chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 68 y.o. female with PMHx of focal epilepsy, SCC of lung, COPD (stage IV), HTN, fibromyalgia presenting with SOB and cough.    Assessment and Plan   Acute hypoxic respiratory failure with ARDS d/t COVID-19/influenza co-infection w probable superimposed bacterial PNA COPD, not in exacerbation Hx of SCC of R lung Shock Acute encephalopathy with somnolence Hx of focal epilepsy pAF with RVR vs MAT Likely septic shock from coinfection with COVID/influenza and possible superimposed bacterial PNA with ARDS.  Remains intubated On high-dose pressors On Tamiflu, Remdesivir, stress dose Decadron Bronchodilators Inflammatory markers elevated 2D echo with EF 70%, grossly unremarkable Aztreonam/doxycycline Palliative care following  On IV keppra  Therapeutic Lovenox Discussed with critical care Prognosis very poor Discussed with the family at bedside; in keeping with goals of care vasopressors discontinued.  Patient peacefully expired today at 8:55 AM in the presence of family.  Psychological emotional support provided
COVID-19; Fever; Body Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PYREXIA (Fever), MYALGIA (Body Aches) and HEADACHE (Headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body Aches) and HEADACHE (Headache). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), PYREXIA (Fever), MYALGIA (Body Aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101 (High) Fever 101 F. On an unknown date, SARS-CoV-2 test: positive (Positive) PCR test tested Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Additional information received New event COVID-19 was added
fine macular papular rash on trunk & extremities , blanched by pressure, T103 x 1-2 days;seen in office 18MAR98 by later in day inc rash;atarax, observe;
Patient received first dose on 5/30/21. He came to pharmacy to receive 2nd dose on 7/5/21. During screening questions, patient mentioned after 1st dose, the next day he experienced chest tightness. It only lasted that day and then went away. He did not experience any SOB. Due to his chest tightness, I recommended talk to his PCP and obtain 2nd dose in a more controlled environment.
Patient has hematoma on left arm on deltoid area. Patient was complaining of pain and the area around hematoma being warm to touch. Patient was advised to seek medical attention ASAP. Also patient used ice pack.
I received heart palpitations for Seven days after receiving my second dose of the COVID-19 Vaccine. They began within an hour after I received my second dose but did not occur during the period; I was asked to stay at the Hospital for monitoring. I did not receive Heart palpitations after my first dose. These palpitations were extremely brief; lasting about 1-2 seconds and occurred spontaneously throughout the day. They occurred multiple times throughout the day (up to 20 times). I had an EKG done showing no concerning results. These palpitations stopped after a week and I have not had any since 1/15/21. I did not get lightheaded or nauseas from these palpitations. They were strong enough to notice but did not have a negative impact on my day-to-day activities.
This spontaneous report was received from a Registered Nurse. On 07-JUL-2014, the reporter requested stability for doses of (Oka/Merck) VARIVAX which were evaluated and supported. On22-JUL-2014, the reporter was requesting stability data for an additional temperature excursion, and she reports that the doses of (Oka/Merck) VARIVAX (dose, frequency and route unknown) that were supported on 07-JUL-2014, have been administered to unspecified number of patients on unspecified dates since 07-JUL-2014. Concurrent conditions and relevant medical history of the patients was unknown. Concomitant medications were not reported. No adverse effect was observed or reported. Product quality issue was not involved. This case is linked to #1407USA012378 and #1407USA012043 via same reporter link. Additional information has been requested.
A few hours after his vaccines he was lethargic, stumbling when walking, fever, vomiting, diarrhea .. the following day his lips, hands and feet were turning blue/purple on and off and very cold. Took him to the ER and all tests, X-ray and oxygen came back fine but his color came back too. Brought him home and he was turning blue again and I gave him albuterol and it went away. Still very lethargic, no appetite and constant fever for 4 days. Broke out in a bad rash/ Eczema on day 3 and I had to rush him to pediatrician. Was told it was normal and Keep monitoring him and that it was definitely a reaction from vaccines. Slowly started getting better on day 4 but still a little lethargic and losing his balance. Day 6 and he is finally eating and doing better.
upper chest pressure for several days.  On the morning of June 1 I went to the ER to insure I was not have a heart attack.  As noted below after a CT scan it was determined I had not had a heart attack but symptoms were more like myocarditis.
Anxiety attack, 30 seconds after shot was administered Frantic crying and behavior Light headed Patient appeared to pass out, but responsive to commands and words, required assistance, was supported, no injuries. Heart rate and pulse was present The following was an experience of 30 minutes
Information has been received from a registered nurse concerning a 28 year old pregnant female who in approximately 1999 was vaccinated with two doses of varicella virus vaccine live. It was reported on 09/14/01, that the pt "now" had a negative titer. The patient did not receive the varicella virus vaccine live during pregnancy. The patient works with children and is not concerned about her immunity to chickenpox. Additional information has been requested.
10/13/13 Pt states she woke up the morning after the vaccine feeling "BLEH" and had not slept well, experiencing chills and diarrhea. 10/14/13 states she had swollen sinuses and c/o lungs, and nose burning as if she "had a sniff of chemicals".  She experienced her whole body as if in "a vice grip with SOB and tight chest" after which she "either fell asleep or passed out". In the middle of the night she sat up and couldn't breathe with the "sensation of impending doom", and was "wiped out for days and days afterwards".  Returned to work 10/18/13 and still felt "rundown", experiencing a bout of dizziness and not being able to "get fresh air".  Reported to the ER.   She reported to employee health 12/9/13.
Swelling of R upper arm and pain severe enough to prevent patient from moving his arm beyond neutral position. No cardiovascular or nervous system compromise.
Injection site developed a 3 inch circular area of redness, swelling, was extremely hot and painful to the touch. Developed into hard mass. Dizziness the morning after the vaccine and throughout the day. Fever x3 days, body aches, lethargy, chills, profuse sweating
Moderna Vaccine was given beyond the refrigeration use; Moderna Vaccine was given beyond the refrigeration use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR (Moderna Vaccine was given beyond the refrigeration use) in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Vaccine was given beyond the refrigeration use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Vaccine was given beyond the refrigeration use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR (Moderna Vaccine was given beyond the refrigeration use) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  The vial was initially stored in the refrigerator on 02-Jun-2022  The vial did not undergo any temperature excursion.  Treatment information was not provided.
Pt received 2 dose of Moderna today at 1432, at 1445 pt raised arm to notify me that her "throat felt tight", no other symptoms. Report she took Zyrtec this morning for allergies and took insulin this morning and had lunch at noon. Escorted patient to vital station, VSS T97.8, HR 95, BP 124/82, a&ox3, well appearing.  Gave pt water to drink, swallowing ok,  2 nurses also observing her. 1455 per pt throat tightness still there, stable. 1500 Notified Dr of patient status, escorted patient over to his office within the vaccine clinic to further evaluate. At 1515 with orders by Dr to give sublingual Zyrtec 10mg, and monitor for 30min and repeat vitals. @ 1550 Pt well appear, VSS 141/95, HR 85, T97.6, swallowing improved, throat tightness improved,  with orders to d'c home, Dr instructed pt to pick up EpiPen for worsening symtoms, ED precautions reviewed. No further questions.
Inflammation starting yesterday in his hands; Hands feel weak; hands feel weak and hurt; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "pneumonia" (unspecified if ongoing), notes: hospitalized for one day (27Sep2021); "hospitalized", start date: 27Sep2021, stop date: 27Sep2021, notes: for pneumonia. The patient's concomitant medications were not reported. Past drug history included: Xeljanz xr, start date: Sep2020, for Rheumatoid Arthritis, notes: Strength: 11Mg, Manufacturer: Pfizer, Dose 11mg once daily. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; INFLAMMATION (non-serious) with onset 09Nov2021, outcome "unknown", described as "Inflammation starting yesterday in his hands"; MUSCULAR WEAKNESS (non-serious) with onset 09Nov2021, outcome "unknown", described as "Hands feel weak"; PAIN IN EXTREMITY (non-serious) with onset 09Nov2021, outcome "unknown", described as "hands feel weak and hurt".  Additional information: The patient reported, he reported starting back on xeljanz for about a week, and then was back on hold with his xeljanz because his md instructed him to hold his xeljanz for 15 days after his covid booster, he was on day 10 withholding his xeljanz.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SHINGLES (MUSCLE ACHE,PAINFUL RASH,FEVER,HEADACHE,CHILLS); FATIGUE; REDNESS AT INJECTION SITE; SWELLING AT INJECTION SITE (2 INCHES BY 3 INCHES); This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included chicken pox, and concurrent conditions included gave birth.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced shingles (muscle ache, painful rash, fever, headache, chills). On APR-2021, the subject experienced redness at injection site. On APR-2021, the subject experienced swelling at injection site (2 inches by 3 inches). On an unspecified date, the subject experienced fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: aciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from redness at injection site, and swelling at injection site (2 inches by 3 inches) on APR-2021, and the outcome of shingles (muscle ache,painful rash,fever,headache,chills) and fatigue was not reported. This report was non-serious.
Dizziness for several hours, sleepiness for three days, arm pain getting worse the day after the vaccine (it hurt from the right side of the neck to he finger tips ranging from severe on the site of the shot to more mild in the neck and finger tips), joint pain for several days, nausea a few minutes after the first meal of the day for several days, mild swelling of the body during the day of the vaccination(delay reaction).  For the dizziness I had a banana and potato chips to stabilize the sugar in the blood and took about and hour nap.  Co-workers and Supervisor monitor me in case EMS needed to be call. For the pain in general I took 1 capsule Tylenol 500.  Nothing for the nausea and plenty of water to reduce swelling.
woke up w/t102 @ 6AM 4NOV94 also had flu sx, achey all over, h/a; fever stayed 102 until 5NOV94 about 5PM; felt like had the flu for 3 full days p/shot;
Information has been received from a consumer.  The consumer reported that she saw on the internet that a patient "had shingles, then he got the shingles vaccine, and then he got nerve pain."  The consumer could not recall where on the internet she read this.  She had no further information.  There was no product quality complaint.  No further information is available.
Hives; Really bad body aches; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PAIN (Really bad body aches) and RASH (Rash) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced URTICARIA (Hives), PAIN (Really bad body aches) and RASH (Rash). At the time of the report, URTICARIA (Hives), PAIN (Really bad body aches) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included Benadryl, Zyrtec and Pepcid.  Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Approximately three hours after the shots,  started screaming uncontrollably for 30 minutes. The doctor's office had warned us of this and told us to give Tylenol when it occurred. After about 15 minutes the cryiyng stopped.   From 6-15 weeks, had been sleeping through the night. The day we got these shots he stopped sleeping through the night (waking every hour) and didn't sleep more than an hour at a time until the following January, 2004.
Injection site left deltoid. Patient said 2 hours after injection arm hurt so bad they went to the ER.
My daughter presented with a fever of 101.9 and complaints of chest tightness about 24 hours after her 2nd Pfizer vaccine. She also was coughing a very shallow, tight cough that was triggered by trying to take a deep breath. She rated the chest tightness a 7/10. By bedtime, fever down to 100.1 without any medication. Gave one ibuprofen for chest tightness. The next morning she was feeling much better and said she could barely feel chest tightness. As day progressed and over next several days, the symptom would come back, but was mild. Pediatrician saw her on 6/4 - no abnormal findings. Due to lingering , though mild symptoms over weekend, pediatrician made referral for cardiologist. Cardiologist performed EKG on 6/9 and results normal.
72 hours of flu like symptoms, low grade fever.  Dull headaches and fatigue continue 12 days after injection.
Extreme itching and sensitivity in toes spreading to feet, legs and hands over several days.  Seen in ER 11/11/09, referred to neurologist.  Told Guillain-Barre.  Treated with Tegretol, Motrin.  11/20/09 ED records received service dates 11/11/09 and 11/16/09. Assessment: Guillain-Barre status post FluMist for H1N1. Presented with complaints of bilateral foot, toe and hand pain. Later presents with paresthesias, toes and fingers ache at tips. Constipation. To see neurologist. 12/09/09 Neurology consult  records received for DOS 11/11/09 DX: mild Guillain Barre syndrome is a consideration; dysesthesias consistent with a peripheral neuropathy.
I received my first Pfizer vaccine shot on a Thursday afternoon as referenced in this report. I had no issues immediately after the shot. However, I woke in the night with an extreme case of tinnitus. I have had tinnitus for many years, but, my tinnitus issue worsened horribly just 12-13 hours after my injection. My doctor recommended waiting 3 weeks to see if my condition would improve. It has not. It's now been over a month and I am still stuck with a debilitating tinnitus hiss, and, ringing in my left ear. I am scheduled to see audiologist and ENT in the next 10 days. I am also seeking counseling to help with the mental struggle I am currently facing due to the worsening of my tinnitus.
chest fluttering, tightness and wheezing within one hour after vaccination. Used Maxair inhaler/Singular from 11-11-08 to 11-16-08
Injection site swelling, induration redness. Treated with Keflex for possible secondary infection.
severe pain in bilateral wrists and elbows, heaviness and weakness in arms ongoing for 3 months
A report from a Health Professional concerns a 7 year old female patient. Medical history and concomitant medication were not reported. On 17-Oct-2014 received FLUMIST QUADRIVALENT (intranasal). Lot number was CJ2127 and expiry date of 31-Dec-2014. Patient had Influenza A test and result was positive with a diagnosis of influenza A which started on 22-Dec-2014. Further, there was worsening of flu symptoms. Patient was treated with TAMIFLU. The outcome of the influenza A and lack of efficacy was unknown. The company physician identified and assessed the lack of efficacy to be serious as an important medical event and other symptoms to be non-serious.
Redness, rash, swelling, pruritis on right deltoid area where 2 vaccines were administered; tx included icing, Benadryl, ibuprofen, Allegra.
Next evening after the vaccine (9/24/19), on the ventral aspect of the left arm from injection site to elbow was red, hot, painful to movement, swollen. Symptoms lasted until 9/27/19. Patient took Benadryl from 9/25-9/27 and did not seek medical care. Condition was self-resolved.
patient received imovax intramuscularly into their gluteal area/doses were administered to the incorrect location and need to be re-administered with no reported adverse event; Initial information received on 12-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 23 years old female patient who received RABIES (HDC) VACCINE [IMOVAX RABIES] intramuscularly into their gluteal area/doses were administered to the incorrect location and need to be re-administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Jun-2023, the patient received an unknown dose (dose 1) once of suspect RABIES (HDC) VACCINE (Powder and solvent for suspension for injection) (lot: V1B591M; expiry date: 10-May-2024) via intramuscular route in left gluteal region for immunization. On 09-Jun-2023 she also received a dose 2 of the same vaccine (lot: V1B591M; expiry date: 10-May-2024) via intramuscular route in right gluteal region for immunization.  On 05-Jun-2023 the patient received imovax rabies vaccine intramuscularly into their gluteal area/doses were administered to the incorrect location and need to be re-administered with no reported adverse event (product administered at inappropriate site) (latency: same day).  It was reported, "Caller noted that the patient/patient's family realized the incorrect positioning for administration. Caller had further questions about when to restart the rabies vaccine series. Do they need to wait until the next scheduled date or should they start it sooner? The next scheduled date in the series would be 16JUN2023. Caller would like to know how to proceed and whether they could start the revaccination series earlier? Caller requested any additional information available in regards to when the series should be restarted as there was limited information available in this document."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 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 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.
Postmenopausal bleeding.  Period started on 5/17/21, again on 6/13/21, again on 8/18/21 and again on 9/21/22.  I have been in menopause for 13 years with no periods.
Injection site swelling; Injection site pain; Injection site redness; swollen area was feverish to the touch; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site redness, feeling of warmth and fever. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site redness, feeling of warmth and fever were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site redness, feeling of warmth and fever to be related to Shingrix.  Additional details were provided as follows: The patient experienced fever and the area of the injection was swollen, sore, and red. The swollen area was feverish to the touch.
KINRIX given to a 4mth old. Intended for 4-6year old. No adverse reactions.