chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching is driving her "crazy."; The area is warm to the touch; Has itching on the same side; Redness, red bumps which are spreading; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Itching is driving her "crazy."), VACCINATION SITE PRURITUS (Has itching on the same side), VACCINATION SITE ERYTHEMA (Redness, red bumps which are spreading) and VACCINATION SITE WARMTH (The area is warm to the touch) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced FEELING ABNORMAL (Itching is driving her "crazy."), VACCINATION SITE PRURITUS (Has itching on the same side), VACCINATION SITE ERYTHEMA (Redness, red bumps which are spreading) and VACCINATION SITE WARMTH (The area is warm to the touch). At the time of the report, FEELING ABNORMAL (Itching is driving her "crazy."), VACCINATION SITE PRURITUS (Has itching on the same side), VACCINATION SITE ERYTHEMA (Redness, red bumps which are spreading) and VACCINATION SITE WARMTH (The area is warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information included benadryl for itching.
If more than half of the dose or if less than half of the dose was administered; Vaccine went into eyes; 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 INCORRECT DOSE ADMINISTERED (If more than half of the dose or if less than half of the dose was administered) and ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine went into eyes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history and concomitant drug information was provided by reporter.     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 INCORRECT DOSE ADMINISTERED (If more than half of the dose or if less than half of the dose was administered) and ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine went into eyes). At the time of the report, INCORRECT DOSE ADMINISTERED (If more than half of the dose or if less than half of the dose was administered) and ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine went into eyes) had resolved.        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 medical history and concomitant drug information was reported by reporter. No treatment medication was provided by reporter.   This case was linked to MOD21-070696 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow-up information received on 06-APR-2021 contains no significant information. On 26-Jun-2021: Follow-up information received on 26-JUN-2021 contains contact information of immunization center was updated.; Sender's Comments:  MOD21-070696:CROSS LINK
Initial soreness in arm and flu-like symptoms. Increasing joint pain in hands, elbows, knees, and feet. Severe pain getting in and out of cars attempting to stand or sit; lack of sleep due to pain. Joint pain continues, some relief with prednisone. Doc 200895 states that patient continues to experince arthritis in feet, knees, elbows. She has had no change for the last 6 months plus having trouble finding shoes that she can walk in. On 3/14/03, pt was contacted and provided an update regarding her condition and the adverse event she experienced following the Lyme vaccine. She stated that she  is still having considerable trouble with her knees. She has seen two rheumatologists in the past year for treatment. She complained that the rheumatologists do not accept any possibility of a relationship between the Lyme vaccine and her symptoms. She also stated that she was recently sick, and has been diagnosed with Lyme disease by western blot within the past two months. She wanted to knwo what kind of info was available regarding how long her protection. She is currently being treated with her second course of Doxycycline in two months and is doing better.
strong pain in right heel that caused pain when walking--prior to this was sitting down with no activity.  never had this before so thought might be reaction to vaccination. at home I took some 8hour tylenol and applied some icyhot cream.  resting has helped but when get up again, the pain returns.  have an appointment with my Dr. monday,Feb. first to see what he says.  sending this report as was suggested
This spontaneous report was received from a pharmacist refers to a patient of unknown age (gender unspecified). Approximately on an unknown date in 2012 (reported as few months ago), the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiration and route was not reported) which was potentially improperly stored. No concomitant medications were reported. The patients present status was unspecified. Additional information is not expected.
Let hand became stiff several hours after vaccination and knuckles on her left hand swelled to the point that she had difficulty bending fingers.  Swelling resolved in a few days.
Site: Pain at Injection Site-Severe, Additional Details: Pt has had ongoing arm pain that has been life-debilitating. It started after 2nd dose on 5/9/21 and has continued ever since without resolution.  Pt states they have disabled child that the pain is now interfering with her care for.
Flu like symptoms for 24 hours. I took Tylenol and am starting to feel better
Patient experienced pain at the injection site 15 days after injection. After speaking to her, pain has gone away after she took cayenne pepper. Patient is concerned with clotting and pain wand symptoms went away after 4-5 hours.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient states sharp pain at injection site immediately after vaccination. He was told pain would go away in 2-3 days, but hasn't resolved. He didn't take any pain meds at the time, but dr has advised on ibuprofen and possible further testing. States administration of vaccine felt like stabbing motion.
DAY 8 POST VACCINATION: ELEVATED TEMPERATURE x3 DAYS, GENERAL MALAISE, NON-PRODUCTIVE COUGH, JOINT TIGHTNESS, MUSCLE ACHES x3 DAYS. Rx:IBUPROFEN 800mg, AZITHROMYCIN 250mg. POSSIBLE PNEUMONIA Dx BY CHEST X-RAY.    DAY 11 POST VACCINATION: RASH / CELLULITIS AROUND VACCINATION SITE ON LEFT UPPER EXTREMITY, MACULOPAPULOPUSTULAR LESIONS 1mm IN SIZE ON BOTH UPPER EXTREMITIES. TREATED IN E.R.; 2L, NS, TYLENOL, ROCEPHIN 1gr IM, Rx FOR SEPTRA. DAY 13 POST VACCINATION: SEEN IN CLINIC, A FEW NEW LESIONS NOTED. rX FOR RIFAMPIN 300mg.
On 01/11/2001 the patient developed chicken pox that consisted of a few lesions and resolved in 5 to 7 days. Unspecified medical attention was sought. No further information is expected.
Patient signed up and received the Moderna vaccination when not in the eligible age group. Patient's father was alerted of event after discovery. Parent reports no side effects or symptoms from the vaccine.
At first dime sized knot and redness, then the redness spread and arm got very soar. Went to hospital and doctor was worried, he?d never seen that before. Redness is continuing to grow and soreness still happening. Just got a steroid cream hope that helps
death SHORTNESS OF BREATH Non-ST elevation (NSTEMI) myocardial infarction  Acute respiratory failure with hypoxia
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "lupus" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing); "Scleroderma" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "Known allergy: Amoxicillin" (unspecified if ongoing); "Colitis" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE; RITUXAN; NIFEDIPINE. Past drug history included: Known allergy: sulfa, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: very minimal Clinical course: symptoms on 5/6/2022 when tested, positive; (05Jun2022) Positive, notes: Complete return of symptoms on day 14, positive rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Adverse event: delay of covid 19 illness- very minimal symptoms on 06May2022 when tested positive, completed course of Paxlovid d/t immunocompromised status. Complete return of symptoms on day 14, positive rapid test, loss of taste/smell day 15  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
ill; can patient receive 2nd dose beyond the 42 days; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (ill) and PRODUCT DOSE OMISSION ISSUE (can patient receive 2nd dose beyond the 42 days) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (ill) and PRODUCT DOSE OMISSION ISSUE (can patient receive 2nd dose beyond the 42 days). At the time of the report, ILLNESS (ill) and PRODUCT DOSE OMISSION ISSUE (can patient receive 2nd dose beyond the 42 days) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications was reported. Treatment information was not provided.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 50.67.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration at 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Seizures recurrent in a 3 month old with seizures as a neonate, treated and on Phenobarbital, no seizures since nursery.
Irritability x 5 days since vaccines administered. Ordered CXR and Bld cx, CBC, Chem 7
My son has been diagnosed by Developmental Pediatrician with PDD NOS. Per follow up report-Onset 12/02 is when we noticed a change in child's behavior and decreased language he has not recovered from this, although he is in a preschool where is using sign language and has stopped banging his head, because he is less frustrated, as he uses some words and signs.  Parents planning on having a mercury testing done.  At this time they believe he has a vaccine injury, also their 2yr old son showing the same symptoms.
Hepatitis A vaccine was given instead of intended Hepatitis B vaccine.   No adverse reactions reported by patient. This was the first Hep A vaccine patient has received.
I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within 24-48 hours ~ except the Right Axillary Lymph Node Swelling and Pain ~ This is still currently present, please let me know if you want me to let you know when this last symptom/reaction resolves?)   Fatigue Sore Right Arm (injection) Chills Fever Headache Cough Right Axillary Lymph Node Swelling and Pain
04/12/21: chills, headache, deep body aches, muscle stiffness, hot flashes, severe pain at injection site (11/10 pain) dehydration, brief nausea.  All symptoms lasted from 5AM on 4/12/21 through overnight on 4/13/21.  04/13/21: headache, back and shoulder aches, severe pain at injection site (11/10 pain), red hot and painful welt at injection site, dehydration.  All symptoms present from 5AM on 4/12/21 until present.
MMR vaccine administered earlier than the 28 day recommendations. No adverse reactions reported by employee (patient).
she was feeling bad in the first hour; ER doctor said he never seen a reaction like that before; Sick; Patient laid down from Friday afternoon until Sunday. missed Saturday; Running a fever; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she was feeling bad in the first hour), IMMUNISATION REACTION (ER doctor said he never seen a reaction like that before), ILLNESS (Sick), HYPERSOMNIA (Patient laid down from Friday afternoon until Sunday. missed Saturday) and PYREXIA (Running a fever) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058628) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu Vaccine. Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Heart disease, unspecified and Lung disorder NOS. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 13-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 13-Oct-2023, the patient experienced FEELING ABNORMAL (she was feeling bad in the first hour), IMMUNISATION REACTION (ER doctor said he never seen a reaction like that before), ILLNESS (Sick), HYPERSOMNIA (Patient laid down from Friday afternoon until Sunday. missed Saturday) and PYREXIA (Running a fever). At the time of the report, FEELING ABNORMAL (she was feeling bad in the first hour), IMMUNISATION REACTION (ER doctor said he never seen a reaction like that before), ILLNESS (Sick), HYPERSOMNIA (Patient laid down from Friday afternoon until Sunday. missed Saturday) and PYREXIA (Running a fever) outcome was unknown.            Patient reported that she called her doctor and was told to go to the ER. They ran a lot of test and then send her home. They also told her she should see her doctor. They ran a metabolic panel, complete blood count with differential, and hepatic function panel however, the outcomes/results of the tests were not provided. No treatment information was reported.  Company Comment: This is a Spontaneous case concerning a 79-year-old female patient with concurrent medical history of heart disease and unspecified lung disorder, who experienced the non-serious unexpected AESI of Hypersomnia which occurred on the same day after a dose of mRNA-1273.815 received as the fifth dose for COVID-19 Vaccination.  It was also reported that the patient received Flu vaccine on the same day which remains a confounder. Laboratory tests were performed; however, the results were not provided. The medical history of concurrent heart disease and unspecified lung disorder also remains confounding. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-745891 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745891:Same Reporter Different Patient
Bell's Palsy Developed 3 days after being given Flu mist in my office, symptoms 95% resolved in 6 days from onset. 10/16/06 Received medical records from PCP which reveal patient on track developmentally on 6/8/06 visit.  Received FluMist on 10/4/06.  On 10/6 had difficulty visualizing at school with right eye.  On 10/9/06 noted to have 2 days of erythematous right infra orbital area with slight facial asymmetry which increased on 10/8 & was taken to ER.  Labs & CT scan were reported as WNL. ER started patient on antibiotics, antivirals & steroids with improvement noted on 10/9 office visit.  Dx: Bells Palsy, r/o Lyme, virus & AE to FluMist.  Right eye was patched for protection.  Seen again on 10/13/06.  continued on same meds.  Was much improved: frown symmetrical & smile only slightly asymmetrical.  Able to close both eyelids tightly. Dx: Idiopathic Bells Palsy, almost completely resolved. 12/7/06 Received medical records from hospital which patient seen in ER on 10/8 w/right facial paralysis since 10/7.  Tx w/antibiotics, antiviral & steroids. CT scan of head was WNL.  Only lab included in records was partial CBC which was WNL.
Patient submitted MyChart message as below detailing her adverse reaction to COVID-19 vaccine: "Hello, I received my first Pfizer COVID vaccine on Friday Jan 22 at a health care program. On Friday I felt no arm discomfort, but had a stomach ache all day. Saturday I was very tired and in the evening I noticed my left shot shoulder/arm pit area, bra line area was swollen and uncomfortable. Woke up in the night feeling like my left arm pit, and breast area was more swollen and if I had to paint it I would describe it as tiny bubbles all enlarged underneath my skin. Guessing it is my lymph nodes? This unusual feeling has since spread to the left side of my neck inside my throat and out.  It is not painful, I have taken a warm shower,  only wearing loose, comfy clothing and am sitting with a warm bean pillow on my neck. I just wanted to report how I am feeling if others are having similar reactions."
Moderna Bivalent dose but he had only received 1 dose of monovalent vaccine; no adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Moderna Bivalent dose but he had only received 1 dose of monovalent vaccine) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Moderna Bivalent dose but he had only received 1 dose of monovalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Moderna Bivalent dose but he had only received 1 dose of monovalent vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Moderna Bivalent dose but he had only received 1 dose of monovalent vaccine).    Concomitant medication was not provided. Patient was given Moderna Bivalent dose but had only received 1 dose of monovalent vaccine. Treatment medication information was not provided by the reporter.
Upper lip had swollen; Swelling in back of tongue on right side; Swelling in back of tongue on left side; sore shoulder; This spontaneous case was reported by a patient and describes the occurrence of SWOLLEN TONGUE (Swelling in back of tongue on left side), SWOLLEN TONGUE (Swelling in back of tongue on right side), LIP SWELLING (Upper lip had swollen) and ARTHRALGIA (sore shoulder) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE and VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ARTHRALGIA (sore shoulder). On 13-Feb-2021, the patient experienced SWOLLEN TONGUE (Swelling in back of tongue on left side). On 14-Feb-2021, the patient experienced SWOLLEN TONGUE (Swelling in back of tongue on right side). On 15-Feb-2021, the patient experienced LIP SWELLING (Upper lip had swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Swelling in back of tongue on left side), SWOLLEN TONGUE (Swelling in back of tongue on right side), LIP SWELLING (Upper lip had swollen) and ARTHRALGIA (sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication taken by the patient included thyroid meds, gout meds, prostrate meds, stomach meds.