chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with twenty second of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 15-years-old adolescent patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 24-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number:  1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case-correction received on 10-Aug-2017: The narrative and case comment were corrected.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 12-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose/frequency one single 0.5ml injection, lot number and route not provided). The prefilled syringes "started leaking between the needle and the base." A new prefilled syringe was used for the patient. Due to the fact that the syringe was in the patient's arm at the time of the leaking, there was a chance that the patient had already received some of the vaccine before another prefilled syringe was used; therefore, a misuse adverse event was filed. No adverse reactions were reported to the physician by the patient. Product quality control (PQC) was involved. Additional information is not expected.
Induration and reddened area measuring 4cm x 5.5cm--ice packs applied, advised analgesics for discomfort.
Erroneous administration of 2nd dose of Tender Age Moderna to a patient that had previously received an initial dose of Tender Age Pfizer.
A few minutes after injection patient felt "funny", like her "arms were noodles". Her face turned red, her blood pressure went up (182/110). After resting in the office lying down for about 45 min - 1 hour, Dr. advised patient go to the E.R.
Headache; Body Cramps; Fever; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 08:45 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy towards mango. The patient did not receive any other concomitant medications within 2 weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 16Mar2021 at 08:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 23:00, the patient experienced headaches, body cramps, fever, chills and fatigue. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, body cramps, fever, chills and fatigue was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Raised, red area with warmth and tender to touch. On  right deltoid around injection site Kelflex 500mg TID x 7 days and ice packs until redness is resolved Reaction 12/27/2020 Resolved 12/29/2020
Pregnant patient got second dose of moderna; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient got second dose of moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient got second dose of moderna). On 21-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient got second dose of moderna) had resolved.         Action taken with mRNA-1273 in response to the event was not applicable.
Severe Nausea, vomiting, fever + joint pain. 6/19/09 Pt reports she never sought medical tx.  Took Benadryl.  Case closed
2-year-old patient received a dose of Kinrix on 31/Jul/2023; 2-year-old patient received a dose of Kinrix on 31/Jul/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 31-JUL-2023, the patient received Kinrix. On 31-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2-year-old patient received a dose of Kinrix on 31/Jul/2023) and inappropriate schedule of vaccine administered (Verbatim: 2-year-old patient received a dose of Kinrix on 31/Jul/2023). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14th August 2023 The medical assistant called to inform that a 2-year-old patient received a dose of Kinrix. The reporter told that it was the 4th dose of the series of the patient, intention was to give dtap and ipv. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  2 years old patient received a dose of Kinrix as 4th dose of the series of the patient which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
permanent scarring; balance and breathing problems; balance and breathing problems; a rash and painful shingles on her neck and face; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 28-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), in November 2017, the patient suffered a rash and painful shingles on her neck and face that resulted in permanent scarring as well as balance and breathing problems. These conditions resulted in prolonged medical treatment. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered severe injuries and disfigurement not present prior to using the product, which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of rash and painful shingles on her neck and face that resulted in permanent scarring, balance and breathing problems were considered to be disabling.
Completed initial report regarding vaccine dilution error. Patient did not have any immediate adverse effects at the time the error discovered. The covering hospitalist was notified to continue monitor patient for any adverse effects.
Patient reported shaking violently, chills, 7 hours after injections. Next morning had headache, nausea, minor aches + pains
patient reported a few hours after vaccine left side of face feels numb and some weakness around left side of mouth
Infection; She went to the pharmacy to get some antibiotics but the pharmacist told her that she would either take the vaccine or the antibiotic but not both; 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 female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFECTION (non-serious), outcome "unknown", described as "Infection"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "She went to the pharmacy to get some antibiotics but the pharmacist told her that she would either take the vaccine or the antibiotic but not both".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain, shortness of breath, joint myalgias, lower extremity swelling, low grade temp, cough, congestion started on 5/25/21. Admitted to hospital and given Xopenex treatments, tessalon Perles, IVFs,.  Also had zofran, toradol, and acetaminophen as needed.  Cough controlled with medication, myalgias to joints improved, afebrile, chest pressure improved by discharge on 5/28/2021
By 6:00 pm I was unable to move my arm. I developed a fever of 101.8. My upper arm became swollen and red about 4in by 5in. Morning of 10/4 high fever started to subside. By early evening my fever was back. I called my doctors nurse hotline and was directed to go to the ER. I however went to Urgent Care first. Temperature was back to 101.8. Doctor gave my a prescription for Cephalexin 500mg and Triamcinolone 0.1%. It is now 10/18/1019 and I still have redness and a small amt of itching
Patient received seasonal flu vaccination on 10/30/2009. In the days following, patient began experiencing severe sore throat and was having trouble swallowing. Was evaluated in the ER and treated with steroids and antibiotics. Symptoms continued to worsen, and patient began to experience muscle pain and paralysis. Patient called ambulance and was brought to the hospital on 11/16/2009. At that point, patient was only able to move her right arm. Patient was seen by multiple physicians-ENT, neurologist, family practitioner- and based on patient symptomology, a diagnosis of Guillain-Barre syndrome was made. Patient is currently improving on steroid therapy.  12/15/09, 12/17/09, 12/18/09 ED, Hospital records, discharge summary received. Service dates 11/07/09 to 11/20/09, inpatient 11/16/09 to 11/20/09. Assessment: Urinary tract infection, dysphagia, arthralgias, deconditioning.  Patient originally presents with diffuse itching urticarial rash, sore throat, decreased urinary output. Outpatient, multiple visits, with progressive worsening over course of a week. Syncopal episode, patient admitted. Steroids caused euphoria and vertigo, penicillin caused rash. Then developed joint pain in (L) shoulder and ankles. Continued rash. Developed severe pain 'all over', unable to move, weakness, admitted. Fever. Dark foul smelling urine. Bone spurs calcaneous, left shoulder osteoarthritis of AC joint. General malaise, pharyngitis. Headache. Stressed. (L) arm grip strength weak. Leukocytosis. Depression.   12/16/09 Rheumatology Consult 12/3/09 (Includes labs from 10/30/09 to 11/7/09). Assessment/Diagnosis: None provided. Patient reports fever, chills, stiff neck, blood in urine, shortness of breath, heartburn, difficulty in swallowing, trouble sleeping, constipation, difficulty walking, weakness, sores in mouth.
APPROXIMATELY 12 HOURS AFTER INJECTION SITE BECAME INFLAMMED AND SWOLLEN. SWELLING WAS APPORXIMATELY 3-4 INCHES IN DIAMETER. PT RETURNED TO PHARAMACY TO INFORM STAFF NEXT DAY. AT THIS TIME THE SWELLING HAD DESCENDED APPROX 4 INCHES AND WAS CENTERED AROUND THE BICEP. NO PAIN INVOLVED. SWELLING HAD ALREADY BEGUN TO DECREASE AT ~24 HOURS.
lichenplanus; This case was reported by a nurse via call center representative and described the occurrence of lichen planus in a female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   In January 2019, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced lichen planus. On an unknown date, the outcome of the lichen planus was unknown.   It was unknown if the reporter considered the lichen planus to be related to Shingrix.  Additional details were provided as follows: The licensed practical nurse (LPN) reported that patient developed lichenplanus after receiving Shingrix in January 2019.
Shin pain; 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 PAIN IN EXTREMITY (Shin pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Shin pain). At the time of the report, PAIN IN EXTREMITY (Shin pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
CHIEF COMPLAINT:   Pt states dx with UTI 12/07, on ABX. Was at follow up appt today and states "low BP and low oxygen". States general fatigue, denies any other complaints.   HISTORY OF PRESENT ILLNESS:     Presents with: _uti recent abx and low bp and low o2 noted, at wlak in  Duration: _cosntat  Onset: _acute  Course: _same  Location Pain Onset: _generla aches  Location Pain at Present: _same  Pain Radiation: _denies  Pain Quality: _achey
1 week after receiving Moderna Vaccine #1 redness, itching, warm to touch  to injection site .
Noted 3 small bumps around the injection sites, which then progressed to redness, pain and swelling. Continuing to worsen. Area marked off last night with a pen, and is still spreading beyond. No fevers. Able to walk well.
Vaccine administered after 30-day Use By Date/vial exposed to room temperature for more than 24 hours; No Adverse event; Vaccine administered more than 12 hours post puncture and after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered more than 12 hours post puncture and after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine administered after 30-day Use By Date/vial exposed to room temperature for more than 24 hours) and NO ADVERSE EVENT (No Adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.    Co-suspect product included non-company product QUADRACEL for an unknown indication.    No Medical History information was reported.   On 21-Nov-2022, the patient received dose of QUADRACEL (Intramuscular) .5 milliliter. On 21-Nov-2022 at 4:23 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-2022 at 4:23 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered more than 12 hours post puncture and after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after 30-day Use By Date/vial exposed to room temperature for more than 24 hours) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered more than 12 hours post puncture and after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine administered after 30-day Use By Date/vial exposed to room temperature for more than 24 hours) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered more than 12 hours post puncture and after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine administered after 30-day Use By Date/vial exposed to room temperature for more than 24 hours).    No concomitant products reported.  Nurse reported that 1st primary dose of Moderna Monovalent was administered to a patient on 21 Nov 2022, more than 12 hours post puncture and after 30 day use by date. Vial size was 2.5 ml. The vial was initially stored in the refrigerator on 18 Oct 2022. The vial was first punctured on 18 Nov 2022 around 9 AM. The administration of vaccine was on 21 Nov 2022 at 4:23 pm. The vial stored post puncture returned to the fridge. The vial did not undergo any temperature excursions. The vial exposed to room temperature for more than 24 hours. The patient did not ever had COVID positive test or diagnosis. Patient received additional vaccines on 21 Nov 2022. 5th dose of QUADRACEL MMR Lot number: W024973.  No treatment products reported.
Tingling and numbness in fingers, hands and arms. Abdominal tightness. No special treatment done other than waiting for symptoms to subside.  Symptoms passed in approx. 1 hr.
he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19; he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19; diabetes; heart surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; CARDIAC OPERATION (non-serious), outcome "unknown", described as "heart surgery". Therapeutic measures were taken as a result of cardiac operation.  Clinical course: The caller mentioned that he is calling regarding the availability of the new COVID-19 vaccine, and he would also like to know where he can get it in his area. The caller also said that he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19. The caller would like to know if his wife can have the vaccine. The caller also stated that he had heart surgery and diabetes. I created two manual AE forms because his wife is in rehab and took the vaccine. Also, the caller had heart surgery and diabetes, and he also took the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
full body rash and it's itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (full body rash and it's itchy) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced RASH PRURITIC (full body rash and it's itchy). At the time of the report, RASH PRURITIC (full body rash and it's itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Nausea, vomiting, diarrhea, lightheaded on 2/20/17. Then on 2/21/17 employee complained of lower back pain, general muscle pain, esp. in legs.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-DEC-2015 at time- 00:46, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperatures at which the product was stored were 2.8 and 2.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.