chrisvoncsefalvay/vaers-outcomes huggingface dataset:
78 year old male with history significant for AAA (stable), HTN, HLD, DM type II, recent Covid-19 (7/21/22) presents to the hospital with chest pain. Cardiology consulted for further evaluation. Echocardiogram completed, revealing LVEF 70%. The left ventricular appears hyperdynamic. No segmental wall motion abnormalities are identified. There is moderately increased thickness of the interventricular septum without significant obstruction to outflow. There is trace valvular regurgitation. There is no pericardial effusion. Pt discharged to home.  well.  She received half dose of Neulasta after chemotherapy. Physical examination was only remarkable for in injected pharynx. Labs on presentation showed WBC of 0.2, RBC 2.69, Hct 25.2, RDW 16, Platelets 45, neutrophil 0.1, Hb 8.8 and CMP was within normal limits. Afterwards, blood culture were sent from oncology, normal saline fluid bolus initiated in clinic,  and patient received first dose of cefepime at 14: 30 in clinic. And patient was started on Paxlovid (nirmatrelevir & ritonavir)1 dose orally twice per day. Patient was diagnosed with febrile neutropenia and was admitted to the inpatient ward to continue IV antibiotics, fluids and for monitoring. On 08/04 at midnight, patient developed a fever of 100.7 and was started on Tylenol. Aftwerwards, her congestion and sore throat improved and patient has been afebrile since. On 08/05, patient was doing well with no fevers, chills or night sweats. However, patient's platelet count decreased to 27 and was given 1 dose of platelet transfusion and no transfusions reactions occured. Furthermore, blood cultures showed no growth at 1 day. Patient was deemed stable for discharge on 08/05 to home.
Refridgeration excursions identified; No adverse event; There were excursions noted; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 2:33 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 2:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    Allergies to medications, food, and other products were not provided.  On an unknown date, patient had received dose 1, dose 2, dose 3 of moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.  No concomitant medication was provided.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. Storage condition at the time of the excursion-Refrigerator There were 2 unbroken cartons and 20 vials. The vials moved from freezer to refrigerator on 7-SEP-2022. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. It was reported that no adverse reactions were reported to their knowledge for any patients. It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.  Treatment medication was not provided by the reporter.
This spontaneous report was received from a registered nurse referring to a 3 month old patient of unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. It was reported that the patient received the first dose of ROTATEQ late (dosage schedule, lot #/expiration date were unknown) on 11-JUN-2016, the second dose of ROTATEQ (dosage schedule, lot #/expiration date were unknown) on 10-SEP-2016 and the third dose of ROTATEQ (dosage schedule, lot #/expiration date were unknown) on 22-OCT-2016, orally. There were no concomitant medications reported. No adverse effects were reported. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient experienced flu-like symptoms, which lasted a day or two. This case has been linked with the case US2018223387, reported by the same reporter.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 5, para 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression since 2019, Allergic rhinitis since 1990 and Alcohol use since 03-Mar-2006. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 01-May-2020 to an unknown date, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergic rhinitis, CELECOXIB (CELEXA [CELECOXIB]) from 01-Sep-2019 to an unknown date for Depression, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 01-Jul-2020 to an unknown date for Vitamin A.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Dec-2020 and the estimated date of delivery was 12-Sep-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.; Sender's Comments: Based on current available information and the temporal relationship between product use and the start date of the event a causal relationship cannot be excluded.
Patient was 11 (turning 12 next day) and received fill 0.3 ml dose
Excessive sleepiness, extreme clumsiness, regression of skills, difficulty staying upright, difficulty gathering balance (taking five or six times to stand up after falling for no reason), extreme agitation and pain, non contagious rash appearing everywhere except chest and back lasting 2+ weeks (not bacterial, allergy related or viral).
This case involved a 39-year old female patient who experienced joint pain (arthralgia), weakness in right arm (muscular weakness), Saturday moved to right knee and foot, Saturday evening went to her back (pain in extremity), Saturday evening went to her back (back pain) and Saturday moved to right knee and foot (arthralgia), while patient received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 25-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, injection (lot number: UT7000DA and expiry date: unknown) via an intramuscular route at an unknown administration site for prophylactic vaccination. Suspect vaccine was administered with medical device FLUZONE QUADRIVALENT PRE-FILLED SYRINGE. On 25-Sep-2020, the patient experienced joint pain (arthralgia) and weakness in right arm (muscular weakness), same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 26-Sep-2020, the patient on Saturday moved to right knee and foot, Saturday evening went to her back (pain in extremity), Saturday evening went to her back (back pain), 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient on Saturday moved to right knee and foot (arthralgia, (latency: unknown) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. The outcome was reported as unknown for all events.
Pt is having exacerbation of asthma and allergies. Just walking up stairs makes her short of breath. No fever. Pt is currently taking inhaler and CLARITIN. Pt felt like this was helping and now it is not working. Stuffy nose, itchy throat, and chest congestion. Rt ear is also painful. S/S x l month. Pt is currently taking SINGULAIR and a nasal spray.
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed a breakthrough case of varicella. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Patient received vaccination in upper left deltoid on 6/20 at around 3:30pm, evening of 6/21 patient had soreness at injection site and night sweats. 6/22 in the morning patient had a low grade fever, continued regular activities and went for a walk during the day. By the evening patient had a red, hot, sore patch about 2 inches below injection site. Came into pharmacy to report and on 6/25 the patch is about 4x3 inches in size patient said it is still warm to the touch but not as hot as when it first appeared.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were inadvertently vaccinated with improperly stored doses of PROQUAD (Merck) injection (lot # K009890 with expiry date: 11-JAN-2016 and lot# K019102 with expiry date: April 2016; strength, dose and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Headache & Myalgia Narrative: 1/26 at approx. 3:00pm- started having body chills that continues until today 1/26 at approx. 6:00pm started experiencing muscle aches (lower body) 1/27 at approx. 6:00am continue to have some body chills. Muscle aches ,low grade HA
"the same side effects that she had when she had the COVID-19 virus"; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ADVERSE EVENT ("the same side effects that she had when she had the COVID-19 virus") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 ADVERSE EVENT ("the same side effects that she had when she had the COVID-19 virus"). At the time of the report, ADVERSE EVENT ("the same side effects that she had when she had the COVID-19 virus") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller did not know specific side effects were or other pertinent information.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD21-074395 (Linked Report). This case was linked to MOD-2021-074907 (Patient Link).
Indurated inj. site, non-tender with irregular round eryth. blanchable lesions asymmetrically around indurated area.
Pt received ZOSTAVAX at his worksite on Friday, 4-18-08 and developed a rash on his elbows + knees the next morning.
After 4 days of severe symptoms to the Pfizer Covid-19 booster shot (102 fever for almost 36 hours, beyond painful body aches, nausea, headaches, cognitive issues, chills, etc.), I was feeling better, just tired from mounting such a large immune response and then 2 days later, I woke up with loud ringing and reverberation all over my entire head and could not hear. Upon getting up, I realized it was only my right ear that had the ringing, tinnitus, underwater muffled head pounding and complete hearing loss. I went to my PCP that day who confirmed it was not a blockage or infection and gave me 125 mg steroid shot immediately to calm the immune/inflammatory reaction. She referred me to an ENT specialist who I saw the next day, on December 9th, who has seen this unfortunate reaction in all three doses of the Covid-19 vaccine. He checked my hearing to confirm the difference between the ears and total loss in the right ear. I was prescribed high dose oral Prednisone for 17 days and have still seen no results at all. I still have complete unilateral hearing loss and bad tinnitus and discomfort in my right side of the head, I can barely function. It is unclear if this will improve or if I will get any of my hearing back. I am not against vaccines at all, but this tragic and I am NOT the only person who has had this experience, pleaae do more research and share more information with the public about this. A vaccine should not be able to take away someone's hearing.
I got flu symptoms after the vaccine. Then, my start heart started racing and then I passed out. Then, I started having chest pain. I went to an ER about this. They did an EKG, normal results. They did blood work, showed evaluated WBC. The CT scan to make sure there was not blood clot, normal results. They did an ultra sound of the heart, normal results. I then followed up with my doctor. They was worried about my SOB and my evaluated heart rate. They started me on some medicine.
3rd dose 26 of Aug 2021; soreness in his arm; swelling without pain in his ankles on the bottom of his legs /  I had severe swelling of both ankles.; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling without pain in his ankles on the bottom of his legs /  I had severe swelling of both ankles.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose 26 of Aug 2021) and PAIN IN EXTREMITY (soreness in his arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028l20a, 053e21a and 039k20a) for COVID-19 vaccination.     The patient's past medical history included Thyroid cancer in April 2021 and Kidney stones. Concurrent medical conditions included Sarcoidosis and Diabetes. Concomitant products included METHOTREXATE and PREDNISONE for Arthritis, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Breathing difficult, GLIPIZIDE and GEFITINIB (B-D NANO 2ND GEN NEEDLE) for Diabetes, METHYLPHENIDATE for Narcolepsy, TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE]) for Urination pain, AMLODIPINE, ATORVASTATIN, FOLIC ACID, LOSARTAN, OMEPRAZOLE, ZOLEDRONIC ACID from 20-Aug-2021 to an unknown date, LEVOTHYROXINE SODIUM (SYNTHROID), BROMAZEPAM (TENSONIL), TRAZODONE, ESCITALOPRAM OXALATE (LEXAPRO), TRAZODONE HYDROCHLORIDE (TRAZODONE [TRAZODONE HYDROCHLORIDE]), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) and AMLODIPINE for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced JOINT SWELLING (swelling without pain in his ankles on the bottom of his legs /  I had severe swelling of both ankles.). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose 26 of Aug 2021) and PAIN IN EXTREMITY (soreness in his arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, JOINT SWELLING (swelling without pain in his ankles on the bottom of his legs /  I had severe swelling of both ankles.) and PAIN IN EXTREMITY (soreness in his arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose 26 of Aug 2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Surgery: unknown (Inconclusive) thyroid cancer removed.         This case was linked to MOD-2021-299975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant follow up appended :Concomitant Drugs
About 45 minutes after the vaccination I felt like my body was buzzing.  This eventually rose upward until the buzzing sensation concentrated on the top of my head, at which point I developed an excruciatingly painful headache.  About six hours after the vaccine, I started having a fever that eventually was so intense that I felt like my eyelids were going to peel off.  Then I started having chills.  I was so cold when I had the chills that I shook like someone having convulsions.  When I felt hot, I felt like my eyelids would peel off.  I drank some water at one point and felt like I'd vomit.  Then, a bit later, I felt like I was going to have diarrhea.  About eight-ten hours after the shot, it felt some my tendons were being twisted so that my bones were being ground together at the joints.  Then I started having muscle pain.  I have a very high pain tolerance.  This was ungodly.  I felt like I was being tortured.  This lasted 36 hours.  Then my hair started falling out.  The week before the vaccine was the snow storm.  I had no power for a couple days and no usable water for about five days.  I think that my unfortunate telogen effluvium is the result of extreme stress during the storm followed by extreme stress due to the vaccine.  However, given that I had beautiful. long, abundant curly hair, this is obviously not a felicitous event.  On 3/11, my levator scapula and rhomboid on the left side (shot side) started feeling hot and very hard.  Then my posterior and medial deltoid and triceps muscles started rippling (visibly).  Then the injection site swelled up so that it looked like I had a large grain of rice sticking out from my arm.  Then the anti tragus of my left ear swelled and turned red.  I developed floaters in my left eye.  This lasted for about 48 hours.  My hair, which had stopped falling out, started shedding again.   I have lost about 55% of my hair at this point.  My arm never really stopped hurting.  I have gotten my second shot (3/25) and am at present working through my adverse events after it, but will wait for a couple weeks before reporting them.  I don't know if I'll have "Moderna arm" again, so once the two-week mark passes, I'll report.  As best I know, I have never been exposed to COVID19, so the idea that I had such a reaction because of that is not relevant.
Extremely enlarged lymph nodes on same side of injection. Supraclavicular. Still present two weeks later but smaller in size
Received PNEUMOVAX 3. 4. 14. 3. 6-14 developed rash on left upper arm, arm red/tender. Temp up to 101.8 on exam had several well-demarcated raised red welts, 2-3 cm in diameter. Injection site was not red/swollen. Treated with heat/cold compress, ibuprofen, BENADRYL, ZYRTEC.
Info has been received from a consumer concerning her 8 year old son with no allergies or medical history who at 18 months of age was vaccinated, SC with a dose of varicella virus vaccine live. There was no concomitant medication. On 1/8/06, the pt developed a break through case of chickenpox. Unspecified medical attention was sought. No diagnostic or lab tests were performed. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Additional info has been requested. It was also reported that the pt's brother developed chickenpox after therapy with varicella virus vaccine live.
1/6/00, pt had poor appetite, sleeping more than usual. 1/7/00, c/o stomach pain, feeling cold, diarrhea. 1/8/00  Arm warm to touch no appetite.  1/9/00, pt r/arm area dusky red in deltoid area.
I have developed an itchy rash a week after my injection with raised papules on my hands, wrists, arms and upper legs. The site of my injection has a large (half-dollar size) red rash that is itchy and slightly raised.  A visual examination by 2 providers that I work with (Family Practice office)  today due to extreme itching.  I was instructed to take Ranitidine and Zyrtec at approximately 9am.  It is now 12pm and the itchiness is a little better.
Felt hot and nauseous. Got out of bed to go to bathroom and fell on bathroom floor and lost consciousness for approximately 30 seconds with eyes rolled back. Subsequently came to, but very dizzy. Paramedics were called and blood pressure, pulse ox, glucose and EKG were all normal. After about 45 minutes of lying on bathroom floor was helped up into bed. Drank a small amount of Coca Cola and went to sleep feeling a little better.
I received my 2nd Pfizer vaccination in April 2021 and in early May 2021, I started noticing my resting heart rate slowly increasing day by day and my heart felt like it was constantly pounding. I also started losing more hair than usual & would sweat excessively. After about a month of these symptoms not improving, I finally saw my primary care physician. I had an EKG completed and some blood work to check my thyroid levels. It was revealed that my TSH was extremely low and my FreeT4 was high. I was referred to an endocrinologist who, after more testing, confirmed a diagnosis of Graves Disease on June 16th. I was prescribed methiMAzole (commonly known as Tapazole) at a dose of 10mg once daily. I recently had my thyroid levels re-checked after two months of being on the medication and my FreeT4 and FreeT3 are back to the normal ranges, while my TSH still remains extremely low.
3 am fever 101 . Lost color nausea and vomiting. symptoms lasted 4 complete days .
Significant bruising of entire deltoid. Patient said bruising develeoped approximately 2 days after receiving vaccine. Was originally very dark black/purple. As of today 9/24/18 it is very purple with a yellow border.
Shortness of breath within 30 min so stayed another 20 min and the RNs offered EpiPen or Benadryl injection or take Benadryl at home so I went home and took antihistamines and struggling to breathe and throat construction feeling continues even on day 3 post vaccine. I came very close to going to ER on Friday but took another antihistamine instead. This is scary,  feeling I can?t get enough air & also having headaches at the base of my head.