chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling down to the elbow from the injection site.; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: Pharmacist left after hours voicemail message. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and experienced swelling down to the elbow from the injection site. It was improving. The reporter consented to follow up. No further details were provided in the voicemail message and pharmacist was not available when specialist attempted callback.  The message was left with the pharmacy staff requesting pharmacist return call to Medical Information and submitting limited available details as provided via voicemail message.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019129045:Same reporter
2nd Dose of Moderna Vaccine administered on 9/6/21 from Lot #011A21A expired 8/16/21.  *Site leadership consulted with Moderna and received the below confirmation: * If the dose given in error is the first dose, a second dose should be administered 28 days later. If this dose is the second dose, the series is complete and no additional doses are needed.
Sharp pain in shoulder following removal of needle. Pain & loss of range of motion for 1st 48 hrs. 5 days later, shoulder was immobile. Returned to clinic - Rx - prednisone boost & naproxen for 6 days. Shoulder ROM & pain improved, but, when meds gone, pain returned. Saw FP 3 days later. Rx - Arthritis & topical NSAID. Pain continued.
Swelling of left thigh initially adjacent to injection site then 2 days later generalized swelling of upper thigh? if red given partially subcut. Antibiotic started 4/19.
Arm red, swollen and tender around site of injection left leg. Treated with Keflex 250 TID --> Cellulitis.
01/23/23 presents to ED for "breathing problem". PMHx of "metastatic triple negative BCA w/malignant effusion s/p thoras & L VATS"
I was having PVCs for a long time and got a device to monitor it. I had several moments of Atrial Fibrillation. and only had PVCs prior to being vaccinated. Now I am dealing with Atrial Fibrillation Then, on 10/25/22, It happened again, and I went to the Emergency Room. This lasted for 20 hours. This was two days before my vaccination. On 3/11/23, 3/22/23, 4/4/23 I had Atrial Fibrillation again. The one on 4/4/23 Lasted for about 10 hours. Then on 4/5/23, 4/6/23, 4/8/23, 4/9/23, it happened again. I had to be hospitalized with the incident on 4/9/23. I have a procedure happening soon. I am also having a lot of Gastrointestinal Issues.
TINGLING BLE Narrative: Employee reported numbness/tingling to BLE almost immediately upon receipt of vaccine. Within one hour, he reported back to provider, that symptoms had not subsided. I tried to call him today to follow up but was unsuccessful in contacting him.
Swollen shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen shoulder) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ATORVASTATIN and LOSARTAN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen shoulder). At the time of the report, PERIPHERAL SWELLING (Swollen shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Non significant follow up received on 20-APR-2021, no new information
Pain at injection site. Complained they felt like they had an allergic reaction due to the pain.
Pain in muscle that is preventing me from lifting over my head, using to lift, sleeping on that side or bending from the elbow. I've had one massage that's helped a bit and take Ibuprofen and ice it.
Rash bilateral arms, chest, back, face within 10 min. of injection. Gave 25 mg BENADRYL IM and 80 mg DEPO MEDROL IM. Within 5 minutes of BENADRYL rash beginning to resolve; within 15 minutes of BENADRYL rash completely cleared. No edema of face, throat, lips.
On Saturday November 6th the left ring ring and pinky finger were painful. The pain was all the way through the hand to her wrist.  Monday the 8th she noticed a vesicular rash on the left forearm, this turned out to be shingles.  She started Valacyclovir Monday night.
expired dose of ADACEL was administered with no adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. (GMI number: 01226493).  This case involves a 11-year-old female patient to whom expired dose of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine A/C/Y/W CONJ (DIP TOX) (Menactra) for Immunization, and HPV vaccine for Immunization.  On 08-Aug-2022, the patient received a 1st dose of suspect Adacel vaccine at dose 0.5ml once via intramuscular route in the left deltoid (Lot: U6767AA, expiry date: 31-JUL-2022) with Immunization (expired product administered, same day latency). No adverse event was reported.  Action taken: Not applicable.  At time of reporting, the outcome was 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 guidelines. 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.
Patient's right bicep was red, swollen and warm around injection site 2 days after receiving the flu shot.  Patient stated that it was also tender.  She said that she had been taking benadryl and it wasn't helping with the reaction. She was not running a fever.  We had the nurse practitioner look at the arm.  She prescribed Cephalexin just in case it was an infection.
Initial information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old male patient who was vaccinated with FLUBLOK QIV (batch number, expiration date was not reported) via intramuscular route in the left deltoid, on 27-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether the patient had any adverse 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 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. List of documents held by sender: none.
Information has been received from a Licensed Vocational Nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # K016005, expiration date 27-AUG-2016 (dose and route of administration were not reported) )incorrect product storage). No adverse effects were reported. Follow up information has been received from the Licensed Practical Nurse (initial reported as Licensed Vocational Nurse) during a telephone call on 13-NOV-2015 concerning one of the multiple patients of unknown age and gender. On 08-JUL-2015, the patient vaccinated with the improperly stored RECOMBIVAX HB. Additional information has been requested. Patients information, products, events and narrative were updated.
Information has been received from a nurse concerning a female patient who on 11-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine, Lot #659657/1487U. It was reported that the patient was lightheaded, but she did not actually faint. The patient received the second dose of GARDASIL and was fine. The patient sought medical attention in office. This is one of several reports received from the same source. Additional information has been requested.
Patient in for second COVID vaccination. 1st dose Pfizer given 1/2/2021. Was greater than 28 days.  Information for Pfizer vaccine given and Lot number of Pfizer compared. Nurse inadvertently administered Moderna Vaccine that was also drawn up for vaccine POD. Patient had no complications from fist dose. Patient waited for 15 minutes after this administration without complications or adverse reactions
pt recv vax NOV96 & pt exp flu sx & had a positive viral cult;pt treated w/rimantadine;reporter indicated pt had been vaccinated w/one of the recalled lots, but was unable to ID a specific lot#
expired dose of Daptacel was administered to a patient/No AE; Initial information was received on 19-Feb-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a four year old female patient who was vaccinated with expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  On 15-Feb-2020, the patient received a 0.5 mL dose 5 of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5367AA, expiry date: 31-Jan-2020] via an intramuscular route at the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  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 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.
This spontaneous report as received from a other healthcare worker refers to an unknown number of patients of unknown age and gender. The healthcare worker reporter that less than 5 patients received does of PEDVAXHIB (dose, route and lot# not reported) that were exposed to temperatures of 50.7 F for 4 hours. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the status of the patient was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Approximately 10 am 2/11 headache Approximately 3 pm 2/11 chills, fever, body aches, worsening headache x36 hours Continued daily headaches.  2/17/21 6 am intense vertigo with mild headache and nausea
Morbilliform rash with Koplik's spots, appeared approx 10 days from last administration of MMR. 2 days of fever.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001694 is a spontaneous case report initially received on 27-Jul-2022 from a health care professional via Communication (reference number: USBAV22-0690) and concerns a *29-years-old female patient*.  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), intramuscularly (IM), at a dose of 0.5 mL, at *right deltoid* for pre-exposure prophylaxis (PrEP) (explicitly coded as Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.   At the time of this report, it was known that the patient did not experience any adverse events due to the Jynneos vaccination.  This case is linked with case no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from a healthcare professional via  on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 29-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at right deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 29-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at right deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
This  medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 44-year female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA, (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml. (Medication error). No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA. The patient was revaccinated with FLUZONE Quadrivalent (49281-415-88, batch number UI439AA) on 16-Sep-2015 in left deltoid. No averse events reported.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a non-contactable nurse (patient) and a contactable consumer. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID Prevention because of occupation. The patient's medical history and concomitant medications were not reported.  The patient experienced tested positive for COVID on 02Jan2021 with outcome of unknown.  The patient underwent lab tests and procedures which included COVID test: positive on 02Jan2021. The patient got the first dose of the COVID vaccine, and then tested positive for COVID afterward. The patient was inquiring about if there are any recommendations for getting the second dose, if the person tested positive for COVID after getting the first dose. The patient did not provide prescriber information. The patient should come off of quarantine on 15Jan2021. It was unknow if the patient received any other vaccines on the same day as the COVID vaccine and if there were any concomitant medications, history or investigations other than the COVID test. The type of COVID test the patient received was unknown, just that she got the positive result on 02Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Diagnosed with lightheadedness -- Patient states she felt a warm feeling in her chest, dizziness and like she was going to pass out at 11:45.  She stated it would come and go, then she went to the ED at 12:33.  She also had increased heart rate and blood pressure.  Patient was treated with 10mg Dexamethasone IV and 1,000 ml lactated ringers solution.  She was then discharged home.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 22-FEB-2018, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N005274, expiry date: 03-APR-2018) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (59.6 degree Fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
COVID vaccine breakthrough case. Moderna 2/25/21 010A21A, 3/25/21 047A21A, 12/001/21 012H21Band bivalent Pfizer 10/7/22 GJ2524
Patient had a high fever, about 103 or above, for three days following this vaccine. She was also irritable, fussy, did not eat or sleep during this time. Had two instances of diarrhea in this time.  We considered going to the ER, but her fever was treated with TYLENOL to provide some relief.   TYLENOL only worked minimally, decreasing her temp from 103 to 101. We were very stressed out about this adverse reaction. She has since recovered from this event.
For the second shot,  it was night sweats, dizziness, brain fog, and just disorientation. Then hot flashes between 1pm- 5pm the next day. THEN I have had nonstop dizziness, disorientation, and some nausea that might be tied to low blood pressure that started right after the 2nd Vax
Major swelling in nasal sinuses noticeable from exterior. Major pain along sinuses and jawline
Right upper arm erythema, warmth, light pink, tender , sore. Worsening since onset . MD appointment 8/4/04 am to evaluate. No cellulitis. Motrin PRN.
835AM pt recv vax;935AM pt returned covered w/bright red hives on face,upper trunk & arm red & swollen,lungs clear;DPH given & pt observed for 1hr w/ice pack to LVA;referred to MD;urticaria relieved w/IM DPH;t103-104
stuck juice in my arm when he went down to get the booster dose; freaked out; Anxiety; Struggling; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB DISCOMFORT (stuck juice in my arm when he went down to get the booster dose), ANGER (freaked out), ANXIETY (Anxiety) and FEELING ABNORMAL (Struggling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 23-Feb-2001, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On an unknown date, the patient experienced LIMB DISCOMFORT (stuck juice in my arm when he went down to get the booster dose), ANGER (freaked out), ANXIETY (Anxiety) and FEELING ABNORMAL (Struggling). At the time of the report, LIMB DISCOMFORT (stuck juice in my arm when he went down to get the booster dose), ANGER (freaked out), ANXIETY (Anxiety) and FEELING ABNORMAL (Struggling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter. Pharmacist gave jab to patient and stated that there was cross contamination. During the administration of the "booster dose" the vaccine was administered high up in the deltoid.
The patient is a 57 y.o. female who was seen at Clinic today for her second dose of the COVID 19 vaccination.    She felt swelling at the back of her sinus after having her last COVID vaccination and with prior allergy testing.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience feeling of swelling in the back of her sinuses again.  She denied difficulty breathing, difficulty swallowing, throat tightness and facial swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to increased swelling and rapid progression of symptoms.
she developed a cold about four days ago and then received the COVID vaccine and now she feels worse; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (COVID Vaccine, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history included cold about four days before vaccination. The patient concomitant medications were not reported. On an unspecified date the patient reported she developed a cold about four days ago and then received the COVID vaccine and now she feels worse. The outcome of the event was unknown.  Additional Information on the lot/batch number has been requested.
Encountered lumbar back problems and got worse over the weekend. Could not walk, stand or sit for one week. On the sixth day after the vaccination I also got symptoms of a cold with running nose and fever.