chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lips and legs were swollen, even got fever blister swelling went down on 11/25. Rash on shin bone on 11/22, lasted for 3 days. Doctor visit today problems have subsided, only fever blister on lip remains.
Child in office on 8/4/01 for 12 month exam. Received Varivax and MMR, SC, both given in left leg. Almost immediately, left leg became swollen about 5cm X 5cm and erythematous. After Benadryl was give, erythema lessened and edema did not increase. No respiratory symptoms, no respiratory distress and no hives. Left office about 10:30 in good spirits and no further symptoms. Inflammation decreased by 8/4/01 PM. Slight bruise only at site as of 8/7/01 PM.
pt vaxed 13JUN91 immed following shot began crying unusually & unconsolably; pt didn't stop crying til a few hrs had passed; on 16JUN91 noticed making strange jerking movements; few days later an EEG was given & dx w/sz; infantile spasm sz
Site soreness and redness in both arms, slight lightheadedness and dizziness afternoon of injections. Evening of injections developed severe chills and headache. Chills subsided by am of day after injections.  Lightheadedness and dizziness persisted for 3 days. Soreness and redness of site still present on 4th day.
1 pm: Flu shot administered. Pt states received other vaccines never flu shot. W/I 1 hr: Pt experienced diarrhea. Approximately 5 hrs: HA, pt went to day down. Call wife into room, starting convulsing seems like approximately 1 1/2 hrs. Called medical center - no directions given, subsided and no repeat. No residual problems, slight lingering HA.
Nearly immediate after administration  of vaccine- stood up to move to a waiting chair & experienced dizziness to the point of near syncope, heart pounding, nausea, sweating- pharmacy brought juice and watched me. Drank juice but was disoriented enough to spill a bit- sat for about 30 minutes until symptoms cleared up enough to walk around and got a ride home.
2nd shot of primary MRNA series was different than 1st, patient received Moderna for his 1st shot on 1/12/21
TIA; off label use; Product use for unapproved combination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 14:00 as dose 4 (booster), single (Lot number: C7J3277) at the age of 72 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), single; manufacturer unknown), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 27Oct2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 27Oct2022, outcome "unknown"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant) with onset 22Nov2022 at 16:30, outcome "recovered", described as "TIA". The patient was hospitalized for transient ischaemic attack (hospitalization duration: 2 day(s)). The event "tia" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: unknown, notes: CT (2); unknown, notes: CT (2); Magnetic resonance imaging: unknown. Therapeutic measures were taken as a result of transient ischaemic attack.  Clinical course:  Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. AE treatment: CT (2), MRI.
"Extreme" muscle, joint tenderness, nausea, vomiting and insomnia.
Local swelling an redness at site of vaccination. Treatment included ibuprofen and apply ice to site.
This initial spontaneous report was received from a registered nurse referring to a 62 year old female patient with tape allergy. On 30-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX23 injection in the arm (lot # K008927; dose, strength, route and expiration date were not provided). There was no concomitant medication described. The nurse stated that on 02-FEB-2015, the patient experienced cellulitis reaction at the injection site (injection site cellulitis). IT was unknown if the patient sought medical attention or received treatment. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of injection site cellulitis was unknown. The relatedness between the event, mentioned above to PNEUMOVAX23 was not reported. Additional information has been requested.
A week after getting my second Moderna vaccine, upon waking up on April 15,  I had vertigo to the point of throwing up.  Tried Epley maneuver a few times.  Couldn't get in with ear doctor until May 6 and by then it had finally improved.  Once side-to-side vertigo abated, I got it when I looked up a certain way or moved too quickly.  By the time I was able to get  to doctor, I had been free of dizziness for four days.  However, i still get a funny sensation a few times a day - it's like time stops for a second and then goes on  -- like freeze frame.  Don't know how else to describe it.
Seven days after the injection I developed fairly severe upper back pain.  Two days later I developed the typical rash of shingles.  Diagnosis confirmed in office and antiviral therapy begun (which was yesterday as I write this),
Acute hearing loss 90% in right ear, 30% in left I also suffered a stroke TIA on July 3, 2021 @ 7PM
Patient was given Flu Mist on 12/30/2021.  Expiration of the the Flu mist was a day earlier on 12/29/2021.  The Manufacturer informed us to fill out a VARES Report.  No Adverse reactions were noted.
Information has been received from an approx 65 year old female RN who in 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, she developed an injection site reaction that was red and warm to the touch. No medical attention was sought. All symptoms resolved within several days. Additional information has been requested.
Patient given HIB shot mixed with MENACTRA instead of diluant, patient had no reactions, was soon later that day with no visible reaction and mother reported no reaction or side effects over next 48 hours.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date: 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reports a pocket of fluid in arm that traveled to his elbow, he went to the hospital and they gave him a steriod shot which helped.
ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included banana allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the patient felt a little lightheaded 15 minutes after vaccination. The patient was then left for 25 minutes to 30 minutes. It was reported that the patient's body got hot all over, ears started itching, face started tingling and was feeling tight. The patient's chest and neck also started feeling tight. The patient visited emergency room for treatment of the events. It was reported that the patient was having an anaphylactic reaction and was given Benadryl and prednisone. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and prednisone non-company. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210436119-covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).
Severe abdominal cramping along with associated diarrhea of varying degrees - still occurring presently relieved by IMODIUM.
This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients. On an unknown date, the unspecified number of patients were vaccinated with liquid PEDVAXHIB (lot #, dose, route not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
10/05/2021 Received first Pfizer Covid shot at pharmacy 10/06/2021 Felt flu like symptoms (body ache, slight headache, chills) 10/07/2021 Severe headaches/migraines began daily 10/10/2021 Began noticing blurry vision/slow focusing and right eye lid twitching/drooping, intermittently right side of mouth would freeze 10/15/2021 Had Dr appt for severe migraines. The doctor scheduled CT scan and prescribed migraine meds ( did not have medical history of migraines until this point ). Recommended vision check also. 10/20/2021 Had CT Scan 10/22/2021 Had vision test at Eye Doctor. Right eye was drooping/fluttering and right side of mouth was froze. They confirmed seeing this during the visit. Dr and assistant got on CDC webite and suspected onset of Bells Palsey since shot after checking several symptoms. They gave me paperwork to register symptoms at CDC. 10/22/2021 Picked up migraine med prescription 10/24/2021 Had severe migraine, took first pill. Headache subsided for 2-3 hours and came back but not as bad. 10/26/2021 Had fairly severe migraine, took pill. Headache subsided for the day. 10/27/2021 Medic suggested downloading migraine monitor app to track migraines. 10/28/2021 Mild headache all day, facial paralysis began around noon and continued into next day. 11/01/2021 Have follow up visit with Dr about adverse side effects from 1st Covid shot, requesting medical exemption for second shot.
isn't going to get the second dose in the series from Moderna's vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (isn't going to get the second dose in the series from Moderna's vaccine) in a female patient of an unknown age 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 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 (isn't going to get the second dose in the series from Moderna's vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (isn't going to get the second dose in the series from Moderna's vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Headache, chest pains, difficulty breathing. Went to ER, had EKG, echocardiogram and blood work. Tested troponin levels bc of recent covid vaccine. Then diagnosed with mild myocarditis Bc troponin levels were elevated to 27. Admitted to hospital and testing enzyme levels until they start heading down. Given Motrin to help with inflammation and chest  pain
(L) high red and tender 2.75 cm area of redness on ant. (L) thigh, deeper 1 cm nodule.
Initial information received from a literature article 08-Nov-2018. Abstract: This manuscript reports a rare association of the development of acute macular neuroretinopathy (AMN) after administration of an influenza vaccination. A 42-year-old female presented with a 2-week history of black spots and a paracentral scotoma in the right eye after receiving a seasonal influenza vaccination. Findings on multimodal imaging were classic for AMN, and these findings improved but did not fully resolve 4 weeks after initial presentation with observation alone. Although a febrile illness or the use of oral contraceptives is most commonly associated with the development of AMN, it is important for clinicians to also consider influenza vaccination as a possible etiology. This case involves a 42 years old female patient who experienced acute macular neuroretinopathy (AMN), black spots and a paracentral scotoma in the right eye, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, patient developed a serious acute macular neuroretinopathy (AMN) (acute macular outer retinopathy). This event was assessed as medically significant. On an unknown date, patient developed black spots and a paracentral scotoma in the right eye and black spots and a paracentral scotoma in the right eye following the administration of INFLUENZA VACCINE. Lab data includes Snellen vision acuity (VA) in the right eye was 20/20 with an intraocular pressure (IOP) of 12 mmHg. The slitlamp examination was unremarkable. Funduscopic examination revealed a slight reddish-brown petaloid lesion superonasal to the fovea. Near-infrared (SLO) imaging of the right eye revealed a wedge-shaped dark lesion superonasal to the fovea. Spectral-domain optical coherence tomography (SD-OCT) demonstrated hyperreflectivity of the outer plexiform layer (OPL), with characteristic shadowing of the ellipsoid zone. A fluorescein angiography was performed, but the findings were unremarkable and did not show signs of any other inflammatory lesions. Final diagnosis was acute macular neuroretinopathy (AMN) and black spots and a paracentral scotoma in the right eye. It was not reported if the patient received a corrective treatment. Outcome of the event was recovering (AMN these findings improved but did not fully resolve). It was reported that, clinicians can also consider influenza vaccination as possible etiology. List of documents held by sender: none. Sender's Comments: Patient experienced Acute macular outer retinopathy after vaccination with Influenza Vaccine (unknown manufacturer). Time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
The patient is 14 and received the Moderna Bivalent vaccine only authorized for those 18 and older.
Received MMR Shot on 2/24/06 7-10 days later I started with fevers, achey joints and also a rash on my upper body.  Went to the Care Center.  Was seen by Dr.  She prescribed Vistaril and put me off work for 5 days.
Subsequent to receiving first dose of Lymerix the pt developed right arm numbness which resolved after six weeks. 48 hours subsequent to receiving second dose of Lymerix, the pts right arm numbness returned and her arm was swollen, red and painful. The pt stated that she felt like she had Lyme disease again. On 07/13/2000 the pt presented to the physician with a huge bull's eye rash. Pt tested positive for Lyme disease and was started on a 21 day regimen of doxycycline.  The most recent information reports the outcome of the event as unresolved.
Pt. called our pharmacy today.  She states she started feeling pain behind her eye and had a sore on the inside of her upper lip and one below her nose on 10/21/20.  On 10/23/20 she was feeling so bad she went to the local ER.  They diagnosed her with shingles and started her on acyclovir 800mg three times a day for 5 days.  Today, patient states the sores are scabbing over but she still has some pain behind her eye and on her face.
Body aches; Sore arm; 100.3 fever; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of known allergies to eggs. Concomitant medications included rosuvastatin calcium (CRESTOR); from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 27Mar2021 at 09:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 08Apr2021 at 01:00, the day after vaccine was given, the patient experienced sore arm, 100.3 fever and body aches. No therapeutic measures were taken as a result of the reported events. The clinical outcome of sore arm, 100.3 fever and body aches was resolving at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced red at injection site. The reporter refused to provide any information for this case as no details available. The reporter did not consent to follow up.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: blood clots. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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. On an unspecified date, the patient experienced shingles. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
fever to 102 2 days p/vax subsequently red macular rash trunk, then @ 4 days urticaria legs;
rabies immune globulin (RIG) being administered at a different location than the IMOVAX RABIES injection, they were administered at the same location (deltoid muscle) with no reported adverse event; Initial information received on 01-Jul-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient to whom rabies immune globulin (RIG) being administered at a different location than the imovax rabies injection, they were administered at the same location (deltoid muscle) with no reported adverse event while receiving vaccines rabies immuneglobulin and rabies (HDC) vaccine [Imovax Rabies].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect RABIES (HDC) VACCINE  injection and RABIES IMMUNEGLOBULIN not produced by Sanofi Pasteur  injection both at an unknown dose (lot number, expiry date, form: not reported) via intramuscular route in the deltoid nos for post-exposure prophylaxis(immunisation).  On an unknown date it was reported rabies immune globulin (rig) being administered at a different location than the imovax rabies injection, they were administered at the same location (deltoid muscle) with no reported adverse event (product administered at inappropriate site) (unknown latency) following the administration of rabies (HDC) vaccine and (unknown latency) following the administration of rabies immuneglobulin. The physician's parents were both exposed to a bat, and it is unknown if they were bitten and there was no obvious wound, but of course they still went to receive post-exposure prophylaxis. Pharmacist wanted to confirm if patients should receive an extra dose of the IMOVAX RABIES vaccine, because the RIG might have inactivated the vaccine dose if administered at the same site? And if so, when should the extra dose be given. Pharmacist stated that she believed this occurred approximately 2 weeks ago, since the physician mentioned that his parents were due for the 14-day dose of the Imovax Rabies.  Action taken: not applicable.   Outcome: Unknown.    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.; Sender's Comments:  SAD20220701002228: 01172861:
Patient received  one Janssen covid vaccine 8/20/2021,  patient than reported she had received the 1st Moderna Covid vaccines in March and the 2nd Moderna covid vaccine in April. At the time of the Janssen administration patient had no immediate side effects.
Moderna COVID-19 Vaccine EUA Eight days after vaccination, tenderness and redness developed at the injection site, a two-inch diameter circle . No itching or pain to the touch, just a bit warmer than usual. It cleared after three days.  Right after vaccination no side effects developed, aside from tenderness at the injection site.