chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via a sales representative and described the occurrence of injection site rash in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk); Merck; unknown; unknown given on an unspecified date; VARIVAX (non-gsk); Merck; unknown; unknown given on an unspecified date. In March 2014, the subject received 1st dose of KINRIX (route unknown, left thigh, batch number not provided). KINRIX was given on an inappropriate site, preferred site is deltoid. Less than one month after vaccination with KINRIX, the subject experienced injection rash. After 3 days, the events was resolved. The physician considered the event was possibly related to vaccination with KINRIX.
Immediately felt nausea; my head felt enlarged.  Dizzy. Next day dizzy feels like the flu-sore muscles in legs/body/nauseous/cant sit up- need to lay down.  Feel very uncomfortable.
Drop of body temperature even wearing layers of clothes and bedsheets, drop in body temperature caused me to have uncontrollable shaking. The hyperactivity of having the uncontrollable body shaking accelerated my heart palpitations and felt intense pain in my chest. This reaction lasted for about an hour and felt like I needed to go to emergency care.
At 0901 pt reported tingling sensation of tongue. Pt stated he has never felt that before. Pt denied SOB, denied difficulty breathing/swallowing. No angioedema noted to lips/tongue. Pt was not able to let me know if his tongue looked bigger than normal. Pt speaking in clear, complete full sentences. Vital signs stable.   Pt was given Benadryl 25mg po at 0903 as a precaution. Pt's vitals were checked, pt was observed for 30 minutes after medication given. Pt given ambulatory test before he drove off. Pt denied dizziness, SOB, or difficulty swallowing/breathing. Pt reports tingling sensation decreased. Pt educated on importance of calling 911 if he experiences SOB, difficulty swallowing, facial edema. Pt understood and stated he would call 911 if he felt any of these symptoms.
Severe headache and body aches Severe fatigue and weakness Pain at the injection site and throughout the arm
Giant urticaria, epigastric pain, and continuous symptoms for past 4 days. Treatment - Pepcid, Allegra, prednisone- mild improvement, still severe widespread hives on entire body after treatment and worse at night.
2 minutes after injection, right arm went numb, heart racing at 120 bpm.  High blood pressure. Then irregular heart beat, rash on neck and chest. Nurses administered 50 mg Benadryl.  10 minutes later, heart racing again and inability to catch my breath. Dizzy and light headed. Irregular heart beat.  Pulse ox was ok throughout.  Total time of nurses observing these symptoms was  45 minutes.  Two days later, still light headed and dizzy.
No adverse events reported for pt- CDC determined expiration date was prior to immunization date after shot was given on 10/10- was moved back to 9.30- must report
Red blotches on both arms at bicep and minor blotches at groin (itchy) lasted approximately 1 day. This occurred twice in a period of 3 weeks. Severe swelling of the right hand lasted approximately 3 days. Severe swelling of left-side of face. Lasted approximately 3 days. Severe swelling of entire face including lips. Lasted approximately 3 days. The doctor prescribed a Medrol Dose Pak 3 times to correct the 3 events of swelling.
Patient is a 58 year old man with recently elevated glucose levels after his second dose of his Pfizier COVID-19 vaccine and 10 days after began with polyuria, polydipsia, blurry vision, and then diagnosed with type 2 diabetes.  On labs, 6/2/21 show fasting blood glucose of 331, and hemoglobin A1c of >14.0%, and eGFR of 97.
5MAR99 pt exp silver-dollar sized inj site sore;8MAR99 pt seen by MD c/o fever, sweats, a swollen arm & pain;tx w/med for poss cellulitis;pt hosp;dx poss sepsis & sterile abscess;tx: IV antibiotics, reportedly not getting better;Annual follow-up received on 11/27/00 provides no additional data.
Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the following day and symptoms had resolved.
fell sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the flu vaccine and experienced fell sick. This case has been linked with same patient cases US2020AMR223839 and US2020AMR223804 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223804:same patient US-GLAXOSMITHKLINE-US2020AMR223839:same patient
Clinic was contacted that injection site was very inflamed and swollen the evening post the vaccination. As nurse on staff was not on site; patient was taken to the ER - given Benadryl and topical steroid cream to apply to site.
VERY PAINFUL CAUSING LIMITED RANGE OF MOTION FOR FEW DAYS NOW AND REDNESS THAT EXTENDS DOWN INTO HIS SIDE AND IT IS SWOLLEN, SLIGHTLY WARM TO TOUCH
High fever, chills, Supra-ventricular Tachycardia - heart rate 200, EMS gave adenosine with resolution 3 doses, Hypokalemia, hypomagnesemia
Information has been received for the Pregnancy Registry for GARDASIL from a registered nurse concerning a 17 year old female who on 21-MAY-2007 was vaccinated with a first dose of GARDASIL (lot # unknown).  On 21-MAY-2007, a cervical smear was performed and the results were within normal limit.  A gonorrhea test, HIV test and a rapid plasma reagin card (RPR) test was performed and the results were negative.  A Chlamydia test was performed and the results were positive.  The date of the patient's last menstrual period was 31-MAY-2007.  Medical attention was sought.  On 24-JUL-2007, the patient had a beta-human chorionic gonadotropin test (unspecified) that showed positive results for pregnancy.  On 24-Jul-2007, the patient was vaccinated with a second dose of GARDASIL (lot# unknown).  On 24-JUL-2007, the patient was treated with one gram of ZITHROMAX and 125 mg of ceftriaxone sodium for Chlamydial infection.  An HIV and rapid plasma reagin card (RPR) test were also performed and results are pending.  The estimated date of delivery is 6-MAR-2008.  Follow-up information was received from the physician's office from a health professional.  It was reported that the patient delivered a normal, healthy baby girl on 18-FEB-2008 via C-section (baby was breech).  The baby weighed 6 pounds 7 ounces.  The patient did not breastfeed the infant.  The infant developed reflux shortly after birth.  No additional information was available.  Upon internal review breech presentation was considered to be an other medical event.  Additional information is not expected.
Immunization: 2nd dose of Typhoid Ty21 oral Vaccine Date: 21-23 March 2005  Onset date: 23 March 2005 Symptoms: This 25 year-old received oral typhoid on 21 March 2005. She reports feeling sick to her stomach with minimal abdominal bloating.  She reports approximately 8-10 hours after taking her second dose on 23 March 2005 her abdominal bloating increased and became extremely tender, with nausea, vomiting, diarrhea and flu-like symptoms. She complained that "fingers swollen at MIPs" for one week.  She complained of a sore throat with difficulty swallowing due to a burning sensation along the esophagus (throat, chest and stomach). She denies any change in weight, activities or diet; however, her son had a viral illness.  She presented to medical on 24 March 2005 with the above complaints and was diagnosed with an allergic reaction to typhoid. She was treated with Famotidine (Pepcid) 20 mg PO and Atarax 10 mg PO and referred to allergy and immunology.  She was evaluated on 03 May 2005 and referred to a Healthcare Center.  Prior to evaluation by allergy and immunology and the HC, all symptoms had resolved.  She reports a history of lactose intolerance during childhood with no current problems.  Typhoid Ty21 oral contains 100-180 mg lactose. She reports no adverse events with IM Typhoid in 2001.
Tinnitus; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005021A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, TINNITUS (Tinnitus) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication  were provided  No treatment medication was provided  It reported that the patient will not be getting second dose.
Patient reported severe swelling in arm and redness at injection site as well as marked discomfort the day following vaccination. Event was severe enough that patient visited her primary care provider and was prescribed prednisone.
According to mom, pt screamed for the better part of the evening (of the day of the vax);
Information has been received from a LPN concerning a 31 year old female adult pt who on 09/11/03 was vaccinated SC once with a 0.5mL dose of varicella virus vaccine live (Lot # not available). Today, on 10/01/03 the pt came to the office with "3 lesions of chickenpox". The LPN reported that the pt developed the chickenpox after being vaccinated on 09/11/03, and confirmed the rash started on 10/01/03.  The LPN indicated the pt had received the vaccination at another location. It was noted the pt recovered from the chickenpox.  It was noted the therapy was discontinued. No treatment was required. There was no product quality complaint reported. Follow up information received from the LPN indicated that on 10/01/03, the pt had a VZV antibody (IgG) EIA,the result was 0.28 I.S.R. (reference range 0.0-0.90) with an interpretation of negative or non-immune, and was indicated as unsuitable for detection of post-vaccination immune status. Also on 10/01/03, she had a VZV antibody (IgM) EIA, the result was 0.61 I.S.R. (reference range 0.00-0.90), interpreted as negative, but indicated the result should not be used as a sole determinant of current or recent infection, and reliance on a single test could be misleading. It was reported the pt would have a repeat titer in 5 weeks (approximately 10/29/03).  Additional follow up information received on  11/20/03 from a LPN indicated that as of 11/14/03 the pt had not converted to an immune status with serum titers. On 11/05/03 the varicella zoster IgG was 0.61 I.S.R. (negative or non-immune), which reliably measures immunity due to previous infection, but is unsuitable for detection of post-vaccination immune status. On 11/05/03, the varicella zoster IgM was 0.42 I.S.R. (negative). Additional information is expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03020A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (Diphendramine (Benadryl) suppresses her respiratory system).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with FAMOTIDINE (PEPCID AC) at a dose of 20 mg. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  The patient reported treatment of events was with Pepcid 5 tablets of 20 mg.
A report was received from a health care professional on 10/31/03 concerning a 30 month old male vaccinee who was inadvertently administered Fluvirin on 10/31/03. The vaccinee had not experienced any adverse effects at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/19/04: A follow up report was received from a health care professional indicating that the vaccinee was two years old and received Fluvirin on 10/22/03. No adverse events had occurred at the time of reporting. No follow up pending, all information received.
Dizziness, Fever, Chills, Eyes Feverish. Arm near injection site swollen, bright red, hot (area measured 2"x4"). Symptoms have decreased however, on 10/14,2013 I developed itching in this area.  Still red and swollen.
12/13 - came to ED SOB. BP 133/97, RR 26, HR 83, O2 97% rm air, T- 98.4.  Admitted for CHF exacerbation. Covid test pending 12/14 - covid test positive. Respiratory failure likely secondary to Covid 19 determined. CRP 4.2. Starting on Remdesivir x5 days, Decadron x10 days, Ceftriaxone, and Doxycycline. Requires 2L O2NC. O2 sat 94% /RR32-Rest of vitals WNL. Chest Xray shows bil pulmonary effusions and infiltrates.  12/16 - SOB improving - on rm air. Patient feeing better. 12/18 - Completed Remdesivir. Decadron/Doxy continued at home. Discharged.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # L037356, expiration date 28-AUG-2017 and VARIVAX lot # M024683, expiration date 18-MAY-2018 (strength and dose for both products were not provided) subcutaneously, which had a temperature excursion of 24 Celsius Degrees for 72 hours. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
medication error due to accidental administration of an expired PENTACEL dose with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old female patient who experienced medication error due to accidental administration of an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (Frequency = once) (Strength = standard) (lot UJ791AA and expiry date: 10-Oct-2023) via unknown route in the left thigh for immunization.  On 16-Oct-2023, the patient experience medication error due to accidental administration of an expired pentacel dose with no reported adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  It was reported that "Medical assistant states they inadvertently administered an expired PENTACEL dose to one of their patient today. She asks for manufacturer's guidelines and asks how soon can they re-vaccinate."  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.
Patients mother reported at least 10 nose bleeds within the first 24hrs of receiving the shot. Patient also developed flu like symptoms with nausea, vomiting and fever.
Patient reported feeling dizzy and short of breath 15 minutes after vaccine was given while sitting in the observation area. SHe was placed in an anti gravity chair, given a bottle of water, and vitals were taken. Her HR was slightly increased HR: 101, BP: 133/77, O2: 98%. Patient has a history of panic and anxiety disorder. She stated she felt better at 12:10 PM. She was alert and oriented times 4 the entire time while in the observation area. Vitals were taken at 12:10 PM and were as follows: HR: 97, BP: 119/80, and O2: 98%.  She left the observation area with a steady gait and was advised to follow up her primary care provider. She did not have any reaction with her first 2 doses of Moderna.
Woke up around 5AM with a severe headache and tenderness at injection site. Throat was also very dry. Was not able to go back to sleep due to pain. Checked temperature around 7AM and it was at 99.6. Took a rescue medication for the headache. Headache still has not gone away. If not drinking something, throat becomes dry within minutes. Dizzy when standing and it is exhausting to move/walk around. Checked injection site around 9:30AM, site is very red and swollen, redness is about the size of a strawberry. Have the chills. Checked temperature at 9:40AM and temperature is now at 101.3. Heart is also pounding and beating very fast.  Called local urgent care to determine if medical assistance was needed, they were vague and said they do not know how/if they could help or treat me but I was welcome to make an appointment with a current wait time of 90 to 120 minutes.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Additional Details: Patient reports to be a nurse and stated that the injection site looked like cellulitis and almost abscess like appearance. Patient reported to have 2 nights of fevers and chills.
Left side of my face twitching uncontrollable, extreme pain in my jaw bones,wrist ,ankle,shoulder joints, extreme headache, fever,large red spot from injection site that stayed for several weeks,
First symtom occurred after shot while driving home: I can only explain it as as 'rush' in my head; some kind of dizziness I've never had. 1:30 am on 2/28/21:  Chills and fatigue.  The next day and since then I have had: extreme fatigue, malice,  headache, extreme joint pain,  dizziness. I still have it today on 5/2/21. I cannot search for a job, I feel debilitated.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical histories and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (dose, strength and route were not reported). These unspecified doses of GARDASIL might have been administered using the following lot#: K006124 with expiration date 02-FEB-2017; K006960 with expiration date 19-FEB-2017; K007828 with expiration date 02-MAR-2017. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of pain in an unspecified number of patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain, erythema of extremities and swelling. On an unknown date, the outcome of the pain, erythema of extremities and swelling were unknown. It was unknown if the reporter considered the pain, erythema of extremities and swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable. The medical assistant reported that 7 to 10 patients called back reporting pain, redness, and swelling. Redness extending from shoulder to elbow. Customers stated that they see these events more than compared with other vaccines.
After receiving my second dose, my left arm was so sore I could not move.  My joints are so sore I can not move my arm.
06/01/15: Symptoms included diarrhea, vomiting, stopped nursing, extreme tiredness. Took him to the doctor's office on Monday afternoon, June 1, 2015. They said he may have a milk allergy and sent him home. The next day he was rushed to the ER and stayed in the hospital for the next 17 days.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. In April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, pain, fever, shivers, tiredness, headache and muscle pain. On an unknown date, the outcome of the injection site erythema, injection site pain, pain, fever, shivers, tiredness, headache and muscle pain were not reported. It was unknown if the reporter considered the injection site erythema, injection site pain, pain, fever, shivers, tiredness, headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: On 4th April 2019, afternoon, the patient received 1st dose of SHINGRIX. The patient experienced expected side effects of injection site redness and soreness, aches, low fever, shivery, tired, headache and muscle pain. The patient was wondering if the events would last for 24 hours, 48 hours or more. The patient did not feel like she needed a doctor. The patient did not give her contact number to receive the call from product specialist. The patient would take rest and drink fluids to get through these events.
Facial droop on right side.  Unable to close eyelid.  Patient seen at ER, then came to clinic 2 days later (on 12/14/09).