chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sinus congestion; chest congestion; mild cough; laryngitis; loss of voice; nasal congestion; nasal congestion and drainage; mild sore throat; tired; headache; muscle aches; chills; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: ER8727), via an unspecified route of administration, administered in left arm on 27Mar2021 (age at vaccination was 42-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included seasonal allergies and allergy to penicillin and latex. Concomitant medications included biotin, cetirizine hydrochloride (ZYRTEC) and multivitamins; all from an unspecified date and unknown indication. The patient previously took amoxicillin and doxycycline and experienced allergy. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in left arm on 06Mar2021 (age at vaccination was 42-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced tired, headache, muscle aches and chills on 28Mar2021; nasal congestion and drainage, and mild sore throat on 30Mar2021; laryngitis and loss of voice on 31Mar2021; and sinus congestion, chest congestion and mild cough on 01Apr2021. It was further reported that the patient experienced the following: tired, headache, muscle aches and chills on day 1 post vaccine; no symptoms on day 2 post vaccine; onset of nasal congestion and drainage, mild sore throat, headache and chills on day 3 post vaccine; nasal congestion, headache, onset of laryngitis, loss of voice on day 4 post vaccine; and nasal and sinus congestion, chest congestion, mild cough, full loss of voice and headache on day 5 post vaccine (day of report). No therapeutic measures were taken as a result of the events. The outcome of event tired and muscle aches was recovered on 28Mar2021; nasal congestion and drainage (rhinorrhea), mild sore throat and chills was recovered on 30Mar2021; laryngitis was recovered on 31Mar2021; while other reported events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Reported feeling pain in her arm beginning a couple hours after the injection, lasting until Sunday. She reports she is extremely tired and has been resting since Friday. She is still fatigued at the time of this report Tuesday 4/13, and still unable to resume regular activities. I advised client to contact her doctor but she declined.
Patient started feeling pain and stiffness in right arm Sunday evening, which turned to excruciating pain all over the body and rash around injection site on upper right arm. There's sharp shoulder pain but patient is also having trouble breathing. Pharmacist called the PCP so that they are aware of the patient's current status from potentially receiving vaccinations and suggested to the patient to seek urgent care visit.
I started developing hives after being in the cold and/or sweating. For example going on a run. Since then I have had episodes of hives that are itchy and red. Primarily on my thighs and belly. The hives last about 20 mins to an hour after coming back indoors. After about two months I decided to go to the doctor about the hives and was diagnosed with Cold Urticaria. I was prescribed Zyrtec which does help, but it does still happen occasionally. I was also prescribed an EpiPen, but I have not needed to use it. On 03/30/2022 I did have a tele visit with an allergist and he advised it could be either Cholinergic or Cold Urticaria.
Expired vaccine used; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.            No Concomitant medications were reported.  Vial used post 2 days after the time from first puncture.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up contains No New Information.
01/14/22 presents to ED for "weakness and nausea". PMHx of "CAD s/p 3 stents (12/2021), HFrEF, dilated cardiomyopathy, HTN, ESRD, and T2DM"
Life changing and disabling event - Severe extremely loud tinnitus (Hissing and Whistling) in both ears 24 hours per day endlessly. After about two months the Whistling decreased some and the Hissing remained extremely loud and persistent. I went to an urgent care center,  general practitioner, and ENT for help. The urgent care center and general practitioner would would not help me and sent me away. The ENT suggested I go to an audiologist.
On March 7, early morning, patient's right chest was bright red with a dense pancake size rash over his original rash.
02/04/22 presents to ED for "twitching of the right upper extremity and neck". "no prior history"
Pain, swelling at injection site, fever, headache, muscle aches, nausea, fatigue, soreness at site.  Treated with OTCs:  Tylenol #3, APAP, Benadryl, fluids. Did not go to ER.
Patient received Pfizer vaccine as IM into left arm at approximately 10:05am on Tuesday 4/6/2021. Patient had a vasovagal response at 10:20am on Tuesday 4/6/2021. Patient fell out of chair, face down onto gym floor. This RN went over to patient. Patient noted to be unresponsive, however after 30 seconds woke up and was alert and oriented x 4. Patient log rolled onto back and noted to be pale and diaphoretic. EMS called by RN at 10:20. Initial set of vital signs BP 132/80, SpO2 98% on room air, HR 90 and RR 20. Legs elevated onto chair and patient remained lying flat on his back until EMS responded. EMS initial arrival at 10:49 am ... EMS response time 33 minutes with arrival onsite at 10:53am. Patient taken to hospital by EMS.
Case previously recorded as MA2009-4261. Initial case report received from a consumer via Novartis on 13 NOV 2009. A 44-year-old female patient was vaccinated during pregnancy with FLUVIRIN (batch no. unknown), on 10 NOV 2009. MedCom reference no.: NA09-008182. Reference #: S2009US25756.
Experienced sore arm pain after first dose for a few days.  Then no pain normally except when I tried to lift my left arm above 90 degrees.  When I try to lift my arm above 90 degrees I experience pain in my left arm in the injection area.  This has persisted since the first dose of the vaccine.  I did not have any additional pain after the 2nd dose and had no other Covid symptoms that others have shared after either vaccine shot.  This is the only problem I have had.  I am only reporting this because it has persisted now for 4 months.  No change.  Not better not worse.  It does not hurt accept when I try to lift my arm.
fever; headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle aches) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H21A) for COVID-19 prophylaxis.     Never diagnosed with COVID-19 Allergies: Sulfite, artificial crab legs Asthma from inhaling certain chemicals and cooking oils. There was no parental vaccine exposure.  The patient's past medical history included Allergy and Asthma. Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE on 25-Feb-2021 and COVID-19 VACCINE on 09-Dec-2021; for an unreported indication: COVID-19 VACCINE on 28-Jan-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE. Concurrent medical conditions included Allergy and Asthma.    On 14-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle aches). At the time of the report, PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Dec-2022, SARS-CoV-2 test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
This study case was received from the investigator on 27 August 2012. A female subject who was a prior cigarette smoker had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 18 January 2011 a rapid Troponin I level that was not within normal limits (positive). The subject's central laboratory Troponin I level on 18 January 2011 was <0.10 ng/ml. No ECG was performed. The subject had no additional cardiac-related medical encounters, labs, or radiology information available. According to the investigator, repeat test was normal. Concomitant medication included SEASONIQUE. No further information was available at the time of the report. The subject's outcome was not reported. According to the investigator, the event of rapid Troponin I level positive was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
p/vax 5min starring, listing to rt, eyes fluttering, then drooling began;facial nerve noted shortly p/drooling;responsive @ that time;child moved to floor VS note 60/38, 66, 10;
sick; vaccine was affecting neurologically/any neurological damaging the path was attacking the nervous system; something like concussion; This is a spontaneous report received from contactable reporter (Consumer).  A patient (no qualifiers provided) received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "vaccine was affecting neurologically/any neurological damaging the path was attacking the nervous system"; CONCUSSION (non-serious), outcome "unknown", described as "something like concussion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021449118 Same reporter/drug, different patient/event.
Severe hives starting the 3rd day of vaccine. Since then, patient gets hives all the time from eating something or during a flu. Her body doesn't get hives before the vaccine.
shots and got them in left leg pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of leg pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced leg pain (Verbatim: shots and got them in left leg pain). The outcome of the leg pain was unknown.   It was unknown if the reporter considered the leg pain to be related to Shingles vaccine.     It was unknown if the company considered the leg pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR036699   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had both shots and got them in the left leg pain. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose refer linked case US2023AMR036699, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR036699:
Redness swelling pain at site of injection, muscle aches, headache, upset stomach, fatigue, shivering. Took TYLENOL twice on second day. Symptoms except soreness abated third day.
Client phoned on 10/10/00 and stated that she developed severe swelling and pain in her left shoulder over the weekend and is now taking Darvocet for the pain. Has not seen the doctor for this, although did see a physician on 10/9/00 for "another problem".
Suspected vaccination failure/Had a shingles vaccination, got them (shingles); Got them (shingles) for the second time; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The case was received from interactive digital media. The patient had the shingles vaccination and got them again for the second time. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Six patients were vaccinated with FluBlok QIV, patients were under the indicated age, no AE; Initial information was received on 17-Nov-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves six patients (demographic unknown) who were under the indicated age when they were vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE produced by Sanofi Pasteur (lot number and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported "This case created for 6 Patients. pharmacovigilance: I want to alert you of the following report where a product was used outside of indication: Product: FluBlok QIV Incident: 6 patients were given FluBlok QIV, which the indication starts at 18 years of age. These patients were under the indicated age. Actions Taken: representative communicated to the Centers for Disease Control and Prevention (CDC) the incident and was told FluBlok was less effective in this age group and possibly may have to immunize. I instructed her to call in to report incident. She also shared the nurses who administered the vaccine said the product syringes and boxes are similar and easy to mix up"  No adverse event was reported.  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.  There will be no information available on batch number for this case.
Approximately 15 minutes after the injection (noon) my face started to become numb (I 'needed" to physically try to stretch my face by moving it) and itchy, my lips went numb and my speech became slurred.  I immediately took 25 mg of Benadryl, at 12:10pm, my husband was with me and monitoring me continuously.    By 12:30pm my symptoms started to level off and my speech became more clear.    By 1pm I was able to rest and doze on and off for roughly two hours after which time the facial numbness was gone and my speech was clear and recovered.     As I of this report my family is still monitoring me.
9 days post vaccine pt. developed rapidly spreading rash over entire body.  She had  fever and sore throat with it as well and severe redness in her vagina lips (not assocoated with diaper rash.  Rash appeared to be chicken pox.  Was treated with Tylenol, Benadryl, Caladryl and oatmeal baths.  The redness in the vagina was treated with 1% cortisone and bagbalm.  The symptoms resolved on the 3rd day.
Began after the vaccine + 6 hrs after receiving the vaccine - Began to feel tired and achy about 6 hours after receiving the vaccine + 8 hrs - Fever of 101.3 for roughly 24 hrs with Aches and Chills                 Itchy rash by the vaccine location - roughly 4 by 6 inches, lasted 5-6 days + 36 hrs - Brain fog noticed - lasted through day 6 after getting vaccinated                       unable to focus or concentrate and forgetful through day 8 after the vaccine                       - weary and slept more than usual (10 hrs vs 7 or 8/day)
High Fevers (103.6 orally, shakingchills/sweats, eye pain/sorness,& non-productive cough. Received vaccine on 6/26/07, developed signs by 6/27/07 am & highest fever on 6/28/07. 6/30/07: She still has sweats but fever down normal 6/30/07. She still has eye pain/soreness esp. when moving eyes from side to side & non-productive cough. Saw Dr. on 6/29/007 :lab neg for  bacterial or strep. Dr. thinks it is all reaction to the meningococcal vaccine.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Since 22-SEP-2014, the patients were vaccinated with improperly stored oral, ROTATEQ (lot#, expiration date and dose were unknown). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Started as headache / migraines and fatigue and eventually over time escalated to many other symptoms like tachycardia, joint pain, chest pain, redness around joints.
Case number PHEH2015US021098, is an initial spontaneous report received from a health care professional on 19 Oct 2015. This report refers to a 5 year old female patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) intramuscularly at a dose of 0.5 ml on 16 Oct 2015. The case was reported as non-serious. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
nose is running like crazy; head cold; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose is running like crazy), NASOPHARYNGITIS (head cold) and PAIN IN EXTREMITY (sore arm) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced RHINORRHOEA (nose is running like crazy), NASOPHARYNGITIS (head cold) and PAIN IN EXTREMITY (sore arm). On 26-Sep-2023, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, RHINORRHOEA (nose is running like crazy) and NASOPHARYNGITIS (head cold) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Patient recently received Spikevax vaccine and was asking how many days it will take to be fully protected after getting the vaccine. Patient had head cold, nose was running like crazy and asked if she could take antihistamine after taking the Spikevax vaccine. She will have a dentist appointment soon, and asked if she could take antibiotics. After getting the Moderna vaccine on 25-Sep-2023 she had sore arm during a day and a half after getting Spikevax.  No treatment drug was reported.
Patient's spouse called today 2/9/21 to report that the patient experienced muscle weakness, especially in the right lower extremity, which led to a fall. Patient reportedly went to emergency department . Patient's spouse says that she continues to experience right sided weakness as of today's date, and she saw her primary care provider yesterday 2/8/21 who suspects vaccine-related muscle weakness. I advised patient's spouse to contact her neurologist as she has a history of left-brain stroke and brain tumor and I am concerned that the patient may have experienced another cardiovascular event.
started menstruating; This is a spontaneous report from a contactable consumer or other non-health care professional. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/ Batch Number: Not reported), dose 2 via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient received first dose of BNT162B2 (Lot/ Batch Number: Not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient experienced started menstruating on an unspecified date. The patient was 18 months post menopause and menstruating started exactly three weeks after her first dose. Patient underwent lab tests and procedures which included tests was biopsy of uterus were negative on an unspecified date. Upon follow-up general company information was reported. Patient stated Does the vaccine have anything to do regarding this. Thanking you advance for looking into this matter. The outcome of the event was unknown. Information regarding lot/batch number has been requested
Injection site soreness, fatigue, nausea, generalized aches, low grade fever experienced within a few hours after administration. Self-limiting; no treatment necessary except rest. Soreness persisted for 2 additional days. The other symptoms resolved within 24 hours.
Patient developed hives on lower back to the side and left leg. 25mg of benadryl tablet was given in ER  and later a dose of 500mg tylenol was given by patient herself at home. The next day patient reported woke up with  joints stiffness all over whole body . Hives has been diminished by day 2.