chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after rcvd 2nd vaccination that evening I noticed that I was fatigued. All of a sudden i started getting a headache Pressure ( light) and seeing spots. 20-45 minutes later I started feeling better
Patient was admitted after having a syncopal episode. After evaluation by cardiology and neurology, patient was discharged
My mensural cycle has stopped. I haven't had a cycle since I took the Moderna Vaccine; that was 5 months ago!. Prior to the shot my cycles were regular. My iron levels and Vitamin B levels are now very low and that has never been an issue before. My vitamin D is also low however this has been low before.
Pain in lt arm where vax given; generalized aching, fever & inflammation & swelling, also exp weakness;
fatigue; heart rate elevated; blood pressure went up to 198/92; vision turned blurry; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate elevated), BLOOD PRESSURE INCREASED (blood pressure went up to 198/92), VISION BLURRED (vision turned blurry) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, VITAMIN D3 and PROBIOTICS NOS for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (heart rate elevated), BLOOD PRESSURE INCREASED (blood pressure went up to 198/92) and VISION BLURRED (vision turned blurry). On 14-Feb-2021, the patient experienced FATIGUE (fatigue). On 13-Feb-2021, HEART RATE INCREASED (heart rate elevated), BLOOD PRESSURE INCREASED (blood pressure went up to 198/92) and VISION BLURRED (vision turned blurry) had resolved. At the time of the report, FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood pressure measurement: 198/92 (High) (198/92).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment has been taken by patient for symptoms.
felt dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 10:00 (Lot number: EN6207) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 22Apr2021, outcome "not recovered", described as "felt dizzy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received the first dose Pfizer Covid 19 Vaccine over in the vaccination center, felt dizzy. This is persisting. The paramedics checked out the caller's arterial pressure in patient's left site and everything seemed normal. patient clarifies it first occurred in the vaccination center after receiving the first dose Pfizer Covid 19 Vaccine and after that caller felt nothing until Monday, 03May2021. But since this last Monday, 03May2021, Patient has been feeling really dizzy Its not something only feels in the morning or afternoon or night, it is constant. Patient was worried about that. Patient did not received any other vaccines same date of the Pfizer vaccine. No adverse events occurred following prior vaccinations. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. patient was plan to visit doctor on next Thursday for the adverse events.  No follow-up attempts are possible. No further information is expected.
I went to get my physical with Dr. and had my blood drawn. The previous year my liver enzymes were high. When I received my bloodwork back from Dr. this time my levels had doubled from last year. I am currently waiting on a referral to see a specialist. Dr. is unsure of what is going on.
The patient is a 75-day-old child who is brought in by parents with chief complaint of having vomiting since last night. The one episode last night was just breast milk. They did not think too much about it. Today she has vomited five times, the last three times were bile color of yellow green, bitter smell to it, they said. She has been crying and fussy. She still cries even with holding, but still has appropriate behavior. She has decreased urine output, none since last night. Mom has not been able to nurse since last evening. The child has normal bowel movements. There is no change with quantity. Mom did take a temperature of 100.7 at 1500 hours. No medications were given. The child did get immunizations yesterday. Mom has three other children at home and seems well-educated and appropriate care has been attempted.
24 hours post vax, the pt developed swelling of right arm, 6 x 4 cm red, indurated, slight warm area of right upper arm.
Administered vaccine at 1:15pm on 9-3-09. Symptoms were reported at 6:00pm. Red face going down neck splotchy rash, flushed feeling. Skin hot to touch. No swelling in airways.
Cold sores-herpes simplex 1-fever blisters; Herpes simplex type I; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 72F23, expiry date 22nd March 2022) for prophylaxis.   On 4th September 2020, the patient received the 1st dose of Shingrix. On 6th September 2020, 2 days after receiving Shingrix, the patient experienced cold sores and herpes simplex type i. On 6th September 2020, the outcome of the cold sores was not recovered/not resolved. On an unknown date, the outcome of the herpes simplex type i was recovered/resolved.   It was unknown if the reporter considered the cold sores and herpes simplex type i to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. On 25th september,2020 pharmacist reported that the female patient received 1st dose of shingrix on 4th september,2020 and experienced cold sores-herpes simplex 1-fever blisters on 6th september,2020        The reporter consented to follow up.
pt recv vax 15MAY96 & on 18FEB97 pt exp one lesion on chin;
This spontaneous report was received from the registered nurse regarding a 5 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 07-NOV-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693:
Profound unilateral hearing loss pursuant to flu shot Second shot 11/07/19 resulted in further hearing loss in already affected ear 20 days later  Most recent repeat test 11/27/19 revealed further damage
patient has not experienced any adverse events; 3 year old male patient was administered PNEUMOVAX23 by mistake; the physician who placed the order for pneumococcal vaccination entered it in the system as PNEUMOVAX23, when he should have entered PREVNAR 13; This spontaneous report was received from a medical assistant and refers to a 3-year-old male patient. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  It was reported that on an unknown date in 2021, the physician who placed the order for pneumococcal vaccination entered it in the system as  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) when he should had entered pneumococcal vaccine conj 7v (CRM197) (PREVNAR) (Product prescribing error). On 06-JUL-2021, the patient was vaccinated with a unspecified dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T036820 with expiration date 01-JUL-2022, at a dose of 0.5 milliliter one dose, for prophylaxis, as this was the vaccine the physician had ordered (Wrong product administered). The error was caught by the office until a billing audit. The patient had not experienced any adverse events or reported any complaints related to the administration. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T036820; expirationdate: 01-JUL-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient has a fever 102.4 degrees, c/o diffuse body aches, and arthralgia unable to sleep since last night. Advised to go to ER. Ibuprofen 600 mg q6 hours prn/ MEDROL dose pack Rx given.
3 days after shot I woke up with a swollen reddish yellow left eye.  The cornea  close to the nose side of the eye was swollen, like bubbly-ish.  It does not hurt. It was Sunday so I could not contact my doctor.  I googled this and read that there are rare cases of viral keratitis associated with the shingrix vaccine.
2nd COVID vaccine given too soon. First vaccine given 12/19, second vaccine given 12/31
This was a vaccine administration error. Second Pfizer dose given 6 days before the minimum interval. The patient contacted immediately. No adverse event associated with this error.
first dose in 2018, never received a second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not applicable for this report. The patient received her first dose but she never received a second dose, which led to incomplete course of vaccination. The reporter wanted to know what the recommendation. The provided information per content and PI. Referred to HCP and offered medical advise disclaimer. The reporter consented to follow up to contact health care professional.
He is not feeling well. He has a cold; He is not feeling well. He has a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021422759 (Pfizer).  A male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), MALAISE (non-serious) all with onset 2021, outcome "unknown" and all described as "He is not feeling well. He has a cold".  Additional information: Patient was asking if it was okay to have tooth extraction day before his 2nd dose schedule (23Mar2021). He got his 1st dose on 03MAR2021 and his 2nd dose schedule 24MAR2021. Patient stated that he made his inquiry a long time ago and does not need this information at the time.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient got flu shot on 12/16/16, 48 hours later she started feeling itchy, 60hrs later shot developed rash all over (not at site of injection). Went to clinic, started Rx for Prednisone on 12/22/16. Completed Prednisone on 12/28/16, still symptomatic. Also taking BENADRYL.
COULD NOT SEE FOR A FEW MINUTES; This spontaneous report received via social media from a patient via a company representative concerned a male of unspecified age. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  It was reported by consumer that his friend's son on unspecified date 2021, was experienced temporary blindness for few minutes after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporary blindness for few minutes. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210503255-covid-19 vaccine ad26.cov2.s-Could not see for a few minutes. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Caller reported patient received first dose of GARDASIL on 19-AUG-2011 at 13 years old and second dose on 28-OCT-2014.; no additional AEs; This spontaneous report was received form a medical assistant and refers to a patient of unknown gender who would be 23-years-old at the reporting time. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 19-AUG-2011 at the age of 13-years-old, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), and on 28-OCT-2014, the patient received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration). No additional adverse events were reported.
brought from nursing home secondary to  fever and dried blood around her lips.  History was obtained from ER  physician, also from her daughter.  The patient had blood around her mouth and  her lips.  There was a question of seizure activity raised by ER physician,  but patient has on examination a lower tooth, which is quite anterior and  every time we move her lip up and down it completely covers underneath the  lip, which could be a source of occasional mouth trauma.  She is already on  anticoagulation Eliquis which would increase the risk of bleeding even from a  small area.    She underwent a CT face, which shows evidence of what seems to be a  sialoadenitis.  The patient had a fever.  Her COVID test came positive.  She  was vaccinated about 7 months ago.  The patient suffers from dementia,  slightly poor historian, but her eyes are open.  She tries to verbalize.  Does  not follow commands appropriately.    Does not look in any distress.  After evaluation and discussion with the ER  physician and review of CT, patient is being admitted for the IV antibiotic  for sialoadenitis.    She has no hypoxia.  COVID-19 test Abbott is positive.  Will obtain a PCR test  with a different technology since she has been already vaccinated.  Treatment  may not change. Eliquis was placed on hold at this time, hemoglobin 10.2 , plan for recheck outpatient 09/17/21. Currently no active bleeding noted. Patient is also scheduled to have her teeth pulled 09/22/21. I recommended for her to stay off anticoagulants , if no bleeding , Eliquis can be resumed after her procedure .    She was noted to have Acute  metabolic encephalopathy on chronic severe dementia    There was also Concern for oropharyngeal mass as well as acute right sialoadenitis on CT 09/08/21  , ENT evaluating s/p EGD with PEG 09/13/21 and microlaryngoscopy with biopsy right tonsil 09/13/21 . Pathology negative for malignancy.  Patient was managed on Unasyn for suspected  Sialadenitis right. Blood cultures 09/08/21 negative. She was discharged on Augmentin.    Hypokalemia resolved    Apparently vaccinated with Pfizer about 7 months prior , COVID-19 positive 09/08/21 . CXR no acute infiltrates , she is on room air.
Pt came to hospital 07/26/2021 for his first COVID-19 vaccine accompanied by his girlfriend. Pt completed appropriate paperwork. LPN reviewed paperwork with pt and gave pt Moderna vaccine Lot# 027B21A expire 09/18/2021 at about 1000 in Right Arm. Pt proceeded to the lobby with girlfriend. At about 1010 pt was witnessed falling from chair in lobby. Staff activated the emergency response protocol crash cart and 02 tank was brought to pt side within a few seconds. Staff called 911. On assessment pt was lying supine in lobby breathing normal and pulse WNL diaphoretic and pale. RN noted that pt eyes where rolling back. Pt head was supported, few seconds later pt came was awake. BP was checked 138/82 in left arm. Breathing WNL and HR WNL.  Pt states "I was afraid this was going to happen I had this happen about 5 yrs ago with a booster shot". Pt girlfriend stated that he turned to her and stated I don't feel good and he leaned back into the chair then fell onto the floor bottom first then onto left side then onto back. Pt states he is not hurting anywhere other than where he got his shot. Pt was then assisted to the sitting position on floor. pt stated he felt better just week pt then was assisted to the chair. While sitting in chair pt was diaphoretic and pale pt was given a cold bottle of water and a cool wet paper towel. Pt continued to improve after that. EMS arrived at 1020. EMS got vitals and pt signed EMS document refusing transport to hospital. EMS left at 1027 Pt girlfriend called for a ride because he was driving. Pt back to normal by the time his ride got here at 1043 last vitals WNL BP 126/80.
Rectal bleeding/ Bleeding from the rectum; A spontaneous report was received from a consumer concerning a 67-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced rectal bleeding.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Xarelto, Sotalol, Synthroid, Vitamin D, Calcium Vitamin b12, Clonazepam, Hydrocodone and Metamucil.   On 26 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 032L20R) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.    On 27 Jan 2021, the patient experienced rectal bleeding. The subject informed that she got the vaccine for the first time on 26 Jan 2021 and did not tell them that she takes Xarelto. Later she experienced bleeding from her rectum while taking a bowel movement. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event rectal bleeding was not reported.; Reporter's Comments: This case concerns a 67year old female patient with medication history  within two weeks prior to the event, included Xarelto, Sotalol, Synthroid, Clonazepam, Hydrocodone and Metamucil. who experienced a serious unexpected event of Rectal haemorrhage. The event occurred approximately one day after first dose of the study medication administration. Based on medication the patient is taking, Xarelto which is blood thinner, the event is assessed as unlikely related to mRNA-1273.
Pt. received PREVNAR 13 (RA) and FLUZONE HD vaccines (LA). Developed a rash in right arm near injection site. Rash has spread down arm. Called on 10-4-15 -> got hydrocortisone cr and BENADRYL.
Approx. 1530 Varicella vaccine was administered SQ on (R) thigh with 1 hive appearing within 5 minutes. BENADRYL 1/2 tsp. given immediately.
possible adverse rxn pertussis on 27AUG97 pt presented w/fever & congestion for 2 days;inc fussiness, low grade temp;pt alert & active but temp 104.6;
Pt developed severe muscle pain in right deltoid at injection site within 12 hours. Within 24 hours, he developed redness, swelling, heat and hardness to touch on medial upper extremity and into elbow.
As the patient was at the register checking out over the counter products, she was leaning on the counter. She complained of some tightness in her throat and the clerk had her sit down immediately once he learned she had gotten a vaccine. I was summoned immediately. This was at the end of the recommended 15 minute time to wait in the area for vaccinations. When I was with her, I did not notice any laborious breathing or any other indication that she was in any kind of respiratory distress. She had a little bit of a catch while talking but otherwise there were no difficulties talking normally. After about 5 minutes, she said she was feeling better. I asked if she was sure if she didn't want to wait any more and she said she was fine with leaving. I escorted her out to her vehicle to make sure she was alright and could observe no difficulty moving or any other issues. After 15 minutes, I called her to make sure she arrived at home alright and she said yes. She had taken a cetirizine to assist with resolving the symptoms, I recommended diphenhydramine 25-50 mg in addition to that as being more effective in resolving that. About an hour after this, she returned to the pharmacy to pay for a water that she had been given while she was in the chair and said that she was feeling fine at this point.  During the time while she was resting while I was talking with her, as I indicated in the allergy section, she mentioned a mild allergy to eggs. She said that she had not had any major reactions to them previously or to other influenza vaccines. I explained that allergies can become more strong over time. Because of this, I made sure to indicate that she has an allergy to eggs in her profile with us. As I also stated in that section, this allergy was not known to us at the time of administering the vaccine and was not indicated on the VAR.
This was booster to J&J initial vaccination early April.  Very sore muscles both arms & legs, nausea (no vomiting, just stomach a little upset to eat for 24 hrs), extreme fatigue.   Onset late Friday, by Sunday when I woke up all symptoms except a little fatigue were gone.
Second in the Moderna series was given to me on 2-2-21 and it initially made me very sleepy. I went home 3 hours early and went to sleep, I slept the majority of the next 24-30 hours and then started to feel better. The lingering severe fatigue and massive joint pains (I have never had elbow, shoulder, wrist, hip pains) is what is concerning me now. I did see my PCP Dr.  yesterday and he mentioned as there are so many things we still do not know about the vaccines or virus - he was concerned and if these continue at the 4-6 month period would like to review rheumatoid issues (negative before) . The severity of the fatigue has not allowed me to work as a provider of healthcare for the past 2 weeks and this is very concerning to me.