chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a published literature article. The objective of this study was to determine whether asthma was associated with an increased risk of vaccine-preventable disease, e.g., breakthrough varicella infection. This was a retrospective population-based case-control study that examined cases of breakthrough varicella among children between 2005 and 2011. Children with a diagnosis of breakthrough varicella infection (infection of >42 days after vaccination) between 2005 and 2011 and two, age- and sex-matched controls were enrolled for each case. Asthma status was determined by using predetermined criteria. Conditional logistic regression models were used to calculate matched odds ratios (OR) and their corresponding 95% confidence intervals (CI). Of the 165 cases and their 330 matched controls, 48% were boys and the mean (standard deviation) age at the index date was 6.6 plus or minus 3.5 years for both cases and controls. Of the 330 controls, 80 (24%) had two doses of the varicella vaccine compared with only 23 (14%) of the 165 cases (OR 0.29 [95% CI, 0.14-0.61]; p approximately 0.001). Children with a history of asthma ever had a higher risk of developing breakthrough varicella compared with those without a history of asthma (adjusted OR 1.63 [95% CI, 1.04-2.55]; p approximately 0.032) when adjusting for elapsed time since the first varicella vaccination and the number of varicella vaccine doses. This retrospective study report was received from the author refers to 495 patients of unknown gender and age. The patients' concurrent condition included asthma. On unknown dates, the patients were vaccinated with VARIVAX (dosing details not provided). No concomitant medications were reported. On unknown dates, the patients experienced breakthrough varicella infection. Outcome of the event was unknown. Author concluded that condition of asthma might be an unrecognized risk factor for breakthrough varicella infection. Children should follow the two-dose VARIVAX policy. Reporting author considered the event to be related to VARIVAX. Additional information has been requested.
Arm swollen, redness, pain from shoulder to approximately 4 inches above elbow.
I got chills the day after the shot.  It happened mid day for 3 hours.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-JUL-2016, the patient was inadvertently administered an expired VARIVAX (lot # K010339, expiration date 22-JUL-2016, dose and route not reported. No adverse effects wree reported. Additional information has been requested.
Syncopal episode with twitching for about 30 seconds. HR 50, BP 182/49, 100% O2 Sat
Extreme fatigue immediately following  the shot. Next day, achiness, fatigue, and general feeling of unwell/hotness. Weekend following had extreme nausea and dizziness to the point of wanting to throw up/fall over. Have had very fatigue in the weeks that have followed/general feeling of unwell, as well as cough/runny nose.
This spontaneous report as received from a physician via company representative refers to a 62 year old patient. On 31-JUL-2014 the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route were not reported). No concomitant medications were reported. On 02-AUG-2014, 2 days after the vaccination the patient experienced large welt at the injection site. The patient sought medical attention via office contact. The patient used Ice Pack and ibuprofen as a treatment. The outcome of welt at the injection site was reported as recovered on an unknown date in August 2014. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Vial initially punctured on 6/22/22 at 5:05pm. Dose for this patient was drawn up at 8:15am on 6/23/22, more than 12 hours after the initial puncture date. Vaccine was administered. Error was identified, patient was notified. No adverse health effects.
Hyperglycemia starting 10 hours post vaccination lasting for 20 hours. Blood sugars were in excess of 300 mg/dL. Correction insulin doses (basal and bolis) were unsuccessful to correct.
This is a 79-year-old male with a past medical history of coronary artery disease, possible sarcoidosis, Barrett's esophagus, diabetes, hyperlipidemia, BPH, insomnia, anxiety, chronic kidney disease stage 3 who presents to the emergency room when his wife found him leaning over a sink in the bathroom feeling weak and confused.  In the emergency room patient was febrile  and his O2 sat was 90% but he was not in any respiratory distress.  Has been intermittently confused in the emergency room.  He is oriented to person and place but not to the year.  Other times he seems to answer questions appropriately and accurately.  We do not have recent records on him or prior labs.  In the emergency room he was in acute versus.  This is a 79-year-old male with a past medical history of coronary artery disease, possible sarcoidosis, Barrett's esophagus, diabetes, hyperlipidemia, BPH, insomnia, anxiety, chronic kidney disease stage 3 who presents to the emergency room when his wife found him leaning over a sink in the bathroom feeling weak and confused.  In the emergency room patient was febrile  and his O2 sat was 90% but he was not in any respiratory distress.  Has been intermittently confused in the emergency room.  He is oriented to person and place but not to the year.  Other times he seems to answer questions appropriately and accurately.  We do not have recent records on him or prior labs.  In the emergency room he was in acute versus chronic kidney disease, hypoxia, COVID positive and worsening renal failure.  Chest x-ray was also concerning for possible pneumonia.  Patient states he has had a cough and fatigue along with decreased appetite recently.  He states he did get the COVID vaccines with Moderna.   Patient denies any chills, rhinorrhea, sore throat, chest pain, shortness of breath, palpitations, orthopnea, paroxysmal nocturnal dyspnea, nausea, vomiting, diarrhea, constipation, hematuria, dysuria, frequency, melena, hematochezia or focal neurological complaints        Surgical history:  Cardiac catheterization with 3 stents, vats, neck and cholecystectomy   Social history:  He states he quit smoking 25 years ago, rare use of alcohol, no illicit drugs.  He is married
Information has been received from a nurse practitioner concerning a 17 year old female who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL. On 02-APR-2008 the patient was vaccinated with the second dose of GARDASIL (lot # 659655/1486U). On 20-AUG-2008, the patient was vaccinated with the third dose of GARDASIL (lot #: 660389/1986U). Concomitant therapy included birth control pill around August 2008 and she had 3 to 4 partners at that time. It was reported that the patient had a "colposcopy in March 2009 and a lip procedure". The patient sought medical attention form the nurse practitioner/ Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2009.  Follow-up information was received from the nurse practitioner concerning the 17 year old female with no pre-existing allergies, birth defects or medical conditions who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL (lot # 658490/0802U).  On 02-APR-2008 the patient was vaccinated with the second dose (lot # 659655/1486U) and on 20-AUG-2008 was vaccinated with the third dose (lot # 660389/1968U).  There was no illness at the time of vaccination.  On approximately 17-APR-2009, cervical cone was performed.  It was reported that the specimen labeled "cervix" in formalin was an unoriented, 2.5x1.5x 1.4 cm annular portion of cervical tissue.  The exocervix was tan-pink and glistening with patent.  Slit like, less than 0.1 cm.  The margin was tan, dull and granular.  The margin was inked black.  The specimen was serially suctioned sequentially and submitted in entirely in six cassettes, two pieces each, multiple levels.  It was noted that the ectocervical and endocervical margins were free of dysplasia.  The diagnosis was mild and moderate dysplasia with CIN (carcinoma intraspithelial) I and II.  Mild and moderate dysplasia with CIN (carcinoma intraspithelial) I and II was considered to an Other Important Medical Event.  Additional information has been requested.
Initial report was received from a health care professional on 10 Feb 2010: It was reported that caller had withdrawn a 0.5 mL dose of S-OIV FLUVIRIN batch no. 102149P1 out of a syringe to administer to a patient on 10 Feb 2010. While she was tapping on the side of the syringe barrel to get some bubbles out of the solution, some vaccine emerged from the tip of the syringe and splashed caller in the left eye. Caller stated that the left corner of her eye was slightly irritated and had burning sensation. Caller stated that she washed the area thoroughly but it seems some resolution of side effect. The outcome of the event was reported as ongoing.
Patient received an additional dose (3rd dose) of the Shingrix vaccination. Patient has been informed and is aware. Patient is not experiencing any adverse reactions to the vaccination. Patient currently has a sore arm and feels a bit sore all over which are normal side effects from the vaccine.
Breakthrough case admission after 4 vaccines Pfizer 2/10/21 Lot# EL 9267;  Pfizer 3/3/21 Lot# EN6205; Pfizer 10/18/21 Lot# FF2590;  Pfizer 4/13/22 Lot# FK9894
03/22/2006 complained of fever and rash at vaccine sites.  Had fever 103 last night.  Left deltoid with induration, red, warm 7x5cm and 2x5.5 cm.
Diarrhea, NauseaVomting, swelling, redness, pain, discomfort, headache, nausea, diarrhea, chills Narrative: Day 1 - swelling, redness, pain and discomfort to injection site; headache, nausea, and diarrhea; Day 2 - same symptoms but addition of chills; no further notation of symptoms after
There is a possibility Bryce may have received 0.25 ml of vaccine rather than the recommended 0.2 ml. of the Moderna Bivalent presentation for 6 months to 5 years.  A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined if the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
Pt experienced significant bruising from high dose flu vaccine. Bruising was approximately 2x6 inches on upper arm. Pt reports bruise appearing "shortly after" receiving vaccine then increasing in size over next few days.
starting abput 6 hour post injection, extreme lethargy, fever, fitful sleep morning brought muscle pain and aches (similar to flu sx) started to recover around 36 hours after immunization.
"the next day [after vaccination] the injection site was extremely sore and the pain went up to my neck and down into my hand. From what I heard this is pretty normal so I had no concerns. Over the next couple days the injection site pain was gone along with the neck pain but the wrist/hand pain persisted. It?s now been a week since the pain started and my wrist/hand/forearm are still really sore/achy. I?ve been icing it multiple times a day but the pain persists. It?s especially bad when typing or doing any repetitive motions with my hand. "
c/o soreness lt arm since 27JAN94; pt stated had to leave work 27JAN94 because arm was so sore could not do work; noticed redness inject site over weekend; c/o soreness; approx 2 1/2 diameter reddened area noted @ inject site;
This spontaneous report as received from a nurse refers to a 4-years-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided. On 22-OCT-2015, the patient, at the age of 12 months, was vaccinated with the first dose of PROQUAD, albumin status recombinant Human albumin (rHA), injection, subcutaneously, in left lateral tight, lot number L023111, expiration date 24-DEC-2016, for prophylaxis (exact dose was not reported). On 13-NOV-2018, the patient, at the age of 4-year-old, was vaccinated with the second dose of PROQUAD, albumin status recombinant Human albumin (rHA), injection, subcutaneously, in left lateral tight, lot number R022568, expiration date 04-FEB-2020, for prophylaxis (exact dose was not reported). On 08-FEB-2019, the patient, at the age of 4-year-old, the third dose of PROQUAD, albumin status recombinant Human albumin (rHA), injection, was administrated inadvertently (subcutaneous, in left lateral tight, lot number R011803, expiration date 21-OCT-2019). No adverse effects were reported.
This case was reported by a healthcare professional via a sales representative and described the occurrence of fever in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). In February 2010 the subject received 1st dose of KINRIX in an unknown arm. In February 2010, at an unspecified time after vaccination with KINRIX, the subject experienced fever over 103 degrees and a swollen arm from the shoulder to the wrist. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with KINRIX. Information received via QA indicated that they have not received any other product complaints for this lot number of KINRIX. No product was available for return to GlaxoSmithKline. Quality assurance (QA) results received on 02 March 2010, concluded that based on the fact that no precise technical problem was reported, no technical investigation has been accordingly; GlaxoSmithKline Biologicals considers this complaint as not verified. This is one of two reports made by the healthcare professional, for the other case see A0846121A.
p/vax pt broke out w/chickenpox w/mult papules on trunk, face & limbs a low grade fever;pt sought unspecified medical attention;
(+) loss of consciousness for 20-30 min. SNM awoke disorientated.
Patient came in 3 days after flu shot to let us know he had to go to ER due to his throat swelling after flu shot. ER administered epinephrine and pt was able to go home.
From left shoulder to elbow very red, swollen and hot arm. Temp 100 degrees lasting until 10/23/2011. Following day, developed rash (similar to roseola) from top of legs to top of feet.
1/19/12 about 4:00 pm: Per client, she discovered a red welt about half dollar size in location of MMR vaccine. Red welt was slightly itchy and warm w/no pain. On 1/20/12 - welt was not as red, still itches, and area is slightly larger per client. Client encouraged to see her physician.
Case number PHEH2015US004140, is an initial spontaneous report from a medical assistant received on 27 Feb 2015. This report refers to a 3 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN, (batch numbers: U5036CA, U5018AA, U5I73AB, UI207AB and 14511P) intramuscularly at a dose of 0.5 ml on 29 Jan 2015, which reached 31 degree Fahrenheit for two hours. No adverse event was reported following this administration error (incorrect storage of drug, drug use in unapproved population).
Hoarseness, shortness of breath, dizziness, slurred speech, rapid heart beat. Continued till late 12/21/2009.
Leg pain, body aches, fatigue, fever with chills 101.2 f.
Patient identified a shellfish allergy after reaction. Within fifteen minutes of receiving vaccine, patient reported "a lump or rock in my throat", redness noted at injection site. Flushing noted to chest and neck and left arm. Patient reported nausea approximately two minutes later. Hypertension and tachycardia also noted upon assessment. Diphenhydromine HCL 25mg liquid given by mouth by staff. EMS transported to hospital.   Patient states that approximately twenty minutes after arriving to ER, "that lump feeling came back". States ER gave her a steriod. States heart rate was still elevated today.
Patient arrived to clinic. His record was checked with no record indicated and he shared he had no history of COVID-19 vaccination before. He also stated that he had no identification on him. He was vaccinated at 10:21 AM on 12/20/2022 with a primary series Pfizer. To get vaccinated, he needed to remove his sweater. After he was vaccinated, it was noticed that he was wearing a hospital wristband. We asked about it, he said he stole it. However, it was noted that the name on the wristband was other. We looked up that name. He did have a COVID-19 record with a second dose Moderna on 10/18/2022. He was eligible to receive a bivalent booster. During his monitoring time, he admitted that he was openly high on marijuana. He had no complaints during this time. He remained in the clinic area but would not sit down in monitoring. Even Loaves & Fishes security was trying to get him to take a seat in the monitoring section. Once his monitoring was completed, he left the clinic.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In February 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Day after shot(3-10-05), vomited once, nausea, sweating, area around vaccination on left arm red, swollen, warm and the size of an orange in diameter.
Vaccine Administered in error.  Parent did not consent to influenza vaccine.  Mom did consent to Pediarix, Hibarix and Prevnar 13, which were also administered at the time of the visit.  The patient did not sustain any injuries or adverse reaction to the vaccine, which was administered correctly but parental consent was not obtained.
numbness, tingly sensation, swelling, redness, and warmth to the area of injection
Approximately 6 hours after Pneumovax given, RN noted injection site swollen. No other symptoms noted.
no adverse effects; the patient was administered an improperly stored dose; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.  On 13-AUG-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S002874, expiration date 29-JAN-2021) (exact dose, route, site of administration were not reported) for prophylaxis. Administered dose was stored in a temperature of 7.64 Fahrenheit degrees (F) for 20 minutes. Previous temperature excursion was 19.34 F for 34 minutes. Sterile diluent used to reconstitute the administered vaccine was properly stored. Digital data logger was involved. No adverse effects were reported.
Rash on back of neck (cluster of small red bumps with a few more extending outward from local area) with mild itching.
Vaccinee received 3 doses of Engerix B. 2 months /p the last dose titers were ck - pt is a non responder
Cellulitis (R) arm after PNEUMOVAX elevated fever x 5 days (104). Received IV & oral antibiotic.
I got Shingles even though I was vaccinated for Shingles in 2016
She had Influenza, Quadrivalent (P-free) (6 Mo And Older) (Inject). My daughter is experiencing muscle pain, headache, stomach ache, and fever. They all began around 2 pm the following day.
Covid arm; Hot; Covid arm It is 6 by 6 inches in size swollen; Red arm; Red arm, it hurts; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (Covid arm It is 6 by 6 inches in size swollen), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Red arm, it hurts) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (Covid arm It is 6 by 6 inches in size swollen), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Red arm, it hurts). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (Covid arm It is 6 by 6 inches in size swollen), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Red arm, it hurts) was resolving.        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 relevant concomitant medications were reported.