chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain,swelling & redness of left thigh(site of injection).O/E Teft thigh swolen,tender,erythematous&warm to touch.Patient was admitted in Lincoln Hospital as possible cellulitis.   11/24/09:  Discharge summary and Hospital Records received from dates of service 10/29/09 to 10/31/09.  Final Dx:  Cellulitis of L thigh.  Assessment:  Presented with swelling and redness of L thigh, admitted for antibiotic therapy.  Hospital course uneventful, remained afebrile with normal PO intake.  Tenderness improved, minimal redness and induration on day of discharge.  ICD 9 code 682.6
I develop a decent sized bruise (1.5x size of a quarter) on the side of my right leg. I am not sure exactly when it developed but my roommate noticed it on the night of December 15th. The bruise is black and purple and red in the middle. I do not believe this is from a trauma event because I do not recall anything that would?ve happened to get this bruise.
Following the injection, I felt soreness in my arm at the injection site.  However, over the following days, weeks,  and months, the muscle soreness continued.  At times, my hand even felt stiff, a symptom that has resolved.  However,  my shoulder has gotten progressively worse.  What initially felt like long term soreness and bruising in my shoulder, has now become sharp pains when I move my arm in different positions.  Because I was working from home, the stress on my shoulder was fairly minimal and managing the demands of being a working parent, as well as limiting my exposure,  during the Covid-19 shutdown prohibited me from seeking out treatment until the condition began severely impacting my daily life.  Currently, I have severe pain when I lift my shoulder.  It has caused me to wake at night several times, as the pain is severe when positioning myself in my sleep.  It is hard to change clothing, wash myself, exercise, and interact with my children. On 6/11/21, I was able to seek treatment from an orthopedist.  He took an x-ray, did an evaluation, and diagnosed "rotator cuff tendinitis".  He administered a cortisone shot, which had no effect, and possibly aggrivated the issue.
Had taken all four doses of Vivotif without them being refrigerated; Spontaneous report received on 19FEB2020.  A pharmacist reported that a consumer "had taken all four doses of Vivotif without them being refrigerated" (PT: Product storage error). The consumer was receiving Vivotif (lot number: 3003317) for immunisation. The consumer had taken all four doses of Vivotif which were not refrigerated. It was reported that consumer had taken all the doses correctly. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer had taken all four doses of Vivotif without them being refrigerated" (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer had taken all four doses of Vivotif without them being refrigerated" (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
My specific  adverse effect that other people I know didn't report is the amount of urination I had to deal with over a 2 day period. There were times I didn't make it to the bathroom even though I had just finished going. My Pharmacist recommended I report yhis to you.
Sharp pain in shoulder/arm when raised above shoulder level; constant ache in shoulder, pain while doing normal activities (washing hair, putting on/taking off clothes, driving, etc.); diagnosed by orthopedist as having suspect myositis or bursitis after persistent pain for 4 weeks following vaccine. 5.5 weeks out today and physical therapist suspects bursitis.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Concurrent conditions, medical history of the patients were not reported. Since 16-MAR-2015, improperly stored PROQUAD (Merck) (lot # K008579, expiry date: 13-DEC-2015) (dose, route unspecified) was administered to unspecified patients. Other suspect and concomitant therapies were not reported. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
3 days following Flu vax developed pain and tenderness LUE with decreased ROM persist Sx as of 12-29-08.
Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one episode of emesis.  Vital signs at 0830 were bp:184/108, p:112, SpO2:99%. At this time pt was flushed, skin was hot and dry. Vitals at 0835 were bp:179/124, p: 92. Pt began feeling chest pain. Vitals at 0840 were bp: 182-108, p:86. Emergency services were called and pt was transferred to local ED.
vaccine was administer at 9:07 am  patient started complaining at 9:09 am  numbness on the lips , tongue , it was having difficulty of swallowing . nausea . vitals were check every 5 min  .  patient started emesis .  per Dr order i administer epi -pen  at 9:13 am   911 was call .
Presented in office with progresssively worsening pain and redness at injection site six days post administration.
approximately 7:00 pm started body aches, blurry vision, heavy feeling, increased tenderness at injection site, chills, sweating, headache, 2 min headaches after 36 hours on L side of head, minimal tingling in L side of face after 2 min headaches occured , difficulty sleeping without waking. symptoms have decreased after this document was created.
This spontaneous report was received from a patient's mother and refers to an 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 28-NOV-2017 (reported as yesterday), the patient was vaccinated with VARIVAX injection, 1 dose (route of administration, lot#, expiration date were not reported) for prophylaxis (reported as unspecified live virus chickenpox vaccine). The patient's mother stated that her son had autism, however it could not be verified if the patient had autism before receiving the vaccine, so the report was being taken as a precaution. The patient's mother also verified that the patient had not received any vaccines before. The outcome of autism was unknown. The reporter did not assess relatedness between the event and therapy with VARIVAX. Upon internal review, the autism was determined to be medically significant.
temperature excursion due to door gasket that was replaced, reached a minimum of 33.6 degrees F for 5 minutes & a maximum temperature of 50.9 degrees F for 500 minutes with no reported adverse event; the vaccines were given post excursion with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter reported that temperature excursion due to door gasket that was replaced, reached a minimum of 33.6 degrees Fahrenheit for 5 minutes & a maximum temperature of 50.9 degrees f for 500 minutes and the vaccines were given post excursion with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO) (lot: V1B901M Expiry date: 02-Jun-2024, lot: U1A452M Expiry date: 20-Feb-2023) via unknown route in unknown administration site as Immunization.  On an unknown date the caller reported a temperature excursion due to a door gasket that was replaced and caused the excursion. The temperature of the refrigerator reached a minimum of 33.6 degrees Fahrenheit for 5 minutes and a maximum temperature of 50.9 degrees Fahrenheit for 500 minutes (product storage error) (unknown latency) and all the vaccines were given post excursion with no reported adverse event (poor quality product administered) (unknown latency).  It was reported "The vaccines involved were DAPTACEL, ACT-HIB, IPOL (opened), QUADRACEL, and PENTACEL, MENQUADFI, ADACEL. and caller does not have the patient information at this time. IPOL-OPEN-CLOSED. First time product used : No Still using product : No"   Action taken with was not applicable.  It was not reported if the patient received a corrective treatment for the events.  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.
This spontaneous report was received from the administrator referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 26-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot# M041181 (dose and expiration were not reported). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20a and 013M20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included MELOXICAM (MOBIC), PARACETAMOL (TYLENOL), METFORMIN, AMLODIPINE and NABUMETONE for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Patient used Benadryl cream as a treatment medication.
I had my second Covid vaccine and woke up with vertigo today, two days after. I have not had any treatment. I searched online and found out other individuals have been reporting vertigo as a side effect of the vaccine.
intense local reaction-redness and swelling 8 cm x 4 cm on upper arm (Left)
Covid19 breakthrough.  1st Vaccine received on 04/19/2021.  53 y/o PMH Asthma, COPD, Metastatic Breast Cancer/Left mastectomy, OSA, Diastolic HF, CAD, Pulm emboli presents to ED with 1 day history of c/o SOB, dry cough, sore throat, fevers, chills and generalized body aches.  CXR negative.  CT chest with multifocal patchy groundglass infiltrates RLL.  Pt requiring O2 at 2L NC sats 94%.  Treated with IV Steroids/IV ABX and Remdesivir.
lt deltoid region hard, reddened spreading down arm w/some numbness of fingers; t100.2 oral;
This spontaneous report was received from a pharmacist and refers to female patient, currently patient was 83 year old. No medical history and current conditions reported. On an unknown date (in the past) the patient was vaccinated with ZOSTAVAX (dose, frequency and route unknown) for unknown indication. No concomitant medications reported. On an unknown date, the patient experienced swelling around the injection site. The outcome of patient experienced swelling around the injection site was unknown. The causality was unknown. This report is linked to 1410USA006971 (same reporter). Additional information has been requested.
pt to hosp for eval of 4day hx of fever, productive cough & rt pleuritic chest pain;T101, tachycardia, dec breath sounds;tx IV & O2;mental status dec;resp distress;ARDS;pneumonia;ventilator;recurrent pneumothorax;bradycardia;COD septicemia;
severe dizziness, severe chills, fever (101.6) , body aches, weakness and flue like symptoms
Tightness in left arm immediately; dizziness - 2 hrs later; significant diarrhea from 8pm - 4am.
PATIENT RECEIVED HER FLU SHOT. APRROXIMATELY, 20 MINUTES LATER, SHE RETURNED TO THE PHARMACY FEELING FAINT. SHE WAS SWEATING AND PALE. SHE ADMITTED THAT SHE HAD NOT HAD A VACCINE IN AWHILE, AND SHE REMEMBERS SHE HAD TO STOP A TATTOO PROCESS WHEN SHE WAS 18 BECAUSE OF HER FAINTNESS. I CHECKED HER BLOOD PRESSURE, WHICH WAS LOW. I GAVE HER WATER TO DRINK. I OFFERED TO CALL AN AMBULANCE OR HER SPOUSE. BUT, SHE PREFERRED TO STAY AT THE PHARMACY, AND CALLED HER FRIEND TO KEEP HER COMPANY OVER THE PHONE. I CONTINUED TO CHECK HER BLOOD PRESSURE, WHICH GRADUALLY RETURNED TO NORMAL OVER APPROXIMATELY 30 MINUTES. SHE DIDN'T REQUIRE FURTHER TREATMENT AND WAS FINE GOING HOME.
(R) arm was numb on top and (R) shoulder hurt still after 7 days after injection.
Two days after the immunization she started with significant allodyina on the middle of her spine from her neck to her sacrum.
SWOLLEN  FACE; BODY ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight was 140 pounds, and height was 62 inches. The patient's pre-existing medical conditions included: Patient had no known allergy to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced swollen face. On 05-AUG-2021, the patient experienced body ache. On 05-AUG-2021, the patient experienced headache. On 05-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-AUG-2021, and had not recovered from swollen face, headache, and body ache. This report was non-serious.; Sender's Comments: Vo: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Since receiving the vaccine something has activated the Epstein-Barr Virus in my body. My whole body itches. I have sores in my throat, mouth, arms, and legs. The allergist did the bloodwork, and it was 600 it was the high as he could test it and my levels were way over that. He put me on medicine Acyclovir 800mg 3xday for 3 months. I am taking Zyrtec 10mg 1 time a day for the itching, sometimes 2 times a day. I have sores everywhere and all I do is itch.
Shortness of Breath, fever, chills, "blacking out,"  difficulty breathing, dizziness, nausea, vomiting, weakness; starting after vaccination approximately 40 minutes.  patient was at home at symptom onset
Headache; fever; Muscle pain; joint pain; chills; nausea; swollen injection site; whole arm hurt; cough; Pain when she touched injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (whole arm hurt), COUGH (cough), VACCINATION SITE PAIN (Pain when she touched injection site pain), HEADACHE (Headache) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY), LISINOPRIL, ATORVASTATIN and OMEPRAZOLE for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain when she touched injection site pain). On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (whole arm hurt), COUGH (cough), HEADACHE (Headache), PYREXIA (fever), MYALGIA (Muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE SWELLING (swollen injection site). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (whole arm hurt), COUGH (cough), VACCINATION SITE PAIN (Pain when she touched injection site pain), HEADACHE (Headache), PYREXIA (fever), MYALGIA (Muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE SWELLING (swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Nasal congestion; Pressure behind eyes; Cold sweats at night; Sore throat; Hoarse voice; Loss of energy; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 09:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 17Apr2021 at 08:00, the patient experienced nasal congestion, pressure behind eyes, cold sweats at night, sore throat, hoarse voice and loss of energy. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nasal congestion, pressure behind eyes, cold sweats at night, sore throat, hoarse voice and loss of energy were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
stutter after he got the vaccine; part of the body was weird; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHEMIA (non-serious), outcome "unknown", described as "stutter after he got the vaccine"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "part of the body was weird".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse practitioner via company representative refers to a 64 year old female patient. On an unknown date in 2010 (reported as approximately 4 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unspecified). On 17-MAR-2014 the patient presented with shingles in the nurse practitioner's office. Patient visited nurse practitioner on 17-MAR-2014 for medical attention. Patient was treated with VALTREX, Gabapentin and unspecified pain medications. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
began feeling the worst of the symptoms (lethargy, fever, general malaise); began feeling the worst of the symptoms (lethargy, fever, general malaise); began feeling the worst of the symptoms (lethargy, fever, general malaise); This is a spontaneous report from a contactable consumer or other non HCP (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, formulation: solution for injection), dose 1 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication was not reported. Patient received first vaccine dose on 10Feb2021 and have had an intermittent fever, began feeling the worst of the symptoms (lethargy, fever, general malaise) on 11Feb2021 at morning and went home sick that day. The patient underwent lab tests and procedures which included body temperature: 100 degrees Fahrenheit on 11Feb2021. The fever was low grade when it comes, has never risen above 100 degrees F. It was reported that patient feeling better within 24 hours by 12Feb2021 but had never been able to shake the intermittent fever. The outcome of event intermittent fever was not recovered and other events was recovering.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
On the morning following my vaccination around 8:30am, I woke up to my tongue and mouth swollen with difficulty swallowing.  Due to this my body broke out in red splotchy hives around my hands and legs.  I immediately injected myself with a Epi pen and after a few hours all of these symptoms went away.
Case number PHEH2014US024332, is an initial spontaneous report received from a nurse on 02 Dec 2014 with a follow up information received from the nurse on 19 Jan 2015. This report refers to a 9 years old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of previous FLUVIRIN (batch number: not reported) which was previously tolerated. He was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in the left deltoid on 05 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. No adverse event was reported following this maladministration. The reporter confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received from the nurse on 19 Jan 2015: Updated vaccination history, site of vaccination and reporter's comment.
elevated temp, rash all over started 8/11/99 no treatment other than APAP and/or motrin for fever;rash & fever gone 8/15/99;pt doing fine;