chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hip replacement; hip or knee replacement; came in today to get the second shot at day 56; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HIP ARTHROPLASTY (hip replacement), KNEE ARTHROPLASTY (hip or knee replacement) and PRODUCT ADMINISTRATION INTERRUPTED (came in today to get the second shot at day 56) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HIP ARTHROPLASTY (hip replacement), KNEE ARTHROPLASTY (hip or knee replacement) and PRODUCT ADMINISTRATION INTERRUPTED (came in today to get the second shot at day 56). At the time of the report, HIP ARTHROPLASTY (hip replacement) and KNEE ARTHROPLASTY (hip or knee replacement) outcome was unknown and PRODUCT ADMINISTRATION INTERRUPTED (came in today to get the second shot at day 56) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Woke up this morning with vertigo- room spinning - followed by occasional dizziness and couldn?t fall back asleep.
(L) shoulder/neck/chest and head pain started 5 hours after injection and has persisted.
Developed "Covid Arm" two days after injection.  Red, hot bump, warm to the touch, with soreness.  Red rash spread to about 3.5 inches in a circle near injection site.  Bump got smaller over next 2-3 days, and soreness left, but itching developed.  Still have rash 15 days after injection.  Rash remains slightly itchy and warm, but overall size of rash has diminished.
After receiving the vaccine I initially had some arm soreness that later progressed to a headache and just an overall run down feeling with some slight body aches.   I woke up for work this morning with worsened body aches and had felt like I had a fever throughout the night. I took my temperature just to be safe and it was 100.5 (take twice). I called into work and was told I was not allowed to come in today to contact employee health. I went back to sleep and now my temperature is 98.6. I still have some slight body aches but it seems improved.  I am sending this email at your request to state that I no longer have a fever as result of my COVID vaccine obtained 12/21. My temperature has returned to a range of 98.2-98.6.   Sx resolved
Generalized very ill feeling, bone aches, cold deep inside and unable to warm up, unable to move injected arm due to extreme pain. Symptoms following 2nd dose only and lasting 36 hours. First dose symptoms were very mild.
Redness & swelling at site.  Mostly resolved before pt back to office.  Crying a lot, but consolable.
No treatment  violent flu like symptoms, fever 101.6 severe muscle and joint pain. Severe head, shoulder neck pain ,chills, nausea. Extreme headache dizzy  light headed and faint, weakness and fatigue.  Frequent urination, kidney pain. Acetaminophen and Benadryl, hot bath, muscle rub, ice packs and heating pad.
Mild hives on neck and chest were noted  before going to bed on  2/6.  An antihistamine was taken (Aller-tec). On morning of 2/7 hives were significantly worse and had spread to torso.  An Allegra pill was taken around 1 pm..  There have been no changes in hives.
Patient is a 50 year old female with history significant for autism, developmental disability, hypertension, seizures, frequent falls, Tourette syndrome, s/p CVA. She presented 3/31/2021, through the Emergency Department from home with following an unwitnessed fall. She was found by her mother this evening on the floor at the bottom of a flight of stairs. She was last seen by her mother sometime in the morning. Patient not capable of providing history as verbalizations are limited at baseline to occasional single word expressions of needs. Patient was noted in the ED to have multiple bruises to her head, arms and legs in various stages of healing. Patient lives with her mother who is also her legal guardian. Mother was poor historian in the ED and was unable to help determine how long patient was on the floor. Patient's mother verbalized to ED provider that she is not able to supervise the patient at all times due to her own medical needs. ED provider noted that upon leaving the ED the patient's mother stated to staff that they should put the patient out of her misery. County Crisis Center was contacted by ED staff and a referral was made to Adult Protective Services. Patient does not answer review of systems questions when asked.   Admit date: 3/30/2021  Discharge date:  4/5/2021    Primary diagnoses:  Principal Problem:   Severe sepsis, unknown origin, without end organ failure o Resolving, no fever o Vancomycin stopped.  o Wbc improving, fever resolved o Blood cultures still negative o After 4days of IV antibiotics she was transitioned to oral augmentin whenDcing flagyl.  o PCP to follow fever curve, white count...            CT chest abdomen and pelvis negative at admission             Blood cultures have remained negative Active Problems:   Benign essential HTN   Developmental disability   Residual autistic disorder    Fall o Most recent fall 03/30/2021, unwitnessed, possibly down unknown number of stairs o Followed by Neurology, for frequent falls, EEG on 01/18/2021 abnormal with focal epileptic seizures suspected, she has been started on Lamictal taper o Continue Lamictal as prior to admission    Rhabdomyolysis o Due to Unwitnessed fall and immobile on floor for unknown number of hours on 03/30/2021 o CPK trending down.            Kidney function has remained normal with ongoing IV infusion   Hyponatremia    Elevated troponin I level Cardiology, Dr. consulted from the ED, elevated troponin suspected to be secondary to rhabdomyolysis o Troponin 1.58 upon arrival, peaked at 1.88 and declining is subsequently o EKG demonstrates sinus tachycardia with 1st degree AV block and RBBB, rate 101, QTc 487 Echo was normal at 60% ejection fraction     Closed anterior dislocation of right glenohumeral joint was reduced in the emergency department which will explain the large bruise over her right shoulder  right shoulder active and passive range of motion intact   Hypomagnesemia
Ear pressure and fullness, discomfort in both ears. Very loud ringing. Sinus headache
Pt. was advised not to get pregnant for 3 months following vaccination.  She reported Last Menstrual Period was 4-18-19 and was taking oral contraceptives.  I saw her today for New OB appointment and she is approximately 9 weeks pregnant (by her LMP).  Therefore, she would have conceived one week after receiving Varivax.  I'm waiting for ultrasound confirmation of the fetus' gestational age.
Arm became red, hot, and swollen. Redness was approximately 6 inches by 4 inches. Painful to touch. This is the third year in a row that patient has had reaction with each one seeming to get worse.
16Oct90 pt vax w/ hepta B; 18Oct90 pt devel diarrhea, n/, arthralgia, and fever.  Missed one week of work, was not hospitalized but was considered disabled.
Blurry vision after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision after 2nd dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry vision after 2nd dose). At the time of the report, VISION BLURRED (Blurry vision after 2nd dose) had not resolved.      Treatment received: Got new eyeglasses made after checkup.  No concomitant medications reported.   This case was linked to MOD-2021-396201 (Patient Link).
Drowsy, pain in lower back, had a procedure done 10 years ago (Endometrial ablation) and started to spot like a light cycle after receiving vaccination.
Information has been received from a consumer via her mother, a nurse, that a male child was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  The next day, the child was "different".  It was unknown whether the child sought medical attention.  Additional information has been requested.
Migraine - Resolved within 8 hours Fever - On and off from night of vaccination to present (2/17) Rash on Arm - Appeared within 24 hours after vaccination. Continued to grow over the course of a few days, raised and hot to the touch.   I went to urgent care for my fever and rash and was given antibiotics and steroids. I was given Keflex and Prednisone. I am currently on day three of taking both meds. My rash has gone down significantly however I am still feeling dizzy and feverish.
Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 52-year-old male patient who received mRNA-1273 (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided No prior temperature excursions for the patient
9:30p 3/5 fever 100.2, mild headache, stuffy nose 3/6 mild headache, no fever, stuffy nose 3/7 mild headache, no fever, stuffy nose, mild lazy eye 3/8 8:30a migraine, no fever, stuffy nose, mild lazy eye 3/9 11a more severe headache, stuffy nose, mild lazy eye
Pt says, Tuesday night began having pain in (R) DT and (R) shoulder Wednesday upper arm swollen placed ice on arm and took couple of TYLENOL. Thursday am decided to come to H.D. (R) upper arm swollen, erythematous, and warm to touch.
screaming unable to be comforted; no fever; APAP was administered but did not help; pt did not even want leg or even foot touched; MD contacted & rx Motrin which was given; pt began to be calmer p/taking Motrin about 930PM; slept all noc;
she twisted her ankle; This is a spontaneous report from a contactable consumer (patient herself). A 48-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Right on 03Sep2021 as single dose for covid-19 immunisation. Medical history and concomitant medication were not none. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm left on 13Aug2021 at 14.00 as single dose for covid-19 immunisation that was not kept at proper storage temperatures that may have been thawed and then refrozen and experienced left arm sore and bruised. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the Pfizer covid vaccine. On unspecified date in Sep2021, she twisted her ankle. Therapeutic measures were taken as a result of she twisted her ankle and she started with diclofenac 75mg tablet, 1 tablet twice a day with food. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
NOV93 rash-seen 1SEp93; seen 17OCT93 for a cold otherwise fine;
TOOK VIVOTIF ON CONSECUTIVE DAYS; This spontaneous case report (PVX2019-1937) was received from a pharmacist on 26-Jul-2019. It described a female consumer who "took Vivotif on consecutive days" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took a dose of Vivotif on 25-Jul-2019 and 26-Jul-2019, respectively. Further, the consumer took Vivotif on 28-Jul-2019 and 30-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on consecutive days" was considered as not applicable.
Fever, chills, muscle aches, skin aches, injection site extreme pain, disoriented, heart racing, elevated heart rate, loss of sleep, exhaustion, brain fog, nausea for over 40 hours
flu; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves a female patient age unknown who got the flu for some reason (influenza), when she received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE years ago .  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment or not.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Within 36 hours, patient suffered frozen shoulder. Then debilitating moved to the wrist in the same arm, then spread throughout the body -- hips, knees, ankles, belly. Deep, aching pain, not in the joint but near joints. Patient did not even consider the flu vaccine as a culprit until a supervisor inquired about the timing and location of the shot in relation to the onset of symptoms.
death; This is a spontaneous report from a Pfizer-sponsored-program. A contactable consumer reported that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated "You are despicable. Your VAX caused my dad's death. Apparently, lives are disposable as long as you make your money. I hope your family members don't die slow, agonizing deaths from this vax like my dad did". It was unknown if autopsy was done. The outcome of the event was fatal.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: death
Mistakenly, a Moderna vaccine (first and second dose-28 days later) was given to the patient who was 16 years old.  Patient reported no adverse events and is in good health.
This spontaneous report as received from a consumer refers to herself a 46-year-old female patient. The patient's medical history, concurrent condition, concomitant medication was not reported. On an unknown date in November 2017, the patient was vaccinated with GARDASIL 9 (Lot#, Expiry date: not reported) for prophylaxis. On an unknown date in November 2017 (reported as one day after the vaccination), the patient experienced encephalitis for which the patient had to visit the emergency room and was treated at an unspecified hospital and was diagnosed with encephalitis. The outcome of encephalitis was reported as not recovered. The causality of the adverse event encephalitis with the suspect GARDASIL 9 was unknown. Upon internal review the adverse event encephalitis was considered medically significant.
states noticed sore neck w/swelling behind neck on 14APR93; on 15APR93 broke out w/itchy red rash on face, chest;
Pt recvd 1st 2 hep B vax w/Recombivax & 3rd dose 06MAR90 w/ Energix-B.Test results 11APR90 neg for HBSAB.Addt'l Energix-B dose given & test results again neg for HBSAB.
Local reaction, redness, heat, pain, at 24 hours in area of vaccination. Spoke with his PCP, gave PO BENADRYL, cool compress.
"Brain fog; Intense fatigue; Joint pain; Tingling on whole arm, injection side; top half of arm doubled in volume; Itching on whole arm, injection side; Swelling of whole arm, injection side; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling on whole arm, injection side), FEELING ABNORMAL ("Brain fog), PERIPHERAL SWELLING (top half of arm doubled in volume), VACCINATION SITE PRURITUS (Itching on whole arm, injection side) and VACCINATION SITE SWELLING (Swelling of whole arm, injection side) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concomitant products included CEVIMELINE, PROGESTERONE, ESTRADIOL and TESTOSTERONE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling on whole arm, injection side), PERIPHERAL SWELLING (top half of arm doubled in volume), VACCINATION SITE PRURITUS (Itching on whole arm, injection side) and VACCINATION SITE SWELLING (Swelling of whole arm, injection side). On an unknown date, the patient experienced FEELING ABNORMAL ("Brain fog), FATIGUE (Intense fatigue) and ARTHRALGIA (Joint pain). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling on whole arm, injection side), FEELING ABNORMAL ("Brain fog), PERIPHERAL SWELLING (top half of arm doubled in volume), VACCINATION SITE PRURITUS (Itching on whole arm, injection side), VACCINATION SITE SWELLING (Swelling of whole arm, injection side), FATIGUE (Intense fatigue) and ARTHRALGIA (Joint pain) 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.   Treatment administered: "green tea" No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: The Additional information was received on 16-MAY-2021. Event was added.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient had no medical history, concurrent condition, drug and allergy history to be reported. The patient's concomitant medications were not provided. On 30-MAY-2017, the patient was vaccinated with an expired dose of GARDASIL lot # M014929, expiration date 27-MAY-2017, (route, dose were not provided) for prophylaxis. The patient's concomitant medications were not provided. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Pt recvd 2 doses of Engerix-B & devel neck stiffness p/1st dose which persisted up to the 2nd dose; remains unresolved; Pt recvd 2nd dose of vax 15JUN92 & exp sore neck;
The morning of 12/06/2017 she developed a slight fever (99.7), achy, tired and very pale. The morning of 12/07/2017 she was doing better. No fever but still not 100%.
Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills; Mild dizziness; Intermittent heart racing; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 11Jan2021 (20:00) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EJ1685), via an unspecified route of administration (left arm) on 21Dec2020 (03:30 PM) at single dose for Covid-19 immunization. The patient's medical history included idiopathic neuropathy to bilateral feet; no known allergies. Concomitant medication included tramadol. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache, body aches more in the legs, low grade fever, chills, mild dizziness, and intermittent heart racing on 12Jan2021 (08:00 AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Upper arm swelled, turned bright red and felt hot to touch. By morning-slightly red but swelling down back to normal size.
pt recv MMR vax in high school & on 21JUL97 pt exp secondary transmission characterized by 8-10 lesions on legs p/was exposed to son who had recv varicella vax;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3247), on 11Feb2021 as dose 2, single (Lot number: EL3247), on 17Nov2021 as dose 3 (booster), single (Lot number: FF8841) and on 05Apr2022 as dose 4 (booster), single (Lot number: EL3197) at the age of 50 years for covid-19 immunization. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; LOVAZA; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; MAGNESIUM; VITAMIN D NOS; CALCIUM; VITAMIN B NOS; TURMERIC [CURCUMA LONGA]. Past drug history included: Propranolol, reaction(s): "Rash", notes: propranolol (rash); Fluoroquinolone, reaction(s): "Rash", notes: fluoroquinolone (rash); Morphine, reaction(s): "vomit", notes: morphine (vomit). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about covid treatment: Yes. Product: COVID 19 Treatment, Brand: Paxlovid. Treatment start date: 04Aug2022, Lot number: GA8851, Indication-Treatment of COVID-19, Administrator route: Oral. Known allergies: propranolol (rash), fluoroquinolone (rash), morphine (vomit). Other medical history: high cholesterol, overweight.
Parents report about 24 hours after receiving vaccines patient developed increase area redness, swelling, pain with walking & warm to the touch.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included AFib (She also has Afib).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        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.   Concomitant medications reported were blood thinner medication. No treatment information was provided.