chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills, low-grade fever, fatigue, headache, muscle/joint aches, sore arm. Chills started at bedtime, muscle and joint pain started during the night. Had headache and low-grade fever in the morning. Was tired most of the day. Felt much better by evening. Headache finally went away. Was fine the next day. Sore arm persisted a couple of days.
01/07/2020 11:00AM 1in red mark on injection site, warm to touch, mild itch and slightly raised. Fever 103. Mild headache Follow up with PCP and red mark has increased in size 1 1/2in in size.
Headache, runny nose, sore throat. Some mild cramping in colon. 2 - 3 more bowel movements than normal.
Needle separated from syringe; Medicine ran down her arm and dripped onto her pants leg; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE CONNECTION ISSUE (Needle separated from syringe) and UNDERDOSE (Medicine ran down her arm and dripped onto her pants leg) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (Needle separated from syringe) and UNDERDOSE (Medicine ran down her arm and dripped onto her pants leg). On 16-Mar-2021, DEVICE CONNECTION ISSUE (Needle separated from syringe) and UNDERDOSE (Medicine ran down her arm and dripped onto her pants leg) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received a second primary dose in advice from the primary care physician as the first primary dose was suspected partial dose. No adverse event reported after the second primary dose. No concomitant medication details was reported by the reporter. No treatment medication details was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Additional information received on 12-MAY-2021, updated second primary dose details.
Information has been received from a nurse practitioner (NP), via a company representative, concerning a female patient, who was vaccinated in her deltoid muscle with the second dose, 0.5ml, of Gardasil (date unspecified). The NP stated that "immediately after the administration of the vaccine," the patient developed swelling in an "adjacent part of the injection site." The NP confirmed that the patient did not have a reaction following her first dose of Gardasil (date unspecified). At the time of the report, the NP stated the patient was recovering from the event. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up reports previously submitted on 4/13/2007. Information has been received from a nurse practioner, concerning a female patient, who was vaccinated with a dose 0.5ml of PNEUMOVAX 23 (previously reported by the company representive as swelling at the injection site from GARDASIL. The NP reported that the patient had a severe reaction to the PNEUMOVAX 23 (details not specified). It was unknown if the patient had recovered from the event. Additional information has been requested.
Covid arm red, rash, tingles down to hand, up neck, warm to touch shoulder area. Started 1 week after injection Improving
Rash to hands and feet (blisters) sores in mouth. Treated with ZYRTEC and BENADRYL mouth wash mixture.
Multiple red 2-4mm papules, mainly on face and chest with some on arms and legs.Some have very small clear centers.
Received vaccines: Hep A #1, Varicella #2, Influenza at 5 year check and within 12 hours developed fever to 102.3 despite Tylenol and had febrile seizure (1st febrile seizure). Was evaluated in ER and released. Seizure believed to be <5 minutes in length.
Pituitary tumor; Diagnosed with Polycystic ovary syndrome; diagnosed with  non-determined viral infection; Mononucleosis; shingles; H1N1 immediately following the first dose of Gardasil 9; This spontaneous report as received from a 13 year old female patient referring to herself. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not provided. Concomitant therapies included cabergoline. It was reported that the patient had zero health issued up until the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.   On 31-AUG-2010, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Immediately, after vaccination, the patient presented H1N1 with a fever that lasted for 34 days.  On 13-OCT-2010, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Then, on 30-AUG-2011, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis.  On an unspecified date in January 2013, the patent experienced shingles (herpes zoster). On an unspecified date in September 2013, the  patient developed mononucleosis (infectious mononucleosis) and was symptomatic for 6 months. On an unspecified date in September 2014, the patient was diagnosed with a non determined viral infection which lasted for 6 months. On an unspecified date in May 2020, the patient was diagnosed with polycistic ovary syndrome.  On an unspecified date in June 2020, the patient had a pituitary tumour and received cabergoline as treatment. Antibody tests were performed but results were not reported. The outcome of pituitary tumour, polycystic ovaries, infectious mononucleosis, herpes zoster and h1n1 influenza was reported as not resolved. The outcome of viral infection was reported as resolved. The reporter considered h1n1 influenza, pituitary tumour, polycystic ovaries, viral infection, infectious mononucleosis and herpes zoster to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).     Upon internal review, pituitary tumour was determined to be medically significant.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2009USA000340:
Pain, redness, and swelling at injection site; pain and redness radiated down the entire arm, including shoulder and hand; pain radiated down entire left side down to my lower calf.  Because of the severe pain on the left side of my rib cage, breathing hurt.  Those symptoms lasted three days.  I am a fit and active senior, however I needed help getting in and out of bed during that time because of the crippling pain.   High fever and listlessness lasted 40 hours, including severe nausea and stomach pain.  Shivering and sweating with the fever.  Severe to bad headache lasted three days, headache for an additional three days.
I developed a lump with redness. burning and itching at the injection site 8 days after injection.  Using hydrocortisone cream to relieve symptoms.  Still ongoing.
Pt with witnessed ground level fall from chair due to syncopal event after receiving vaccine. Pt sustained blunt trauma to his head that included a contusion over his right forehead and laceration to posterior right ear. Pt was AOx2, not oriented to time, confused and repeating himself. Pt was also diaphoretic and hypotensive after the event.  Due to altered mental status pt was transported by EMS to a local hospital for further evaluation.
Pt recvd HIB/OPV on 15OCT91 & DTP on 24OCT91 & on 25OCT devel rash over chest, abdomen & back; pt recovered;
Muscle pain and swelling/hardness in left shoulder for 72 hours, tenderness in left shoulder for an additional 48 hours, Chills for 6 hours, Joint pain in left shoulder for 120 hours. Fatigue 72 hours.
Developed a moderate fever (101-103) that lasted days.  Not long after the fever developed she began experiencing what I assume is joint pain.  She would not walk or stand and was very stiff.  This continued for days.  She began to improve after a few days but continues to walk stiffly and uses the wall for support.
vomiting, blackout, fever, chills, muscle aches, coughing up blood, rash, sore throat, headache
Fever every day!!!! Now going on four months. Wakes with 101.6 and night around 102.9. Daily pain in stomach, legs, back, hair follicles, numbness in hands.
carpal tunnel; Skin around collar bone was irritated/itchy; Skin around collar bone was irritated/itchy; swelling my elbows; wrists were feeling enflamed; my left thumb went partially numb, spread to index finger/right thumb and half of index finger also partially numb; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: En6205), via an unspecified route of administration, administered in Left arm on 13Mar2021 09:15 at the age of 38-years-old as dose 1, single for covid-19 immunisation. Medical history included did heavy lifting for years injuring his elbow tendons at times on unspecified date. The patient had no known allergies. Other medical history was none. Concomitant medication included Multivitamin gummies [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) taken for an unspecified indication from an unspecified date received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. Facility type vaccine was Hospital. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that within 10 minutes after dose 1, on 13Mar2021, his left thumb went partially numb, spread to index finger. In 20 min right thumb and half of index finger also partially numb. By days end (12 hrs later) on 13Mar2021 at 21:15, any place he had any amount of swelling his elbows and wrists were feeling enflamed. On an unspecified date, he was probably developing carpal tunnel, and did heavy lifting for years injuring his elbow tendons at times. 14 hours after injection, on 13Mar2021 at 23:15, Skin around collar bone was irritated/itchy. Went to bed and woke up without this concern. Next day thumbs still a partially numb. Took a week for them to be normal. The outcome of events, Skin around collar bone was irritated/itchy and Numbness in fingers was recovered on an unspecified date in Mar2021 and other events was unknown.   Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
shot 10min p/vax in rt buttock @ mom request;pt became pale, then limp & lethargic /sleeping;pulse was 40 & regular, resp 40 & regular;pulse oximetry 97-98% onroom air;color returned p/about 5min;
Woke up in the middle of the night to use the bathroom the day after receiving 2nd vaccine.  I needed to turn left to get to the bathroom but turned right instead.  Same morning woke up and felt really bad.  I could not see right.  I could not read my phone.  Went back to bed and slept 8+ hours.  Was sick feeling on Friday, Saturday and Sunday. Slept a lot!! Had chills.  Took my temperature and it was 93 degrees.  Could not see correctly for about one week.  I usually wear reading glasses but could not as glasses made me really dizzy.  I could smell really really well (smelled sour milk about 2 feet away).    It was like the vaccine made my senses better.  Took about a week before my vision seemed to return back to normal.
Myalgia and injection site pain, peripheral edema. Diphenhydramine 50 mg at bedtime, prednisone 5 mg every day.
hives from injection site; hives from injection site across chest; blood feeling cold; itching of the chest; experienced hot / at the injection site; experienced / red at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received Shingrix. On 4th January 2021, several hours after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, pruritus and feeling cold. On 5th January 2021, the patient experienced injection site hives and hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site hives and feeling cold were unknown and the outcome of the pruritus and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site hives, pruritus, hives and feeling cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and few hours after vaccination the patient had hot and red area at injection site, on the same evening of injection patient had itching of her chest. On the next morning, the patient had hives from the injection site across her chest with itching, the patient also experienced blood feeling cold since receiving the dose of Shingrix. It was stated that till 21st January 2021 the patient was still experienced some hives and itching but not as severe. The patient received Benadryl for treatment for those experiences. The patient demographics was not provided. This case was linked with US2021015613 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021015613:same reporter
SHORTNESS OF BREATH; LIGHT HEADED; BODY ACHES; SORE THROAT; COUGH; JOINT PAIN; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included COPD, asthma, and sensitive to drugs, and other pre-existing medical conditions included patient was sensitive to vitamins.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced light headed. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, light headed, body aches, sore throat, cough, joint pain, fatigue, and headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
flu like reactions; chills; exhaustion; weakness; fell; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reactions), CHILLS (chills), FATIGUE (exhaustion), ASTHENIA (weakness) and FALL (fell) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included RA. Concurrent medical conditions included Immunocompromised.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reactions), CHILLS (chills), FATIGUE (exhaustion), ASTHENIA (weakness) and FALL (fell). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like reactions), CHILLS (chills), FATIGUE (exhaustion), ASTHENIA (weakness) and FALL (fell) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported.   This case was linked to MOD-2022-557675, MOD-2022-557659 (Patient Link).
strange feeling in face.....best way to describe is if you went to the dentist and you had to be numbed for a procedure   My face "feels numb" but isn't numb to the touch.  I can move my face/mouth/etc......but it just feels like when the numbness is fading and your feeling is starting to come back.......not sure if that helps for a description?    this happened right after I left the clinic,  it last maybe an hour or two I can't quite remember and has not happened randomly several times in the last 2 wks.  Nothing ever major - not trouble breathing or swallowing, etc.......just that weird sensation in my facial area best described previously when feeling is coming back after having been numbed by the dentist.  Not in my mouth but in my face--outer lips and face.   Lasts about an hour or two-is and then I'm fine again.
Pt returned to flu clinic area complaining of feeling jittery. BP at the time was 134/88, HR-76. Symptoms increased to feeling very hot. Face was flushed, BP increased to 150/100, HR-100 and complaining of mucous feeling in throat. Seen by MD, given Atarax 25mg. Pt allergic to Benadryl. No shortness of breath. Pt fidgety. BP decreased after 30 minutes to 138/94. Monitored for a total of 90 minutes. Returned to work at 09:20. BP 132/74; HR-80.
Initial report received from a healthcare professional on 31 July 2013. This case is invalid as individual patients identifiers are missing. Three patients whose date of birth, gender and age at the time of event were not reported, had received an intramuscular dose of MENACTRA vaccine (Lot number: U4584BA, dose number and anatomical site were unknown) on 31 July 2013. On 31 July 2013, same days after vaccination, the patients experienced black circles around injection site. Corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: none. Follow-up information received from a healthcare professional on 27 August 2013: A 20-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of MENACTRA vaccine (Lot number: U4584BA, dose number and anatomical site were unknown) on 31 July 2013. The patient had not received any vaccine 4 weeks before administration of MENACTRA. On 31 July 2013, on the same days of vaccination, the patients experienced black circle around injection site. Corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from event. Documents held by sender: none.
Onset of serious hypertension. Never had hypertension before in my life.  Now need medication to control
Erythema, 3-4 inches lower than the injection site and more medial measuring 3cm wide and 6cm long; The area is slightly tender to touch; A spontaneous report was received from a consumer concerning for herself, a 65-Year-old female patient, who received Moderna's COVID-19 vaccine and experienced Erythema, 3-4 inches lower than the injection site and more medial measuring 3cm wide and 6cm long/ Vaccination site erythema, The area is slightly tender to touch/ Vaccination site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 19Jan2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: 025J20-2A) via unknown route on Right Arm for COVID-19 infection prophylaxis.  On 21Jan2021, patient noticed an erythema, 3-4 inches lower than the injection site and more medial measuring 3cm wide and 6cm long. The area is slightly tender to touch. It was still present (22Jan2021) but the color has gone a little lighter.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events Erythema, 3-4 inches lower than the injection site and more medial measuring 3cm wide and 6cm long and the area is slightly tender to touch was not recovered, at the time of this report.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events,  and excluding any other etiology, a causal relationship with the event cannot be excluded. Vaccination site erythema and vaccination site pain are consistent with the established safety profile of mRNA-1273 vaccine.
5 hours after Menactra, patient had acute onset of severe headache that has been constant and continuous (for past 5 months). Also, history of arm/leg weakness and joint/muscle pain b/l in upper and lower ext. Has only been to school 2-3 days per week because of headache and fatigue. Has been evaluated by HA specialist, neurally-mediated hypotension specialist and by me pediatric infectious disease fellow. Currently on gabapentin 600mg TID, midodrine 5 mg TID, and Migreliff (OTC).01/25/07- telephone call from PCP, indicating that she has a family history of migraine headaches. Brother sustained concussion which subsequently triggered migraine headaches. Brother is seeing same specialists as patient. PCP does not believe that the Menactra is a result of the migraine but perhaps triggered the migraine.  01/25/07-records received from PCP Healthy child. Diagnosed at age 9 with asthma with some exercise induced component. The asthmas has been worse since 4/06, any exposure to second hand smoke prompts bronchoconstriction, improves with nebulizer. Constant  headache began on 8/31/06. Began 6 week course of Singular on 8/7/06 for asthma.  Seen in ER on 9/15/06 and received a regimen of medications, alleviated headache for about half a day. Tried on Imitrex, amitriptyline without much effect. Nausea treated with Zofran and metoclopramide, little effect. Had nausea, sore throat, headache and myalgias at the onset. Lyme disease blood test negative, EBV negative. Also treated with Amerge and prednisone, Migranal nasal spray with transient relief with first use but effect disappeared. Activity aggravates the headaches. Headaches increase with showering. MRI brain normal CT of head normal.  Assessment: daily persistent headaches shares her brother's tendency to orthostatic intolerance and is getting an aggravation of her headache whenever she is standing upright for any length of time. Her connective tissue laxity, most evident in her joint hypermobility is also causing some vascular distensibility, thereby contributing to the pathophysiology of her orthostatic intolerance. The hypermobility has probably contributed to her mechanical movement restriction as well.  Plan manual physical therapy. Physical therapy noted degree of dysfunction in terms of myofascial pain and mechanical and postural patterns through the spine. Positive Adson test consistent with a thoracic outlet syndrome. Muscle testing in the arms produce the frontal and temporal headache and increased tension in the head was present when the Adson test was performed.