chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional via a company representative on 10 August 2011. The reporter who was a health care professional had called the company representative to ask if a patient passing out after receiving MENACTRA was common. She had reported that an unidentified patient had received a dose of MENACTRA on an unspecified date and after receiving the MENACTRA (date and time not reported) the patient passed out. The reporter indicated that several other factors could have led to the event, but the other factors were not reported. At the time of this report, it was unknown if the patient had recovered. Follow-up information was received from the healthcare professional on12 September 2011. The patient was a 15-year-old male, who received MENACTRA (lot number U3674AA) on 10 August 2011; the event occurred after vaccination. The patient was still in the office when the event occurred. Outcome was reported as recovered. Documents held by sender: None.
On Day 8, large read rash developed on left arm (site of injection).  Hot to the touch, slightly itchy, slightly sensitive to touch.  On Day 10, I contacted my primary care physician, but reaction was already starting to disappear.  Dr's office said to contact them if it got any worse. By Day 11, it was gone.
1 3/4 X 2.O" SWOLLEN, MILD ERYTHEMA, NOT WARM TO TOUCH
Localized rash at injections site starting 7 days following initial injection and lasting for roughly 12-20 hours
2nd dose missed; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose missed) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose missed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose missed) 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.   No concomitant medications reported by reporter. Treatment medication not reported.
No other vaccine received the day of my booster  Dry almost constant cough w fatigue and low-grade fever & sore throat
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included bronchitis. Previously administered products included ZOSTAVAX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, appetite absent, general body pain, nausea, chills and tremor. On an unknown date, the outcome of the fever, appetite absent, general body pain, nausea, chills and tremor were unknown. It was unknown if the reporter considered the fever, appetite absent, general body pain, nausea, chills and tremor to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter reported that the patient experienced fever, chills, body aches, shaking, nausea and could not eat.  The reporter stated that the patient went to the emergency room. The reporter stated that her pharmacist informed her that this patient in the area had a similar reaction to SHINGRIX that was similar to her reaction. The reporter stated that she was assuming that this patient experienced the some same symptoms but could not be sure. The reporter did not have any additional details regarding this patient or event. This case has been linked to the case US2018139522, reported by the same reporter for similar events.
COVID 19 Treatment: Paxlovid; COVID 19 Treatment: Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Sep2022 at 01:00 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 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "diverticulitis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol"; Oxycoton, reaction(s): "Known allergies: Oxycoton". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment: Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: I have diagnose with REBOUND Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other medication in 2weeks. The patient received treatment for COVID-19 with Paxlovid drug, Treatment start date was on 19Dec2022, Treatment stop date was on 23Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
PATIENT CALLED TO STATE THAT AFTER RECEIVING ZOSTAVAX VACCINE THE INJECTION SITE WAS PUFFY WITH A KNOT AND WARM TO THE TOUCH. PHARMACIST ON DUTY TOLD PATIENT THIS WAS NORMAL AND SHOULD GO AWAY WITHIN A WEEK. ADVISED PATIENT TO CALL US BACK IF SITE LOOKED WORSE OR ANY OTHER REACTION OCCURRED. TRIED TO CALL PATIENT ON 11/12 AND 11/13 BUT WAS UNABLE TO REACH HER. HAVE NOT HEARD ANYTHING BACK FROM PATIENT.
Left arm/deltoid with erythema starting 08/10/2006, 1 hour after vaccination over 4 days, persistent fevers (daily temperature 102.2 F), painful left arm, increased erythema, edema, and induration, extending 12 by 12 centimeter by 08/14/2006 after labs done.  Patient seen on  day 4 (08/14/2006) treatment fever control with TYLENOL and MORTRIN, BENADRYL every eight hours. Return to clinic supportive treatment only.
Discharge Provider:  MD Primary Care Provider: MD Admission Date: 2/6/2023 Discharge Date: Feb 9, 2023  PRESENTING PROBLEM: Severe sepsis (HCC) [A41.9, R65.20] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 36 y.o. male with a past medical history of TOF/situs invertus s/p fontan, heterotaxy syndrome s/p heart proc, DM2, NASH cirrhosis, schwannoma, OSA on CPAP nightly, obesity, DM2. He comes in for COVID per congenital cardiology recommendations in the setting of his extensive cardiac history.  Patient did not have any shortness of breath or chest pain.  Patient's main complaint was a cough.  There are no fevers or chills.  In the emergency room, patient had lactic acidosis of 3.2 that resolved with fluids.  Patient also had elevation and CRP and D-dimer which remained stable during admission.  Patient's oxygen saturations ranged between 88-90%.  Patient is usually at 90%, but does go down to 80% at night and uses CPAP machine.  Patient did technically meet criteria for sepsis on admission, but his heart rate is normally around 100.  Pediatric cardiology was consulted for medication recommendations.  Patient's GDMT was held including Lasix, losartan, spironolactone, and metoprolol.  Patient did receive digoxin and GDMT  was slowly restarted as he washed his fluid status.  Patient received 3 days of IV remdesivir.  Decadron was not started given patient's baseline oxygenation status and improvement in symptoms.  Patient's glucoses had a few readings in the 70s with his home 100 units nightly Lantus, so we discharged him on 90 units with recommendations to follow-up with his PCP for adjustment if needed.  Patient also had a normocytic anemia with iron studies showing iron deficiency and was given IV iron treatment.  Patient uses CPAP at night like he does at home for sleep apnea.  On day of discharge, patient was back on his home GDMT and was feeling very good and ready to go home.  Ambulatory pulse ox was done on day of discharge and patient was satting at his baseline to an 88 and 90%.  At requested pediatric cardiology, cardiac monitor for 7 days is paced at discharge. Instructions given to the patient to return if any worsening in symptoms.
Received varicella vaccine on 5/13/03. Varicella rash appeared on 8/24/03, checked in office 8/25/03 and diagnosed with varicella.
Rash after given varicella vaccine 5/9/11 - Temp 100.4.
Client received Tdap (Adacel) on April 24, 2007.  Her arm started to become sore that evening.  Next morning, April 25, 2007, states, she "could hardly move".  Client worked that day, and took Motrin 800 mg. TID. April 26, 2006, client states she felt the same way as she did on April 25.  Her arm had begun to swell, was hot to touch, and she was very uncomfortable.  States the swelling was "pretty large and had a lump" under the skin.  Worked this day.  Placed ice on the injection site that night.  April 27, 2007 client states arem was still hurting.  She took Motrin 800 mg. TID, applied ice to the are during the morning and evening, worked entire day.  April 28 & 29, 2007, arm remained swollen but was starting to cool.  She remained uncomfortable and was unable to sleep.  April 27, 28, & 29, 2007 the shot site began to itch.  April 30, 2007 client went to doctor.  Arm was warm to touch but not hot, remained slightly swollen.  Physician instructed client to apply ice to area QID.  Was also given Dexamethasome 1.5 mg. titrated dosage (6 pills Monday, 3 pills Tuesday, 1 pill Wednesday, 1 pill Thursday).  May 3, 2007 Client states she is feeling better, pain and swelling have resolved, she is applying ice to area PRN.
Moderna COVID vaccine found to be out of date after administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine found to be out of date after administration ) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine found to be out of date after administration ). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine found to be out of date after administration ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided. It was reported that the individual was notified and opted not to repeat the vaccine. No adverse events were reported as a result of the event.; Sender's Comments: This report refers to a case of Medication error, administration of expired Covid 19/ mRNA-1273 vaccine with lot number/batch number 015M20A with no known associated adverse event.
Lethargy Headache Brain fog Little bit of Nausea but not bad Soreness at injection site  But the weirdest side effect was this strange toothache - front teeth and gums, down to the bone, top and bottom rows, felt like sinusitis toothache (except bottom teeth were also aching) - but also as if I?d over-bleached them. Very sensitive to pressure/hot/cold.   For reference I did not bleach my teeth and have no sinus issues currently.  Sensation was gone by the next morning.  Currently (4/9 9:29pm) no side effects to report except a little lingering arm soreness. All good :)
5 days post vax, R leg swollen, 'gave way' when he walked. Apply cold compress per Dr. Resolved by 1/24/2000.
three days following vaccination I began having itchy, red hives all over my body, bilaterally including knees, ears, fingers, thighs.
11A1 19 y old pt received 1 st dose Moderna vaccine, after 5 mins she had episode of syncope, fell from her chair and bump her head. She had seizure for about 10 seconds.  After seizure she was A/O x4 , neurologically intact, good PERRLA.  Her BP was 95/65, HR 59, O2 sat 98 RA.  Pt able to speak and was aware of the situation.  911 was called to take the pt to the hospital for head injury to R/O any abnormality.
Onset of L sided pleuritic chest pain 2 days after receive Moderna dose 1. Continued to worsen prompting evaluation. No systemic symptoms but significant pain, exam showed normal ECG, normal auscultation, but exquisite TTP at 4th and 5th costochondral junctions. Treated with topical and oral diclofenac.
p/vax pt had inability to swallow, gagging;as time progressed muscle weakness, forgot how to suck, sz, tremors (ongoing), visual (optic neuropathy), demyelinating brain cells;  Annual follow-up received on 01/29/2001 states the pt had extreme weakness that began right after the adverse reaction, developmental delays, occasional seizures, tremors and sleep disturbances.
Swelling and pain under arm pit as if the lymph node is fighting an infection.  I saw it after my shower the next day.  Swelling is clearly visible when arm is down.  When my arm is raised, the swelling area is as large as the palm of my hand.  Tylenol has helped the pain, but the swelling has not decreased.
ERYTHEMA, PAIN, EDEMA, HARDNESS INJECTION SITE PROGRESSED FROM INJECTION DATE UNTIL 2 DAYS POST INJECTION STARTED ON ANTIBIOTIC REGIMEN WITH RAPID RECOVERY
Fever, headache, pain in head, abdominal pain, muscles twitching, queezy, irratable, weakness
1 day following injection; red bicep (upper arm) - pain to the touch - warm - itching, headache.
Blood clots in her lungs; COVID-19; Sores in mouth; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clots in her lungs) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in her lungs) (seriousness criterion medically significant), COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever). At the time of the report, PULMONARY EMBOLISM (Blood clots in her lungs) outcome was unknown and COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) 103. On an unknown date, COVID-19: positive (Positive) Positive.         No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021 is a TCR and it is significant. Event outcome updated, Event is added2nd dose information is added.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Mom called in on 9/19/22 stating that child had developed a ''diaper rash'' on Thursday(9/15/22) night that spread by Friday morning to include butt, legs, stomach, arms, and a little on the face. Mom states that she used breast milk in the child's bath on Thursday evening d/t the diaper rash. Child has had no fever and had no trouble breathing. Rash is not itchy. Child has remained ''lively.''  Instructed that she should call her doctor for advice on the administration of medicine and to have the rash looked at since it could be caused by something else and the doctor would have a better idea of any illness that is going around.
The caller reports after receiving the Shingles vaccine, a rash on her back, circles the size of nickels that were raised and red. Mostly looked like Chicken Pox. She has seen a dermatologist for this and has received two biopsies.
Severe insulin reaction - hypoglycemia- blood sugar level 39 - during a nap after the vaccination. PT had eaten a solid meal after vaccination. PT does not normally experience low  blood sugar at this time of day.
Information has been received from a health professional concerning an adult patient who was vaccinated with MMR II as a child and had a negative titer in the Fall of 2007.  The patient was vaccinated subcutaneously with a 0.5 ml booster dose of MMR II 0.5 ml in the fall of 2007.  A titer was redrawn in December 2007, and the patient remained negative for rubella.  No additional information is available.
Soreness throughout body; Weak throughout body; Sore and tender at injection site; Muscles aches; Fatigue; This is a spontaneous report received from a non-contactable pharmacist, the patient. A 34-year-old non pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL3247) via an unspecified route of administration in the left arm on 18Mar2021 at 09:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 14:30 as a single dose for COVID-19 immunisation. On 18Mar2021 at 22:00, the patient experienced sore and tender at injection site, muscles aches, soreness and weak throughout body and fatigue. Therapeutic measures were taken as a result of adverse events and included treatment with Tylenol. The clinical outcome of sore and tender at injection site, muscle aches, soreness throughout body, weak throughout body and fatigue were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
High fever (103), red bumps about a cm across all on left side. On Oct 17th she now has a puffy red eye an r bumps that look more like a mosquito bite on her arms and one on her leg.
Nausea; body aches; headache; fatigue; This is a spontaneous report from a non-contactable other health care professional. A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318), via intramuscular route of administration, administered in Left Arm on 02Feb2021 at 14:15 (at the age of 21-years-old) as First Dose, Single Dose for COVID-19 immunization. The patient's medical history included none. The patient's concomitant medications were not reported. The patient did not get tested for COVID post vaccination. The patient did not suffer from COVID prior vaccination. 1hr after vaccination, on 02Feb2021 at 15:15 the patient experienced nausea, body ache, headache, fatigue. The patient did not receive any treatment for the AEs. The outcome for the events was recovering.  No follow-up attempts are possible. No further information is expected.
4" square red welp on day 2 after 2nd dose; swelling, hard, hot and itchy at site of injection as well as the extended area of a 4" diameter As of today, day 4 after the 2nd dose - the swelling has decreased and redness has gone decreased - now it is a pinkish color. I felt no pain until Day 3 - at bedtime. I have taken Tylenol which has helped a lot; I have applied ice - which helped; and I have rubbed aspercreme  on the injection site.
(L) deltoid area red, swollen, "> 1/2 dollar size". No fever, fatigue - able to attend school. No N/V/D. Headache on 8/21. Mom concerned of reddened area.
Red circular rash at injection site noted 7 days after injection. Discomfort and itching noted periodically.. Has persisted for 7 days.
pain only worsened; she woke up with a UTI; tendonitis; pain in her entire arm and tendons of the muscle; pain; minor arm pains started in her elbow down to her wrist in the muscles; minor arm pains started in her elbow down to her wrist in the muscles; little red spot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TENDONITIS (tendonitis), URINARY TRACT INFECTION (she woke up with a UTI), ERYTHEMA (little red spot), PAIN IN EXTREMITY (minor arm pains started in her elbow down to her wrist in the muscles) and PAIN (pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included UTI.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ERYTHEMA (little red spot). On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (minor arm pains started in her elbow down to her wrist in the muscles) and MYALGIA (minor arm pains started in her elbow down to her wrist in the muscles). On 22-Mar-2021, the patient experienced PAIN (pain). On 23-Mar-2021, the patient experienced TENDON PAIN (pain in her entire arm and tendons of the muscle). On 24-Mar-2021, the patient experienced TENDONITIS (tendonitis). On an unknown date, the patient experienced URINARY TRACT INFECTION (she woke up with a UTI) and PAIN (pain only worsened). The patient was treated with CIPROFLOXACIN for UTI, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) on 24-Mar-2021 at an unspecified dose and frequency. At the time of the report, TENDONITIS (tendonitis), URINARY TRACT INFECTION (she woke up with a UTI), ERYTHEMA (little red spot), PAIN IN EXTREMITY (minor arm pains started in her elbow down to her wrist in the muscles), PAIN (pain), TENDON PAIN (pain in her entire arm and tendons of the muscle), PAIN (pain only worsened) and MYALGIA (minor arm pains started in her elbow down to her wrist in the muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medications provided Treatment medication includes rovastatin shot .