chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Daptacel expired 5/17/19 and was administered today; Initial information received on 31-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that Daptacel expired 5/17/19 and was administered today.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported and expiry date: 17-Sep-2019 via unknown route in unknown administration site. It was a case of actual medication error due to expired vaccine used.  It was unknown if 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.  Information on the batch number was requested.  List of documents held by sender: none.
Swollen arm, raised, warm to the touch, erythema. Had patient apply BENADRYL cream and try ibuprofen.
Arm was very sore first 1-3 days, unable to lift or lay on. Pain went away after a few days. But noticed in the last 2-3 days that it's a little achy AND there's a red spot/patch in the injection area. It's not painful, raised, or itchy. But concerning just because I have my second dose coming up in a few weeks.
I got up from my sofa about 6 hours after the 2nd Moderna shot, and felt lightheaded. My husband was concerned and walked with me up the stairs then started going back down. He heard a thud and I had collapsed on the floor and it took him a few seconds to wake me up. I don?t remember passing out, but do remember him calling my name. This event happened six times in a row, but I don?t remember it. He had to hold me upright to get into bed. He called clinic, and they wanted me to go to emergency, but I just wanted to sleep and did not go in until the next day. I went to hospital and they ran many tests, but everything seemed to be ok, so I went home and have been ok since. Because I was ok before the shot, I believe that I had a bad adverse reaction to the 2nd shot.
chest pain/shortness of breath/myalgias/malaise/fatigue/headache/tachycardia  IV fluid therapy, completion of medical work-up
Suddenly got weak and felt very faint, nausea and profuse sweating, rapid breathing .  I crawled to phone called 911 and was barely able to get my words out then I passed out twice while lying on kitchen floor, holding on to the phone with dispatcher while waiting  for EMT's to arrive).  I felt like I was dying. My blood sugar was 150, my BP was 150/59 and they checked me out thoroughly.  Oxygen levels okay and EKG fine.. We discussed possible Anxiety attack but that did not make sense as i was going about my normal routine and was not upset about anything.  I have passed out a couple times in my life but I've never felt like that or  had anything like this happen to me before! It's hard to know with all my other conditions exactly what happened but this event was nothing like anything I've experienced before.   I am following up with my doctor and seeing if  I need medication adjustments but I don't think there is any definitive answer and I'm afraid to get the second dose of the vaccine now.
Pt was in her usual state of good health prior to Dec 2008. Looking back, pt recalls developing symptoms of hyperglycemia sometime around December 2008/Jan 2009 while deployed. She experienced 3-4 month hx of polyuria, polydipsia, fatigue, and blurred vision prior to being diagnosed with T2DM. At diagnosis, her blood glucose level was greater than 440, without evidence of ketoacidosis. Documented exam at diagnosis reported BMI about 25 and absence of acanthosis. Pt was med-evac'd to another clinic after being started on oral agents. She continued on various oral agents with diet modification and varying degrees of glycemic control over the next 18 months. Following fibroid arterial embolization and suboptimal glycemic control in Jan 2010, she was hospitalized for DKA in Feb 2010. In June 2010, she was referred to a Diabetes Center where in Oct 2010, she was reclassified as having Latent Autoimmune Diabetes in Adults (LADA). At that time, she was taken off all oral agents and intensive insulin therapy was initiated. She currently is following a regimen of premeal NOVOLOG with supplementation for hyperglycemia and once daily LEVEMIR. Since diagnosis, pt has been followed through the Diabetes Center, as well as with a local primary care provider. Pt received AVA (4) vaccine in Dec 2008 and INFLUENZA vaccine in Aug 2008 prior to onset of DM-related symptoms. She denies any unusual or prolonged reactions within the first week following vaccine receipt, except for 1-2 weeks of fatigue following receipt of vaccines. Pt does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to her diagnosis of DM. Pt reports a history of gestational diabetes (GDM) in 2003; of note, she inadvertently received her first anthrax vaccine in 2003 before she knew she was pregnant. She denies previous history of elevated blood pressure levels or history of hypertension. She has a strong family hx of T2DM.
Got the shot the next day it was a little shot. Then woke up on Sunday morning and from shoulder  down the the elbow there was a red rash. It is just on the front of the arm and some around the back of the arm.  Feeling foggy in the head and does not feel well. Before getting the shot had blood work done and everything was fine it was just the red rash down the arm . Got a red rash down the other arm from the pervious vaccine as well and it lasted for the 4 months. Every time the rash comes it is 48 hours after the vaccine.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received 13 August 2008 from another manufacturer who received the report from a health care professional.  An unidentified patient experienced a convulsion after receiving pertussis vaccine as a baby (manufacturer unknown, lot number not reported).  No further information was provided at the time of the report.  A corrective version of this case was create on 19 August 2008 to amend the seriousness of this report to serious, as the event was considered to be medically significant.
pain in left elbow that restricted full motion and use of left arm and hands.  no signs of swelling, no indications of another problem somoewhere else
Day after vaccine, the left side of my face between my nose and mouth it felt very irritated, burning and itchy. No rash was seen. I was advised by doctor to take Benedryl.
Itchiness; Redness; pain in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchiness), INJECTION SITE PAIN (pain in the injection arm) and INJECTION SITE ERYTHEMA (Redness) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (pain in the injection arm). On 13-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchiness) and INJECTION SITE ERYTHEMA (Redness). In February 2021, INJECTION SITE PAIN (pain in the injection arm) had resolved. At the time of the report, INJECTION SITE PRURITUS (Itchiness) and INJECTION SITE ERYTHEMA (Redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.    Reporter did not allow further contact
rash-redness-swelling orally lips-ears, eyes; torso arms & legs-blistering rash; pt given Epi & DPH;
This spontaneous report was received from a nurse referring to an unspecified multiple patients of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified dates, the patients were vaccinated with a dose of improperly stored VARIVAX lot # L035124, expiration date of 14-SEP-2017 and lot #: L027287, expiration date of 21-JUL-2017  (strength, dose number, and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 63 hours: >5° Fahrenheit but < 14°Fahrenheit; the highest temperature was 6°Fahrenheit. Reportedly, there had been no previous temperature excursions. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA004735:
triggered considerable swelling from my lymph edema in both legs, ankles, and feet -- enough swelling that I couldn't even get my pants on, so it was much more than any other bout of swelling from the disease ... it's only just now starting to subside, and I believe that was helped along by the steroid shots I got in both knees and my left shoulder this past week. I have been told that this is something that could happen with all three versions of the vaccine, and while it put a great deal of weight on me for a while, I'm not in pain or suffering in any way from it. Just wanted you to know about it! I am currently in recovery.
This spontaneous report was received from a 65 year old female registered nurse regarding herself. Patient's current condition included chronic obstructive pulmonary disease (COPD), hypertension and codeine allergy. The patient's medical history included hip replacement, swelling and soreness at the injection site following multiple prior doses of unspecified influenza vaccines (brand name and manufacturer unknown). On an unknown date in September 2006 (approximately 6 years ago), the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number unspecified). Concomitant medications included TOPROL XL tablets, hydrochlorothiazide (manufacturer unknown), SPIRIVA and FLOVENT. On an unknown date, the patient was hospitalized for a hip replacement. On 19-SEP-2012, while she was hospitalized for a hip replacement, she was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number unspecified). On 19-SEP-2012, approximately 6 hours following the vaccination, she experienced short of breath, asthmatic, pulse oximetry reading dropped from 96 to 70, her heart rate increased to 140 beats per minute that she needed to use oxygen and albuterol therapy way too often. On the same day, she experienced swelling and soreness at the injection site. Hospitalization was not prolonged. She was discharged on the following day (20-SEP-2012) but the patient was still experiencing the shortness of breath. She followed up with an unspecified physician on the next day the doses of SPIRIVA, FLOVENT were increased. On 22-SEP-2012, her respiratory symptoms were resolved. The outcome of swelling and soreness at the injection site was unknown. The relatedness for all the events was unknown was unknown for PNEUMOVAX 23. This case is related to 1210USA004946 (Same Patient Link). Additional information is not expected.
Patient presented at clinic for her second dose in the Moderna Covid series at which time I determined she was a minor at 17 years old. I contacted my supervisor and was informed that per store policy I should administer the second dose to complete the series and file a VAERS Report.
Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MIGRAINE (Migraine). On 31-Mar-2021, MIGRAINE (Migraine) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment given included Ibuprofen. Concomitant medications were not provided.   This case was linked to MOD-2021-109707 (Patient Link).
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: swollen and hot at the injection site-Mild, Additional Details: wife called and said  her husband got swollen at the injection site and hot
Muscle pain; Joint pain; pain; This case was reported by a consumer and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced muscle pain, joint pain and pain. On an unknown date, the outcome of the muscle pain, joint pain and pain were unknown.   It was unknown if the reporter considered the muscle pain, joint pain and pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient asked if could symptoms of Shingrix vaccine show up 3 weeks after injection and he/she experienced muscle pain, joint pain and pain. The follow-up would not possible, as no contact details were available.
Information has been received from a registered nurse concerning a patient who on an unspecified date during a several week interval in June and July 2010, was vaccinated with a dose of PNEUMOVAX 23 (lot#666639/0564Z). Subsequently, the patient developed a case of cellulitis centered on the injection site. The patient was treated with antibiotics. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Within a couple of hours of the shot, the patient was feeling some itching at the site. The next day there was swelling within several inches of the injection site and redness. Today, 12/27, the patient's upper arm is still swollen with some redness.
Mother noted red rash in genital area. Called MD office. No treatment given since rash was not bothering pt. Not even seen by the MD.
Narrative: COVID infections following completion of COVID vaccine series 03/22/21 COVID vaccine dose #1 07/23/21 Pt reports no symptoms; pre-op COVID swab performed - COVID POSITIVE 07/29/21 Pt remains asymptomatic, reports will isolate until 8/1 08/05/21 Pt rescheduled for COVID swab on 8/10
mom states pt has had fever been cranky, had diarrhea (2x in 24hr) x 2 days;advised mom to call pvt MD & advise of this;mom agreed to do this;
I got pregnant on April 30th.  I had very mild symptom.  I had a sore arm and a slight fever
Itchy red hives, sometimes all over body, mainly been arms and legs and during the evening. Recently, swelling has occurred near mouth. Pressure on body parts can result in large swelling (arm pushed on edge of table while using a electronic device). Been taking Benadryl to relieve symptoms.
Several hours after the vaccine skin felt hot like sunburn; no itching or rash. Also legs felt restless. Symptoms disappeared by next morning. No medications taken.
No additional adverse events reported; an expired dose of VARlVAX was administered today 22Jul2021; This spontaneous report was received from a registered nurse, also an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 22-JUL-2021, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 1 dose (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number S021927, expiration date 15-JUL-2021) as prophylaxis (expired product administered). It was reported that the dose of varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored up through the time of administration. No additional adverse events reported.
Patient states arm is still a little sore at the injection site. Patient also reporting occasional numbness in arm that is temporary but reoccurring.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and an approximately 54-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX by a healthcare provider at a medical center/hospital (lot number, dosage and route of administration not provided). Later in 2013, the patient was treated by a healthcare provider at a medical center/hospital, for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself and economic losses. The outcome of the shingles was unknown. Causality related. Additional information has been requested.
dx GBS;hospitalized 3-4 wks, now in rehab hosp;collapsed, unable to move, no movement in legs, late spread up arms, never on mechanical ventilation;treating neurologist @ hosp;
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (arm is swollen from elbow to shoulder) and VACCINATION SITE RASH (raised red rash at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. Co-suspect product included non-company product CEPHALEXIN [CEFALEXIN] for an unknown indication. No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ATORVASTATIN, GABAPENTIN, ABALOPARATIDE (TYMLOS), LAMOTRIGINE, HYDROXYZINE, VITAMINS NOS, ZOLPIDEM and AMPHETAMINE for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started CEPHALEXIN [CEFALEXIN] (unknown route) 500 milligram three times a day. On an unknown date, the patient experienced VACCINATION SITE SWELLING (arm is swollen from elbow to shoulder) and VACCINATION SITE RASH (raised red rash at the injection site). At the time of the report, VACCINATION SITE SWELLING (arm is swollen from elbow to shoulder) and VACCINATION SITE RASH (raised red rash at the injection site) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt stiffened, aching back, closed eyes, seizure like movements x 10 seconds with the Dtap injection. Sleepy afterwards then behavior completely normal w/in one hour, eating, responsive. B/P 82/44, P 84, EEG ordered.
reconstituted lyophilized menA with normal saline and administered; reconstituted lyophilized menA with normal saline and administered; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The age at vaccination was not reported. The case was reported by nurse for patient. Nurse reported that the new office staff member incorrectly reconstituted lyophilized menA with normal saline and administered to patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not agree to follow up from GSK
It started out as a slight nasal drip that lead to a sore throat. I thought I was coming down with a sinus infection again. I had, had lunch with a friend the prior weekend who called and told me they had tested positive for COVID-19. I immediately took a home COVID-19 test that came back negative. Three days later I really started feeling bad, called my primary care physician who instructed my to go to an urgent care to be tested with a Rapid and a PCR COVID-19 Test. Both came back positive and I was prescribed Paxlovid which has helped me to feel better. I feel that I am ninety-eight percent back to my normal self.
Arm swelled and real hot.  Went down after 5 days.  Now a rash has developed in injection site and itches terribly.  Don't know if I should get second dose.  Very tired.
Pain in the arm on the same day (Sunday). Given Tylenol to the child to have a better sleep time. The next day feeling well (Monday). Today (Tuesday) I received a call from the school nurse at 3 pm reporting he was complaining of headache (forehead). At 6:30 pm he reported not feeling so well and worsening of headache. Temperature 101.4. Given Motrin. Now, about 45 min after taken medication is reporting a little improvement.
Large (approx. 3" diameter), raised, red welt around injection site. Fever, chills, fatigue
28 y.o. female after 2nd COVID Pfizer Vaccine. Stated h/o of throat irritation & itchiness which occurred after 1st dose done & reoccurred today. 2nd vaccine @ 12:45 pm. Pt c/o of slight itching in throat which occurred w/ 1st dose per pt. VS: 1:00pm: 117/70- 80- 22- 99% RA O2 Sat. Bilat lungs clear to ausculation. Good air movement over trachea. Pt stated she feels better. Repeat VS @ 1:15pm: 108/60-78-22-98% RA O2 Sat Pt d/c'd, steady gait, moves all extremities well, no acute distress. Speaks in clear, full sentences.  Notified site lead
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Nausea-Medium, Additional Details: Patient's symptoms match those of "COVID Arm".
The same day of vax, the pt developed moderate redness and swelling at the Infanrix site. Half of his thigh became inflamed. He recovered without treatment. The reporter considered the thigh inflammation, injection site redness, and injection site swelling to be related to Infanrix administration.
2.5 hrs post vax developed period of frantic crying had long bowel movement, passed out & turned very pale for approx 5 min, regained color was also clammy & cold;
Pt received duplicate vaccination according to staff at primary care office. provider's office states that the pt received these last year. Pt denies any adverse effects. Office notes that they do not report to system, the vaccine database, so administering pharmacist provided based on (signing guardian)'s statement that the immunizations were needed.