chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lump under the skin; redness of entire upper arm; This case was reported by a nurse via call center representative and described the occurrence of mass in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced mass and erythema of extremities. On an unknown date, the outcome of the mass was unknown and the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the mass and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as an adult as per Shingrix indication.  The patient received vaccine in unknown arm. The patient received the initial dose of Shingrix on unknown date, developed a lump under the skin and redness of entire upper arm. 10 days later the redness resolved. The healthcare professional was not at the office so she did not have any patient information. The reporter consented to follow up.
Sudden loss of hearing in left ear on 11/02/2021. Went to my ENT doctor Dr. the morning of 11/05/2021. He did an audiogram and confirmed my severe hearing loss of left ear. He started me on prednisone 60 mg/day for 10 days, then tapering off for 5 days. Went back to Dr. on 11/19 and the new audiogram showed the dramatic recovery of my left ear hearing.
Mild arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Mild arm soreness"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Mild arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Mild arm soreness".  Additional information included the patient states the other 3 Pfizer vaccines he previously received caused him "mild arm soreness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
down for a couple of days; A little wheezy; Flu like symtpoms; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (down for a couple of days), WHEEZING (A little wheezy) and INFLUENZA LIKE ILLNESS (Flu like symtpoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery in December 2020.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MALAISE (down for a couple of days), WHEEZING (A little wheezy) and INFLUENZA LIKE ILLNESS (Flu like symtpoms). In April 2021, MALAISE (down for a couple of days), WHEEZING (A little wheezy) and INFLUENZA LIKE ILLNESS (Flu like symtpoms) had resolved.            Patient had surgery to remove polyps after receiving the vaccines in April. No concomitant medications were reported. No treatment medications were reported.
Right arm with large area of erythema 8 cm x 4 cm, non-tender, swelling. Left arm with quarter-size area of erythema, mild pain.
Hx of taking the flu injection three days ago and two days ago a red rash and itching began. States it worst on face, back, chest and arm. Never had a problem before taking the flu shot in the past. Hx of SOB with COPD, no, no chest pain. Pt give vistaril and discharged from ER. Pt actually came back to the ER on 11/23/05 to say that the rash had not gotten any better. More vistaril given and pt discharged.
8/12/2015 child felt warm to mother but she did not take temp.  Second day after child did not feel well and took a nap.  When he woke T 104.5 ax, withing a half hour down to 103.5  She was willing to give antipyretics, and was going to call doctor for the recommended dosing. Using alternative therapies, soaking vinegar water in feet.  Writer recommended cool rags, but not so cold to induce shivering.  Follow up call 8/18/2015 Mom reports child ran fevers until Friday evening, but has been fine since then.
irritability for 4 days, not sleeping;induration/tenderness lt leg laterally;given Ibuprofen;
Itchy rashes formed on foot, groin and buttocks; Small spots appearing on arms, legs and back; This spontaneous case was received on 22-Sep-2021 from other non-health professional with additional information (being processed together) received on 23-Sep-2021, and concerned a 42-year-old, male patient.   The patient's medical history and concomitant medications were not reported.   On 20-Sep-2021 at 5:30 pm, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose, route of administration, anatomical location and indication: not reported). The batch number reported was P100352329.   On the same day, reported as two hours after receiving Afluria Quadrivalent, at approximately 7:30 pm, itchy rashes formed on patient's foot, groin and buttocks and small spots appeared on arms, legs and back.  The outcome of the events was not reported.   The reporter did not provide causality assessment.  Company comment: The events of 'itchy rash' and 'spot-like rash' were assessed as related to Afluria Quadrivalent. .; Sender's Comments: The events of 'itchy rash' and 'spot-like rash' were assessed as related to Afluria Quadrivalent.
Breakthrough case: Patient was hospitalized on 4/2021 after developing acute hypoxemic respiratory failure. Per limited notes, he first tested positive for Covid on 4/13/21 and was transferred to a dedicated Covid facility. His status worsened and he was admitted to the hospital on 4/20/21.
after a couple of weeks I had really bad hair loss and i had to go to the doctor and dermatologist The doctor said I had alopecia.  felt really tired and headaches after the vaccination
Post vax, the pt complained of redness, swelling, and tenderness at the site of DTAP injection. The pt's symptoms seemed to worsen with a larger area of redness, tenderness, and swelling from injection site to the knee, which felt hot. Treated with cool compresses and Children's Tylenol.
Throat swelling/tightness, shortness of breath, coughing, red and swollen eyes, pus coming out of eyes.
Migraine headache and nausea the first night and next day and again 6 days later. Dizziness and nauseas for 8 days. Hot flashes intermittently continually and at present.
Patient received the flu vaccine at approximately 0830 at a shot-ex. Pt reported that at about 0945 his leg started tingling. At about 1345 pt reported that his throat begin to hurt and he was experiencing difficulty swallowing. Pt reported to the emergency room for treatment.
Runny stool, foul-smelling, once daily, for 3 weeks following vaccine.
Dose leaked out of connection between syringe and needle; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Dose leaked out of connection between syringe and needle) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergic reaction to drug, Allergic reaction to drug and Blood pressure.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced UNDERDOSE (Dose leaked out of connection between syringe and needle). On 22-Apr-2021, UNDERDOSE (Dose leaked out of connection between syringe and needle) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No treatment medication information was provided.
NauseaVomiting Fatigue, Uncontrolled PVC's x4-5 hours treated in ED with NTG and Potassium. Normal cardiac function with PVC's and treatment. related to vaccine; Echo done. sent home next day with "Zio patch" x 2 weeks. Narrative:
erythematous, swollen, 3" diameter lump lt deltoid;tx w/DPH;
Patient C/O "agonizing" itching from head to toe, along with abdominal cramps/ discomfort similar to indigestion/ heartburn. Onset of symptoms were almost immediate and progressed throughout the day. Patient stated that symptoms did not require ER visit, but was able to obtain a prescription for Atarax (Hydroxyzine). Patient was able to drop off the prescription to be filled, but still needed to pick it up after work. Patient was recommended try the Atarax to see if symptoms resolve. Recommended that if Atarax does not help to try Zyrtec or Allegra.
Severe swelling, pain in arm, unable to lift easily and extreme itching. Help was sought on Wednesday, September 13. Given prescription for Methylprednisolone 4mg dose pack. Medication is helping the redness and swelling but itching is still bad on September 14. Perhaps by weekend will be better.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, or concomitant medications were not reported. On 29-JAN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 2.5 ml, five dose vial, (lot number J004332, with an expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 32 Fahrenheit (F) (0 Celsius) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Legionnaire's disease; Initial information received on 28-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media (global digital media).  This case involves a patient (unknown demographics) who experienced Legionnaire's disease (pneumonia legionella), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Legionnaire's disease (pneumonia legionella) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pneumonia legionella.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demographics) who suffered from pneumonia legionella after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Moreover, patient's medical condition at the time of vaccination, lab tests ruling out predisposing etiologies were not reported. Based upon the reported information and considering the infectious nature of the event, the role of the vaccine cannot be assessed.
Right arm red and sallowing from arm pit to 2 inch below elbow, fever, chill, joint pain for a weeks time.
No adverse event; Patient received 1st dose on 11-Feb-2021 and 2nd dose on 30-Mar-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 11-Feb-2021 and 2nd dose on 30-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a and 024m20a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 11-Feb-2021 and 2nd dose on 30-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 11-Feb-2021 and 2nd dose on 30-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 11-Feb-2021 and 2nd dose on 30-Mar-2021).    No concomitant medication was reported.  No treatment information was provided.   This case was linked to MOD-2022-688151 (Patient Link).
Patient stated he started to get muscle pain at local injection area (right arm) a few days after injection and has been more than 5 days. Manufacturer stated average of 2.5 days possible for local injection site muscle pain. He stated it has been getting better but concerned still.
APPROX. 1 HR POST VACCINATION,  REPORTED AND ASSESSED TO HAVE HIVES TO UPPER CHEST  ONLY NOTED.  RETURNED TO VAC. FACILITY SITE AND REPORTED TO VAC. TEAM.   MONITORED FOR 15 MINUTES, GIVEN BENADRYL 25 MG P.O. TAB.  WAS SENT HOME BY HER EMPLOYER.
The patient had an STD (sexually transmitted disease); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of SEXUALLY TRANSMITTED DISEASE (The patient had an STD (sexually transmitted disease)) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEXUALLY TRANSMITTED DISEASE (The patient had an STD (sexually transmitted disease)). At the time of the report, SEXUALLY TRANSMITTED DISEASE (The patient had an STD (sexually transmitted disease)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, Treponema test: reactive (Inconclusive) Reactive, positive (Positive) Positive/False positive and reactive (Inconclusive) Reactive. On 29-Jul-2021, Treponema test: non reactive (Inconclusive) Non Reactive, reactive (Inconclusive) Reactive and reactive (Inconclusive) Reactive. On an unknown date, Treponema test: non reactive (Inconclusive) Non reactive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not had any history of exposure or symptoms. Concomitant and Treatment medications were not reported.
Pt had a seizure and vomited, lost feeling in hands and lost eye sight for short while.
Arm pain; Body aches; Fatigue; Injection site bruising; Pruritis at the site; Swelling at the site; Erythema at the site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PAIN (Body aches), INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE PRURITUS (Pruritis at the site) and INJECTION SITE SWELLING (Swelling at the site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE PRURITUS (Pruritis at the site), INJECTION SITE SWELLING (Swelling at the site) and INJECTION SITE ERYTHEMA (Erythema at the site). On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PAIN (Body aches) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm pain), PAIN (Body aches) and FATIGUE (Fatigue) outcome was unknown and INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE PRURITUS (Pruritis at the site), INJECTION SITE SWELLING (Swelling at the site) and INJECTION SITE ERYTHEMA (Erythema at the site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: Follow-up information processed with initial report. Updated reported events, start date for vaccine, batch/lot number, and medical history. On 15-Apr-2021: Follow-up received on 15-Apr-2021 included no new information.
I received a shingles shot SHINGRIX on 8-6-2018. I was in immediate pain and redness at the injection site. I became chilled, extreme body aches, flu like symptoms. The next day my ear felt like ice picks were being stabbed in them. This pain also was on both sides of my jaw. I had to leave work. I have headaches, fever, upset stomach, tiredness, breathing problems of a weight being on my chest and shortness of breath. I am dizzy, have nausea, and can eat very little. My arms and legs feel very heavy. It is 8-15-2018 I am still have headaches, shivering, nausea, breathing problems of weight being on my chest and shortness of breath, dizzy and arms and legs feeling heavy. I still have a red spot at the injection site. When are these side effects going to go away?
This spontaneous report was received from a Nurse Practitioner and refers to a 17 year old male patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. At 10:12 AM on 03-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the right arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Menactra vaccine rec on 7/31/06 approx 1pm. On 8/2 in the evening, sudden onset of aching pain in head, spine, joints with fever of 100.4.  Also c/o generalized weakness and sore throat.  Took to ER that evening, was given IV anti-inflammatory medication. Took blood and urine specimens. Sent home with Toredol po for pain. At 6 am this morning temp 102, has been taking tylenol for this. Normal @ 1pm but with tylenol. To call doctor for follow-up appointment tomorrow.
Starting  just a few hours after the immunization I had a red swollen rash around the injection sight, about the size of a nickel. It was painful, but not anymore then a regular flu immunization. I thought I was possibly just reacting to the bandage. However, by the end of the night the redness and swelling had grown to about the size of a silver dollar. The next morning it had swollen to the size of a baseball, was red inflamed and warm to the touch. It only itched when it was touched by something, but was quite sore. I tried some Benadryl cream and took my normal allergy pills I also started using an ice pack trying to keep the heat and swelling down. None of this seemed to help. I also started to feel dizzy and had a headache, normal reactions to immunizations. I did sleep off and on all day this first day after the immunization as I felt weak and dizzy. The swelling just kept getting larger and large no matter what I tried. The second day after the immunization the swelling was around the size of a soft ball, and it was very red, inflamed and almost hot to the touch. Again I used Zyrtec, Benadryl cream and also tried a washcloth soaked with witch hazel, this did not seem to help. Later I went to a friends house and she had some Triamcinolone cream and colloidal silver, I tried both of these and the swelling and warmth did start going down. The redness has stayed about the same (now about the size of a grapefruit). It has started itching, but not constant, and not like my typical allergy itch.
Pt received her dose of Janssen Cover 19 vaccine administered to left arm intramuscularly by RN given at 06:54 PM. Pt was seated for observation when scribe noticed pt being pale and sweaty.  Sribe asked pt how is she, pt stated that she is dizzy , warm and nauseous. Scribe called RN to assess pt. Pt is alert oriented to self, time, date  and location. Initial vital signs was taken by RN at 07:00 PM and it was 145/110mmhg, PR 138 ppm, RR20 cpm, Temp 98.1, Oxygen saturation of 99% at room air. RN assisted pt to lay patient down safely. No SOB and chest pain noted. Pt stated feeling better upon laying down for couple of minutes and stated that her dizziness comes and goes. Pt had no allergic reactions to any other vaccination but pt also stated that she has been feeling dizzy couple of times as her history. No history of elevated BP as well was stated by pt. Pt continuous to complain on and off dizziness, NP assess pt and Called 911 for further assistance. Repeat vitals check done by RN  BP 135/100 mmhm, PR 81 ppm, RR 20 cpm, oxygen saturation 98% at room air. EMT came at 07:45 PM came assess pt, checked her vitals, pt requested if she could walk and have the EMT assist her to evaluate herself, no complaints of dizziness reported. EMT offered to bring pt to hospital for further evaluation, pt refused to go to hospital. Pt was advised to go to hospital if episode of dizziness happens again. EMT walked the pt to her car and have her sister drive. Pt left facility at 08:00 PM without any complaints. VAERS was filed and education provider RN was reported.