chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a adolescent patient who received BEXSERO for prophylaxis. Co-suspect products included BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO and 1 year after receiving BEXSERO and BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO and BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient was with no known underlying conditions. The patient developed meningococcal disease 1 year following completion of primary series. The isolate was not tested but on route to CDC. This case was 1 of 4 case reported by the same reporter.
This spontaneous report as received from a pharmacist who stated there were an unspecified quantity of MMR II (indication, route, dose and lot # were unknown) doses that experienced a temperature excursion (72F for 14 hours0 and may have been administered to an unspecified number of patients. No adverse effects reported. The outcome of event was unknown. Additional information is not expected.
Patient got her flu vaccine on 10/13/17. Two days later she broke out in hives on both arms. Her right arm, which is where she received her vaccination, was worse than her left arm. Patient stated she had no fever but her arms are very itching and have hives on them. Patient has been using hydrocortisone cream and taking BENADRYL to stop the itching.
1 of 3 pts who recvd DTP/MMR; immunized from the same DTP vial; pt devel low grade fever, localized hives around inject site & 8 cm area erythema below site; seen by MD; treated w/APAP;
Swollen Salivary Glands, Runny Nose, Cold Like feeling W/O sore throat, itchy red rash on trunk (front and back) light headedness, dizziness, irregular heart beat on 4/27/06 given antihistamine.
Patient presented with multiple complaints including shortness of breath, cough, nausea, vomiting, diarrhea, weakness and fatigue.   His workup was notable for COVID-19 positive.  He is immune suppressed due to his transplant status.   He has been treated with dexamethasone, Remdesivir, ceftriaxone, azithromycin, and oxygen support. ID and Pulmonology have been following. He worsened and required HFNC.      March 20, has high-flow nasal cannula requirement has increased to 60L 70%. BUN/Cr 59/1.2. D Dimer on March 18 1,616. PCT on March 17 0.32. Will start IVF, doxycyline, and check CTA Chest. Encouraged incentive spirometer.   March 22, O2 requirement had been trending down yesterday and this morning it increased. He was not in distress and complained of only minimal dyspnea. He had been weaned to 50L 50% but then increased to 60L 90% with NRB overlay. CXR is consistent with covid without evidence of acute changes. CTA is negative for PE and notable multifocal infiltrates consistent with covid.    March 23, O2 requirement HFNC 60 L 75%. CRP down-trending, now 1.29; will reduce dexamethasone to 6 mg by mouth once daily from twice daily. BMP notes stable renal function BUN/Cr 47/0.8.    March 24, patient had brief episode where his O2 requirement dramatic the increased.  He denied any shortness of breath during that episode.  Pulmonology has encouraged him to lay prone.  His CRP has continuously trended down so we will not change his dexamethasone dose at this time.  Laboratory studies demonstrate stable kidney function with BUN creatinine 44/0.8.  Potassium was 5.3 reported as hemolyzed.  Nephrology has made no changes to his medications or attempted to correct that potassium.   March 25, his O2 requirement has been reasonably stable at 60 L and 75% high-flow nasal cannula.  He is encouraged to prone and alternate side laying.  Will begin weaning dexamethasone currently at 6 mg daily.  Will wean to 4 mg and then 2 mg and then resume his prior to admission prednisone 5 mg daily.   March 26, O2 requirement improved to HFNC 50 L 60%. He has oral thrush. Dexamethasone is stopped and home dose of prednisone 5 mg daily is resumed; Nystatin suspension S/S is ordered.    March 27, O2 requirement is continuing to improve he is now at 45 L 45%.  Will try him on nasal cannula today.  We will try to get him out of bed today as well.  Renal function stable with BUN creatinine 51/0.9.  Chest x-ray notes improvement in his multifocal bilateral opacities.  Patient has no new complaints today.  March 28, patient complained of an episode of chest pain last night, currently on HFNC 55 L 70%.  Chest x-ray stable infiltrate in the left mid lung with possible increasing consolidation in the retrocardiac space with mention of possible left pleural effusion.  Neither Pulmonology nor Nephrology have significant changes to the POC today.  Labs are essentially unchanged BUN creatinine again 51/0.9.   Patient was reevaluated by specialty HCF on March 28 and accepted. He will discharge from 1st HCF and transfer to the Specialty Hospital
Information has been received from a physician concerning a 22 year old female patient who on approximately 02-DEC-2009, "about two weeks ago" was vaccinated with a dose of GARDASIL (Lot No. not reported). Right after receiving the dose GARDASIL, the patient "got light headed" and fainted. The physician reported that the patient was 98 pounds so they did not know if she fainted because of her weight or because of GARDASIL. The patient sought unspecified medical attention. On an unknown date the patient recovered. No further information is available.
One day after receive vaccine had shingles like blisters on my face. Went to urgent care clinic and was diagnosed with shingles. Had me increase Famclovir to 3 times daily.
Case number PHEH2012US020830 is an initial spontaneous report received from a physician on 11 Oct 2012. This case refers to an 11-year-old female patient. She was vaccinated only with the MenCYW-135 liquid conjugate component of MENVEO (batch number: M11050) intramuscularly on 04 Oct 2012. She did not receive MenA lyophilized conjugate component of MENVEO. No adverse event was reported follow this drug administration error. No other information was available.
Pt received Gardasil on Feb 5 2007 in pm. She went home the next day she woke up 6:00 am with dizziness, legs shaking, nauseated, feeling faint lasting 3 days unable to go to school.  The fourth day she felt better.
My dad had the same thing; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (My dad had the same thing) in an 80-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (My dad had the same thing). At the time of the report, CARDIAC DISORDER (My dad had the same thing) outcome was unknown.            Concomitant medications was not reported. No treatment information was provided.  Company comment This case concerns a 80-year-old male patient with no details on relevant medical history, who experienced the unexpected non serious event of Cardiac disorder after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the second dose of mRNA- 1273 vaccine. Very limited information was provided at this moment. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 80-year-old male patient with no details on relevant medical history, who experienced the unexpected non serious event of Cardiac disorder after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the second dose of mRNA- 1273 vaccine. Very limited information was provided at this moment. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Red raised papules with central vesicle 2 with pustules on legs, arms, back, abdomen neck and fact. SX began 4/1/06 varicella administered 3/17/06.
Information has been received from a health professional concerning a 14 year old female who on 23-JAN-2008 was vaccinated with her first dose of Gardasil (655327/1287U) in her right deltoid.  On 23-JAN-2008 the patient experienced swelling and erythema of her right palm, wrist, and forearm.  The patient sought unspecified medical treatment by contacting the nurse.  The patient was instructed to apply ice, elevate her arm and to take Benadryl.  Additional information has been requested. Follow-up received 04/16/2008. The swelling and erythema extended 3 inches up her forearm. The nurse advised to see an ER doctor if the symptoms increased or changed. Follow up information obtained thru a telephone call on 24-JAN-2008 to the patient's mother includes a decrease in symptoms. The mother declined a physician appointment for evaluation. No additional information is expected.
Pads of little fingers left hand began itching, then spread to ring finger (pad only). Next morning spread to middle finger pad and tiny blisters were showing under skin. Has not spread any further by today (4/2/07) but itching continues today.
TIGHTNESS OF CHEST; SHORTNESS OF BREATH; VOMITING; COUGH; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included myasthenia gravis, and penicillin allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced tightness of chest. On 16-MAY-2021, the subject experienced shortness of breath. On 16-MAY-2021, the subject experienced vomiting. On 16-MAY-2021, the subject experienced cough. On 16-MAY-2021, the subject experienced nausea. On 16-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tightness of chest, shortness of breath, cough, nausea, fatigue, and vomiting. This report was non-serious.
Rash/systemic rash localized in joints; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash/systemic rash localized in joints) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 028L20A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GUSELKUMAB (TREMFYA) for Psoriasis.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash/systemic rash localized in joints). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Rash, at a dose of every day. At the time of the report, RASH (Rash/systemic rash localized in joints) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included: unspecified steroids
This is a spontaneous report from a contactable pharmacist. A 70-year-old male patient received PREVNAR 13 (lot number: T35176, expiration date: Jan2020) intramuscular in right deltoid on 18Feb2018 at 16:30 at 0.5 ml, single to prevent pneumonia. Medical history included blood pressure abnormal from an unknown date. Concomitant medication included amlodipine taken for blood pressure. It was reported that no other vaccine was given on the same day. On an unspecified date in Feb2018, the reporter stated that the patient was displaying a rash about a size of a soft ball so it was probably about 6 inches rash and it's tender to touch and radiating heat. It was also reported that the patient had a rash about 2 or 3 days after a shot and further reported that it was still growing and confirmed it was getting worse. It was reported that the patient has not had any rash from any vaccination of any kind. The patient has not recovered from the events. The pharmacist assessed that there was a direct correlation from getting the shot with the events; the pharmacist assessed as events related to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein).
Client reports dizziness, weakness, and pain in L hand, arm, neck and shoulder immediately after receiving H1N1 vaccine. Left clinic and went to work. Went to ER about 3 hrs. after immunization. Was given medication for pain and advised to report to Health Dept. which administered vaccine.
DX:  Demyelination    Impaired mobility (walking/balance/weakness)  Impaired speech (garbled words, unable to remember words) Impaired memory (short and long term) Slow mental function,  Poor judgement, Fever 101.8, normal flu symptoms, Hearing and seeing things not present or said.  Shortness of breath (this probably due to anxiety and impending doom)
pt recv vax 4AUG97 & ran fever 10AUG97-13AUG97 t101.6;broke out w/rash on 11AUG97;rash stayed until 16AUG97;gland (submandibular) were swollen;rash was mainly around joints w/swelling of knees & warm to touch;all sx gone;
Very cold, threw up, naseau, diarrhea, headache, sore arm but not as bad today as first two days
4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose).    Concomitant medication not reported. Treatment medication not reported.
11 year old came  in for 2nd dose of Pfizer vaccine. Patient was given 0.3 ml (30 mcg)  of Pfizer vaccine instead of 0.2 ml (10 mcg)
The patient experienced two adverse events. On 11/19/09 she experienced cholecystitis including abdominal pain due to gall bladder, vomiting and decreased appetite. On 12/09/2009 she experienced a miscarriage. She was 12 weeks pregnant. The patient had prior gall bladder problems and experienced complications relating to her pregnancy. The patient reported that physicians advised that her pregnancy aggravated her existing gall bladder problems.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Amoxicillin.
Swelling in lymph nodes under arms, knees, neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in lymph nodes under arms, knees, neck) 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 LYMPHADENOPATHY (Swelling in lymph nodes under arms, knees, neck). At the time of the report, LYMPHADENOPATHY (Swelling in lymph nodes under arms, knees, neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications details were provided No treatment details were provided
This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with PEDVAXHIB (dosage, route of administration, lot # and expiration date were not reported). Concomitant therapies were not reported. On an unspecified date (reported as "for a long time"), in the office had been using a "3 mm syringe blunt plastic cannula" to insert into rubber vial stopper to draw up PEDVAXHIB, then switching to a needle to administer it to the patients. No adverse effects were reported. Additionally, on an unknown date (reported as "recently"), some rubber was going into vial upon entering vial with blunt needle cannula on the PEDVAXHIB vial with lot # M014927, so the vial was not used. A product quality complaint (PQC) was filled. Additional information has been requested.
just yesterday my arm started itching. No rash. A little worm and it might be a little swollen.
Multiple excoriated pap lesions, some crusting on ankles. Scattered erythema pap vesic lesions-trunk, few on arms and in scalp. Keflex 250/5 200ml 2 tsp PO Bid x 10d. Atarax 10/5 4 on 1 1/2 tsp PO every 6 hours prn itching rx 2.
Patient received Moderna COVID vaccine on 3/22/21 and 4/19/21. On 1/22/22, patient admitted to our inpatient facility with acute left lower extremity ischemia, acute pulmonary artery emboli, and COVID-19 with acute respiratory failure. Patient underwent unsuccessful revascularization procedures on 1/22/23 and 1/23/22 and was in CCU from 1/22/22 to 1/25/22. As of today (1/25/22), patient is still admitted in our med/surg unit and will be undergoing BKA/AKA soon (left leg no salvagable).
After receiving vaccine 2, I had severe fatigue in my joints and muscles about 4-5 hours after injection. Around 8 hours post injection, it was difficult to walk without pain and it felt as if my legs were bricks. Throughtout the course of the next 2 days, I was extremely fatigued, had dizziness, headache that came and went, and after 48 hours, symptoms lessened.: Sunday around 7pm, (about 54 hours post-vaccination), I developed what looks like livedo reticularis all over my legs (upper thighs) and have the "Covid Arm" reaction. The rash on my legs seems to come and go and is sometimes warm to the touch and itchy. At times, I also get shooting pains up my body and have muscle and joint pain.
Pt got vaccine after lunch. Since she received the injection she felt bad. Swelling of her tongue, tenderness in neck. Took BENADRYL then came to ER. Received SOLUMEDROL 125 mg IM.
I experienced the expected fatigue/soreness for two days following my first dose and haven?t had any other symptoms until today (1 week later) when my arm became  itchy/swollen/red approximately two inches around the site and my fatigue returned. I haven?t used any treatments.
I got mildly sick, like people do after the vaccine. I had a little bit of vomiting. 24 hours later I was fine. Until the massive headache and vomiting again. That was 2 or 3 weeks after the vaccine. They sent me to the ER. I do not remember if they did any medical tests. I just remember sitting there with an IV forever. They just gave me Benadryl while I was there. I just started feeling better about 4-5 days ago. It was like cold symptoms. I had stuffiness, sore throat, the fatigue was awful, achy, mild fever, I lost my smell and taste. I took some Tylenol.
p/vax lab eval revealed negative varicella titers;pt never contracted varicella despite exposure as a kindergarten teacher;pt sough unspecified medical attention;
Patient received his first Covid vaccine on 1/7/2021 at 12:00p. At 0000 on 1/8/2021 he started having vomiting, diarrhea, and chills. Pt had ambulance take him to ED. Pt given fluids and nausea medications and discharged home at 8:30a the same day. Pt discharged with nausea meds as well as pain meds. Covid test was collected at time of discharge.
Rash that never go away; Dermatologist diagnosed Dermatographism itchy rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash that never go away) and RASH PRURITIC (Dermatologist diagnosed Dermatographism itchy rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 010M20A and 10323711) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine in 2020. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Drug allergy (Zyban), Pernicious anemia and Fibroids.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced RASH (Rash that never go away) and RASH PRURITIC (Dermatologist diagnosed Dermatographism itchy rash). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA 24 HOUR) on 06-Jan-2022 for Rash and Itchy rash, at a dose of 180 milligram, once a day and HYDROXYZINE on 06-Jan-2022 for Rash and Itchy rash, at a dose of 10 milligram twice a day. At the time of the report, RASH (Rash that never go away) and RASH PRURITIC (Dermatologist diagnosed Dermatographism itchy rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she never tested positive for Covid-19. No concomitant medications were reported.