chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient noticed swelling the evening of injection, flu like symptoms the next day and difficulty swallowing. Went to urgent care on 4/23/23. Took benadryl, prednisone, tylenol, and ibuprofen. Followed up with her primary care doctor. The swelling has improved and is no longer having difficulty swallowing as of 4/26/23
Numbness in hands, shoulders and neck. PCP diagnosed it as Brachial Plexus Neuropathy.
They have a patient who got their first dose on 28May2021 and has not gotten their 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (They have a patient who got their first dose on 28May2021 and has not gotten their 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-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 (They have a patient who got their first dose on 28May2021 and has not gotten their 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (They have a patient who got their first dose on 28May2021 and has not gotten their 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Aches to upper back and hipsLeft axillary pain; Aches to upper back; Aches to upper back and hips; This is a spontaneous report from a contactable Nurse, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 15Mar2021 at 18:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Aches to upper back and hips Left axillary pain 17Mar2021. The patient did not receive treatment for the reported events. The clinical outcome of the events Aches to upper back and hips Left axillary pain was not recovered.   No follow-up attempts are needed. No further information is expected.
Within the past month my blood pressure has gone significantly higher, with no apparent connection to diet, alcohol consumption or other reason.  Physical activity has been limited by rainy weather and high heat index, which may be a reason.  My cardiologist has adjusted my medication to see if that helps.  I am only reporting this because you have asked us to report any changes in health since vaccination.  It is unlikely that the BP issue is connected to the vaccination since 6 months went by without any BP problems.
The evening/night of 12/4/2009 patient was complaining of a lot of pain in the injection sight. The afternoon of 12/5/2009, There was a red lump about the diameter of a golf ball at the injection sight. Patient, at that time, also developed approx. 14 chicken pox lesions a little bit smaller than a dime on her chest and stomach. By 8:30 PM on 12/5/2009, patient has approx 50 chicken pox lesions varying in size on her stomach, chest, neck, back, and groin.
Subsequent to receiving vax, the pt developed a low-grade fever (less than 100 degrees F) and general aching that persisted for one day.
TENIVAC was administered to 36 year old pregnant women/ NO AE; patient received TENIVAC instead of prescribed ADACEL/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Agency via call-center (Reference number- 00359588) and transmitted to Sanofi on 16-Nov-2020.  This case involves a 36-years-old female patient who received once 0.5 mL DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (strength: standard, batch number: U6603AA, expiry date: 05-Mar-2022 via an intramuscular route at an unknown administration site) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date not reported) (wrong product administered) on 02-Nov-2020 for prophylactic vaccination while she was pregnant (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.   The date of last menstrual period was not reported.  The estimated due date was not reported.  The medical history, medical treatment, vaccination and family history were not provided.  No other concomitant vaccines were used.   It was the case of actual medication error due to wrong vaccine administered and also involve vaccine exposure during pregnancy (latency same day). The patient was pregnant when she received TENIVAC vaccine.  No adverse effects reported so far.  Pregnancy outcome was unknown at the time of report.   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 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.
Late period (1 week) Period heavier than normal Period again 1 week later Spotting in between periods
Intention tremor of upper extremities beginning several hours after vaccine. Decreased activity level. Vomited several times 2 days after vaccine. Tripping more than usual.
HEADACHE; FELT A LITTLE STRANGE; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and other pre-existing medical conditions included: patient was not taking any concomitant medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On JUL-2021, the patient experienced felt a little strange. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from felt a little strange on JUL-2021, and headache. This report was non-serious.
Hives randomly on my body on stomach and other areas on and off almost every other day.  Comes and goes in the morning and evening
Shot was given high, had no muscle discomfort initally, the next morning I had deep joint aching and it hasn't stopped aching.
Right arm became painful swollen, red, and warm about 2 inches below were the vaccine  was administered. Reaction occurred a couple hours after administration and worsened over night. Patient went to local urgent care clinic 12/11/19 and received rx for cephalexin
After receiving flu shot pt walked out of the exam room but pt was stating he did not feel good. The pt was dizzy and taken to a chair to sit down. The pt is a diabetic so the pt's blood glucose was checked and was out of range as well as having a blood pressure out of range. The pt was given glucose tablets and after 10 min the pts BP and BG was within normal limits and physician released pt. to home.
Initial health care professional report received on 19 Jan 2010: This patient was vaccinated with FLUVIRIN (batch number 104043P1 on 04 Jan 2010, intramuscularly. On 04 Jan 2010, the patient presented with slight bump that looked like a mosquito bite. The outcome of the event was not reported. The seriousness criteria of the events was not reported.
pt recvd 2nd dose of Hep B vax 27JUL89 & later devel itching & a red maculopapular rash on trunk.
Morning after second dose, started with complaints of tummy aches and nausea at breakfast shortly before 8 am. It was looking a bit better. She asked for food around 10 am. From 2 pm on fever of 101F and vomiting. Vomiting stopped after about an hour. Fever went on until 11 pm. No medication given after discussing with nurse on the phone, who assured this was a possible side effect and Tylenol should only be given after keeping solid food down. Continued with broth for dinner around 7 pm, some soda for electrolytes and a banana an hour before bed. Next day with no fever or complaints but slept for 2 hours during the day, which is uncommon. Third day after complete recovery with no fatigue. No side effects observed after the first shot.
15FEB91 pt vax; 01MAR91 exp onset of joint pain in knees, ankles, back & neck.  Tx w/ Prednisone, ASA, ibuprofen, & antibiotics.
Pt called the office on 4/30/01, to report developing an itchy rash, the evening of 4/26/01. Also stated, on 4/30/01, that the rash had occurred after the 1st dose of vaccine but not reported.
Patient received moderna covid 19 vaccine on 2/5/21, 3/5/21, and 11/6/21.  There's a cardiology document on 9/2/21 from patient's cardiologist to see if there's any evidence of myocarditis or ILD to indicate start of immunosuppression for a presumed diagnosis of scleroderma.  Cardiac output elevated at 6.5 (4 indexed, SV 87).  Below is the impression from the cardiac mri. 1. The left ventricular size is moderately dilated. The left ventricular ejection fraction is 45 % by Simpson's method. Global left ventricular function is mildly decreased. The left ventricular wall is diffusely hypokinetic. The left ventricular mass is moderately increased. There is diffuse increase of T2 signal throughout the myocardium and native T1 times are diffusely elevated: 1337-1340 ms (normal value 3T: 1200 +/- 80ms). GLS measures 10% which is reduced.   2. The right ventricular size is mildly dilated. The right ventricular ejection fraction is 46 % by Simpson's method. Global right ventricular function is mildly decreased.  3. Left atrial size is normal. Right atrial size is normal.   4. There is evidence of tricuspid regurgitation which is not quantified on this study.
A report has been received from a Study Investigator concerning a 38 year old, female subject, Weight: 215.0 Pounds. A post marketing Safety study of Q/LAIV in Subjects 2 through 49 years of age. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date. The date of last menstrual period was 05-MAY-2013. The patient experienced pregnancy which started on 05-MAY-2013. The estimated date of delivery was 08-FEB-2014. The outcome of the pregnancy was reported to be a healthy baby female weighed 3.99 kg born on 30-JAN-2014. The number of weeks at outcome of pregnancy was 38.4. The report was considered to be non-serious. The study investigator considered that there was no casual relationship between pregnancy and study therapy.
didn't feel good; felt like they had the flu; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell and influenza like illness. On an unknown date, the outcome of the feeling unwell and influenza like illness were unknown.   It was unknown if the reporter considered the feeling unwell and influenza like illness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter stated that she had heard from couple people that had the luxury of getting Shingrix that they did not feel good after receiving Shingrix. They felt like they had the flu. The nurse reported that they just received Shingrix (US product) and did not administered any yet. No additional information was available for report.  The reporter consented to follow up.
tinnitus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as received from a medical assistant (also reported as "nurse") refers to an unspecified number of patients of unknown age. On unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (lot M040268, expiration 14-MAY-2018; lot M040271, expiration 30-APR-2018). There was no adverse events. The doses of vaccines experienced temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. There was no previous temperature excursions. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006990: US-009507513-1707USA008739:
Initial report was received from a patient on 04 November 2011. A 46-year-old male patient received an Intradermal (ID) injection in left deltoid of FLUZONE (lot number not reported) on 29 October 2011. In the evening of the injection, the patient developed pain on the left side of his groin which subsided. On 30 October 2011, in the morning he woke up with nausea, vomiting, a pounding headache and two in a half inch wide reddened area and pain in left deltoid. No further informational was available at the time of the report. The patient outcome was reported as recovered/resolved. Follow-up information was received on 26 March 2012 from a health care professional. The lot number of FLUZONE Intradermal was UT4163AA. The patient's outcome remained recovered. Documents held by sender: none.
pt had laceration of finger & unk date of DT-so was given booster along w/flu shot @ pt's request; next seen 30NOV94 w/ c/o bilat pain mid-humerus & tenderness over deltoid insertion; pt request @ this time an adverse react form be filed;
about ten hours after injection chills then fever then difficulty breathing sinuses draining couldn't slrrp took benadryl called 911 they came and took my vitals highblood pressure a fever of 101 it wasn't to bad so they left i stayed awake all night and started to feel better the next day
Information has been received regarding a case in litigation from a lawyer concerning a female who on or about 29-SEP-2005 was vaccinated with a dose of MERUVAX II.  On an unspecified date the patient sustained "grave, serious and permanent personal injuries" and "was caused to terminate her pregnancy".  "Grave, serious and permanent personal injuries" was considered to be disabling.  Upon internal review, "was caused to terminate her pregnancy" was considered an other medically important event.  Additional information has been requested.
Earache starting around 9 pm after Moderna dose 2, followed by headache and fever starting during the night and lasting throughout the next day. Symptoms had cleared up around 36 hours after injection.
Pt received MENACTRA then HPV. He was sitting on exam table and told his mom he felt dizzy. He then became unconscious and fell off the table, hitting to left side of his face on the chair. He was back to normal in about 5 minutes. DERMABOND to small laceration on left forehead.
04/23/03- Received smallpox (repeat- 15 pokes- left arm) and anthrax #1. 04/25/03- Noticed her heart "missing beat"- lasting anywhere between 1 min to more than 20 mins- no aggravating or ameliorating factors- not related to activity- "comes and goes"- makes her breath deeper- but no dyspnea, sob, cp, diaphoresis, weakness, dizziness, syncope, or nausea- attributed to anxiety d/t deployment anticipation 04/28/03 through 08/29/03- Deployed 09/03/03- Had post-deployment physical- pt. c/o "irregular heart beat"- was told had a "sloppy valve 09/24/03- Noticed above sx persisting for "36-48 hours"-concerned- saw PCP and was told she had a "heart skip"- Cardiology referral generated- labs drawn (results of labs and diagnostic tests pending at this time)  A copy of the patient's clinical summary sent to VAERS via FedEx on 10/07/03.
I woke up with vertigo which lasted several hours. I was fatigued for full day. I was exhausted and needed to nap a couple of times and struggled to focus on work. All symptoms were gone by 4/23.
Pt developed 9/10 substernal CP 9/30/18. Pain worse lying down and on deep inspiration. Eval at PCP 10/1/18 noted EKG change 1mm ST elevation. To ED via EMS. Seen by cardiology. Dx acute idiopathic pleuropericarditis. Treated with NSAIDS.
01:18 PM:  administered Moderna Vaccine  01:33 PM:  Reported adverse effect of heart palpitation.    01:34 PM:  V/S= BP115/75, P73, O2 sat97%, R16.  01:36 PM:  Pt drank a cup of water.   01:40 PM:  Pt states that she is feeling better  01:43 PM:  Pt states given another cup of water  01:46 PM : Pt states that the heart palpitation almost resolve.  Pt was discharged.  Pt ambulated with no assistance.   Pt was advised to go to E.R or urgent care if symptoms continuous of worsens.   02:00 PM:  Contacted pt via telephone on file.  Pt states that she is doing well.  no more heart palpitation.  Pt states that she was driving and that she feels good.   Again E.R for worsening symptoms advised.
Information has been received from a certified medical assistant concerning her 32 month old female who on 25-FEB-2009 was vaccinated with a dose of VARIVAX (Merck) 0.5ml (route not reported). There was no concomitant medication. On 15-MAR-2009 the patient experienced macular rash that covered her entire body except for her face and feet. The rash did got away the next day (16-MAR-2009) and the patient recovered. Additional information has been requested.
Within 15-minutes of vaccination, the patient experienced a syncopal episode. EMS evaluated the patient on-site. The patient reported taking a marijuana edible prior to vaccination and stated he was anxious about the vaccine. The patient was normotensive (121/68). EMS administered 0.5L normal saline and 4mg IV Zofran. EMS transported the patient to Emergency Department. In the ED, the patient reported taking a marijuana edible at 1200 and that after their vaccination they experienced feeling flushed, nausea, vomiting, and near-syncope. After several hours waiting in the ED, the patient noted feeling improvement. The patient's labs and tests were unremarkable. Patient was discharged with vasovagal reaction and cannabis abuse.
Information has been received from a physician's assistant (PA), concerning a 25 year old female patient with asthma and acne, who on 12-APR-2007 was vaccinated IM in the left deltoid, with the first dose, 0.5ml, of Gardasil (Lot #657621/0387U). Concomitant therapy included Nuvaring, Accutane and albuterol. On 13-APR-2007 the patient developed a lump in her left axilla, though the PA there was no swelling or redness present. Treatment consisted of warm soaks and Motrin. At the time of this report, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Though an office visit was not required. The PA informed the patient that if the condition persisted for more than 2 weeks, a fefferal to a surgion would be ordered. At the time of this report (08-May-2007), the patient had not recovered. Additional information has been requested.
Vomiting: toddler was crying middle of the night and we discovered that she threw up her dinner. Dinner foods were familiar - no new foods introduced. We gave her PEDIALYTE to replenish fluids.
BODY ACHES; HOT FEELING; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. The Batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On 08-APR-2021 18:00, the subject experienced body aches. On 08-APR-2021 18:00, the subject experienced hot feeling. On 08-APR-2021 18:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, hot feeling, and headache on 10-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210422653.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in approximately 2014 (also reported as since May 2014), an unspecified number of patients were administered GARDASIL (dose, route of administration, lot # and expiration date were not provided) that tell to a temperature of 33F. This excursion was supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Starting at 10pm on 4/20/21 I started having chills, woke up on 4/21/21 with a 100.2 fever, chills, muscle aches, moving super slow and just exhausted.  Symptoms subsided by the time I woke up on 4/22/21 and felt "normal" that day.  Woke up on 4/23/21 feeling a bit dizzy, kind of in a brain fog is the best way to describe it, almost like my head is floating outside my body