chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750 (same reporter). This case involves a 5 years old patient (gender not reported) who received vaccine FLUZONE QUADRIVALENT lot U1997AA via intramuscular route in the left deltoid on 03-Oct-2018 (expiry date 30-Jun-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that patient was given vaccines that were outside of the recommended temp range (below 32F). It was unknown if any adverse event 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. Documents held by sender: none.
Red scaly rash developed on December 31, 2022 on chest, then spread to arms, stomach, and back in the days and weeks following. On January 17th, 2023 I saw my doctor, and it was then diagnosed as pityriasis rosea. As of February 15, 2023 the rash is still present, but getting better. Some scarring is occurring with the rash spots, but the color is fading to skin tone on the first of the spots. The rash spots that did not develop initially are still red.
soft stool; felt the heaviness in my arm; the injection site is red warm there's mild swelling; the injection site is red warm there's mild swelling; the injection site is red warm there's mild swelling; it's firm and hard to the touch as pain in the muscle of my arm and it's tender; This is a spontaneous report from a contactable consumer (reported for herself). A 47-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 16Jul2021 (at the age of 47-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that after directly after receiving the vaccine the patient felt the heaviness in her arm, she also felt the needle was still in her arm even though it was not. it's been over 24 hours and the injection site were red warm there's mild swelling it's firm and hard to the touch as pain in the muscle of her arm and it was tender and it would hurt to move her arm a little bit as well. She also had a soft stool, and she don't know if that's related to the injection or not. The outcome of all the events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up
Pt received 5 vaccines was sitting in waiting room after injections, with her family. Approximately 5 minutes later mom yelled for help. Patient was lying on floor face down. She had been feeling dizzy and fainted. BP 106/60, P 76 diaphoretic. Recovered after approx 5 minutes.
Fever with rash, conjunctivitis x 10 days. ECHO - multiple aneurysms. Kawasaki disease - Rx with IVIG. 9/27/07-vac records received-lot numbers not included for DOS 7/20/07-only data available from provider is for date of service 9/25/2007. Will contact provider to obtain information related to vaccines administered on 7/20/07. 10/30/07-records received for DOS 8/31-9/4/07-DC DX: Kawasaki disease. Presented with fever on 8/21/07-subsequent visit to ER presented with fever rash, continued to spike fever. Blood and urine culture negative. Transferred on 8/31/07-listless, lethargic, crying. Sclerae red. Lips red and cracked macuopapular rash. Per 60 follow up: Child is being followed up for coronary artery dilatation with cardiologist.
Some of liquid comes out of syringe and doctor did not receive complete 0.5 ml dose; Some of liquid comes out of syringe and doctor did not receive complete 0.5 ml dose; A spontaneous report was received from a healthcare professional concerning a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the liquid came out of the syringe and did not receive complete 0.5 ml dose.  The patient's medical history was not reported. No Relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events, the patient received their second dose of mRNA-1273 intramuscularly  for prophylaxis of COVID-19 infection.   On 27 Jan 2021, the patient experienced the events of some of the liquid came out of the syringe and did not receive complete 0.5 ml dose.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.    The outcome of the events some of the liquid came out of the syringe and did not receive complete 0.5 ml dose were considered resolved on 27 Jan 2021.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe issue for mRNA-1273, lot # unknown with no associated AEs.
achy in my arms and my core; injection site is a little red, but not bad; a little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (a little dizzy), PAIN IN EXTREMITY (achy in my arms and my core) and INJECTION SITE ERYTHEMA (injection site is a little red, but not bad) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced DIZZINESS (a little dizzy). On 23-Sep-2021, the patient experienced PAIN IN EXTREMITY (achy in my arms and my core) and INJECTION SITE ERYTHEMA (injection site is a little red, but not bad). At the time of the report, DIZZINESS (a little dizzy), PAIN IN EXTREMITY (achy in my arms and my core) and INJECTION SITE ERYTHEMA (injection site is a little red, but not bad) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J004159 and expiry date: 08-APR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 24 year old female with a penicillin allergy who on 03-MAR-2007 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (Lot#654702/0011U). Concomitant therapy included CYCLESSA. On 04-MAR-2007 post vaccination the patient started spotting, menstrual cycle. It was reported that the patient is not pregnant. At the time of this report the spotting, menstrual cycle persisted. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Follow up information received from a health professional stated that the dose of GARDASIL was from Lot # 654510/0962F, not lot # 654702/0011U as perviously reported. It was also reported that the patient recovered from the event on 15-Mar-2007. Additional information is not expected.
Covid 19 PCR positive on 12/24/2021. Covid 19 1st and 2nd pfizer doses given on 12/16/2020 and 1/7/21 outside this facility visit. Narrative:
h1n1 influenza; Initial information received on 23-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/ non-health care professional.  This case involves an adult patient of unknown gender and age who experienced H1N1 influenza while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date, the patient developed a non-serious event H1N1 influenza (unknown latency) following the administration of influenza vaccine.  It was reported that the patient got the flu shot each year, got the h1n1, then the h1n1a, then the h1n1b. None of them were fun and was out of work for one week each. Worked forv school system, retiered- no flu. He/she did get it this year my doctor advised me. Also grew up military and had every vaccine imaginable. If someone doesn't want the vaccine, their business. Just because you took a vaccine doesn't mean you can't get it or spread it so safety for others doesn't mean you can't give it.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (H1N1 influenza).  At time of reporting, the outcome was Unknown for the event H1N1 influenza.
06:30PM felt weak and hot in air conditioned store.  08:15PM  - 08:30PM started having heart palpitations, temperature.  On 07/29/2005 nausea and diarrhea.
Patient presented to the ED with generalized abdominal pain, worse in bilateral lower quadrants.  Symptoms started on 4/13/21, and he did report nausea and one episode of emesis.  CT abdomen shows "acute appendicitis with peri appendiceal inflammation and likely appendicolith. No abscess collection is seen."  Patient was initiated on piperacillin-tazobactam in ED with a plan for appendectomy.
My first was 16Apr. Today I just had my second dose; small headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, I did have a small reaction with the first shot.), administration date: 16Apr2021, for Covid-19 Immunization, reaction(s): "small reaction with the first shot". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Nov2021, outcome "unknown", described as "My first was 16Apr. Today I just had my second dose"; HEADACHE (non-serious) with onset 08Nov2021, outcome "unknown", described as "small headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received two vaccinations on 11-14-14. Woke up at 5:30 AM on 11-15-14 vomiting every 20 minutes for approximately 4 to 5 hours. At about 5 PM developed itchy rash (hives) all over (breasts, genitals, back, shoulder, neck, stomach, legs, hands, feet) 102.5 fever, tingling to fingers and feet (and swelling) and lips began to swell, eyes were also red, watery and itchy. Next two days feet stayed swollen and painful to walk on.  Loss of appetite for a few days also. Feet still swollen on writing this report 11/19/14.
Went to bed around 10 pm. Woke up at 11:30 with moderate to severe chills and 100 degree fever. Added blankets and clothes. Took Tylenol. Drank water. Chills subsided. At 12:45am temp was 100.4 degrees F. Woke up at 6am. Temp was 98.2. Took Advil at 6am to help with muscle aches from the chills.
Supraclavicular lymphadenopathy (left side) first noted 22 days after Moderna Booster because of immunosuppressant therapy (methylated idol one for dermatomyositis)
Red at the injection site; swollen at the injection site like a bump; itchy; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of   in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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 treatment information was provided.  No concomitant medication was provided.
BODY ACHE; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On 2021, the subject experienced body ache. On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, fatigue, and body ache. This report was non-serious.
Severe pain in right arm, that radiates to the neck. Went to chiropractor twice, Emergency room, Urgent Care, and neurologist for treatment. Given gabapentin TYLENOL #3 prednisone.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a female patient who experienced administered PREVNAR 13 which was stored out of temperature range. The patient received a dose on 03-Jun-2010. The patient experienced administered PREVNAR 13 which was stored out of temperature range on 03-Jun-2010. No adverse event was reported. No additional information was available at the time of this report.
This spontaneous report was received from a registered nurse, referring to a 105 patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (15 patients with doses of lot number: L013203, expiration date: 28-JAN-2017, 10 patients with doses of lot number: L004456, expiration date: 07-AUG-2016, 50 patients with doses of lot number: L006184, expiration date: 13-DEC-2016, 30 patients with  doses of lot number: L027067, expiration date: 06-APR-2017) orally (doses and anatomical sites were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
I got the vaccine at 3:45 arm was sore but I wasn?t worried Later that night around 6 I started feeling disgusting from vaccine so I took an Advil.  Around 8-10pm my body started getting chills, I started shaking, I had a headache my muscles were sore, and I started getting a fever. Around 12am all of the previous symptoms got worse my fever was at about 101 and rising and I was extremely tired. At 1am I felt the worst I have ever felt in my entire life. I could barely walk because my muscles and joints hurt and my fever was over 102.5 and I felt like my veins were on fire. At 2 am I moved to my bathroom because the floor was cold and I didn?t want my roommate seeing me cry from how much pain I was in. I have a high pain tolerance but this was the worst pain I?ve ever been in. In the bathroom I was at the peak of the pain of the vaccine. My fever was over 103 all of my previous side effects were worse than ever I felt weak and a little dizzy. I also was having a hard time breathing, my breathing was weak and I felt like I wasn?t getting enough air. I tried looking up on my phone if I should go to the hospital but I could barely pick up my phone to type or look. I dropped my phone and fell asleep in the floor for 20 minutes before I woke up. I walked slowly over to my bed and took a Tylenol and then had a sip of water and felt like I was going to puke. I tried to use my inhaler and I couldn?t hold my breath to use it. I crawled into bed and slept until 11 the next day and was too sore to walk to class all of my joints still hurt and I had a fever of 101 and a headache . I took a Tylenol and around 6pm my fever broke and I was feeling better. The next day I was still too sore to walk to class and had a headache. Today I am still sore but better my lungs still feel a little tight, I feel unfocused , and I still feel dizzy occasionally. I have no appetite and I feel nauseous when I eat so I?ve been eating in smaller portions . Every single day since the shot I?ve felt very tired. I hope these symptoms get better and Looking back on the night of vaccine I should have gone to the hospital.
Patient had felt sick all weekend (received vaccine on friday); joint pain significantly increased 4 days following injection; patient given opoid medication for pain
First day :headache/dizziness Second day :headache/chills/sweats (no temp) Third day :headache/chills/sweats (no temp) Fourth day to now :headache, sinus pressure/congestion
Patient hospitalized with acute metabolic encephalopathy. This visit is within 6 weeks of receiving vaccine.
After I waited the required 15 min. before I could leave, my husband and I went to our car and I started to feel lightheaded and dizzy. Figured this was normal so continued home. For the rest of the that day I felt lightheaded, dizzy and just wonky off and on the entire day. I later felt exhausted, like someone flipped a switch on me, around 3:00 pm and took a nap for 2 hours. After the nap I felt nauseous and like I was going to vomit. I ate dinner and later in the evening, I took some allergy medicine and felt a little better and went to bed.  The next day, Friday, I felt a little dizzy and lightheaded and again felt like I was going to vomit in the morning. I ate breakfast, felt nauseous, started cramping, had diarrhea and was then fine.  No more symptoms after that.  Although my arm is still tender today, Saturday.
Initial misuse report received from a healthcare professional on 03 January 2014. This is invalid case as the individual patient identifiers missing. Patient received ACTHIB which was missed with DAPTACEL. It a product reconstitution issue. No adverse event was reported. List of documents held by sender: none.
This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 16Apr2021 at 16:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), anxiety, depression and seasonal allergies. 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 COVID vaccine. The patient received unspecified medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 26Mar2021 at 19:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, within 24 hours of the second shot, the patient experienced chills, muscle aches, fatigue and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events chills, muscle aches, fatigue and fever was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients. The patients' Concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored (0.2C for 251 hours, 55 minutes and the data logger was involved) doses of VARIVAX (dose, frequency and route were unknown, lot # L023587, expiration date 26-JUN-2017, another  lot # L024250, expiration date 30-JUN-2017). The VARIVAX didn't have previous excursions and currently backed in range. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
This spontaneous report was received from a medical assistant regarding a 15 year old female patient with no pertinent medical history and with an unknown reaction to penicillin and aspirin. On 06-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). The medical assistant reported that on 06-AUG-2013 reported as "immediately following", while still in the physician's office, the patient "fell over the side of the bed onto the floor". The medical assistant reported that the physician was able to arouse the patient "shortly after". It was reported that they continued to monitor the patient for the next hour and the patient fully recovered (on 06-AUG-2013). It was reported that the patient sustained no injuries. The medical assistant reported that the vital signs were checked within normal limits. Ice was put on the patient's forehead as treatment. The reporter did not assess the causality between GARDASIL and "fell over the side of the bed onto the floor". Additional information has been requested.