chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slit under tongue; Small white round 'stuff' coming out of tongue slit; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE INJURY (Slit under tongue) and TONGUE DISCOLOURATION (Small white round 'stuff' coming out of tongue slit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TONGUE INJURY (Slit under tongue) and TONGUE DISCOLOURATION (Small white round 'stuff' coming out of tongue slit). At the time of the report, TONGUE INJURY (Slit under tongue) and TONGUE DISCOLOURATION (Small white round 'stuff' coming out of tongue slit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Significant hair loss, scalp visible through hair on entire crown of head. Finding shed hair on sinks, counters, floors daily. Reminiscent of mid stage chemotherapy induced hair loss over 20 years ago.
Information has been received from a licensed practical nurse concerning a male who on 01Jul2003 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced "fever" and "varicella lesions". The pt was not hospitalized. The patient received "symptomatic treatment". Unspecified medical attention was sought. There was no product quality complaint. No additional information was provided. Additional information has been requested.
Left arm from elbow to shoulder, red, swollen, raised, hot to touch, hard to touch and very tender ?-lasting from Friday evening to Sunday morning when symptoms SLOWLY began to decrease... tenderness,  hardness and complete redness did not cease until Thursday.. almost a week after symptoms occurred
Patient partially vaccinated with Covid vaccinations and was admitted to the hospital with Covid symptoms.  Patient had O2 90%  on outpatient visit and was then admitted to hospital for further treatment.  Patient was experiencing generalized weakness , fatigue, body aches, and shortness of breath at rest.
Chest pain approx 24-48hrs after vaccine #2. Rash and pain on neck, shoulder,  and chest  started  approx 5/27. Diagnosed with shingles on 5/29/2021. Started on  Valacyclovir
PREPARATION AND ADMINISTRATION ERROR. PATIENT RECEIVED 180 MCG OF COVID 19 VACCINE IMx1.
Headache, Myalgia & Fever Narrative:  pain at inj site- difficulty to move arm ;ha;fever 102.3, bodyache;chills;pain;fatigue
Patient is a 4 month old with a history of MECP2 duplication, Grade I IVH, global developmental delays who presented with progressively worsening acute emesis over a 2 day course. Symptoms started Saturday 2/26 with feeding intolerance, some emesis that was originally white/yellow (non-bilious) that progressed to green and then subsequently to dark brown/black color. During this time family paused his tube feedings due to abdominal distention.   In the ED patient patient with distented abdomen with feculent material coming out of mouth. Cap refill prolonged, mottled. Gave NS bolus x1, obtained chemistry, cultures, blood gas that was significant for hyperkalemia and elevated lactate without acidosis. KUB obtained that showed dilated loops of bowel. Surgery was consulted given clinical concerns for obstruction. UA concerning for infection, started on Rocephin for UTI. BMP showed hyperkalemia. Gave insulin 1unit/kg, D10 bolus, albuterol and sodium bicarb. Abd US showed intussusception. Repeated NS bolus. Repeat VBG showed lactate had normalized after IVF, and potassium down trending. (original hyper kalemia believed to be due to hemolysis). Attempted air contrast enema to reduce intussusception, ultimately was unsuccessful ands thus was sent to OR for ex-lap open reduction. In OR necrotic tissue ileum, proceeded with small bowel resection and primary anastomosis on 2/28 with Dr.    Patient was subsequently admitted to the PICU for post-operative management. PICU course complicated by post-op ileus and is on TPN now POD#5.
Initial localized left shoulder pain and swelling followed by decreased flexion and abduction. Unresponsive to conservative treatment (P.T.) formally diagnosed with frozen shoulder.
gave adjuvant without reconstituting it; gave adjuvant without reconstituting it; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number DN74H, expiry date 10th July 2023) for prophylaxis.   On 3rd October 2022, the patient received the 1st dose of Shingrix. On 3rd October 2022, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comment: Nurse practitioner stated that a medical assistant accidentally given the adjuvant portion of the vaccine to the patient without reconstituting it on the day of reporting. This would had been patient's first dose in the series. The reporter had consented to follow-up. Additional supportive information: The patient had accidentally received the adjuvant portion of the vaccine only without reconstituting it, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Small splotchy erythematous area on left thigh. Not warm. Began 1 day after vaccine enlarged inguinal node.
Soar  throat for weeks after vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Soar throat for weeks after vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Soar throat for weeks after vaccine). At the time of the report, OROPHARYNGEAL PAIN (Soar throat for weeks after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Doses were given from a vial that had been more than 12 hours after the first puncture; More than 27 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given from a vial that had been more than 12 hours after the first puncture) and PRODUCT STORAGE ERROR (More than 27 hours at room temperature) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given from a vial that had been more than 12 hours after the first puncture) and PRODUCT STORAGE ERROR (More than 27 hours at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given from a vial that had been more than 12 hours after the first puncture) and PRODUCT STORAGE ERROR (More than 27 hours at room temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that there were no reported symptoms and no additional doses or treatments. Also stated that on 14-Feb-2022 the vial was initially stored in the refrigerator, on 15-Feb-2022 at 11:42 AM vial was first punctured. And after administration of vaccine on 16-Feb-2022 the total amount of time the vial exposed to room temperature range (8 degree Celsius to 25 degree Celsius which is equal to 46 degree Fahrenheit to 77 degree Fahrenheit) was more than 27 hours. And the vial did not undergo any temperature excursions.   This case was linked to MOD-2022-494549, MOD-2022-494555 (Patient Link).
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 42-year-old male 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 2:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, 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 the patient was 42.72 years. On 15-April-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 6-April-2021, vial was moved to clinic on 15-Apr-2021. 14 vials were sent to clinic. Vaccine BUD date was 9-MAY-2021.  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 Fisher brand 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
urticaria developed on thigh below site of MMR inj; No other sx; given Epi SC followed by oral DPH; urticaria resolved;
Patient complained of sore arm, 3 wks after vaccine administration. Could not lift arm all the way.
Flu like symptoms.  100 degree fever, muscle aches, extreme fatigue and very tired.  All day on May 15, 2021
chronic small vessel ischemic disease; Felt Bad; Arm pain; Headache; Body ache; Sweating; Cold Feet; Tremors; Slurred speech; Elevated blood pressure; Stuttering; A spontaneous report was received from a Healthcare professional concerning a 31 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced non-serious events of body pain, headache, arm pain, hyperhidrosis, peripheral coldness, tremor, dysarthria, elevated blood pressure, dysphonia and serious event of exacerbation of preexisting chronic small vessel ischemic disease after the 2nd dose of Moderna vaccine chronic .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21-JAN-2021, prior to the onset of the events, the patient received their second dose of planned doses of mRNA-1273 batch no:028L20A  intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On the same day, The patient experienced arm pain, headache, sweating, body ache, cold feet, tremors, slurred speech, elevated blood pressure measured at 183/90., and sluttering.  On 21-JAN-2021, CT brain normal. MRI was abnormal and showed flare signal regions in the brain which signified early microvascular ischemic changes, a demyelinating process, vasculitis, or sequelae for migraines. The subject was treated with intravenously with lorazepam 2mg and Benadryl.  On 03-FEB-2021, the subject was referred to a neurologist and was improving.  On 05-FEB-2021, another MRI was performed and showed multiple scattered punctate foci of unenhancing white matter, signal alteration which were nonspecific but unchanged in comparison to previous MRI. Report suggested that findings were most likely to reflect an early onset chronic small vessel ischemic disease, other somewhat less likely considerations in a patient of this age would include migraine syndrome, various cerebral vasculopathies, or demyelinating conditions.  Action taken with mRNA-1273 in response to the events was not applicable as second dose had been administered.   The outcome of the event was resolving.; Reporter's Comments: The non-serious events of pain, headache, sweating, body ache, cold feet, tremors, slurred speech, elevated blood pressure, and sluttering are temporarily associated with the mRNA-1273 use and a causal association cannot be excluded.  The serious event of chronic small vessel ischemic disease is considered a pre-existing event based a diagnostic findings and thus assessed as unlikely associated with mRNA-1273 use.
administered >12 hours after vial puncture; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered >12 hours after vial puncture) 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 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered >12 hours after vial puncture). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered >12 hours after vial puncture) 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 concomitant and treatment medications were reported.
Mom stated 12-6-07, child c/o itching to left arm where vaccine was given. Child continued to c/o itching throughout day and evening. Mom was not concerned. Child c/o itching this morning and went to school. School nurse called and request the child be seen by MD. Presented to HD with left arm red, swollen, hot to touch from shoulder to elbow. Contacted doctor - encouraged child to go to ER for tx.
Systemic Lupus Erythematosus, joint pain, extreme fatigue, thinning hair,malar rash, anemia; deep vein thrombosis; pulmonary embolism; costochondritis; neurological; constellation of adverse symptoms, complications, injuries, and other adverse events; complications and other adverse events; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently adult female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was a healthy prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On unknown dates (at age of 16 of the patient), the patient vaccined with first, second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strength, dose, lot #, expiry date and route of administration were not provided) for prophylaxis. Following her vaccinations, the patient began to have joint pain, extreme fatigue, thinning hair, and malar rash. As the months progressed, so did the patient's symptoms. She was seen by multiple physicians and specialists for her complaints. Based upon her chronic and severe post-vaccination symptoms. The patient had been diagnosed with various medical conditions with autoimmune and neurological (neurological disorder), injuries, including but not limited to: lupus, systemic lupus erythematosus, anemia, deep vein thrombosis, pulmonary embolism, costochondritis as well as a constellation of adverse symptoms, complications, injuries, and other adverse events (Ill-defined disorder, adverse event). The patient had been unable to engage in activities a young person would normally enjoy and had been unable to maintain a full-time job due to her symptoms. The outcome of all events was considered as not recovered. The lawyer considered quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) caused all events. Upon internal review, the events systemic lupus erythematosus, deep vein thrombosis and pulmonary embolism were determined to be medically significant. All events were considered as disability.
This spontaneous prospective pregnancy report as received from a physician refers to a 16 year old female patient. On 07-APR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX. Other suspect therapies included MMR II and RECOMBIVAX HB. The patient was administered (Oka/Merck) VARIVAX, MMR II and RECOMBIVAX HB on 07-APR-2015. Urine and serum pregnancy test and prenatal ultrasound performed on 07-APR-2015 confirmed pregnancy. The physician reported the patient to be 11 weeks gestation. No adverse effects reported. No further information was provided. Additional information has been requested.
After the client received his immunization of Tdap, HAV, HPV and Proquad he felt weak and dizzy. He also turned pale and diaphoretic.
This spontaneous report was received from a physician, via a company representative refers to a patient of unknown age and gender. On 10-NOV-2014 the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU (dose, route of administration and lot # were not reported. No adverse events were reported. It was mentioned that ZOSTAVAX did not have any previous temperature excursions. Additional information has been requested.
The day of the 1st dose, I felt achy, chills and headache. The day of the 2nd dose (within an hour after receiving), I had itching all over my body for roughly 5 hours. Within 2 days of receiving 2nd dose, lymph nodes on left-side of body were all swollen. I noticed I was much more tired than usual. Roughly 3 ½ weeks after the 2nd dose, I started getting a low-grade fever every day at some point. Aches, chills and headaches every day.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of an unknown age and an unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with LIQUID PEDVAXHIB. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 02-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Approx. 10 days from receiving intranasal flu vaccine patient developed facial weakness/paralysis, difficulty swallowing and inability to chew. Her jaws are consistently locking and inability to say any words. She was hospitalized on Dec. 21, 2010 at Hospital for the very first time since birth. She was diagnosed with aspiration on a swallow study and restricted from liquids and regular diet. She had never experienced any of these symptoms before. The possibility of reaction from flu vaccine is unknown and we feel that the timing is coincidental. We told several doctors we feel this may be the cause. She had previous weakness to her legs and the cause is still not diagnosed. But now she is being feed through a syringe and about to have surgery for a G-tube.
7/23/99 pt recv vax & devel pain & tender in 6hr;7/25/99 flu-like sx;7/26/99 severe sx bed-ridden for 24hr;h/a, eyeball pain, fatigue, T102, dizziness, terrible awful feelings, include depressive sx;myalgia;no rash-no arthralgia;
Covid-type headache, severe neck muscle pain, fatigue, injection site pain, injection site fever, chills
He started having some pain in the back of his legs bilaterally that woke him from sleep. It was a soreness and cramping. He then developed tingling in both of his legs from his thighs to his feet. He subsequently developed some tingling in his arms and hands bilaterally. Lost ability to walk due to weakness.
Pt's arm started to get red less than 24-hours after given the vaccine - Tuesday late AM. Pt reports very sore to the touch, painful to lift arm.  Redness originally from top of shoulder to 10 inches down.  Pt used ice on arm and this was hardly noticed.  Pt in for visit today at clinic and the redness is reduced to 5.5 inches long by 6.5 inches wide.  The area is red, warm, no exudates, no wound.
sore arm; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 2 via an unspecified route of administration on 14Feb2021 as single dose as for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient previously received BNT162B2  for covid-19 immunization  as dose 1 on an unspecified date. The patient experienced sore arm on an unspecified date.  The patient underwent lab tests and procedures which included blood work which was good on an unspecified date.  The outcome of sore arm was recovered on an unspecified date.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
This case was reported by a physician via sales rep and described the occurrence of injection site muscle pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The date of birth of patient was unknown. The age at the vaccination was not reported. The patient experienced pain at injection site. The pain was described as myalgia in the upper arm where the vaccine shot was administered. It was unknown if the reporter agreed for follow up contact.