chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Husband called and reported uriticaria on 3/2, responded well to benadryl. pt reported additional  symptoms yesterday, of erythematous swollen left injection site. prescriber informed to continue current therapies of advil/tylenol/benadryl, use an Ice pack for comfort, present to clinic today which she did.  Historically, Pt has had covid infection previously in  April 2020.  College aged Son who lives in the home, reports symptoms of covid, incidentally. pt presented today with cellulitis of left arm, swelling, erythema, tenderness and heat to affected left deltoid area. Given Ceftriaxone 1 gram IM today, prescription of clindamycin 300 mg PO Q8 X 10 days.
patient needed to be vaccinated again because of the wrong temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient needed to be vaccinated again because of the wrong temperature) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient needed to be vaccinated again because of the wrong temperature). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient needed to be vaccinated again because of the wrong temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Patient received the COVID 19 vaccine on 3/30/21.  He died at home on 5/10/2021.  Per his daughter, he began to decline approximately 2 weeks prior to his death (poor po intake, weight loss, increased sleep) and had not been dx or treated for an acute illness prior to his death.
A week after the shot I have a tingling pins and needles feeling in my left arm going down to all my fingers. It comes on randomly and not from laying on it.  I also now have had 2 long menstrual periods and am getting ready to start another one when I Have not had a period since November. Back then, they usually lasted 2-3 days. Now they are 7 days heavy bleeding.
Information has been received from a physician concerning a white 42 year old male who on 5/19/99, was vaccinated with a 1st dose of MMR. On 5/28/99, the pt developed the following symptoms: sore throat, fatigue, posterior neck stiffness, fever, and anterior bilateral enlargement of glands. On 5/30/99, the pt developed a flat rash all over body,  bilateral pain, swelling, stiffness and effusions of the knees, night sweats and enlarged anterior cervical glands. The pt sought medical attention at a physician's office and therapy with acetaminophen was initiated. On 11/9/99, the pt recovered. No further details were provided.
Patient reported headache and nausea after vaccine. She was observed for 45 minutes and given water and a snack. She was CAOX3, vital signs 156/80, HR 104, R 18, 98% on room air. NAD noted at discharge.
Case number PHEH2013US017317, is a combined initial and follow up spontaneous report received from nurse on 12 AUG 2013 and on 14 AUG 2013, with a follow-up received on 17 SEP 2013. This report refers to 24 year old male patient. His medical history an concomitant medication were not reported. Nurse reported that the patient received only Men CWY135 liquid conjugate of MENVEO (batch number: M12092/X12092) intramuscularly at a dose of 0.5 ml into left deltoid without being reconstituted with Men A lyophilized conjugate on 12 AUG 2013. No adverse event was reported. No further information was provided. Follow-up was received on 17 SEP 2013. Patient demographics, vaccination site and vaccination dose were updated.
Arm killing; Severe headache; Chills; Joint pain; Feel tired slept for 9.5 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm killing), HEADACHE (Severe headache), CHILLS (Chills), ARTHRALGIA (Joint pain) and FATIGUE (Feel tired slept for 9.5 hours) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fractured vertebra.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm killing), HEADACHE (Severe headache), CHILLS (Chills), ARTHRALGIA (Joint pain) and FATIGUE (Feel tired slept for 9.5 hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm killing), HEADACHE (Severe headache), CHILLS (Chills), ARTHRALGIA (Joint pain) and FATIGUE (Feel tired slept for 9.5 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
SIRVA (unable to life arm pass shoulder, pain  from shoulder to lower arm, limited motion).
2/21 Patient presented after slip and fall on the ice, admitted for hypertensive crisis. hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.
Red raised hives noticed to Left arm 10 minutes after administration of vaccine, within 5 minutes hives were spreading to upper chest/neck area and back. No other complaints verbalized. BENADRYL 50 mg IM administered to Right arm at 12:47 PM. Hives to Lt. arm began to faint in color to pale pink after 5 minutes of BENARYL IM administration. Student was picked up by father at 1305 PM. Student ambulatory no complaints voiced.
pt recvd vax; less than 24 hrs p/ vax, pt awoke w/ edema of face & neck;she had hives all over body w/ intense itching;devel arthritis of the liver 8 days p/ inject;
Running a fever since Saturday Morning, as of 48 hours after the vaccine, still running a fever of at least 101.
Expired vaccine administration; Vial expired on 02-May-2022, pulled from freezer at 10AM on 03-May-2022, put in refrigerator until approximately 1:45 PM; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) and PRODUCT STORAGE ERROR (Vial expired on 02-May-2022, pulled from freezer at 10AM on 03-May-2022, put in refrigerator until approximately 1:45 PM) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Allergies to medication, food and other products were unknown. It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. Chronic and acute illness at the time of vaccination and one month prior was unknown.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:50 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:50 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration). In May 2022, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 02-May-2022, pulled from freezer at 10AM on 03-May-2022, put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) and PRODUCT STORAGE ERROR (Vial expired on 02-May-2022, pulled from freezer at 10AM on 03-May-2022, put in refrigerator until approximately 1:45 PM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial expired on 02-May-2022, pulled from freezer at 10AM on 03-May-2022, put in refrigerator until approximately 1:45 PM).    The reporter's occupation was given as COVID operation chief. Prescription, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of the adverse event was unknown. The vial was pulled from freezer at 10 AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM. The vial did not undergo any temperature excursions. The event did not cause the patient to seek medical care. It was unknown if the patient had experienced a similar event in the past. Treatment information was not provided.
DTaP given on L thigh on 9/16/02. Redness and induration 8cm x 3.5cm.
This spontaneous report was received from a licensed practical nurse concerning an unspecified numbers of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored GARDASIL 9 (dose, frequency, route, indication, lot # and expiration not reported). Temperature that the vaccines exposed to was 13.1 C with time frame of 22 minutes. There was a previous temperature excursion of 14C for 22 minutes.  No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007693:
I have been diagnosed with Anterior Ischemic Optic Neuropathy commonly known as an eye stroke. It was a gradual onset. There is probable permanent loss of vision in my left eye. It was treated with one week of Prednisone at 30mg per day with 2 days of weaning off the medication. I'm still under treatment to prevent potential neurological events in the future like brain or eye stroke. It's greatly impacted my vision. At the same time that I was losing vision, I developed a cough, some nasal congestion, and a sore throat. It got worse, better, and then perceptibly worse over the course of three to four days. It prompted a visit to urgent care on the 5th day due to difficulty breathing. At that time, I was advised to follow up with an Ophthalmologist due to the loss of vision.
Left Bell's Palsy diagnosed by me on 04/19/2021. Symptoms began 4/17/2021.
Extreme fatigue and flu like symptoms including cold chills but no fever for 24 hours after 2nd dose commencing 6 hours after injection.
hives on both lower arms.  First on the left vaccinated arm, then the other ( right) arm.  Still having a reaction.  Not affecting breathing.
47 hours after receiving the shot Patient started getting a fever that lasted 48 hours in length. While he had the fever he was really sleepy during the day and then had a hard time sleeping at night. He had a poor appetite and was extremely irritable.  After the fever went away he developed a rash that started on his buttocks and bilaterally on the back of his lower legs. Patient was taken to his primary care pediatrician but they did not think any treatment was necessary besides offering him whatever food or drink he would consume.
At 2:30 am I got up to use the restroom.  I felt very dizzy and cold as if I were going to pass out. I got out my blood pressure machine and my BP was 80/60. It is usually 117/70 so this was way out of the ordinary. I felt like I was going to need to call 911 due to the weakness and not being able to stand up without wanting to pass out. Got some salt and water and relaxed until the about 7am  when it subsided.
From telephone contact received on 2/12/02 at manufacturer, it was reported that an 81 year old male received Influenza (Fluzone SV 2001-2002) vaccine on 11/12/01. Patient reported that he went to the ER on 11/16/01 with a fever of 105, red face and neck, fatigue and dry cough. Patient was instructed to force fluids, take Tylenol and to follow up with his family physician. Patient returned to his physician on 11/28/01 and informed him of the ER visit. Symptoms resolved.
woke up with lots of pain on our side/pain was about a 7 on the 1-10 scale; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (woke up with lots of pain on our side/pain was about a 7 on the 1-10 scale) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (woke up with lots of pain on our side/pain was about a 7 on the 1-10 scale). At the time of the report, PAIN (woke up with lots of pain on our side/pain was about a 7 on the 1-10 scale) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.    This case was linked to MOD21-120904 (Patient Link).
Sporadic red rash in patches on different areas of the body starting the day after injections. Patient reported symptoms to us on 8/20/18. Still has red, itchy patches on body.
PRESENTING PROBLEM: Acute respiratory insufficiency COVID-19 Sepsis due to COVID-19   HOSPITAL COURSE: Patient is a 91 y.o. male who presented with symptoms of cough, shortness of breath and vomiting overnight. His wife urged him to come in. He repeatedly says he is fine and not sick. He eventually admits that he was having difficulty catching his breath when he was outside hunting. This has been going on for about a week. His wife also says that he has been complaining of fatigue over the past week as well. He denies diarrhea, fevers, sweats or chills. He was using his albuterol more than usual during the last day but was not using his spacer. He usually doesn't need to use his albuterol at all and only uses Dulera regularly. His shortness of breath worsened at night that led to post-tussive emesis. He started feeling much better after having duo-nebs at the hospital. He still desatted to 89% when ambulating which is not normal for him. He was also slightly tachycardic in the ER, but he did not take his metoprolol this morning in fear he would throw it up. He was discharge the next morning as he remained in improved condition without shortness of breath after being shown to use his spacer with his albuterol inhaler.
Chest pains, sharp pinches in heart, ER visit, pending blood work and appt to cardiology
Pt received #2 varicella on 7/28/09.  Developed clinical varicella on 8/07/09.
After 2nd dose high fever of 105. Had to immerse in cool bath to bring down to 102.  Fever for over 12 hours
Patient stated that after she received the immunization, she went home and that afternoon she started having numbness and tingles in her right food.  She stated that she kept dropping items and could not climb up the stairs. Patient had gallbladder surgery two weeks prior tot he immunization.  It went up her right leg and her entire right side became numb. She then was admitted into the ER and her doctor concluded that she had a "mini-stroke".  The patient is still having ankle/right foot numbness and describes it as a "tight feeling" along with vision problems.  She has followed up with her PCP and he has referred her to a neurologist.
A non serious report of administered expired FLUMIST was received from a registered nurse concerning a four-year-old female. Medical history and concomitant medications were not reported. On 22-Dec-2008, the patient received FLUMIST that expired on 10-Dec-2008. The physician was made ware of the incident and has decided not to redose FLUMIST. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments, are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month for FLUMIST.  This is in follow-up to report(s) previously submitted on 12/23/2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. On 08-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events. Follow-up information received on 24-MAR-2009 included Product Complaint Investigation results.
9/2/21 pt presents to ED via EMS; c/o extreme nausea, poor oral intake, cough, SOB, fever, body aches; pt had a positive COVID test on 8/30/21; O2 sats 88% on RA; O2 supplementation with improved saturation; COVID pneumonia; EKG showed Sinus tachycardia with occasional PVCs; pt admitted; given steroids, remdesivir, ABX, on BiPAP; pt showed no improvement; pt decided to remove all aggressive tx, and be comfort care; aggressive tx was dc'd and pt passed away in the hospital
flu; headache; muscle ache; chills; Queasy stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Jun2023 at 09:15 as dose 1, single (Lot number: GT0538, Expiration Date: 31Oct2024) at the age of 65 years intramuscular, in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 28Jun2023, outcome "unknown", described as "Queasy stomach"; CHILLS (non-serious) with onset 28Jun2023, outcome "unknown"; INFLUENZA (non-serious) with onset 28Jun2023, outcome "unknown", described as "flu"; HEADACHE (non-serious) with onset 28Jun2023, outcome "unknown"; MYALGIA (non-serious) with onset 28Jun2023, outcome "unknown", described as "muscle ache". Therapeutic measures were taken as a result of influenza, headache, myalgia, chills, nausea.  Additional information: He took Tylenol as treatment for side effects.
Full body rash within 48 hours had to take prednisone for 3 days and hydrocortisone topical - went to walk in Urgent Care facility. This is the first time this happened.
(L) deltoid injection site edema. Pain at (L) deltoid injection site. Pain radiating to (L) axilla. Malaise. Low grade fever (99.8).
Pt received vaccination 4/25/06. Pt called office next morning c/o arm swollen and cannot bend. Pt came in for exam.
This is a new problem. Episode onset: x 3 days. The problem has been gradually worsening. There has been no fever. Associated symptoms include congestion, coughing, rhinorrhea, sinus pain and wheezing. Pertinent negatives include no diarrhea, dysuria, ear pain, nausea, plugged ear sensation, rash, sore throat or vomiting. She has tried inhaler use and increased fluids for the symptoms. The treatment provided no relief.  Smokes 1 pack of cigarettes per day.  History of asthma.  Completed vaccination for coronavirus in May, 2021.  No recent travel.  No loss of smell or taste.  No known exposure to coronavirus. Review of Systems  Constitutional: Positive for fatigue. Negative for appetite change, chills, fever and unexpected weight change.  HENT: Positive for congestion, rhinorrhea, sinus pain and voice change. Negative for ear pain, sore throat and trouble swallowing.   Eyes: Negative for pain, discharge, redness and itching.  Respiratory: Positive for cough and wheezing.   Gastrointestinal: Negative for diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria.  Musculoskeletal: Positive for arthralgias and myalgias.  Skin: Negative for rash.  Neurological: Positive for weakness. See pg.2
Havrix was expired and administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 18th June 2022) for prophylaxis.   On 20th June 2022, the patient received Havrix. On 20th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comment: Nurse reported that Havrix was expired on 18th June 2022 and was administered on 20th June 2022 to the patient. The HCP (Health Care Professional) did not have permission to provide further details of patient or vaccine. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.
more than 36 days from first vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) 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.    In January 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 PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) had resolved.        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.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. This consumer reported similar events for two patients (himself and his wife). This is the first of two reports. A male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on 17Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that he and his wife received their first dose of the vaccine on 17Mar2021. 1 week later, in Mar2021, he started experiencing flu like symptoms but no fever. He and his wife got tested for COVID-19 about 10 days after the first dose, on 27Mar2021, and the result was positive. Outcome of the event was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021347028 same reporter/drug/event, different patient