chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACTHIB was administered to 6 patients and the diluent supplied was expired with no reported adverse event; Initial information received on 12-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 patients who were administered HIB (PRP/T) VACCINE [ACT-HIB] and the diluent supplied was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of 0.5 ml once of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (LYOPHILIZED POWDER LOT: UJ674AB, EXP: 04-Jun-2023; DILUENT LOT # U7261AA, EXP: 07-Apr-2023; strength: standard) via unknown route in unknown administration site for immunization.  On an unknown date 6 patients were administered HIB (PRP/T) VACCINE [ACT-HIB] and the diluent supplied was expired with no reported adverse event (expired product administered) (latency: same day).  It was reported, "They are declining to provided any patient information citing possible HEPA violations. Caller is upset stating that Sanofi supplied these vaccines but the expiration dates are different. Caller is asking if the vaccines can be replaced. Caller is questioning the use of alternative diluents with the product and ask is this a contamination issue with the expired diluent. Caller is requesting a case summary to be emailed. Caller was attempting to justify the use of the diluent and states, "it is bad on you all" for supplying the product with different expiration dates on the diluent. Caller asks, "Am I going to get in trouble?"  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Substantial rise in blood pressure to 205/110.  This was recorded 20 minutes after injection.  The dizziness associated with the high blood pressure started within 5 minutes of the injection.
Information has been received from an unspecified reporter referring to an 11 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Product storage error; No adverse event; Given vaccine which was beyond the 30 day use by date; Given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion). On 22-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (Product storage error) 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 (Given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant products reported. It was reported that the lot number underwent temperature excursion on 15 to 17-Aug-2022 and was administered to the patient post temperature excursion.  No treatment products reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Live follow up received contains significant information: Updated patient demographics and event (expired vaccine use)
Chills began about 1/2 hour later. The chills got continuously worst as the day went on.; Immediately after the shot I felt nauseated; lethargic; ache and pain in my arm is tremendous; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 vaccine; unknown lot number and expiration date), intramuscular left arm on 21Jan2021 11:30 at a single dose for covid-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient received the most recent COVID-19 vaccine in nursing home/senior living facility. The patient reported that she has never had an adverse effect to this degree from any injections or vaccinations. She mentioned that immediately after the shot (21Jan2021 11:30 AM), she felt nauseated then chills began about 1/2 hour later. The chills got continuously worst as the day went on. It has only been about 4 hours since the shot and she was very lethargic and the ache and pain in her arm was tremendous. She was an extremely active athlete and she has not been sick in over 2 years. The patient did not receive treatment for the adverse events. The events were considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event chill was not recovered while the outcome of the other events was unknown.  The following information on the batch/lot number has been requested.
Extreme nausea for 1 week, accompanied by headache,  dizziness, and overall feeling of "unwellness" for 1 week.  Injection site was painful for 2 weeks. Note: I had had my yearly physical two days before the vaccine injection (Feb. 10) and I felt fantastic on that visit. My doctor commented on how well I was doing and how happy and positive I was.
7 days after shot Severe tremoring/still lasting after 5 months Dizziness/can't drive some days Memory issues Brain fog Depression Headaches Muscle weakness Body pain Shaking Urinary issues Bowel issues Severe chronic fatigue  Still trying to see doctors and naturopath to find what's happening Blood draws show nothing Had to quit job
paresthesia down right arm.; This is a spontaneous report from a non-contactable other healthcare professional. A 30-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Lot number: EN6205) via an unspecified route of administration on 18Mar2021 (at the age of 30-year-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: unknown) via an unspecified route of administration on an unknown date, for COVID-19 immunization. On 18Mar2021, during 15 min of waiting period after the injection, the patient experienced paraesthesia down right arm. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling, tongue swelling and weakness in arm. The patient's treatment included ice pack and the follow up response to treatment was fair. The patient was stable to go home and follow up with primary care physician. The clinical outcome of the event paraesthesia was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Country added in patient tab, Dose Number/ Dose Description updated to 2nd dose, and Lot number updated as unknown in narrative for 1st dose.
Pt recvd 1st dose of Engerix-B & devel nausea, vomiting, weakness & cold sz;
This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 19-year-old female patient who received BEXSERO (batch number 166201, expiry date October 2018). On 29th March 2018, the patient received the 1st dose of BEXSERO. On 29th March 2018, unknown after receiving BEXSERO, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXSERO subcutaneously instead of intramuscular route, which led to inappropriate route of vaccine administration. No side effects were reported. Follow up information received from other health professional via call center representative on 25th April 2018: The patients demographic details were updated. The patient received BEXSERO on an unknown arm. On an unknown date, in less than a month after receiving BEXSERO, the patient experienced injection site swelling and injection site redness. On an unknown date, the outcome of the injection site swelling and injection site redness were unknown. It was unknown if the reporter considered the injection site swelling and injection site redness to be related to BEXSERO. This was the medication error associated with harm. The VAERS details were updated.
Patient received FLUZONE HIGH DOSE in right arm on 11/26/15. Patient calls 5/3/16 saying shot made her sick, had chills, caused pain in arm, can't raise arm, pick up anything, gets worse every day. She didn't seek treatment or medical attention and still hasn't to date.
Sore shoulder; This spontaneous case was reported by a pharmacist and describes the occurrence of ARTHRALGIA (Sore shoulder) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (COZAAR) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRALGIA (Sore shoulder). The patient was treated with IBUPROFEN (IBUPROFEN ACTAVIS) at a dose of 400 mg. At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient states that approximately 8-9 hours following vaccination (around 9pm), she started to develop a fever and what she reported as "extreme" chills.  She states that the shaking from the chills was enough that she was unable to hold a book or concentrate on anything.  She took a dose of acetaminophen and went to bed, waking midway through the night still running a fever of 100.3.  At the time she called me on 9/25/19, she stated that her fever was resolving, and she had not had any repeat episodes of the chills, but she wanted to inquire why those side effects were not listed on the VIS given at time of vaccination.
did not feel great; had a slight fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (did not feel great) and PYREXIA (had a slight fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MALAISE (did not feel great) and PYREXIA (had a slight fever). At the time of the report, MALAISE (did not feel great) and PYREXIA (had a slight fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient concomitant medication include anti inflammatories. The caller does not remember which arm that patient received Modern vaccine in. No treatment medications were reported.   This case was linked to MOD-2022-609742, MOD-2022-609744 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Follow up contains non significant information.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 26-AUG-2008, patient received improperly stored VARIVAX dose 1, for lot # 661445/0525X expiry date: 27-MAR-2010. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Raised red circle around injection site with another circle around it. Warm, sore, firm to the touch.
I had my vaccination on 09/17/2022. On 03/30/2023 I started to feel really tired congested headache. I tested COVID-19 on 04/01/2023. I contacted my physician's office and I was prescribed Paxlovid. I presently feel fine on 04/26/2023.
Noticed rash on arm spreading to chest and trunk of body.  Used topical Benadryl and Calamine lotion with no improvement.  Complained of headache after vaccination, took Tylenol.  Doctor prescribed Prednisone for rash on 08/21/2005 - on 08/19/2005 noted buzzing in right ear and on 08/21/2005 noted decreased hearing in right ear.  Has appointment for follow up.
experienced allergic reactions; her eyes got red; Her eye lids were red; Her eye lids were red, swollen, and puffy.; Her eye lids were red, swollen, and puffy.; cheeks were bright red; This is a spontaneous report from a contactable nurse (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on the left arm on 14Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included that the patient was diabetic and hypertensive; both were ongoing. Concomitant medications included atenolol taken from 14Jan2021 for blood pressure high; pioglitazone hydrochloride (ACTOS) and ongoing metformin both were taken from an unspecified date for diabetes; ongoing montelukast sodium (SINGULAIR) for history of food and drug allergies and ongoing chlorothiazide for diuretic. It was reported that she had the first dose of the covid vaccine on 14Jan2021 and experienced allergic reactions after she left the facility; they were not life threatening but were not pleasant. She realized how bad it was after she got in the car, removed her mask, and looked at her face. She was concerned about getting the second dose. She even took Benadryl 1 hour before getting the shot and still had a reaction. She clarified her allergic reaction to be as her eyes got red. Her eye lids were red, swollen, and puffy. It looked bad. When she got in the car took her mask of her cheeks were bright red. She sat in the ER parking lot for an hour waiting for it to resolve. It resolved after like an hour and half. After it resolved and went away she went back home. She stated that this allergic reaction is anxiety producing. She gets anxious because she knew what could happen. The outcome of the events was recovered on 14Jan2021.
This spontaneous report was received from a pharmacist, referring to a 65 year old male patient who has chronic obstructive pulmonary disease and smoker as current conditions. No medical history was reported. On unspecified dates, less than 5 years apart, the patient received "several doses" of PNEUMOVAX 23 (dose, route, lot number and expiration date were not provided). No concomitant medication reported. Since an unspecified date, the patient had chronic obstructive pulmonary disease (COPD). The COPD was not recovered at the moment of this report. Additional information is not expected, because the reporter did not allow to contact him.
Lips started swelling @ 1230; started eating lunch, throat started closing; went to ER 145PM BP 70/0; Kept in ER for 6 hrs, had sl lip swelling p/vax; no other sx; denies egg allergy; Had IV & other meds @ ER;
Patient discharged after vaccinations and had a syncopal episode. Mother stated patient was sweating then hunched over. Nursing staff notified. Physician went out to check patient and he was responsive without any seizure activity. Vitals (BP 105-70 Pulse 92 Blood sugar 90)
20 y/o male says he was well on 8-1-2007, prior to receiving Penicillin G Benzathine IM (strep prophylaxis). The same day, about 10-15 minutes later, he received MMR(1) and Hep A (1). About 5 minutes after receiving the vaccines, he noted intense itching in the groin area, which progressed to generalized itching, followed by eruptions of 'hives' on both arms, redness across his chest, headache, throat tightness and SOB. He was unable to focus his vision, seeing 'only shadows', although he could hear normally. He felt faint but did not lose consciousness. EMS was called and he was treated with IV fluids, Epinephrine and Benadryl. He was transported to ER, treated with more Benadryl, then admitted overnight for further observation. He was discharged the following morning. He was feeling better, except for a sensation of throat tightness on 8-3-2007 for which he presented to clinic and saw his PCM. He was prescribed oral steroids, Zantac, and referred to Allergist for f/u for anaphylaxis. He saw Allergist 8-15-2007, and diagnosed with anaphylactic reaction to Penicillin. Because he also had vaccines the same day as the adverse event, he was advised to receive next immunizations in controlled setting with 30 minutes observation following.  09/10/2007 Clinical summary and MR received from military.  Withing minutes of receiving PCN shot and vaccines, pt experienced itching, hives, chest redness, headache, throat tightness, and SOB.  Pt also had visual disturbance and felt faint. TXd with Epi and Benadryl with relief. Observed o/n.  The following morning pt presented with throat tightness and was txd with oral steroids and Zantac. DX: Anaphylaxis.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
All over dermititis rash.  Swelling in joints.  accelerated heart rate. Dizzy. Weak.
12Sep95 pt recv 1 dose vax. Approx 19Dec97 pt devel 2 varicella-like lesions on neck & shoulder. Another pt WAES97121283 had similar exp following vax.
Fever, fatigue, arm soreness Narrative: Patient stated via phone on 3/10/2021 that he had the second Moderna covid vaccine yesterday and last night he developed a fever (although he did not take temperature he felt like a fever) face flush, fatigued, headache, joints were sore, he felt off balance, and his left arm that vaccine was administered into and shoulder were very painful. Patient reporting that today he has slight headache, knee joints still have discomfort, he is fatigued, and left arm/ shoulder is sore. We discussed that these SX are normal if they do not go away few days Ior if they get worse call the clinic and or seek emergent care. Unknown at this time if adverse effects have resolved or if patient took any medication to treat the adverse effects.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 15-APR-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (strength, route, lot# and dose were unkonwn). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I was diagnosed with a breakthrough case several days ago and am on my way to a full recovery; I was diagnosed with a breakthrough case several days ago and am on my way to a full recovery; This is a spontaneous report from a Pfizer sponsored program Pfizer.com - General Company Information.  A contactable consumer (patient) reported he/she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced as reported "I was diagnosed with a breakthrough case several days ago and am on my way to a full recovery" on an unspecified date.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Soreness in both jaw muscles and moderate headache, followed shortly thereafter with mild nausea and soreness in both calf muscles. Symptoms persisted for about three hours. The following day I felt extraordinarily fatigued. By the second day all symptoms vanished.
Admitted to hospital 12/25/2021 with chief complaint of shortness of breath since 12/18/2021, also productive cough, myalgia, chills, runny nose and wheezing.  She presented with t tachypnea and hypoxia (SpO2 65% on RA) . She was treated initially with Tylenol, albuterol inhaler, and  PO Decadron and placed on O2.  She died on 12/27/2021 primary: Acute Hypoxic Respiratory Failure due to Covid-19 pneumonia.
Inj site erythema and swelling, Myalgias, Pox vesicles (rare).
Pt recvd 3 doses of Engerix-B & did not respond & would not have any more injections;