chrisvoncsefalvay/vaers-outcomes huggingface dataset:
massive bloody nose that lasted for two hours; This spontaneous case was reported by a physician and describes the occurrence of EPISTAXIS (massive bloody nose that lasted for two hours) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced EPISTAXIS (massive bloody nose that lasted for two hours). On 17-Feb-2021, EPISTAXIS (massive bloody nose that lasted for two hours) 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.   blood thinners were included as concomitant medications; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Pt was given GARDASIL vaccine was informed would have to wait 20 minutes to be observed, pt was sitting on exam table after injection passed out -  falling forward hitting cabinet broke tooth & cut to head.  Pt observed stabilized.  8/5/09 Medical records received DOS 3/27/09. Assessment: Syncopal episode with scalp laceration and tooth fracture. Fell forward off of exam table from seated position, lost consciousness 10-15 seconds. R parietal upper scalp laceration. R front tooth chipped. Upper lip contusion.  8/17/09 Hospital records received DOS 6/14/09 to 6/15/09. Assessment: Right facial cellulitis, fever, broken tooth causing abcess, hyperglycemia, hyponatremia. Patient fell forward and damaged right upper teeth. Root canal performed. Developed increased swelling and redness in right upper part of face. Oral surgeon performed I&D. Pain and swelling increased. 2 cm X 1 cm area of swelling redness and fluctuance posterior to right central incisor on the hard palate.  ICD-9 Codes: 682.0 Cellulitis of Face, 276.1 Hyposmolality, 522.4 AC Apical Periodontitis, 790.29 Other Abnormal Glucose, V45.89 Postsurgical States NEC, 521.81 Cracked Tooth.
Her symptoms started with tiredness. She had no other symptoms but got a call from her friends that had tested positive. That day, she had symptoms of a cold of a runny nose, headache, sore throat, body aches, and a low grade fever. So she took an at home COVID-19 test that was positive. Her symptoms progressed. She was in bed for 1 week. She had to go to the urgent care due to pain in her chest. While there, her breathing was fine. She was prescribed a steroid for 3 days to help with the inflammation. And also took the prescribed Albuterol as well if needed. She still has lingering effects of the tiredness.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: oats" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2023, stop date: 13Sep2023; IMBRUVICA, start date: 25Aug2023, stop date: 13Sep2023. Past drug history included: Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. with paxlovid from 13Sep2023 to 17Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311187 Same patient, different drug/event;
Information has been received from a physician concerning her son a 17 year old male who is overweight, has gastroesophageal reflux disease, acne, and is allergic to sulfamethoxazole (+) trimethoprim, and amoxicillin who 9/19/04 was vaccinated SC in his right deltoid with a first dose of varicella virus vaccine live (lot # 648313/0281P). Concomitant therapy included omeprazole and fexofenadine hydrochloride. Subsequently, the patient experienced a stiff neck and a rash on his forearm. It was reported that the rash did not appear to be varicella. The patient's stiff neck cleared up in six days. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. Follow up information from a healthcare professional indicated that on 9/20/04, the patient experienced a stiff neck that was tender to touch, a rash on his forearm, blisters at site of vaccination and his right arm hurt. Subsequently, the patient recovered. The physician stated that she did not see the patient, his mother is a physician and reported this to her on 10/28/04. The patient was advised to get titer and possibly eliminate the need for a second immunization. No further information is available.
After the first and before the second dose, my blood sugar was raised by 20% to an average of 180. After the second dose, my blood sugar was raised an additional 20% to an average over 210. Even after several months, my daily readings still average around 180. I have increased my exercise and been more attentive to my diet since the 2nd dose without progress. The only thing that works is a 3-4 day fast, but the morning readings return to around 180 after a few days.
significant discreet rash-same lot number as another pt  from this facility;more so of rash than seen w/MMR;
Complained of itching head, face, lips, eyes, after injection 15-20 min. States it is my nerves. But then complained of lip swelling, client reports could eat cake with eggs and bread. Benadryl 25mg PO taken only as precaution, Benadryl 25 mg po given. No actual hives, swelling and redness observed after 1 hr, client states felt better and left. Promised if symptoms returned to go to ER.  States flu reactions was within 5 minutes.
Patient stated after receiving the annual flu shot her arm became sore. It continues to be sore 5 months later. She states she can't lift her arm >90 degrees and this it is constantly aching, unrelieved by APAP or Ibu.
Lymph node under right jaw swelled and is tender and painful; Lymph node under right jaw swelled and is tender and painful; Very dizzying; Nauseating; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 19Apr2021 at 14:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. 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 vaccination. Concomitant medications included levothyroxine sodium (UNITHROID), cyanocobalamin (VITAMIN B12) and colecalciferol (VITAMIN D3); taken for unknown indications from an unknown date and unknown if ongoing. On an unknown date in Apr2021, the patient experienced, the first 24 hours after the vaccination, were very dizzying and nauseating. Then she was fine. On 25Apr2021, a full week later, the lymph node under her right jaw swelled and was tender and painful. She had not seen any reports of an adverse reaction beginning a full week later, and she wanted to report it just in case. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very dizzying and nauseating was resolved on an unknown date in Apr2021. The clinical outcome of the events lymph node under right jaw swelled and was tender and painful was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
About 2 hrs after vaccination, patient reported throat closing up. Swollen after a few hours, difficulty breathing resolved, fine by next day. Patient reported no previous allergy to eggs or thimerosal. Mother gave BENADRYL after reaction.
Severe headache, muscle aches, chills and fever over 100 degrees.  Effects started approximately 12 hours after the vaccine was administered and lasted roughly 36 hours.
One week after the first injection, the injection site became very itchy and red. That subsided after several days.   I received my second injection in the same location. The red patch at the site began several hours later and had been expanding over the last few days. It is also extremely itchy, with no sign of letting up after four days.  I've read that this is a reasonably common reaction and just wanted to report it to add to the database.
Breakthrough case after three vaccines Moderna 2/11/21 Lot# 032H20A;  Moderna 3/11/21 Lot# 043L20A;  Moderna 12/8/21 Lot# 012H21B;
Pt received AVA in his right arm on 21Aug09 in the am. At the time he had burning at the injection site and his arm was sore--nothing unusual for getting a vaccination. When he woke on 22Aug09 his upper right arm was more sore (3/10) and his right hand was very swollen--the pt stated that his knuckles were indistinguishable. He had full ROM of his shoulder, arm and elbow. It was difficult to make a fist and he had intermittent tingling in his fingers. The pt noted that the swelling in his hand improved during the night while the hand was elevated but the swelling returned with activity. Of note the pt had been in the field had had been working on an "old" ship in the harbor. He had removed 3 ticks from his neck, right leg and left arm. He noted several bugs/spiders in his environment but did not recall being bitten. The pt's symptoms worsened on 9/4/09. At that time the pt noted increased swelling of his right hand which extended to his right wrist and elbow. There was also increased pain in the right hand. The patient went to the hospital where he was treated with a posterior swelling of the hand and pain. He took the naprosyn until 9/6/09. The pt has continued to work to full duty and to PT as required. General overall feeling. No fever, no chills, and no night sweats. Weight Pt states he has lost about 10 pounds which is not unexpected due to his work environment and lack of dining facilities. No headache. No neck pain, no neck stiffness, and no swollen glands in the neck. Not feeling congested in the chest and no cough. No dysphagia, no heartburn, no nausea, no vomiting, and no diarrhea. No musculoskeletal symptoms, no shoulder joint pain, no swelling of the shoulder joint, and no shoulder joint stiffness. Physical findings. General appearance: Well-appearing. Awake. Alert. Oriented to time, place, and person. Well developed. Well nourished. Well hydrated. Active. Neck: Palpation: no tenderness of the neck. Lymph Nodes: Cervical lymph nodes were not enlarged. Supraclavicular lymph nodes were not enlarged bilaterally. Axillary lymph nodes were not enlarged bilaterally. Epitrochlear lymph nodes were not enlarged bilaterally. Musculoskeletal system: General/bilateral: A range of motion evaluation was performed of the hand. Finger: General/bilateral: No pain was elicited by motion of the thumb neg Finkelstein on right. Fingers of the right hand: Examined. Pain was elicited by active motion. Hands: Right hand: Examined radial pulse palpable and equal to left; unable to palpate ulnar pulses. Full ROM and strength intact. Neurological: System: normal pinprick sensation to right hand, fingers, wrist.
02:00 Fever, chills, body aches and sore arm 10:00 woke up with fever, body aches and sore arm and also headache and nausea  10:30 took Tylenol and fell asleep 13:00 checked temp and was afebrile, still had nausea and body aches and sore arm 16:30 body aches, headache, nausea and sore arm
potential AE, Possible to receive the 2nd  dose of Moderna vaccine 35 days after receiving the 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (potential AE, Possible to receive the 2nd  dose of Moderna vaccine 35 days after receiving the 1st dose) in a 28-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (potential AE, Possible to receive the 2nd  dose of Moderna vaccine 35 days after receiving the 1st dose). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (potential AE, Possible to receive the 2nd  dose of Moderna vaccine 35 days after receiving the 1st dose) outcome was unknown.        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.   Concomitants was not reported.
Information has been received from a physician concerning an approximately 22 week old female (reported as 5.5 months) who was vaccinated with the first dose of ROTATEQ (reported as "individually pouched single-dose tube").  There was no concomitant medication.  The physician reported that the patient received the first dose of ROTATEQ at 4 months and 6 weeks later developed rotavirus gastroenteritis and was hospitalized.  The patient recovered on an unspecified date.  There was no product quality complaint.  The rotavirus gastroenteritis was considered to be another important medical event.  Additional information has been requested.
Uncontrolled body spasms, shaking, headache, chills, exhaustion
Tiredness Slight headache Muscle pain Chills Joint pain Fever Feeling unwell
Information has been received from a consumer (the patient's father) referring to a 14 year old female patient. There was no concurrent condition, concomitant medication or drug reactions/allergies. On 03-MAY-2017, at age 13 years old, the patient was vaccinated with the first dose of GARDASIL 9 (strength, route, lot# and expiration date were not reported) for prophylaxis. On 03-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 (strength, route, lot# and expiration date were not reported) for prophylaxis. On an unspecified date in August 2018, the patient experienced a seizure. On an unspecified date in 2018, the patient had an electroencephalogram (EEG) and a magnetic resonance imaging (MRI) without results and KEPPRA prescribed by an unspecified neurologist. The outcome of the event was unknown. The causality between the event and GARDASIL 9 was not reported. Upon internal review, seizure was determined to be medically significant.
Patient complains of headache since time of vaccination, and nausea/dizziness/blurred vision 5 days later. Patient has never gotten covid before to their knowledge.
This spontaneous report as received from a medical assistant refers to a 15 months old patient of unknown gender. The patient's current conditions or medical history were not reported. On 17-JUL-2014, at the age of 12 months, the patient was vaccinated with the first dose of VAQTA (dose, route, lot number and expiration date not reported). On 23-OCT-2014, at the age of 15 months, the patent was vaccinated with the second dose of VAQTA 25/0.5, intramuscular injection, 0.5 ml (lot number and expiration date not reported). No adverse effects were reported. Additional information has been requested.
The patient is a 76 y.o. female who presents to the Emergency Department with three days of left ankle pain and swelling status post mechanical GLF. Patient reports that she fell onto her left side three days ago. She is not anticoagulated and denies striking her head or any LOC. Since then she has had constant dull left ankle pain which is acutely worsened with ROM and weight bearing. Patient reports a history of fracture to this ankle. Patient notes that she is able to shuffle when wearing her compression stocking, but this elicits pain. She has pain radiating up her LLE, into her buttocks, and up her back "all the way to my neck." Patient has not taken any pain medications symptomatically. Patient reports feeling chills last night.
Information has been received from a certified medical assistant concerning a 9 month old female who on 07-APR-2008 was vaccinated with her third dose of ROTATEQ.  The patient was administered her first dose on 12-SEP-2007 and her second dose on 06-DEC-2007.  No other information.  There was no product quality complaint.  Additional information has been requested.
MEMBER HAD SORENESS AND ITCHING AT INJECTION SITE. NOTED IRRITATION AND REDNESS. WAS ADVISED BY MEDICS AT WORKSITE TO GO TO EMERGENCY ROOM FOR FURTHER TREATMENT. UPON, ARRIVAL AT EMERGENCY ROOM MEMBER WAS DIAGNOSED WITH LOCALIZED INFECTION AND TOLD THAT IF SYMPTOMS WORSEN, HE HAD FEVER, OR SITE WORSENED TO RETURN FOR ANTIBIOTICS.
On 1/22/2023, patient presented to the emergency department for evaluation of dyspnea, lethargy, weakness, and recent positive at home COVID-19 test. He began having mild symptoms on 1/18/2023 and was prescribed Paxlovid but his symptoms worsened. In the emergency department, patient was given a COVID-19 NAA test which resulted positive; He was hypoxic with an oxygen saturation of 68% on room air; He was treated with supplemental oxygen and his oxygen saturation improved to the upper 90s. Patient?s chest x-ray showed bilateral patchy consolidations and ground glass opacities in both lungs compatible with mild Covid-19 pneumonia and small right pleural effusion; His CT scan showed acute pulmonary embolism, extensive emphysema/COPD, enlarged pulmonary arteries, mass-like opacity in the left upper lobe, and bilateral pulmonary nodules. Patient was diagnosed with COVID-19, acute pulmonary embolism, lung mass, hypoxia, dyspnea, and hyponatremia. He was admitted to the hospital for further evaluation and treatment.    Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital:
Painful urination and bladder spasms; Painful urination and bladder spasms; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 02Mar2021 at 09:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, pre-diabetic, kidney stones, diverticulosis and obesity. 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-19 vaccine. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), fexofenadine (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN); all taken for an unspecified indication, from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 09Jan2021 at 00:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 02Mar2021, at 00:00, the patient experienced painful urination and bladder spasms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful urination and bladder spasms was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Shortly after vaccination pain started around inj site. Pain grew worse and arm started to swell. Pt called dr and pt was evaluated following day. CBC with diff drawn and pt started cephalosporin for prophylaxis.
No adverse event; temperature excursion on ROTATEQ and PEDVAXHIB; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 03-MAY-2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1694406, expiration date 08-DEC-2021, orally for prophylaxis (dose and vaccination scheme frequency were not reported), and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #T011167 expiration date 27-MAY-2022 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No additional adverse events were reported.   The rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was stored in a temperature of 36 degree Fahrenheit (°F) to 46°F (80°F) for 4 hours, 24 minutes as recorded by a data logger. There was no previous temperature excursion reported.  The haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was stored in a temperature of 36°F to 46°F (80°F) for 4 hours, 24 minutes as recorded by a data logger. There was a previous temperature excursion of 36°F to 46°F (68.4°F) for 3 hours.
15mins p/vax pt became very pale, eyes rolled back & became limp; no sz activity; pt seen by MD w/in next 15mins; @ that time was pale & lethargic but conscious;pt was hot to touch even w/APAP;temp not taken; inj site red, sore & hard
Within 10 minutes of receiving vaccine, I experienced shortness of breath, irritation in my throat, felt flushed and was dizzy. I was immediately transported to the emergency room where I received benadryl and was monitored.
1 day p/vax pt devel fever 104, myalgia, h/a, an inj site rxn characterized by swelling, induration & pain;orthostatic dizziness;fell @ home & was briefly incoherent;taken to ER T102;WBC count 19,000 & lt shift had hematuria;hosp
3-5 minutes after receiving injection I felt a heart fluttering.  Very short.  Maybe 5 seconds.  The rest of the 15 mins went uneventful.  After returning home I had 4 other heart palpitation experiences within the first couple hours.  The palpitations each lasted less then 10 seconds in duration.  Within the first 24 hours I also felt pressure in the back of my head on the left lower side.  It wasn't pain, or a headache but pressure.  I also had pain in my arm (which I know is normal) and pain in my left armpit.  I also started menstration within the first 5 hours of the shot even though my period was not expected for another 5 days ( and I am NEVER that early---my periods are regular! This was only 22 days since my last menstration!).  The next 2 days I had pressure continue on the back of my head.  Some pain in my chest and muscle pain in my upper back.