chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left facial numbness, hypoesthesia in CN V-1 distribution. Later developed left arm numbness which persisted more than 2 weeks. Saw neurologist and was treated with oseltamivir.
On 8/6/01, pt was inadvertently given DTAP, instead of DT and mom was instructed to watch child closely and let us know how the child is doing tomorrow. On 8/7/01, mom here and states that child had a temperature of 104F last PM and was treated with Tylenol and cool baths. Had doctor's visit today and was instructed to continue with fever medication and heat treatments to right axillary area. They are to call LMD if rash develops. On 8/8/01, per telephone call from mother; she states that the pt's temperature is down to normal range and that now he has muscle cramps and that the lymph nodes are still swollen under his right arm. Asked mother to continue to observe and notify LMD if condition worsens or further questions.
Patient received her second dose of Moderna COVID-19 vaccine at approximately 11:00 a.m. She had no reaction within the first 15 minutes of recieveing the vaccine and went back to work. She is a worker in our facility and presented to the hospital floor at 12:20 complaining of itching to her chest and arms and redness to chest, arms, and abdomen.  On-call health care provider was contacted and informed of situation and orders for 50 mg PO benadryl were carried out by nursing staff. Health care provider states patient could return to work if she feels able and report back to the hospital floor if her symptoms worsen.
Information has been received from a 53 year old female referring to herself. Patient's pertinent medical history and previous drug allergies were unspecified by the reporter. On 06-AUG-2015 the patient was vaccinated with PNEUMOVAX 23, (strength, dose were not reported) intramuscular. No concomitant medications were reported. After receiving vaccine on an unknown date in August 2015 the patient experienced muscle pain, headache, fatigue and soreness. Patient has not communicated with or sought treatment from her provider concerning her adverse events. The outcome of pain, headache, fatigue and myalgia was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Tick bite 5/15/12 (large egg size nodule on (L) deltoid with swelling & redness at site of inj.) which was given on 5/15/12. Given Doxycycline 100mg.
Received the Moderna COVID 19 booster on 11-1-21.  Developed scattered  rash on right arm on 11/4/21 pruritic and red. On 11/5/21  area around the left eye became swollen. Redness and swelling developed down the left check. Area became pruritic.  Rash developed on lower abdomen and left groin red and pruritic.
Asthma became unpleasant about 30 hour following inoculation.  Noticeable improvement with an oral Montelukast pill, about 40% better.
2nd dose administered 21 days after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (2nd dose administered 21 days after 1st dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011j20a and 016m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced OFF LABEL USE (2nd dose administered 21 days after 1st dose). On 04-Feb-2021, OFF LABEL USE (2nd dose administered 21 days after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Information has been received from a registered nurse concerning a 69 year old male patient, who on 11/18/2002 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Concomitant vaccination included a dose of influenza virus vaccine in the left arm.  On 11/20/2002, the patient called the doctor's office reporting that he had developed a rash from his elbow to his shoulder on his right arm.  No other symptoms were reported.  The patient was expected to be seen at the doctor's office.  Subsequently, the patient fully recovered.  The reporter indicated that two other patients (WAES #'s 0212USA01969 & 0212USA01970) received pneumococcal vaccine 23 polyvalent from the same lot and also experienced "worse than usual local reactions".  The reporter also noted that "This office has given [pneumococcal vaccine 23 polyvalent] for over 10 years and we have never had the type of reactions that these 3 (and subsequent) patients experienced" (WAES # 0303USA00344).  The reporter stated that she was "uncomfortable using the rest of the vial or other vials from the same lot".  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information is not expected.
Information has been received from a physician concerning three children who are 12 months old who are vaccinated with varicella virus vaccine live. Subsequently 2 wks after the vaccine, the pt developed shingles. No further details were provided. Unspecified medical attention was sought. Additional information has been requested.
Redness, swelling, pain upper arm of injection site occurring within 24 hours of injection and referred by day #3 post injection. Systemic symptoms including body aches, fatigue, shaking chills.
Swelling at injection site, redness at injection site, formed a knot at injection site, fever in injection site, redness growing
09/02/2003: Crying a lot; 09/05/2003: high fever, rash, swollen glands in back of neck, crying continuous 48 hours screaming as in pain.
A couple weeks ago she started developing ticks.; Information has been received from a pharmacist via an unspecified reporter, referring to a 13 years old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in October 2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly (dose, lot number, expiration date and anatomical location were not reported) for prophylaxis.    On an unspecified date in October 2020 (discrepant information also reported as "a couple weeks ago"), the patient started developing tics (also reported as"ticks"). The reporter stated that she researched and found there were some nasty side effects for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and tics was one of them. Now the patient's mother was taking her to a neurologist. The outcome of tic was reported as not resolved.    The casuality assessment between the vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the tics was not provided.
Parent called stating child's vaccine site, left deltoid, has become red, swollen and hard as rock. Approximately 2 1/2 hours after vaccine was given. Patient was taken to the urgent care and given benadryl po and 5 day steroid pack po. Local reaction.
testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 13th of 14 report. An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown a not available/provided to reporter at the time of report completion), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. For concomitant medications, it was unknown if other vaccine in four weeks or other medications in two weeks. The patient was testing positive for COVID after receiving vaccine. A total of 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The events start date was 21Jan2021, and resulting in doctor or other healthcare professional office/clinic visit. It was reported as unknown if treatment was taken for the events. The outcome of the events was unknown. It was unknown if patient had COVID prior to this vaccination. The patient had been tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "testing positive for COVID after receiving vaccine".,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
Extreme pain in muscles and joints, Headaches, Nausea, weakness. Symptoms started 12 hrs after injections and lasted 12 hrs. and subsided as quickly as onset.
Client states she noted an exacerbation of asthma. Had SOB and Asthma medication did not work as well. Client needed to take an increase in asthma medication. Needed Albuterol inhaler 3-4 x a day 10/15, 10/16 and 10/17. Improved later 10/17.
slept for 2 days; rebound effect; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (slept for 2 days), REBOUND EFFECT (rebound effect) and FATIGUE (fatigue) 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 SOMNOLENCE (slept for 2 days), REBOUND EFFECT (rebound effect) and FATIGUE (fatigue). At the time of the report, SOMNOLENCE (slept for 2 days), REBOUND EFFECT (rebound effect) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
SITE OF INJECTION VERY PAINFUL (COULD NOT SLEEP ON ARM); This spontaneous report received from a consumer concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced site of injection very painful (could not sleep on arm). The action taken with covid-19 vaccine  was not applicable. The patient recovered from site of injection very painful (could not sleep on arm). This report was non-serious. This case, from the same reporter is linked to 20211044978.
Information has been received from a registered nurse and a physician concerning a 12 month old male pt with no past medical history and no known allergies who on 09/05/2001 was vaccinated SC in the left upper thigh with the first dose of varicella vaccine. Concomitant vaccination in the same day included first dose of MMR SC in the right thigh and the third dose of poliovirus in the left lower thigh. There were no illnesses at the time of vaccination. On 09/16/2001, the pt developed a rash. The pt presented to the physician's office with 20 lesions on his torso. His temp was reported as 97 deg F axillary. The pt was diagnosed with chicken pox. It was reported that the rash lasted for four days. No further info is available.
Febrile Seizure, limp and not breathing.  Lips and face turned blue.  Lasted approx 20-30 seconds.  Checked at ER afterwards.  Temp 100.7 when seized and 103 10 minutes later at the ER.
Major breakthrough bleeding in middle of mensural cycle along side painful cramps. Breakthrough bleeding is not common for patient.
On approximately the evening o 01/21/21 the patient began to experience headaches.  The headaches have been intermittent continuing on till the date of this report (02/04/21).  The patient has been taking acetaminophen with relieve.  On approximately 02/01, it was noted by coworkers that the patient's right side of the face would not move when he would talk.  Around the same time, the patients right eye became watery and the patient's wife stated she noted some gurgling.  Due to the onset of these new symptoms, the patient went to see the doctor on 02/04/21.  Per the patient's wife, the doctor diagnosed the patient with a very mild form of Bell's Palsy and prescribed steroids to the patient.  The name of the steroid was not disclosed.
Began around 3 am: significant all over joint pains, headache, temp., fatigue and general malaise. Basically couldn't get out of bed for about 28 hours
Extremely sore muscles, upset stomach and other flu symptoms lasting 36 hours. Better after that.
Bumps and itching under hands and feet. Bumps on stomach, shoulder and around belly button (Wednesday 4/18/2018. Swelling of mouth Thursday 4/19/2018.
Issue with her bowels; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Issue with her bowels) 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 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ABDOMINAL DISCOMFORT (Issue with her bowels). At the time of the report, ABDOMINAL DISCOMFORT (Issue with her bowels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Issue with her bowels) 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 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ABDOMINAL DISCOMFORT (Issue with her bowels). At the time of the report, ABDOMINAL DISCOMFORT (Issue with her bowels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Had chest pain and shortness of breath, felt dizzy and off balance. Went to the Emergency room due to the chest pain and was found that my D-DIMER levels were elevated and they suspected a pulmonary embolism. CT angio was done and there were no clots, but there was borderline cardiomegaly and reactive lymph nodes that were found on the scan. Since then, I was diagnosed with Hashimoto's and have been flaring for a year. I have been feeling dizzy, off balance, lightheaded, had blurred vision for 2 weeks, and was placed on levothyroxine. I continue to have these symptoms including the chest pain and have visited multiple doctors but have not received a diagnosis.
Pt received Rotateq #1 12/29/06. Pt developed intussusception 2/23/07 which was successfully reduced by barium enema. Child did well following reduction without significant sequelae. 3/15/07 Received medical records from hospital which reveal patient experienced loose stools 1 of which was bloody.  Became lethargic w/low grade fever. BE enema successful.  Held overnight for observation.  Did well & was d/c home next day. FINAL DX: Intussusception, successfully reduced w/BE enema.
head injury/head trauma; eye infection; syncope/passed out; felling bad; has no balance; felt dizzied; irritated; This spontaneous case was reported by a consumer and describes the occurrence of HEAD INJURY (head injury/head trauma) and SYNCOPE (syncope/passed out) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included CLONAZEPAM (KLONOPIN) for Glaucoma.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HEAD INJURY (head injury/head trauma) (seriousness criterion hospitalization), SYNCOPE (syncope/passed out) (seriousness criterion medically significant), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied) and IRRITABILITY (irritated). On 25-Mar-2021, the patient experienced EYE INFECTION (eye infection). The patient was hospitalized from 09-Mar-2021 to 11-Mar-2021 due to HEAD INJURY. At the time of the report, HEAD INJURY (head injury/head trauma), SYNCOPE (syncope/passed out), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied), IRRITABILITY (irritated) and EYE INFECTION (eye infection) outcome was unknown.            No treatment medication was included.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-071179 (E2B Linked Report). This case was linked to MOD-2021-071179 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-071179:Case for first dose
Pt is a 45 y/o F who presents w/ epigastic pain and intermittent L arm numbness. She was found to have extensive clots in descending thoracic aorta with additional clot in  L subclavian and axillary arteries.   She denies any birth control and does not smoke. We have a hypercoaguable workup pending. Transthoracic echo 5/13 did not reveal a cardiac source nor PFO.   She developed sx and saw PCP 4/6/21 which was 3d after second dose COVID vaccine, Moderna (administered 4/3/21). At the PCP 4/6 pt complained of some left arm numbness and a decreased pulse and the doctor noted that it was a little bit cooler to touch and ordered a arterial ultrasound and MRI of the brain.  However, the patient did not feel like she needed it therefor did not have either test done.   During her admission the pt has been evaluated by vascular surgery and cardiothoracic surgery. Surgically the patient is to have 5/14/21 Penumbra thrombectomy of L axillary and L subclavian artery. Then she will have 5/17/21 removal of thrombus in descending thoracic aorta via L thoracotomy/L heart bypass.
rapid heart beat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (rapid heart beat) and HEADACHE (Headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLONIDINE HYDROCHLORIDE (CATAPRES [CLONIDINE HYDROCHLORIDE]).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (rapid heart beat) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (rapid heart beat) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a healthcare professional and described the occurrence of rash in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a female subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759347A - A059351A. Follow-up information received on 08 January 2009 indicated that approximately 9 days after receiving FLULAVAL, the subject developed a rash. She saw her doctor and was diagnosed with a bacterial infection that was reportedly not related to FLURAVAL. The subject has a history of many illnesses. The outcome of the events was not reported.
Hives, cotton mouth, tachycardia (150?s), and itchy throat. Treated with Benadryl and epi.
~ Approximately 2-3 weeks after the vaccination, facial skin products (with exfoliants) that I have been using for over a year caused my skin to burn, i.e., a burning sensation and red tender skin on my cheeks and around my eyes. I had to switch to neutral products for sensitive skin. I also tried Claritin and applied Cortizone cream, which didn't seem to help. Within the same time period, I developed a painful and itchy rash on my lower front neck. It went away after a few days.A couple of weeks later (1/1/22), the rash on my neck reappeared and again disappeared after about three days.Everything has returned to normal - there has been no further recurrence of the rash and I'm able to use my regular skin care products again.
Pt recvd 2 doses of Engerix-B on 24JUN92 & 22JUL92 & 22JUL92 following vax devel pain @ inject site w/discoloration & itching;
AS PER PT, NIGHT AFTER RECEIVING THE VACCINE SHE STARTED GETTING ITCHY ON HER LEFT HAND. EVENTUALLY SHE ALSO STARTED GETTING SORES/BOILS AND THEY WOULD POP. UPON EXAMINATION, SKIN IS SCARRED FROM BOILS AND SCRATCHING. PT DOES NOT HAVE INSURANCE SO DID NOT GET SEEN. THEY ALSO DID NOT REPORT UNTIL NOW BECAUSE IT HAS GOTTEN WORSE AND POTENTIALLY SPREAD TO HER RIGHT HAND.
Several minutes after vaccines patient became light headed, he then passed out for several minutes and became very stiff. When patient came to he was disoriented (didn't know where he was or who I was). Patient felt nauseous. Patients blood pressure was 81/50. Patient was taken to ED for further evaluation.
Left arm swollen, slightly red, warm to touch, slight hardness. Tx Advil, warm compresses. MD advised: Benadryl and cold compress x 3 days.