chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight chills, head hurt only when coughing  day 2 friday night,  slight swelling (2inches by 3 inches), redness  and itching below injection site days2 to  4 (friday night to sunday). all symptoms did not start until friday around 4 or 5 pm. itching was most noticible on saturday and slightly better on sunday. washed area 2 times on saturday  and changed shirts just to be careful.  as of now (sunday 2pm)  i just have 2-3 inch swelling . redness and itching below injection site.
Patient received vaccines on10/28/2005 right arm swollen to quarter size, left arm swollen to about soft ball size. Denies any redness , soreness on and off with movement. Mom called office 10/31/2005 to report symptoms that started on 10/29/2005
Information has been received from a Registered Nurse concerning an adult patient who was vaccinated with a dose of Gardisal. The patient complained of pain while being injected using the prefilled syringe. The nurse reported that another patient did not complain of pain when a "normal" syringe was used. The nurse suggested the pre-filled needles may be dull causing pain during injection. The patient's out come was not reported. A product quality complaint was involved. No further information is available.
ADMINISTRATION OF VACCINE STORED OUTSIDE RECOMMENDED CONDITIONS; This spontaneous report received from a physician concerned multiple patients. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administration of vaccine stored outside recommended conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine stored outside recommended conditions was not reported. This report was non-serious.
Red hard lump, swollen and itchy, slightly painful at injection site that started 7-8 days after injection.
pt recv ax 1AUG96 & 24AUG96 pt devel less than 50 lesions some vesicular, some macular over the trunk, & some early blisters;
Since the vaccination day my shoulder is sore. But it began to get worst, sharp pain and lack of mobility. I came back to see a doctor that said that I shoul wait and get some ibuprofen. I am a dentist and my symptoms are getting worst.
Tachycardia with heart rate into the 140s starting 7mins after injection. Subsided over the course of 2 hours.
Information has been received from a pharmacist concerning a 12-month-old patient who was inadvertently vaccinated with a dose of PROQUAD instead of MMR II. It is reported that there were no adverse symptoms and no product confusion. It is unspecified if medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Pt recvd vax in JUN92 & devel burning sensation upon inject as well as soreness & or an aching sensation in the arm; heaviness in the arm;
fever; Chills; Fatigue; had flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, fatigue and had flu like symptoms. Clinical outcome of the events was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Information has been received from a mother and a worker in a physician's office concerning a 5-year-old white female with no medical history or allergies, who on 04/04/2001, was vaccinated SC in the right thigh with the first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot #6363661340K). Concomitant vaccinations on that same day included the first SC dose in the right thigh of measles virus vaccine live (Enders-Edmonston) (+)mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot #637256/1381K), the third IM dose in the left thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot #473347) and the third SC dose in the left thigh of poliovirus vaccine inactivated (Vero) (IPOL) (Lot #T0559). Illness at the time of vaccination included a runny nose and a right middle ear effusion. The patient's mother reported that on 11/11/05, her daughter was sent home from school because she was diagnosed with chickenpox. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. Subsequently, the patient's chickenpox resolved. Additional information is not expected.
Headache, Myalgia, NauseaVomiting, itching Narrative:
Received first dose of the Pfizer vaccine LOT: #FL3197 at 1635. Patient experienced a syncopal episode that lasted approximately 3 seconds in the vaccination chair. Patient did not fall to the ground during syncopal episode and did not hit his head. Head was being supported by his mom who was standing behind him. After syncopal episode patient felt nauseous but did not vomit. Patient stated that he has a history of syncope with needles. Patient stated that he is not on any medications. Patient stated the last time he had a syncopal episode was two years ago.  EMT took patients vital signs at 1640. BP: 144/81, HR: 80, RR: 16, O2: 99%. Patient was then moved to observation area. Patient was able to walk unassisted and with a steady gait. Patient was asked to wait in observation area for 30 minutes. EMT reassessed and retook patients vital signs. BP: 138/82, HR: 93, RR: 16, O2: 99%. Patient stated that he was "feeling a lot better" and was not experiencing new symptoms. EMT retook patients vital signs. BP: 136/82, HR: 82, RR: 16, O2: 98% at 1710. RN reassessed patient. Patient was not experiencing any new symptoms. RN educated patient on adverse symptoms of COVID vaccine and when to seek EMS. Patient verbalized understanding. Patient left vaccination site after completing observation time with his mom unassisted and with a steady gait.
Large area of erythema/edema/induration, redness localized to vaccine admin site (L) leg.
not feeling well; I am super dizzy like I am going to faint; I checked my heart rate seems to be elevated; I am kind of anxious; I checked my oxygen level is good it is like 98; I had my third shot; I had my third shot; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 3 via an unspecified route of administration on 27Aug2021 as DOSE 3, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration on unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 2 via an unspecified route of administration on unspecified date for covid-19 immunisation. On 27Aug2021, Patient had his third shot (Further clarification unknown) yesterday (Confirmed as 27Aug2021) and patient just had like a normal shot nothing major and next day morning patient woke up feeling pretty well and mean  progressively started not feeling well which kind of anxious with the third shot but like completely dizzy like super dizzy like I am going to faint and  checked oxygen level is good it is like 98 and checked  heart rate seems to be elevated, that is 101 for resting heart rate which normally is like 70 or 80, like 75-80 so patient's just little concerned is this like a side effect of the vaccine or is it something  need to go to hospital for or not finding anything regarding the dizziness. The patient underwent lab tests and procedures which included heart rate increased: 101 on 28Aug2021, oxygen saturation normal: 98 % on 28Aug2021.The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a licensed practical nurse (L.P.N.) concerning to an unspecified patient of unknown age and gender. No concurrent conditions or medical history were reported. On 12-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX with a lot # reported as L046887 and expiration date: 23-JAN-2017, (dose and anatomical location of administration were not reported). No concomitant therapy was provided. The temperature excursion was -12.3C. The time frame was 1 hour. No previous temperature excursion was reported. No data logger was called. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink/day before pregnancy) in 2008 and Marijuana use. Concomitant products included PARACETAMOL (TYLENOL) for Pain management and Headache, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 14-Oct-2020 to an unknown date and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore at injection site) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred  on 08-May-2021, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. pre-eclampsia diagnosed on 07-May-2021, emergency C-section took place on 08-May-2021. On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2020, Pregnancy test: positive (Positive) positive. On 15-Jan-2021, Ultrasound abdomen: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included unspecified antimalarial drugs.  Obstetric panel tests (first trimester maternal sequential screening panel) were conducted on 02-Nov-2020 which showed normal pregnancy-associated plasma protein A. On 11-Jan-2021, Maternal serum alpha fetoprotein screening test showed negative. Regular ultrasounds were normal.  The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during this pregnancy. Number of fetuses was reported as 1.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up received on 13 May 2021 added outcome of events, concomitant medications and laboratory details.
Bruising at injection site for influenza vaccine, redness and swelling on left arm near injection below injection site, arm soreness
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension (treated)" (unspecified if ongoing), notes: Hypertension (treated). Concomitant medication(s) included: LOSARTAN/HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Weak positive on at-home antigen test; (Aug2022) Positive, notes: Strong positive result; (Aug2022) Positive, notes: Still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No Known allergies were reported. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Device date was 25Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Parent stated a mild macular rash began on her neck and trunk, 24 hours, post vax, then in 48 hours, child began to cry inconsolably. Follow-up on 1/30/01 by phone, rash lasted 2-3 days; more started behind ears.
Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports on 01/11/2021 to this RN that she had a couple nightmares after the first injection. Pt reports that she had two nightmares after the first dose. Since her second dose was received on January 8, 2021 she reports having disturbing night mares and requested reporting of the events. Pt declined evaluation at the clinic after notification of the event. Pt voiced she will follow-up with her PCP if the nightmares continue.  Other side effects she reported with the second dose is nausea, tiredness, fatigue, headache, chills and some weakness. Those symptoms have since improved.
Fever - 104 -  Chills - body ack -  4 days.
Case number PHEH2014US015164 is an initial spontaneous report received from a nurse on 28 Jul 2014 with a follow up report received from the nurse on 28 Jul 2014. This report refers to an 11 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) intramuscularly at a dose of 0.5 ml on 22 Jul 2014. On 25 Jul 2014, the vaccination site was red, warm and raised. She also had a painful area at the vaccination site. Final outcome was condition unchanged. The seriousness and causality were not reported. Follow up report received from the nurse on 28 Jul 2014: Added MENVEO batch expiry date (30 Sep 2014).
I had night sweats starting on Day 2 thru Day 6. from 2 to 3 times per night I had to change my night shirt. On day 5 I woke up to fever blisters/cold sores under/in my nostrils and fever blisters around/inside the corners of my mouth.
feels terrible after receiving the second dose; This is a spontaneous report received from a contactable consumer (patient herself). A 83-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3302), dose 2 via an unspecified route of administration, administered in arm Left on 03Feb2021 (at the age of 83-year-old) as single dose for covid-19 immunisation in a pharmacy. The vaccine was not administered in a facility. The time the vaccination was given between 13:00 to 14:00. The patient's medical history was reported as none and concomitant medications were not reported. The patient received first dose of bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, on an unspecified date (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other additional vaccine administered on the same day. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient experienced feels terrible after receiving the second dose on 03Feb2021. The patient did not visit emergency room.  No relevant tests was reported. The outcome of the event was resolving.  Follow-up attempts are completed. No further information is expected.
CHEST TIGHTNESS  SOB, SWELLING OF THROAT, DIFF BREATHING  HIVES AND ITCHING  EPINEPHRINE 1:1000  .2CC SUBQ  AT ER BENEDRYL 25MGS Q 4-6 HOURS
Began having hives over body that have been continuous since approx 1 month following vaccine.  High level of body inflammation that has led to other sequelae
This spontaneous report as received from a Registered Nurse regarding a 4 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 13-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error).  Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
12/29 c/o fatigue, heavy eyes, and numbness, tingling and swelling to left arm.  Also numbness, tingling to left leg and foot.  She was seen in ED , prescribed naproxen and sent home.
fever between 99 and 103; Nausea; slight HA; A spontaneous report (United States) was received from a female patient, concerning herself 63  years of age, who received Moderna's COVID-19 vaccine and Pyrexia, Nausea, Headache.  The patient's medical history was not provided.   Concomitant product use was not provided by the patient.  On 19-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (023M20A batch number) via intramuscular route for COVID-19 infection prophylaxis and experienced Headache, Pyrexia, Nausea. She has been home since then and has not returned to work yet. She has no question, just calling to report her side effects.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was considered to be unknown at the time of this report.
Experienced a lump on their arm; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB MASS (Experienced a lump on their arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB MASS (Experienced a lump on their arm). At the time of the report, LIMB MASS (Experienced a lump on their arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on one additional medication other than Imitrex. Treatment information was not provided. After receiving the booster dose had experienced a lump on their arm that had persisted up until today. That information was collected from the patient today by a colleague of the individual reporting. They currently take 3 concomitant medications including Imitrex, a medication for migraines, and one additional medication.
This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (route, dose, lot # and expiry date were not provided). It was reported that on unspecified date, the patient was inadvertently administered with a second dose of ZOSTAVAX (route, dose, lot # and expiry date were not provided). No adverse effects were reported. Additional information is not expected as reporter declined to participate in follow up collection process.
Fevers 104, chills, congestion, cough, vomiting. I had to seek emergency care, require chest X-ray, I had to miss 4 days of work. My 15 month infant also tested positive for influenza A even though she required the flu shot.
swollen L lyphm node did go down in 2-3 weeks; sorness of L arm next day for less than 24 hrs / soreness at injection site; moderate fussyness feeling for 30 hrs; Had moderate tiredness for 24 hrs; very slight nausea for 3 hrs; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (moderate fussyness feeling for 30 hrs), VACCINATION SITE LYMPHADENOPATHY (swollen L lyphm node did go down in 2-3 weeks), FATIGUE (Had moderate tiredness for 24 hrs), NAUSEA (very slight nausea for 3 hrs) and VACCINATION SITE PAIN (sorness of L arm next day for less than 24 hrs / soreness at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Hypothyroidism. Concomitant products included LEVOTHYROXINE from 1997 to an unknown date, ALBUTEROL [SALBUTAMOL] from 1998 to an unknown date, VITAMIN D NOS from 2004 to an unknown date and VITAMIN E NOS from 1998 to an unknown date for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (sorness of L arm next day for less than 24 hrs / soreness at injection site). On an unknown date, the patient experienced FEELING ABNORMAL (moderate fussyness feeling for 30 hrs), VACCINATION SITE LYMPHADENOPATHY (swollen L lyphm node did go down in 2-3 weeks), FATIGUE (Had moderate tiredness for 24 hrs) and NAUSEA (very slight nausea for 3 hrs). In January 2021, VACCINATION SITE PAIN (sorness of L arm next day for less than 24 hrs / soreness at injection site) had resolved. At the time of the report, FEELING ABNORMAL (moderate fussyness feeling for 30 hrs), VACCINATION SITE LYMPHADENOPATHY (swollen L lyphm node did go down in 2-3 weeks), FATIGUE (Had moderate tiredness for 24 hrs) and NAUSEA (very slight nausea for 3 hrs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details were reported. The patient reported that the first dose was the most effective.   This case was linked to MOD-2021-434069, MOD-2022-437656 (Patient Link).