chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt Received first COVID Pfizer vaccine (LOT#:FK5618) at 1437 on 12/06/21. Patient alerted  EMT. Patient stated that she felt something in her throat at 1451. EMT took patient vital signs at 1435. BP: 105/68, pulse: 79, O2: 99%. 1st RN and 2nd RN arrived on scene at 1452. 1st RN called EMS at 1452. RN's made decision to give patient IM Benadryl 0.7 mL based on patients weight. 2nd RN gave IM Benadryl to patient at 1458 on patients right arm. Patient stated that her throat feels the same and patient feels cold to touch as stated by the EMT at 1459. EMS arrived on scene at 1500. BP: 122/81. Patients Father signed AMA form from EMS. EMS left vaccination site at 1506. Patient stated that she still felt something in her throat at 1506. Patient was able to stand on her own at 1506. The EMT retook patients vital signs. BP: 110/76, HR: 102, O2: 99%. Patient stated she was shaking from being cold. Father put his jacket on patient. The EMT provided a warm pack to patient. Patient stated that she was feeling better. Patient drank water without any difficulty at 1516. Patient stated that she needed to use the restroom. 1st RN accompanied patient to the restroom. Patient walked to the restroom without help and with a steady gait at 1528. Patient completed observation time. Patient stated that she still felt something in her throat but was feeling a lot better. 1st RN advised that patient stay 30 more minutes for observation. Father stated that they could not stay any longer. 1st RN stated that patient was leaving AMA. 1st RN educated patient and her father on worsening signs and symptoms of COVID-19 vaccine and when to seek EMS, ED, or urgent care. Patient and father both verbalized understanding. Patient and father left vaccination site at 1533. Patient left vaccination site unassisted and with a steady gait with her father.
No signs, symptoms of local reaction at site. At 6pm of day of injection client was on a treadmill and began to have palpitations. On 11/05 at 12PM client began to have palpitations again, dizzy, heaviness in chest, client advised to see MD with these symptoms ASAP.
At site of RSV injection it was swollen and bright red and hot to touch for two days. I've had a bad headache and congestion all week and it now feels like it is moving into my lungs.   If I'm not better by Monday I will be calling the doctor.
Two hours after receiving the vaccine on 3/4/21, he started feeling very tired and had a 100.2 temp. By evening he was feeling very cold and  not eating much. On 3/5/21 he was sleeping alot, had headache, chills and fever, no appetite, diaphoretic.  At 8pm he could not get up out of his chair and was disoriented.  Wife call an ambulance.  He was admitted for altered mental status.  Blood cultures showed streptococcus pneumoniae. He was hypoxic at 89%.  BP 171/96, pulse 85, temp 37.3C.  Chest xray showed bilteral infiltrates and a masslike density in the right lung apex. Encephalopathy, pneumonia and sepsis diagnosed. Ct of head normal.WBC count 19 and amonia 24. Wife told me he had a spinal tap on 3/9/21 and that it showed bacterial meningitis. I do not have the lab reports on that yet.  THe infection control doctor told wife he is critical.
I started with chills/fever the night of my 2nd shot. All night, I had body aches, joint pain, migraine, unable to sleep and SEVERE stiff neck pain. The most concerning side affect for me was I felt as though my central nervous system was affected. I had difficulty speaking, formulating sentences and experienced general confusion. I couldn't communicate with my husband to tell him how sick I felt or what I even needed.  The fever went away after 24 hours, the joint pain stuck around for 3-4 days, as did the migraine and exhaustion.  My menstrua cycle has also been affected. It's heavier, lasting longer and affected my usual cycle time.
Facial numbness that started at the hard palate then across cheekbones then upper lip. Numbness persisting but is better when taking vitamins. Seems worse in afternoon
2 days later began experiencing stroke like symptoms of  acute onset numbness to the right hand and right foot and dizziness upon standing. He was later evaluated in the ER and had Imaging which later confirmed likely TIA.
Redness more than 1-2 inches around the injection site on the arm; This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer sales representative. This physician reported similar events for four patients. This is the second of four reports.  A 16-year-old patient of an unspecified gender received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date on the patient's arm at a single dose for routine vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness more than 1-2 inches around the injection site on the arm. The outcome of the event was recovered on an unspecified date (subsided after a few days).  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019291868 same reporter/drug/event, different patient
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, these multiple unspecified patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L019297 and expiry date 18-AUG-2017) (strength, dosing details, anatomical location were unknown). The vaccine was exposed to the temperature of 48 degree Fahrenheit for 14 hours. No previous temperature excursion was reported. No adverse effects were reported. The temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Systemic: Anaphylaxis-Severe, Systemic: Exhaustion, Systemic: Nausea
This case was reported by a healthcare professional and described the occurrence of arm swelling (injection site) in a child subject of unspecified gender who was vaccinated with combined KINRIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included live attenuated MMR II (strain not specified); manufacturer unspecified given on the same unspecified date as KINRIX; VARIVAX virus vaccine; manufacturer unspecified given on the same unspecified date as KINRIX.  On an unspecified date the subject received 1st dose of KINRIX (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling (injection site).  A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children or their parents reported significant swelling in the arm where they were injected.  All of the children were within the four to six years age range.  She stated that she gave KINRIX on one arm and a MMR vaccine and Varicella vaccine on the other arm.  Please see A0780868A, A0780875A, A0780876A, A0780877A, A0780878A and A0780879A for the six additional cases reported by the nurse.  At the time of reporting the event was resolved.  The healthcare professional considered the event was probably related to vaccination with KINRIX.
I had a seasonal flu vaccine on 10/19/18. On 10/22/18 my feet started tingling and burning. As the week progressed, the burning and tingling traveled to my whole body. It didn't tend to happen when I rested during the day, but it seemed to flare up at night when I laid down and after a day in which I did some walking or mild exercise. It is now two weeks later and my symptoms are not as bad but they are still present: slight tingling or pricking sensations during the day and tingling all over my body at night. Ibuprofen or lorazepam seem to help for night-time sensations to allow me to sleep.
Information has been received from a health professional concerning a 6-year-old female who on 16-JUL-2007 was vaccinated subcutaneously in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 654282/0776U). On 17-JUL-2007, the patient developed a warm, red welt 1 1/2 inches in diameter, and soreness at the injection site. No medical attention was sought. No outcome was reported. This is one of several reports from the same reporter. Additional information has been requested.
Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 78 years old male patient who was vaccinated with a 0.5 ml second dose of FLUZONE HIGH DOSE (lot UI994AA; expiry date: 09-Apr-2019) via intramuscular route in the left deltoid on 15-Nov-2018. It was also reported that the patient was vaccinated with a first dose of the same suspect (lot number and expiry date was not reported) on 18-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was administered. It was a case of actual medication error due to extra dose administered (Consumer received two FLUZONE HD in one season, inadvertently). No reaction reported, not treatment needed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
About an hour after the injection, my tongue began to tingle and started to swell a little. I also experienced loss of feeling in my face/head (but not complete numbness). I did not have shortness of breath/difficulty breathing. I did not notice any sensation of throat swelling (apart from slight tongue swelling). These sensations lasted for about 2.5 to 3 hours, then feeling in my face/head began to slowly return to normal, as did my tongue. In addition to this, I also experienced normal side effects described with the Moderna vaccine (fatigue, headache, slight soreness in arm, brief nausea). The non-severe allergic reaction lasted about 3 hours; the normal side effects lasted three days with decreasing intensity.  I followed up with my doctor via virtual visit a few days later to discuss.
Pt hospitalized today 04/08/2021 with chest pain and was found to have a pulmonary embolism.
Initial misuse report received from a healthcare professional on 14 January 2014. This is invalid case as the individual patient identifiers missing. On 13 January 2014 the patient received ADACEL vaccine intravenous. It's an incorrect route of vaccine administered. No adverse event was reported. List of documents held by sender: none.
This child broke out with the chicken pox 11/28/00. Varivax was given on 07/23/99.
Stiff neck with pain moving in all directions, and headache up the back of my head. Started several hours after vaccination and I still have it 8 days later. I NEVER get headaches!!!!!!!!!!!
Uncontrollable screaming, grunting, groaning, firm, tense and abdomen, admitted to hospital. Numerous diagnostic studies done. Lasted 14-16 hours. DC DX: adverse reaction to DTAP.
Breakthrough Covid positive test on 7/12/2022; runny nose, scratchy throat, dry, "hack" cough, upper chest tightness, fever, chills, fatigue.  Started Paxlovid on 7/13 for 5 days.  Tested negative on 7/19/2022 and 7/22/2022.  Symptoms persisting to date (7/26/2022) of upper chest tightness, cough (both wet and dry), nasal congestion, fatigue.
Patient awakened from sleep at night with difficulty catching his breath. He turned pale. Duration about 10 seconds. After event had labored breathing. Taken to hospital by ambulance for abnormal respirations. Medical records states lifethreatening event,. msv
Weakness, chills, nausea, diarrhea, abdominal pain, vomited x 1, dizziness, joint pain.
Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot on tongue-no treatment  still visible but no pain or irritation  Other symptoms were expected and include injection site pain, heat rash likely from fever during the night but never had a recorded fever-subsided through day, fatigue, mild headache, overall just feeling like I was fighting a cold.  (Viewed as immune response to me)
Patient has Shingrix on 03/28/23. Patient notices a rash on 04/03/23 when he woke up in the lower abdomen area, the rash was gone by the evening. Patient woke up the next morning, 04/04/22 to a rash on both arms which also went away by the evening. On 04/07/23 patient woke up with a rash on his back. He did call the health dept to notify us of this rash. Patient also went to PCP to address this rash. Patient was prescribed prednisone. Called patient this morning to check on status. Patient stated he has not has a rash since 04/07/23 and never took the prednisone that was prescribed to him.
This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02552024) for COVID-19 vaccination. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]). On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Sep-2020 and the estimated date of delivery was 11-Jun-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy. On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. 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. It was reported that the estimated date of conception was 14 Sep 2020.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Headache, Myalgia, Fever, NauseaVomiting, swelling to inj site, chills, myalgia, headache, nausea Narrative:  Day 1 - discomfort and swelling to inj site, chills, myalgia, headache, nausea; Day 2 - discomfort and swelling to inj site, myalgia, headache, nausea
This spontaneous report as received from a nurse and refers to unspecified number of patients of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. The nurse reported that on an unknown date, the patients were vaccinated with PROQUAD, (lot # N008825, Exp date:12-SEP-2018) for prophylaxis which were improperly stored (incorrect product storage of PROQUAD). Other suspect therapies included VARIVAX, (Lot # N007930 Exp date: 08-MAR-2019) for prophylaxis (incorrect product storage of VARIVAX) which was also improperly stored (Captured in MAARS #1708USA010551), sterile diluent Merck injection. For both the products, temperature was between -9 (degree centigrade) °C to 8°C. Time frame was 4 hours and 43 minutes. Previous temperature excursion was between -9°C to 8°C for 57 hours and 40 minutes. Between -14°C to -10°C for 23 hours and 57 minutes. It was reported that call was not because of a data logger. No adverse effects were reported. No additional information was provided. No product quality compliant (PQC) was involved. Outcome of event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010551:u
Dizziness, Myalgia & NauseaVomiting. Narrative:  missed work following second dose due to above symptoms
Information has been received from a physician's assistant (PA), via a company representative, concerning a female patient (age not specified), who on an unknown date was vaccinated with a dose of Gardasil.  Concomitant therapy at the same visit included MENACTRA, VAQTA (MSD), and MMR (MSD).  The PA reported that after Gardasil was administered, the patient fainted.  The PA helped her to lie down for "awhile."  The patient recovered on the same day, "before leaving the office."  Additional information has been requested.
Hives on thighs near Varivax and MMR immunizations 1-2 per thigh.
Child became pale & fell backward. Had a petite mal seizure which lasted only a few seconds, eyes open, pupils dilated and fixed. Some perspiration following, child stated she felt dizzy, BP 110/60 lying, B/P 110/72 sitting. Mother to call to MD, child able to play softball that evening; no problems since.
11/07/07 Mother called stating child has large red swollen area to left deltoid at site of hep A #2 vaccination he received on 11/01/07.  She had been out of town since last friday so she did not know when reaction started.  Child was with father.  Instructed to apply warm moist packs on 20 minutes off.  She might give Benadryl for age, instructed to contact her family doctor.  11/14/07 Mother called states child saw family Dr.  Topical ointment applied and ordered Benedryl and Ibuprophen.
Severe foot pain; could not walk; pain even upon laying down.Excruciating; Could not sleep; Brain fog; Tightness in chest; Went to podiatrist , diagnosed me with acute gout; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 10Jul2021 15:30 (at the age of 43-years-old) at single dose for covid-19 immunisation. The patient medical history included tendon pain in legs, Back discs bulging and small arthritis in back, had tendonitis in foot once, all form an unspecified date. The patient concomitant medication was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced severe foot pain 6 hours after vaccine on 10Jul2021 21:30; on 10Jul2021 could not walk, pain even upon laying down. Excruciating. Could not sleep. Advil did not take it away. Brain fog. Tightness in chest. Went to the ER, tests came back fine. Went to podiatrist, diagnosed me with acute gout. Never had gout before. Have a history with tendon pain in my legs. The patient had not been tested for COVID-19 since the vaccination. AE resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Gout medication was received for the events and the outcome of the events was Not Recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10 days p/immun given t102; sz 15 mins p/APAP given; described like hiccups, shallow breathing; 911 administered 02, taken to ER:
Pt had routine check-up on 1APR91; had mild nasal URI; HIB given 1630PM; 2230 PM devel sx of irritability, vomiting, diarrhea, fever 101.4, & BOM; Hospitalized 2APR91 for 9 days & treated for sx; recovered;
pt stated a sore arm after vaccine. She said she has been having trouble for ~5 months raising her arm and with mobility. She states a friend had a vaccine and had bone cancer later and was concerned.
headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300034302 Same reporter/ drug/ event for different patients;
Headache, Myalgia, Arthralgia, Fever, fatigue Narrative:  flu like symptoms 5 hours post vaccination. Missed one day of work due to symptoms  Other Relevant History:
After the shot given by (tech), within a few minutes the patient felt dizzy, blurred vision, then stomach felt irritated and patient started to throw up. At this moment when I saw the patient, he also had nose bleeding. While sitting, then patient stood up and was then asked to stay on sitting position. Soon patient stopped throwing up and right away felt much better. Within 15 minutes of observation patient return to normal and felt fine. The patient had breakfast right before the shot.
It was more painful to receive the vaccine then others I have had and since then my shoulder hurts when I lift arm and lay on it. It is almost a month since I received my one dose and the pain has not gone away.
Couple of mins after vaccine got metallic taste in mouth and heart rate increased chest became red,  mouth and tongue felt funny/ thick.  Paramedics on site checked heart rate 115 and BP 160/80  oxygen was normal, swallowing felt funny but I was able to swallow,  monitored for about 30 mins on site  coworker drove me to get Benadryl, but did not take right away-  around 4:45  symptoms persisted and face started feeling numb  especially my upper lip on right side , skin became pale and  around lips tightness in chest and very shaky, took 25 mg Benadryl then called paramedics heart rate was still 115 BP was 130/80  I believe and was still very shaky  paramedics said oxygen levels OK and advised to take another Benadryl. So took 25 mg more,  after 30 mins mouth/ tongue and chest started feeling better and shakiness went away metallic taste went away after couple hours. Day 2 feel much better injection site sore only symptom
Received Varicella vax 06/27/1995. Developed pox 02/01/2000.
Within 24 hours from vaccine, site of injection became red, swollen with a 3x3 in diameter elevated sore. Patient had a dizzy spell when waking 3 days p-shot this AM but now feels well.
Information has been received from a licensed visiting nurse, via a company representative, concerning a female student in twelfth grade, who on 14-MAY-2007 was vaccinated at a high school health fair, with the first dose of Gardasil. Concomitant therapy included MENACTRA. The nurse reported that after receiving the vaccination, the patient fainted, and later recovered on the same day, 14-MAY-2007. The patient sought unspecified medical attention. No further information is expected.