chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 11/20/03 concerning an unspecified number of vaccinees under the age of 4 years who inadvertently received Fluvirin on unspecified dates. On unspecified dates the vaccinees inadvertently received Fluvirin IM. At the time of reporting the reporter had not been informed of any subsequent adverse events. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee was a 21 month old male who inadvertently received Fluvirin on 11/19/03. No adverse events were reported at the time of the report. Follow up pending.
Patient complained of face feeling swollen.  Patient asked to look at reflection and patient states face is visibly swollen and cheeks red.  Patient given 25mg Benadryl IM in right deltoid.  15 minutes post Benadryl, patient stated that she felt like her tongue was swelling.  Patient denies SOB, no wheezing, no stridor.  BP 114/78 manual in right arm.  HR 74, pulse ox 100% on Room air.  SWAT was called and patient went to ED for further evaluation.
Vomit, chills, flu like symptoms, arm swollen, couldn't lift arm. Couldn't sleep. Felt like unknown threat. No way to describe.
Narrative:  patient reported to primary care that he had arm swelling when he received zoster. No record of administration.
Fever at 100.6F, Headache, Chills, Sore throats, tiredness.
715PM pt playing w/cake pan, began crying, circumoral cyanosis noted, eyes glassy; mom shook her-thought pt was choking; incontinent urine & feces; pt non-responsive - eyes open; face turned dark; mom thought seizure; took to ER, then hosp;
1/4 vaccination 10 days later, I woke up and my arm was achy and weird feeling; huge rash at deltoid, huge (size of a lemon/lymph node) under armpit. I tried to make appt with PCM. I had a computer visit that day; convinced it was cellulitis. They prescribed me medication. After 2 days, it did go away. The rash stayed for another 3 days, fading but still there.
Fever, myalgias, headache. Erythema and significant tenderness at Pneumovax injection site.
Information has been received from a nurse concerning her daughter, a 13 year old female who on 27-DEC-2006 was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 27-DEC-2006 the patient developed dizziness and nausea. The patient's dizziness and nausea persisted. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report as received from a practice administrator refers to a 10-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 17-APR-2017, the 10-year-old patient was vaccinated with properly- stored expired dose of M-M-R II lot # L010488, expiration date: 26-MAR-2017 (rHA; dose, and route of administration were not provided). No adverse effect was reported. Additional information is not expected, as there was no consent to contact the physician.
Stomach hurts; Arm is sore; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurts) and MYALGIA (Arm is sore) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurts) and MYALGIA (Arm is sore). At the time of the report, DIARRHOEA (Diarrhea) had not resolved and ABDOMINAL PAIN UPPER (Stomach hurts) and MYALGIA (Arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Moderna COVID-19 Vaccine EUA I noticed raised itchy bumps and redness on my left arm at injection site the morning after my shot, they could have been shortly after I was vaccinated, but I was really only looking for any issues that might be life threatening. Over the following two weeks, the bumps/itchiness worsened and spread across all of my body except at my hands, feet, face, and lower back. Nearing the end of the second week, as the conditions worsened my skin felt painful all over (like a very bad sun burn). Due to the discomfort, I was largely unable to sleep during this period and had difficulty focusing on work. At week one I started taking Benadryl and applying lotion on my skin. I informed my PCP as well as the clinic that administered the vaccine of my condition. The clinic said they could do nothing unless my condition was life threatening. My PCP advised that an itchy rash is a rare side effect of the vaccine but that it would get better typically within 8-12 days. He also advised on taking an additional over the counter antihistamine along with the Benadryl, which I did.  None of the antihistamines made the conditions better, they continued to worsen. I started taking Ibuprofen for the discomfort and pain. By the end of the second week, my rash became more painful especially at my chest, neck, and ears - the skin became quite red and looked a bit like a burn. At this point I did not believe I was having a safe reaction and reached out to my PCP and vaccine clinic once more.  I was not able to reach my PCP but did connect virtually with an online doctor who reviewed photos of my skin and prescribed a topical steroid. Doctor advised I see a specialist in person, with concern that taking an oral steroid might  mitigate the effects of the vaccine. I alerted the clinic that I would be seeing this specialist and they advised that I instead go to urgent care. The following day (4/6/21), I did both. Healthcare facility provided an oral steroid and did not think it would impact the vaccination. The Specialist did not want to prescribe a steroid in concern that it would mitigate the effects of the vaccine. He advised to endure the rash another 1-2 weeks. Later that night, I could not bare the pain and starting taking the oral steroid. Within 24 hours I started feeling some relief. I am on day three of six of the steroid and each day the pain, itching, and rash are getting better. I will have a meeting in person at the clinic where I received my vaccine this Friday for a doctor to assess my rash and determine if it is appropriate for me to take a second dose healthcare facility requested this meeting.
Nephrotic syndrome 04/2010. No live vaccines until cleared by nephrology. H/o RVS 2007.
Patient reports lightheadedness and sweating after the injection with loss of consciousness. Patient was observed, vitals taken, water given, went home with grandfather.
two years since first dose, never received second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, two years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient asked, what he/she should do.
The child had a low grade fever of about 100 during the first 24 hours. Following the fever the child had a small red rash (no lesions) on his back.
This is a spontaneous report received from a contactable consumer or other non-HCP (parent). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jan 11, 2022, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed a rash (spots all over his face) and erythema (whole face is a little bit red/his face getting red), onset Jan 11, 2022, with outcome of unknown. Additional information: Reporter stated, "My son got the first dose for Pfizer vaccine this morning at the hospital. His whole face is a little bit red and there are spots all over his face. I want to know if this is normal, because I don't see that kind of side effect on the information they gave me this morning." No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Child had fever for 2 weeks (intermittent), had fever 4 days before his one year immunizations June 29, 2009. Developed petechiae (July 11) on legs which spread to arm, face, and bottom. Bruising also developed in hands, face, legs. Child was taken to primary physicians office. CBC was performed. Total platelet count was 3000 so child was admitted to hospital.  8/10/09 Hospital records received DOS 7/11/09 to 7/11/09 and 7/20/09. Assessment: Severe thrombocytopenia and neutropenia. Patient presents with petechia on left lower leg this morning. Spread to both legs, arms, face, and bottom. Bruising on hands, face and legs. Intermittant fever over past 2 weeks. Plasmapheresis.
On March 5,2021, I started to experience a hot red rash on both my cheeks and ran a low grade fever that evening. I took 2 Tylenol and fever went away for that day. 2 days after my vaccine, most of the redness and heat on my cheeks was mostly gone and I felt better.   3 days after my vaccine,  which is today, I didn?t sleep at all the prior night because my rash returned and my checks were extremely hot.  I?ve taken my temperature throughout today and my body temperature is normal but cheeks  are still extremely warm and red
This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (lot number, expiration date, dose and route of administration were not reported). Concomitant therapy included sterile diluent used to reconstitute. The PNEUMOVAX 23 was stored at -0.24 degrees Celsius for 124 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. As of 26-MAY-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000822: US-009507513-1706USA000921:
Patient got her second shot of Moderna (COVID vaccine) on 5/6/2021 ar 11 am. When she woke up the next morning on 5/6, she had a blister and pain on her right deltoid where the vaccine was administered . Her deltoid was red and warm to touch. Pt had limited movement on the affected side.  The band aid had been left on the vaccine administration site and the pt had an adverse reaction not only to vaccine but to the adhesive/ band aid. The band aid was imbedded in the blister. When attempting to slowly remove the Band-Aid the blister popped. It drained clear fluid. I cleansed the area with saline, applied antibiotic ointment and a nonstick dressing.  Pt was advised to take OTC Bendryl and keep area clean. Pt was contacted after 2-3 days and her symptoms had resolved completely  Pt reports to clinic on 9/24/2021 states that she has had soreness ever since she got her vaccine. When she makes certain movements with her right shoulder its painful. She denies any weakness, numbness or popping in the affected joint. The pain usually occurs more when she is reaching over her head. She was advised to call and get appt with local ortho to evaluation right shoulder
Initial reaction: fever 101.8 for ~8 hours that night; headache, fatigue for 48 hours. 13 days later, developed severe heartburn, GERD which lasted for 2 weeks, along with 10# weight loss. 21 days after vaccine, episode of dyspnea during conversation. 27 days after vaccine, felt like not enough energy to sing in church choir. 28 days after vaccine, began having lower abdominal cramping, fatigue, episode of dyspnea upon climbing 1 flight of stairs. 29 days after vaccine, extreme fatigue and another episode of dyspnea with 1 flight of stairs. 30 days after vaccine, developed worsening palpitations, tachycardia, dyspnea, arrhythmias, dizziness, headache, tightness in chest/neck. Went to ER
On 2 Nov 12 member came in to clinic presenting concern with raised red round bump underneath left arm. Member denies chest pain, fever, but states underarm swollen and feels like a bruise. Seen by Dr.
Hives to bilateral legs/ abdomen and lethargy approximately 2 hours after vaccine administration. EMS called and IM benadryl given. Patient observed in the ED for 2 hours and returned to baseline.
Patient reported that about 2-3 hours after receiving fluzone injection his blood pressure was elevated.  He checked it at home and reported it to be 155/98.  He had been doing yardwork (planting flowers).  He reported that his pulse was elevated at about 105.  He reports that after about 2 hours of elevated blood pressure he stopped the yard work and just rested.  He monitored both blood pressure and pulse for about the next 8 hours, it decreased after about 7 hours and patient reports he went to bed as usual.  The next morning patient states his blood pressure was only a little elevated.  He does suffer from high blood pressure which is normally controlled by medication, and he reports that he did take his medication as usual the evening before the vaccination, and the evening after the vaccination.  He did not seek any medical attention and reported this back to the pharmacy 2 days following the vaccination.  He reports he has received a flu shot every year for about the last 10 years without any problem.
Puffy itchy eyes within 30 minutes, breathing difficulty, chest rash. Patient went to ER was given IV BENADRYL. Prescribed Prednisone and BENADRYL.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who experienced patient received vaccine QUADRACEL by SQ route. The patients past medical history included a bleeding disorder. Concomitant medications included MMR on 05-Sep-2018. On 05-Sep-2018, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number, expiry date not reported via subcutaneous route in the posterior arm. It was an actual medication error due to inappropriate route of vaccination. It was reported that patient received QUADRACEL vaccine by SQ route. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
Swollen lymph nodes under armpit; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 07May2021 at 08:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 08:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08May2021 at 17:00, the patient experienced swollen lymph nodes under armpit. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes under armpit was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients  (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 9 of 15.   No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 9 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Left eye pain developed in afternoon along with left injection site pain (expected.) Later on I had a bad headache, fever, chills, all expected. When all other symptoms were resolved 2 days later eye pain persisted. Still present today even though milder .
Mother reported on 10/26/17 that child developed "shooting pains in feet, shoulder and abdomen", also stated child had diarrhea. No other s/s reported by mother.
This spontaneous report as received from a healthcare professional refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored VARIVAX injection, lot # K021485 with expiration date 03-NOV-2016 and lot# L024250 with expiration date 30-JUN-2017 (dose and route of administration were not provided). No adverse effects were reported. Data logger was involved. The vaccine was exposed to a temperature of 30 Celsius (C), time frame of excursion was reported as 1104 hours total cumulative time. There was no previous excursion. This is one of several reports from the same reporter. Additional information has been requested.
16sep2021 is my Conception date for my pregnancy. At the time of the 2nd I, was about 10/11 weeks. Sore arm at injection site. There was no other symptoms. Went to a routine appt for my pregnancy on 15Nov2021. I had a medicated abortion on the following Monday.
Patient had bleeding gums within about 12 hours of having the vaccine.  Bleeding gums lasted about 48 hours.  She also had a nose bleed which started about 24 hours after the vaccine was given and lasted 2-4 hours
Information has been received from a physician concerning a 25 year old female with asthma, anaemia and arthritis who on an unspecified date was vaccinated with the first dose of GARDASIL.  The second dose of GARDASIL was given 08-APR-2008.  Concomitant therapy included montelukast sodium (MSD), daily multivitamins (unspecified), vitamin D (unspecified), iron (unspecified), B-12 injection, SYNTHROID, MOBIC and RELPAX.  On 29-APR-2008 the patient called the doctor's office complaining that the injected arm was tender, she had limited range of motion in the arm, and she had feelings of malaise.  The patient was seen in the doctor's office on 01-MAY-2008 and was treated with over the counter MOTRIN.  No outcome information has been provided.  Additional information has been requested.
On drive home (left office @ 1110) approximately 1130 or so patient reports numbness in lips, around mouth between top lip and bottom of nose.  Felt sleepy & slight headache At approx 1230am 1/28/2021 patients states has a heat sensation that irritated chest and throat down to stomach.  Drank ice water with relief. Woke on 1/28/21 @ 0745  & c/o Nausea after eating "Cream of Wheat"  c/o deep tissue muscle aches in arms shoulders and back. Check Temp at 11am with fever of 101 Temp. now 3:42 pm (1542) is 100.2
Pt received flu vaccination; pt returned approx 20 minutes later stating he was not feeling well and was very pale.  Pt received epinephrine and 911 was called.  Pt transported to local hospital for evaluation.
Rash on face, began Sunday evening. Put birth control patch on Sunday AM does not know name of patch