chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large rash at the site of injection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE RASH (Large rash at the site of injection) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Large rash at the site of injection). At the time of the report, VACCINATION SITE RASH (Large rash at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 19-OCT-2015, the patient was vaccinated with a dose of VAIRVAX (Merck) (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Pt. states she received a flu vaccine on 11/1/11 in the AM. Shortly thereof.
Pt. reported feeling dizzy 5 min. after getting vaccinated.  BP done 94/40.  Pt. stated, "I suffer from anxiety and depression."  "This afternoon I have an appointment with my psychiatrist."  An IV was placed and NS was started.  At 11:32am BP 126/80, HR 97, O2Sat 100%, R 19.  Pt. also stated, "I have a history of alcoholism and last night I had a drink."  "I think I'm dehydrated."  At 11:37am BP was 113/78.  Pt. agreed to be transported to the hospital.  At 11:41am pt. was transported to the hospital.
pt recvd vax 6OCT94 & 4 hrs later pt devel redness, swelling & pain @ inj site & fever & exp a general feeling of malaise, muscle aches, chills;pt recovered by 8OCT94;MD felt was a problem w/vial involved
At 2:00 pm pain on top of hand radiating through fingers. Patient's joints hurt. Lasted 5 minutes and went away. Pain scale 3 out of 10. At 2:30 pm face and tongue started to feel sort of numb and swollen, but no swelling existed. The sensation intensified over the next hour (around 3:30 pm), at the most it felt like "shots of novocaine given" and that the feeling was starting to wear off in cheek, tongue and lip areas. Patient states if took about a total of 8 hours for sensations to wear off. Patient also reports feeling tired.
Fatigue and high fever onset ~9 hours post-injection. Fever of ~101-102 F + chills, aches, etc. lasted 9-10 hours. ~20 Hours post injection, fever dropped to ~100 F; severe headache onset treated/relieved with 400mg ibuprofen; still fatigued and experiences aches and chills; fever broke around ~30  hours post-injection.
Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not informed. On unknown dates, the patients were administered improperly stored doses of GARDASIL 9, lots # M024261 and M018810 with expiration dates 30-JUL-2018 and 28-MAY-2018 respectively, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. Exposure temperature, time frame and prior excursions were not reported. A data logger was not used to track the temperature. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-09507513-1612USA005776.
Racing heart rate that night (Fitbit registered 110 heart rate as I was laying down) and I could hear the blood rushing through my left ear and had ringing in both ears. I took tylenol to hopefully lessen the immune response but still have tinnitus in both ears five months later. It is worse on left side,
sudden tight feeling in throat followed by feeling like I couldn't breathe, then a red face. This happened for like 5-10 minutes, almost went to hospital. Also was shaking, coughing, felt nauseous, had diarrhea, bad body aches, a headache, and felt weak. All of this lasted for about 2 hours.
Initial misuse report received from a health care professional on 23 September 2013. This case was received on 21 March 2014 at GPV. FLUZONE HD was administered to a patient less than 65 years of age. No adverse event was reported. List of documents held by sender: none
Pt received dose one of Varivax (Varicella) vaccine. 2 1/2 weeks after dose started breaking out with pox across face, head, back, abdomen and arms, continued to increased number another 5 days. Some have crusted over. (No history of disease as child, no titers prior to vaccination).
My tinnitus worsened significantly. Before, I could only hear it in a completely quiet area. Now, I can hear it over most noise except for very loud sounds.
I went to visit my family overseas, and they were coughing, and they had irritation. My husband was really sick with fever and dry cough. He was positive so I tested as well, and mine was positive too for COVID-19. This was on October 29. I got in touch with the doctor, and he put me on azithromycin for 5 days and crotin. I was sick but not as bad as most people. I have recovered but I still have really bad joint pain and lots of fatigue.
Patient fainted after receiving vaccine, her face went white, she came to about a minute later and was okay and requested a coke. She sat for about 30 minutes and her husband came to pick her up. She said it happened before normally due to her fear of needles.
Hours after receiving my booster, I started developing fever blisters in the roof of my mouth. I have purplish-blue blotches on my neck and severe chest pains in my bottom heart. Both of my legs turned a purplish-blue color in my thigh area and were extremely painful and felt they would explode with too sudden movement. I had ruptured blood vessels all over my body and pain/pressure in my eyes cause an itchy sensation. I had some shortness of breath and muscle/joint pain as well. I thought it was a flare up but the longer it took to pass, I knew it wasn't a normal flare up but more of a reaction to my booster from that morning. I woke up the next morning with rectal bleeding, and all of the veins in my legs were pumped up and could be seen through my skin. I contacted my doctor and cardiologist to touch base and inform them on my symptoms and reaction; the doctors presumed it was vasculitis and tried to prescribe me steroids. My husband didn't want me to take anything additional to my normal medication routine so we waited to see if the symptoms will subside on their own with time. As of now, my veins are settling, the rectal bleeding ended, and the abnormal flare-up is settling on its own.
Information has been received from a physician concerning an approximately 5 month old male with a history of "reflux" who in approximately October 2007, was vaccinated orally with a second dose of Rotateq. Two weeks post vaccination, on 08 NOV 2007, the patient was seen "in the office" at which time the patient was "congested with on an off vomiting". The patient presented with "a good bowel movement" and was given amoxicillin and sent home. Approximately 16 hours later the patient was taken to the emergency room (ER). "The child passed away on 10 NOV 2007". The patient's status was not recovered. The reported cause of death was "necrotic bowel". The adverse events reported were considered to be, Disabling, immediately life threatening by the reporter. Additional information has been requested.  1/25/08 Received vax record which reveal patient also received Pediarix #2 AC21B133AA, Hib #2 Merck lot # 0436U, Prevnar #2 B54007H & Rotateq #2 0670U..  1/29/08 Reviewed ER medical records of 11/9/07 which reveal patient arrived in cardiopulmonary arrest having been brought to hospital by parent.  Had voided & had bloody stool, possibly vomited & had been lethargic prior to coding.  Was in severe acidosis, shock, dehydration, hypercarbia, arrhythmia, infection.  Resuscitated & transferred to higher level of care ER. FINAL Initial ER DX: abdominal castrophe; respiratory/cardiac arrest; and septic shock. 2/1/08 Reviewed hospital med records which reveal patient transferred from outlying hospital in critical shock condition.  Admitted 11/9-11/10/2007 to ICU.  Had 36 hour hx of poor feeding, increased crying & developed bilious emesis & bloody stools. Intubated & emergent laparotomy & ileocecectomy was performed in ICU.  Finding at surgery: IS extending to hepatic flexure w/small area of necrosis in cecum & entire small bowel w/diffusely involved ischemia thought likely secondary to shock & cardiac arrest.  Bowel remained dusky at end of procedure & abdomen left open w/bowel wrapped in order to visulize recovery. developed compartment syndrome of bilateral legs.  Deteriorated, developed hepatic failure, DIC, fixed & dilated pupils, seizures & absent reflexes.  Defibrillated numerous times & expired 11/10/07.  Preliminary autopsy report included w/medical records reveals COD as Intussusception leading to ischemic bowel resulting in sepsis complicated by prolonged cardiac arrest & multiorgan failure.  Findings included: ischemic bowel; diffuse alveolar damage,mild; sepsis; hepatic failure; DIC; renal petechiae; gastric mucosal petechiae; bilateral lower extremity ischemic damage; hyperemic lower extremities.
Skin rash. 2 days post vaccination noted pruritic rash on both hands. Resolved over 6 hours. No therapy.
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOZAPINE, ZOLPIDEM TARTRATE (AMBIEN), LEVOTHYROXINE, APIXABAN (ELIQUIS), PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), LORATADINE (CLARITINE), VITAMIN B12 NOS, VITAMIN D NOS, MELATONIN and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.    This case was linked to MOD-2021-211411 (Patient Link).
Tinnitus appeared 7/11/2021 and is still present ithough not all the time, n both ears, rumbling in 1 and tone in other ear, disturbing sleep and affecting quality of life
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 10/28/2008 with Pneumonia. Vaccination took place on 9/22/2008. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  6/19/09 Received SAE hospitalization of 10/28-11/1/2008. FINAL DX: pneumonia Records reveal patient experienced increased work of breathing, fever, chills.  Tx w/IV antibiotics & steroids.  Improved & d/c to home on continued oral antibiotics & steroids. ICD9 codes: 486.00.
Narrative: BASED ON CHART REVIEW, UNKNOWN CAUSE OF DEATH. PATIENT WITH MULTIPLE CO-MORBID CONDITIONS. No documentation found in chart review indicating that death was related to COVID-19 vaccine administration.
The Pfizer covid Monovalent was given in error instead of the pfizer covid bivalent for a booster. No reaction
like the flu; breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days; breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days; chills / could not get warmed up and then would go away; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (like the flu), DYSPNOEA (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days), CONDITION AGGRAVATED (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days) and CHILLS (chills / could not get warmed up and then would go away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 821A21A and 120A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia in 2006. Concurrent medical conditions included Blind. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Difficulty breathing.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (like the flu), DYSPNOEA (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days), CONDITION AGGRAVATED (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days) and CHILLS (chills / could not get warmed up and then would go away). At the time of the report, INFLUENZA (like the flu) and CHILLS (chills / could not get warmed up and then would go away) outcome was unknown and DYSPNOEA (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days) and CONDITION AGGRAVATED (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days) was resolving.            Patient does breathing exercises to try to breathe better.  The patient stated that she was regularly on inhaler (SYMBICORT) which helped her the first time , but did not help the second time.
Mom noticed large red area on R upper arm the day post immunizations given when she started to bathe him that night. Says it swelled a lot but child did not say it hurt. Mom called today abt area and HV made to see reaction. 5" x 5" red area with large swelling on R upper outer arm and rounding arm. Warm to touch. Inst. to use warm compresses and continue Tylenol. See PMD if worsens. Child alert and cooperative. Playing today at babysitter's.
This is a spontaneous case, initially received from other health professional on 08-Oct-2018, concerning a 33-year-old, adult, female patient. The patient had no medical history. The patient did not receive any concomitant medications. On 05-Oct-2018 (Friday), the doses were withdrawn from FLUCELVAX Multi-dose vial (MDV). On 08-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230 and expiry date: 31-May-2018), which was pre-drawn three days in advance (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804360 was cross-linked to case 201804361 due to the same reporter.
Patient called in to report dizziness, aversion to bright light, felt "stoned", slept for 4 hours, chills, fever, vomiting, also reported having bad case of COVID in early November, where she was in bed for 12 straight days.
No adverse effect; Expired dose of VAQTA; This spontaneous report as received from an office manager (also a vaccine coordinator) refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 23-MAY-2019 the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated(VAQTA) injection (dose and frequency: not reported) (lot # N032753, expiry date: 23-MAR-2019) intramuscularly for prophylaxis (expired product administered). No adverse effects were reported. No product quality complaint was involved.
Tingling Skin: Within 1 hour, persisted for several hours, then subsided into clammy skin Headache: Within 1 hour, persisting to now Body soreness: Within 6 hours, persisting to now Dizziness: Within 6 hours, persisting to now Clammy Skin: 6 hours after, persisting to now Chest Pain: Morning After Difficulty breathing: Morning After Fainting: Morning After
Narrative:  Patient went to local emergency room with a rash around injection site and swollen arm 4 days after the J&J one time vaccine. She had been taking Tylenol and was given ice packs.
12 year old female patient receives her second dose of Pfizer from the 5-11 year old presentation. According to the guidelines, the patient should receive the purple presentation for her second dose, since it was 12 years old. The immunizer says that she was confused about the indication of the age of the orange cap vaccine.
Dizziness,chills,nausea,feeling faint-all resolved over course of 6-7 hours
Gave shot before the bivalent vaccine was approved. Ran at end of day after bivalent approved. No side effects.
On the evening of 1/26/02, the pt developed a maroon rash on her legs, pain in her ankle and opposite knee. She saw MD and was dx'd with allergic purpura. On 2/5/02, the rash is resolving and will continue medical evaluation for a week.
Passed out; Seizure; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and SEIZURE (Seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and SEIZURE (Seizure) (seriousness criterion medically significant). On 22-May-2021, LOSS OF CONSCIOUSNESS (Passed out) and SEIZURE (Seizure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Frequent urination; Got sick; Night sweats; Blood in urine; Pain in the arm; Foul smell of urine; Frequent urination, little bit pain; Light fever; Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), BLOOD URINE PRESENT (Blood in urine) and PAIN IN EXTREMITY (Pain in the arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018b21a and 005c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 positive) in February 2021, Chills from 30-Nov-2020 to 15-Dec-2020, UTI from 30-Nov-2020 to 15-Dec-2020, Fever from 30-Nov-2020 to 15-Dec-2020 and Myalgia from 30-Nov-2020 to 15-Dec-2020. Concurrent medical conditions included Kidney stones (Patient was being treated for Kidney stones lithotropsy in November and again at the end of December) since 01-Jan-2014.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), BLOOD URINE PRESENT (Blood in urine), PAIN IN EXTREMITY (Pain in the arm), URINE ODOUR ABNORMAL (Foul smell of urine), DYSURIA (Frequent urination, little bit pain), PYREXIA (Light fever), MYALGIA (Aches) and CHILLS (Chills). On 04-Apr-2021, URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Pain in the arm), URINE ODOUR ABNORMAL (Foul smell of urine), DYSURIA (Frequent urination, little bit pain) and PYREXIA (Light fever) had resolved. On 05-Apr-2021, BLOOD URINE PRESENT (Blood in urine), MYALGIA (Aches) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) antibody test by blood bank. On 02-Apr-2021, Blood urine: present (Positive) Blood in urine. On 02-Apr-2021, Urine output: increase (High) Frequent urination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-MAY-2021 contains reporter details, patient demographics, patient medical history, lab data, dose details, vaccine facility and event stop date were updated.
Severe arm pain that is preventing sleep. Ongoing since onset -  currently 2/3/21 through 3/31/21
has not had an adverse effect, but he was given the first dose under the age of 18.  He was rejected on getting his second dose and we are up against the wall on timeline allowance to get a second vaccine.  He is autistic. He has been acting out lately emotionally which was NOT happening in advance of the vaccine.
High blood pressure started in May time frame.  I am now taking medication for high blood pressure.  No symptoms, documented during doctor visits
Patient's husband called and said she was feeling dizziness so she went to sleep.  On 11/11/2015 patient's husband reported that she was feeling better but had fever.  He was convinced that she had the flu and he was advised that the patient needs to see a doctor for an actual flu diagnosis.
Within a few minutes into the vaccination she broke out in hives. generalized. No respiratory distress. Pulse ox at 98%. Though we drew up epinephrine given no respiratory distress or any other systemic symptoms and also slowly the hives started to fade away, we did not have to administer epinephrine. However given she will need another preschool booster need to determine if it is safe to do any more boosters. Did receive Heamophilus influenza dose (#4) same day but would think the allergic reaction likely was from  Daptacel.
RECEIVED AN EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced received an expired vaccine. On 27-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the received an expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931810, 20210931844, 20210932593, 20210932036, 20210932567, 20210931951, 20210931982, 20210933076 and 20210933129.