chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Round red rash, very very scratchy itchy 2inches below injection site; Round red rash, very very scratchy itchy 2inches below injection site; puffy red welt an inch across/Sort of swell; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Round red rash, very very scratchy itchy 2inches below injection site), RASH PRURITIC (Round red rash, very very scratchy itchy 2inches below injection site) and VACCINATION SITE SWELLING (puffy red welt an inch across/Sort of swell) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL and METOPROLOL for Hypertension, TAMSULOSIN HYDROCHLORIDE (TAMULOSIN), FINASTERIDE and VITAMINS NOS for an unknown indication.   On 16-Jan-2021, the patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Round red rash, very very scratchy itchy 2inches below injection site), RASH PRURITIC (Round red rash, very very scratchy itchy 2inches below injection site) and VACCINATION SITE SWELLING (puffy red welt an inch across/Sort of swell). At the time of the report, RASH ERYTHEMATOUS (Round red rash, very very scratchy itchy 2inches below injection site) and RASH PRURITIC (Round red rash, very very scratchy itchy 2inches below injection site) had resolved and VACCINATION SITE SWELLING (puffy red welt an inch across/Sort of swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment provided with anti- itch   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Outcome of the event rash was updated from unknown to recovered. Patient had not visited the physician regarding the AR. Adverse reaction onset date from 25 Jan 2021 to 26 Jan 2021.Patient received second vaccine dose and has experienced any rash.
OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sudden cardiac death (in 2011), and concurrent conditions included: no alcohol use, non smoker, tachycardia (heart issues), premature ventricular contractions (Pre-ventricular compression (PVCs)), sulpha allergy, and drug allergy (Steroids (Unspecified)), and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient had previously received elasomeran (Moderna covid-19 vaccine) (Dose number in series: 1) (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, dose 1 administered on 27-JAN-2021 for covid-19 prophylaxis.  On an unspecified date following vaccination with elasomeran (Moderna covid-19 vaccine), the patient experienced allergic reaction (Dose number in series: 1). The outcome of allergic reaction was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: Unknown) dose was not reported, 1 total, dose 2 (first booster) administered in left arm on 13-SEP-2021 for covid-19 prophylaxis which was an off label dosing frequency associated with Off label use and revaccination with different covid-19 vaccine (Dose number in series: 2). Age at time of vaccination 74 years old. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and revaccination with different covid-19 vaccine was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series: 3) (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: Unknown) dose was not reported, 1 total, dose 3 (second booster) administered in left arm on 19-NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second booster of covid-19 vaccine ad26.cov2.s (Dose number in series: 3). This report was non-serious. This case, involving the same patient is linked to 20221227610.
Swelling in arm; Knot in arm; This case was reported by a nurse and described the occurrence of swelling arm in a 20-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included LIVE VARICELLA VIRUS VACCINE (VARIVAX) for prophylaxis.   Previously administered products included Havrix pediatric with an associated reaction of accidental underdose (1st dose received on 21st June 2019 (batch number:K5FA5; expiry date:21st June 2021) intramuscularly).   On an unknown date, the patient received Bexsero and VARIVAX. On an unknown date, less than 2 months after receiving Bexsero, the patient experienced swelling arm and local swelling. On an unknown date, the outcome of the swelling arm and local swelling were unknown.   It was unknown if the reporter considered the swelling arm and local swelling to be related to Bexsero.  Additional case details were reported as follows: On 22nd July 2019, reporter spoken with patient over phone. The patient had knot and swelling in other arm where Bexsero and Varivax was given. The patient stated that she did not have any problems with pediatric Hepatitis A dose that day. The patient was scheduled on 23rd July 2019 to be vaccinated with adult Hepatitis A vaccine. The reporter gave permission to follow up. This case had been linked to the case US2019118379, reported for same patient by same reporter.
Headache, Seizures, Myalgia, Arthralgia, Fever & Diarrhea Narrative:  Headache, fever, myalgia, arthralgia, diarrhea; 2 days later had seizure. has hx of seizure well controlled with meds for years; treted by neurologist. Resolved.
Headache; Vertigo; Dizziness; prescribed was meclizine/because of his Parkinson's medications she believes it interacted; Couldn't walk/ the medication (meclizine) really affected his walking and so forth; This is a spontaneous report from a contactable consumer reporting for a patient. A 75-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK4176), intramuscular on 12Jan2021, 11:00 at SINGLE DOSE for COVID-19 immunisation, at 75 years old; and started to receive meclizine (expiration date 20Jan2022) via oral route of administration from an unspecified date in 2021 at 25 mg, thrice daily for vertigo. Medical history included ongoing Parkinson's from 2011, and ongoing glaucoma from 2017. No other vaccines administered on the same date. No other vaccines within 4 weeks. The patient's concomitant medication included unspecified lots of medications for Parikinson's from an unspecified date.  The patient experienced headache on 12Jan2021, on the first day; and vertigo on Jan2021 described as on the 4th or 5th day and dizziness on Jan2021. He slept in the chair for 5 days. He could not lay down without having vertigo. The vertigo has slowly gone away but now he is experiencing dizziness. When he tries to stand, he gets quite dizzy. Patient is due to receive his second vaccine tomorrow at the facility. Reporter wanted to know if patient should get the second vaccine. Patient still has very mild headaches off and on. The vertigo has gone away but he believes the dizziness has gotten a little worse. When he goes to stand up or anything, especially after laying down, he gets quite dizzy. They called the doctor's office and his doctor put him on a medication that was supposed to help with the vertigo. But, because of his Parkinson's medications she believes it interacted and did not work with him. He couldn't take it. He couldn't walk (unspecified date in 2021). She clarifies further the medication (meclizine) really affected his walking and so forth. The medication he was prescribed was Meclizine 25mg. He was prescribed to take one tablet by mouth three times daily as needed. She confirms the medication is dispensed in a pharmacy bottle. Patient wanted to know if there is any history of other people having dizziness and vertigo. The action taken for meclizine was unknown. Outcome of the event headache, Couldn't walk/ the medication really affected his walking and so forth, and "prescribed was meclizine/because of his Parkinson's medications she believes it interacted and did not work" was unknown. Outcome of dizziness was not recovered. Outcome of the event vertigo was recovered on an unspecified date in 2021.
Headache, muscle & joint pain, nausea, red swelling at injection site followed by prickly rash and reddness purple edge 4x4 expanding in oval pattern, severe fatigue.
No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    No concomitant medications were provided. It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine. No treatment medication was provided. This case contains information for the 9th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Master case  (Elderly Patient no 1)
Patient  received the pediatric Pfizer COVID vaccine (lot FK5618) at 16:55. At 1705, patient reported feeling dizzy. PHN  monitored patient as she transferred unassisted to zero-gravity chair. PHN  positioned patient supine. RN  approached to assist. Vital signs: O2 100%, pulse 90, blood pressure 112/82, respirations 18. Patient's mother reported patient had eaten and drank fluids prior to arrival but patient had a fear of needles. Patient's mother reported the patient had no allergies, medical conditions, nor did she take any medications. At 1710, PHN  offered patient's mother Benadryl for patient, patient's mother declined. PHN  educated patient's mother on remaining for 30min monitoring from time of symptom report, following up with provider, and ER precautions. Patient ate goldfish and drank water provided by site. Patient reported improvement in symptom. At 1725, vital signs: blood pressure 112/84, respirations 20, O2 100%, pulse 81. RN  assisted patient to seated position, patient reported symptoms resolved. Patient stood up continuing to report no symptoms. Patient left walking with steady gait at 1725 accompanied by parent, against medical advice of remaining onsite for 30min monitoring.
For 3 weeks now I have been having reddish itchy spots on my stomach and ribs and recently mice to my lower back. My main concern is the relentless itchiness and irritation. I have attempted to treat this with calamine lotion, tea tree oil and Hydrocortisone to no avail.
Pt reported blood shot eyes, swollen throat, glands and dry throat. Saw above MD. He was not aware of this being due to shot. She said - happened w/in 3h of admin.
Patient ambulated to general observation, sat in chair and suddenly fell straight back and slammed back of head on floor. Patient was unconscious, pale. Immediately turned onto left side. within a few seconds began having generalized rigid jerking for approx 5 sec, then patient came too, sat straight up, disoriented looking around. Able to recall name. states he was here for covid vaccine. Assisted to w/c by 2 EMT's and taken to private observation area. Patient c/o nausea and head pain. Color pale. Has an almond size swollen area at posterior base of head. Initial VS - BP 90/p; HR 53; O2 91% on room air. Responding to questions, but states he feels disoriented. Bilateral pupils 3cm with right reacting sluggish. Patient states he is a student. EMT attempted to contact patient's father and LVM. Patient's step mother returned called. Informed her that patient is being transported to Hospital downtown FW for further eval. She asked him what did she need to do. Nurse informed that his vehicle will be left at the vaccine location and he will need assistance pending hospital eval. Patient then called his boss to notify him that he will not be at work tonight. Patient states that he had a reaction to his first HPV - states he fainted, but completed the series without further problems.  Repeat VS at 1550 BP 90/p; HR 67, O2 98%. Color remains very pale. EMS activated. patient states he needs to lie down. Assisted to stretcher per EMT, elevated legs, cushion under head with ice packs on back of head. 1602 EMS arrived, BP 121/75; HR 69 O2 100% on room air. Transferred to stretcher  1605 Patient transported to Hospital
Fever and chills: 3am-4:30 am Vomiting: 7 am Headache, fatigue, dizziness, nausea: 7 am -ongoing as of 1:33 pm
minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reported to job 1/15. She had hard time to ambulate wearing a facemask. 1/17 sx fully resolved.
Initial unsolicited report received from a nurse on 09-Aug-2016. This case involves a 54 year old female patient who was vaccinated with a dose of ADACEL via intra muscular route in the right deltoid (batch number: UI558AA, expiry date: 10-Apr-2018; unknown dose in series and batch number) on 08-Jul-2016. Patient denied any pre-existing physician diagnosed allergies, birth defects, medical conditions etc. Concomitant medication was unknown. On 09-Jul-2016, one day following the vaccination, the patient had persistent pain at injection site with limited ROM and certain movements trigger the pain and Reporter stated patient has also complained of a burning sensation at the injection site without redness or swelling. Patient was evaluated by the physician on an unknown date. The patient required ER/doctor visit. Laboratory data included X-ray of right arm (reported as negative). The patient received corrective treatment with Baclofen 10mg every 8 hrs as needed, Ibuprofen 600 mg and Tylenol 1000 mg both every 6 hours as needed. Application of ice to the upper R arm and rest was also reported. The outcome of events was unknown. List of documents held by sender: none.
Patient had his first vaccine on 1/12/21. On 1/13/21 and 1/14/21, he was more confused then normal, very emotional, and has decreased appetite.  Patient recieved the second vaccine on 2/2/21.  On 2/3/21, he was once again more confused, emotional, and had little appetite.  He is now back to normal.
Patient presented at approx 10:10AM to receive a yellow fever shot.  Patient advised that he felt OK before receiving the shot.  Once the shot was given the patient began to sweat, we sat him down in a chair where he lot consciousness for a few seconds.  EMS was called. The patient advised he had not eaten.  He was given water and glucose and transported to medical center.  Patient was released same day back to work.
the patient came into pharmacy on 12/10/22 and said she notice a 3 inch radius rash , feverish on injection area, itching, sore . patient said she called VAERS and left message this am.
Dizziness, Headache, Fever,  sx persist > 1 week Narrative:
Patient prescribed oral typhoid Vivitof vaccine. Patient reports 1hour after taking first pill developed hoarse voice which subsided within 24h. On 2nd dose of vaccine severe hoarseness again within 1hour with increased severity. Patient reported this prior to 3rd dose and then finished last 2 doses of vaccine.  There was no associated shortness of breath, rash, fever or difficulty swallowing. Of note wife who also started oral typhoid vaccine the same day noted hoarseness after first dose but not subsequent doses. Please note this vaccine was purchased through a commercial pharmacy by the patient. Patient was given hep A vaccine in MD office 2/5/13, but oral typhoid not started by pt until 2/28/13.
Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 30-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
I started experiencing a ringing in the ears after about a week that continues, non-stop, to this day. (tinnitus)
Spotting blood from the vagina. I'm 83 and not sure of when it started ... I didn't realize there might be a connection until recently. I have had two ultrasounds and the GYN said nothing shows adnormal.
No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (the site of injection was red), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE PAIN (ainfull injection site), VACCINATION SITE PRURITUS (intensely itchy) and PAIN (mild body aches). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (the site of injection was red), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE PAIN (ainfull injection site), VACCINATION SITE PRURITUS (intensely itchy) and PAIN (mild body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
no adverse event; Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife).; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife).) and NO ADVERSE EVENT (no adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 02-Jun-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 02-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife).). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife).) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife).).    No concomitant medication details was reported. It was reported that the patient received 5 previous Moderna doses. The vial was initially stored in the refrigerator 19-May-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to MOD-2023-727336 (Patient Link).
MA gave first dose of covid vaccine 5yrs-11ys undiluted to the patient.
pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient said that the injection caused pain in his arm for a few days. The patient consented to follow up. This case has been linked to US2019183610, reported by the same reporter.
Patient was given the Janssen vaccine on Left Deltoid. After administering the vaccine the patient was instructed to wait for 20 minutes and there was no reaction at the end of the 20 minute wait.
Information has been received from a licensed practical nurse concerning a 12 month old female who on 19-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of ProQuad (lot# 654474/0815F). Concomitant therapy included Varivax (lot# 654756/1335F). The nurse reported the office confused the ProQuad with the MMR II in the freezer. The patient received a dose of ProQuad and a dose of Varivax during the same visit. The patient sought unspecified medical attention. No problems reported. Additional information has been requested. This is one of several reports from the same source.