chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 2 doses, 3 weeks apart; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number PD237, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Fluarix QIV (received only 1 dose of fluarix quadrivalent in 2020). Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX QUADRIVALENT).   On 20th October 2021, the patient received the 3rd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Fluarix QIV 3 weeks apart by mistake, which led to shortening of vaccination schedule.  The reporter consented to follow up.
Pt said he noticed "bump"  approx one week after immunization but not sure of exact date.  Pt said he continued to play sports/work out and he thinks the physical activity may have exacerbated it and caused the skin to break. I physically looked at the bump and today it looks like a circular raised area approx dime-sized with inverted red center (appears to be under the skin) Pt said it was not painful until the skin kept re-breaking making the area worse. I told pt to check in with his regular doctor to see what to do next.  Bump was located in in the very upper area of shoulder about an inch from collar bone so unsure if this was caused by the immunization or a separate issue (ex. spider/insect bite, infected follicle, cyst)  the site is far above where injections have been regularly administered by same rph.
Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Additional Details: pt had covid in march 2021, received moderna vaccine on 09-17-2021, she experienced high bp, and myocarditis
Began to have slight redness at injection site the evening of the injection.  By the next morning stated it was red, swollen and warm.  Pt. went to class and showed nursing instructor who circled the area. At the end of the day the area had doubled.  Pt went to the ER that evening.  She stated her BP was elevated and was running a fever. The Doctor measured the site at 7.5cm x 10.5 cm.  They placed her on Bactrim and told her it was a cellulitis. Since then, now some 15 hours later, patient states it has doubled in size again, and remains warm to the touch and painful.
Dizziness that has not gone away for two months. Chronic fatigue, depression, sleeps constantly, always feels sick to stomach, lost 15 lbs so far, lack of interest, change in personality. Exhaustion after small tasks. Unable to concentrate.
Expired 2nd dose given; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 019F21A) for COVID-19 vaccination.     Concurrent medical conditions included Cervical dysplasia. Concomitant products included ESTRADIOL for Birth control.   On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The vial was moved to refrigerator on 29-Nov-2021. No previous temperature excursions.   This case was linked to MOD-2021-399872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Significant follow up received contains medical history, race,  route of administration,,Anatomical Location,  concomitant medication,
4 hours post injection, arm pain began at injection site. 10 Hours post injection suffered  fever, chills, sweating, pain in all joints which lasted overnight for 10 hours. I was weak all day next day and now OK.
dilated cardiomyopathy; This spontaneous case was reported by a consumer and describes the occurrence of CONGESTIVE CARDIOMYOPATHY (dilated cardiomyopathy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy (Egg products).   In November 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONGESTIVE CARDIOMYOPATHY (dilated cardiomyopathy) (seriousness criteria death and medically significant). The patient died on 20-Nov-2021. The reported cause of death was Dilated cardiomyopathy. An autopsy was performed, but no results were provided.            Patient had not tested positive for COVID  test or diagnosis. No other vaccines was taken by patient within 1 month prior to moderna covid-19 vaccine.The medical history was none except allergy. No concomitant and treatment medication was reported.  Company comment: This is a spontaneous case concerning a 44-year-old, female patient with relevant medical history of food allergy to egg products and vaccine history of receiving mRNA-1273 vaccine as the first dose of Covid-19 vaccine in Covid-19 vaccination in series, who experienced the unexpected serious (death and medically significant) AESI event of dilated cardiomyopathy. The event occurrence was unknown with respect to the second dose of mRNA-1273 vaccine administration. It was reported that the patient died within 2 days after receiving the second dose of mRNA-1273 vaccine. The reported cause of death was dilated cardiomyopathy. Autopsy was performed however the autopsy findings has not been reported. The medical history of food allergy to egg products remain confounder for the event dilated cardiomyopathy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 44-year-old, female patient with relevant medical history of food allergy to egg products and vaccine history of receiving mRNA-1273 vaccine as the first dose of Covid-19 vaccine in Covid-19 vaccination in series, who experienced the unexpected serious (death and medically significant) AESI event of dilated cardiomyopathy. The event occurrence was unknown with respect to the second dose of mRNA-1273 vaccine administration. It was reported that the patient died within 2 days after receiving the second dose of mRNA-1273 vaccine. The reported cause of death was dilated cardiomyopathy. Autopsy was performed however the autopsy findings has not been reported. The medical history of food allergy to egg products remain confounder for the event dilated cardiomyopathy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Dilated cardiomyopathy
Customer called on Wed 12/5 to report that her arm his red, swollen and warm to the touch. It has been that way since Tuesday, she only received the vaccine 2 days ago and sometimes these symptoms subside after a few days. She has been taking ibuprofen for the swelling.
Information has been received from a office secretary concerning 36 year old mother female who on 27-FEB-2009 was splashed in the eye with VARIVAX (Oka/Merck). The mother's eye was burning. The mother was in with a patient coming in to see the office physician but had not been examined yet. The mother's eye burning persisted. An ophthalmologist was contacted. Additional information has been requested.
became hyporesponsive, hypotonic, w/shallow breathing, poor perfusion w/in min of getting all vax;pt required 02 by mask;pt was taken to ER, put on a monitor, then adm <24hr for observation
Patient reported headache and went to lie down around 5:00 pm.  Started experiencing shortness of breath and vomited once so husband called for an ambulance. ER visit at 6:30pm with shortness of breath, headache and productive cough.  Physician saw elevated cardiac enzymes and patient was transferred at 21:30.
Patient received her first Moderna immunization on 04/08/21 and is due for her second dose this week. She came by the pharmacy today and said the night after her first dose she had sharp aches along her chest and upper back, along with at the injection site. She said it was better the next day but still ached for a few more days after. I told her that achiness can be a common side effect after this immunization. It resolved after a few days so I told her it would be ok to get her second shot to complete the series but that if she was concerned it was something else to get in contact with her primary care physician.
G47.33 OBSTRUCTIVE SLEEP APNEA 1/20/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Mother of child noticed (L) arm swelling, redness, and child complaining of (L) shoulder pain. Patient was taken to hospital for evaluation. Clindamycin was prescribed for 9 days. Patient had follow up 8/14/14, patient better.
throw up; had a little tickle in the back of my throat; Her left arm was also sore; They both had the first 2 shots with Moderna. She and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago; They both had the first 2 shots with Moderna. She and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago; They both had the first 2 shots with Moderna. She and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-years-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Aug2021 (age at vaccination was unknown) as dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first and second dose of COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single and dose 2, single for COVID-19 immunization. The patient and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago, last Sunday. It would have been 14 days on 06Sep2021. They both had the first 2 shots with Moderna. She asked if Pfizer was making a study about mixed doses and their side effect. She said that they could be a subject. The patient didn't know if that was related to Pfizer. It didn't happen until last Saturday. On an unspecified date in Aug2021, the patient did throw up and had a little tickle in the back of her throat. She said that she was going to take a COVID test to double check. Her left arm was also sore but she wasn't sure if it was from old age. It was a little sore all week. She also had some medications and not sure if those might have caused it. She noted that it was deep in the muffle, from her shoulder to elbow. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Moderna COVID-19 Vaccine EUA  Experiencing HEADACHES. I'm trying to rule out if it is my pillow, coffee, or edibles. My pillow has never caused me problems even though it feels it is getting more firm. Coffee has never given me headaches. I stopped taking a specific brand of edibles that would give me headaches if I ate more than one at once, but I have stopped taking them for a few days now.
her arm hurt; She got the booster instead of the first dose of the primary series; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 34-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 1 (bivalent), single (Lot number: GH9697) at the age of 34 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 15Oct2022, outcome "unknown", described as "She got the booster instead of the first dose of the primary series"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt". Additional information: Caller reported she received Pfizer BioNTech COVID-19 Vaccine Bivalent booster on 15Oct2022. Only received the Pfizer BioNTech COVID-19 Vaccine Bivalent Booster and had not received any primary series vaccinations. She was trying to get the second shot and no one was giving this to her; wanted the Moderna Vaccine. She had zero reactions except her arm hurt and that was it.   No follow-up attempts are possible. No further information is expected.
I had a two degree fever; extreme chills with violent shaking for three or four hours. (I say two degrees of fever because my normal temp is 96.5 to 97, but my temp during this experience was 99.1).
This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The coordinator reported that, the patient vaccinated with the powder component of Shingrix reconstituted with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter could not identify the patient or the vaccination date, but found 3 AS01B Adjuvant. The reporter consented to follow up. This case was linked with case US2021248441 and US2021248437, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021248437:Same reporter US-GLAXOSMITHKLINE-US2021248441:Same reporter.
Patient had severe muscle pain in her arm. Mentioned that she had swelling too. Went to the emergency room.Ddr prescribed pain medication.
About a week after the injection, I started having a headache every day for about 2 months. it has subsided some. I have never in my life had a headache like this before. It is the top of my head and on some occasions the top center of my head is more painful. It has not completely stopped. when the pain is severe, I really can't do anything. and it interferes with my employment and daily living routine.  24 hours after my second dose i began severely itching from my head to my toes. I continually itch to the point i have drawn blood. My doctor again said it i not from the injection and told me to take benadryl. This is interfering with my daily routine, my employment and loss of sleep as i wake up often itching.
Patient received her 2nd moderna COVID vaccine today in left arm at 1555. No history of allergies. Patient at 1612 told PHOA her left arm felt funny. COVID LPN and RN3 called pt back to clinic room to assess pt. Pt walked into clinic room no issue.  Pt. reported her left arm "felt hot and then cold and just felt funny". Arm was normal no redness or swelling noted b/p 152/88 heart rate 87 pt with no SOB and no complaints of difficulty breathing. Pt speech normal. Pt able to move arm in all ranges of motion. No issues with grip. Pt reports hx of high b/p. No issues with first vaccine other than sore arm after. RMD called at 1615 no orders given. Ok to leave at 30 mins time. After phone call pt states arm feels about the same no worse. Instructed pt she was ok to leave and that if s/s got any worse to see PCP or go to ER due to left arm pain could be another medical problem.  And see PCP about b/p issues.
I thought I was getting the flu but I did not have a fever. My stomach was real upset and I was extremely tired and I had a cough. The first couple of days starting the 20th of May I felt the worse and by that Tuesday, 4 days later, I had an appointment with my doctor. I was feeling better by the time I went to see them. It can be allergies, however I still have the cough now in July and my throat is still pretty dry. This happened weeks after the vaccine, however I do not know where this came from if it was a viral illness or allergies, but it hit hard and fast out of no where.
Breakthrough case./Covid test -Positive; Breakthrough case./Covid test -Positive; DOSE 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Oct2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 11Oct2021, outcome "unknown", described as "DOSE 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "Breakthrough case./Covid test -Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Therapeutic measures were not taken as a result of covid-19. The patient did not receive any other vaccines in four weeks. Patient did not diagnosed with covid prior to vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash-red, macular with suspicious borders on face, arms, legs, back, abdomen.
pt was reported to have jerking movements, no loss of consciousness;no definite sz activity;no reports postictal phase;jerking movement followed by high fever;
Body aches, fatigue,fever Tylenol to treat Resolved in 24 hours
No additional AE or PQC reported; HCP called to report an expired dose of GARDASIL 9 was administered to a patient. Caller confirmed the GARDASIL 9 has not had any temperature excursions. No additional AE or PQC reported. No additional information provided.; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.  On 18-MAY-2023, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 ml as prophylaxis (no more vaccination details provided) (lot number 1687293 and expiration date of 30-APR-2023; both have been verified to be a valid) (expired product administered). The vaccine had not had any temperature excursions. No additional adverse event (no adverse event) was reported.
Pt recv vax on 5/18/98; post vax pt exp swelling, erythema, induration of vax site-40% of right upper arm
A report was received from a health care professional on 11/20/03 concerning a female vaccinee aged between 15 and 18 months who inadvertently received Fluvirin on 10/31/03. On 10/31/03 a vaccinee under 4 years of age inadvertently received Fluvirin. No adverse symptoms were experienced at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1/13/04: A follow up report was received from a health care profession indicating that the vaccinee was 14 months old at the time of vaccination. No adverse events had occurred at the time of reporting. No follow up pending, all information received.
per patient experienced within seconds bilateral arm and shoulder pain immediately after receiving both moderna COVID vaccines. she continues to have bilateral arm/hand pain and numbness every night since vaccination.
Dizziness, Nausea Vomiting, Tachycardia, epigastric pain and off; Narrative: advised to see his doctor regarding the abnormal ECG[NONSPECIFIC ST-T CHANGES] in view of the  epigastric pain;
Sudden loss of hearing in right ear - low frequency.  High frequency is actually better than before incident.       Steroid treatments did not increase hearing.
Within 2 hours I suddenly experienced severe pain on the muscle on my left arm around the injection site. It severely painful on movement requiring that muscle. It is painful at rest too. I woke up about 17 hours after the injection experiencing very uncomfortable throbbing over the same area. It is now almost 24 hours since the injection, and I am still at aboutthe samelevel of discomfort. I have tried icing, ibuprofen, PERCOCET, and ZANAFLEX with little-to-no improvement.
Patient is a 12 year old male who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: loss of consiousness. Pfizer-BioNTech COVID-19 vaccine # 1 in series administered.  o Action(s) taken: Other - placed in gurney supine, monitored vital signs, provided water,  o Allergy to COVID-19 vaccine documented in Allergies activity: No     0825 patient received vaccine, first dose of pfizer.  0831. Patient loss consciousness for approx 2 secs next to mother.  0832 Placed patient in gurney. A/Ox4. Speaks in full sentences. No difficulty breathing. Denies pain. No signs of allergic reaction noted.  Mother at bedside.  Per mother, patient has not had anything to eat before vaccine.Vital signs stable. See below   Vitals:   08/05/21 0823 08/05/21 0832 08/05/21 0844 08/05/21 0855 BP:   122/80 111/64 113/69 BP Patient Position:   LYING LYING SITTING BP Location:   LA-LEFT ARM LA-LEFT ARM LA-LEFT ARM Pulse:   99 77 81 Resp:   14 14 15 SpO2:   99% 99% 96% Weight: 129 lb (58.5 kg)         0855 d/c home stable. Advised to see clinician if happens again or for any signs of reaction. Patient and mother states desidre to come for second dose and would want the patient in gurney for 2nd shot for safety.    VAERS filed
Patient felt twitching and passed out for short time (maybe less then 1 minute) within 5 minutes of receiving vaccine. When he came to he was sweating but reported no shortness of breath or labored breathing.