chrisvoncsefalvay/vaers-outcomes huggingface dataset:
did not get her 2nd dose; Lymph node pain; Muscle aches; Vomiting; Chest pain; Pain in back; Started to feel sick; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), BACK PAIN (Pain in back), ILLNESS (Started to feel sick), PRODUCT DOSE OMISSION ISSUE (did not get her 2nd dose) and LYMPH NODE PAIN (Lymph node pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included VALSARTAN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHEST PAIN (Chest pain), BACK PAIN (Pain in back), ILLNESS (Started to feel sick), LYMPH NODE PAIN (Lymph node pain), MYALGIA (Muscle aches) and VOMITING (Vomiting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get her 2nd dose). At the time of the report, CHEST PAIN (Chest pain), BACK PAIN (Pain in back), ILLNESS (Started to feel sick), PRODUCT DOSE OMISSION ISSUE (did not get her 2nd dose), LYMPH NODE PAIN (Lymph node pain), MYALGIA (Muscle aches) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Tylenol    Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: No specific follow-up information recorded.
It was discovered that the pt was given 5. mls instead of 0.5 mls. Pt had complained of feeling lightheaded, nausea and vomiting occured. At injection site, pt had swelling, tenderness, and erythema.  Informed mother if it continued to take the pt to ER.  Pt was taken to ER, treated with Benadryl IM and Solu-Medrol IV then admitted.
pt recvd vax & 6 days p/dose had erythema @ site inject;
Muscle weakness - eventually admitted on 9/2/16 for Guillain-Barre syndrome.  Not clear if pneumococcal vaccine led to this, but was only vaccine prior and was not sick with other illnesses.
At 10:30PM I suddenly became very cold. At 1:30AM my hands and feet were freezing. At 3:30AM I had to wrap myself up in a number of blankets. My fingers and feet felt like they were frozen solid. By 6:30AM I also had a very bad headache and felt sick to my stomach. At 8:30AM I began drinking as much water as I could hold. At 11:30AM my whole body broke out in a sweat. By 1:00PM I was feeling better. When I recieved my first dose on 2/20/2021, I had no side effects. lot#024M20A.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: Pt claims chills, weakness, headache, and difficulty walking since recieving vaccination. Has not had this issue with prior vaccines.
7/15/99 acute herpes-zoster 9shingles) outbreak upper back/neck;
PS I also had Covid back in January; PS I also had Covid back in January; This is a spontaneous report from a contactable female consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, patient had Covid back in January. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from a certified medical assistant concerning nine patients of unknown ages and genders. The patients concurrent conditions and medical histories were not reported. On an unknown dates, nine patients were vaccinated with improperly stored doses of ROTATEQ, oral, lot # K017576, expiration date: 12-JUN-2016, (frequencies, does and strengths were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse symptoms reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
DTaP-IPV component of PENTACEL given without the Hib component with no reported adverse event.; Initial information received  on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old female patient was given dtap-ipv component of pentacel given without the hib component with no reported adverse event, after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 08-Sep-2022, the patient received a total dose number 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6970BA and expiration date:  31-Jan-2023) at a dose of 0.5ml via intramuscular route in the right thigh for immunization.  On 08-Sep-2022 (Latency: same day),the patient was given dtap-ipv component of pentacel given without the hib component with no reported adverse event(Product ingredient issue) following the administration.   Action taken :not applicable  It was not reported if the patient received a corrective treatment for the event.   Outcome: unknown   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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt had excessive somnolence & was difficult to arouse p/1st DTP; grandma described as limp & up only for about 1 hr during 24 hrs period;
At 10:38 a.m , patient stated " I'm hot, why am I so hot?" Then removed her jacket. Vitals  were taken at 10:40 a.m. as :B/P 132/108, p 87, O2 99, resp 18.  Patient was kept seated in observation area for furter evaluation.  Patient stated " I feel like I'm floating out of my chair" at 10:50a.m.; vitals were taken : B/P 126/101 p 89 O2 99, resps 19.  Patient appeared drowsy. Patient was repeatedly asked orientation questions. Pt. stated " What, I'm confused."  Patient was able to answer question and was shown to be A/O x4.  Patient stated she was very sleepy. At 10:56 a.m. Emergency Services were called and notified of situation, while on phone with EMs patient complained of itching to both arms. EMS stated not to give her anything  PO or IM including the Benadryl that we carry. At 10:56 patient was made aware EMS would be arriving to transport her to hospital for further evaluations. Patient stated "No, I don't do hospitals, My brother died in that hospital." Vitals taken at 11:06 :  B/P 139/107, P 89, Resps 17, O2 99.  EMS arrived at 11:12 to examine patient further. Patient initially refused examination, then agreed. Patient was examined by EMS and stated " Whatever this is it'll pass, God got me". EMS VItal machine read BP 137/87, P 87, O2 99% at 11:20 a.m. and at 11:21 a.m. vitals read 133/93 BP, P 87 and O2 100%. Patient refused hospital transport by EMs. Patient states she has a doctor's appointment at 1:20p.m. and if she's not feeling better by then she'll go to hospital. EMS departed at 11:30a.m. Pt. was kept in observation area for further evaluation. Patient ate lunch and walked out of observation area at 12p.m.
Flashing light reaction; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (Flashing light reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHOTOPSIA (Flashing light reaction). At the time of the report, PHOTOPSIA (Flashing light reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Had rash on neck, ears, & chest; No itching noted at present; First noticed on 15APR91; Lasted approx 1 day;
I got covid 3 months after being fully vaccinated with the Pfizer Vaccine.; I got covid 3 months after being fully vaccinated with the Pfizer Vaccine.; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: er8731), via an unspecified route of administration in the left arm on 14Apr2021 at 15:00 (age at vaccination: 37-year-old) and second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: Ew0173) via an unspecified route of administration in the left arm on an unspecified date, both as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 16Aug2021 at 17:00, patient got COVID 3 months after being fully vaccinated with the Pfizer Vaccine. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. The patient underwent lab test and procedure which included PCR covid test post vaccination, nasal Swab: positive on 18Aug2021 and 2 at home tests. The clinical outcome of COVID-19 was recovering.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-AUG-2015, the patient was vaccinated with the first dose of an improperly stored PROQUAD (Merck) (lot # L010143, expiry date on 24-SEP-2016) subcutaneously. This was the only dose of PROQUAD (Merck), that the patient had ever been administered. No known adverse effect was reported. Additional information has been requested.
My menstrual cycle should have begun August 23-26th.  No period happened in August.  I then began menstruating on Sept. 7th.  Bleeding has been HEAVY! Bleeding through tampons within 20 minutes. Clumps of blood the size of golf balls coming out EVERY DAY.  I'm sTILL bleeding.  Today is Sept. 21st.  2 weeks of a heavy period.  This is not normal.  My periods have been regular since I was 11 years old.  I'm seeing a doctor this Friday (my day off) to address this issue.
Potential AE; first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.; first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Potential AE), INTERCHANGE OF VACCINE PRODUCTS (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.) and COVID-19 IMMUNISATION (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.) in a 23-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 21-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2023, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Feb-2023, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.) and COVID-19 IMMUNISATION (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.). On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE). At the time of the report, IMMUNISATION REACTION (Potential AE), INTERCHANGE OF VACCINE PRODUCTS (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.) and COVID-19 IMMUNISATION (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.) outcome was unknown.        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.   No concomitant medications were reported. No treatment medications were reported.
HOT FLASHES; CHILLS; HIGH GRADE FEVER/LOW GRADE FEVER; POUNDING HEADACHE; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: 09-JUL-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced hot flashes. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced high grade fever/low grade fever. On 05-MAR-2021, the subject experienced pounding headache. On 05-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 102.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, chills, and pounding headache on 06-MAR-2021, and high grade fever/low grade fever on 07-MAR-2021. This report was non-serious.
01/05/22 presents to ED for "chest pain and shortness of breath". PMHx of "hypertension and Dm2"
About 10 days after receiving the Pfizer booster (3rd shot) I started getting a sore throat 12/20/21.  The next day 12/21/21 I couldn't stop sneezing although my sinuses were not clogged & it felt different from a regular cold.  I felt like I had a slight cold & stayed home from work on Wednesday 12/22/21.  I tested negative for covid using an at home test on 12/22/21.  The symptoms seemed to go away except for the sore throat from 12/23/21 - 12/29/21.  On Thursday 12/30/21 I had piercing pain in my head, was really tired, dizzy & had vertigo.  My body kept pulling to the left, had to walk holding the wall.  It felt like the left side of my body wouldn't move.  Sneezing rapidly, non stop.  Tested positive for covid-19 using an at-home test on 12/30/21.  Isolated at home for 10 days.  After the second day had no symptoms at all.  Long term symptoms are tiredness at times, brain fog.  Antigen test was negative on 1/9/22, took at pharmacy.
I became very thirsty and light headed about an hour after the vaccine. 5 hours later, I was unable to stay awake. The following day, I had a temperature, I was foggy and slow moving. 2 days later I had a low grade persistent headache.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022 at 6:51 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 24-Sep-2022 at 6:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant product reported by the reporter.  Patient had previously received dose 1 , dose 2 and dose 3 of Moderna vaccine in the intramuscular route at the deltoid body site. Patient received dose 4 of Moderna vaccine in deltoid.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial(s) moved from freezer to refrigerator was on 07 Sep 2022.  No adverse reactions experienced by the patient. It was unknown if patient had ever been diagnosed or tested positive for COVID-19.  No treatment medication reported by the reporter.
Mother mentions that the baby girl started to have seizures on 7/21/06. Had seizures during the weekend then was taken to the doctor and was referred to the emergency room of the local hospital. In the ER, she did not have seizure nor in the doctor's office.
Vomiting once, pain all over, sore muscles/joint. Chills, fatigue.
MOTHER REPORTS PATIENT RECEIVED COVID BOOSTER ON FRIDAY, SATURDAY MORNING HE BEGAN EXPERIENCE INTENSE LOWER BACK AND BILATERAL THIGH AND KNEE PAIN.  PATIENT STATES PAIN WAS SEVERE , HE ALSO HAD MUSCLE WEAKNESS  OF BILATERAL LEGS AND WAS UNABLE TO WALK WITHOUT SUPPORT AS HE FELT UNSTABLE.  PATIENT ALSO DEVELOPED A RIGHT ARM AND AXILLA SHOULDER PAIN AT INJECTION SITE.  PATIENT DEVELOPED FEVER 101.7 FAHRENHEIT.  PATIENT DENIES ANY CHEST PAIN, SIGNIFICANT DIFFICULTY BREATHING, CONFUSION, DIZZINESS.  MOTHER REPORTS PATIENT RESTED THROUGHOUT WEEKEND; PAIN AND WEAKNESS RESOLVED ON MONDAY.  HE HAS NO LINGERING SYMPTOMS OF WEAKNESS OR BODY PAIN SINCE THAT TIME.  PHYSICAL EXAM IS WITHIN NORMAL LIMITS, NO NEUROLOGICAL OR MUSCULAR DEFICITS WERE NOTED.  AS PATIENT IS CURRENTLY ASYPTOMATIC HE WILL BE MONITORED AT THIS TIME.  MOTHER WAS ADVISED TO SEEK MEDICAL ATTENTION SOONER IF NEEDED FOR ANY CONCERNING SIGNS AND SYMPTOMS . SHE STATED UNDERSTANDING.
Periodical lingering weird headaches in my head and face and jaw almost like a migraine that happens at weird times all of a sudden have way more spider veins in my legs -
I had a breakthrough case of Covid with sinus pressure and congestion, fever and headache with some soreness at injection site.
low-grade fever the night of the vaccine that lasted 3-4 days 8/11 : onset
Headache, facial flushing, severe hip and back pain, vaginal pain, 101 degree fever, chills, inability to get comfortable, nausea, inability to sleep for more than 90 minutes at a time
Starting Thursday night (2/18/2021) my arm became extremely itchy. When I woke up this morning (2/19/2021) my arm was swollen, red and stilly itchy at the injection site. This is a week after the shot was given.
Information has been received from a physician concerning an approximately 38 year old female pt who on an unspecified date was vaccinated with a dose of MMRII (Lot # not available). Subsequently, a recent titer was negative for measles. Unspecified medical attention was sought.  The physician also reported that a male pt was vaccinated with a dose of MMRII and had a titer that was negative for mumps (WAES # 0402USA01110) and an unknown number of pt's were vaccinated with a dose of MMRII and subsequently had negative titers (WAES # 04042USA01993).  Additional information has been requested.
Patient had extremely high blood pressure (284/188) and was sent from her Doctors office to the ER at Hospital. She remains in Afib and on increased blood pressure medications and blood thinners. She has had EKGs and Chest XRays determining CHF. Currently she is on a heart monitor and scheduled for a CAT scan.  She is now scheduled with cardiologist. Doctor and patient believe this was a reaction to the vaccine as pt was previously stable. Patient will not be getting second dose of vaccine due to high risk and potential worsening of condition.
Case number PHEH2014US019190 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 59 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
On Tuesday, June 8 I was diagnosed through a CT scan with Cerebral Venous Thrombosis. I was sent to the ICU where I stayed for 3 days and luckily never had a stroke. I am now on blood thinners and seem to be recovering fully. i was initially thinking this was oral contraceptive related, but having been on the pill for 6 years with no adverse results, wonder if the Moderna vaccine or a combination of the vaccine and the oral contraceptive, caused it. I would like my info to help outcomes for others as this was one of the most frightening weeks of my life. I had headaches, 1 incident of vomiting , nausea and vertigo before heading to urgent care, where I was diagnosed.
Initial report received from healthcare professional on 06 Oct 2014. A 79-year-old male patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (lot number, dose, dose number, site of vaccination not reported), on 25 Sep 2014. The patient had a reported medical history of allergies to penicillin and sulfa drugs. It was reported that on 01 Oct 2014 (one week after vaccination), the patient developed frequency and burning on urination. The urologist advised him to increase his fluid intake and symptoms resolved. The patient diagnosed himself with possible prostatitis. The patient's urine culture reports on 03 Oct 2014 were negative. The patient required ER/doctor visit. Corrective treatments were not reported. The outcome of the event was reported as recovered. Documents held by sender: None.