chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blister on her index finger; injection site is "typical bruise looking and is tender; injection site is "typical bruise looking and is tender; This is a spontaneous report from a contactable physician (who is also the patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient noticed a blister on her index finger and said it was a round, red, raised, red spot on the index finger of the same side of her vaccination. She also stated that the injection site was typical bruise looking and was tender but did not look red or raised. The outcome of the events was unknown.  The information on Lot /Batch Number has been requested.
inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report  was received from a health care professional (HCP) concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) inadvertently from a vial that was punctured a day before/expired vaccine used.  The patients' medical history was not provided. Concomitant medication history was not provided.  On 13 FEB 2021, the patient received his dose of mRNA-1273 (Lot number 016M20A) intramuscularly for prophylaxis of COVID-19 infection.   The HCP stated that this patient was inadvertently given the vaccine from a vial that was punctured a day before.  A single dose was taken out of that vial and put back outside the six-hour window.    Treatment for this event was not provided.  The outcome of the event, expired vaccine used, was recovered on 13 Feb 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, Lot number 016M20A with no associated adverse events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-013964:same reorter, different patient
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, fatigue, chills soreness at injection site Narrative:
Fever (2 days so far)  Extreme Fatigue Migraine  Muscle aches Red swollen arm that is itchy
rash; itching; Lip Numbness; Red Puffy eyes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), PRURITUS (itching), HYPOAESTHESIA ORAL (Lip Numbness) and OCULAR HYPERAEMIA (Red Puffy eyes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced RASH (rash), PRURITUS (itching), HYPOAESTHESIA ORAL (Lip Numbness) and OCULAR HYPERAEMIA (Red Puffy eyes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash), PRURITUS (itching), HYPOAESTHESIA ORAL (Lip Numbness) and OCULAR HYPERAEMIA (Red Puffy eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Per patient, pt received SHINGRIX vaccination on 3/10/18 and 2 days letter, her arm was swollen, red and hot to touch. Pt called clinic and was advised to go to Urgent care. Pt went to Urgent care and MD said to apply Ice for 2 days and then heat. Patient states the reaction went away after 8 days. Pt is doing fine as of now.
Sudden crash of the nervous system - shaking, panic - muscle pain etc. Have tried anti-depressants and a battery of supplements and tinctures. Condition persists 13 months later, but definite improvement noted.
Very painful swelling at injection site, followed by redness down the arm extending about 4-5" from the injection site lasting for over 48 hours, headache began about 3 hours after and subsided about 36 hours later after taking NSAIDS ibuprofen and aspirin, fever-like chills began about 5 hours after injection and lasted about 36 hours later. Lymph node in the armpit of the injected arm began swelling after about 36 hours after injection. Still tender and swollen as report is being written. Extreme fatigue and body aches, flu-like symptoms began about 3 hours after, were intense for about 30 hours, and then disappeared after 48 hours.
7 DAYS AFTER THEY RECEIVED THEIR PFIZER FIRST DOSE THEY FELT WEAKNESS AND TINGLING IN ARMS AND LEGS.  THEY COULD NOT MOVE FOR ABOUT 8 HOURS.  THEY WERE FINE AFTER THAT.  IT'S BEEN 10 DAYS SINCE THEN. THEY ARE DOING GOOD ON THE FOLLOW UP.
Within 24 hrs. after receipt of vaccine, large red bump developed at site of vaccine given. Over next 24 hrs, bump began to spread to todays measurements, with discomfort to touch. Treatment: Cool compresses, Ibuprofen, BENADRYL, 1% Hydrocortisone cream.
Uncontrollable muscle spasms/tremors, whole body pain ,very difficult to do much because of the pain.
After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars.  Rapid response called , patient observed for 30 minutes and walked to car.  Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child.  Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given.  Patient provided education on managing anxiety and discharged.
Fever of 104 for 24 hours; muscle spasms and charlie horses throughout legs and back for 12 hours; Horrible headache for 2 full days after vaccine; Bad nausea for 12 hours; I had been in menopause for a year and it started my menstrual cycle back fully on day 2 after the vaccine; had spotted after the 2st vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 08Oct2021 20:30 (at the age of 51 years old, Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included sporadic anemia, hashimotos disease, vitiligo. Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID). No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnancy at time of vaccination. The patient previously received first dose of bnt162b2 on 17Sep2021 08:30 PM in left arm for covid-19 immunisation, propylthiouracil for thyroid disorder and experienced drug allergies, Cataflam and experienced drug allergies, tetanus and flu vaccines and experienced allergy to vaccines. The patient had been in menopause for a year, and it started her menstrual cycle back fully on day 2 after the vaccine on 09Oct2021 with outcome of unknown. The patient experienced fever of 104 for 24 hours, muscle spasms and charlie horses throughout legs and back for 12 hours, horrible headache for 2 full days after vaccine and bad nausea for 12 hours on 09Oct2021 13:15 with outcome of recovered with lasting effects in Oct2021. The patient had spotted after the 2st vaccine in Oct2021 with outcome of unknown. No treatment received. Events were reported as non-serious and did not result in death, life threatening: caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 31-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Pt developed severe headache, neck soreness, photophobia, muscle aches, fever to 102.4. Improved with Tylenol, MS (IV). No hives, rash. Problem with injection site. Neuro exam OK.
Numbness of left cheek; Tingling of left cheek; Blinking abnormality/blink was hard, blink was prolonged; Change in taste; Bell's Palsy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbness of left cheek), PARAESTHESIA (Tingling of left cheek), CORNEAL REFLEX DECREASED (Blinking abnormality/blink was hard, blink was prolonged), TASTE DISORDER (Change in taste) and BELL'S PALSY (Bell's Palsy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness of left cheek) (seriousness criterion intervention required), PARAESTHESIA (Tingling of left cheek) (seriousness criterion intervention required), CORNEAL REFLEX DECREASED (Blinking abnormality/blink was hard, blink was prolonged) (seriousness criterion intervention required), TASTE DISORDER (Change in taste) (seriousness criterion intervention required) and BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness of left cheek), PARAESTHESIA (Tingling of left cheek), CORNEAL REFLEX DECREASED (Blinking abnormality/blink was hard, blink was prolonged), TASTE DISORDER (Change in taste) and BELL'S PALSY (Bell's Palsy) 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.  There were no further change in the patient's symptoms since 29-Apr-2021. The patient was prescribed prednisone 60 mg for 7 days. The patient had no medications prior to development of symptoms.  The concomitant medications were not provided.  Company Comment: 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.; 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.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Patient was experiencing arm pain, hot to touch, swollen and red (about 6 inches), and itch. Patient left message with MD on 01/20/2022.
The patient developed a left nasolacrimal duct obstruction.  The patient had surgery for nasolacrimal duct obstruction, a dacryocystorhinostomy (DCR), in Feb 2004 for a left nasolacrimal duct obstruction.  He had a patent lacrimal system after his surgery.  The day he was administered the FluMist vaccine, he developed URI symptoms: stuffy nose and congestion.  The day after he got the vaccine, he developed epiphora, increased tearing, like he had prior to his DCR.  The patient tried blowing air into his punctum by holding his nose and blowing, but he could not get air into his left lower lid punctum.  He has had excessive tearing on the left side since then.
Pounding heart,nausea,throwing up,diarrhea,dizziness,over all weakness,arm craps,high pulse rate
vaccine administered of which diluent and powder had expired 20-Sep2022 with no reported adverse event; Initial information was received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1 year old male patient who was administered vaccine of which diluent and powder had expired 20-Sep-2022 with no reported adverse event while receiving vaccine HIB (PRP/T) Vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant included: Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for immunization.  On 29-Sep-2022, the patient received 0.5 ml (dose 4) of suspect HIB (PRP/T) Vaccine powder and solvent for solution for injection (unknown strength) (batch number: UJ574AAA, expiration date: 20-Sep-2022) via intramuscular route in the left leg (left thigh) for Immunization of which diluent and powder had expired 20-Sep-2022 with no reported adverse event (Expired product administered ) (latency: same day).  Action taken: Not applicable.  Corrective treatment: Not reported.  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.
Right after I had the first vaccine I started having mild chest pain. I shrugged it off and didn't say anything. Over the course of the next few months I experienced intermittent chest pain on and off followed by extreme bouts of fatigue.  I had overall body aches, and had days where I could barely get out of bed I was so tired.  For lack of a better term, I had an overall general feeling of unwell. Upon exercise it was worse. If I went for a hike the next day I could barely move. My whole body hurt and I would feel extremely tired. I work in healthcare and counseled a few providers who recommended I hold off on the second dose and waited two months vs one.  I don't have insurance and did not see a doctor at that time for a visit to have test run. I work in the medical field and know how expensive it is to "go digging." I thought with adequate rest, hydration, whole foods, and time my symptoms would improve.   I received my second vaccine on 8/13/21.  Immediately after I once again experienced mild chest pain.  The next day I had extreme nausea and diarrhea along with an agonizing headache. For around 4 weeks i suffered with bouts of on and off chest pain, and once again, extreme fatigue. I eventually did go in to be seen and had labs drawn.  Unfortunately the provider i saw wouldn't even speak with me about how my symptoms linked to the vaccine. Her thought was that i had lymes disease, a vitamin B12 deficiency, and/or acid reflux. I had lab work done and all of these tests came back negative and/or normal.  The provider i saw didn't even follow up with me. At that point i realized that seeking any medical advice would be met with a stale mate. No one wants to even talk about adverse side effects from the vaccine even if your  onset of symptoms correspond, and there is no other answer.    Since the beginning of the pandemic i haven't even had as much as a runny nose and have been perfectly healthy outside of the side effects experienced from the vaccine. I haven't (to my knowledge) contracted covid, and have had multiple tests performed, although have not been tested for antibodies.  Two months after my second dose I began to feel like myself again. My energy levels are back to normal, but every once and awhile I do experience mild chest pains.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored vaccinated with RECOMIVAX HB (dose, frequency, route and lot number not provided). No adverse effect reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been quested.
Patient reports pain, redness, swelling, and stiffness of the entire right upper arm, from elbow to shoulder, and the right upper back, associated with feeling feverish for 2 days (she didn't check her temperature.)  She was not examined until 2 weeks later, when all signs had resolved.
5 to 7 days p/vax pt devel fever 105f. no further info available
Observation Area Patient felt dizziness, desire to vomit and weakness in the body Paramedic gave him oxygen and took his vitals. Pt recovered.
Pt reported "flu-like symptoms" further described as fever of 100, feeling tired; symptoms began on the evening of 04-03-2019 after receiving the shot.  She also reported nasal congestion.  She stated that her arm is swollen, red, and hot; but that this is resolving. Pt reportedly has not taken any medications to manage the symptoms and has been applying ice and heat to the injection site.  The patient received Prevnar 13 previously in 2013, and reported that she had a similar reaction, but that it was worse this time than the last.  She reportedly forgot that she had this reaction until it happened again.
FASTER THAN USUAL HEART RATE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On MAY-2021, the subject experienced faster than usual heart rate. Laboratory data included: Heart rate increased (NR: not provided) 71 bpm. Laboratory data (dates unspecified) included: Heart rate increased (NR: not provided) 94-107 bpm, and Heart rate normal (NR: not provided) 58 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of faster than usual heart rate was not reported. This report was non-serious.
Suspect COVID breakthrough case  presented to the ED with acute stroke-like symptoms 1/3/22, negative for COVID 1/3/22; subsequently tested positive 1/15/22 while hospitalized
I FEEL LIKE SOMETHING WAS ON MY THROAT, COUGHING AND LOWER LIPS GOT SWOLLEN, EYE RED IRRITATED.
Swelling, redness, severe induration lower half of posterior upper right arm - 5 inches in diameter at its worst and felt very tired x 2 days. still 2" in diameter redness and mild induration.
unilateral tinnitus in right ear. there was cerumen impaction which was cleared. Patient continued w/ sxs. She was referred to ENT
Positive Covid-19 test after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication were reported.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication were reported.   No treatment information was provided.
Child received IPV and DTAP in Right thigh on 4/3/2009. Now has pink/red and hot area to site measuring 3.5 x 4 inches.  Painful to palpation. Placed on Bactrim 2 tsp po bid x 7 days.
Headache; some nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (some nausea) and PYREXIA (Fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced HEADACHE (Headache), NAUSEA (some nausea) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache), NAUSEA (some nausea) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was provided. It was reported that for Treatment Headache medicine was took.  The lot number from the first or second shot (caller wasn't sure which) was 031H21A. The second dose was given on 10 Mar 2021.
I received the first dose of the Pfizer-BioNTech COVID-19 Vaccine EUA on 3/31/21.  My arm soreness never subsided by the day of my second dose, which was on 4/24/21 at 12:00 p.m.  Here we are on 5/27 & the soreness still has not gone away.  It's been 8 weeks and it's actually gotten worse the last 2-3 days.  I can't find information on this particular situation anywhere.  My arm is not swollen or red and there are no hard bumps or anything like that in the area.  It's just sore whenever I move it.  This is not right.  Please let me know what to do.
Pt recv vax on 9/4/98; on same day pt exp screaming, crying & stiffness x 2hr, fever, poor appetite, unable to sleep