chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a pharmacist concerning a 13 year old, female patient. Concomitant medications included influenza virus vaccine polyvalent and human papillomavirus vaccine. Patient received FLUMIST QUADRIVALENT (intranasal), 0.2 Millilitres, started on an unknown date. Patient received FLUMIST 1/2 dose (not sure if it was expired) after this they got the FLUZONE and HPV (first dose), 2 days later nosebleed, 4 days later hematemesis and, 12 days later dizziness. The outcome of hematemesis, dizziness, nosebleed and patient received 1/2 dose of FLUMIST was unknown. Company physician assessed hematemesis to be serious with the seriousness criteria of important medical event and rest of the events to be non-serious. AZ physician suggested to capture additional non-serious event patient received 1/2 dose of FLUMIST from the source narrative.
I can not walk a straight line.  My balance is off.  Body movement is OK, But I can not turn my head or move my eyes fast without going off balance.  It feels like I am on a ship in a storm and need to hold on to the side.
UNABLE TO WALK; UNKNOWN DIAGNOSIS SIGNS OF SYMPTOMS OF STROKE; PAIN IN THE LEGS; BAD CRAMPS THAT RUN IN THE BACK OF THE LEG; SWELLING OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 26-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-APR-2021, after 1 month of receiving the vaccine the patient experienced swelling of left leg and she felt it would burst, the right leg was almost swollen by then. She had visited the doctor and she gave her Lasix and Augmentin. Couple of weeks later the swelling had gone down but in MAY-2021 the swelling in both legs had come back. She was then prescribed with Augmentin (amoxicillin/clavulanic acid) and Lasix again along with potassium (furosemide/potassium chloride). Treatment medications included: Lasix with potassium and Augmentin for swelling of legs. On an unspecified date, the patient experienced very bad cramps that had run in the back of her legs. On NOV-2021, the patient experienced pain in the legs. On 15-NOV-2021, the patient was able to bend over and tie her shoe but three weeks later that was, on 06-DEC-2021, the patient was unable to walk and she was hospitalized. On an unspecified date, she had undergone CT (Computerized Tomography). The patient reported that there was an unknown diagnosis- signs and symptoms of stroke but the CT had not showed it at all. The patient was hospitalized for 1 month and then transferred to a nursing home rehab hospital. She was in a wheelchair seemed like Guillain-Barre syndrome (GBS) syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of both legs, bad cramps that run in the back of the leg, pain in the legs, unable to walk, and unknown diagnosis signs of symptoms of stroke. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0-20220236867-covid-19 vaccine ad26.cov2.s-Unable to walk, Pain in the legs, Unknown diagnosis signs of symptoms of stroke. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Severe chills and shaking from 8:30-9:30 pm - no further treatment given.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was reported.
This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 15 year old female student, with no pertinent medical history, who on 26-JUL-2007 at 3:15 pm, was vaccinated IM in the right deltoid with a second dose of GARDASIL (lot # 658094/0524U). There was no concomitant medication. Several hours after receiving the vaccination, the patient experienced red, raised and itchy rash. The patient sought unspecified medical attention. The patient was encouraged to use BENADRYL for the itching and watch the area. About a week later the patient recovered. It was reported that it may be possible that the patient developed a rash after the initial vaccination but can not be confirmed. The patient's mother recalled the patient had a very mild rash around the time of the first vaccination but could not be certain of the arm or the time frame. Additional information is not expected.
THE VACCINE ADMINISTERED WAS OUTSIDE OF APPROVED STORAGE & HANDLING INSTRUCTIONS FROM MANUFACTURER.pfizer does not have data to support vaccine stability.
pt recv vax & devel 15-20 lesions that were papular & vesicular on trunk & proximal extremities;pt was seen by MD;
This spontaneous report as received from a physician and unspecified specialist refers to a 72 year old female patient of unknown age with dyslipidemia, arthritis, acid reflux, tetracycline and neomycin allergy and latex allergy. on 24-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H014653, expiration date: 19-APR-2014, reported as 10-APR-2014, 0.5 ml, intramuscular) that was improperly stored (post non-supported excursion). Concomitant therapies included baby aspirin (manufacturer unknown), calcium (unspecified) CHONDROITIN SULFATE SODIUM (+) GLUCOSAMINE SULFATE, omeprazole (manufacturer unknown), simvastatin (manufacturer unknown) and trazodone hydrochloride. On an unspecified date in approximately September 2013 the patient couldn't hardly move her unspecified arm after vaccination. The outcome of couldn't hardly move her unspecified arm was unknown. No lab diagnostic tests were performed. This is one of several reports received from the same source (related MARRS#: 1310USA006418). Additional information has been requested.
Severe pain, swelling, and rash decreased level of consciousness severe muscle weakness vertigo ataxia encephalitis
Ringing in head to the point of distraction and mild confusion , body aches, headache (worse than usual), dizziness and some queasiness.  Fluctuates very bad for 6-12 hours, then slightly better for a few hours, then pattern repeats.  Unusual fatigue occasionally but not too severe.
Arm hurt; 104.8 fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and PYREXIA (104.8 fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt) and PYREXIA (104.8 fever). At the time of the report, PAIN IN EXTREMITY (Arm hurt) and PYREXIA (104.8 fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provded.  Reporter stated, "I got the Moderna my arm hurt, the second shot I had 104.8 fever. I ain't call anybody. It is just use the app they gave you, report it move on." Clarification about the type of reporter was unknown hence captured as consumer. Further probing could not be done as the consumer was unwilling to complete the report. Hence limited  information available over the call.
Initial report received from a healthcare professional (physician) via Merck (reference number 1-11130268781) on 29 April 2014. An unidentified 4 year old with no reported medical history or concomitant medications, developed uncontrollable seizures and left sided weakness following vaccination with DTP (manufacturer reported as Sanofi Aventis, batch, date of administration, route and site not reported). The patient has had seizures ever since then. The physician of the patient was unknown to the physician. No additional information was reported. The patient outcome is not recovered. Note: This case was forwarded by Merck, who was not able to provide the name for the physician who reported the event. Since the contact information from the reporter is not sufficient to obtain an address or phone number, no additional follow-up requests can be sent. Documents held by sender: None.
Low grade fever, inflamed area of upper arm surrounding injection site, chills, ache, headache, and muscle aches reported.
Left Lymph node behind my collar bone is extremely swollen and sore. It started the size of a marble, but is now, within 24 hours from noticing the size of a bouncy ball. The pain in radiating through my neck, back and down my arm.
Vaccination administered at approximately 10:30 a.m. on Thursday, May 28, 2015. Immediately following the vaccination my arm felt like I had been stung. 7:30 p.m. started to get chills/shivers. 9:45 p.m. went to bed. Throughout the night I had dizziness, fever, fast heart rate. May 29, 2015 In the morning, contacted physician. Other events during the afternoon were continued dizziness, projectile vomiting, a very enlarged lymph node on the left side of my neck and passing out. Other events were that my arm, which had been swollen and very painful a few hours after the vaccination, was now brilliant red, swollen, and very hot. Went to The walk-in clinic. I passed out at the clinic. My blood pressure was very low. The doctor referred me to go immediately to the Emergency Room at Medical Center. I was admitted to hospital. The hospitalist diagnosed me with a severe reaction to the PCV 13 and cellulitis. I was prescribed Cephalexin 500 mg three times a day. I was discharged from hospital May 30th. I suffered some dizzy spells for five weeks. Had I been given the information sheet before the vaccination was administered, I would not have had this vaccination. (See #19 on form).
Patient had Chills and uncontrollable shaking that started approx. 24 hours after the vaccine was given patient did not provide information on how long before the symptoms resolved
reported tachycardia and sweating and headache 30 minutes following vaccine, observation time had ended patient stated it came and went quickly but was not observed at facility
sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
starting day after booster shot: extreme fatigue with cough for two days, on the third day 12/03/2021 was tested positive for CoVid 19.  Went to the ER on 12/06/2021 with renal failure and CoVid pneumonia.  Was administered Remdesivir for two days and became confused and agitated to the point of being restrained. Remdesivir was stopped. Released from the hospital on 12/16/2021,  tested negative for CoVid 19 on 12/31/2021.  Continual decline until death on Jan. 7, 2021.
facial swelling devel overnoc;seen in clinic the following day;tx w/hydrocortisone & DPH;completely recovered in less than 48hr;
hot to the touch; weak; little red; dizzy; covid arm; red rash on the side of arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on the side of arm), FEELING HOT (hot to the touch), ASTHENIA (weak) and ERYTHEMA (little red) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN 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 FEELING HOT (hot to the touch). In February 2021, the patient experienced VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on the side of arm), ASTHENIA (weak), ERYTHEMA (little red) and DIZZINESS (dizzy). On 18-Feb-2021, FEELING HOT (hot to the touch) had resolved. At the time of the report, VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on the side of arm), ASTHENIA (weak), ERYTHEMA (little red) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was unknown.   This case was linked to MOD-2021-410109 (Patient Link).
This spontaneous case reported by a consumer, describes the occurrence of fatigue (patient felt fatigued since Tuesday) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 017F21A) for COVID-19 immunization. No medical history reported. On  Nov 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Nov 2, 2021, patient experienced fatigue (patient felt fatigued since Tuesday). At the time of the report, fatigue (patient felt fatigued since Tuesday) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information provided. Reporter did not allow further contact.
Sore arm,  difficulty breathing,  severe headache, and heart palpitations.  All of these occurred within 2-3 days of the vaccine.  The breathing issues were reported to AMI but the headache and heart palpitations were not.
Interesting dreams while sleeping perhaps from extra sleep.; Interesting dreams while sleeping perhaps from extra sleep.; Blotchy face and blotchy around neck; Redness or flushed; Sore arm at injection site; Very tired; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6455 or EP6955), via an unspecified route of administration in the right arm on 20Mar2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and COVID-19. The patient did not receive any other medications in two weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 21Mar2021 at 09:00, the patient experienced sore arm at injection site, redness or flushed, blotchy face, blotchy around neck, very tired and interesting dreams while sleeping perhaps from extra sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore arm at injection site, redness or flushed, blotchy face, blotchy around neck, very tired and interesting dreams while sleeping perhaps from extra sleep were recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severe lt arm pain . Continued to get worse. Thought it woulld go away but now radiates down arm and prevents from lifting at times.
Just typical injection site pain and fatigue; Just typical injection site pain and fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in left arm on 02Mar2021 09:00 AM (Lot number: EL3247, at the age of 53-year-old) as dose 1, single dose for COVID-19 immunization. The patient's medical history was not reported. No COVID prior to vaccination. No other vaccine administered in four weeks. The patient's concomitant medications in two weeks included secukinumab (COSENTYX) taken for an unspecified indication, start and stop date were not reported. On 02Mar2021 12:00 PM, the patient experienced just typical injection site pain and fatigue. Patient not tested for COVID post vaccination. No treatment received for the events. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Vaccine given to a 16 year old age/Given to less han 18 years; 2nd dose administered beyond 35 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age/Given to less han 18 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 041b21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021 at 11:41 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021 at 10:51 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age/Given to less han 18 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days). On 13-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age/Given to less han 18 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.    This case was linked to MOD-2021-288047 (Patient Link).
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and 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 06-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
This literature market report has been received from authors of a published article. An 85 year old male patient's adverse event was captured in this report. The patient's medical history and concomitant medication were not provided. The patient's concurrent condition included hypertension (HTN) and diabetes mellitus type 2(DM II).  On an unknown date during an annual visit, the patient was vaccinated with Zoster Vaccine Live(manufacturer unknown) (dose, frequency, route, batch/lot number and expiration date were not provided) for prophylaxis. On an unknown date when drive home, the patient began experiencing body aches. Within 2 days, the patient's pain worsened, and he became very weak. In emergency room (ER), the patient was found to be febrile with a white blood cell count (WBC) of 13 unites unknown. The patient was treated with ceftriaxone and admitted for a possible infection. Work up found no infection so antibiotics were not continued. Prednisone was added with no improvement. As no other reversible cause was found for the patient's symptoms, the patient was discharged after a few days to a subacute rehabilitation facility (SAR). Ten days later, the patient was readmitted with acute renal insufficiency. The patient was dehydrated and much weaker. The patient was again worked up with the only new finding being a pause in his heart rate. The patient remained weak despite pacer placement, so he was again discharged to SAR where he became quickly immobile. The patient continued to decline and was transferred out of state 2 months later to be closer to his son who could assist him with care oversight. The outcome of immobility was not recovered. The reporter considered immobility to be related to Zoster Vaccine Live (manufacturer unknown). This was a rare adverse effect of immunization that led to immobility in a previously independent patient. The event of immobility was considered to be serious due to disability and hospitalization. Upon internal review, immobility was determined to be medically significant.