chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 18-NOV-2015 the patient was vaccinated with ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a nurse concerning a 12 year old female with juvenile diabetes who on 25-MAR-1998 was vaccinated with a first dose of VARIVAX (Merck). The nurse reported the patient was vaccinated with her second dose of the vaccine on 6-APR-2009 (lot number: 663299/1774X). Subsequently, The nurse reported on 07-APR-2009, the patient experienced swollen, red, hot at the injection site that was "5x4" in size. "The patient also had ulceration as well as other small bumps". The nurse stated the bumps were not vesicles and did not look like shingles or chicken pox. The patient was treated with hot compress and antibiotic treatment. The outcome of the patient was not recovered and sought at the office medical attention. Additional information has been requested.
High Fever, muscle pain and Joint pain throughout body, super sensitivity to touch, nausea, headache, weakness.  To put this in perspective, I have had kidney stones 11 times in my life which is painful.  This was worse.  I contemplated going to the ER, but I did not have the money to spend.  So I used tylenol, cool compresses, a hot bath with essential oils, and tried to keep hydrated with water and pedialyte.  After about 24 hours I thought I was feeling a bit better.  I attempted to get showered, and run a few errands.  After about 2 hours, the headache returned and I had muscle and joint discomfort which was not as severe as the pain the day before.  I had intermittent fever like symptons as on and of nausea. Today I am starting the day with a headache, and general lethargy.  But the day is still young.
Verified the patient by full name and date of birth.  Explained the immunizations that are due to be given today.  Mother of patient was given the vaccine information sheets for each vaccine.  Administered vaccines at 1150am.  I came back to the exam room, and the mother stated that the patient leg was not looking right.  I visualized a circular red area approx. 7-8 cm.  The patient was not in distress.  She was sitting up on the table licking a lollipop.  Mom asked her 3 times what does you leg feel like.  The patient answered after the third question stating it hurts.  She said it did not itch after I asked her.  Called the providers nurse, and the provider was in the room with her nurse.  I informed her that the patient had a localized reaction to the MMRV vaccine, and if she could come to the room to examine the area.  Provider came to the room within 1 min of the call and examined the area.   Provider asked the patient if the area was itching.  The patient responded by saying no.  The provider informed the mother that the area looked like a localized reaction to the injection site.  Mom verbalized an understanding.  Provider informed the mother to continue waiting the 15 mins after vaccine administration.  Mom verbalized an understanding.   Patient ambulated to the lobby and left with her mother following the 15 min wait time.
It was reported in a published article, that a male pt's mother was vaccinated with a dose of MMR II shortly before conception. The mother had a son who was developmentally delayed and had Landau-Kleffner Syndrome. Upon internal review, Landau-Kleffner Syndrome was considered to be an important medical event (OMIC). The author noted that "vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins." "It can also be frequently associated with early onset autism." It was also reported that "in spite of its limitations, this study suggests that an autism/vaccine connection may exist." It was unknown if medical attention was sought.
The day after vaccine administration, the patient reported "silver dollar sized" swelling on her arm that feels hot to the touch with some pain
COLD-LIKE SYMPTOMS; HEADACHE; LOSS OF APPETITE; BODY JOINTS PAIN; FEVER; This spontaneous report received from a patient concerned a 50 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-JUL-2021, the subject experienced loss of appetite. On 30-JUL-2021, the subject experienced body joints pain. On 30-JUL-2021, the subject experienced fever. On an unspecified date, the subject experienced cold-like symptoms, and headache. Treatment medications (dates unspecified) included: caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, cold-like symptoms, body joints pain, fever and headache was not reported. This report was non-serious.
Fever, chills, sneezing, chills, cough, abdominal pain, congestion
Information has been received from a medical assistant concerning a female patient who in approximately October 2010 was vaccinated with the first dose of GARDASIL (lot #, expire date and route not reported) 0.5 ml. In approximately October 2010, 72 hours after receiving GARDASIL, the patient experienced nausea, headache, abdominal pain and hair loss lasting for an unspecified period of time. On an unspecified date "blood work" was performed but results were not provided. The patient sought medical attention first at the clinic where she received the vaccine and then went to a hospital and received outpatient treatment. At the time of the report, patient had recovered. Additional information is not expected.
it made her "sick"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "it made her "sick"".  Additional information: After taking a Pfizer COVID vaccine, she had "reactions" and that it made her "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At 7:30 pm, I passed out and was very nauseous.  I was given ZOFRAN through an IV. At about 8:00pm I broke out in hives mostly on my body,  I was given benedryl,  methylPREDNISolone and PEPCID.  This calmed down the hives. I became light headed again (time unknown) and puked. I was discharged around 11:00pm.
Patient reported shortness of breath, throat swelling, shaky, tingling in arms and legs approximately 8-10 minutes after administration.  I immediately gave patient 2-25mg diphenhydramine caps.  Patient felt better but still difficulty breathing, I called 911 approximately 10 minutes following injection. EMS arrived on scene in approximately 4-5 minutes. Checked vitals, BP and heart rate were elevated. EMS transported patient to Hospital.
Patient was given Janssen vaccine on 05/11/21 at 3:02pm. Patient was asked to be seated for 30 minutes after receiving the vaccine, because he had food allergies.  Immediately after administration, patient started complaining he felt dizzy. Pharmacist checked patient's vitals. Pulse was at 46. He was sweating profusely, drowsy, dizzy, not coherent, tingling in right hand, trouble seeing, blacking out. Paramedics were called to the scene by pharmacy technician. Upon arrival, they also checked his blood pressure, pulse, and blood glucose. Patient refused to go to hospital and signed a form provided by EMS. Before leaving, patient was alert and able to walk and carry a conversation on his own.
Tightness of chest and short of breath.  Lasted 3 days and then got better as time went on
Information has been received from a certified medical assistant concerning a 4 year old female with an allergy to rubbing alcohol and no other relevant medical history who on 5/20/00 was vaccinated with a dose of varicella virus vaccine live (lot # 632057/1450J). There was no concomitant medication. On 3/26/04, the patient developed a rash of chicken pox on the face and neck and more on her skin. It was noted that the office did not specify where else on skin. The physician gave the patient cetirizine hydrochloride for the chicken pox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.
On January 15, I developed urticaria to my face and neck, with a faint papular rash on my forearms also. On Jan 16, I developed facial edema with continued rash which worsened throughout the day despite Benadryl. On Jan 17, the rash was improving, but the facial and neck edema had worsened to the extent that my eyes were nearly fully closed. I presented to the ED and received treatment for allergic reaction, including Epinephrine, steroids, and histamine blockers. I have no known allergies.
Numbness in the arm and hand (left arm and hand); This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW196) via an unspecified route of administration in the left arm on 22Jun2021 at 11:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 26May2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021 at 17:00, next day of vaccination, the patient experienced numbness in the arm and hand where the vaccine was received (left arm and hand). The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event numbness in the arm and hand (left arm and hand) was recovering at the time of this report.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. An 20 year-old male subject with no significant past medical history was found to have congestive heart failure, unspecified 20 days after the subject had received the following vaccines on 05 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported), Typhoid oral vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Results of Troponin I, ECG and echocardiogram were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
broke out; rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out) and RASH (rash) in a 20-year-old patient of an unknown gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (broke out) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (broke out) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No details provided regarding Concomitant Medications.
Information has been received from a healthcare worker referring to an unspecified number of children of unknown age and gender. On unknown dates, the children were vaccinated with improperly stored doses of oral ROTATEQ (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Patient called Clinic stating that she received her second dose of the Moderna Vaccine yesterday at pharmacy and has been experiencing uncontrollable itching all over her body and in her mouth.
High blood pressure first noticed at dermatological physician visit Aug 23, 2021.  Subsequent physical Nov 11, 2021 and follow up visit Nov 19, 2021.
Pt admitted 01/10/2003 with respiratory distress, eventually diagnosed with primary pulmonary hypertension.
Patient complained of extreme fatigue for more than 2 days which got better as time went by, states that took 2-3 weeks to subside, still complains of SOB (especiually when wearing mask) had diarrhea that began 2 days after vaccination that resolved the same day, severe headache and a low temp of 99 degrees Fahrenheit that existed for a few days. Covid arm (rash,swelling) appeared on 2/28 and patient had a visable rash on arm when presenting for second dose on 3/18/2021. On advise of oncologist that stated that it should be ok to administer the 2nd dose, I administered it while observing patient for 30 minutes in which she was fine. Did advise patient that she may have a delayed or extended reaction to the second dose and  discussed what to do in the event that a reaction did occur and patient was in agreeance.
Employee reports onset of redness and swelling to injection site to right deltoid a few hours after injection.
Developed shingles on right side of forehead, eye that resulted in a scar on my cornea and blurry vision.
Initial pain and soreness at and around injection site. Small bruise at injection site. Soreness lasted about a week, then I did notice a lingering discolored area around injection site with slight swelling and warmth.  Area still slightly warmer and discolored.
pains in neck; Pain in arm; spots on chin/side of face; Pains from neck to her head; pains in head; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pains in neck), PAIN IN EXTREMITY (Pain in arm), RASH MACULAR (spots on chin/side of face), PAIN (Pains from neck to her head) and HEADACHE (pains in head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy (Full thyroidectomy). Concurrent medical conditions included Hypertension, High cholesterol, Penicillin allergy and Nickel sensitivity. Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, CLONIDINE and AMLODIPINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced NECK PAIN (pains in neck), PAIN IN EXTREMITY (Pain in arm), RASH MACULAR (spots on chin/side of face), PAIN (Pains from neck to her head) and HEADACHE (pains in head). On 09-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, NECK PAIN (pains in neck), RASH MACULAR (spots on chin/side of face), PAIN (Pains from neck to her head) and HEADACHE (pains in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient went to the emergency room where all tests were negative.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up document was received. It contains no new information.
I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger or heavier) and my mouth was dry. I thought maybe I was just thirsty. Shortly after that, I felt a pressure toward the bottom of my neck, like someone was pushing their thumb on my lower neck. Then, I felt pressure going down my chest. I told the monitor, and she brought the nurses over. The nurses took me to a different location for monitoring. I took some benadryl at about 12:45 pm. At 12:55pm, my throat began to close up, and when I breathed in, it was like a tiny straw was in my throat. The nurses gave me an epinephrine shot and called the ambulance. This event happened on 3/20/2021. On 3/21, I was physically and emotionally drained. I still had a slight pressure going down my chest. On 3/22, I went to work and developed a headache and was nauseous and my stomach was cramping by 10am. I went to the allergist at 3pm. She told me to take non-PEG liquid benadryl and Pepcid AC. On 3/24/2021, I still feel like I have some tightness in my chest (very minimal but still present) and a headache and am continuing to take liquid Benadryl.
The day after receiving my vaccine, I had a lot of loud noise in my head. It sounded like bees buzzing loudly with chirping, banging, clanging. It lasted around three weeks to that degree and was so bad that I couldn't sleep at night. Around a month ago, in September, it started to calm down a little bit. I have a benign brain tumor behind my ear, and I have experienced tinnitus in the past but never to that degree.
MED STAFF INJECTED  PATIENT,  TISSUE FELT TIGHT,  MED/SYRINGE GENTLY PRESSED INTO SKIN AND NEEDLE RETRACTED, POSS.  LOSS OF VACCINE  (UNKNOWN AMOUNT)  NOTED.  PT. LEFT ALERT/ORIENTED
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve prolapse repair" (unspecified if ongoing); "LAD bypass" (unspecified if ongoing); "right coronary stent" (unspecified if ongoing); "dual chamber pacemaker" (unspecified if ongoing); "cardiomyopathy" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: SOTALOL; ELIQUIS; COZAAR; COREG; ASPIRIN [ACETYLSALICYLIC ACID]; LIPITOR, stop date: 21Nov2022 (other medication in 2weeks). Past drug history included: Ranexa, reaction(s): "Known allergies: Ranexa"; Lisinopril, reaction(s): "Known allergies: Lisinopril". Vaccination history included: Tb shot, reaction(s): "Known allergies: TB shot". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 21Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sweating a lot all over; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating a lot all over) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating a lot all over) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweating a lot all over) and CHILLS (Chills) outcome was unknown.        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.   Treatment medicines were not reported.
Rash on bilateral arms and chest, leg (body).  Benadryl 50mg every 4 hours for 24 hours taken with no more than 6
IMMEDIATELY AFTER RECEIVING THE VACCINE PATIENT REPORTED FEELING TINGLING IN THE ARM THAT RECEIVED THE INJECTION.  PATIENT SAID IT FELT LIKE THEIR ARM FELL ASLEEP.  THERE WAS NO REDNESS AT THE INJECTION SITE.  NO INDICATION OF HIVES, SWOLLEN LIPS OR TONGUE, OR DIFFICULTY BREATHING.
I woke up laying on the side that the vaccine was administered. My arm has been hurting since then, similar to a serious muscle pull, and it has not subsided since last week. I have used ice and heat and ibuprofen, which helps. Much more painful than what I reported at the beginning in days following vaccine. My next vaccine is tomorrow and I?m worried if I will be the same if my other arm is vaccinated or if I should stick with the same arm so that I can sleep on the other side.
Muscle Pain, Fatigue, Headache, Chills. This is my second dose . Had similar reaction for two days last time.
Patient started breaking out with rash on ankle about 7 days after receiving 1st dose; Rash has been spreading all over the body since then and itching.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient started breaking out with rash on ankle about 7 days after receiving 1st dose) and RASH PRURITIC (Rash has been spreading all over the body since then and itching.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Mar-2021, the patient experienced RASH (Patient started breaking out with rash on ankle about 7 days after receiving 1st dose) and RASH PRURITIC (Rash has been spreading all over the body since then and itching.). The patient was treated with TRIAMCINOLONE ongoing since an unknown date at an unspecified dose and frequency and HYDROXYZINE PAMOATE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Patient started breaking out with rash on ankle about 7 days after receiving 1st dose) and RASH PRURITIC (Rash has been spreading all over the body since then and itching.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Blood pressure medication and Cholesterol Medication.  Treatment medication include Triamcinolone Cream, Hydroxyzine Pamoate He started breaking out with rash on ankle around 12Mar2021. It has been spreading all over the body since then and itching. As of now, it was still there. Some of them went away and some came back.  Action taken with mRNA-1273 in response to the event was unknown