chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an unknown number of patients who were vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that in the past 2-3 years the office had seen about one case of breakthrough varicella every 2-3 months. It was unknown if medical attention was sought. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that she did not have any additional information to provide. Follow-up information from the registered nurse indicated that the patient was a 4 year old female who at the age of 12 months old on 22-AUG-2003 was vaccinated subcutaneously in the left thigh with a dose of varicella virus vaccine live (Oka/Merck) (lot # 645045/0208N). On 07-JUN-2007, the child was diagnosed with a case of breakthrough chickenpox after receiving subcutaneously in the left thigh a dose of varicella virus vaccine live (Oka/Merck). Approximately 20 to 30 vesicular and papular lesions and few crusted lesions on trunk and legs. The patient had a history of submucosal cleft palate repair done on August of 2004. On an unspecified date the patient recovered. Additional information is not expected.
continuing lethargy after 5 days; Injection site pain; Sharp chest pains when exhaling; Sternum pain when bending over; dizziness; Shortness of breath; Tremors in left pointer finger; Left side lymph node swelling along collar bone very painful; Left side lymph node swelling along collar bone very painful; lower back pain between S5 and L1 and right hip; lower back pain between S5 and L1 and right hip; Extreme dry mouth; This is a spontaneous report from a contactable consumer (patient himself). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196, Expiration date: Unknown), via an unspecified route of administration in left arm on 18Jul2021 at 15:30 as dose 1, single (at the age of 42-years-old) for COVID-19 immunization. The patient was diagnosed with COVID-19 prior vaccination. The patient was not tested COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient's medical history was none. The patient's concomitant medication included pramipexol taken in two weeks of vaccination for an unspecified indication, start and stop date were not reported. On 19Jul2021 at 07:00, the patient experienced injection site pain, sharp chest pains when exhaling, sternum pain when bending over, dizziness, shortness of breath, tremors in left pointer finger, left side lymph node swelling along collar bone very painful, lower back pain between S5 and L1 and right hip and extreme dry mouth. On 24Jul2021, after 5 days, the patient experienced continuing lethargy. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
She experienced some expected minor local swelling but no local rash. About 10-14 days later she developed axillary and anticubital adenopathy in her vaccinated (left) arm. It has become progressively painful over past weeks. Pain is pulsating with out radiation in her left elbow which has been especially bothersome at night for her.  On the inner aspect of the elbow she has a "lump the size of a pecan" and two nodules the size of a pea inlinear orientation, above this lump.  She has a history of arthritis, hypertension. There's been no fever. Her physician, is unsure about the cause and is treating presumptively with levoquin antibiotic.
This spontaneous report as received from a physician assistant refers to a 11 weeks old male patient with gastrooesophageal reflux and milk protein allergy. The patient's medical history included oral thrush. The patient was vaccinated with his first dose of ROTATEQ orally on 02-OCT-2012. Lot# was reported as 0380AE, expiration date on 30-OCT-2013. Concomitant medications included: MAALOX. It was reported that patient had diarrhea on 05-OCT-2012, vomiting on 07-OCT-2012, continued vomiting decreased oral intake, and blood in his stool on 08-OCT-2012 and "currant jelly stools" and dehydration on 09-OCT-2012. The patient was seen in the emergency room throughout this time period. The patient was admitted to the hospital on 09-OCT-2012, where an ultrasound was performed and the intussusception was discovered. The patient received a barium enema which was stated as "didn't produce any results so the patient had surgery". It was mentioned the patient's gastric reflux worsened after the surgery. At reporting time the patient was recovering. The reporter considered the events as life threatening, significant disability or incapacity, and need intervention (surgery) to prevent serious criteria (medical significant). Additional information has been requested.
Admitted on 4/1/2021 with severe COVID 19 pneumonia on life support as of 4/16/2021
Area of redness at injection site L where DTaP given. Some fever up to 100 degrees. Area no longer tender but parent reports much tenderness x 2 days.
6 inch red, swollen, warm and numbing sensation occurred 24 hours after vaccine administration.
Patient is a(an) 6 y.o. female who complains of headaches for past 3 weeks. Patient has been having headaches almost daily since she got her 2nd vaccine dose on Dec 15th. Mom thinks it is more like 3-4 x a week. Mom thinks it is lessening. She also has seen a bit fatigued.  She will lay down on the couch and close her eyes and rest while everyone is up and moving around, Tv on, ect. Very unlike her.  She is also fatigued. She thinks it is because she is trying to rest her eyes and lay done. She is laying more on cough and curling up.  Headaches are frontal, more in the morning and sometimes still there in the afternoon. The headaches last hours. Mom gives her tylenol and it helps.   Patient does not have headaches that regularly wake her up or that occur routinely first thing in the morning. She does not routinely have AM nausea without headache. She does not have vision or hearing or balance or speech problems. Her headaches are not associated with vertigo, diplopia, confusion, or lack or coordination.   Per last well child check note also had "lots of GI issues, h/o GERD and colic. Mom sees GI. Tried cutting out dairy . She had eating issues as an infant and ate nonstop". I had recommended going lactose free, trying miralax for constipation and follow up if not improving. She had a lot of underlying anxiety which I referred her to therapy for about 3 months ago.  Brother had similar SIDE EFFECTS but his resolved after 1 week
Patient was given Pfizer Bivalent booster during protocol mom did say patient had 2 vaccines, did not speak (language) and had used interpreter on phone. after patient had left it was noted that she had only had 1 monovalent injection recorded. No adverse reaction noted.
Information has been received from a nurse practitioner concerning a 17 year old female who was vaccinated into the left arm with a 0.5 ml third dose of Gardasil.  On 06-Dec-2007, the patient experienced a tingling feeling on her tongue.  The patient also experienced numbness on the top of her right hand, right foot and right leg.  The patient was given diphenhydramine hydrochloride (Benadryl) and the experiences went away.  Unspecified medical attention was sought.  On 07-Dec-2007, the patient recovered. 02/10/2010 There were not illnesses at the tiem of the vaccination. On 06-DEC-2007, the patient experienced a tingling feeling on her tongue. The patient also experienced numbness on the top of her right hand , right foot and right leg, which resolved spontaneously. Tbe patietn developed a swollen tongue on the evening of the vaccination. It was reported that 72 hours later the swelling was not evident upon inspection. The patient was given Benadryl and the experiences went away. Unspecified medical attention was sought. No laboratory diagnostics were performed. On 07-DEC-2007, the patient recovered.  Additional information has been requested.
High blood pressure with High heart rate and headaches daily; High blood pressure with High heart rate and headaches daily; High blood pressure with High heart rate and headaches daily; This is a spontaneous report received from a contactable other healthcare professional. A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 23Feb2021 (at the age of 48-years) as single dose for COVID-19 immunisation. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9581) on 02Feb2021 at 07:00 hours as a single dose for COVID-19 immunisation. Medical histories included high cholesterol, hormonal hair loss and ocular migraines. The patient had allergies to phenergan, compazine, tigan, sulfa, demerol and codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), Nexium, Advil, atorvastatin (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN) and finasteride (MANUFACTURER UNKNOWN). Patient received all these medications within 2 weeks of vaccination and exact therapy dates and indications of these medications were not reported. On 24Feb2021 at 06:30 hours, the patient experienced high blood pressure with high heart rate and headaches daily. The patient was treated with blood pressure and heart rate control medication. At the time of this report, the patient was not recovered from the events high blood pressure, high heart rate and headaches.  No follow-up attempts are needed. No further information is expected.
his various vein in his leg started bleeding; bleeding from his shot site; This spontaneous case was reported by a consumer and describes the occurrence of VENOUS HAEMORRHAGE (his various vein in his leg started bleeding) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VENOUS HAEMORRHAGE (his various vein in his leg started bleeding) (seriousness criterion medically significant) and VACCINATION SITE HAEMORRHAGE (bleeding from his shot site). At the time of the report, VENOUS HAEMORRHAGE (his various vein in his leg started bleeding) and VACCINATION SITE HAEMORRHAGE (bleeding from his shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a spontaneous report from a contactable health care professional who reported on behalf of a physician. A 66 years old female patient received PREVNAR 13 on 22Apr2015 at 0.5 ml single. Medical history included hypertension, vitamin D deficiency reflex and colon problems. Concomitant medications were not provided. Reporter mentioned that on 22Apr2015 PREVNAR 13 was the only product administered to the patient. On 24Apr2015 the patient experienced local cellulitis and pain at and below the injection site. Events outcome was not provided.
Patient presented to ED with two day history of hives over body.  Received treatment for anaphylaxis in ED including Epi-Pen, Pepcid, Benadryl, and Solumedrol.  Patient initially hypotensive.
Information has been received from a pharmacist concerning a 60 year old male with chest pain, obesity, gastrooesophageal reflux disease, vitamin B12 deficiency, tremor, post-traumatic stress disorder, dumping syndrome and a history of chickenpox as a child, a history of a drug reaction to etodolac (manufacturer unknown) which caused stomach problems and a history of knee replacement, who on 13-APR-2009 was vaccinated SC in the left deltoid with a 0.65mL dose of ZOSTAVAX (Merck) (lot number 663199/1551X). Concomitant therapy included aspirin a day, alprazolam, sertraline HCl, ranitidine, primidone, propranolol HCl, cyanocobalamin, ferrous SO4, omeprazole and gabapentin. On 25-APR-2009 the patient experienced itchy lesion on legs, arms, chest and back. The patient had very small lesions in which some were dry and some had fluid in the lesions. These were "discrete individual lesions" on legs, arms, chest and back. There were half a dozen on the chest and back but most of the lesions were on the legs. An unspecified nurse practitioner who examined the patient said it looked like chickenpox. The patient was taking BENADRYL prior to the office visit. The patient was given hydroxyzine for the itching. At the time of reporting the patient had not recovered from the events. Follow up information has been received from a pharmacist. The pharmacist reported that vesicles started on legs on 25-APR-2009 and then spread to another sites. The patient experienced a vesicular rash with many lesions on lower legs scattered, as well as scattered on torso and arms. As of 01-MAY-2009, the patient still had lesions. The patient was enrolled in the Varicella Zoster Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 20-APR-2009 and 01-MAY-2009. The sample was taken from a vesicle and the site of specimen was not reported. The results were not provided. The pharmacist reported that patient had no recent exposure to chickenpox or shingles. Follow up information received revealed that the VZVIP specimen was inadequate, negative for B-globin, and no strain was identified. It was reported that the source of specimen was collected from a vesicle. The vesicles were very small and the scabs were very tight. It was unknown if any fluid was obtained in capillary tubes on 30-APR-2009. On 01-MAY-2009, the physician removed a scab and used a swab on the lesion. The VZV DNA was not amplified, neither the B-globin DNA. Additional information has been requested.
INITIAL PAIN AND SORENESS OF INJECTION MOVED TO MODERATE TO SEVERE PAIN THROUGHOUT ENTIRE UPPER ARM WHERE INJECTION WAS GIVEN. THE PAIN IS CONTINUING AND IS NOT RESOLVING EVEN AFTER TAKING IBUPROFEN FOR PAIN. IT IS VERY DIFFICULT TO LIFT MY ARM WITHOUT SEVERE PAIN.
Heavy menstrual  bleeding / period clots more than usual larger than a quarter; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1075) via an unspecified route of administration in the right arm on 04Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1050) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 13May2021 at 12:00, the patient experienced heavy menstrual bleeding / period clots more than usual larger than a quarter. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 heavy menstrual bleeding / period clots more than usual larger than a quarter was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
5 days burning pain in abdomen, fever, chills, shaking, period started early by 3 days and ended late by 2 days
Insomnia, swollen glands in both armpits, diarrhea, tired, headache, dizziness.
Patient was given the 12 and older vaccine 0.3 ML, no known symptoms or problems
This spontaneous report was received from a registered nurse and refers to a unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with a dose of improperly stored PROQUAD, lot number M034692 with expiration date 24-JAN-2018, (dose, route and anatomical location were not reported) for prophylaxis. The vaccine was exposed to temperatures between -14 (0 Celsius (C)) to -13 (0 Celsius (C)) at -12(0 Celsius (C)) during 1 hour and 15 minutes and also at -13(0 Celsius (C)) during 1 hour and 3 minutes. On unknown date, the vaccine was also exposed to -11(0 Celsius (C)) for 1 hour and 23 minutes. The storage type was reported as "data logger." No adverse effects were reported. Additional information has been requested.
Initial pain post-injection followed by vigorous, throbbing pain from lateral aspect of upper humerus to anterior mid-humerus and continuing to posterior aspect of forearm and hand. Visited family physician 1 week post-injection. Am now receiving physical therapy. Arm pain and limited movement left arm.
delay between the first and second shots; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that there was delay between the first and second shots. The patient received second dose at interval longer than the recommended interval, which led to lengthening of vaccination schedule. The patient enquired if the third shot was needed.
Started having unilateral facial paralysis on 2/15/21,  Presented in clinic on 2/17/21 with: R sided facial paralysis with smiling, frowning, raising eyebrows. No other systemic symptoms: no rash, no right sided body weakness - diagnosed with Bells Palsy and sent home with steroids and valacyclovir.
Itchy/burning sensation on tongue, associated with an altered taste with food and metallic taste in mouth. Symptoms began 12:00 pm 01/11, with metallic taste onset at 15:15 01/11.
Vaccine given at 3:35pm. Asked him how he was feeling at 3:40pm. Patient replied "not too good." Patients was visibly pale and sweaty, but did not lose consciousness. He was able to walk back into the consultation room for BP monitoring. BP was 105/45 P 54. Patient admitted to a fear of needles and a history of anxiety. Also said he had not eaten today. BP measured again at 3:45pm --106/55 P 58. Gave patient a pack of peanut butter crackers and a water and rechecked BP at 4:00pm--104/57 P 65. Patient did not know the name of his regular doctor, so we called a clinic in town that he went to in May 2020 for a baseline BP reading.  NP clinic reported that his BP at last visit was 120/72. BP at 4:10pm had dropped back to 99/46 P 62. Declined EMS service, but I did make him call a family member to come get him since he had driven himself. Advised family to keep an eye on him and to take to ER if he declines. Patient stated that he felt better, but was hungry. Released to family at 4:20pm.
Chills, fever of 102, nausea. Bones and teeth aching. Had to go back to the doctor to get medicine to relieve fever. Pain and chills, sore neck and arm for 3 weeks. August 3, 2018 still in pain.
Pt stated her arm, face and lips swelled. She went to the hospital and has since recovered.
Numbness and tingling in legs the first day; within hours of receiving a flu shot at a work location no longer leased by my employer. Numbness and tingling increased and rose up my body each subsequent day to midsection (within 24-36 hours) and then my chest. Was seen by a neurologist within a week, and then had an MRI and Lumbar Puncture the following week. Inflammation/lesion on spine detected.  Diagnosed with multiple sclerosis on Friday, 11/17/2006. Hospitalized for a week and put on high dose steriods via an IV.
Administration of adjuvant portion only; Administration of adjuvant portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: The reporter was medical assistant. The reporter stated that what were the recommendations for a patient that had been given the Shingrix vaccine without reconstitution. The reporter confirmed the administration of the adjuvant portion only. The reporter disconnected the chat before providing any additional information.  The reporter address was not available.  The reporter was unable to obtain follow up permission due to this. The reporter stated that please follow up via email, if follow up was made. Additional Supportive Information: The reporter confirmed the administration of the adjuvant portion only to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Red at injection site; injection site is raised; Sore arm; A spontaneous report was received from a consumer concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, injection site is raised, red at the injection site.  The patient's medical history included the patient is HIV positive and is ongoing. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event(s) sore arm,On 11 Feb 2021, the patient experienced the event(s) injection site is raised, red at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, injection site is raised, red at the injection site was unknown.
Dizziness, light headed within 10 minutes of administration. Treated with orange juice and sitting since pt. reported. Not eating-pt. felt better in 5 minutes.
Nurse administered Adult dose of Hep B instead of Ped dose of Hep B.