chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received second dose of Pizer COVID vaccine on 6/23/21 and developed knot with pain in right lower extremity.  Pt had negative DVT study on 7/2/21. Pt had continued swelling to Right lower extremity.  Referral to Vascular Clinic with repeat DVT study on 8/6/21. Repeat study showed nonocclusive DVT in distal superficial femoral vein. Pt started on Apixaban 10 mg BID for 7 days, then 5 mg BID.
Moderna COVID-19 Vaccine  EUA 30 hours after receiving vaccine, upper lip became numb and swelled up, swelling began to subside after 16 hours but upper lip remains numb.  No other apparent side effects.
I got my vaccines in April and May of 2021 and then in June my whole body started to get uncontrollably itchy. June 20th is the first text message I have stating I was itchy, but it could have been before that. I have never been itchy or had problematic skin. My skin would inflame to leave behind long red marks where I itched, but it ever did this before. After several month (6-8 months) I started to become less itchy but am still itchy. My skin still becomes inflamed and red all the time. I could lightly scratch, put a shirt / hoodie on, brush my hair, and my skin will be red and inflamed. I had no change in products use (shampoo/conditioner/etc) and I had no change in consumption (vitamins/medicine/food/etc). I changed nothing in my routine during this time.
There was no adverse event related to any of the four doses of the Moderna vaccine I have received.  The ADVERSE EVENT is that I contracted Covid on June 25, 2022, after having had two doses and two boosters.  I had my first dose of the Moderna vaccine on February 22, 2021.  I had my second dose on March 29, 2021,  I had my first booster on October 23, 2021.  I had my second booster on April 20, 2022.
pt to hospital with malaise, weakness and decrease in appetite after testing positive for COVID; pt also had a syncopal event at home; EMS contacted; gave fluids which brought BP up; no O2 requirements at that time; admitted to hospital; DNR/DNI; began to have O2 desaturations; started on Decadron, remdesivir, Vapotherm; developed fever; given ABX; was dc'd to hospice  where he passed away the next day
Fevers fatigue painful muscles joint inflammation. Diarrhea for 1 month. Headaches
Shots given 07/29/04, left arm sore since shots given but redness and swelling noticed today. Parent to apply cool compress and give Motrin.
One day of fever to 101.5F; onset mid-December of tingling in hand, arm pain on total body involvement by latter January. On February 12, dx'd with Sjogren's Syndrome. 60 day follow-up states that there is a new diagnosis of MCTD (Standford) not Sjogrens as previously reported. Doc 210790, annual follow up states the following: swelling (hands, legs, feet) athritis pain. Also states that patient was type I diabetic, had asthma and had thyroid.
Received vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history reported.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-May-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while pregnant). On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while pregnant) had resolved.        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 were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: No new information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
6 days after receiving Zoster vaccine in left arm patient developed shingles vessicles on neck, ear, jaw.  PCP prescribed Famvir 500mg TID x 10 day, until lesions are healed.  Per phone conversation with RN
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: ,; "asthma" (unspecified if ongoing); "Known allergies: Shellfidmsh" (unspecified if ongoing); "Known allergies: cats" (unspecified if ongoing); "Known allergies: mold" (unspecified if ongoing); "Known allergies: tobacco and maybe caraway" (unspecified if ongoing); "Known allergies: tobacco and maybe caraway" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE, start date: 01Oct2010; OZEMPIC, start date: 01Oct2010; METFORMIN, start date: 01Oct2010; LISINOPRIL, start date: 01Oct2010; ATORVASTATIN, start date: 01Oct2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Other medication in 2weeks product: Jardiance, Ozempic, metformin, Lisinopril, atorvastatin. The patient received Paxlovid as COVID 19 Treatment from 23Sep2022 to 27Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had me wait 15 mins after injection. Came home started getting dizzy, lasted about a hour.  Have been itching all over(inside nose, mouth, eyes and body) with no rash that can be seen, still am.  Yesterday till this morning: Pressure on my throat, like someone is pushing on it with their finger, but can drink and swallow, very uncomfortable.   Tightness around my chest, like the beginning of a asthma attack.  Pains in my abdomen.  Throat very dry, had to keep drinking water. Left ankle swelled and hurt.  My ears always ring, but they stopped ringing for about 12 hours, which was a blessing, but they are back ring now.   Arm is sore.  Upset stomach.
Patient was given the Varicella vaccine after the labeled expiration date. No side effects were reported since the vaccine.
Received immunization on 8/17/15 at approximately noon. About 2am, she woke up and the right side of her tongue was numb. The numbness lasted for about 8 hours and she has been fine since.
11 years old was given influenza 0.5cc of vaccine indicated for 18 years of age and older. No adverse reactions were noted. Re-checked on pt. on 09/30/10- No problems noted per mom.  GSK AFLLA577CA
Carbuncle right thigh. Keflex 250 mg/ 5 ml. sig: 2 ml QID X 10 days. Warm compresses as needed.
Client was given adult dose of Pfizer Bivalent vaccine instead of the pediatric dosage age 5-11. Spoke with child's mother on the phone today and explained the mistake. Mother stated that the child has not had any side effects so far and is doing fine. I advised mother to continue to monitor the child for any side effects and she verbalized understanding and thanked me for the phone call.
(R) arm warm to touch, swelling  5" x 3 1/2", lesion, itching started 3/1/11.
Convulsions; Burning in nostrils; Hyperventilation; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 22Jul2021 14:00 (Lot Number: Ewo202), as single dose, for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination the patient has not been diagnosed with COVID-19. Patient was not pregnant and was not pregnant at time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced convulsions (disability, medically significant) on 23Jul2021 with outcome of not recovered, burning in nostrils (disability) on 23Jul2021 with outcome of not recovered, hyperventilation (disability) on 23Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): unknown in Jul2021 (after vaccination).  No follow-up attempts are possible. No further information is expected.
The next morning after the vaccine the tip of my tongue on the right side was numb. After a day or two a small part of my upper lip also went numb.
rash on right hand; blisters look like they are gonna open; red places on nose; red places on hand; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red places on nose), ERYTHEMA (red places on hand), BLISTER (blisters look like they are gonna open) and RASH (rash on right hand) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included WARFARIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced ERYTHEMA (red places on hand). On 05-Mar-2021, the patient experienced ERYTHEMA (red places on nose) and BLISTER (blisters look like they are gonna open). On 09-Mar-2021, the patient experienced RASH (rash on right hand). At the time of the report, ERYTHEMA (red places on nose), ERYTHEMA (red places on hand), BLISTER (blisters look like they are gonna open) and RASH (rash on right hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-138794 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: concomitant medications updated, event updated, product information updated.
At 32 weeks 5 days pregnant on 8/15/21, experienced discharge of mucus and blood. Advised by OBGYN nurse line to go to labor & delivery ER. Tests were conducted and determined suspected preterm labor. Was admitted to labor and delivery for treatment and observation. Treated with intravenous magnesium sulfate for about 36 hours and given two doses of betamethasone 24 hours apart.  Moved to antepartum for continued monitoring. Contractions still observable by NST monitoring and also determined to be experiencing uterine irritations. Was monitored and observed in the hospital for 5 days for preterm labor before being released home on bed rest on 8/20/21.
Began having sore left shoulder.  Moved to right shoulder,hips, and knee.  Pain so bad couldn't lift arms. Trouble walking.  Some days had to use a walker to get around.  Began steriod treatment for inflammation.  Seeing Rheumatologist.  Diagnosis unclear but thinking Polymyalgia rheumatica.
This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable Other-HCP on behalf of physician reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age race/ethnicity and gender received four doses of PREVNAR 13, all on an unknown date, at single dose, for immunization. Lot number of the fourth dose was 563665; while lot numbers of the other doses were not reported. Relevant medical history and concomitant medications were unknown. It was reported that the four doses did not immunize the patient. Possible 5th dose will be required. Clinical outcome was unknown at time of this report. The information on the lot numbers has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018128826 same reporter/drug/event, different patients. US-PFIZER INC-2018129213 same reporter/drug/event, different patients.
Hive, vomiting, tachycardia, itchiness. Was given Epi and steroids.
Loud ringing ear's/brain about two (2) month's after injection. Complained to DR. Recieved M.R.I of brain and E.E.G during next six (6) month's. Talked to brain doctor about three (3) time's during course of investigation (2017). Remembered notice given before injection stating ringing in brain possible side effect. Informed brain doctor. DR. stated; "Nothing can be done." Note: M.R.I./E.E.G report clear. Note: Previous done with-in year of injection. (maybe more) About one (1) year ago doctor gave me pills for ringing in brain. Ten (10) day supply. Ringing stopped for two (2) seconds. Doctor refused to supply more pills. Ringing persists, to date. Extreme misery for me. I pray for death. I suffer horribly. Thursday "12-12-19" I suffer horribly. I pray for Death. P.S. I am "only" asking for help with "cure". CDC refused to aid me claiming: "It's no big deal". It "IS" big deal. I suffer from ammonia gass build up on brain and bi-polar depression with "severe" manic episodes. I desperately need help. The ringing causes me severe distress. The ringing in my brain from your vaccine (2016) cause's me "sever" distress. I ask for "NO" money. I ask for "CURE". C.D.C refuses to help me.
Light-headedness, high blood pressure, high blood sugar.  Approx. 8 hours after injection, blood pressure reading was 163/89.  It is going down slightly each day.  Blood sugars have been higher than normal, ranging from 140 to 223.
Day 1: arm was sore, and the area was red, slightly swollen, and hard Day 1-2: feverish, body chills, extreme fatigue, decreased appetite  Day 6: large rash near vaccine site on left arm, extremely itchy, red, swollen, bumpy, hard Day 7: rash on arm still present, still itchy, more red, less swollen
The first day I?d say about 3-4 hours after getting the vaccine I noticed a headache, was also fatigue, and slightly dizzy (pretty common side effects.) as the days went on I noticed that the headaches would not go away, they did with taking Ibuprofen and Tylenol, but would return 4 hrs after taking. Monday (6-14-21) I really noticed that my neck was stiff feeling, I was getting really bad random bruises on my legs, I would get really ?airy? feeling in my head, dizzy, my heart would start racing, and my hands would get really sweaty, I also felt hot even in colder temperatures. Made an appointment Monday (6-14-21) to get bruises checked out thinking it was from something unrelated, Tuesday (6-15-21) I made an appointment to make sure I didn?t have the blood clot they did a full work up, and noticed that my blood sugar was abnormally low (58) I do not have a history myself of diabetes or ever been suspected of being prediabetic. Tuesday (6-15-21) was definitely the worst of it. Later on in the day while I was working I was seeing black spots out of the corners of my eyes, I could hardly stand, I could hardly breathe (felt like a horrible panic attack,) my heart was beating so fast I felt like it was going to burst, my hands were extremely sweaty and I felt like my body was shutting down, I had a horrible headache, I could barely drive, and when my mom was taking me to the ER, I could barely lift my arms up. Went home as my blood sugars were then fine and I was feeling okay. From that day forward I noticed that at 6:30pm every night I would get these same side effects. Saturday (6-19-21) the pattern finally broke, I no longer felt like I was dying (I wish I was exaggerating.)
vaccination went into the skin and started bleeding a little bit; patient was not sure if he received the complete dose; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 to 3 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site hemorrhage and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site hemorrhage was recovered/resolved and the outcome of the inappropriate dose of vaccine administered was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 2nd dose of Shingrix and the vaccination went into the skin and started bleeding a little bit. The patient had a band it on it and it kind of blood through the band it and then stopped (as reported), so patient was not sure if he received the complete dose, which led to inappropriate dose of vaccine administered. The reporter consented to follow up.
Patient experience mild allergy reactions to the Moderna Vaccine. Patient has swollen eyes that cause blurry vision. Patient consulted with a physician to start treatment for his symptoms.
Having heart problems. Went to the dr and he is now on a defibrillator device. Reporter stated that when receiving the vaccine he was stuck in the front of his shoulder. His nervous system was kicked into overdrive. It made his gout worst and he has a sciatic nerve that sent severe pain down his back and leg. Extreme itching all over. His groaning area enlarged and his headaches became extreme.
pt recvd vax & 14AUg92 1235AM 12 hrs p/vax exp sudden onset explosive diarrhea, rigor repetitive (chills), was spiking fevers, had nasal stuffiness, nasal occlusion, marked myalgias, anorexia, malaise, h/a;
fluzone high dose qiv leaked during administration, resulting in patient receiving unknown partial dose with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 83 years old female patient who reported that influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] was leaked during administration, resulting in patient receiving unknown partial dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Sep-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot UT8043AA, Expiry date : 30-Jun-2024, formulation, strength was unknown) via intramuscular route in the left deltoid for Immunization.  On 25-Sep-2023 the patient developed a non-serious event of fluzone high dose qiv leaked during administration, resulting in patient receiving unknown partial dose with no reported adverse event (incorrect dose administered) (latency : same day).  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone high dose qiv leaked during administration, resulting in patient receiving unknown partial dose with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
redness in her injection arm; body aches; chills; fever; oxygen level, it gets roll into 90, when I was sitting down; sore arm; headache; Gets worsened; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in left arm on 29Mar2021 as dose 1, single (at the age of 52-years-old) for COVID-19 immunization. Medical history included hypertension, high cholesterol, asthma, helps me breath, and high creatinine. It was reported that, the patient when probed about medical history stated, she was about to undergo some testing for Kidney, a physician found high creatinine level and so he got to go tested. Concomitant medications included metoprolol and hydrochlorothiazide, lisinopril; both taken for hypertension, Astra Statin and fenofibrate; both taken for high cholesterol, salbutamol sulfate (PROAIR HFA) taken for asthma, alprazolam taken for helps me breath; all start and stop dates were not reported. On 29Mar2021, the patient had a sore arm and little bit of headache for the first 2 days and then the patient started getting body aches, and it started getting worse. On 31Mar2021, the patient started to experience redness in her injection arm, body aches and chills and has a fever of 102 (degree) F. The patient on 31Mar2021, has experienced oxygen level on oximeter, it gets roll into 90, when she was sitting down. The patient had an increasingly bad reaction, had body chill and aches and It was reported that overnight it turned into fever and, it was low grade like around 100 and in past couple of hours it has gone up. The patient had taken Tylenol 1000mg. Upon reconfirmation patient stated, her oxygen level went down to 90, when she was sitting down relaxed, and never had it that low. The patient confirmed that all the events the patient was experiencing was since 31Mar2021. The patient also stated it gets worsened when asked whether still experiencing the problem. The patient confirmed taking Tylenol 1000mg about an hour, may be quite an hour bit. The patient underwent lab tests and procedures which included blood creatinine: high creatinine level on an unspecified date, body temperature: 102-degree F on 31Mar2021, body temperature: it was low grade like around 100 on 31Mar2021, oxygen saturation: 90, when she was sitting down relaxed, and never had it that low on 31Mar2021. Therapeutic measures were taken as a result of body aches, chills, fever, sore arm, and headache. The patient had recovered from the events headache and sore arm on 31Mar2021. The patient had not recovered from the other events at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On the second day, experienced muscle pain all over body. The pain lasted approx. 6 hours. I took two Aleve pills. Felt better and better as time progressed.
She got her vaccine, and started out about 45 minutes later felt like she had been stung by a bee.  She stayed for 55 minutes, got in the car, took off her mask and her face/chest were bright red, itchy.  She started Benadryl and then started getting a headache.  During that night started with projectile vomiting that lasted for about 4 times, and then was done.  Then she had chills that lasted for 2 days off and on.  Her arm was a little sore but that was nothing.  She is still having the rash and on Benadryl 2 tablets every 6 hours.   Her face, chest, head and the itching is all over her body.  She is visually impaired and says that her face and chest are bright red like a sunburn.   She cannot drive as she can only see out of one eye.  She called her  physician who told her to continue with the Benadryl.