chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in their arm which spread throughout the arm; tingling on right side of tongue; numbness on the right side of the tongue/lips feel half asleep, with little sensitivity, like coming off the effect of the dentist's anesthesia; numbness on the right side of the tongue, like itching; a little heat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbness on the right side of the tongue/lips feel half asleep, with little sensitivity, like coming off the effect of the dentist's anesthesia), TONGUE PRURITUS (numbness on the right side of the tongue, like itching), FEELING HOT (a little heat), PAIN IN EXTREMITY (pain in their arm which spread throughout the arm) and PARAESTHESIA ORAL (tingling on right side of tongue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) (The patient mentioned having a pacemaker). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (numbness on the right side of the tongue/lips feel half asleep, with little sensitivity, like coming off the effect of the dentist's anesthesia), TONGUE PRURITUS (numbness on the right side of the tongue, like itching), FEELING HOT (a little heat) and PARAESTHESIA ORAL (tingling on right side of tongue). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in their arm which spread throughout the arm). The patient was treated with DICLOFENAC SODIUM, MISOPROSTOL (DICLOFENAC + MISOPROSTOL AUROVITAS) for Adverse event, at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA ORAL (numbness on the right side of the tongue/lips feel half asleep, with little sensitivity, like coming off the effect of the dentist's anesthesia), TONGUE PRURITUS (numbness on the right side of the tongue, like itching), FEELING HOT (a little heat), PAIN IN EXTREMITY (pain in their arm which spread throughout the arm) and PARAESTHESIA ORAL (tingling on right side of tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medication. Treatment information included hot and cold water and diclofenac ointment to the area where vaccine was applied to combat pain in their arm, which spread throughout the arm and also moved it so that pain would go away. The patient reported that symptoms were not intense but a bit annoying. The patient also reported that drinking water lessened the symptoms of mouth momentarily. Patient mentioned having a pacemaker.   This case was linked to MOD21-050151 (E2B Linked Report).; Sender's Comments:  MOD21-050151:direct relative of patient
Tested positive for COVID-19 on 15-Dec-2021; This spontaneous case was reported by a medical assistant and describes the occurrence of COVID-19 (Tested positive for COVID-19 on 15-Dec-2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0b5P21A) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products.  Patient had no chronic or long standing health conditions.  Concurrent medical conditions included GERD. Concomitant products included OMEPRAZOLE from 10-Aug-2018 to an unknown date for GERD.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021 at 9:50 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19 on 15-Dec-2021). At the time of the report, COVID-19 (Tested positive for COVID-19 on 15-Dec-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received no other vaccines on the same day as that of Moderna vaccine.  No treatment information was provided.   This case was linked to MOD-2022-666044 (Patient Link).
A report was received from a healthcare professional on 03 December 2003, concerning a 3 year old male vaccinee who was inadvertently administered Fluvirin on 02 December 2003. On 02 December 2003, the vaccinee inadvertently received Fluvirin.  No adverse effects were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Administered flu mist to me client in morning. By afternoon had bad headache. Sore throat. Low grade fever.
Nausea; Headache; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 10:00, (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and vertigo that was off and on for years. The patient was allergic to penicillin drugs (PCN). The patient received unspecified concomitant medications within two weeks of vaccination. 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 vaccines within four weeks prior to the COVID vaccine. On 09Apr2021, the patient experienced nausea, headache and dizziness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events of nausea, headache and dizziness was not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Skin Rash - itching - began 11am on 4/1.  Treated with Benadryl OTC medication at noon - symptoms subsided until 9:30 am on 4/2 when the resurfaced again. Treated again with Benadryl OTC Medication at 11:00am
On 11/21/2022, I was just feeling mildly sick. My sister had come down with COVID-19, so I was tested for COVID-19 on 11/23/2022 and 11/25/2022 but was negative. My symptoms weren't severe, I was able to work the whole time. On 12/05/2022, I tested for COVID-19 again and I was surprised to see it was positive. I was mostly fatigued and had flu like symptoms. I never ran a fever or had muscle aches, but I just didn't feel right. I isolated for the required time and began to feel better. However, every time I would be mildly active, I would get sick again. I went to see my doctor on 12/29/2022 and the COVID-19 test was inconclusive. At that point I was having a cough and sore throat. He prescribed and antibiotic that helped all of my symptoms.
Patient is a 69 year old male with a PMH significant for CKD, DM, CAD, HTN, HLD and GERD presents for shortness of breath, fevers, and malaise.  States symptoms started on Friday and have gotten progressively worse.  He reports contact with a granddaughter who was subsequently Covid positive.  He does report Covid vaccination approximately 1 month ago.  He denies loss of taste or smell.  No nausea vomiting diarrhea.  No chest pain.  Noted to be 92-94 percent the emergency room
approx 3 hrs p/vax pt noted to became pale, limp, unresponsive, eyes rolled backin head; mom states stopped breathing for several seconds; responded to stimulation but had 2 more episodes w/in 5 mins; was brought to ER by squad; t101.8
Narrative:  Patient called facility reporting red rash with sores on his hairline, chest, back, under arms and down to his thighs and still spreading and chills. Pt states the rash is "kinda red to purple" itchs, no pain with some areas open a little draining - first notice a couple days after receipt of the 2nd dose of COVID vaccine. Patient encouraged to present to ED - Evaluation in ED documented skin rash with itching that was thought to be consistent with diffuse atypia or allergic reaction. Patient discharge from ED with permethrin cream and hydroxyzine with instructions to return if worsening. PCP placed dermatology consult for patient - Dermatology evaluated patient on 7/28. At that time the erythematous component had already faded and they described a postinflammatory mild hyperpigmentation. Discussed pityriasis rosea, dermatologist explained can be due to a viral infection or drug or in this case COVID vaccine - and that resolution can take weeks to months. No additional follow up needed at this time per note
A non-serious spontaneous report of administration of expired FLUMIST was received from a physician concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received expired FLUMIST. The product expired on 20-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Couldn't get out of bed; Was Achy / Pain throughout her body/Pain upon movement; Crying with the achiness; Light headed; Nausea; Vomiting; Fever; Chills; Hot feeling; Diarrhea; Incapacitated for 2 days; This case was reported by a consumer via call center representative and described the occurrence of disability in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Afluria quadrivalent with an associated reaction of nausea (received the year before the date of reporting and experienced nausea, vomiting,  itching, fatigue, flu like symptoms and achiness) and Benadryl (pre-medicate with 50mg.). Concurrent medical conditions included chronic idiopathic urticaria. Concomitant products included cetirizine hydrochloride (Zyrtec) and fexofenadine hydrochloride (Allegra).   On 18th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced disability (serious criteria GSK medically significant), bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea. On an unknown date, the outcome of the disability was recovered/resolved and the outcome of the bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea were unknown.   It was unknown if the reporter considered the disability, bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient was incapacitated for 2 days. The patient could not get out of bed.  The patient was achy, cried with achiness, light headed, nausea, vomiting, fever, chills, hot feeling, diarrhea, pain throughout her body. It was reported that  it hurted upon movement. For tolerance of 2nd dose of Shingrix, refer case US2019AMR165478.
the patient received an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 09-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R022232 wit expiration date of 16-APR-2020 (upon intenla validation) for prophylaxis. No additional or clarifying information provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R022232; expirationdate: 16-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
received his first dose of the Pfizer vaccine for 12-16 year olds on May 14.  On May 19th, he fainted.  He has never fainted before.  On June 10th, he received his second dose and on June 15th he fainted again.  Both times he fainted 5 days after receiving the vaccine.
Patient received 3rd shot in L Deltoid on 1-16-2020 and the next morning she noticed a nodule, tenderness and itchiness. Patients site is swollen red and warm. Cold pack applied with some relief of soreness and inching.
Nausea,  vomiting,  diarrhea,  itching,  brain fog, speaking in tongs, dizziness. It has been one week since last vaccine and I am still having symptoms.
Pt devel measles following vax w/measles vax; no further details were provided;
Patient became very fussy and gassy. Having multiple episodes loose bright green stools. Vomited x1.
RASH @ INFECTION SITE THEN SPREAD TO KNEES R FOOT LESS ON THE TRUNK AND ARMS.
Chills started at 4:30am the next day - then I had nausea, then I had a fever of 101, then I had a headache
A non serious spontaneous report of blinding headaches during FLUMIST administration has been received from a health professional concerning an adult female nurse who administers FLUMIST. Medical history included an immunocompromised status. Concomitant medication included long-term steroid therapy. The event was reported to occur in the nurse responsible for the administration of FLUMIST and after she administers the vaccine to patients. The nurse complains of immediate blinding headaches after administration of any dose of FLUMIST. She wears a mask and does not have any splash back or part of the dose getting into her eye. The headaches resolve once she is done giving the doses. She normally does not give FLUMIST except when there is no one else in the clinic who can administer it. The outcome of the events is resolved.
Next day after vaccine, Feb. 6 - chills, fever (about 3 and a half degrees higher than normal), increasing pulse and bp 2 and a half days after vaccine, Feb. 8 - TWO rashes above elbow on right arm --  today, 8 days later, the rashes are worse -- have a virtual doctor's appointment tomorrow, Feb. 17
Patients arm is red, hot.  Symptoms persisted from Sat until Monday am.  Patient reported taking some motrin to ease symptoms.
I was extremely fatigued for over 3 days and unable to do my dailey activities as well as continued issues with being able to take deep breaths consistently
FELT HOT (NO FEVER); CHILLS ON AND OFF; PAIN IN ARM OF INJECTION; SEVERE HEADACHE; This spontaneous report received from a patient 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 was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced felt hot (no fever). On 10-APR-2021, the subject experienced chills on and off. On 10-APR-2021, the subject experienced pain in arm of injection. On 10-APR-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm of injection, and had not recovered from severe headache, chills on and off, and felt hot (no fever). This report was non-serious.
Yesterday was day 8 and i woke up with my arm hot, itchy, red and had a welt about 2 inches round. its gotten slightly bigger today.
Severe head to toe papular rash with intense pruritus and elevated temperature of 101.6
I filed a VAERS report on 12/16/09 due to the fact that the H1N1 mist was charted as given to a pregnant female. The doctor phoned the patient to inform her and she claims that she received two shots and no mist. She received season and H1N1 at the same influenza exercise.
After the 2/4/2021 second dose of Pfizer COVID-19 vaccine, I began experiencing unusual menstrual cycles.  For four (4) months, I had a menstrual cycle 2x per month (every 14 days).  After the first 2 months of this, I went to my PCP at Medicine clinic for blood work (checking hormones) and followed up with my gynecologist's office (APRN) to discuss the sudden unusual cycles and had a check-up. Results of bloodwork were inconclusive, no signs of abnormal hormonal changes and no infections. Dr. mentioned that they had a few other women notice unusually menstrual cycles after receiving COVID vaccines.  It took approximately six (6) months to fully recover from having multiple menstrual cycles per month.
PAIN IN RIGHT ARM WHERE SHOT WAS GIVEN. DOES NOT HURT TO TOUCH. NOT ABLE TO PERFORM FULL RANGE OF MOTION.
Within 5-10" after injection large welts and blotches at injection sites, back/top of scalp, neck, back and cheek. Approximately 15" after injection increase swelling also at DTP-HIB site left thigh. Received 3/4 tsp Benadryl PO. Within 20' welts, fading. Happy, active with no respiratory distress at any point.
Information has been received from a registered nurse concerning a nurse who on 11-SEP-2007 administered a dose of Rotateq to an infant.  Subsequently the infant spit up the dose and it went into the nurse's eye.  The eye was rinsed and flushed with water, but continued burning and was red.  Medical attention was sought through examination by the nurse practitioner.  Subsequently, the patient was noted to be "ok" after eye was flushed with water and the eye redness "cleared up".  There was no product quality complaint.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007.   Follow-up information has been received from a nurse indicating that there was no adverse experience for the administering nurse.  The vaccine of ROTATEQ was spat into nurse's eye only.  This is one of several reports from the same source.  Additional  information has been requested.
C/o redness at site, soreness, inflammation. Pt instructed to put ice on site and take an antiinflammatory PRN.
I had a sore arm with mild body ache. I had fatigue. I started having SOB, fever, chills, and low oxygen. I had 3 negative COVID-19 test. I went to urgent care twice. I had an appointment with my doctor which she thinks that it was because of my booster shot. They have given my an inhaler and referred me to a pulmonary doctor.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 29-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of administration of expired product was received from a physician concerning a 30-month-old female subsequent to receiving FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 12-Dec-2010. On 17-Jan-2011, the patient received the expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
DEATH; This spontaneous report received from a consumer via a social media via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 death. On an unspecified date, the patient died from unknown cause of death. It was reported that, "that is was they want. These people are killing us. Lost my sister in law who was fully vaxed, lost a friend also vaxed, and an uncle who is critical fully vaxed. These people are playing you very badly. I am sorry you live in fear. I am not vaxed had covid it sucked but dr. Prescribed hydroxychlorquin and I took zinc and vitamin d3 felt great in 30 hrs. No hospital required. I am 43. You do not deserve this". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220231552 and 20220232101.  Version created to amend previously reported information on 13-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events.  20220231819-COVID-19 VACCINE AD26.COV2.S-Death. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
My doctor believes that I have a breast infection but I am not breastfeeding.  She said that she did not believe it is related to the COVID-19 vaccine but I reported a change to my health to V-Safe.  On 12/3/21, Right Breast became itchy, red, painful, hot and I felt a lump.   I was given a 10 day supply of Antibiotics and also an Anti-fungal for treatment.  I am on day 8 of the antibiotic medicine and the breast does feel better and lump is smaller.
inj site warm to touch, run w/diff, discomfort; dull pain;advised to use DPH & ice;c/o ROM;