chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 8 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012709 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
This spontaneous report as received from a physician's assistant refers to a 56 years old female patient with Amyotrophic lateral sclerosis (ALS) and allergy to sulfa drug. It was reported that on February 2012, the patient was vaccinated subcutaneously with a dose of PNEUMOVAX23 lot # (0225AE) (exp 03-JUN-2013), with no problems. There was no other co-suspects were reported. No concomitant medications. The physician's assistant noted that then, the patient was administered another dose of PNEUMOVAX23 on 12-NOV-2012 and that on 13-NOV-2012 the arm circumference of the arm where the PNEUMOVAX23 was inject doubled, and that the arm was also red, painful, and stiff. The physician's assistant notice this adverse event was resolved by 14-NOV-2012). The patient sought medical attention (the patient called the office). The relatedness for circumference of the arm where PNEUMOVAX23 was injected was red, painful and stiff is unknown for PNEUMOVAX23. This is one of several reports received from the same reporter. Additional information has been requested.
Nausea, Headache, arm pain, Neck pain, Swelling,  Headache
Total body shakes, fever and chills and sweats. Nauseated. Symptoms initially lasted 48 hours and then intermittent following. Patient states has had symptoms over the last two weeks. Saw Personal MD yesterday and lab work today. Spoke with MD on November 16th but not an appointed visit.
ActHIb was reconstituted with sterile water and not the proper diluent; Initial and follow up information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (with unknown demographics) who received HIB (PRP/T) VACCINE [ACT-HIB] (lot number and Exp. Date not reported via unknown route in unknown administration site) that was reconstituted with sterile water and not with the 0.4 % NS diluent provided, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique.  It was unknown whether the patient had any adverse reactions.  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.  Information on the batch number was requested.  List of documents held by sender: none.
5 days after vaccination she had a fever. 7 days post vaccination she had a complex febrile seizure and developed ATAXIA, clumsiness, and weakness of left side. These symptoms are gradually improving.
Really pale, cold, sleepy. White stools, lasted a couple days. Got better on his own. Called Dr who was gone and left message, but did not get called back.
Reports 12 Jan 2008 with symptoms of dull ache in right arm. 2 cm nodule found center of tender area (deltoid)  Ache extends down forearm at night. Slightly sore during the day. No signs/symptoms of infection noted.  MD reccomended treatment with anti-inflammatories and follow up in one month.
PATIENT INADVERTANTLY REC'D SECOND DOSE INFLUENZA IN ONE SEASON. FIRST DOSE WAS GIVEN AT SCHOOL BASED HEALTH CENTER (10/14/2022) AND SECOND DOSE GOVEN AT COMMUNITY FLU CLINIC WITH PARENTS CONSENT (10/29/2022). NO ADVERSE REACTIONS. PATIENT PASSED SCREENER/CONSENT FOR VACCINATION.
Diagnosed with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM, DILTIAZEM HCL, ALENDRONATE SODIUM, LORATADINE, ACETYLSALICYLIC ACID (BAYER ASPIRIN) and MULTIVITAMIN & MINERAL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (Diagnosed with COVID-19). At the time of the report, COVID-19 (Diagnosed with COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Janssen COVID-19 Vaccine EUA  Patient reported feeling dizzy about 10 minutes post vaccination. BP within normal range. Skin cool and sweaty. Patient stated that she has "anxiety when getting shots". Patient monitored on-site for 45 minutes.  Patient stated she felt better. Left with husband. clinic.
Flare of arthritis on right side of body. Extreme pain in R hip, and  R ankle making it difficult to walk. Also both hands are stiffer than usual and both shoulders are more sore. For the last year, until a week ago, the symptoms of autoimmune arthritis were very managed. I could run and jump on a trampoline with my granddaughter, very minimal pain, slept well at night without pain but now it has flared up. The vaccine is the only thing different in the past two weeks. I have not been ill or had a fever in over a year. I have not changed any medication or had any new stressors in my life. I am in a lot of pain and cannot  perform my normal activities fo daily living. I am trying to get in to see my doctor but they are booked up.
Arm pain, elbow to shoulder, days 2-5, itching day 6-10, redness over large area around injection site, days 7-12
Pt has a knot in left thigh 22mm X 25mm and erythema at injection site. The knot persist.
This case was reported by a medical representative and described the occurrence of fatigue in a 86-year-old female patient who received SHINGRIX for prophylaxis. On 17th February 2019, the patient received the 1st dose of SHINGRIX. On 17th February 2019, less than a day after receiving SHINGRIX, the patient experienced fatigue and general body pain. On an unknown date, the outcome of the fatigue was unknown and the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the fatigue and general body pain to be related to SHINGRIX. Additional details were reported as follows: The medical representative reported case for his or her family member. The patient experienced pain, aches and pains throughout body as well as fatigue beginning the night after SHINGRIX shot. The aches improved within first 24 hours.
Information has been received from a consumer concerning her daughter, an 18 year old female patient with a history of "asthma as a child," who on 06-MAR-2007 was vaccinated with the first dose of GARDASIL (lot #, route and injection site not reported). According to the consumer, on 07-MAR-2007 her daughter had "terrible pain and abdominal cramping" after receiving her first dose of GARASIL. The patient contacted doctor and went to the emergency room on 08-MAR-2007 (reported as 08-MAR-2008). CT scan of pelvis and abdomen, wet smear, urinalysis, blood count, Gram smear, gonorrhea and Chlamydia tests were performed without results reported. It was reported that the patient was not hospitalized. The patient was placed on unspecified therapy and the event improved. At the time of the report, the patient was recovering from the event. Additional information is not expected.
4/4/23 I had a lesion on the roof of my mouth that would not go away. It was very painful. I could not eat or drink anything hot. I went to the dentist about a week later. He could not figure out what it was. He said to gargle with salt water and be careful with what you are eating. I stopped taking all dietary supplements. The lesion is still there. It has gotten better but has not gone away. I saw the dentist today. He said it has not gotten any smaller. I go see an oral surgeon next week for a biopsy to see what is going on.
Pt vaccinated with Engerix-B developed acute asthma exacerbation, allergic rx to immunization, dizzy, face remained puffy, fleas jumping all over body sensation, hands remained puffy, incoherent, irritable. See WORM very detailed.
3 mins p/vax pt head rolled back, turned completely blue; pupils dialated, unresponsive, pulse thready; 2 mins into episode pt's muscles contracted for approx 30 seconds; No incontinence; pt pale & drowsy;
Development of vomiting and red rash appeared about 15 minutes after 2-month vaccines were administered. Respiratory distress with retractions and tachypnea noted. Treatment included one dose of inhaled racemic epinephrine, one dose of intramuscular diphenhydramine, and one dose of oral prednisolone. Resolution of respiratory symptoms was observed after administration of racemic epinephrine and diphenhydramine.
This case was reported by a nurse and described the occurrence of injection site burning in a female patient who received hepatitis B vaccine recombinant (Engerix-B). On 19 November 2004, the patient received the 1st dose of Engerix-B in the right arm (lot ENG5595BC-incorrect lot number). At an unspecified time following the first administration of Engerix-B, on 19 November 2004, the patient experienced an injection site reaction characterized as burning. The events resolved on 19 November 2004. The nurse reported that, "the vaccine had just been removed from the refrigerator prior to the injection and it was cold." The nurse considered the injection site reaction to probably be related to vaccination with Engerix-B.
Adverse effect of other vaccines and biological substances, initial encounter on 2018-06-06.
she developed an infection in the leg 2 weeks later; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.     The patient's concomitant medications were not reported. The patient reported she could not get the second dose as she developed an infection in the leg 2 weeks later on Mar2021 with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
My previous vaccines were Pfizer. I started getting symptoms of like a sinus infection with headache, stuffy nose, sneezing, fatigue. I had a serious bloody nose. I took an at home COVID-19 test that was positive. I did lose my taste and smell for one day that would come and go for 3 days. I contacted my doctor and we discussed antiviral medications but I decided not to due to my GERD. I still have lingering symptoms of stuffy nose, headaches, and fatigue.
At 6 month vaccine visit mom reported with last vaccines (7/22/14) (L) leg had swelling redness and blue streaks occur about one hour after vaccinations. The blue streaks lasted approx 1 hour. Infant had nonstop crying for approx 20 min- knots stayed for several weeks.
02/12/01; received Hep-B vaccine, 1st dose. Five minutes, post vax, she became very itchy. Treated with Benadryl and told to continue series; no respiratory distress.
Patient says that he's having right lower quadrant pain, started right after vaccination. Last night he said he's been having low grade fever, along with nausea and headaches.
feeling numbness in his left calf area; fatigue; breathlessness; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 07Apr2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He stated he received his first Pfizer Covid vaccine dose on 07Apr2021 in his left arm. He has since reported feeling numbness in his left calf area and reports fatigue and breathlessness during physical exertion on an unspecified date. He was due for his second dose tomorrow 28Apr2021. He wanted to know if this was a normal side effect. He was concerned because it has been going on for 20 days. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Injection site red and hot, hard oblong swollen place; also, tingling in thumb; weakness & trembling in that arm.
No adverse event. Pt was given vaccine incorrectly. The Rotarix vaccine was not mixed with the diluent. Patient only recieved the diluent no vaccine.
Received Moderna vaccine on 2/9. Developed a rash 5-6 days later at the injection site. Over time the rash has gotten larger and developed white bumps. Tenderness. +Itching. Works as a police and fire dispatcher. At time of visit: Localized erythema of the left upper arm at injection site of Moderna COVID-19 vaccine Recommend applying cool compress, aloe vera gel, topical benadryl, or hydrocortisone cream to relieve irritation and itching Benadryl as needed for itching Tylenol or Motrin as needed for pain relief Follow-up as needed
Patient expressed fear of needles before injection. After injection, suffered syncopal episode, taken to hospital Emergency Room for evaluation. Discharged shortly after.
little bit of pain on arm of injection; very intense pain on arm of injection; cannot lift her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little bit of pain on arm of injection), PAIN IN EXTREMITY (very intense pain on arm of injection) and LIMB DISCOMFORT (cannot lift her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported ). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for COVID-19 immunization.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (little bit of pain on arm of injection), PAIN IN EXTREMITY (very intense pain on arm of injection) and LIMB DISCOMFORT (cannot lift her arm). At the time of the report, VACCINATION SITE PAIN (little bit of pain on arm of injection), PAIN IN EXTREMITY (very intense pain on arm of injection) and LIMB DISCOMFORT (cannot lift her arm) had not resolved.        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.   This case was linked to MOD21-075957 (Patient Link).
Fully COVID vaccinated patient admitted to hospital through ED for shortness of breath with COVID positive test on 09/06/21.  Ambulatory PO2 at 82%.  D/C home on 2L/NC and additional 5 day course of decadron.
Information has been received from a nurse concerning a 4 year old female with no past medical history and no known drug allergies who on 5/10/00 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 632616/1688J). There was no illness at the time of vaccination. Concomitant vaccinations that day included a third dose of hepatitis B virus vaccine (lot # 635269/0423K) given IM in the left arm and a first dose of MMR (lot # 634036/1711J) given SC in the right arm. On 6/6/03, also reported as 6/12/03, the patient was treated at the physician's office for a varicella breakthrough, described as approximately 20 varicella lesions on her neck and torso. The outcome was reported as recovered. No other details were provided. Unspecified medical attention was sought. There was no product quality complaint. No laboratory data or diagnostic tests were reported. The reporter also indicated that 2 other patients experienced breakthrough varicella. No further information is expected.
Patient received the vaccine and moments after passed out (head and eyes rolled back), starting slouching on his right side and started to show twitching/convulsions and turned pale. Regained conscience soon after his name was spoken to him. Called RRT, took vitals while waiting for RRT. Mother of patient explained that this happens every time the patient receives a shot or blood drawn. RRT showed up and assisted soon after.
Received call from patient today. States he did have reaction to MMR dose he recv'd in June. States it began about 11 days later when he developed jaw pain, throat swelling, fever, and golf ball size lump on back of arm at injection site. States he went to his physician, and saw one of the partners. He was given a 10 day steroid pack to take. He states his work is still wanting him to get a 2nd MMR and he is requesting I write a letter to them stating he can not take MMR safely. Made another attempt to reach patient to see how he doing after MMR shot. I called patient of Friday 6/14 to inquire if he had any reaction to MMR given 6/11. Unable to reach him or leave message. Patient returned to get MMR. The credentialing company requests he get vaccinated for work since his titer shoiws "negative". He spoke with his MD about the risks and his MD said he felt it would be "ok to get MMR, as it is more dead than alive." Patient felt comfortable getting MMR again even though he had a serious reaction to childhood dose. I requested he call PPH back if he experiences any negative reaction. Patient had titer reports from MD and questioned results of Rubella (measles). The result indicated he is not immune, but he clearly remembers getting MMR dose as a child and 2 weeks later coming down with bad case of measles (skin peeling etc). We discussed giving him booster today, but I encouraged him to speak with MD first. He may call and return for MMR id MD is okay with this.
Symptoms starting appearing on Day 4 (09/01/21): Rapid heart beating and extreme tiredness and fatigue, Day 6 (09/03/21) - Post menopausal heavy bleeding that lasted for 13 days (09/03/21 through 09/16/21).  Day 12 ((09/09/21) Painful throbbing in right thigh.
No adverse effect until 48 hours after injection whereby I noticed a red circle on my right arm at the site of the injection.
Vertigo, dizziness, off balance ringing in right ear. Meclizine 25MG. No longer taking Meclizine but still having feeling of off balance.  .
High fever, chills, headache, nausea, vomiting, lethargy, muscle aches
Has headache; This is a spontaneous report from a Pfizer-sponsored program Support. An unspecified age of female patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on 24Feb2021 to 24Feb2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that caller received first dose of vaccine today, has headache and would like to know if she can take anything for it or if it will affect the effectiveness of the vaccine- declined ISI - cold transfer due to wait times to PSCC for AE: side effects, will fax . The outcome of event was "unknown".  Information on lot number/batch number has been requested.
On Saturday night, I felt like something was stuck in my throat. It was bothering me. In an hour, I started to get cold, I was shaking, and I used heating pads - but it didn't provide much relief. I took Benadryl as a result.   On Sunday morning, I was lethargic and tired. By Monday, my face was swollen, I had trouble breathing, and had a rash all over my face & neck. I went to Urgent care that day. I received allergy & steroid medication by the doctor.   I was urged by the doctor not to take my second dose.
received less than half of the recommended dose; needle screwed onto the syringe coming off; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (received less than half of the recommended dose) and DEVICE CONNECTION ISSUE (needle screwed onto the syringe coming off) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced UNDERDOSE (received less than half of the recommended dose) and DEVICE CONNECTION ISSUE (needle screwed onto the syringe coming off). At the time of the report, UNDERDOSE (received less than half of the recommended dose) and DEVICE CONNECTION ISSUE (needle screwed onto the syringe coming off) outcome was unknown. Not Provided      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 concomitant medication reported  No treatment information was provided
April 7, 2021    To:  Dr Patient arrived at the  Health Department today to receive her second dose of Moderna Vaccine.   It was then discovered that she was only 17 years old when she received her first dose on March 10, 2021. Upon investigation, we pulled her original paperwork to discover the registration and injection had been done by a student from the University.  The instructor was present and signed off on the injection. Please advise for second dose protocol. VAERS and ARIA to be completed.
Woke up at 3am with throbbing in legs and left arm.  Pt said she felt super achy in joints. Felt a tinging in spine and still has to current day (8/19/2021)
I had an odd petechiae rash appear on my body and then had low blood platelets of 3000. O had to receive transfusions of IVG Immunoglobin and 100mg of high steriod treatments. To get my platelets up. After 7 days my platelets were up to 143k. Currently still on high doses of steriods and will begin tapering down 10mg less per week starting 4/9/2021
Five months after the vaccine I thought I had a Spider Bite. It was an itchy spot on my mid to lower back on the left side. It was like six little spots that were a little painful at first. It seemed to be spreading. I went to the Urgent Care and the doctor diagnosed me with Shingles. I was given some medication and the spots cleared up in two weeks. The spots remained very itchy and later on I started to have some nerve pain which is still happening. It has been six weeks and the spots have visible cleared up, but I have some nerve pain. I had the Chicken Pox when I was a child.