chrisvoncsefalvay/vaers-outcomes huggingface dataset:
-"next day aching all over and totally no strength" -"every bone was putty" -next 4 days in bed sleeping -"it was terrible."  Today, patient reports: -"finally beginning to feel a little less tired" -still has an "awful lot of saliva in mouth"
Tested Positive for COVID 19 No prior symptoms or known exposures Flu Like Symptoms occurred Day after Running nose 2 days after Sore Throat
TOOK THE FIRST DOSE OF VIVOTIF ABOUT 4 DAYS AGO AND HAS NOT TAKEN THE REMAINING DOSES YET; This spontaneous case report (PVX2019-2897) was received from a consumer on 21-Nov-2019. It described a 25-year-old male consumer who "took the first dose of Vivotif about 4 days ago and has not taken the remaining doses yet" (PT: Product dose omission). He was receiving oral Vivotif for typhoid fever.  Case report: The consumer took first dose of Vivotif four days before reporting. It was reported that the consumer has not taken the remaining doses till the time of reporting.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the events "took the first dose of Vivotif about 4 days ago and has not taken the remaining doses yet" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the events "took the first dose of Vivotif about 4 days ago and has not taken the remaining doses yet" was considered as not applicable.
Acute onset of localized pain and tenderness around in the left scapula. Recurrence of Sx in the same region after the second dose on 1/15/2021. Sx more severe this time along with development of weakness in the same arm, specifically affecting hand muscle strength.
3 days after injection developed left arm pain, swelling.  persisted when presenting for second injection 4 weeks later which was deferred.  evaluated next day in clinic.  reported feeling feverish, left arm pain weakness which was in a sling.  noted have swelling with moderate edema in hand.  tender left lateral shoulder, hand.  decreased strength in arm, hand possibly due to pain.  no lymphadenopathy.  afebrile.  WBC normal.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 27-JUL-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Afebrile, tonic-clonic generalized seizure during school on 11/13/09. Duration < 1 minute.
Patient brought in by ambulance for respiratory distress, recent DX of COVID; given 2 breathing treatments w/o relief; 500 mg ketamine, 10 of vec, 2 DuoNebs and 1 solumedrol prior to arrival by EMS. Allergies: Lamictal, penicillin, sulfa, tape, cephalexin, emycin, azithromycin, and morphine. HPI: sob, came to ER 2 days prior with SOB; associated symptoms included fever, chills, weakness, fatigue, cough, nausea, vomiting; patient has HX of AFib, HTN, and a trach from OD 3 years prior. Endotracheal intubation 09/07/21
Shivering, slight nausea, diarrhea, headache and 99.5 fever.
His stomach was upset; Nausea; Vomitting; Diarrhea; Feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (His stomach was upset), NAUSEA (Nausea), VOMITING (Vomitting), DIARRHOEA (Diarrhea) and MALAISE (Feeling sick) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced DYSPEPSIA (His stomach was upset), NAUSEA (Nausea), VOMITING (Vomitting), DIARRHOEA (Diarrhea) and MALAISE (Feeling sick). At the time of the report, DYSPEPSIA (His stomach was upset), NAUSEA (Nausea), VOMITING (Vomitting), DIARRHOEA (Diarrhea) and MALAISE (Feeling sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Nurse called another nurse over to her station.  Client was talking to partner.  Suddenly went silent and started grunting.  Client pale and sweating.  Eyes wide open, fixed and dilated.  Client's tongue was out.  One ammonia tablet was popped with no effect another was popped and EMS was called.  Client remained unresponsive for 45 seconds.  Suddenly client awakened and started shaking head and pushing ammonia tablet away.  Client began talking and color returned to his face.  He was being fanned and given water and apple juice.  Client continued to sweat but said he "felt better."   Paramedics arrived.  Client alert and oriented and stated that he did not need to go to the hospital.  Once the paramedics cleared him, he sat for another 30 minutes to ensure there were no other issues.  Client stated he did not eat breakfast so food was advised at the time of departure.   Client walked out with no assistance.
Case number# PHEH2014US014069, is an initial spontaneous report from a health care professional received on 07 Jul 2014. This report refers to an 11-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: A12132) intramuscularly at a dose of 0.5 ml on 02 Jul 2014, that had a temperature excursion to 9 degrees Celsius for 1.5 hours on 01 Jul 2014. No adverse event was reported following the medication error.
The day of my shot my right ear got very hot. The next day I had ringing in my right ear. It has been constant ever since.
blood glucose would go really high or dangerously low as low as 50 or 60s/ sugar would be low even after eating; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE FLUCTUATION (blood glucose would go really high or dangerously low as low as 50 or 60s/ sugar would be low even after eating) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN for Diabetes.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced BLOOD GLUCOSE FLUCTUATION (blood glucose would go really high or dangerously low as low as 50 or 60s/ sugar would be low even after eating). On 26-Mar-2021, BLOOD GLUCOSE FLUCTUATION (blood glucose would go really high or dangerously low as low as 50 or 60s/ sugar would be low even after eating) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included fruits and juice.
Developed a local skin reaction with swelling, redness, pain around 6x4 cm in size, raised by 1mm.  Recommended benadryl and cold compresses.
pt inadvertently recvd DTP instead of TD; pt felt tired & lethargic; no fever or any other sx reported;
I went into the pharmacy to receive my 2nd COVID vaccine. I handed the healthcare worker my vaccination card and waited in the designated waiting area. He came out and said I would be getting Pfizer. I remember asking him if that was allowed since my first dose was Moderna. He said yes. he administered the dose in my right arm and signed my vaccination card and I left. This was on 09/24/ 2021. Today, 02/28/22, I went into a pharmacy at a different location and was ready to receive my booster shot. I waited in the designated waiting area, and when it was time to receive the vaccination, she looked at my vaccination card once more and said she had never seen someone come in with two different doses for the first two COVID vaccines. She asked me to wait while she spoke with the pharmacist. She came back and told me that she cannot administer the booster shot because she believes there was a medication error with my first two doses. She advised me to speak with my doctor.
Loss of vision in the left eye; This case was reported by a pharmacist via call center representative and described the occurrence of loss of vision in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 5S43T, expiry date 5th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of vision was not recovered/not resolved.   It was unknown if the reporter considered the loss of vision to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and loss of vision in the left eye. The reporter did not consent to follow up.
Patient received both Fluvirin and Pneumovax in left deltoid and experienced soreness, redness, and her skin was warm to the touch about 6 inch patch of upper arm.  When reported on 10/3/2014 she stated it was getting better but she wanted to make sure it was ok.  I told her to apply cold compresses and take tylenol for comfort and if the condition worsens contact her physician.  She stated that she may have had a reaction like that once before with the pnuemonia shot but wasn't sure.
Large knot under skin at injection site, redness, soreness. 10 days after injection. ("Covid arm")
Flu like symptoms. Headache, muscle aches, fever 100.6. Weakness. Using TYLENOL per MD instruction.
With first vaccine patient complained of a large rash that progressed over a 3 week period with soreness and pruritis. With second dose of vaccine patient stated he had severe flu like symptoms consisting of severe freezing chills, sweat, and again the start of a rash that is progressing in size in arm in which vaccine was given in.
Dizziness; Rash on her injection arm that extended from her shoulder to wrist; Injection site is red; Injection site is swollen; Injection site is very itchy; Low-grade fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), RASH (Rash on her injection arm that extended from her shoulder to wrist), INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen) and INJECTION SITE PRURITUS (Injection site is very itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced DIZZINESS (Dizziness), RASH (Rash on her injection arm that extended from her shoulder to wrist), INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PRURITUS (Injection site is very itchy), PYREXIA (Low-grade fever) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Apr-2021, DIZZINESS (Dizziness), PYREXIA (Low-grade fever) and NAUSEA (Nausea) had resolved. At the time of the report, RASH (Rash on her injection arm that extended from her shoulder to wrist), INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen) and INJECTION SITE PRURITUS (Injection site is very itchy) outcome was unknown.            No concomitant medication was reported.
Cellulitis- Seen at ER 04/23/2005- Given Antibiotics.
Inferior STEMI. ED Visit and Hospital Admission. This visit was within 6 weeks of receiving the COVID vaccine,
Pt experienced a seizure event; became stiff and passed out for about 30 seconds. When he came to he expressed that he was dizzy and his neck hurts.
Inconsolable crying from 16:00 until 20:45 PM. R thigh painful, hard area, no redness, no fever. R thigh slightly swollen. On 5/4/06, 11:00 AM, temp. was 99.2F (ax). Decreased appetite. R leg 1 1/2cm area of induration. Not crying.
female patient received Flublok vaccine while she was pregnent/no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 25 years old female patient who was received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] while she was pregnant.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported. The estimated due date is 05-Jun-2020. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Dose reported for vaccines = 0.25-2 mL) lot number not reported via unknown route in the right deltoid.  It was case of vaccine exposure during pregnancy.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested.
67-year-old male presenting with complaints of diaphoresis and tingling in his extremities approximately 10 minutes after receiving his initial Covid vaccination.  He denies any history of allergic reactions like this in the past.  At the time he did feel lightheaded though he did not pass out.  He had been feeling slightly short of breath with onset of symptoms though it has improved now.  He has not taken anything for relief and overall feels slightly better than when symptoms began.  His blood sugar was approximately 270 Was discharged home with resolution of symptoms
cold and numbness in feet, and tinging and twitching of right arm, and numbness in arm, and losing strength
I woke up at 3am.  Could not get back to sleep for 2 hours, so decided to drink some  liqueur (Kahlua).  Because I very rarely drink alcohol, a little bit makes me sleepy.  After about 4 sips, I broke into a cold sweat, could barely manage to stand up and call out to my husband.  I then lost consciousness  (and wet myself).  (My husband caught me).  I have never fainted or passed out in my entire life!  I regained consciousness about 2 minutes later and then had the shakes for quite a while.  For the next day and a half I felt as if a truck had run over me.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 18-MAY-2015, the patient was vaccinated with a dose of M-M-R II lot # J003787, that had expired on 28-MAR-2015. No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Had a ZOSTAVAX injection approximately 48 hours ago. At 24 hours after injection, noticed extreme itching at injection site. Broke out in rash about the size of a tennis ball. Application of BENADRYL creme and ACYCLOVIR did not take away the itching. This morning, when fabric touches site it itches, but otherwise it seems to burn and I notice a numbness in the bend of my arm...feels tingly.
had a sore arm after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "infection of the chin" (unspecified if ongoing), notes: has been on an antibiotic prescribed by his HCP off and on for the past two months. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm after the first dose".  Additional Information: The patient was prescribed with an antibiotic by his HCP and has been on an antibiotic off and on for the past two months for an infection of the chin and was asking if he can take the antibiotics after dose 2. The patient received the second dose of the BNT162B2 on 26Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: patient came in to pharmacy to report that they went into the doctor and were seen and continue to be treated for lower body numbness and said they were being treated for Guillan Barre Syndrome.
Vaccine was given around 2 pm, by 6 am felt extremely achy, headache, wanted to stay in bed, flu like. By 11 am symptoms were completely gone.
This spontaneous report as received from a registered nurse refers to a 4 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 08-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
A serious, spontaneous report of conversion disorder reaction, facial muscles have not moved and numbness in toes and fingers was received from a consumer concerning a 12 year old female subsequent to FLUMIST. The patient has a history of psychosocial issues. The patient received GARDASIL the same day as FLUMIST. The patient received FLUMIST intranasal for Flu vaccination on 11-Nov-2008. On 11-Nov-2008 the patient was seen in the pediatricians office for chest pains and during the visit received FLUMIST and GARDASIL. Since 24 hours after administration the patients facial muscles have not moved and she has numbness in her toes and fingers. The patient subsequently was seen by a neurologist, cardiologist and the pediatrician for the events and an MRI was taken. Results are not available. The events are on going and the patient is scheduled to begin physical therapy. The responsible physician assessed the events as not related to vaccine administration and instead considered the event a conversion disorder reaction. The event is considered a serious important medical event.  1/2/09 Received PCP, ER & Neuro medical records of 11/24-12/3/08 FINAL DX: none provided; possible conversion reaction Records reveal patient experienced HA, weakness, difficulty walking, pain in all extremities x approx 3 wks.  Missed several days of school.  Had been seen in Urgent care 11/24 & 11/27 for sore throat, HA & body aches.  W/u WNL.  Dx w/viral illness & pharyngitis.  Flat affect, weight loss.  Required follow-up attempts have been performed, requested information unable to be obtained.
Not feeling well; Head doesnt feel clear, feel disconnected all the time; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), FEELING ABNORMAL (Head doesnt feel clear, feel disconnected all the time), CHILLS (Chills) and HEADACHE (Headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 033A21A) for COVID-19 vaccination.     The patient's past medical history included Hip surgery (Year ago but still have difficulty with her hip). Concurrent medical conditions included Heart disease, unspecified.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), FEELING ABNORMAL (Head doesnt feel clear, feel disconnected all the time), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MALAISE (Not feeling well), FEELING ABNORMAL (Head doesnt feel clear, feel disconnected all the time), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-039828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Reporter information was updated and second dose and first dose Batch/LOT numbers were added.
I developed a swollen red rash on my upper left arm, which I noticed on Thursday, December29th, 2022.  It quickly grew.  I went to the urgent care and was I took the 10 day prescription for Augmentin that I was prescribed. The swelling and rash seemed to subside.  After I completed the dose,  my rash flared up again.  I saw a Dr. on January 10, 2023.  He said it was ok to take the 10 day supply of doxycycline that another Dr. had prescribed if my rash got worse.  I am now in the middle of the course of doxycycline, and it seems like the rash is spreading under my left arm.  This morning I felt heat and throbbing under my left arm.
Headache, nausea/vomiting, fever.  Admitted to hospital with questionable meningitis diagnosis on 01/20/06.  Released from hospital on 01/23/06.  ???vaccine related???
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 12:00 as dose 2, single (Lot number: FE3594) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 21Mar2021 at 17:00 as dose 1, single (Lot number: AD26), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "hypertension (controlled)" (unspecified if ongoing), notes: other medical history: hypertension (controlled); "GERD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "migraine" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; ADVAIR; AMLODIPINE; OMEPRAZOLE; CETRIZINE; VIENVA; ALBUTEROL [SALBUTAMOL]; ZALEPLON; LORAZEPAM; EMGALITY [GALCANEZUMAB GNLM], start date: 04May2022; NARATRIPTAN, start date: 15Apr2022. Past drug history included: Morphine, reaction(s): "known allergies: Morphine"; Codeine, reaction(s): "known allergies: codeine". 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: (28Jul2022) Positive, notes: positive home antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.