chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took first dose of Vivotif and on the very next day took a second dose; Spontaneous report received on 20JAN2020.  A nurse reported that a female consumer "took first dose of Vivotif and on the very next day took a second dose" (PT: Inappropriate schedule of product administration). The consumer was taking Vivotif for immunisation. The consumer took first dose of Vivotif on an unknown date and on the very next day, she took a second dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first dose of Vivotif and on the very next day took a second dose (Inappropriate schedule of vaccine administered). Vivotif doses should be taken every alternate day, and the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif and on the very next day took a second dose (Inappropriate schedule of vaccine administered). Vivotif doses should be taken every alternate day, and the causality of the event is assessed as not applicable to Vivotif.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Heavy breathing and feeling of dehydration
Patient complained of redness, swelling. said injection site was warm, but, overall, getting better.
Testing positive for COVID; Testing positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EN6201), on 06Mar2021 as dose 2, single (Lot number: EN6200) and on 24Oct2021 as dose 3 (booster), single (Lot number: EN FE3592) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Bone density" (unspecified if ongoing), notes: Bone density. Concomitant medication(s) included: ALENDRONATE oral taken for bone density abnormal. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Oct2021, outcome "unknown" and all described as "Testing positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She tested positive for COVID.  No follow-up attempts are possible. No further information is expected.
body aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 09:00 (Lot number: EP6955) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Auto-immune like symptoms: migraines; "fatigue" (unspecified if ongoing), notes: Auto-immune like symptoms: Fatigue; "pain" (unspecified if ongoing), notes: Auto-immune like symptoms: pain; "cognitive impairment" (unspecified if ongoing), notes: Auto-immune like symptoms: cognitive impairment. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; VITAMIN B2 [RIBOFLAVIN]; VITAMIN B12 [VITAMIN B12 NOS]; MAGNESIUM; PROBIOTICS. Past drug history included: Aleve, reaction(s): "allergy", notes: known allergies. Vaccination history included: Bnt162b2 (First dose; Time: 09:00 AM; Anatomical location: Left arm; Lot No. EL3247), administration date: 01Mar2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 23Mar2021 21:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 23Mar2021 21:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of pain, fatigue.  Additional information: Clinical course: On 23Mar2021 21:00, 12 hours post dose 2, the patient experienced body aches and fatigue. Next day, on 24Mar2021, patient had continued body aches and on 25Mar2021, patient had increased fatigue. Patient's concomitant medication also included "Multi". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Within 1 week began having stomach cramps and diarrhea; severe pain and crying; lasted for over 1 week
Symptoms are a significant increase in anxiety, fatigue and cognitive impairment. Our doctor made us aware that the HPV vaccine may have triggered dormant Lyme disease. Now she has full blown Lyme symptoms including neurological/vision problems. The symptoms began right after the vaccine and have been getting progressively worse.
After vaccination, pt irritable and emesis 1-2 x.  No fever.  Acting better by morning.  Mom gave pt bottle at ~4:30 am.  Pt developed respiratory difficulty at ~5-5:30 am.  Dad initiated CPR and ambulance called.  Pt received CPR to local hospital.  Coded there for 30-45 min (not at my facility).  Pronounced dead at ~6:30 am.  Nurse follow up on 05/14/04 states: Unresponsive, cyanosis, pupils fixed, apneic, asystold (stupor, cyanosis, mydriasis, apnea, heart arrest).
The patient developed a fever of 105.1F in the ER on 07/04/2001.
DOSE ADMINISTERED AFTER BEUBG STORAGE FOR 30 DAYS BETWEEN 2-8 DEGREE C
Two days after receiving shot I realized after I would take a shower my skin would become very itchy and seemed to be dry. So I thought that maybe I just strangely developed dry skin but then it persisted and has become quite uncomfortable. I have never had dry skin to that extent let alone any skin allergies to cause the itching. I would use lotion heavily all over my backside and backs of my thighs and back and my arms were itchy as soon as I would shower.  It got so bad I had huge rashes on my  back from scratching just in the shower before I was able to get lotion on it. Also I noticed I thought I was having panic attacks and that's why my chest was tight. Until one night while having intercourse, shortly after starting it would become hard for me to breathe. It feels like I can't get a whole breath in and then it sends me into panic mode because it feels like I can't breathe. I do not have asthma, I am in decent shape and often have sexual intercourse so nothing in my daily routine has changed except getting the Pfizer shot. I didn't think anything of it and so I continued with my second shot in hopes that whatever was happening would go away with lotion and time and it has not and it has not let up. I am in the process of scheduling an appointment with my primary care physician to get checked out.
I had a sore arm on vaccination site. The second day my thighs were really sore. Three to fours day later my rheumatoid arthritis started acting up and my hand is stuck, my joints are inflamed that haven't been before, my vertigo also got really bad that I had to crawl to get anywhere, and eczema on the arm I received my shot. I talked to my doctor and she put me back on prednisone.
Small red bumps occurring on:  1) Face - on & surrounding lips; swollen lips too, feels similar to mild allergic reactions I've had before. Some rash marks by chin, disappeared after a few days but bumps remain 2) Left arm - red & white bumps on back of left hand, and inside of left forearm. 18 small bumps total  3) Left leg - 4 small red bumps around knee and on left thigh  These bumps occurred a few days after receiving the Pfizer shot, and after a full week past injection, bumps are still apparent. The ones that appeared first (left forearm & leg) appear to be starting to flatten/heal, but still reddish brown scar discoloration. The ones on the back of my left hand are still bumpy/itchy.
On 7/27/21 I administered the Moderna Covid 19 vaccine to patient about 9:40am.  On her form she indicated that she had allergies to latex (topical reaction), shellfish, whitefish, tree nuts (muscle aches, tongue swelling, itchy reactions), chicken and coffee (same but milder reaction as listed before), cabbage, mustard, ginger (upset stomach reactions).  She informed me she had no issues with medications but does get dizzy after vaccines at times due to her fear of needles.  About 945am she came to me saying her arms, legs and face felt itchy, so I gave her 25mg of diphenhydramine.  She asked to hold off on the second dose of 25mg due to the side effect of drowsiness. The first dose helped but about 25 minutes later she felt she was getting itchy again and asked for the second 25mg dose of diphenhydramine.  I had the patient wait about 15-20 minutes at which point she was feeling better, and the itching had again subsided.  At that point the patient asked to head home and I advised her if any symptoms arise after the diphenhydramine wears off to take another dose.  If things seem to be worse, she may need to consider going to the ED.
61y.o. female with PMH of  Asthma, Carotid artery occlusion, CVA with left hemiparesis (06/13/2020), DM type 2, Fatty liver, HTN (hypertension) who presented to EC on 10/2/2022 with AMS. It is thought that possible pt was given her mother's medications by mistake, causing the AMS. Pt was also diagnosed with COVID 2 days PTA.  Labs noted acute kidney injury, chronic anemia, and positive covid testing. Head CT was negative for acute findings. Chest x-ray was negative for pneumonia. Troponin was negative. ECG appeared abnormal with question of PACs versus possible flutter waves. She was not hypoxic.She was seen by ID, no indication for antiviral or steroid at this time/ remains on room air. Mentation is at baseline.
got the covid vaccine and has a red spot on the arm that is getting bigger and itchy; got the covid vaccine and has a red spot on the arm that is getting bigger and itchy; feeling sick; nausea; feel lightheaded and dizzy; This is a spontaneous report from a contactable other HCP and consumer.  A 44-years-old female patient received BNT162B2, dose 1 via an unspecified route of administration, administered in arm on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the Covid vaccine and had a red spot on the arm that was getting bigger and itchy. She was feeling sick and nausea started exercising and nausea went away but after exercising she felt lightheaded and dizzy. The outcome of the event nausea was recovered. The outcome of the other events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Gave pt COVID vaccine this morning. Was using a different syringe than normal and accidentally gave pt 1 mL instead of 0.5. Called pt 2/16/21 at 3 pm said he was doing fine just had a sore arm. Told him to call me back if he is having any issues.
very little local reactions; Tenderness; headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021. The most recent information was received on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very little local reactions), TENDERNESS (Tenderness) and HEADACHE (headache) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Trigeminal neuralgia since 18-Mar-2020, Penicillin allergy, Fruit allergy, Latex allergy, Hay fever and Cholesterol. Concomitant products included CALCIUM for Calcium supplementation, PRAVASTATIN for Cholesterol, CYANOCOBALAMIN (VIT B12) for Elderly, ASCORBIC ACID (VITAMINS C) for Immunization, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation.    On 27-Jan-2021 at 3:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very little local reactions), TENDERNESS (Tenderness) and HEADACHE (headache). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (very little local reactions), TENDERNESS (Tenderness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-239138 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow-up received. Updated reporter name, patient current condition/allergy, and concomitant drugs.
Severe Headache and body aches started with in a few minutes and because progressively worse. Fever 102. 7, and body aches started within a few hours. 12 hours post vaccine severe chills and uncontrollable muscle tremors ( this happened with both vaccines, tremors occurred for 5.5 hours both times). Nausea started after 5 hours, vomiting of fluids started 10 hours after vaccine. Selling at the vaccine site and severe myositis, 6/10 at rest, 10/10 with any movement, unable to touch site, 4 cm swelling of Left  deltoids compared to the right. Previous vaccine site was still tender 4 weeks after the vaccine, not sure how long this one will hurt, but unable to use arm or touch it without severe pain 30 hours later. Pain and shortness of breath within 5 hours of vaccine, this improved by 24 hours after vaccination, Because I have had shortness of breath that has persisted after the first vaccine I plan to do some follow up lab work with possible chest x-rays and echo with my primary care MD in the next 1-2 weeks.
The day after I received the vaccination, my left arm was slightly red and swollen at the injection site; swollen at the injection site and remained that way for 2 days; The evening of the day I received the vaccination, I became nauseated; Could not eat dinner; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 26Feb2021 at 10:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes, chronic lumbar pain and known allergies to penicillin, grasses and insect bites. The patient previously received procaine hydrochloride (NOVOCAINE), and acetylsalicylic acid (ASPIRIN) and experienced allergy to the medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 26Feb2021 at 18:30, the evening of the day the patient received vaccination, she became nauseated and could not eat dinner. This went away by the next morning.  On 27Feb2021, the day after the vaccination, the patient's left arm was slightly red and swollen at the injection site and remained that way for 2 days. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nauseated, could not eat dinner was resolved on 27Feb2021 and slightly red and swollen at the injection site was resolved on 01Mar2021. No follow-up attempts are needed. No further information is expected.
Red spot on (R) cheek above injection site on (R) thigh, a week after 12 month shots. (R) thigh injection site red, hard, painful. Also runny nose, congestion, fever 100.8. Scattered red lesions on torso, face, legs. Advised to avoid contact with susceptible individuals and supportive care of varicella.
The pt's mother called at approx. 17:40 to report head to toe body rash. The pt received Hep-A vaccine on 2/4/02, in the arm, during a well child exam. The pt's mother was told to take the pt to ER with immunization record. Allergic reaction to Hep-A vaccine.
Inj site red and swollen, 104 fever, blank stares, stopped eating and speaking, later diagnosed with autism.
18 days of non stop screaming, not eating well, not sleeping well. At first we thought he may have caught something else while being at the dr office so we waited it out a week. Went back, got referred to GI, went there and was told is now gluten intolerant where he had no problems even the day before getting the vaccines. We were told to keep him gluten free and this is problem an adverse reaction the the preservatives in the vaccines. We have kept him gluten free since and he is doing great. We have put off any further vaccines at this time now.
Approximately 30 minutes after the vaccine, patient reported "feeling itchy" (similar to previous Tdap reaction) and scratched at different parts of her body (neck, stomach, arms, legs) intermittently for several hours, including after a 25 mg dose of Benadryl. Patient experienced significant pain and redness at the injection site for a few days.
No adverse event; Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023).    It was unknown patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.    Vaccines were thawed on 13-JAN-2023 and 4 doses were administered on 17-FEB-2023. Bivalent vaccine administered and no symptoms have been reported at that time. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712038, US-MODERNATX, INC.-MOD-2023-712309, US-MODERNATX, INC.-MOD-2023-712328 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712038:Master case US-MODERNATX, INC.-MOD-2023-712309:Patient 2 of 4 US-MODERNATX, INC.-MOD-2023-712328:Patient 3 of 4
A few days after receiving the vaccine I noticed a flare of the plaques I get on my arms, etc. from my MCTD. My symptoms were controlled and not noticed for months prior to the vaccine. At this time, the plaques are slowly progressing.
Runny nose constantly, cough that was nonproductive; fatigue; low grade fever. I see have some symptoms now and in the middle of the protocol. My doctor gave me PAXLOVID and I started it on Tuesday the 18th.
Fever 102.9, then running 99.9-101 for a week, extreme muscle pain, body aches, felt like deep bone pain, diarrhea, nausea, fatigue
pt recv vax 1MAR99 & 2wk p/vax pt came to office w/rash knees & feet;seen by dermatologist-viral type vasculitis-labs normal;sent to rheumatologist for eval 4MAY99;
patient experience syncope episode approximately a minute after receiving the vaccine and fell out of the chair and hit his right temple. he came to disoriented and sprung upright. he was placed in a chair and moved to the floor where his feet were elevated on a chair. we gave him an ice pack for his head. he reported a rapid heart rate and feeling nauseous. once he felt better he sat up and we gave him some water and crackers. the patient stated he hadn?t ate anything today. after approximately 30 minutes in store he left on his own accord.
Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional (office staff). This case involves a 60 years old patient of unknown gender who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number was not reported), on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose. No adverse event was experienced. 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. Additional information received on 07-Dec-2018 an unsolicited valid non-serious case received from non-healthcare professional (office staff). Information regarding no adverse event was updated. List of documents held by sender: none.
Your online text survey allows for a selection of "pain" but does not have an option for muscle soreness at the injection site. I experienced soreness for about 36 hours after the injection but did not consider this to be "pain." Thus I reported nothing. I'm confident others reported this same experience as "pain." Your text survey should make a distinction between "pain" and normal "muscle soreness" so that you get consistent results.
Severe pain started a few hours after injection. Pain is worst with movement - put arm in sling.
In 2 hrs pt developed swelling and purpura to upper parts of both legs and urticaria all over body pt was given Benadryl.