chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right arm inflamed and hurting, heart pounding out of my chest, Afib with pulse of 145 and a high blood pressure of 145/112, took 200 mg Multaq plus 75 mg of Pradaxa, waited 1 hour then took an additional 200 mg Multaq, waited one hour and still in Afib, then I took 25 mg of Metoprolol.  Then I had experienced an episode of almost passing out due to low BP of 75/40.  I should have taken 1/2 per instruction on the bottle but I hadn't taken this med for so long.  This was following doctors orders over the phone and he just said "take a metroprolol if it doesn't stop"....a bad miscommunication and I should have known myself as well.  The afib continued for another hour or so then it stopped.
patient did not feel well after first dose; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing diabetes mellitus. The patient's concomitant medications were not reported. It was reported that caller inquiring if a diabetic patient recieved second dose of vaccine if it could possily affect the preexisting condition, as patient did not feel well after first dose. Also wondering how to register to recieve first dose of vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested
5/12/21 -patient reports waking with severe fatigue and feeling "flu-like all day"  5/13/21 - patient reports fatigue and Flu- like symptoms had dissipated but woke with ? icy and uncomfortable feeling in both lungs as well as a  non productive cough with a majority of exhalations. Patient reports this lung discomfort persisted for 5 days and then disappeared.
He states he sit down pulled out his phone to play and he started to feel dizzy and clammy.  Pt noted to be diaphoretic and noted to be slightly pale. Report s he has not ate yet today but did take his b/p med. 1049 HR-34, R-18, B/P 70/50, 02 sat 97% RA, he is sweaty to touch.  1057 HR-42, 02 sat 97%. 1104 B/P 130/82, HR 50-60, 02 sat 96%. 1110 B/P 120/78, HR-66-68, 02 96%RA. 1117-B/P 122/87, HR-60, 02 96% RA, R-18. 1123 walked pt to care and his wife was in the car, instructed her she needed to drive him home. Wife verbalized understanding. Pt instructed to f/u with MD as needed.
No initial reaction, but patient reports that later that day she developed some dizziness (no falls or loss of consciousness), weakness, and confusion. Weakness and confusion resolved completely by the time she reported these symptoms on 1/6/20 (seen in clinic for a scheduled appointment for other reasons); she continues to feel intermittent dizziness but gradually improving. Please note that she has a history of vertigo in the past so unclear whether these symptoms are truly related to vaccination or if this could be a coincidence.
I recently had a positive TB quantiferon lab test and I am wondering if this could be related to the vaccine.
Warmth and swelling of (L) upper arm noted in 1st 24 hrs, persistent ring of erythema 5 days later and calcinosis at injection site. No apparent cellulitis.
RETURN OF PLAQUE PSORIASIS SYMPTOMS; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (RETURN OF PLAQUE PSORIASIS SYMPTOMS) and FATIGUE (Fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (RETURN OF PLAQUE PSORIASIS SYMPTOMS) and FATIGUE (Fatigue). At the time of the report, PSORIASIS (RETURN OF PLAQUE PSORIASIS SYMPTOMS) had not resolved and FATIGUE (Fatigue) had resolved.            Concomitant medication was not reported.  On an unknow date, patient experienced fatigue after second dose of COVID-19 vaccine. Treatment details were unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient complained of moderate lightheaded/dizziness. BP was 128/77. We had her stay an extra 5 minutes at which point she felt better enough to go home with friend.
Moderate Itchiness all over the body. The onset of the itchiness was within 1 hour of the vaccine. The itchiness has persisted every day since then. The itchiness is most itchy in the groin/scrotrum region and inner thighs. Other parts of the scrotum/groin are also itchy every day ever since getting the vaccine. The individual has no STDs and had only normal male itching prior to the vaccine.   There is also itching on the arms, lower neck/sides of neck, thighs, and sides of the back, but not as intense itching as the areas described above. I had never experienced generalized itching on my body ever before getting the JNJ vaccine and am positive it is related.
blood clotting in legs, lungs, resulting in hospitalization. Second clotting event resulting in stroke and hospitalization, ongoing treatment and evaluation
ADACEL given to patient on 7/31/18 10+ of pain and marble size lump - about 2 inches from injection site about 5 hours after shot was given.
Headache, sorethroat, body aches, fever, vomiting. 11/17/09 ER recs received for date 11/7/09. DX: flu like syndrome. Chief c/o pt. states received H1N1 vax this AM felt ill rest of day. Pt states c/o sore throat, fever, N/V,  myalgias, HA, cough  12/09/09 Immunization records received for DOS 11/06/09.
Pain, warm, red rash at injection site. Extreme fatigue, nausea. Migraine headache. No temp. Patient experienced extreme fatigue and nausea the evening of the 12th. The rash she did not notice until 6/17 and it also was itchy. There is also what looks like a potential bite on her left arm.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 7 years old patient (gender not reported) who received 0.5 ml fourth dose of vaccine QUADRACEL (lot C5248AA, expiration date 21-AUG-2019) including IPOL and DAPTACEL instead of ADACEL via intramuscular route in the right deltoid on 22-May-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR and VARICELLA VACCINE. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. No adverse event noted. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
RED CIRCULAR BRUISE AROUND INJECTION SHOT, IT WAS HOT ON 10/28/12. BUT NOT AT 1:10PM ON 10/29/12.
Within 5 minutes of receiving the Flumist vaccine, the patient started breaking out in hives. Patient was immediately given Benadryl.  Within 20 minutes the hives started to resolve. The nurse checked on the patient on 10/18/2011 and the mother reported the patient was doing fine but still had a few hives still.
Started w/general mild malaise, throat clearing, scratchy throat, mild nasal congestion, generalized body warmth, site soreness. Progressed to mouth and lips feeling fuller and prickly, then mouth lip tightness. The submandibular area of mouth became puffy. Then progressed to true swelling of submandibular area.
blue purple discoloration of right thumb, right toe, left toe, no injury or bruises. Contacted Teledoc and provided pictures.  Dr. described it abnormal findings, clotting vessels.
I was having migraines all nightmigraine; body ache; arm hurts a little bit; couldnt sleep well last night; A spontaneous report was received from a healthcare professional concerning a 70-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Migraine (having migraines all night), Myalgia ( body ache), Pain in extremities (arm hurts a little bit) and Poor quality sleep (couldn't sleep well last night).  The patient's medical history was not provided. Concomitant medications reported were Amitriptyline, Sumatriptan for unknown indication.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient stated experiencing that her arm hurts a little bit and was having migraines all night, had body aches and she couldn't sleep well last night.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was reported to be unknown.
3-5 min following second dose of daily/regular lamotrigine, blood pressure fell (to the level of being lightheaded almost passing out), rapid heart rate and tightness in chest and decreased ability to fully inflate lungs when attempting to take a deep breath.  Symptoms began almost immediately following ingestion of lamotrigine and lasted approximately 5-7 min. Other symptoms include-fever (100.4), extreme body chills, swelling in left knee, extreme fatigue, painful muscles at site of injection. Symptoms began approximately 12 hours following injection. High fever and extreme body chills lasted approximately 3 hours, low grade fever and fatigue lasted ~24 hours after injection, swelling in left knee lasted ~ 4-5 days following injection.
I was fine for 12 hours. At 930PM bilateral legs to ankles were 3" larger-at 2AM 3-6-20 had a bathroom call & fell out of bed on my butt I could not walk without a cane until Friday the 13th of March. Friday the 13th of The only comfort I had was ice packs and Motrin 800mg Q 8 hrs. I hope I was helpful with my description
Information has been received from a nurse practitioner concerning a 17 year old female with no known drug allergies or pertinent medical history who on 27-MAY-2008 was vaccinated IM with the first dose of GARDASIL vaccine (yeast) (lot n. 654272/0073X). Concomitant therapy included an unspecified birth control pill. The patient received the first dose of GARDASIL vaccine (yeast) and immediately fainted. She was unconscious for 5-10 minutes. The patient sought medical attention at the office. No treatment was required and the patient recovered on 27-MAY-2008. Additional information has been requested.
(L) deltoid area, redness with hard swollen approx 19 cm x 11 cm started 10-18-11 approx 9:00 am. Seen at clinic by RN. Referred to dr. Seen at another clinic approx 10:00 am - was given rx for clindamycin, ATARAX, prednisone. Started rx at 1:0pm within 20 min rash  & itching was gone.
This spontaneous report as received from a certified medical assistant (C.M.A.) (also reported as a nurse) refers to an unspecified number of unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of GARDASIL (dose, frequency and therapy route were not specified by the reporter, lot# and expiration date were not reported) that were improperly stored. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
15 YOA was given one dose of Bexsero / have not provided the second dose yet / has not come back for second dose / asked if she should administer it after a month; This case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a 15-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received on an unknown date at the age of 15 year old).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The 15 year old was given one dose of Bexsero immediately before traveling/moving. The Nurse knew about the ACIP recommendation and the vaccine indication but had not provided the second dose yet with the concern about what to do with a 15 year old vaccinated.  The patient did not come back for second dose, which led to incomplete course of vaccination. The nurse was concern about giving the vaccine to a 15 year old , as they follow the ACIP recommendations. She also understand that Bexsero was approved for 10 to 25 year old age. She wanted to find more information on how to proceed with the second dose. The nurse asked if she should administer it after a month, when the patient turns 16 or restart the series then. No further information was reported. Reporter did not consented to follow up.
Large tender local reaction approximately 6 in diameter. Lasted 4d and then began to subside (Rt arm).
fever, chills, and body aches started 11pm (99 degrees) headache and fever at 3am (101 degrees) headache and fever at 7:30am (100 degrees) arm soreness and difficult to move (starting at 3am)
4 days after injection upper (R) arm site became reddened & swollen - then painful.
Case number PHEH2015US019584, is an initial spontaneous report from a healthcare professional received on 30 Sep 2015. This report refers to a 43 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. On the same day it was found that FLUCELVAX was kept at room temperature for 24 hours and was administered to the patient. No adverse event was reported following this maladministration (incorrect storage of drug).
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-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 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken for m-RNA -1273 Moderna COVID -19 vaccine was not applicable.  No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Patient received vaccine on 12/12/19.  She contacted me on 1-20-20 that she was having stiffness on the right side down into her hand so that she was having a hard time opening a jar. She contacted her physician who told her to wait a couple weeks but she was still having problems.  I then contacted GSK to determine if any other patients had had similar reactions to Patient.  They couldn't see that anyone had anything other than from the list of side effects of decreased mobility or muscle pain.  Patient contacted me again on March 10 and told me she was still having problems.  She had been back to the doctor and I believe that he had done an x-ray of the arm and didn't see anything but arthritis.  He suggested she get an MRI.  That is all the information I have at this time
I had a rash/hives break out all over my stomach. The entire front of my stomach was covered in small dots and scabs, almost looked like chicken pox. These bumps were extremely itchy, but never painful.
Some leakage from the hub of the side of needle; May not have received a full dose of the vaccine; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 Vaccine and who might not have received a full dose of the vaccine when there was some leakage from the hub side of the needle.  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On 31-Dec-2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. A physician reported that some leakage was observed from the hub of the side of a needle when the dose of vaccine was administered.  The patient may not have received a full dose.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, might not have received a full dose of the vaccine when there was some leakage from the hub side of the needle, was resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect route of product leakage and incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product leakage and incorrect dose administered.
PATIENT CALLED COMPLAINING OF HEADACHE WHEICH STARTED APPROXIMATELY TWO DAYS AFTER RECEIVEING  ZOSTAVAX.  tHE PATIENT ALSO STATED HE SUFFERS FROM ALLERGIES AND TAKES ANTIHISTAMINES.
We have tried to contact patient to come in for second dose to complete the series, patient kept delaying. Until yesterday 9/6/18, patient refused to get this second dose. He said that since the first shot he experienced nerve pain on left arm (around injection site) here and there. So, he's scared to get the second shot now.
Numbness continued to throat; Swelling in throat; Numbness in her left cheek and neck; Itching on the back of her neck continuing down her left arm (arm she received injection in).; Whelps; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on the back of her neck continuing down her left arm (arm she received injection in).), PHARYNGEAL HYPOAESTHESIA (Numbness continued to throat), PHARYNGEAL SWELLING (Swelling in throat), HYPOAESTHESIA (Numbness in her left cheek and neck) and URTICARIA (Whelps) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Whelps) and RASH (Rash). On 07-Mar-2021 at 3:00 PM, the patient experienced PRURITUS (Itching on the back of her neck continuing down her left arm (arm she received injection in).). On an unknown date, the patient experienced PHARYNGEAL HYPOAESTHESIA (Numbness continued to throat), PHARYNGEAL SWELLING (Swelling in throat) and HYPOAESTHESIA (Numbness in her left cheek and neck). At the time of the report, PRURITUS (Itching on the back of her neck continuing down her left arm (arm she received injection in).), PHARYNGEAL HYPOAESTHESIA (Numbness continued to throat), PHARYNGEAL SWELLING (Swelling in throat), HYPOAESTHESIA (Numbness in her left cheek and neck) and URTICARIA (Whelps) had resolved and RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp.   A 77-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history was not reported. Concomitant medication(s) included eltrombopag olamine (PROMACTA) taken for an unspecified indication from an unspecified date to an unspecified date, then from 14Apr2021 to an unspecified date.  The patient experienced diarrhea on an unspecified date with outcome of not resolved.  Patient reports that he is currently holding his Promacta per his doctor. He received his COVID-19 vaccine and was experiencing diarrhea. On 14Apr2021 patient has resumed his daily Promacta after being treatment on hold. He continues to have diarrhea and did received his second COVID-19 vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.