chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient discharged after (3) day inpatient admission.  A patient is a 59 y.o. male with a past medical history significant for diabetes mellitus type 2, essential hypertension, hyperlipidemia, and BPH who presented with a chief complaint of shortness of breath.  The patient reports the symptoms began approximately 7 prior to arrival.  He noted shortness of breath, nonproductive cough, diarrhea (2 days duration).    He was diagnosed with COVID-19 on 11/23/2021.  He was previously vaccinated for COVID-19 with 2 doses of Moderna.     In the ER, he was noted to be tachypneic and hypoxic on room air.  He was subsequently placed on 2 L nasal cannula.  CMP was significant for sodium of 130, chloride 93, glucose 247. Complete blood count demonstrated leukocytosis 12.46, hemoglobin of 12.9 and platelets of 408. Chest x-ray demonstrating moderate bilateral hazy and streaky peripheral non-uniform pulmonary opacities consistent with pneumonitis.  The patient received a dose of Decadron 6 mg IV in the ER.  He was then transferred to hospital for admission as inpatient status in stable condition for further workup, monitoring, and treatment.   Inpatient course:  Patient continued on Decadron.  Remedesivir started on 11/28.  DVT prophylaxis with Lovenox.  His home diabetes medications were held and he was started on basal-bolus insulin per inpatient protocol.  His Lisinopril, Tamsulosin, and Statin were continued.  With steroids, remdesivir and pulmonary toilet patient's respiratory status did improve.  He had improvement in his energy level as well as oral intake.  He was seen by pulmonary rehab on 12/01, and prescribed supplemental oxygen at the time of discharge, with 1 L/Min at rest and 4 L/Min with activity.  As the patient was clinically improved, he was transitioned to oral Decadron which was continued at the time of discharge.  The patient was discharged to home on 12/01/2021.  The patient was encouraged to follow up with his PCP within 7-10 days, for re-evaluation of O2 requirements.  He was instructed that he may not return to his factory work until he has been weaned off of supplemental oxygen.
pt recv vax 14MAY97 & 24hr later pt had hives on back & stomach;given DPH for itching & hives disappeared;reappeared on 16MAY & 17MAY & the noc of 18MAY;no hives on 19MAY so far (3PM talked to mom);
(L) upper ext with 6 x 3 inches erythema macular no pustules no vesicles warm mild swelling.
Patient felt Dizzy and passed out for about 30 seconds to a minute.  Also patient vomit after vaccination about 3-5 minutes after vaccination.
Resting heart rate increased from 58 to 77 over the course of 7 days.  racing heart rate, not correlated with activity, tired, fatigued, unable to sleep, loss of appetite, headache
Had ZOSTAVAX 12/10/2009-1-11-2013 to 2/11/2013 on going pain. Shingles with PHN & rash.
the muscle on her leg from her hip to her knee was really sore (same side she was injected); This is a spontaneous report received from a contactable consumer. This consumer (patient) reported that a 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that just got 2nd dose yesterday, was reading about the vaccine and it said it prevent severe illness. But didn't state what kind of illness it prevents. She didn't get any side effects except 1: no fever or chills. It had been 24 hours since her 2nd dose the only side effect she had was: the side where she got injected, the muscle on her leg from her hip to her knee was really sore (same side she was injected). Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The consumer reported that on an unknown date but even after vaccination, the patient experienced shingles every year. The outcome of shingles every year was unknown. Additional information has been requested.
Fever began seven or eight hours after receiving the vaccine (evening). Did not take any medication; fever broke early morning the next day.
within 24 hours of vaccine mom noted a lump at injection site status remains the same and darken tan area of induration 7mm Left ALT
pt recv vax 12noon on 15AUG95;16AUG in morning pt devel hives & rash-afeb w/APAP;rash & hives spread over body;mom took pt to MD 4:30;MD felt it could be Hep B rxn because it was the 1st Hep B vax;DPH given 18AUG95;pt recovered
No adverse event; A HCP called and reported that doses of VARIVAX that were improperly stored were administered to four different patients with different dates of administration. No adverse effects reported. Additional AEs filed for the other three patients. No additi; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 10-AUG-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (mL), once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number reported as W003820, expiration date reported and validated as 02-FEB-2024) as prophylaxis, and a sterile diluent (product storage error). No adverse effects reported.  The vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) up to 14F for 14 hours and 10 minutes and 14F up to 46F (16.7F) for 5 hours and 40 minutes, for a total time frame of 19 hours and 50 minutes. There was no previous temperature excursion.; Sender's Comments:  US-009507513-2208USA006387:
Patient requested and received bivalent covid vaccine, but it is an administration error, due to fact that this is the patient's second dose of bivalent vaccine. Patient was unaware that the vaccine dose she received in October was bivalent. No adverse reactions reported at this time.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Patient was given a dose of Moderna on 10/14 that expired on 10/12
Headache, upset stomach, cold sweats, arm pain.  Bed rest.  Relieved in 4 to 8 hours (except arm was 2 days).
Within 15 minutes, I had hives on my arms, around injection site, tops of thighs and my stomach and chest. My heart was racing and I had a feeling of tightness in my throat. Breathing was fine. Called office and started BENADRYL immediately. Took BENADRYL continuous for 6 days. Hives would come back when it was getting close to time to take another dose. Injection site was hard and swollen, very sore and baseball size. After 5 days I contacted Dr. and was seen. Put on steroid for 6 days. Hives would come back usually in the evenings even on steroids and BENADRYL. After 10-11 days I think I am ok. 11th day was first day system free.
After 2nd shot in series I experienced a very painful, swollen lymph node under my right arm. Reaction occurred 2 days after injection, resolved 5 days after symptom first appeared.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 5 year old female patient who received a fourth dose of Prevnar on 12/31/2001. On 3/23/2006 the patient developed pneumococcal sepsis and septic shock. The patients concurrent illness included asplenia. Indication for Prevnar was immunization. Product was administered on 12/31/2001. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On 12/31/2001, the patient received a fourth dose of Prevnar. On 3/23/2006, the patient was admitted to the pediatric intensive care unit with septic shock. On the same day, a blood culture was preformed which was positive fore streptococcus pneumoniae and the patient was diagnosed with pneumococcal sepsis. Treatment included Ceftriaxone, Vancomycin, Dopamine and other medications. As of 4/4/2006, the patient remained hospitalized and was reported to be improving, with discharge scheduled for 4/5/2006. The reporter also stated that the patients physician felt that this was not a case of the vaccine being ineffective, but rather attributed the events to the patients underlying history of asplenia. Serotyping was requested and results are pending. Blood culture (positive for streptococcus pneumoniae) was done on 3/23/2006. No additional information was available at the time of this report.
COUGHING; MILD HEADACHE TO TERRIBLE HEADACHES; NAUSEA; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (COUGHING), HEADACHE (MILD HEADACHE TO TERRIBLE HEADACHES), NAUSEA (NAUSEA) and FATIGUE (FATIGUE) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (COUGHING), HEADACHE (MILD HEADACHE TO TERRIBLE HEADACHES), NAUSEA (NAUSEA) and FATIGUE (FATIGUE). At the time of the report, COUGH (COUGHING), HEADACHE (MILD HEADACHE TO TERRIBLE HEADACHES), NAUSEA (NAUSEA) and FATIGUE (FATIGUE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication were not provided.
muscle spasms; extreme muscle pain in his back, from his neck to his waist; a lot of stiffness; he can barely walk/ couldn't walk; This is a spontaneous report from a Pfizer-sponsored program, COVAX Support, from a contactable consumer (wife of patient). A 78-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL9262) via an unspecified route in Feb2021 (reported as both 04Feb and 09Feb) (at the age of 78-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukemia (CLL). Concomitant medications included ibrutinib (IMBRUVICA) for CLL, finasteride, tamsulosin, metformin, and glimepiride; start and stop dates unspecified. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249) in Jan2021 (reported as both 04Jan and 14Jan) as a single dose for COVID-19 immunization. About 2 weeks after the second dose (Feb2021), the patient developed extreme muscle pain in his back, from his neck to his waist. He was in the hospital twice and he was having spasms, then it happened again last week where also a lot of stiffness, he can barely walk, again he just out of blue, he got these muscle spasms and he couldn't walk again. She reported that they have led off but in the meantime, we were trying to figure out if he has done anything, which he did not. She stated the only odd thing was the vaccine. The patient was hospitalized for the events in Feb2021 for about three days, reporter estimated dates as 18Feb2021 and again on 22Feb2021. The muscle spasms ended up going away and then on 12Apr2021 they started up again. Patient had lab test done every 2 months (results not provided). Treatment for events included muscle relaxants, which didn't help. The clinical outcomes of extreme muscle pain in his back, a lot of stiffness, barely walk/couldn't walk were unknown, while of muscle spasms was not recovered.
DVT in calf that turned in to substantial pulmonary embolisms in both lungs with no prior blood clot history. Treatment included a TPA to dissolve clots as well as vascular surgery to remove clots not dissolved in the left lung.
Patient was given vaccine from Bivalent vial which was left out for more than 24 hours.
pt recv vax & 2wk p/vax pt had a similar episode w/red, swollen, puffy, itching eyelids again which also subsequently flaked;1mo later pt recovered;MAR97 pt devel crossed eyes & devel some diplopia;dx multiple sclerosis;diarrhea;
ITCHY bumpy rash at injection site. Approximately 2 or 3 inch diameter patch.
I woke up with what at the time I assumed was a spider bite near my left armpit. Redness was diffuse (could not see an actual ?bite? spot). Gradually got redder and larger and lymph nodes were swollen and very sore. This lasted about 7 days.
Developed Guillain Barre Syndrome about 1 week after receiving flu vaccine. Had strep pharyngitis about 6 weeks before onset of Guillain Barre. Experienced peripheral numbness and about 1 week prior to requiring hospitalization for weakness on 11/08/2006.  5/11/07 Received medical records from hospital which reveal patient experienced LE numbness, difficulty walking & went to ER.  Neuro consult done.  LP done was abnormal & combined w/LE areflexia, ataxia, paresis of LEs admitted 11/8/06-11/18/06 for GBS.  Tx w/plasmapheresis x 5 w/good results.  Continued to have some weakness of toes & numbness of LEs but was minimal at D/C to home w/PT.   FINAL DX: Guillain Barre syndrome, s/p plasmapheresis.
Chills, Bodyaches, Nausea & Back Discomfort developed 12 hours after receiving vaccine - resolved after 48hrs.
Severe chills, nausea, and soreness in body and arm. Took Tylenol which helped ease symptoms
A few days post vax, the pt developed constipation. The constipation resolved after 1 day.
Whole body convulsions and chills sudden onset with fever, fever spiked to 103.2, maintained after two hours and convulsions/chills stopped.  Nausea/emesis.  One hour after fever onset, took diphenhydramine and ibuprofen, fever unrelenting.  Fever broken around 8 hours after onset.  Rest of following day (8/11/2012) maintained normal body temp with intermittent low grade spikes, however had malaise and general feeling of illness.
Patient missed 2nd Vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd Vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd Vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd Vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
hives worsened; Itching; This case was reported by a consumer via call center representative and described the occurrence of condition aggravated in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of urticaria (1st dose received at the end of February or early March 2019, see case US2019123826).   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced condition aggravated and hives. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the condition aggravated was not recovered/not resolved and the outcome of the hives was unknown.   It was unknown if the reporter considered the condition aggravated and hives to be related to Shingrix.  Additional details were provided as follows: The reporter not provided the lot numbers for either of the vaccines dose 1 and 2. The reporter did not know the specific dates or which arm the vaccines were administered. In June 2019, the patient went to get the 2nd dose of Shingrix. When the daughter of the patient questioned whether the patient should receive the 2nd dose at that time, the doctor said the hives were not associated with the vaccine, so the 2nd dose was administered. The hives worsened and were very itchy. Emergency room (ER) visit required.
reports chills, dizziness, fever, diarrhea approx 4hr p/vax;has had diarrhea x 4-5 days;29APR97 sx resolved;
Two different reports: First indicated the patient developed redness, swelling, warmth and blotchiness the day of vaccine. Second indicated the patient developed redness and warmth a week after vaccine.  Pt was taken to urgent care, diagnosed with cellulitis and given one round of antibiotics.
Developed hives 2 days after shot that turned her skin white and caused her skin to sag.
Pt developed swelling L/stemoclavicular area, had discomfort and pruritis associated with the swelling.  Had discomfort and pruritis at injection site. RN reported significant swelling, no redness or temp increase.
Received vaccine on 4/11. 4/15 developed headache, low back pain/bilateral hip pain, very painful. She has been relieving symptoms by stretching and using a heating pad
pt dx w/chickenpox by MD on 13MAY98;presented to clinic w/rash & elevated temp;
Client states 2 weeks after receiving the flu shot she had pain in her neck and couldn't turn it. She went to a chiropractor six times and felt a little better. About that time she also noticed her Lt arm feeling weak. Her Rt arm was okay. She saw a nurse practitioner and had elevated BP and was put on medication for this. She states her gait is unsteady and when she walks "goes to her Lt." Flu shot was given on 10/4/05. She was seen in the emergency room on 12/2/05 and sent home on a med for arthritis. Today she states she is "maybe a little better but still feels weak."
Shingles. T8 and T9 dermatomes of LEFT flank. Onset on 9/26/22 with diagnosis by virtual provider on 9/28/22. Started Valcyclovir on 9/28/22.
1st dose 3 years ago, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years prior to the reporting).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comments: The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting, patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination.
Flu-like symptoms; Initial information was received on 17-Oct-2021 regarding an unsolicited valid non-serious case received from a Consumer.  This case involves a 84-year-old female patient who experienced flu-like symptoms (influenza like illness) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 14-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On 14-Oct-2021, the patient developed a non-serious flu-like symptoms (influenza like illness) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It is unknown if patient's physician provided consent to be contacted.  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from the event.  There will be no information available on batch number for this case.
diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient herself) A 84-years-old non female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201 ; Expiration Date: 30Jun2021 ) dose 1 intramuscular, administered in Arm Left on 07Feb2021 as SINGLE DOSE for covid-19 immunisation .Medical history included hypertension from an unknown date and unknown if ongoing , irritable bowel syndrome from an unknown date and unknown if ongoing. Concomitant medications included amlodipine taken for hypertension from an unspecified start date and ongoing.The patient experienced diarrhea  on 08Feb2021 02:00 and  vomiting on 08Feb2021 02:00 with outcome of recovered. She did stop vomiting, but vomited about 4 times and the diarrhea kept up for a little while and then stopped.The events were considered as non-serious by consumer. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
I gave patient a KINRIX injection in right deltoid and immediately noticed hematoma develop approximately 2.54 cm in size. Supervisor was notified. Mother stated child had pediatrician appointment that afternoon. On 11/19/2013 at 9:04 a.m., I gave patient a KINRIX injection in the right deltoid and immediately noticed a hematoma approximately 2.65 cm developed. I immediately called the house supervisor and informed her of the observation. Supervisor took a picture of the child's arm. While speaking with the mom, she stated that the child had an afternoon appointment with his Pediatrician today. She was instructed to give TYLENOL and use ice pack as needed. On 11/20/2013 at approximate 8:35 a.m., I called mother to check on the status of patient. She stated his arm was still a little swollen, but Dr. said he should be fine. On 11/21/2013 a VAERS report was created and mailed. On 11/22/2013, a revised VAERS Report was submitted.
Felt extremely tired and achy for a full day. Lymph node in armpit very tender and swollen - still swollen after 4 days.
pt rcvd vax, devel urticarial rash,followed by angioedema of feet;pt was irritable; Area of erythema & some warmth noted;