who had the seasonal flu injection the same day at school also developed a facial rash. The mom mentioned that she prepared Pinacbet on 11-15-09 a stew-like dish with chicken and vegetables, but with no fermented fish sauce. She left it out overnight and her son ate some the next morning making her wonder if the food contributed to her son's reaction.
pt crying unconsolable x 5 hrs; both legs very swollen lt more than rt so swollen diaper cutting into leg; tx ice & APAP for comfort;
On 8/8/2021, I woke up achy and with a low-grade fever and headache. That very day, I went to an urgent care clinic, where I tested positive for COVID-19. On 8/9/2021, I received a Remdesivir infusion at Hospital. On 8/11/2021, I went to the ER when I had trouble breathing. I was put on oxygen and given tests, after which I was informed that I had COVID pneumonia and was admitted to the hospital. During my hospital stay, I was given DECADRON every day. On 8/15/2021, I was given another Remdesivir infusion and discharged that very day. The two days following my discharge were worse than my time in the hospital, because I had no Decadron or inhalers to provide relief. On 8/18/2021, I went to see my PCP, Dr. She ran tests and performed X-rays, and afterwards she informed me that I still had double pneumonia. Dr. gave me antibiotics, an albuterol inhaler, and Ventolin. She also prescribed me a breathing machine for at-home use. On 8/30/2021, after I had finished my antibiotics, I went back to see Dr. for a follow-up, and she informed me that both of my lungs were now clear.
Difficulty breathing; Slurred speech; Odd chest pain; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Slurred speech), CHEST PAIN (Odd chest pain), DIZZINESS (Dizzy) and DYSPNOEA (Difficulty breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20a) for COVID-19 vaccination.     The patient's past medical history included Cardiac disorder.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DYSARTHRIA (Slurred speech), CHEST PAIN (Odd chest pain) and DIZZINESS (Dizzy). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSARTHRIA (Slurred speech), CHEST PAIN (Odd chest pain), DIZZINESS (Dizzy) and DYSPNOEA (Difficulty breathing) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. Treatment medications were not provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
8/20/08, patient states headache & disoriented a couple of hours after shot administered. Went to bed early with severe headache. Nausea, diarrhea, sensitive to noise and light. 8/27/08, felt some better. Still had headache. 8/28/08, saw PCP, feeling better.
reportedly devel urticaria like rash on back, chest, arms & legs 9 days p/vax;rash reportedly itchy w/partial response to DPH;
This spontaneous report as received from healthcare worker refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that the unknown number of patients might had received with a dose of PEDVAXHIB (lot#, expiration date, dose and strength not reported) that was exposed to a high temperature of 47 degrees F., 7 different times since January 2014, 5 minutes for each excursion, for a total of 35 minutes. No adverse effect reported. It was unspecified if the patient sought medical attention. This is one of four reports received from the same source. Additional information has been requested.
reports of pt post vaccine experienced very severe arthritis. Per mother all joints are stiff and painful. His L knee is huge, infusion fluid full. The pt's jaw, chest bone, wrist and shoulders were painful. He had muscle cramps.F/U update box 24, dob,date of vaccine,date of report.
Expired Havrix admiistered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 28-year-old patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 4th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 9-Feb-2023 Reporter's comment:  The health care professional reported that the patient was administered a dose of Havrix that had expired on 30th January 2023. The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up. Additional supportive information: As patient received vaccine which was already expired.
"Covid Arm" (erythema, macular rash, puritis); myalgia; arthalgia
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) PROQUAD (lot # was reported as M034933 with expiration date 11-MAR-2017; dose and route were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.