chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I don't feel good today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): EC-2021-101205.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral since 06Aug2021 (Lot number: 1562116) at 10 mg daily for endometrial cancer. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I don't feel good today". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was unknown.  Additional information: Patient stated that she don't feel good today. She had a PET scan today and had covid vaccine. She will have blood work and see the oncologist 13 Oct 2021. Patient stated her next infusion was 15 Oct 2021. Instructed patient to call for any questions and concerns. Patient stated that she was okay and had no questions today. There was no drug interaction between the suspect drugs. Dose of LENVIMA was not reduced due to event. LENVIMA was not discontinued due to the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right deltoid pain for 1 week, no redness, no swelling, no knot.
ON 1/28 IN THE EVENING, DEVELOPED WEAKNESS IN HANDS AND LEGS. RESIDENT HAD NO STRENGTH AND WAS UNABLE TO WALK. WAS SEEN IN THE EMERGENCY ROOM THAT NIGHT AND RELEASED SAME NIGHT. VITALS WERE STABLE.
Itchy arms and throat at first, which turned into anaphylactic reaction and facial redness. Facility nursing staff was present during observation. 25mg of Benadryl administered orally. Then epi-pen given in left thigh after symptoms worsened and 911 called.  She was transported to local ER and facility RN was present until after patient left for ER.
Raah appeared in my right breast and between both breast. same side as injected arm.  Very itchy. Lasted about 3 hours or so, then stopped itching out of nowhere.    Called nurse: Took Zyrtec on advice of an advice nurse.   Rash still presenting 4 hours later.  Not getting worse and is not itchy.
got Shingrix and had outbreak/ Suspected vaccination failure; outbreaks continued; This case was reported by a pharmacist via sales rep and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 3 outbreaks per year).   In August 2017, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year 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 was provided as follows: The age at vaccination was not reported. In August 2017, the patient received 1st dose of Shingrix and 2 months later received the 2nd dose. This patient has had about 3 outbreaks of shingles per year which continued which have continued after having 2 Shingrix shots. The reporter asked if a third dose (or booster dose) could be given. The reporter consented to follow up. The case has been linked with the case US2021AMR200646 (1st dose), reported by same same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR200646:Same patient, first dose
p/vax pt exp significant redness & swelling of the arm;the swelling was noted to be 1 to 1 1/2 times the nl size;1 days later pt recovered;
had COVID tested post vaccination by nasal swab and revealed positive result; had COVID tested post vaccination by nasal swab and revealed positive result; Had headaches; no appetite on eating; This is a spontaneous report from a contactable consumer (patient) who reported that a 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 16May2021 (Batch/Lot number was not reported) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not diagnosed COVID prior to vaccination. Patient had COVID tested by nasal swab post vaccination and revealed positive result in May2021. The patient experienced headaches, no appetite on eating in May2021. Lasted for at least two weeks. Outcome of the events was unknown.   No follow-up attempts are needed. Information on batch/lot number cannot be obtained.
Numb arm started a couple minutes after injection. Mouth started tingling a couple minutes after that. Nausea started around the same time. No vomiting. Generalized muscle aches starting about 30 minutes after injection along with slightly itchy throat.
Left shoulder pain, sharp, acute, throbbing,radiating to neck causing burning sensation and then down forearm causing sharp, acute pain with tingling into fingers and cramping of muscles on forearm; same pain then traveled to triceps, to axila and to left flank as well as to left pectoralis muscle. Entire arm is weak, painful to touch. Pain is unrelenting 10 out of 10 (10 being very painful). I have seen 3 medical doctors. I have had 1 shoulder xray, an MRI, and physical therapy since 10/28/2014. I have been prescribed Tramadol, Flexeril, and Daypro with little results. I continue to ice my neck, shoulder and arm. I am on light duty at work down graded from what I usually do as an endoscopy nurse.
got the flu; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional via social meda.  This case involves a patient of unknown demographics, who experienced got the flu (influenza), while he/she received influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was not reported.  On an unknown date in 1991, the patient received influenza vaccine (batch number and expiry date unknown) at an unknown dose via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got the flu (influenza), stopped taking shot no more flu.  No laboratory data was reported.  Action taken with influenza vaccine was drug withdrawn.  It was not reported if the patient received any corrective treatment.  At the time of report, event outcome was unknown flu.  There will be no information available on the batch number for this case.
A non serious spontaneous report of administration of expired product was received from a registered nurse concerning a seven-year-old male subsequent to FLUMIST. The patient is one of the 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medial history nor concomitant medications were reported. The patient received the FLUMIST on 02-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable,and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Erectile dysfunction, acute onset 3 weeks following booster. Libido intact, no signs/symptoms of testosterone deficiency.
Reaction: Dizziness, heart palpitations (HR in the 120s), blurry vision Onset: 15 min post vax Treatment: Observation, fluids, food Summary: Sxs resolved after one hour of close monitoring Reported history of allergies: No, but pt had hx of new onset arrhythmia a few months prior
Patient was administered vaccine and shortly after developed an allergic reaction to it. Patient had denied any allergies or contraindications to the vaccine prior to it being administered. Patient had to be given BENADRYL and medically transported for follow-up, but had no serious consequences. Dizziness, skin rash, rash, urticaria pruritus and sore throat, numbness of tongue, lethargy. Diphenhydramine 25 mg once.
approx 1 wk p/receiving the vax devel severe pain in all joints, including jaw; was unable to sleep @ noc; it lasted for approx 2 wks; MD gave codeine for relief; eventually the pain dec;
Presented to the ED with weakness. As for the weakness, the patient describes it as: of 1-2 week duration, progressive, constant, with no relieving factors, beginning in the feet and hands, spreading to the arms; associated with wrist drop of left and right hands, imbalance with walking, and inability to walk and use hands to eat. On arrival to the ED, the patient's CT of head was notable for: No intracranial hemorrhage, hydrocephalus, or cerebral infarction
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ROTATEQ, oral. On an unknown date the patient experienced contracted rotavirus after received ROTATEQ, (lot# not reported). The patient sought medical attention with physician and was prescribed dextrose, PEDIALYTE. Not lab diagnostic studies were performed. The patient was recovered and the AE improved due to the virus and symptoms subsiding on its own. This is one of several cases received from the same reporter. Additional information has been requested.
The mother of a 6 month old female reported that her daughter received injections of Prevnar and DTP on 8/24/00. The pt had no pre-existing illnesses and was receiving no medications concomitantly. Eight days, post vax, on 9/1/00, the pt awoke from a nap and was unable to open her eyes initially. When she was able to open them, they were "so sensitive to light" that she could not go outdoors. She also had a fever of 104F. She was taken to an ER where meningitis was ruled out. On 9/4/00, she was admitted to a hospital because the symptoms had not resolved, and she was, subsequently, dx'd with bilateral uveitis. The pt was treated with prednisone which "helped". In March, 2001 (approximately), the pt's symptoms returned and she again began prednisone therapy, to which she was noted to be responding. Prednisone therapy continues.
Headache  Narrative:  Stated had vaccine on 12/26/20. On Mon 12/28, noted  severe HA. Took Tylenol which helped to relieve headache. No other  symptoms noted any other days.
got sick to their stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (got sick to their stomach) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (got sick to their stomach). At the time of the report, ABDOMINAL DISCOMFORT (got sick to their stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.    Reporter did not allow further contact
Lymphadenopathy: 0.5 cm left arm tender lymph node and 2 cm left infraclavicular tender lymph node; Lymphadenopathy: 0.5 cm left arm tender lymph node and 2 cm left infraclavicular tender lymph node; This is a spontaneous report from a contactable physician reporting for herself. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EH9899), via an unspecified route of administration on 16Dec2020 at 09:00 (at the age of 49-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and concurrent conditions were reported as "none". The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications ("other medications in two weeks") included valaciclovir hydrochloride (VALTREX) taken for an unspecified indication from an unspecified date and unspecified if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received sulfa (sulfonamide) on an unspecified date for an unspecified indication and experienced allergy. On 22Dec2020, the patient experienced lymphadenopathy: 0.5 cm left arm tender lymph node and 2 cm left infraclavicular tender lymph node. It was reported that the event was non-serious and did not require hospitalization. The patient did not receive any treatment for the event. The clinical outcome of the event lymphadenopathy: 0.5 cm left arm tender lymph node and 2 cm left infraclavicular tender lymph node was not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient was admitted on 8/3 for nausea and vomiting. He was admitted from a nursing home and had a recurrent ileus. His PEG tube was also out of the stomach lumen. On 9/1 he tested for COVID for placement back to his facility and tested positive.
fever; swelling in arm; chills; redness in arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd June 2021, less than a day after receiving Shingrix, the patient experienced fever, swelling arm, chills and erythema of extremities. On an unknown date, the outcome of the fever, swelling arm, chills and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the fever, swelling arm, chills and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The case was reported by the husband of the patient. The patient got her first Shingrix vaccine in an unknown arm and experienced fever, swelling in arm, chills, and redness in arm.  For the tolerance of the 2nd dose of Shingrix, refer case US2021AMR166370. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166370:Same reporter
The patient's parent report on 05/03/2001 that the child was limp, had poor tone and cried a lot. On 05/04/2001 the patient had a CT scan and blood work. Results for both were negative. On 05/07/2001 the patient started stuttering and refused to talk. On 05/10/2001 the patient was seen by a neurologist and the exam was negative. On 07/11/2001 the patient was almost back to normal.
Pt presented shortly after (aprox 15 minutes) injection with a red, round, raised area around where shot was given.  I asked if she was having any trouble breathing, shortness of breath or itchy throat.  She did not - we talked about a dose of benadryl and I gave her one dose from my ER kit.  I asked her to follow up with me.  She came by pharmacy this morning, it was still raised and sore.  I gave her small packs of aceaminophen, ibuprofen, diphenhydramine and an ice pack.  I instructed her to use either the pain reliever and try to ice pack to see if that helped.  I will follow up with her again.
Last august before the first booster came out, the caller got the 3rd full shot and was not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Last august before the first booster came out, the caller got the 3rd full shot and was not immunocompromised) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023D21A, 046B21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Last august before the first booster came out, the caller got the 3rd full shot and was not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (Last august before the first booster came out, the caller got the 3rd full shot and was not immunocompromised) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: high (High) Levels were soaring.         No concomitant medications were reported. No treatment medications were reported.  Patient stated that she was not immunocompromised and was administered with full shot and thought it was a booster at that time and did not know that it was not out yet.
Medication was stored improperly and not viable.  Unknown at the time it was given.  Unaware of any adverse reaction.
This spontaneous report was received from a nurse and refers to a 34 year old female patient with asthma, allergy to ZITHROMAX and to latex. No information about medical history was provided. On 21-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot # N011867 with expiration date: 08-NOV-2018 (dose was not reported) for vaccination and with FLUZONE intramuscularly at the same site in the deltoid area of the same arm. Concomitant therapies included albuterol inhaler and NASONEX. On 22-SEP-2017, the patient developed cellulitis like symptom from the area below the injection site down to the elbow. Unspecified treatment was given for the event. No laboratory diagnostic tests were performed. The patient sought medical attention by seeing the physician. Product quality complaint was not involved. The outcome of cellulitis and the causality between the event and PNEUMOVAX 23 were unknown. Upon internal review, the event of cellulitis was considered to be medically significant.
Pfizer-BioNTech COVID -19 Vaccine EAU increase muscle and joint ache.
PT DEV SWELLING AND ITCHING AT SOI DAY FOLLOWING VAX. SYMPTOMS LASTING 5 DAYS.
A few hours after receiving my first dose, the tips of my fingers suddenly felt like they were being electrocuted (like touching a battery terminal), and my hands, part of my arms, and the lower portion of my face went numb and tingly. This subsided after about 20 mins, with some lingering numbness. Since then this has happened to me every single day (often multiple times, though sometimes only once or twice per day), and lasts from a few minutes to sometimes six hours. I went to an urgent care, and an after-hours clinic here in town to have this looked at, but I am working class, so too poor to be able to see a doctor regularly (or often at all) so I have no primary care physician.  This still goes on in varying degrees every day.  I am concerned this is permanent damage, and I cannot use my hands very well at all at my job when it is happening.
started vaginally bleeding Sunday Feb. 28th and has continued until present  Saw Dr. and had blood work done and am going next week for Trans Vaginal ultrasound
Headache, Diarrhea, Low grade fever, slight headache, fatigue, diarrhea, chills
Horrible headache that made the patient unable to do anything but lay down; Injection site soreness, hurt but could still use arm; Swollen lymph nodes in armpit on the side of injection; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and panic disorder. The patient did not have any allergies to medications, food or other products. 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 COVID vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT), multivitamin (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), levocetirizine dihydrochloride (XYZAL) and cobamamide (VITAMIN B12), all for unspecified indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 03:30, the patient experienced horrible headache that made her unable to do anything but lay down, injection site soreness which hurt but she could still use her arm and swollen lymph nodes in armpit on the side of injection. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events horrible headache that made the patient unable to do anything but lay down, injection site soreness, hurt but could still use arm and swollen lymph nodes in armpit on the side of injection was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Temp 101. Baby presented the day after receiving his immunizations with fever, vomiting and diarrhea. Baby had been having watery stools 2 to his reflux problem - worse following immunizations. Dr felt maybe ROTATEQ may have contributed to this. Was adm to hospital with dehydration.  5/18/09 Hospital records received DOS 4/22/09 to 4/24/09. FINAL DIAGNOSIS: Gastroenteritis with dehydration Post vaccination: nausea, vomiting, fever, acidosis, respiratory distress syndrome, diarrhea, facial eczema  ICD-9: 9995 serum reaction, 78701 nausea with vomiting, 78791 diarrhea, E8798 other procedure, 7821 rash and nonspecific skin eruption, 53081 Esophageal reflux, 78060 fever unspecified.
Redness, swelling, warm to touch, hard knot at location of shot. Chills and flu-like symptoms, shortness of breath.
body rash from neck down to toes for 2 days, took Zyrtec
Within one week post vax, the pt complained of aching in every joint and in her hands. All symptoms resolved except for pain and swelling in the right hand ring finger.