chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient did not wait the recommended period; Dermal fillers; This spontaneous case was reported by a nurse and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient did not wait the recommended period) and DERMAL FILLER INJECTION (Dermal fillers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021. Concurrent medical conditions included Drug allergy (MORPHINE).    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient did not wait the recommended period) and DERMAL FILLER INJECTION (Dermal fillers). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Patient did not wait the recommended period) and DERMAL FILLER INJECTION (Dermal fillers) 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.   Concomitant product use was not provided.  Treatment information was not  provided A nurse from Emergency care, called and seemed hesitant in providing additional demographic information and only wanted her question answered.  1st dose received: month after having covid infection, Apr,2021 (no specific date provided) Lot#: 043B21A, Expiration: unknown. She stated she is calling about a Spanish speaking patient with a language barrier. The patient had covid this year in March but received her 1st dose in April,2021 and is there today for her 2nd dose and persistent in receiving her 2nd dose. The nurse stated that the patient did not wait the recommended period from covid infection before receiving her 1st dose and stated that her 3 months are not up yet before the vaccination.     The nurse stated that patient has various allergies (morphine) and had dermal fillers but was unable to state whether the dermal fillers were before or after receiving the 1st dose. The nurse stated that she cannot provide any additional information about the patient.     The nurse declined when asked for consent to safety for follow up and did not want information in written form.     Since the patient presented today to receive her 2nd dose, the nurse asked, can the patient get the 2nd dose or does she have to wait?
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006769:  US-009507513-1808USA006770: US-009507513-1808USA006771:  US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
A blast of pain in the right side of my head woke me up out of a sound sleep, i think i heard a slight pop  right before and as soon as the intense pain came, it radiated outward and away from between my temple and right ear upward and was gone in a matter of 2 to 3 seconds. I have never felt anything  like this, or scare me as much to make me think it might be life threatening as this. I couldnt sleep right after for 1.5 hours and I emailed my primary doctor immediately. In the morning,  I spoke on the phone to 2 Nurses at my docs office before bs. hours who advised me to go to the emergency. rm for a CTA and did. I've never really had headaches that have amounted to much.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 11-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
SUPRACLAVICULAR LYMPHADENOPATHY  PATIENT STATES: 7 DAYS AFTER INITIAL INJECTION NOTICED PAINFUL SWELLING - LYMPH NODES TENDER TO TOUCH TO  THE POINT OF UNABLE TO HAVE BRA STRAP IN PLACE. THIS SITE HAS  CONTINUED TO ENLARGE
Pt develop redness around the injection site, about 1.5 inch in diameter. It is getting itchy the last couple day. Pt took benadryl to help with ichiness.
Initial needle puncture made in error with syringe with no contents - air, gas, liquid or otherwise.  Syringe plunger was depressed without any movement of plunger.  Administration error noted by Vaccinator post attempted vaccination and subsequently reported issue to Lead.  All supplies and doses were reconciled, patient mother notified and verbal consent obtained to vaccinator to proceed with vaccination of the patient.  Full dose of vaccine was provided and verified - given without further incident.
Narrative:  74 yo M with PMH of asthma, received COVID-19 booster (3rd dose Pfizer) and within 4 hours had chest discomfort. Did not have any reaction to first two covid-19 vaccine doses. Evaluated by pulmonologist following 3rd dose, pulmonologist attributed chest pain to worsening asthma. Symptoms resolved within 1 month.
worms in my body / injected me with horsehair worms; huge mass in my arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HELMINTHIC INFECTION (worms in my body / injected me with horsehair worms) and INJECTION SITE MASS (huge mass in my arm at injection site) in a  patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced HELMINTHIC INFECTION (worms in my body / injected me with horsehair worms) and INJECTION SITE MASS (huge mass in my arm at injection site). At the time of the report, HELMINTHIC INFECTION (worms in my body / injected me with horsehair worms) and INJECTION SITE MASS (huge mass in my arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Company Comment: This spontaneous case concerns a  patient of an unknown age and gender, with no medical history reported, who experienced the unexpected event of Helminthic infection and Injection site mass. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The outcome of the events was reported as unknown. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a  patient of an unknown age and gender, with no medical history reported, who experienced the unexpected event of Helminthic infection and Injection site mass. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The outcome of the events was reported as unknown. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pt. c/o severe nausea, vomiting, diarrhea and dizziness. Visit to primary care physician on 8/5/16; tx. with injectable for nausea/vomiting; RX. for PO PHENERGAN. Pt. stated reactions lasted approx. 24 hrs.
The patient lost consciousness and did not have a pulse. She was also seizing. An epipen was administed and she regained consciousness and Heart rate but was still disoriented
severely dehydrated; threw up; A spontaneous report was received from a nurse concerning a 22-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) who experienced events threw up and severely dehydrated.  The patient's medical history, as provided by the reporter, included eczema. Concomitant medications reported included unspecified eczema medication.  On 28 Dec 2020, approximately 6-9 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 03 Jan 2021, the patient went to eat and threw up. She took Dramamine and Tylenol. On 06 Jan 2021, the subject went to the doctor and had an IV placed as she was severely dehydrated. Treatment for the event included Dramamine, paracetamol, and IV drip.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I am pregnant. I was approximately 6 weeks and 6 days pregnant on 01/13/2021. I am estimated to deliver on 08/26/2021.  At approximately 2:00 am on 01/14/2021, I woke up in the middle of the night experiencing chills. I experienced having chills throughout my body (hot, cold) throughout the day and they subsided by the morning of 01/15/2021. I had a headache throughout 01/14/2021. I had body aches throughout 01/14/2021. I did not have an appetite and ate very little on 01/14/2021. I continued to drink water and Gatorade throughout 01/14/2021. I check my temperature throughout 01/14/2021 and it remained normal throughout the day. By the mid-afternoon of 01/15/201, all of these symptoms resolved.
chills; nausea; vomiting; body aches; headache; fatigue; night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 09:15 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "tuberculosis" (unspecified if ongoing), notes: history of having tuberculosis as a toddler. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot unknown=True, administration date=26Mar2021, administration time=09:15 AM,, dose number=1,, vaccine location=Left arm), administration date: 26Mar2021, when the patient was 47 years old, for Covid-19 immunisation, reaction(s): "body aches", "nausea", "fatigue", "chills", "arm soreness at the injection site". The following information was reported: CHILLS (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "chills"; NAUSEA (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "nausea"; VOMITING (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "vomiting"; PAIN (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "body aches"; HEADACHE (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "headache"; FATIGUE (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "fatigue"; NIGHT SWEATS (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "night sweats". Therapeutic measures were not taken as a result of chills, nausea, vomiting, pain, headache, fatigue, night sweats. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355657 Same patient and product; different events and dose
Welts/rash on my left arm around the injection site. Started with a small bump around the injection site the morning of 2/3/21. By end of day, the welts had spread to a larger portion of my arm. Sore/tight arm, slightly itchy.
Pt recv vax on 10/7/98; on same day pt exp fever (99.1), inconsolable crying, excess sleeping, red vax site -lt leg; tx=Tylenol
Intermittent, spontaneous shortness of breath and tachycardia without activity, chest pain that radiated to the mid-upper back, right shoulder and up the next. Extreme fatigue with any exertion, (yard work, work out activity) and decreased ability to recover. Stamina is half of what it used to be requiring many rest periods during outside work.
swollen upper arm area; arm hurts; sore arm; redness around the injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen upper arm area), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness around the injection) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, OXYBUTYNIN and clareton for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen upper arm area), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness around the injection). At the time of the report, PERIPHERAL SWELLING (swollen upper arm area), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness around the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by Reporter.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 1/22/21 (lot NA) Pfizer Dose 2 2/12/21 (lot NA) COVID Positive 12/18/21  12/25/21: This is a 57 yo male patient who presented to the ED today b ecause of COVID infection via ambulance  The patient has underlying intellectual disability ( could not confirm per chart review but I called the brother who reports patient was born with speech impairment)  Patient lives with his mother who recently was in the hospital until yesterday. He currently is not able to provide much history  The patient tested positive for COVID on December 18th. Per his brother he was vaccinnated with 1 shot of vaccine of unknown brand. He has been having a cough that is non productive without associated shortness of breath. He has been feeling weak with decreased activity, decreased appetite  Patient has history of insulin dependent diabetes, hypertension, hyperlipidemia  He underwent blood work in the ER with a negative d-dimer, elevated potassium at 6.4, renal dysfunction with BUN/Cr 2.12, venous pH at 7.19. CXR shows concerns for viral pneumonia. He was given NS boluses and started on D5W sodium bicarbonate drip. He underwent preliminary treatment for hyperkalemia in the ED. Nephrology was consulted by EDP  Patient's blood pressure is borderline in the ED, responsive for IVF. I have asked EDP to further stabilize prior to transferring to the floor  12/28/21: Patient is admitted hospital, kept on contact and droplet precautions, started on empirical IV antibiotics with ceftriaxone doxycycline along with dexamethasone and supportive care.  Pulse ox is monitored.  Patient is noted to have acute urinary retention, indwelling Foley catheter is placed.  On-call urologist Dr is consulted, and he recommended indwelling Foley catheter placement and outpatient follow-up with Urology.  Nephrology consult is requested for acute kidney injury and hyperkalemia, patient is seen and followed by Dr, fluid management is done as per her recommendations, with IV bicarbonate drip. Hyperkalemia has resolved, renal function is normalized. Patient is afebrile, hemodynamically stable, hypoxic as well, saturating well on room air.  He was given given IV remdesivir due to acute kidney injury.  His blood pressures were soft, antihypertensives were held and was started on midodrine.  Patient's blood pressure stable now, metoprolol XL is resumed.  Lisinopril is discontinued due to acute kidney injury and hyperkalemia.  Patient is stable for discharge today.  His lisinopril is discontinued, this needs to be addressed as outpatient.  Is discharged on midodrine 2.5 mg p.o. t.i.d. for 1 week.  Is also discharged on oral prednisone and doxycycline with supportive care.  Also is discharged with indwelling Foley catheter, needs outpatient follow-up with Urology.  He is started on Flomax daily.  He is discharged visiting nurse services.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
during order prep for dose 2 of pfizer vaccine we noticed that the first dose, given when he was 12, was the pediatric version and dose of 0.2ml.  This dose was given on 12/29/21
I feel not so good in my heart area; I feel like a pressure in the chest area; I do not feel good; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 29Jul2021 as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated I got the vaccine couple of hours ago (Like two hours ago) and i feel not so good in my heart area, i feel like a pressure in the chest area, i do not feel good on 29Jul2021. Patient stated tell me if it is normal or if it could be bad you know because I was afraid to get the vaccine and now I feel bad you know. Consumer wanted to know what to do if it would get worse whether to go to the hospital or something. The clinical outcome of event was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
unborn fetus of 14 weeks and 5 days died. no other explanable cause.
Severe fatigue, nausea, chills, fever, body aches, pain in left arm which developed into a red itchy rash.
Pentacel that reached 33.5C; 11 years old patient received pentacel vaccine; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional   This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves an 11 years old patient (gender not reported)who was vaccinated with a 0.5 ml fourth dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ013AAA and Exp. Date 10-OCT-2020) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C  The patient's medical history not reported and concomitant medications not received.  No other vaccine was given that day.  It was an actual medication error case due to inappropriate age at vaccine administration and incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  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 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.  List of documents held by sender: none.
RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/07/2021. ON 02/20/21 WENT TO URGENT CARE WITH COMPLAINTS OF LOWER BACK PAIN AND LOWER ABDOMINAL PAIN X4 DAYS. DIAGNOSED ACUTE RIGHT FLANK PAIN AND RUQ ABDOMAINL PAIN. SENT TO ER FOR IMMEDIATE EVALUATION. ON 02/20/21 WENT TO ER FOR RUQ ABDOMINLA PAIN THAT RADIATE STO RIGHT FLANK. DIAGNOSED WITH BILARY COLIC AND CALCULUS OF GALLBLADDER WITH OUT CHOLECYSTITIS WITHOUT OBSTRUCTION.   ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL.
Site reaction within 5 minutes of vaccine, swelling taken down with Benadryl. One week (7 days) later she got a high fever that reached 104.3 f, red cheeks, and nasal congestion. The fever lasted 3 days and then a measles-like rash appeared on her back and chest and spread to her face. Currently has rash, day 11 since MMR vaccine.
Patient was anxious on arrival.  History of tachycardia.  610pm reports tachycardia.  Vital signs:  RR 22, o2 Sat % 99, HR 185, BP 140/92. No diaphoresis or SOB noted.  Talkative.  Tachycardia resolving. At 630pm she reported tingling and numbness allover, states she remains anxious and would like to go to ED.  ED adjacent to Medical Office Building- transpoted by PVT by spouse.  LPN to ED with Patient.  No distress noted at time of transport or on arrival.  620pm Vital Signs BP 120/84, HR 115 O2 Sat 99% and RR 17.
All of a sudden the flutters would come and I would have headaches when I first got up in the morning. I had body aches, would last all day and I already had pain in the knees but seem more than usual.  The pain in the knees come and go.
Post vax, the pt complains of screaming since vaccines. Increased gas; this could be cause or effect reaction to shots vs coincidental viral gastroenteritis. Treated with Pedialyte for 2 feeds then advance to formula. Call if she seems ill.