chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I popped them and they bled; red round circles in my mouth; Heard a rythmic heart beat in right ear; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (I popped them and they bled) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, the patient experienced HAEMORRHAGE (I popped them and they bled) (seriousness criterion medically significant), ORAL MUCOSAL ERYTHEMA (red round circles in my mouth) and EAR DISCOMFORT (Heard a rythmic heart beat in right ear). At the time of the report, HAEMORRHAGE (I popped them and they bled), ORAL MUCOSAL ERYTHEMA (red round circles in my mouth) and EAR DISCOMFORT (Heard a rythmic heart beat in right ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter. No treatment medications provided by the reporter. Patient was notice that he had red round circles in mouth. They looked like blood clots. Patient popped them and they bled. Patient also heard a rhythmic heart beat in right ear.  Company Comment: This case concerns a 38-year-old, male patient with no relevant medical history, who experienced the unexpected event of Haemorrhage, Oral mucosal erythema and Ear discomfort. The events occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the events happened after the first dose. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 38-year-old, male patient with no relevant medical history, who experienced the unexpected event of Haemorrhage, Oral mucosal erythema and Ear discomfort. The events occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the events happened after the first dose. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Within 5 minutes of vaccine being administered, I began having hot flashes, sweating, and extreme dizziness. Increased sleeping the past 4 days to about 10-12 hours a day. Currently experiencing heavy mood swings, severe anxiety, and foggy thoughts.
Several days later still very achy; I have diarrhea; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 20:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included blood clotting. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 10May2021 at 00:00, the patient experienced several days later still very achy, "i have diarrhea" and upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events several days later still very achy, "i have diarrhea" and upset stomach was not recovered at the time of reporting.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient inadvertently got an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The reporter was a clinic manager. The reporter reported that the patient was inadvertently administered an expired Havrix vaccine. The reporter did not consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Five days after HAVRIX administration, patient developed a serpeginous rash bilateral upper extremities, blanching macular rash in bilateral feet; pruritus and mild edema of hands and feet. Patient prescribed a 5 day course of steroids. Patient was prescribed ORAPRED, rash improved, but later on, rash got worse. Mother reported that this was after exposure to the TRIAMINIC Flowing Vapors fan. Mother has been using this night before the visit which she failed to mention. I apologize for the confusion.
numbness and tingling in her toes and the palm of her hand; numbness and tingling in her toes and the palm of her hand; numbness and tingling in her toes and the palm of her hand; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 11Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset Sep2021, outcome "unknown" and all described as "numbness and tingling in her toes and the palm of her hand".  Additional information: Caller stated her daughter had the Pfizer covid 19 vaccine 5 days ago. Caller stated her daughter said she was fine but daughter reported numbness and tingling in her toes and the palm of her hand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt received 1st dose of moderna covid vaccine on 01/25/2021, w/o reaction, pt received 2nd dose of moderna covid vaccine 02/12/2021, 18 days apart, instead of recommended 28 day interval. Pt has not reported any adverse events/reactions as of time of report on 08/21/2021.
The whole upper arm was red and swollen and she said it was very painful.  She considered going to the emergency room but layed down instead.
Vomiting/nausea, body aches, coughing spells, sneezing, congestion, chills/sweats, chest pain from coughing, headache that won't go away   Symptoms started 4/13, nausea and chills went away after 24 hours. Headache, coughing, sneezing, etc all still present as of 4/16
presented to ED 1/9/21 with abdominal pain, progressive worsening weakness and fatigue and new onset A fib with RVR likely due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP; progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening clinical decline, palliative care had been consulted on end of life care. Patient expired 1/17/21
After receiving the vaccine on 3/31, experienced typical side effects noted such as sore arm, body aches, etc. - however two days after felt numbness and tingling in feet and hands which went away a few days later.   On 4/14, the tingling in feet returned. Went to ER on 4/16 as tingling/numbness getting worse and progressing upward to legs; evaluated and sent home. Returned to ER on 4/22 as numbness/tingling continued to progress upward, evaluated and sent home.   On 4/25, in addition to constant numbness/tingling, started experiencing tachycardia. Resting heart rate as well as heart rate doing simple tasks was high. Also began experiencing difficulty getting a full breath. Woke up 4/27 to worsening breathing and tachycardia, as well as new feelings of adrenaline rushes and Internal tremors throughout the body. PCP ordered Troponin and D Dimer and D Dimer elevated. Back to ER that day - negative Covid test - CT of chest showed no blood clots; sent home. That evening, resting heart rate was high and elevated even while lying down (90-110 bpm). The next day, 4/28, all symptoms continued and worsened as day progressed. Returned to ER and in the way experienced a pre syncope episode - upon arrival to ER blood pressure was 70/30; stabilized and sent home. Continued tachycardia and another pre-syncope episode that evening.   Was referred to neurology and had appointment 4/29; all symptoms remained and were increasingly debilitating. Neurologist determined more testing needed, and was admitted to the hospital for observation/testing. Diagnosed with Guillain Barre Syndrome after head/neck/spine MRI and lumbar puncture, which showed elevated protein. Hospitalized for 5 day course of IVIG and discharged 5/4.  Started feeling better for a few weeks, although numbness/tingling in legs/feet never went away.  The week of 5/17 started feeling burning in throat/nose/chest and returning tachycardia; returned to ER 5/23, was admitted for observation as D Dimer high again - checked for DVT, all clear; testing and suspicion of Postural Orthostatic Tachycardia  Syndrome (POTS); discharged 5/25.   On evening of 5/30, experienced new concerning neurological tremors and sudden involuntary movements, as well as stiff neck/head. Returned to ER 5/31; evaluated and released. Have continued to experience autonomic nervous system dysfunction, POTS symptoms, tachycardia and bradycardia, constant numbness and tingling in extremities and occasional tingling/numbness in other areas in the body, pressure in head, internal tremors, adrenaline rushes, feelings of burning in throat/chest, suspected reflux; upcoming appointments with an Electrophysiologist and Neuromuscular Doctor for further evaluation.   Note - also reported this using v-safe up until the weekly check ins were over
Mom called day after vaccine administered to report child had rash at injection site along with swelling of lip and around eyes.  No difficulty breathing.  Residual rash at time of her call.
Patient did not stay and refused observation at time of vaccine. Came back 10 minutes later with reported syncopal episode after pulling off the road nearby for lightheadness.  Patient taken to medical tent for observation and medical director called.  VS Stable Kept until 210pm.  No adverse reaction symptoms noted.  Will observe for 30 minutes during second dose.
GI issues; an unusual smell (off and on); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 15:00 (Lot number: EW0171) at the age of 37 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Some chronic GI issues" (unspecified if ongoing), notes: Some chronic GI issues, nothing formally diagnosed. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number=ER8732, administration date=31Mar2021, administration time=02:00 PM, dose number=1, vaccine location=Left arm), administration date: 31Mar2021, when the patient was 36 years old, for COVID-19 immunization, reaction(s): "Within 8 hours of the first dose I experience GI issues loss of appetite lasting about 5 days.", "Within 8 hours of the first dose I experience GI issues loss of appetite lasting about 5 days.". The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset 2021, outcome "recovering", described as "GI issues"; PAROSMIA (non-serious) with onset 2021, outcome "recovering", described as "an unusual smell (off and on)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of gastrointestinal disorder, parosmia.  Additional information: The patient did not receive any other vaccine in four weeks of covid vaccine. The patient received other medications in two weeks. The patient was neither diagnosed with covid prior vaccination. The patient got tested for covid post vaccination. The patient has no known allergies. Within 6 days of the 2nd dose, the patient experienced GI issues lasting 4 days and still ongoing. Also, have experienced an unusual smell (off and on) during the same time frame. Events were recovering.  No follow-up attempts are possible. No further information is expected.
Seen vmh ER 5/17/2021 , Bell's palsy, vaccine reaction, initial encounter, right facial droop, symptoms seem to be related to COVID vaccine, CT negative, suspected vaccine related Bells Palsy, had 2 tick bites and lymes checked - negative, supportive cares, stable on discharge.
Pain and numbness down arm and up to neck at time of administration, by 5-6 pm extreme pain in arm. Pt could not lift arm and was in pain all night. Pt. felt feverish and had headache. Next day and day after pt started to have less pain and more movement without pain. No additional fever.
COVID (+) WITH SYMPTOMS LOSS OF SMELL, COUGH, SORE THROAT NASAL CONGESTION Narrative:
102 degree fever, nausea, vomiting, headache, dizziness, confusion, bradycardia, herpatic encephalitis.
shingles/Suspected Vaccination Failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 05-Aug-2022 Reporter's Comments: The reporter stated that the patient had shingles after receiving both doses of the Shingrix vaccine. The reporter enquired if the patient could receive a third dose. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Developed fever that night after vaccines given.She later developed red eyes, cracked lips, rash, consistent with Kawasaki's disease and admitted to hospital for treatment.
Large local reaction noted on 8/15/14. 4 x 4 cm erythematous wheal noted on the (L) deltoid at the injection site. Warm. Non tender normal ROM, sensation of arm.
Td vaccine this morning, but didn't check the expiration prior to putting it in the patient's arm with no adverse event; Initial information was received on 06-Feb-2023 regarding an unsolicited valid  non-serious case from an other health professional.  This case involves an unknown age/ gender patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine this morning, but didn't check the expiration prior to putting it in the patient's arm with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (expiry date: 22-Jan-2023) (lot number, batch number, dose, strength, formulation: Unknown) for prophylactic vaccination (Immunisation) this morning, but didn't check the expiration prior to putting it in the patient's arm with no adverse event (expired product administered) (unknown latency)  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event td vaccine this morning, but didn't check the expiration prior to putting it in the patient's arm with no adverse event.  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 guidelines. 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.
Patient received the monovalent Pfizer COVID-19 vaccine for their third dose instead of the bivalent vaccine.
Raised warm red itching at and around injection site one first day of injection lasted for two days. Now the warmth and redness and itching is returning a week later.
cut herself/ on the broken vial; broken vial/ crack/ on the bottom of the vial; This case was reported by a other health professional via call center representative and described the occurrence of laceration in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA398A, expiry date 31st August 2021) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. On an unknown date, immediately after receiving Menveo, the patient experienced laceration and pharmaceutical product complaint. On an unknown date, the outcome of the laceration and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not applicable. The Menveo MenCYW-135 liquid conjugate vaccine component vial was broken and the nurse cut herself on the broken vial when she was trying to draw up the MenCYW-135 liquid conjugate vaccine component.  The package or carton or blister tray was not damaged upon receipt.  There was not any evidence of leakage or product in package or carton.  There was glass pieces still in the vial. There was no product still present in the vial.  The crack or breakage was observed on the bottom of the vial. This case is linked to the case US2020210295 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020210295:Same reporter
Information has been received from a physician concerning a 56 year old male with asplenia who on approximately 10-SEP-2007 was vaccinated intramuscularly with a second dose of Pneumovax 23. On approximately 12-SEP-2007, 2-3 days after vaccination, the patient experienced "significant flu-like symptoms", pain and a "systemic reaction." It was reported that at one point the pain was so bad that "he felt as if he were going to die." The patient was hospitalized for 2 to 3 days. The patient underwent unspecified bloodwork and X-rays (results not reported). Subsequently, the patient recovered. Additional information has been requested.
Guillain Barre Syndrome- Pain in Thoracic region, facial weakness, limb paresthesias and weakness, elevated CSF protein, abnormal nerve conduction studies.
Pt received 2nd dose of Gardasil vaccine on 9/20/19. Reports swelling on LUE at site of Gardasil vaccine that appeared a couple days after 2nd dose- swelling has not gone down  +pain with palpation- tolerable, unable to give number on pain scale  very faint ecchymosis present at site of injection on LUE- see photo  ~1.5 cm nodule palpated, non fluctuant, no drainage, no erythema present
On Sunday night I started feeling sick and congested.  I felt a little dizzy.  I started feeling generally overall sick.  I was achy, dizzy, and congested.  I might of had a fever but we couldn't find our thermometer.
4-5 hrs following vax pt reportedly had a shrill, high pitched cry along w/poss apneic episode as stated by mom;
Received the shingles vaccine on 4/16/17 - The next day experienced redness, itching and that the area was red and warm. Over the next 7-10 days the area enlarged 5 inch x 3 inch oval and continued to be warm, inflamed, itch.
"pt seen in ER 3AUG97 for pain, erythema, blisters in lt arm where DTAP had been given 1AUG97;temp nl;pt being seen by FMD 4AUG97;"
Patient reported redness on arm in which pneumovax received that spread down to elbow area; did not have any pain at the time associated with rash;  the redness developed approximately two days post injection and was not noted prior
Covid 19 vaccine was administered at 2:45 pm on 2-21-21. By 2:55 pm patient began to experience Confusion and  loss of short term memory. He suddenly did not know where is was, how he got there, or why he was there. He continuously asked those questions throughout the balance of the day. The nurses on duty in the clinic got a wheel chair and escorted us to the  hospital ER in the same building. He was immediately taken to a room where a doctor met us and began asking him questions. The Dr quickly ordered a multitude of tests. Results shown in item 19
Vaccine was incorrectly given to patient at 2 months, earlier than the recommended time. No adverse reactions noted at time of report.
Pt experienced pain in the evening after administration, with redness and puffiness about 4 inch area. Pt came into pharmacy a few days later and still showed redness which had extended to wider area but less puffiness with no pain. Pt stated she did not feel she needed to see her MD but would continue to monitor symptoms. Pt did not feel this needed attention but spouse recommeded she notify pharmacy.
c/o SOB, cough, sore throat, congestion, fatigue, and sinus pressure. hypoxia secondary to COVID pneumonia, O2 @ 2L NC. Remdisivir and decadron given. pt on RA at dc. given dexamethasone at discharge.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-JAN-2012, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On 07-JAN-2014, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.The outcome of the events was unknown. Causality assessment was related.