chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I haven't had a gout for a long time. But it appears that this vaccination has made my gout come back.
A non-serious spontaneous report of rash has been received from a consumer, patent's mother, concerning a 42-month-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on acceleration reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received one dose of FLUMIST on 29-Oct-2009. The patient received a total of one dose of FLUMIST before the onset of the event given on 29-Oct-2009. On 30-Oct-2009, the patient "broke out in a severe rash." The rash had persisted, and the patient's physician prescribed steroids. The reporter stated that the rash was fading and then coming back. It had extended from the patient's head to his toes. The rash was itchy and did not look as prominent as "it did upon initial presentation". Last season the patient received FLUMIST and did not have any adverse events. The outcome of the event of rash was ongoing. The event of rash was resolved on 08-Nov-2009. On 09-Dec-2009, follow-up information was received and incorporated into the narrative: the outcome of the event and resolution date. on 19-Feb-2010, follow-up information was received and incorporated into the case: lot number.
Immediate red raised area at injection site- within 1 hr face swollen- no shortness of breath- no trouble breathing- no drooling.
Information has been received from a physician concerning a 5 year old female who on an unspecified date, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In April 2006, the patient developed a mild breakthrough case of varicella. unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
one dose of DAPTACEL was administrated post excursion with no adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient whom one dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administrated post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administrated one dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (lot number and expiry date not reported) via unknown route in unknown administration site for immunization post excursion with no adverse event (poor quality product administered) (unknown latency).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.; Sender's Comments:  01266903: 01266768: 01266921: 01266924: 01266780: 01266792: 01266974: 01266976: 01266978: 01266980: 01266982: 01266983: 01266985: US-SA-2022SA372080:
This spontaneous report was received from a 56 year old female patient reporting on herself. On approximately November 2015 (reported as "about 2 months ago"), the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration were not reported). The patient stated that she developed "inflammation and heat" on her arm then a rash on her face. The patient also stated that she had been in contact with her a new born baby after having received the vaccine. The patient did not say if she was experiencing the adverse events at the time of this contact. The patient also stated that she might not have chickenpox previously. The patient sought medical attention. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
only received one moderna vaccine; flu like systems within the first 24 hours of vaccine; really hasn't felt well since getting the vaccine until recently; swollen lymph nodes on both sides/swollen, hurt and be sore, and then go away; headache that was pushing down from the top of her skull and lasted several weeks; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like systems within the first 24 hours of vaccine), MALAISE (really hasn't felt well since getting the vaccine until recently), LYMPHADENOPATHY (swollen lymph nodes on both sides/swollen, hurt and be sore, and then go away), HEADACHE (headache that was pushing down from the top of her skull and lasted several weeks) and PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03(4or9)K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like systems within the first 24 hours of vaccine), MALAISE (really hasn't felt well since getting the vaccine until recently), LYMPHADENOPATHY (swollen lymph nodes on both sides/swollen, hurt and be sore, and then go away) and HEADACHE (headache that was pushing down from the top of her skull and lasted several weeks). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (flu like systems within the first 24 hours of vaccine), MALAISE (really hasn't felt well since getting the vaccine until recently), LYMPHADENOPATHY (swollen lymph nodes on both sides/swollen, hurt and be sore, and then go away) and HEADACHE (headache that was pushing down from the top of her skull and lasted several weeks) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
seeking 2nd dose of primary series which is no longer available; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (seeking 2nd dose of primary series which is no longer available) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (seeking 2nd dose of primary series which is no longer available) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT AVAILABILITY ISSUE (seeking 2nd dose of primary series which is no longer available) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT AVAILABILITY ISSUE (seeking 2nd dose of primary series which is no longer available).    No concomitant medications were reported. Patient was seeking 2nd dose of Primary series which was no longer available. Patient received 1st dose of vaccine within this past 30 days and about to go over 30 days. No treatment details were reported.
JOINT PAIN AND FATIGUE 3 DAYS BED REST BUT RIGHT SHOULDER HAS HURT EVER SINCE AND RIGHT SHOULDER GETTING WORSE 4 MONTHS LATER.
Information has been received from a physician concerning her 6 month old daughter who was vaccinated with her third oral dose of Rotateq.  Two days post vaccination, the patient developed a fever, diarrhea and vomiting.  Unspecified medical attention was sought.  No labs or diagnostic studies were performed.  The patient was treated with an unspecified therapy.  Subsequently, the patient recovered.  The physician who vaccinated her daughter was unknown.  There was no product quality complaint.  Additional information has been requested.
The left ear of the patient became red and swollen.  The patient did have on a mask that was tight fitting.  The mask was removed on that side and the swelling and redness started to subside.  Patient did wait in the pharmacy for 30 minutes before leaving and said he was fine.
received a dose of adjuvant; received a dose of adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that patient received a dose of Shingrix adjuvant that was not reconstituted with lyophillized powder which led to inappropriate reconstitution technique and incorrect dose administered. The reporter did not consented to follow up.
Left arm pit red, swollen and painful. Taking Ibuprofen, Tylenol, using ice/heat. Symptoms within 5 days.
PT REPORTED RADIATING PAIN THAT'S BEEN GETTING WORSE FOR 3 WEEKS, migrated to other arm and neck
Patient reports that after 24 hours or receiving vaccine, her arm became swollen and red with clear visible margins.  It is hot to the touch and small blisters appeared.
Confusion, mumbling, unsteady gait, multiple falls, urinary incontinence, localized reaction at injection site, chills, feverish.
Initial report was received on 12 January 2012 from a consumer who is also the patient. A female patient (date of birth not reported) had received "in October" FLUZONE INTRADERMAL (lot number, site and exact date of administration not reported) and a week later, experienced swollen lymph "that moved across her chest". The patient also reported that "from that time" she also has had persistent joint pain. According to the patient, the swelling had subsided but claimed to be "still feeling side effects". The patient's history was not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Information has been received from a licensed practitioner nurse concerning a 35 year old female who on 12-DEC-2007, was vaccinated with her first dose of GARDASIL vaccine (yeast). On 15-FEB-2008, was vaccinated with her second dose of GARDASIL vaccine (yeast). On approximately 29-FEB-2008, two weeks after the second vaccination, the patient experienced dermatitis. The patient reports that when she lightly scratches her skin she gets an erythema that rises up, that she referred to as "Graphic Dermatitis". The patient's "Graphic Dermatitis" was self diagnosed. The patient discussed the dermatitis on her routine office visit on 09-JUL-2008 and a follow-up visit on 06-AUG-2008. The patient's graphic dermatitis persisted. Additional information has been requested.
Case number PHEH2014US018195, is an initial spontaneous report from a pharmacist received on 10 Sep 2014. This report refers to a 42-year-old female patient. Past medical history and concomitant medication were not provided. She received a full 5 ml (10 doses) of FLUVIRIN (batch number: not reported) intramuscularly in one dose on an unknown date of Sep 2014 (vaccination date was reported as within past two days). No adverse events were reported following the maladministration. No additional information was available.
hypertensive; This is a spontaneous report from a contactable healthcare professional received via information team. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced being hypertensive after receiving the second dose of vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very strong headache, very strong abdominal pain, upper chest respiratory pain, at times difficulty breathing, feeling like I am going to faint.
Since the first dose was administered on June 11th 2021, she has stopped having her period. It has been 5 months since. In addition, after the 2nd dose on July 2nd 2021, she developed a swelling under left armpit. It has been almost five months since. and it hasn't been resolved.
mom reports 3 individual jerks over 1min;the noc of vax T103 no post ictal phase;T104 seen in ER given APAP;CBC done-WNL, referred for EEG WNL;
intermitted side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (intermitted side effects) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (intermitted side effects). At the time of the report, VACCINATION COMPLICATION (intermitted side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
15 month old patient received an expired ACTHIB with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 month old patient received an expired acthib with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination.  On 13-Sep-2023, the patient received 0.5 ml (1X)  dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection lot UJ798AB, expiry: 11-Sep-2023 via intramuscular route in the left thigh for immunization (strength: unknown), patient received an expired acthib with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
PT. c/o of pains to stomach and  H/R - PT. did vomit approx. 1045.  1046 c/o hives, hives noted on bilateral forearms - 50 mg BENADRYL PO - vomited up.
Patient was given Moderna vaccine IM . She  immediately started to complain of weakness, nausea and then could not speak. She was in and out of consciousness. She became very pale. We called 911 and EMS arrived. When patient was able to speak she  chose not to go to the hospital. Her husband was with her.
booster; Rash on neck - warm, but not itchy. Resolved after Benadryl.; Rash on neck - warm, but not itchy. Resolved after Benadryl.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 Immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; RASH (non-serious), FEELING HOT (non-serious), outcome "recovered" (2021) and all described as "Rash on neck - warm, but not itchy. Resolved after Benadryl.". Therapeutic measures were taken as a result of rash, feeling hot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upon completing his 15 min observation time, patient stood and started walking away. After several meters he complained of light headedness, wooziness, and dizziness. He reports eating a good lunch but his mother stated that he is always starving after school, He was brought back to a room. He denied lip swelling, tongue swelling, shortness of breath, wheezing, coughing, nausea or vomiting. His temp was 99F temporal, HR 76, RR 24, BP 112/76, SpO2 95%. Exam was unremarkable without urticaria, edema of the lip or tongue, pharyngeal erythema, tonsillar edema, wheezing, increased respiratory effort, rales. Belly was benign. Extremities were warm and well perfused. He was given 250 mL of water and a Pedialyte popsicle. After 25 minutes of observation, his symptoms improved. He walked out of clinic with complaints of arm soreness.
Swelling/redness to the left thigh and right arm s/p vaccines. Area of redness on left thigh approx. size of tennis ball. Pt started vomiting 1 day after vaccines.
Dose administered to 1 patient after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered to 1 patient after temperature excursion) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Sep-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered to 1 patient after temperature excursion). On 10-Sep-2021, POOR QUALITY PRODUCT ADMINISTERED (Dose administered to 1 patient after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  On 10 Sep 2021, 1st temperature excursion (vaccine went out of range) occurred. Consisted of 3 vials from which 1 vial was opened and administered to 1 patient. Once that dose was administered, the vial was wasted. There were still 2 unopened vials still in the refrigerator that had not been opened or administered to anyone.
Vaccine adm high in L arm. Cried at time of injection. Numbness L arm slight swelling L hand.
Pt. states that after receiving the 2nd dose of Moderna 04/30/2021, started experiencing symptoms 05/30/2021 of chest pains, shortness of breath, and fatigue. Diagnosed with Pericarditis and lung infection. Still continuing to experience symptoms.
Patient describes that after receiving the influenza immunization, he had a dull achy pain that occasionally radiates to his elbow. He has pain daily and it has been present ever since the immunization. He sought medical treatment by his primary doctor on 12/1/16. The doctor is not certain of the cause but attributes his pain to either muscle damage caused by the injection or a torn rotator cuff due to lifting weights several times weekly. He will follow up with physical therapy and X-ray if symptoms do not improve.
Developed 8 x 10 cm area of induration, erythema, pruritic surrounding injection site.
Patient is unsure of the exact day that the rash started but that it was some time in the past week.  She presented 8 days after she received Prevnar 13 with a rash (about 3inx6in) at the site of injection.  She reports that it is warm to touch.
Baby cried, as if in pain, inconsolably for about 36 hours. During the crying spell, she hardly ate and barely slept, maybe 1 or 2 hours total for about 15-30 minutes at a time. The crying spell ended around 03:00 with her falling into a deep sleep for about 6-8 hours and then sleeping on and off for the remainder of the day, waking just to eat. There was swelling, redness and soreness at one of the injection sites for around 4 weeks. Her doctor dismissed both of these reactions and they do not appear in her records. She had the same reaction after her 1st set of inoculations, except no swelling.
High fever, chills, body aches, severe abdominal/pelvic pain, nausea
Tested positive for COVID-19. Remains on room air and states he has not experienced any subjective changes in respiratory status
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender with medical history of unspecified anxiety issue. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency and lot # not provided). On an unknown date, the patient fainted after receiving ZOSTAVAX. The patient could not move for almost an hour after receiving ZOSTAVAX. The physician called an ambulance to have the patient transported to an unspecified hospital. It was unspecified if the patient was admitted to the hospital. The outcome of the patient fainted and could not move was not reported. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information is not expected, as the reporter refused additional contact.
Patient now reports (4.5 months after vaccination) pain in left shoulder, in addition to pain when lifting his left arm. Advised patient seek medical evaluation,.