chrisvoncsefalvay/vaers-outcomes huggingface dataset:
epiploic appendages; nausea; dizziness; blood clot; pain on left side of abdomen; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D17B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced THROMBOSIS (blood clot) (seriousness criterion medically significant) and ABDOMINAL PAIN (pain on left side of abdomen). On 03-May-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). On an unknown date, the patient experienced EPIPLOIC APPENDAGITIS (epiploic appendages). At the time of the report, THROMBOSIS (blood clot), ABDOMINAL PAIN (pain on left side of abdomen), DIZZINESS (dizziness), EPIPLOIC APPENDAGITIS (epiploic appendages) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram: epiploic appendagitis Epiploic Appendagitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment given included antibiotic amoxicillin/clavulanic acid.  Company Comment: 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. However,  Very limited information regarding this events has been provided at this time. Further information has been requested.; 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. However,  Very limited information regarding this events has been provided at this time. Further information has been requested.
On 5/4/2021, I was admitted to the Hospital for shortness of breath. I was diagnosed with a double pulmonary embolism. I had an emobolectomy and was released from the hospital on 5/7/2021.
Light headed/Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed/Dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, VITAMIN B [VITAMIN B NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Light headed/Dizziness). On 03-Mar-2021, DIZZINESS (Light headed/Dizziness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.  Patient said that it wasn't too bad.  This case concerns a 64 year old female. with relevant medical history of hypertension, who experienced Non-serious , unexpected event of Dizziness which occurred on the same day after vaccination with the first dose of mRNA -1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is negative since this event  had resolved and did no recur after the 2nd and 3rd dose as narrated in the source document. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-392024, MOD-2021-392034 (Patient Link).; Sender's Comments: This case concerns a 64 year old female. with relevant medical history of hypertension, who experienced Non-serious , unexpected event of Dizziness which occurred on the same day after vaccination with the first dose of mRNA -1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is negative since this event  had resolved and did no recur after the 2nd and 3rd dose as narrated in the source document. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
The excursion expiration date  by Pfizer was what was followed of 7 days, instead of pharmacy policy of 5 days thawed.
This spontaneous report was received from a medical assistant referring to a currently 4-year-old patient of an unknown gender. There was no information about the patient's medical history, concurrent conditions, concomitant therapies and drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PROQUAD lot number: M031568, expiration date: 24-DEC-2017 (strength, dose, frequency, route, and anatomical location were not reported) for prophylaxis. The vaccine was exposed to a temperature that remained between -15 and - 10 Celsius degrees, for 60 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of three reports from the same source. There was no product quality complaint involved. Additional information has been requested. Sender's Comments: US-009507513-1702USA004244: US-009507513-1703USA002316.
Registered Nurse administered Pfizer for 2nd dose of COVID series when patient received Moderna for 1st dose
Employee received the vaccine at 0805, reported at 0812 that he was dizzy, lightheaded, nauseated and diaphoretic. Employee assisted to cot to lie down. Skin pale, continued to be diaphoretic, respirations in the 20's, BP 115/82, HR 110, O2 98% on RA, denied any difficulty breathing, no coughing or evidence of throat tightening, no sign of any swelling at vaccination site, no rash. Code called overhead, Code team arrived. No medications given at time in clinic. Near syncopal episode, No anaphylaxis. Employee taken to ED for further evaluation and observation.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient left the store after waiting designated time after injection. Came back about 20 min later saying that he felt dizzy and like his throat was tightening (similar to when he was given penicillin in the past). He refused epinephrine and an ambulance. He did take a Benadryl and said he was going straight to the ER. Will contact patient to follow up.
pt doing jumping jacks for sports form, suddenly fell backwards hitting head on lower shelf of exam table; went into tonic/clonic seizure;unable to get good pulse, given 2 mouth to mouth breaths & 1 chest compression, began breathing nl
I went overseas and flew back on July 3rd, and then had the severe rash on the 5th. I saw the Dermatologist on the 6th. On the 7th I tested positive with COVID-19. I believe I picked it up while in flight. That night my fever went to 101.6 and then dropped and I was cold then sweated a lot. I had a runny nose and a cough and after 2-3 days I started getting back to my normal activities. On July 19th I tested negative. Shortly after that the rash started to come back again. I didn't have the rash during the COVID-19 symptoms. On Wed June 8th, I noticed mildly itchy spots. They were described as welts, rashes, hives and they would last for 5 days. They were mostly on my back starting at the tailbone and then way up to my hair line on my neck. Over the past few months I had them on my leg, neck, arm, thigh, behind my knee. Over the months they have become less severe and relieved by ZYRTEC. They will go away for a period of time but then come back, over the course of the few months it's become much less bothersome. The Dermatologist stated it's a post-viral reaction and that it will disappear over some months or weeks. I was prescribed a statin last year and developed a rash. My PCP thought it was due to the statin and he had me stop. While I stopped the statin the rash came back.
Bruising, severe pain, blisters and then subsequent ulcers that needed to be debrided.
Pt was given a dose of Menactra instead of Prevnar as ordered and recommended.
Dose 1 - 12/19/20 - Exactly 12 hrs later, I started vomiting every 15 to 20 min, for 5 1/2 hours. Around 9 am, I had a fever of 102.4, a bad headache and body aches--flu like symptoms. I called the Occupational Health Doctor at my job and was told that I needed to get rehydrated. I took some Zofran that I had on hand and was then able to drink some Gatorade. I stopped vomiting, but was nauseous for the next 5 days. I didn't feel like myself until around 8  days later.   Dose 2 - 1/9/21 - I took Phenergan and Tylenol about 4 hours after I received my vaccine. On the following Monday, I had a fever of 100.4, so I took more Tylenol. I was fine after that. Nothing like my experience with the first dose.
Serious rolling muscle pain, blistering headache, nausea, fatigue, hot and cold.
Muscle in arm stated to hurt and has gotten worse throughout the last 4 months,  Went to Dr. on March 9, 2014. Was given prescription for Prednisone.  Has not helped. The pain moves up and down my left arm from top of arm (where injection site) to hand.
had red spot  that hurts that look like a rush were the needle  was given,; has a red spot that hurts where the needle was given; had red spot  that hurts that look like a rush were the needle  was given,; Had a bump like little rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Had a bump like little rash), VACCINATION SITE ERYTHEMA (had red spot  that hurts that look like a rush were the needle  was given,), VACCINATION SITE PAIN (has a red spot that hurts where the needle was given) and VACCINATION SITE RASH (had red spot  that hurts that look like a rush were the needle  was given,) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 031l20a and 025a21a) for COVID-19 vaccination.     No medication history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MASS (Had a bump like little rash). On 10-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (had red spot  that hurts that look like a rush were the needle  was given,), VACCINATION SITE PAIN (has a red spot that hurts where the needle was given) and VACCINATION SITE RASH (had red spot  that hurts that look like a rush were the needle  was given,). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Had a bump like little rash), VACCINATION SITE ERYTHEMA (had red spot  that hurts that look like a rush were the needle  was given,), VACCINATION SITE PAIN (has a red spot that hurts where the needle was given) and VACCINATION SITE RASH (had red spot  that hurts that look like a rush were the needle  was given,) outcome was unknown.            Patient stated the the events didn't happened with first and second dose.
Information has been received from a health professional concerning over 150 patients who were vaccinated with Gardasil in the hip instead of the deltoid area. Many of the patient reported pain at the injection site and a lump forming at the injection site. Additional information has been requested.
Left clinic feeling fine, mother stated within a few minutes pt c/o feeling lightheaded, became pale and passed out mother drove back to clinic. Pt observed in clinic x 30 min, given juice and crackers and reclined. No further reactions noted in clinic.
Given another full dose instead; needle went loose from the hub and most of the vaccine went down her arm; arm hurts in 2 places; needle went loose from the hub and most of the vaccine went down her arm; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Given another full dose instead), ACCIDENTAL UNDERDOSE (needle went loose from the hub and most of the vaccine went down her arm), PAIN IN EXTREMITY (arm hurts in 2 places) and DEVICE CONNECTION ISSUE (needle went loose from the hub and most of the vaccine went down her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (seasonal outdoor allergies) and Pollen allergy (allergic to pollen and probably other things too). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced ACCIDENTAL OVERDOSE (Given another full dose instead), ACCIDENTAL UNDERDOSE (needle went loose from the hub and most of the vaccine went down her arm), PAIN IN EXTREMITY (arm hurts in 2 places) and DEVICE CONNECTION ISSUE (needle went loose from the hub and most of the vaccine went down her arm). On 15-May-2021, ACCIDENTAL OVERDOSE (Given another full dose instead), ACCIDENTAL UNDERDOSE (needle went loose from the hub and most of the vaccine went down her arm) and DEVICE CONNECTION ISSUE (needle went loose from the hub and most of the vaccine went down her arm) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurts in 2 places) outcome was unknown.            No treatment medication was provided.
Fever for 2 days. Body aches and exhaustion for 6 days. Lump found on right breast. Currently still there. Heavier than normal period that has lasted double the normal length of time.
Patient presented to the ED on 10/22 following a fall at home. Prior to ED, patient was very weak and family was worried about a stroke. Patient was fully vaccinated with Pfizer vaccinations on 1/27, 2/16, and 10/21. Further workup warranted. Patient was admitted 10/22/21 and discharged 11/2/21.
On 07/29/2021  child presented with mother, received Dose 1, was 11 years old at the time and would turn 12 years old on 09/18/2021. Per manufacture recommendations patient is to receive 2nd dose 21 days from the primary dose to complete the series. No adverse reactions expected, not severely harmful. Unable to reach parent t this time.
yesterday itchy rash but not severe; The soreness at the injection site did not bother her at first; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (yesterday itchy rash but not severe) and VACCINATION SITE PAIN (The soreness at the injection site did not bother her at first) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-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. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (The soreness at the injection site did not bother her at first). On 08-Apr-2021, the patient experienced PRURITUS (yesterday itchy rash but not severe). At the time of the report, PRURITUS (yesterday itchy rash but not severe) and VACCINATION SITE PAIN (The soreness at the injection site did not bother her at first) outcome was unknown.            No concomitant medications and treatment information were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Right side of face swollen; This is a spontaneous report received from a contactable consumer, a patient. A 69-year-old non-pregnant female patient received BNT162b2 first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 7/21 en6207, ) as a single dose via unspecified route of administration on the left arm on 17Mar2021 at 09:30 (age at vaccination: 69 years) for COVID-19 immunisation.  The patients medical history included scleroderma and had allergy to penicillin. The patients concomitant medications included infedipine (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and DEXILANT all for an unknown indication since an unspecified date. The patient received shigalar vaccine within 4 weeks prior to the vaccine.  The patients experienced his right side of the face was swollen on 17Mar2021 at 21:30.Patient had not received treatment for the adverse event. The clinical outcome of the event swelling of face was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
developed shaking and frozen arm; developed shaking and frozen arm; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative.  A 15 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "developed shaking and frozen arm".  Additional Information: Unknown history but reported to be otherwise healthy teenager. Vaccination was given in the arm that is affected. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vomiting, diarrhea, fever, body aches, severe cough. Still on-going as to time course.
Pt w/ MDS received flu shot, was found to have rapid increase in her WBC. Family is concerned that this is AE from flu shot vs transformation of MDS to acute leukemia.
3/6 vaccination. 6PM HA, neck pain, body aches, chills, fatigue;  12:AM woke up with increased HR. HR was too fast; up to 178-200. 911 called by husband. A fib with rapid pulse, convert with IV medicines. Low potassium and magnesium levels.  Nitro administer by husband before EMS arrived; had gone down by time ambulance arrived by was irregular.  Kept me in observation floor.  *still not feeling 100%; fatigue, high HR
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office manager). This case is linked with 2018SA280875 (same reporter). This case involves a 14 months old male patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV via intramuscular route in the right thigh on 05-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given on the day of the visit. At the time of the event, the patient had ongoing egg allergy. It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse events have been 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. List of documents held by sender: none.
Information has been received from a registered nurse concerning a 16 year old female with an aspirin allergy who on 04-OCT-2006 at 16:00 and 11-DEC-2006 at 14:30 was vaccinated IM into the right deltoid with a first and second dose of Gardasil (first dose lot #653736/0689F, second dose lot #654510/0962F). Concomitant therapy given on 04-OCT-2006 and 11-DEC-2006 included a dose of Havrix. Three days after the first dose, the patient vomited for 2 days and was out of school. Three days after the second dose the patient threw up a lot more for 2 days and was out of school. The nurse was concerned about this patient and considered her condition to be disabling since she missed  school for two days after each dose. Unspecified medical attention was sought. No diagnostic laboratory studied were performed. No product quality complaint was involved. Additional information is not expected.
Pt called 10/19/1 & complained she developed low grade fever, headache, fatigue & rash - red over face & chest, 10/15/11. She cancelled FU appt as she was feeling better.
He has not received his second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: He has not received his second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter was the patient who stated that he had not received his second dose of Shingrix. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Given ZOSTAVAX 7/6 in (L) arm. Developed swelling & rash under axilla on breast & (L) side of back. Seen 7/18 with shingles. I examined her- classic shingles along T4 dermatome.
Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient (age not reported) who was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 21-APR-2015 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused patient to contract a persistent strain of herpes zoster. On or about the dates of 30-SEP-2015, 22-OCT-2015 and 11-DEC-2015, patient was treated by physician for repeated blistering vesicular outbreaks, which were diagnosed as severe shingles. On or about the dates of 17-OCT-2015 and 23-OCT-2015, patient was further treated by physician for ongoing and worsening symptoms of shingles. Patient has been prescribed acyclovir, gabapentin and hydrocodone-acetaminophen for management of her painful condition. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.