chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3-inch area of skin that turned bright red; the area was like a hot rash but no itching; the area being hot to the touch; the area feeling like rocks under the skin; Initial information was received on 16-Feb-2021 regarding an unsolicited valid non-serious case was received from a Consumer or Non-healthcare professional via Medical Information (Reference number- 00478096) and transmitted to Sanofi on 16-Feb-2021.  This case involves a 82-year-old female patient who experienced 3-inch area of skin that turned bright red (vaccination site erythema), the area was like a hot rash but no itching (vaccination site rash), the area being hot to the touch (vaccination site warmth) and the area feeling like rocks under the skin (vaccination site induration), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), concomitant medications and family history were not provided. The patient's past vaccination(s) included FLUARIX.  On 16-Oct-2020, the patient received 0.7 mL dose (total) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via intramuscular route in left arm for prophylactic vaccination.  On 16-Oct-2020, the patient developed non-serious 3-inch area of skin that turned bright red (vaccination site erythema), the area was like a hot rash but no itching (vaccination site rash), the area being hot to the touch (vaccination site warmth) and the area feeling like rocks under the skin (vaccination site induration), on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  The daughter reported that for the first 72-hours after the vaccine administration, was the worst, then the area on the 6th day began going down, that the color had changed back to normal within a week, that the consumer did apply an ice pack to the area, that the ice pack was not felt due to the area being hot, that Arnica cream was applied and it helped; that the prescriber does not feel it was an allergic reaction, that another patient in the clinic reported the same injection site reaction to the FLUZONE Quadrivalent High Dose this year.  On an unknown date, patient had recovered from the events.  The consumer had almost the same reaction with other flu vaccines in the past, that the consumer had reactions for most flu vaccines but the usual reaction is not as visible as the most recent, that she had the reaction with Fluarix, that the consumer is scheduled to get the Moderna COVID-19 vaccine. and that there have been reports of people getting the Moderna COVID-19 Vaccine having reactions on the arm.The daughter wanting to know would a reaction to the Fluzone Quadrivalent High Dose mean a similar reaction with the Moderna COVID-19 vaccine.  There will be no information available on batch number for this case.
The adverse outcome did not happen immediately after the vaccine. Pt was very healthy but developed a sore throat April 24.  He called the Nurses who recommended hot tea, rest, etc.  Then on the 27th of May he went to hospital and was diagnosed with Peritonsillar abscess
DAY AFTER SECOND DOSE, I FELT LIKE MY ENTIRE BODY HAD THE WORST FLU EVER. MORE IMPORTANTLY, I HAD NEW WIDESPREAD BACK PAIN. THIS SENSATION SPREAD ACROSS MY LOW BACK AND ALSO UP MY SPINAL CORD.  THE NEXT WEEK OR SO, BACK SPASMS STARTED. IT IS ALMOST 10 MONTHS LATER AND I CONTINUE TO HAVE BACK SPASMS IN MY MID-BACK.
My skin on parts of my back feels like it is on fire or severally sunburnt. However, there is no visable sign of anything. No redness, bumps, rash... NOTHING. It has lasted for 9 days now and has gotten worse.
Pain and swelling of injection site and muscle swelling of the arm within 24 hours. Then pain and swelling of the whole right leg, the knee joint still has swelling and pain that has not left since 48 hours after the injection.
After vaccination performed follow up 15 minutes later, employee stated she was fine at 12:20. She returned to office stating she felt nauseous and dizzy. Employee was assisted in laying down, feet were elevated. She then vomited chunky emesis. Symptoms started to subside, still had signs of anxiety. Employee continued to rest in office. After approximately 35 minutes all symptoms had resolved.
This spontaneous report as received from a physician refers to a male patient of unknown age. On 28-JUN-2017 the patient was vaccinated with GARDASIL 9 for prophylaxis. On 29-JUN-2017, 2 days after onset of therapy the patient experienced muscle twitching and dysuria. The outcome of muscle twitching and dysuria is unknown. The reporter did not provide the causality of events with GARDASIL 9.
This spontaneous report was received from a female registered nurse of unknown age, regarding herself. The patient's concurrent conditions and medical history were not reported. On 10-SEP-2018, the reporter was administering a dose of VAQTA lot # R011952, expiration date 27-MAY-2019, to a patient, via intramuscular route, for prophylaxis; however, during the administration, the finger flange broke off of one side of the VAQTA prefilled syringe and the nurse cut her middle finger of her right hand on the broken finger flange. It was also mentioned that the patient received the full dose of VAQTA and no adverse events were experienced by the patient. A product quality complaint (PQC) was filled. At the reporting time, the outcome of laceration and product quality issue were not reported. The reporter  did not provide a causality assessment between the events and VAQTA.
Severe pain in upper arm and shoulder.  Lack of mobility in arm.  Beginning physical therapy on Monday.  Pain still severe at this time.
Pervasive smell and taste of soap or something sweet. It overpowers all taste and smell.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 25th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
Information has been received from a Nurse Practitioner concerning a female who approximately 6 months ago was intramuscularly vaccinated with the third dose of GARDASIL, shortly after which the patient experienced seizures.  The patient's mother is still taking the patient to the doctor a lot.  Electroencephalography (EEG) was performed but the result was unspecified.  At the time of reporting, the patient's outcome was unknown.  The nurse practitioner did not administer any of the vaccinations.  Upon internal review, seizures was considered to be an other important medical event.  Additional information has been requested.
Information has been received from a Registered Nurse (R.N.) concerning a female patient who on 27-JUN-2007 was vaccinated with a second dose of Gardasil. Concomitant therapy included Menactra. The patient developed a sore throat and generalized rash, after her second injection. Unspecified medical attention was sought by the patient. The outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a Registered Nurse (RN) concerning a 17 year old white female student with allergice rhinitis, migraines and anxiety who on 27-JUN-2007 was vaccinated IM into right hand with a second dose of GARDASIL . Concomitant therapy included MENACTRA. The patient developed a sore throat and generalized rash, after her second injection. In follow up it was mentioned that patient developed generalized urticarial eruption approximately 2 hours after the injection was given. Within 24 hours patient developed cough, and signs and symptoms of allergy. The patient recovered from hives with 24 hours. The patient recovered. Additional information is not expected.
I received my third shot (booster) on October 4, 2021. I had not had any issues with the first two shots, but, for those, I had not been instructed to stop taking my Xeljanz. For the booster, my rheumatologist told me not to take it for 2 weeks after my vaccination.  Twenty minutes after the shot, I started feeling nauseous and I laid down at home. Then, I started to have increasing joint pain and by [XXX] I could not stand. [muscle pain??] Due to the severity of my symptoms, my spouse took me to the ER at [time] on [day]. At that time, I was running a fever of 101.5 °C. I also had a headache over my right eye. The muscle and joint pain were so severe it interfered with my ability to sleep.  (Continue on page 2)  The pain was worse than what I experienced during childbirth. I was also having hallucinations and altered perceptions. The hospital staff diagnosed me with altered mental state, which was not a condition that I had previously, and this has since resolved. The summary of the blood work states that I had low blood sodium and leukocytosis. The x-rays [did not find anything?]  I was treated with 20 mg of prednisone and within 4 days my symptoms were starting to improve.  I continued to have muscle pain and some cognitive impairment for several weeks following my stay in the hospital. At this point still have increased pain in hips down. Getting Physical Thearpy and taking tylenol unil I can get back on Xeljanz.
Runny nose was terrible, vomited once and fatigue where I can sleep all day. The fatigue lasted 10 days and I probably didn't feel better till 11/15/2021 and the fatigue was finally over. There was also a little bit of a headache, but I took Tylenol, there was a couple of days that I notice that I had Diarrhea, I did not have any fever.
My neuropathy has really flared up; my neuropathy has really flared up; I feel tired nearly all the time; 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 NEUROPATHY PERIPHERAL (My neuropathy has really flared up) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuropathy NOS.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (My neuropathy has really flared up) (seriousness criterion medically significant), CONDITION AGGRAVATED (my neuropathy has really flared up) and FATIGUE (I feel tired nearly all the time). At the time of the report, NEUROPATHY PERIPHERAL (My neuropathy has really flared up), CONDITION AGGRAVATED (my neuropathy has really flared up) and FATIGUE (I feel tired nearly all the time) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  No further information is available for this case.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  No further information is available for this case
Case number PHHY2012US079963 is an initial literature report received on 12 Sep 2012. The author discussed about the safety and immunogenicity of 2009 Pandemic H1N1 Influenza vaccination in patients infected with human immunodeficiency virus-1 (HIV-1) via perinatal route. This report refers to a patient whose demographics were not reported. The patient's current conditions included HIV-1 infection via perinatal route and facial nerve palsy. The patient was vaccinated with first and second doses of S-OIV FLUVIRIN (each 30 micro gram dose of vaccine) (pandemic influenza vaccine, batch number: not reported) at a dose of 0.5 ml intramuscularly on to unspecified site on unknown date in 2009. It was reported that on day four after the second dose, the patient experienced grade 2 herpes virus reactivation with unilateral facial nerve palsy associated with an oral herpes simplex reactivation. Immunogenicity was assessed by specific hemagglutination inhibition titers in serum collected at baseline, 21 to 28 days after first vaccination, 7 to 13 days after second vaccination and 7 months after first vaccination. The outcome of the event was not reported. The causality was assessed as suspected to be possibly related to administration of suspect vaccine. The author concluded the article stating that two doses of double strength pandemic H1N1 vaccine were safe and immunogenic and might provide improved protection against influenza in perinatally HIV-1 infected children and youth.
Fever and body aches stared 08:00 am the following day after receiving vaccine  Vomitting and diarrhea began at 03:00 2 days following vaccine administration and continued for 7 hours  Severe RLQ pain and lower back musculoskeletal pain hours following diarrhea and vomitting, ended up hospitalized during the night due to pain
redness at the injection site and redness and swelling all the way down to the elbow.; redness at the injection site and redness and swelling all the way down to the elbow.; redness at the injection site and redness and swelling all the way down to the elbow.; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), ERYTHEMA (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "redness at the injection site and redness and swelling all the way down to the elbow.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
30 hours after flu shot was administered, I broke out in rash. It went away and returned about 17 hrs later. I used ice packs and was ok.
Narrative:  required prolonged admission as the patient could not be discharged to his medical foster home following the positive COVID test
Sx: Swelling lips, chills, cough, sore throat Tx: recommend benadryl, tea, cough syrup
one week after second dose I have mild headache all the time. Also fatigue. Two weeks after second dose  loss of taste. This is my first report. I will report  these reactions to the treatment facility that gave me the vaccine.
SM developed large local reaction from shoulder to elbow in R arm approx 12 hrs after receiving her second AVA SQ during her deployment. From time of onset of symptoms to resolution was approx 2 weeks.
Sudden sensorineural hearing loss in left ear noted Jan 12 2021 (4 days after 1st dose). Spontaneous recovery of some hearing within 48 hours. High-pitched tinnitus in both ears. another episode of sudden hearing loss noted Jan 31 2021 (5 days after second dose), with spontaneous recovery. Residual low frequency hearing loss in left hear; High frequency tinnitus remains in both ears as of reporting date (5/19/2021)
PATIENT BECAME FAINT &  DIZZY WHILE SITTING AND WAITING FOR 15 MINUTES. ED CALLED PARAMEDICS ARRIVED. CHECKED VITALS. PATIENT WAS FEELING BETTER. PARAMEDICS STATED IT WAS OK TO GO HOME BUT CONTINUE TO MONITOR IF CHANGE.
My son's arm was red, swollen, hot and 4 times the size of his other arm. I took him to an urgent care for examination. He was able to abduct his arm about 20 degrees.
Ever since I got the booster shot I have had unrelenting pain in all of my joints.  I have pain in my wrists, elbows, fingers, knees, and ankles and random shooting pains in other parts of my body.  Every time I go to a Dr. and mention this new  pain since I got the booster nobody listens to me.  Every morning I wake up like monster.  I can't even bend my limps for several minutes.  This is horrible.  I will never, ever get another booster or Covid shot .
Dizziness, Headache, Extreme vertigo Narrative: Started on meclizine with some relief but not complete relief
Patient with hx of fibromuscular dysplasia and CVAs presented on 06/13/2022 with abdominal pain, vomiting, AKI, lactic acidosis and progressive shock, found to be COVID positive. Admitted and started on broad spectrum ABX, stress dose steroids. Patient started to develop severe back/abdomen pain and had CTA of chest and abdomen that was negative for PE. On 06/14/2022 had PEA arrest with prolonged CPR after ROSC was transferred to alternate hospital.  On transfer patient was in profound chock, on three vasopressors, intubated, acidemic, anuric, profound lactic acidosis, rising AST and ALT and was unresponsive. ECHO showed global HK with EF 25%, troponin rising post arrest to 1.4.  CXR showed bilateral infiltrate's in lower lobes.  Patient expired on 06/14/2022.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: swelling of right arm and armpit-Medium
My arm was very sore for 2-3 days after the injection and then got better. That was expected. About a week after I noticed pain in my armpit (maybe a lymph node ?) and also in my elbow. I wasn?t expecting this and This pain lasted cold several days but is gone now.
joint pain; 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 ARTHRALGIA (joint pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Induration at site with erythema, tenderness, mild fluctuance Tx with warm and cold compresses. (L) medial deltoid.
pt recv vax & leg is extremely red swollen per mom;child not seen; no tx done;
Hives on face, chest, arms  Congestion Used Benadryl, atarax, albuterol inhaler
Noticed slight pressure on chest, causing laboured breathing.  Noticed a decreased oxygen level for about 1 hours.  After that time, I napped and all issues were over.  Also slight headache but nothing disturbing just noticeable.
developed a cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (developed a cough) 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 13-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced COUGH (developed a cough). At the time of the report, COUGH (developed a cough) outcome was unknown.            Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Immediate pain in left arm day of vaccination. Next day pain radiating down left day. Worsting day bay day. 12 days later, unable to walk. Went to hospital 2/15/2021, for inability to walk and radiating pain down both legs. At that time,  found out that i possibly diabetic in addition to the pain.
fever, fatigue Symptoms of essential tremor and spasmodic dysphonia worsened as with previous vaccinations for Covid. Usually last 3-4 days.
He held arms out locked limbs head to the side blanked stare & on responsive. Pale clammy skin he was immediately carried back into the building (never left the property) started coming to & his vitals were checked & blood sugar checked.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via Pfizer concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included covid on an unspecified date in /DEC/2020.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on 03-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 03-JUL-2021, the patient had an antibody test done for which the results were negative (confirmed immunological vaccine failure). It was reported that the patient did not have any reaction. The patient wanted to know whether a re-vaccination is required. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186787; Sender's Comments: V0: 20210743623- Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Fever 102, Chills, body aches, blurred vision, nausea, headache, swelling in throat.