chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lump in mouth; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump in mouth) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced MASS (Lump in mouth). At the time of the report, MASS (Lump in mouth) had not resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter's causality for the event of lump in mouth with Adalimumab Solution for Injection was not provided and assessed as reasonable possibility with Moderna COVID-19 vaccine (Elasomeran). No treatment details were reported.
21 x 17 cm local rxn of redness, warmth, tenderness, local sx may have begun early than 1-31-10 as he had T 102, myalgias dx'd as H1N1 influenza and did not specifically look at
sore arm  6-36 hours after shot headache 8-36 hours after shot chills 8-16 hours after shot tiredness 6-36 hours after shot nausea 6-18 hours after shot  took tylenol every 6 hours
24-hrs flu-like sx w/fever;rash on upper arms,back,chest & face-lasting 2wks;hard,scaly,itchy,burning stated 23FEB96;arthritic pain in thumb joints,rt wrist,rt knee;
First mild symptoms were sore arm and mild aches, tiredness.  On approximately Jan 11 started noticing itching at injection point and by Jan 16 2021 had red swollen area around injection point.  Red area approximately three inches in diameter. .
This spontaneous prospective pregnancy report as received from a nurse refers to an 18 years old female patient with heart murmur (cardiac murmur). The patient's medical history was not reported. On an unknown date in 2016, reported as "no more than six weeks", the patient became pregnant (the dates of last menstrual period and estimated date of delivery were unknown); on 22-JUN-2016, the patient went for an annual checkup and was vaccinated with GARDASIL (lot, expiration date and strength were not provided) dose 1, intramuscular (exposure during pregnancy). There were no concomitant medications. The reporter stated that the patient self-administered, on unspecified dates, six pregnancy test with conflicting results. On 05-JUL-2016, the patient sought medical attention and reported a lack of a menstrual cycle for the past six weeks. On that day, a blood pregnancy test was performed to the patient and the pregnancy was confirmed. No adverse events were reported. No product quality complain was involved. At the time of reporting, the pregnancy outcome was pending and the fetal outcome was unknown. Additional information has been requested.
Neuropathy; muscle twitching; muscle pain; fatigue; numbness (whole body); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 18:30 (Lot number: FF2590) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1; Intramuscular, Left arm, administration time 06:00 PM.), administration date: 15Oct2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 22Nov2021 18:00, outcome "not recovered", described as "Neuropathy"; MUSCLE TWITCHING (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "muscle twitching"; MYALGIA (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "fatigue"; HYPOAESTHESIA (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "numbness (whole body)". The events were evaluated at the physician office visit. Therapeutic measures were not taken as a result of the events. The patient had not COVID-19 prior to vaccination; he did not perform a COVID-19 test after the vaccination.
1 hour post vaccination, patient developed hives, seen on 2/29, still having hives, no other symptoms. Refer to Allergist.
Urinary tract infection moved into kidneys and caused kidney infection resulting in hospitalization and IV antibiotics.  7/6/07 Received hospital medical records which reveal patient experienced fever,  back pain & vomiting while away from home on mission trip.  Exam revealed bilat CVA tenderness. Admitted 6/22-6/23/07.  D/C to f/u for outpatient oral antibiotics. FINAL DX: Pyelonephritis, resolving. 8/14/07 Received vax record which confirms HPV dose & lot # as reported.
onset of cellulitis    11/7/23  , was painful the previous evening as well. was seen for redness swelling pain + treated with Keflex
He vomited about 5 hrs. after being vaccinated and still continues. He became very unresponsive at times. He ended up getting dehydrated which caused us an E.R. visit.
vision change; snoring; sleep apnea; change in appetite; anxiety; difficulty hearing; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health professional reported for an 83-year-old male patient received pneumococcal 13- valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot/Batch number not reported), via intramuscular on an unspecified date at 0.5 mL, single for immunisation. Medical history included dementia from 2015, hearing loss, hip replacement. Patient does not drive and need assistance with meal preparation. His wife lays out his clothing, changes his bed sheets. Patient able to shower, feed himself, toilets, shave, brush his hair, eats 3 meals per day. Amount he consumes fluctuates day by day, had difficulty remembering his birth date, was able to tell his name, the town and year. Patient's wife notes he has very poor memory and gets lost easily even if he walks out front of the house. Patient also gets agitated at times especially towards his wife and has gotten upset and broke furniture in his home especially chairs. The patient had a history of dementia and his wife was wanting him evaluated. On an unspecified date, the patient experienced vision change (chronic), difficulty hearing, snoring, sleep apnea, change in appetite and anxiety. The patient reported no dry eyes, irritation, ear pain, sore throat, bleeding gums, dry mouth, mouth ulcers, teeth problems, cough, wheezing, shortness of breath, coughing up blood, abdominal pain, vomiting, constipation, diarrhea, GERD, depression, sleep disturbances, feeling safe in a relationship, alcohol abuse, fever, night sweats, significant weight gain, significant weight loss, exercise intolerance, frequent nosebleeds, nose problems, sinus problems, chest pain, arm pain on exertion, shortness of breath when walking, shortness of breath when lying down, palpitations, known heart murmur, incontinence, difficulty urinating, hematuria, increased frequency, muscle aches, muscle weakness, arthralgias/joint pain, back pain, swelling in the extremities, abnormal mole, jaundice, rashes, laceration, loss of consciousness, weakness, numbness, seizures, dizziness, headaches, fatigue, swollen glands and bruising. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Day after immunization, patient felt nauseated, tired, could not focus. Had to leave work the next day. Following day felt fatigued.
Pt received vaccine on 11/17/2009 in mid afternoon. He noted reddish purple striations around injection site in pm of 11/18/09 around1200. Denies myalgia, swelling or tenderness. Reports pruritis to the area. Denies systemic symptoms.
erythematous macular rash on R arm, palm.  spread to L arm and palm.  not pruritic or painful.  no other symptoms.
Arm with localized pain.  Swelling & bruising- treated with TRAMADOL.
Developed diarrhea and fatigue on same day of vaccine. Symptoms lasted 24 hours.
Patient reported that within 12 hours of receiving vaccines, patient got a major burning on the arm (received administration), burning up, chills then feeling nauseous so rushed to bathroom. No vomiting. Temp > 101.4F , her symptoms lasted for 5 to 6 hours.
Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284746, 2018SA284747, 2018SA284721, 2018SA284748, 2018SA284750, 2018SA284751, 2018SA284752, 2018SA284753, 2018SA284754 and 2018SA284755. This case involves an unknown gender 10 years old who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number: U1997AA, route: intramuscular, site of administration: left deltoid, expiration date and dose was not reported) on 03-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patients were given vaccines that were outside of the recommended temperature range). No information about any adverse event reported. 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 2001/83/EC 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. List of documents held by sender: none.
PATIENT WAS 17 YEARS AND 9 MONTHS AT TIME OF INJECTION; NOT AT 18 YEARS OLD PER EUA.  NO ADVERSE EVENTS REPORTED (NO SIGNS/SYMPTONS REPORTED).  WILL FOLLOW CDC GUIDELINES AND ADMINSTER 2ND DOSE OF MODERNA IN 28 DAYS PER OFF USE LABEL.
Patient said her face was itchy and she was red.   At 2:31pm gave patient 25mg Benadryl IM ( she did not want 50mg because she was determined to get back to work and did not want to be drowsy Pt stayed until 3pm and said she was better and was going to work- pharmacy sent her with oral benadryl and instructed to follow up with pcp or er if things got worse Pt said she is not allowed to use her phone at work so we called and notified PCP - Dr. and they said they would let us know if doctor wanted anything different than benadryl  Called pt after work at 5:44pm to check on her and she said she was itching again and worried cause her throat kind of itched so she was headed to urgent care.  At this time 9:14pm have not heard anything further.
pt recvd vax 16AUG94 & 1hr p/vax pt devel a 4" by 8" reddened area surrounding the inj site on the lt upper arm, swelling of the lt upper arm from the elbow to the wrist, heat & pain;17AUG94 presented to MD w/same sxs;dx allergy dermatitis
This spontaneous report was received from a licensed practical nurse concerning a patient of unknown gender and age. On 21-SEP-2012 the patient was vaccinated with the first dose of GARDASIL. On 14-JUN-2013, the patient was vaccinated with the second dose of GARDASIL. The nurse reported that the patient was in the office on 12-SEP-2013 to receive the third dose of GARDASIL. No adverse symptoms were reported. Additional information has been requested.
Two after COVID vaccine first dose: severe pain over lateral aspect of right hip (soft tissue) lasting 10 days. Six days after: flu like symptoms with temperatures up to 100, severe fatigue, myalgia lasting 8 days.  Nasopharyngeal PCR was negative for COVID
pt recv vax 24JUN95 & 9MAY96 pt exp chickenpox;pt is one of 3 triplets who also exp p/vax w/varivax vaccine;
post covid pneumonia; having the covid virus; having the covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 62 years as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: COVID-19 PNEUMONIA (hospitalization, medically significant) with onset May2021, outcome "unknown", described as "post covid pneumonia"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "having the covid virus". The patient was hospitalized for covid-19 pneumonia (hospitalization duration: 7 day(s)). Patient had post covid pneumonia over the last year on an unknown date in May2021 and had 3 vaccinations and still has no antibodies. She got the booster which was some time on an unknown date in the end of Jul2021. Serious reported as: Yes. Investigation Assessment: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
mixed vaccine with sterile water instead of diluent /reconstituted ACTHIB vaccine with sterile water diluent with no reported adverse event; Initial information received on 21-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient who got mixed vaccine with sterile water instead of diluent /reconstituted acthib vaccine with sterile water diluent with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 21-Feb-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE at a dose of 0.5 mL once (lot-UJ589AA,25-Oct-2022) via intramuscular route in unknown administration site for immunization.  On 21-FEB-2022 the patient developed a non-serious event "mixed vaccine with sterile water instead of diluent /reconstituted acthib vaccine with sterile water diluent with no reported adverse event" (product reconstitution quality issue)(latency-Same day) following the administration of HIB (PRP/T) VACCINE.  It was reported "reconstituted ACTHIB vaccine with sterile water diluent instead of 0.4% saline."  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event mixed vaccine with sterile water instead of diluent /reconstituted acthib vaccine with sterile water diluent with no reported adverse event.
Information has been received from a registered nurse concerning a 62 year old white female adult who, may be allergic to mercury thimerosal, and who in the PM on 10/27/2004 was vaccinated subcutaneously in the right arm with a first dose of pneuomococcal 23v polysaccharide vaccine (lot 649732/0513P).  Concomitant medications included lisinopril (manufacturer unknown), trazodone, and levothyroxine sodium (Levoxyl).  It was noted that the patient was not ill at the time of vaccination.  On 10/27/2004, the patient developed soreness/pain, redness/erythema and warmth at the injection site, which continued for 3 days and she started feeling better on the fourth day.  It was noted that on the third day the patient called the physician (a relative) to prescribe an antibiotic.  the patient took 4 doses and stopped when she started to feel better on the 4th day (also reported as 4 days after injection).  The patient sought unspecified medical attention.  At the time of this report, the patient was fully recovered.  No further information is expected.
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillins" (unspecified if ongoing), notes: known allergies: penicillins. Concomitant medication(s) included: GABAPENTIN; SOLIFENACIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Three days later I tested positive; Unknown results, notes: Treatment of COVID-19; Negative, notes: tested negative on a rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: I tested negative on a rapid test. Three days later I tested positive. Had a stuffy nose and sore throat but no fever. Also have a rash on my forehead that may a or met not be related.   Follow-up attempts are completed. No further information is expected.
Swelling of arm week after vaccine. Red, swollen lump on left arm. As well as swollen lymph ones under left armpit. The day after vaccine, my arm had the normal inflammation related to the vaccine. It went away after 4 days. A few days after my arm started to become itchy. It has been itchy since. On 2/11, my arm swelled up again and became red around the injection site and hard and warm to touch.
Beginning around date/time listed in #5, felt and to some extent since (severity varying) felt diziness and vertigo-style-consiousness I have not experienced anything resembling since at least the second half of 2005 when I sustained a massive blunt-force-concussion & post concussion syndrome which didn't dissipate for a couple of years.
DTaP given IM in left thigh. Entire thigh is erythematous and swollen.
Information has been received from a physician concerning an approximately 67 year old female who on 30-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot # 667274/0883Z, route and injection site not reported). After administration of the vaccine, the patient experienced redness, pain and swelling at the injection site. The patient also experienced swelling of the arm. Outcome of the events were not reported. Follow-up information has been received from a medical assistant concerning the patient who had injection site reactions after vaccination with the same lot number (Lot # 667274/0883Z) of PNEUMOVAX 23. The patient had "severe" reactions consisting of red, hot, painful and swollen arms with the reaction extending from the injection site to elbow. Outcome of the events were not reported. This is one of several reports received from a same source. Additional information has been requested.
24 hours after injection, experienced fever (100.8), body aches, and fatigue. Symptoms lasted about 24 hours.
around 10 minutes after getting vaccine she reported getting facial numbness at mid-line that then progressed to right side of face to ear. It lasted about 6 hours then went away.
Pt recv vax on 10/23/98; on same day pt exp red/ edema/ warmth/ raised area of LA, fever; tx=Camexin, Motrin
Lightheaded, disoriented, faint (patient fell and may have sustained a bump on head due to falling).
Preterm Premature Rupture of Membranes following diarrhea- presenting as patient passing large clots of tissue and excessive amounts of blood. Event occurred roughly 7 HOURS following dose of vaccine on 01/31/2022. Patient was 19 weeks + 5 days pregnant. Patient was taken to hospital where membrane rupture and complete loss of amniotic fluid were confirmed via ultrasound. PPROM was re-confirmed on 02/01/2022 by MD. Patient was monitored for infection and placed on oral antibiotics until she started having contractions on 02/03/2022 around 7:30pm. Patient continued having contractions overnight and was checked into hospital the following day around 2:30pm, where she received more an epidural, intravenous antibiotics and fluid. Patient gave birth to a baby boy at only 20 wks +3 days pregnant. Baby weighed 9 oz and was 9.25 inches in length. There were no pregnancy complications nor concerns prior to this event. There were no observed abnormalities in the baby upon birth. This was a live birth. Estimated due date was 06/27/2022.
Client verbalized feeling numbness and facial drooping to left side.  Fuss assessment done by onsite Paramedics.  Client was then released for home at 3:34 pm.  Per paramedics no further evaluation needed all symptoms are resolved.
This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelling), PYREXIA (fever), HEADACHE (headache) and EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelling), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelling), PYREXIA (fever), HEADACHE (headache), EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. On 30-Nov-2021, the patient received first dose of Moderna (Intramuscular) .5 milliliter. Batch number was the same as second dose, 049E21A. It was reported that the patient did not want to get the second dose but was eventually forced to get the second dose by her employer. This case was linked to MOD-2022-501302 (Patient Link).
Development of hives to parts of body, neck, chest, abdomen and thighs.  Symptoms (hives) subsided after a day without any treatment provided.
Information has been received from a physician concerning a 5 year old male who on 04/13/2000 was vaccinated with varicella virus vaccine, live. On 04/19/04, the pt came with a mild case of chicken pox. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that another pt has a similar experience. (WAES#0404USA02069). Additional information has been requested.