chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not feeling well; Fever of 101.6; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well) and PYREXIA (Fever of 101.6) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer survivor). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MALAISE (Not feeling well) and PYREXIA (Fever of 101.6). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, MALAISE (Not feeling well) and PYREXIA (Fever of 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 101.6 (Inconclusive) 101.6 degree F.         Treatment information provided included paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.
TC from the patient stating he was tested covid pos on 8/2/21. He stated he was tested because he started having cold like symptoms started around 07/17 and was tested pos on 8/2 which was 10 days passed his symptoms. He was advised to call us if he started having new symptoms. He reported still having on and off cough and reported  having nasal congestion, loss of smell but still has taste. Reported having achy ness on bilateral leg which he reported is not unusual for him when he is having on and off fever. He reported his temp runs between the range of 98.6-100 F and reported taking tylenol as needed.  He denied having SOB,
Hives; Sore Arm; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), VACCINATION SITE PAIN (Sore Arm), CHILLS (Chills) and HEADACHE (Headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm), CHILLS (Chills) and HEADACHE (Headache). On 02-Apr-2021, the patient experienced URTICARIA (Hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), VACCINATION SITE PAIN (Sore Arm), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Pfizer-BioNTech COVID-19 Vaccine   Patient received Pfizer Covid-19 vaccine at 1043.   Patient complained of tingling throat, no swelling noted. Patient alert, oriented and talking/answering questions appropriately. Voice noted to become hoarse with continued conversation. EMS alerted and took over care at 1107.
I had the COVID arm- delayed hyspersensitivity reaction with the large red, itchy circular area on arm where shot was given. It started  about 8-10 days after first dose and started only about a day or two after 2nd dose. Was much itchier on 2nd dose. I saw my PCP when it started on the first arm and he suggested to switch arms and take Benadryl night prior to the 2nd dose but it still occurred again. I?m aware this is now a known reaction but I want to add to the data of those that experienced it.
Information has been received from a licensed practical nurse concerning a 27 year old female with no pertinent medical history or drug reactions. allergies, who on 9/7/06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653736/0689F). Concomitant therapy included ethinyl Estradiol norgestimate (Ortho Tri Cyclen). On 9/7/06, immediately after receiving the vaccine, the pt experienced a metallic taste in her mouth, nausea and sweating. The nurse had the pt lay down for a little while and the pt started to feel better. No further details were provided. At the time of this report, the pt was recovering. Additional information has been requested.
Mom noticed swelling and redness tuesday evening at bath time.  Redness and swelling-half inch above injection site to half way to elbow.  3-4 fingers in width.  Tender to touch.  Feels hot/warm to touch.  Fever up to 101.  Has been using Tylenol.  Recommended Motrin.  Call back as needed.
This case was received on 05 May 2009 from a consumer/patient. A 41 year old male patient received the following vaccinations on 27 April 2009: ACAM2000 (Sanofi Pasteur Biologics Co., lot number not reported) and ANTHRAX vaccine (trade name and manufacturer not reported). Five days following vaccination, the patient reported left-sided lower back pain, shoulder, wrist and left knee pain on bending. The patient's medical history reported a recent sprained ankle on 21 April 2009. The patient was seen in a clinic and had an x-ray and was scheduled to have an MRI of his back. The results of these tests were not reported. The patient reported no flu-like symptoms and no fever. The patient reported that the shoulder and wrist pain were improving at the time of the report but his joint pain was continuing. The patient's pain has not prevented him from working. List of documents hed by sender: None
She got her vaccine, the person who gave her the vaccine said that she was given the Gardasil vaccine under the skin and not IM.  She also got the MMRI-II and then noticed a lump in the lymph node in her arm pit about 45 minutes ago.  The lump is sore to touch, it is about the size of a dime perhaps larger.
Started with tingling sensation on bilateral arms, then a rash appeared and patient experienced itching. Patient received vaccine at 3:00pm and reaction appeared at 3:05pm. Patient stated that she has only ever had a reaction to Morphine and these were the same reactions she had to it. Patient states she did not have any SOB or trouble breathing. Patient was examined and listened to by Dr. Pt was given Benadryl IM in L glute at 3:10pm and was observed for 30 minutes total. Pt states she was ok at the time she left the facility to go to her home. Patient was told to watch for any other reactions and to call 911 if she had any difficulty breathing.
Information has been received from a physical therapist concerning his 12 year daughter with an allergy to ant bites who on approximately 04-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil. There was no concomitant medication. On approximately 04-JUN-2007, post-vaccination, the patient experienced a "headache, became diaphoretic and passed out". Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. The patient recovered from the headache, diaphoresis and loss of consciousness. Additional information is not expected.
She is admitted with fever and generalized weakness due to right lower lobe pneumonia. Casirivimab-imdevimab infusion Procal is normal, yet CRP persistently elevated and still having fevers
This spontaneous report was received from a registered and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (dose was not reported) (lot # M024261 and expiration date 30-JUL-2018) intramuscularly for prophylaxis. There were no adverse effects reported. On 27-FEB-2017, administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit (57.2 degrees Fahrenheit) for 1 hour and 45 minutes. Additionally, the administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit (50.2 degrees Fahrenheit) for 40 minutes. A data logger was involved. Additional information has been requested.
CRAMPS; DIZZINESS; EXHAUSTION; sore arm; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (CRAMPS), DIZZINESS (DIZZINESS), FATIGUE (EXHAUSTION) and MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022d21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (CRAMPS), DIZZINESS (DIZZINESS), FATIGUE (EXHAUSTION) and MYALGIA (sore arm). At the time of the report, MUSCLE SPASMS (CRAMPS), DIZZINESS (DIZZINESS), FATIGUE (EXHAUSTION) and MYALGIA (sore arm) 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.   Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-256663 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received and contain non significant information.
2/27/2023   I had a cough and sore throat. I took an At Home COVID test on 2/28/2023 that was positive.  I had a telehealth appointment with my doctor on 3/1/23. He prescribed Paxlovid which I began taking that day. I finished it on 3/6/23.  I was feeling fine by that time and I have recovered.    I had returned from a trip abroad on 2/26/2023.
Body aches, soreness (L) deltoid, swelling (L) delt, hot. Coughing, shortness of breath, wheezing and phlegm 4 days after shots.
Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to case 2018SA251618. This case involves a 10-month-old patient (gender not reported) who received 0.25 ml of FLUZONE QUADRIVALENT batch number: UT6262MP on 31-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is actual medication error case due to product storage error (received Fluzone Quad 0.5 mL and 0.25 mL syringes after the 48 hours shipping, MA said they were still cool). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
Pt experienced rash and itching on arms and legs from 12/23-12/27. Took Benadryl to improve symptoms.
A few days after I was let out of the hospital. I woke up and both of my legs from the thighs down to my toes were, numb, stiff, tight and painful. Went to the Emergency room on 11/ /13. Diagnosed w/ transverse myelitis. Went through steroid treatment and physical therapy.
Hospitalized 01/11/2022-still currently admitted; COVID-19 positive 01/11/2022; fully vaccinated plus booster  CHIEF COMPLAINT: Acute respiratory failure with hypoxia (HCC)     Assessment/Plan     ASSESSMENT / PLAN: Acute Respiratory failure with hypoxia  Pneumonia due to COVID 19 Virus Immunosuppressed status Vaccinated: 2 doses and booster Symptom onset: 1/4 CXR w/ scattered scattered left peripheral infiltrates and vascular congestion with possible small bilateral effusions Decadron Check procal, consider abx if elevated Not candidate for remdisivr due to renal disease Already on coumadin, check INR to ensure therapeutic Wean O2 as tolerated    Acute CHF exacerbation, unspecified type and chronicity  Elevated Troponins Hx of CAD s/p stenting Hx of Aortic Valve stenosis s/p TAVR (bioprosthetic) Hx of Complete Heart Block s/p PPM Hx of Subclavian Veinoplasty  Trop 143-- >142 BNP 5790 ECG is ventricular paced but does appear to have some increased ST elevation  No previous Hx of CHF Will obtain Echo, Consider cardiology consult pending results He was started on coumadin after TAVR, although it is bioprosthetic valve Will monitor off lasix tonight due to AKI. Low threshold to initiate if decompensates overnight Continue Toprol, ASA, statin, coumadin (pharmacy to dose) 01/14/2022 notes: Assessment and Plan Severe acute respiratory failure with hypoxia COVID19 PNA Immunosuppressed state -Currently O2 need increased from 6L-> HFNC @ 95% and 45L to maintain sats -is s/p vaccination and booster but immunosuppressed from transplant meds -procal normal  -supra therapeutic INR makes suspicion for clot low  -patient confirmed to be full code   Plan: -decadron -> solumedrol 60mg BID with eventual slow taper if he improves  -titrate O2 as able -warfarin for anticoagulation  -repeat CXR   01/18/2022 notes:  Severe acute respiratory failure with hypoxia COVID19 PNA Immunosuppressed state -Currently O2 need stable today at 80% FIO2 @ 50L/min -is s/p vaccination and booster but immunosuppressed from transplant meds -procal normal  -supra therapeutic INR makes suspicion for clot low  -patient confirmed to be full code   Plan: -solumedrol 60mg BID for 7-14 days (day 5 today) with slow prednisone taper afterwards  -titrate O2 as able -warfarin for anticoagulation  -repeat CXR  Disposition:  DC timing unclear given severe hypoxia though hopefully DC in next week given lack of improvement over last few days
From initial information received on 12/05/2003 from the patient regarding an adverse event occurring in the U.S.A., it was reported that the 32 year old female patient received a dose of the FLUZONE SV '2003-'2004 USP, lot number U1087AA administered at 5:00 PM on 11/25/2003. Expiration date of the product is 01/30/2004. The route and site of administration were not reported. 21 hours later, the patient developed blisters at the site of injection. The patient's pre-existing medical conditions include allergies to codeine. Her concomitant medications include Eskalith, Lamictal, Tri-Norinyl and Wellbutrin. Reportedly, the patient recovered from this event.
Patient has had a constant headache since the second dose of the vaccine on 3/20/21. The headache goes across the forehead.
No additional adverse events; Received Rotateq on 12-MAR-2021 and then again 29-MAR-2021; Information has been received from a certified medical assistant concerning to a 2 month 8 days old female patient. No medical history, concurrent conditions nor concomitant medications were reported.  On 12-MAR-2021, the patient was vaccinationed with a dose of vaccine, live, oral, pentavalent (ROTATEQ) (Lot No. 1707306, exp. date not reported but upon internal verification determined to be 26-DEC-2021), 2 ml oral as prophylaxis. On 29-MAR-2021, the patient received a second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot No. 1707306, exp. date not reported but upon internal verification determined to be 26-DEC-2021), 2 ml oral as prophylaxis (inappropriate schedule of product administration). The patient did not experience an adverse event.
rapid heart rate, dizziness and feeling of passing out. Was intense for the first 5 minutes and then was just a little dizzy. Had dissapated after about 30 minutes. Achiness  in joints later in the day.
PT FELT DIZZY/ LAID ON FLOOOR, WAS GIVEN COLD COMPRESS, EMT CALLED, SHE WAS TAKEN FOR EVALUATION.
having pain in my foot and I was having pain in my shoulder, both shoulders; having pain in my foot and I was having pain in my shoulder, both shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Menopause" (unspecified if ongoing), notes: Verbatim: Menopause; "I take my blood pressure pills" (unspecified if ongoing), notes: I take my blood pressure pills; "arthritis" (unspecified if ongoing), notes: That's what I was taking, not because of the Pfizer, but because of arthritis. The patient took concomitant medications. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "unknown" and all described as "having pain in my foot and I was having pain in my shoulder, both shoulders". Therapeutic measures were taken as a result of arthralgia, pain in extremity.  Additional information: No investigation Assessment was done. On confirming the treatment for the adverse event (Tylenol): Consumer stated, yes, but she also was taking another medication. Once before patient was taking another medication. Patient was taking Meloxicam (Further clarifications unknown). Patient was taking that for pain and that was when patient got the first vaccine. That's what patient was taking, not because of the vaccine but because of arthritis. Patient was taking that for pain, like patient said she was having pain in her foot and was having pain in shoulder, both shoulders. Patient was having pain in shoulders as well but it wasn't the pain that patient was having now. (Further clarifications unknown) patient didn't start having the pain till she took that second Pfizer dose. But she didn't look at it as nothing because she just thought it was just normal because it was off and on and patient weren't taking Tylenols like that either but now with this here was different. Vaccination facility details: at the hospital where patient work at.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Joints aching at 4:00pm quite a bit of pain. 900mg's 600mg's. Called nurse hotline, ER - under observation. Labs. Hx of Guillain-Barre. 8/21/2012 (Well/still sore).
5 months after vaccine started having lower back pain and lower left leg. Spinal stenosis in lower back. Prescribed prednisone for a week.
severe headache x 5 days, 102.5 fever x 3 days, 100.5 fever x 3 days, severe fatigue for 36 hours.  symptoms began around day 5.  i went to hospital.  i received fluids, compozine and torodol.  i got plent of bed rest.  took tylenol and motrin around the clock.  i did miss several days of work due to being so sick.
No problem with injection site.  Developed what appears to be a rash (hives?) on my right side at my waistline.  Noticed two spots and at first thought it was bug bites.  Since Wednesday, several more spots have appeared in same area around waist from navel area around to back.  Spots are not large or itchy but have an occasional mild sensation like a twinge (mostly from the new spots).  Been self-treating  with witch hazel, hydrocortisone cream, fexofenadine and acetaminophen.   Note:  I am assuming this is a side effect from Covid vaccine because I have never before had hives.   I had a senior flu shot in October with no side effects.
inflammation, "streaking" @ injection site to underarm 48hr. onset after admin. Sore arm, but able to lift above head still. admin 8/12/2020 @ around 1:00pm pt. called 8/14/2020 @ around 1:00pm discussing inflammation and "streaking" that started @ injection site and spread to under arm. on Left arm w/ Tdap vaccine was given. Sore arm reported, but able to freely move. No doctor visit so far. Additional follow up is needed w/patient.
Narrative: History of Present Illness: October had dirraheal illness octiober 7th and 10 days later admitted in hospital with dehyration and weakness, also had numbness fingers,no c/o numbness feet was in hospital 1 week and discharged to skilled nursing facilty for 8 weeks.Initial 4 weeks after admission in skilled nursing facility could not walk then improved over the next 3-4 weeks and now walking and improved strenght both armn and legs h/o some weight loss last year when he was in nursing home now weight is stable patient was told statin medication caused his weakness,did not have an EMG study no c/o neck pain,no c/o headaches,no h/o strokes h/o TB exposure and was on medication for 6 months Neurological examination: Awake , alert , oriented to person, place and date, Pupils 2-3 mm reactive to light sym ; primary gaze midline, extraocular movements intact ; no ptosis, visual fields intact to confrontation .Touch and pinprick intact on the face, no facial asymmetry, no facial muscle weakness ; hearing grossly intact, shoulder shrug and head turning good strength bilaterally; tongue midline with no atrophy Rapid alternating movements very slow bilaterally, neck flexor neck & extensor strength gave good resistance ; strength gave good resistance both HF,KE,KF both lower extremities left bi and delt 4- right delt 4- BI 4+ tri 4+ both right interossei 1+,left interossei 1-,right APB 2-,left APB 1+ with wasting left APB and less right APB , also both interossei wasted right more so, finger flexors good strenght,finger extensors no mvt,WE 1+ to 1- right foot DF 2+ to 3-,left DF 3- to 3+,PF gave good resisatnce could not see any faciculations DTR's 1+ knees symmetric ; tone normal upper and lower extremities; plantar reflexes flexor , no tremors resting or postural; no bradykinesia. No dysmetria on finger to nose and heel to shin testing. Touch and pinprick intact hands and feet ; position sense seems intact feet. Gait exam : normal base and stride steady gait,Romberg's test negative. Impression: Patient with severe motor axonal neuropathy with clinical h/o significant weakness last several months with some improvement but still has prominent weakness hands. Discussed cannot exclude multifocal motor neuropathy,another possiblity based on antecedent diarrheal illness may have had Guillain Barre motor axonal neuropathy variant 6 months ago with some improvement based on clinical history. Recommended a trial of 2gm/kg IVIG over 5 days.Discussed the risks with IVIG and potential benefits.Patient needs to continue regular Physical therapy and occupational therapy.
Got meningococcal vaccine on 3/10/15. Rash (band across arm formed on day 2. Pain formed day 2, worsened to affect muscle strength with pain (no numbness or tingling). Pain noticeable Kw/use. Sore/weaker today. Sent doctor email today. No other tx.
Information has been received from a healthcare worker (also an office manager) referring to unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the unspecified patients were vaccinated with improperly stored VAQTA (dosage, strength, lot# and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe diarrhea.  Tried max dosage of Imodium Advanced, no relief.  Diarrhea lasted 30 hours.  This was also accompanied by 102 fever, headache, and kidney pain.  Increased water intake and suffered through it.  This was not what I would categorize as mild and I know the difference having served overseas.
started feeling "funny" about 30 minutes after her second covid vaccine. She returned to the covid vaccine clinic at 0928. She had returned to work in the clinic and let her coworkers know how she was feeling. She was given 50 mg PO liquid Benadryl at 0907 due to tingly, full-feeling tongue, and stated her "teeth and face feel funny". VS at 0915: BP 128/85, P 88, O2 100%.  VS 10 mintues later (30 min after Benadryl) were: BP 118/74,P 77,O2 100%. She reports that the tingling and fullness of her tongue is much better. Her color is normal, and she is visiting with staff. Will plan to monitor for one hour.