chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), INJECTION SITE SWELLING (Swollen arm at injection site), TENDERNESS (tenderness in arm), PYREXIA (low grade temperature) and HEADACHE (headache) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), INJECTION SITE SWELLING (Swollen arm at injection site), TENDERNESS (tenderness in arm), PYREXIA (low grade temperature), HEADACHE (headache) and NAUSEA (feeling of wanting to vomit). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), INJECTION SITE SWELLING (Swollen arm at injection site), TENDERNESS (tenderness in arm), PYREXIA (low grade temperature), HEADACHE (headache) and NAUSEA (feeling of wanting to vomit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low grade temperature (abnormal) low grade temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Vaccinated about 8:10 AM. Approx. 8:15, student stated that she felt dizzy. She was sitting down and began to faint. Eased child to lay down on bench. Body stiffened for about1 sec. Rested on bench with feet up for a few minutes. School doctor was paged at this time and twice more in the course of the incident. Awake, alert and oriented to PPT. Child then sat up and felt nauseated and vomited X 2. Child brought back to clinic room to rest. Father present. Child ambulatory. Rested 20 more minutes or so. She felt better and wanted to leave. Father advised to call PMD and our clinic number given if he had further questions. The father was advised to take the student to ER anyway. but he said she was at home and doing fine.
We arrived on 02/10/2021 to give second doses to residents at. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per CDC recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.
Chills, mild fever (99.5F) and very loud Tinnitus   Fever only lasted 6 hours but tinnitus continues
She got her vaccine she was pretty much in bed the next day, which she felt was the normal.   She is achy and stiff in her joints, and she never had that before.   Mainly she has issues with her lower back and knees.  Also her hips, shoulder areas and continues to present.  She has not sought medical attention.
All symptoms on the side effect list... 101.4 fever, pain, chills, headache, joint pain, muscle pain, brain buzz.
1. Fever 102.0 F 2. Heart rate increased by 30 BPM (55 to 85) 3. Blood pressure was at 90/52  4. Oxygen saturation was 79 % to 90 % 5. Difficulty breathing with minimal exertion  6. Chills, had to wear sweatshirt and jacket during 90-degree weather 7. Became dizzy and difficulty with balance 8. Dry cough 9. Nausea and loss of appetite 10. Muscle ache 11. Total joint pain 12. Headache 13. Redness and slight rash within a 2-inch area surrounding the injection site 14. Urinary incontinence
High Fever (103F), chills, muscle aches, joint pain, nausea, vomiting, headaches, extreme soreness at injection site. High fever resolved 12/11. Low-grade fever, muscle aches, joint pain, headaches and nausea continued for three days.
High fever, chills, severe muscle aches, stomach distress/ nausea for 2-3 days. Patient hasn't received a flu vaccine for over 10 years. Had received them for multiple years before then.  The reason patient stopped was because would always get the above symptoms. Because of work, patient was "highly" urged to receive a flu vaccine and again had the reactions listed above.
Redness, heat, itching. Redness etc extends from shoulder area to vaccine area on (R) upper arm to elbow, completely circles arm area, saw health clinic nurse. No tx given, no documentation taken, advises O/T BENADRYL.
Received Varivax 8-26-08 to (R) upper thigh.  Started not feeling well approximately 8-30-08.  On 9-3-08 broke out with a Varicella like rash to stomach and back.  Lasted approximately 3-4 days.  (Right) upper thigh had a quarter sized hard area to thigh with rash.
Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-irms-MOD21-112049 (Parent-Child Link).   See case US-irms-MOD21-112049 for details regarding the Parent case.
Around 10 minutes after vaccine patient reported feeling dizzy, tired and weak.  Patient was still responsive, stated she had eaten breakfast.  She then was given water.  She then became unresponsive, eyes closed, snoring with head slumped down while sitting.  After we realized patient could not be awoken, property manager called 911.  While ambulance was on thier way, patient "woke up" but was drowsy and could barely communicate.  No epinephrine or diphenhydramine was administered.  BP was 130/100.  After EMS arrived, patient's partner came in from the car and reported this has happened multiple times at doctor appointments/procedures.  Patient was unconscious for around 5minutes.  Patient reported she went to the ED but was discharged after a short visit.
Employee was seen by M.D. for nausea and diarrhea. Viremia of MMR.
This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown demographics. There was no information about patient's concurrent condition and medical history. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date, the patient experienced itchiness, at the injection site (as reported rejection site), after receiving ZOSTAVAX. Product quality complaint was not involved. The outcome of injection site itchiness was unknown. The causality between injection site itchiness and ZOSTAVAX was unknown. Additional information has been requested.
24 hour chills, fever, headache, loss of appetite, fatigue, severe lower back pain.
Information has been received from a physician concerning a 5 and 9/12 year old black, female, with no medial history and no allergies, who 05/22/2000 at 2:00PM was vaccinated with a first dose in the left upper arm of varicella virus vaccine live.  There was no concomitant medication.  It was noted that there was no illness at the time of vaccination and there were no adverse events following prior vaccinations.  It was also noted that there is a mild epidemic at the patient's school where about 40 children are affected.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Follow up information from a physician indicated that on 02/10/2005 the patient broke out with less than 50 total lesions that were spread about her body.  The patient recovered on 02/25/2005.  Additional information is not expected.
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated with a first and second (on 04-ARP-2007) doses of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-313106 (Patient Link).
p/vax pt c/o tenderness; swelling at site & warmth to touch; tx: apply ice for swelling & APAP if fever occurs
Pt siting upright on exam table. Pt alert and talking after injection about how proud she was she didnt cry. NP turned to complete immunization form and saw out of the corner of her eye, patient falling off exam table. Np cought pt around her midsections and lowered her to floor face down. Called for PCT to com help. Exam table pushed aside and log rolled pt onto her back.He eyes fluttered open and she appeared confused confused for approx 1 min. She was pale and wanted to stay lying on the floor. Cool compresses applied to her forehead and neck.B/P 100/76 HR80 R 18. Staff brought mom into the room and explained what had happened. Mom states she has passed out once before with an immunization and once with ear piercing. Assisted pt to sitting position on floor and she asked for a drink. Stated her head and nose hurt, and NP noticed small amount of blood inher mouth. Noted teeth all intact. Pt rinsed her mouth and  NP noticed tiny laceration on tip of right tongue. NO further bleeding noted. NO bruising or swelling noted along forehead or nose. Pt suddenly vomited several times. She laid back on the floor for approx 5 min.  Color began returning to her face and she was assisted to chair. She sat in chair approx 5 minutes and walked assisted to waiting area. She left clinic with her mom and sister.  Called the pts. mother at 9 pm 9/3/19. Mother states she has felt fine all day since she got home. No headache or discomfort just embarrassment.
low-grade fever; aching; terrible headache; swollen lymph nodes; injection site swelling; Couldn't get warm; Increased heart rate; Felt really dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt really dizzy), PYREXIA (low-grade fever), PAIN (aching), HEADACHE (terrible headache) and LYMPHADENOPATHY (swollen lymph nodes) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (on Nov2020. No hospitalization was required.) and Unspecified disorder of knee joint (Unknown knee condition.).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DIZZINESS (Felt really dizzy). On an unknown date, the patient experienced PYREXIA (low-grade fever), PAIN (aching), HEADACHE (terrible headache), LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE SWELLING (injection site swelling), BODY TEMPERATURE DECREASED (Couldn't get warm) and HEART RATE INCREASED (Increased heart rate). At the time of the report, DIZZINESS (Felt really dizzy), PAIN (aching), HEADACHE (terrible headache) and BODY TEMPERATURE DECREASED (Couldn't get warm) outcome was unknown, PYREXIA (low-grade fever) had not resolved and LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE SWELLING (injection site swelling) and HEART RATE INCREASED (Increased heart rate) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included acetaminophen and ibuprofen.  Past medications received include "cortisone shot". Concomitant medications were not provided.  Her second dose in the series of Moderna's COVID-19 vaccine is scheduled for 10Feb2021.
Myopericarditis and pleural effusion after Hep A. In the past year has developed CFS and is clearly impaired. Meets criteria for Chronic Fatigue Syndrome now. Also has chronic complement activation. Chest pain, sub sternal, pre syncope, tachycardia comment atrial flutter, fatigue, malaise >60 days. Continued with chronic fatigue syndrome & inability to function at a full time job.  This pt developed CFS secondary to the pericarditis that she developed post HEP A vaccine.  Per 60 day follow up: Continues with debilitating fatigue, hyperesthesias, headaches, necessitating retirement from job.
Headache, Myalgia, CoughWheeze, Diarrhea, NauseaVomiting, Tachycardia, Chills, Joint Pain, Very Sore Arm Narrative:  Per received email from initial person reporting the ADR- "The Chief Medical Officer came to assess her. It is my understanding that she was subsequently tested for COVID19 on 1/3/2021 and determine to be positive. It is unknown if there were any other appointments attended by the employee."
I had a rash on the right arm. The arm got really hot to touch and it became very red below the elbow and up to the deltoid muscle. It look like I had the mumps. It stayed like that for 15-30 minutes. I did not take any medication, because I was not sure. After the 30 minutes it went away and it did not come back.
Presented for SOB, nonproductive cough. Reports COVID + on 8/1 PTA. Hx of HTN, Afib, CAD. Admit for COVID PNA. Spportive tx only required, Vit D, zinc. DC'd to home.
The patient complained of intense arm pain after receiving her second dose of the Pfizer COVID-19 vaccine lot #ER8735 in her left deltoid on April 10th, 2021. The patient returned to the pharmacy after the clinic to inform the pharmacist of said pain. a nurse from school, and a pharmacist from the Pharmacy, assessed the patient. It was confirmed the needle was inserted two finger lengths below the shoulder, and 90 degrees into the deltoid muscle. She was advised to ice her arm and take tylenol which she stated she did on 4/11/2021.    She visited her doctor on 7/27/2021 for the continuing arm pain. The patient has an ultrasound scheduled for 8/10/2021.
pt reported symptoms of bell's palsy 2 weeks following initial pfizer vaccine. pt was diagnosed and treated by physician with 60mg prednisone per day.
Sharp pains throughout body, unable to sleep. Feels like a flu, where everything just hurts. Pain in neck and occipital region, headache, pain at injection site, sore muscles throughout. Tired, groggy.
This spontaneous report was received from a pharmacist, who reported that M-M-R II injection and sterile diluent supplied with it could be potentially confused since they are in extremely similar packaging as "the cartons differ only by one stripe" (product packaging confusion and circumstance or information capable of leading to medication error). It was also stated that at the time of reporting no patients were involved with the potential product confusion yet. Additional information has been requested.
Around 8:00 PM, began feeling itchy all over body. Hives were notably present on arms and neck. Symptoms lasted approximately 3 hours. Benadryl affective in management.
Within 24 hrs after receiving pneumonia vaccine pt experienced high fever, chills, body aches. Site of injection red "3x3", hot to warm to touch. Very sore in muscle area. followed with headache also. Temperature 103.5
Employee reports burning sensation between shoulder blades and bilateral thighs. C/O stiff neck and difficulty standing up from toilet approximately 15 minutes after administration of vaccine.
A spontaneous report has been received from consumer concerning a 7 year old, female patient. No information regarding patient relevant history, concomitant medication and concomitant diseases were provided.  Patient had been received FLUMIST (intranasal), dose unknown which started on an unknown date. It was reported that the patient had post vaccine encephalitis (Preferred Term: Encephalitis post immunisation), pandas/immune system was thrown into a tizzy (unspecified)(Preferred Term: Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection) and her body was attacking her brain(Preferred Term: Cerebral disorder). The outcome of the events of post vaccine encephalitis, pandas/immune system was thrown into a tizzy (unspecified) and body is attacking her brain were unknown. Company physician identified and captured the event of post vaccine encephalitis and assessed it to be serious due to important medical event criteria and the reporter assessed the events of pandas/immune system was thrown into a tizzy (unspecified) and body is attacking her brain to be non-serious. Sender's Comments: Encephalitis post immunisation is not listed in company core data sheet of FLUMIST. Non-serious events such as cerebral disorder and paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection could be contributory risk factors for the event. However, there is limited information on patient's relevant medical history, concurrent diseases, concomitant medications, traumatic head injury and diagnostic workup (complete blood count, cerebrospinal fluid examination, computerized tomography) which makes the causal assessment difficult.
MOTHER REPORTED CHILD HAD REACTION TO FLU VACCINE IN THE PAST. PATIENT WAS REPORTED TO BE ALLERGIC TO EGG PRODUCTS AS A CHILD AS WELL. PHARMACIST CONTINUED WITH VACCINE AND OBSERVED PATIENT POST ADMINISTRATION. WITHIN 5 MINUTES, MOTHER REPORTED PATIENT FELT THROAT SPASMS AND SKIN SPLOTCHES. PARAMEDICS WERE CALLED FOR EVALUATION. PHARMACIST OBSERVED PATIENT. PATIENT CONTINUED TALKING UNTIL PARAMEDICS ARRIVES INDICATING AIRWAY WAS STILL FUNCTIONAL. PHARMACIST HAD EPINEPHRINE INJECTION AND CPR MASK ON HAND IN THE EVENT IT WAS NEEDED. PARAMEDICS/MOTHER AGREED TO HAVE PATIENT EVALUATED IN EMERGENCY DEPARTMENT.
Hives, itching to posterior neck, bilateral axillas, waist, bilateral hips.
Patient complained of swelling, red, whelped, and tender upper right arm noticed about 20 hours after vaccine was given. Patient was seen by Nurse Practitioner and directed to apply ice and give BENADRYL.
Pt received 1st GARDASIL and at 1 min after injection, pt stiffened, fell back onto exam table and twitched. Episode lasted at 1 min. Pt was conscious but doesn't remember what happened. Vitals stable. Pt remained in exam room extra 30 min and left with baseline behavior and vitals.
shingles; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 02-MAR-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around May 2017, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles (herpes zoster). As a direct and proximate result of using Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the event herpes zoster was considered as not recovered. The reporter considered the event of herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
This spontaneous report received from a consumer, concerned a male of unspecified age. Medical history, height, weight, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose, start therapy date; not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced concerning problems. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of concerning problems: not reported.
Pt c/o Upper extremities tingling and tremors.  Pt also complains of dizziness and lightheaded.  Pt reports of history of similar symptoms prior to other vaccines.   Pt's symptoms quickly resolved after vitals were obtained.   Blood pressure 166/98, pulse 80, resp. rate 18
Within 24 hours, Pt developed redness, firmness, warmth surrounding his right deltoid injection site. At time of presentation, it measured 10 cm x 7 cm, blanches to touch. Nontender, nonpruritic.
DIARRHEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included loperamide hydrochloride. On an unspecified date, the patient experienced diarrhea.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.