chrisvoncsefalvay/vaers-outcomes huggingface dataset:
70 yo man who presented to Facility on 1/6/2022 with sepsis, fever, acute hypoxic respiratory failure and COVID pneumonia. He needed high flow oxygen and Bipap for several days, became increasingly more confused and impulsive and transferred to the ICU. Copmlicating his hospital course was AFib - stable on metoprolol, renal dysfunction, DDimer elevation likely associated with COVID, elevated LFTs associated with sepsis, steroid-induced hyperglycemia requiring insulin, and metabolic encephalopathy associated with hypoxemia and critical illness. The patient's oxygenation and work of breathing worsened as did his dependence on BiPap. Ongoing discussions with family who were opting for a short term trial of intubation until 1/13/22 at which point the patient decided "I'm done" and wanted the Bipap off and did not want escalation of cares. The family presented to bedside on 1/13/22 to be with the patient who transitioned to comfort cares on his own accord.  The p70 yo man who presented to Facility on 1/6/2022 with sepsis, fever, acute hypoxic respiratory failure and COVID pneumonia. He needed high flow oxygen and Bipap for several days, became increasingly more confused and impulsive and transferred to the ICU. Copmlicating his hospital course was AFib - stable on metoprolol, renal dysfunction, DDimer elevation likely associated with COVID, elevated LFTs associated with sepsis, steroid-induced hyperglycemia requiring insulin, and metabolic encephalopathy associated with hypoxemia and critical illness. The patient's oxygenation and work of breathing worsened as did his dependence on BiPap. Ongoing discussions with family who were opting for a short term trial of intubation until 1/13/22 at which point the patient decided "I'm done" and wanted the Bipap off and did not want escalation of cares. The family presented to bedside on 1/13/22 to be with the patient who transitioned to comfort cares on his own accord.  The patient expired as expected on 1/13/2022 at 1656 with family at bedside.    Cause of death: acute hypoxic respiratory failure secondary to covid-19 pneumonia. Patient expired as expected on 1/13/2022 at 1656 with family at bedside.    Cause of death: acute hypoxic respiratory failure secondary to covid-19 pneumonia.
Information has been received from a physician concerning a 20 year old female patient with a history of positive human papilloma virus prior to starting GARDASIL series who on an unspecified was vaccinated with the third dose of GARDASIL. The physician reported that the patient developed fever, headache and flu like symptoms that persisted for 5 days after receiving the third dose of vaccine. The patient was due to receive her third dose in August 2009 but had delayed it because of that reaction. On an unspecified date the patient recovered from fever, headache and flu like symptoms. The patient sought medical attention at the office. Follow-up information has been received from a health care professional who indicated that the patient was a student with a history of abnormal papsmear. According to the reporter, on 17-APR-2009 the patient received intramuscularly her second dose of GARDASIL (Lot # 661954/1496X) into her right deltoid at 11:27 AM. There was no illness at the time of vaccination. The patient stated that she had fever and flu like symptoms with the second dose of GARDASIL (previously reported as third dose). No further information is available.
pt experienced 10/10 lower back pain across her upper buttocks, bilaterally and extending across the spine, 30 seconds after administration of flu and pneumovax.  Never had similar pain before.  Lasted about 5 minutes.  Normal vitals during attack, including O2 sat, exept rapid shallow respirations due to the pain.  After that, noted mid upper chest pressure for about 3 minutes, without SOB, diaphoresis or radiation.  Symptoms occurred while seated; made her squirm and moan and very distressed, due to the intensity of the pain.  Significant PMHx:  yearly flu shots without reaction, osteoporosis on Fosamax.
Tested positive for COVID19 Virus; Weak; Chills; Body aches; Headache; Backache; Cough; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), COUGH (Cough), SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 Virus), ASTHENIA (Weak) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Heart disorder. Concomitant products included LEVOTHYROXINE and PANTOPRAZOLE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced BACK PAIN (Backache), COUGH (Cough), ASTHENIA (Weak), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache). On 17-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 Virus). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 26-Feb-2021, BACK PAIN (Backache), COUGH (Cough), ASTHENIA (Weak), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 Virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to Jacobi Hospital and received antiviral IVE Bamlanivimab and IV infusion for testing CVOID-19 positive. The patient was quarantined for 14 days. The treatment medications given were cough syrup and Extra strength Tylenol.
I had body aches lasting for 12 hours and a low grade fever of 99.5. After 12 hours, my fever seemed to break and still had minor aches. By the 2nd day after receiving the vaccine, I was back to normal.
My stomach was hurting, almost felt like an ulcer last night (day I received the vaccine.) My stomach still hurt this morning until about 11:30am, and now I have felt nauseous, absent minded, and lethargic all day.
Information has been received from a pharmacist referring to a female patient of unknown age. Information about patient's concurrent conditions and medical history was not reported. On an unspecified date in January 2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose not reported) intramuscularly instead of subcutaneously. Concomitant medications were not provided. On an unknown date the patient experienced congestive heart failure after receiving ZOSTAVAX> The patient had seek medical attention via an office visit. Beta blocker was given for congestive heart failure. The outcome of the congestive heart failure was reported as not recovered. Additional information has been requested.
Headaches random areas of head. Pain/pressure behind both eyes. Extreme fatigue. Hard to get out of  bed for 2 days. Even resting feels like it's work and I can't get comfortable. Poor sleep. Night  sweats-then chillls. Pain deep In both armpits. Nausea. Body starts to shake when I don't rest. Taking a  shower wears me out. Neck hurts and my head feels heavy to hold up. Feels like a migraine and noises  really bother me. Brain Fog is off the charts ll
This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # K015994, exp. date on 23-SEP-2016, and Lot # L008275, exp. date on 11-MAR-2017, (strength, route of administration and dose were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
has not received a 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient had not received a 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 24-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 19-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 468 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received 1st dose of moderna covid 19 vaccine on 3/25/21 and neglected to inform staff that she had recieved 1st dose on 3/19/21 from another facility.
intermittent burning/tingling in arms, fingers, upper chest, legs, and feet; burning pain and fatigue worsened as day progressed; symptoms the worst about 1-2 weeks following vaccine; these symptoms have lessened, but still occasionally get burning/tingling in extremities.  9/12/08 Reviewed PCP office vaccination records of 6/10/2008. FINAL DX: irritabile bowel syndrome Records reveal patient exprienced bloating, decreased appetite, loose stools, discomfort of chest & arms intermittently
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 13-OCT-2014, the patient was vaccinated inadvertently with an expired dose of VARIVAX (Merck), Lot # H017440 and expiration date on 19-SEP-2014. No adverse effects reported. Additional information has been requested.
Patient arrived at Health Dept. to received #2 dose Of Moderna.  He  denied any side effects from #1 vaccine. . Patient was transferred to  "Holding area" for 15minutes. When time to leave he began to c/o dizziness with headache 2/10 . He denies blurred vision.  No neuro deficits/ VVS 142/80,92HR,92% o2Sat. Fluids offered. . He remained alert  and responsive throughout evaluation.  Patient stated he would go to  Clinic for further evaluation. Ambulated  to car without assistance . Gait steady.
Tachycardia Jittery, Flushing Narrative: Employee was vaccinated with Moderna COVID vaccine at approx 1130am. Within 10 minutes she reported a "flushing sensation", "feeling jittery" and was tachycardic with initial pulse approx 140. She was A&Ox3. EMS called for evaluation.
pt recvd vax 10JUL95 & w/in 3-4 hrs post vax pt got fussy w/inc severity to point @ which sedation was administered @ MN;
Constant pain in deltoid muscle and possibly in joint. Pain increases with extension, which renders certain movements impossible. It seems to be getting worse over time.
This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, 1 hr post administration, the patient experienced sudden onset of chills, vomiting, fever, pallor, diarrhea and also flu or flu like illness (rapid flu & strep negative) and viral gastroenteritis. The patient was not admitted to hospital. The reporter assessed there was a reasonable possibility that the event is related to suspect product. Sender's Comments: Linked Report(s): US-PFIZER INC-2017181830 same reporter/drug/event, different patient;US-PFIZER INC-2017181368 same reporter/drug/event, different patient.
Injection site reaction with diffuse swelling and blotches present from shoulder to elbow. Patient reports elevated heart rate and pain. Patient presented to the Emergency Room and was treated with BENADRYL and Prednisone. Arm is improving as of the following day.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 at 12:00 as dose number unknown (booster), single (Lot number: FH8027) at the age of 47 years for Covid-19 immunisation; CoviD-19 vaccine Janssen (COVID-19 VACCINE JANSSEN), on 30Mar2021 at 12:00 as dose 1, single (Lot number: 1802068) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer (Paxlovid), Treatment start date: 12Jun2022, Treatment stop date: 16Jun2022, lot number: G00470, Indication: Treatment of COVID-19. Sender's Comments: Based on limited information in the case, a possible causal association between the reported events Drug ineffective, Covid 19 and the suspect drug cannot be excluded.
Information has been received from a physician concerning a pt who was vacinated with a dose of varicella vaccine. Subsequently, the pt experienced severe chicken pox. The pt recovered from the severe chicken pox. Additional info has been requested.
10/4/18-hard lump, surrounding area warm, swollen, red, and itchy. Continues as such until today 10/19/18.
7 X 7 CM AREA OF REDNESS AND SWELLING TO INJECTION SITE OF VARICELLA ON RIGHT ARM. GIVEN TYLENOL AND IBUPROFEN BY MOM PRIOR TO COMING IN TO OFFICE. CHILD ALSO C/O ITCHING TO SITE. PRESCRIBED ZYRTEC AND MOM INSTRUCTED TO APPLY ICE TO AREA.
I had a hot, swollen, red area on my arm starting about 24 hours after my vaccine. Each day since, it's kind of gone up and down, from almost not there, to fairly swollen and red and itchy and again, sometimes with a rash around it. There's a hard lump below the red area that's tender if I touch it. The day after the vaccine, my arm was sore, but that only lasted a couple of days, like getting a regular vaccine, just a bit worse. I had a sore throat for two days, starting 2 or 3 days after the vaccine, and symptoms like I was about to come down with a cold- congestion, fatigue, raspy voice. Those symptoms lasted until a week after the vaccine, but seem to be subsiding.
Loud electrical buzzing in the ears.  I drove home from the injection and was freezing and shaking.  The buzzing was noticed when I got out of the car.  It has been constant since.  I have lost hearing since the injection.  I was on a steroid for a knee injury and while taking the steroid the buzzing was diminished.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 74-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 04-OCT-2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a healthcare professional for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Per caller all patients, asymptomatic/ No additional AE's/PQC's reported.; Caller reported a temperature excursion for frozen products. Caller notes PROQUAD administered to (3) patients; This spontaneous report was received from a nurse (vaccine provider), referring to a 5 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant therapy were not provided.  On 12-APR-2021, the patient was vaccinated with improperly stored (frozen) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # T010288 has been verified to be a valid lot number, expiration date reported as 20-SEP-2021) (strength and route were not reported) at a dose of 1 (unit not provided) for prophylaxis, administered by the reporter (incorrect product storage). The vaccine was stored under - 6.8 degree Celsius for 3 hours and 54 minutes. It was reported that there was no previous temperature excursion. The patient was asymptomatic, and there's no adverse reaction. No additional adverse event (AE) or product quality complaints (PQC) were reported.   This is one of several reports received from the same reporter.
Case number PHEH2013US021639 is an initial spontaneous report received from a health care professional on 11 Oct 2013. This report refers to an 11-year-old male patient. He was vaccinated with MENVEO (batch number: A1105, expiry date: 30 Apr 2014) at a dose of 0.5 ml intramuscularly on 07 AUG 2013. It was reported that before vaccination, MENVEO vials had reached 32 Fahrenheit on two occasions; therefore, he received MENVEO that went below the recommended temperature range (reporter stated that crystallization might have occurred, which destroyed the vaccine). After vaccination, he complained of injection site reactions and was taken to the clinic. He had increased redness in the arms, hot to touch and pink area of the upper arm that did not help with ibuprofen. Finally he was diagnosed with cellulitis at the injection site, on an unspecified date and was prescribed with BACTRIM. Outcome of the reactions was reported as resolved. No seriousness and causality was reported for the events.
high fever, nausea, chills, headaches for three days after, and itchy blisters on trunk and thighs starting the 3rd day and lasting for about 4 days
Pfizer 7/30/21 and 8/20/21. Positive on 1/18/22
Patient was administered booster dose in series 1 week too early for severely immunocompromised. 1st dose given 1/13/21, 2nd dose given 2/4/21, and 3rd dose given 8/18/21 at Pharmacy. Per current guidelines, 5 months from 3rd dose would be 1/18/22. Nurse read note from patient's doctor stating that patient was eligible to receive "4th dose", but did not verify that it has been 5 months since the 3rd dose. Patient did not experience any adverse effects as a result.
Patient reported feeling light headed and passed out about 5 minutes after injection.  Immediately returned to consciousness.  Patient reclined until feeling ok to sit up.  Gave patient juice as mom reported patient hadn't eaten.  Patient waited in area for approx. 30 minutes and reported feeling fine.  Follow-up call on 1/8 -- parent reports that patient was completely normal without any side effects or residual effects from episode.
no adverse effects; administered IM instead of SC; This spontaneous report was received from a pharmacist referring to a patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 17-NOV-2020, the patient was vaccinated with a dose varicella virus vaccine live (oka/merck)(VARIVAX) lot # S002084, expiration date 21-JAN-2021 for prophylaxis (strength, dose, frequency were not reported). The vaccine was inadvertently administered intramuscularly rather than subcutaneously to the patient. No adverse effects reported.
Rash started on 4/16 on injection forearm and spread to right upper arm and shins.  The rash itched and looked like clear blisters, burning sensation.  Applied topical hydrocortisone cream.  Severity over a week. Less severe now, but not gone.