chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tachycardia; i just did not feel well.; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia) and MALAISE (i just did not feel well.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (tachycardia) and MALAISE (i just did not feel well.). At the time of the report, TACHYCARDIA (tachycardia) and MALAISE (i just did not feel well.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment and concomitant product was reported For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report as received from a medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patients' medical histories were not provided. On an unknown date in 2014, the patients were vaccinated with doses of VARIVAX (Merck) (dose, frequency, route of administration and lot # were not reported) that were exposed to a temperature excursion since 02-NOV-2014 (exact dates not provided) which was unknown to be supported or not supported at that time. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial misuse report received from a healthcare professional on 24 September 2013. The case was received on 21 March 2014. This is an invalid case as individual patient identifiers are not reported. At the time of FLUZONE ID administration it was noted that the "vaccine ran down arm". (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none. Addendum: 07 April 2014. Upon second medical examination of case at time of internal review the following has been modified in this case. The suspect product was taken as FLUZONE ID in the narrative previously taken as FLUZONE HD.
first 48 hours was normal muscle soreness at injection site. Upon waking the 3rd day was unable to open mouth more then 1 inch. As day progressed was able to unlock and open fully. Next day woke again unable to open mouth. Has been seen by neurospecialist / chiropractor in attempt to relax jaw muscles and get mouth to open fully. Day 17 still unable to open enough to bite into cheeseburger. has been using IB, HMP, stretches and exercises to draw mandible forward. Has been to dentist for night guard appliance to assist with passive stretching but unable to open enough to get tray in for imprints.
Patient reports pain in the early morning and nausea when she woke this morning. She reports not being able to lift her arm without pain and feeling faint, dizzy and nauseous.
Patient reported having difficulty breathing about 5-10 minutes after COVID-a9 vaccine administration. She took her mask off to allow for easier breathing and was given water and 25 mg benadryl. She sat for about 30 minutes and began to feel better. Patient's dad stated that she often gets worked up when getting a vaccine and is anxious about the possible side effects she may experience. Patient and father left. We called them about 1 hour later and spoke with father who said she is feeling better and thinks it was all self-induced.
temperature excursion for GARDASIL 9. The vaccine was gien four times today.; no additional adverse effect reported; This spontaneous report was received from a medical assistant and concerns an approximately 18-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown date, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml (lot # 1687291; expiration date (exp) 11-SEP-2022) (route of administration was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 80.6 Fahrenheit degrees (F) for 14 hours and 51 minutes. There were previous temperature excursions for 73.2 F for 9 hours and 25 minutes; 73.4 F for 8 hours and 48 minutes. The event was reported due to digital data logger. No further information was provided and no additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA008709:
On 03/07/2021 I noticed I got hives they were all over my scalp. They lasted for about 4 weeks. I had a telehealth appointment with my doctor & he suggested Benadryl.
Please note patient did not receive vaccine at this organization.  Submitting  to VAERS following ED visit and admission.  23 y.o. male with no previous past medical history presented 6/10 with complaints of dizziness, presyncope and syncopal episodes.  Initial fainting episode was in January 2021 upon receiving sutures the laceration on his his right index finger.  At the time he reports that although he passed out he did not really lose consciousness as he was aware of his surroundings.  Things seem to go fine for a while until the day after he received his J &J vaccine in April 28, 2021.  Reports having the usual post vaccine symptoms such as myalgias and malaise but the following day  while at the barbershop he reports having another syncopal episode.  He reports a prodromal phase that includes shortness of breath, numbness of the lips and a generalized warm feeling.  During this episode he denied any loss of consciousness, as he was able to unlock his phone and respond to the people around him.  He denies any myoclonic movements or jerks.  He denies any postictal symptoms.  Patient has been seen in the ED 3 times within the last week.  On 6/10/2021 while at the base clinic, he reports feeling like he was about to pass out and was brought to the emergency department for further evaluation.  He denies any nausea, vomiting, headaches.  He endorses some chest pain when he lays down flat that is relieved by leaning forward.  He denies any recent illness.  Denies any new medications or changes to his diet or hydration status.    The day prior to admission, his ED visit for weakness and presyncope occurred shortly after PT eval at the base.  He felt very lightheaded and he attributes that to not eating and drinking prior to the PT eval.     Work-up in the ED included EKG which showed ST elevation in leads V3 and V4 in a biphasic pattern.  CT chest which showed no PE or consolidation pneumonia or pleural effusion.  CMP was remarkable for potassium of 3.4 serum bicarbonate of 21.  CBC was normal.  CK was slightly elevated at 913.  Troponin was negative.  Lactic acid was 1.9.  UA with no concern for infectious process.  UDS was negative.  Due to EKG findings reported above, patient was discussed with cardiologist who recommended that patient be admitted for observation.   Upon further discussion with patient, it was clear that his chest discomfort improved when leaning forward, and his EKG was consistent with diffuse ST elevation.  With a clinical diagnosis of acute idiopathic pericarditis, patient was initiated on colchicine 0.6 mg twice daily and ibuprofen 800 mg 3 times daily.  He is to continue his colchicine therapy for 3 months and his ibuprofen therapy for 1 to 2 weeks with a gradual de-escalation of that ibuprofen by 200 mg/week.  He has follow-up with cardiology scheduled.  Cardiology mentioned in their notes that they would obtain an echocardiogram to rule out structural heart disease and recommended a 2-week event monitor upon discharge with a 3-week follow-up with tilt table testing and exercise stress testing.  Cardiology had high suspicion for possible vasovagal.  Echocardiogram was unremarkable without pericardial effusion.
pt recv vax; devel generalized skin rash over trunk, shoulders; rash resolved w/ no complications;
Right after the vaccine, I had a really sore arm. On the following week, on the 3rd, scratchy throat and then started having congestion. It felt just like a cold. I got tested. I tested positive for COVID. I had a fever that whole night. The next day was the worse, super congested, headache, fever on and off the whole day. I was okay after a few days. I took Tylenol.
Headache, Myalgia, Arthralgia, PAIN AT INJECTION SITE, FATIGUE, HOT FLASHES Narrative:
skin become red; skin became / hard; 4 months baby received her second dose of Bexsero; nurse did not administer the injection at 90 degree angle in my baby's leg.; 4 months baby received her second dose of Bexsero; This case was reported by a consumer via media and described the occurrence of skin red in a 4-month-old 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, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 9 hrs after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced skin red, skin induration, inappropriate age at vaccine administration, wrong injection technique and inappropriate age at vaccine administration. On an unknown date, the outcome of the skin red, skin induration, inappropriate age at vaccine administration, wrong injection technique and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the skin red and skin induration to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device.   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 reported for 1st dose. The patient received 2nd dose of Bexsero and the reporter noticed the nurse did not administer the injection at 90 degree angle in baby's leg. About 9 hrs. post vaccination, baby's skin became red and hard not at the injection site but close to it.   Upon internal reveiw the following corrections were made on 10th February 2021: The device problem for suspect Bexsero Pre-Filled Syringe Device was updated to Adverse Event Without Identified Device or Use Problem.
Extreme fatigue, fever, sore throat, loss of appetite and cough. Very congested. Had telehealth visit, prescribed  Paxlovid. Tested positive Covid the same day as vaccine.
Reporting administration error as per Agency  We contacted Pfizer for expiration dates, pfizer vaccine specialist advised that the expiration dates are deemed viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted pfizer to obtain expirations dates directly from them.  No adverse reaction reported from the patient at the time of vaccination. No adverse reaction reported since the vaccination.
Narrative:  A 71yo male with non Ischemic Congestive Cardiomyopathy, AICD, A-Fib and on Anticoagulant, HTN, DM, CKD stage III, Heart Failure with reduced EF due to Cardiomyopathy, Chronic PTSD, Gout, Hx of substance abuse and drinking He received Pfizer's Covid - 19 vaccine per policy and protocol without complication First dose on March 22, 2021 and second dose on April 21, 2021 The patient presented to Primary Care clinic and complaint of waking up with swollen left arm On April 21, AM. He also reported he received Covid-19 vaccine in the right arm and the swelling started before the vaccine in the left arm Physician's documentation included the patient had been off his anticoagulation therapy x 4 days due to scheduled Colonoscopy Procedure U/S was positive for UE DVT he was admitted to Medicine Unit and started on Heparin However it was reported by the hospitalist physician, on April 23, 2021, as an observed Covid - 19 induced severe ADE of Thrombosis, in a setting of holding previously prescribed AC for a procedure. Per April 24 inpatient progress note gastric imaging result - he was incidentally found to have a foreign body in gastric antrum He was stabilized and discharged with medications on April 26, 2021
Patient tested positive for COVID-19 after vaccination, was hospitalized for other conditions but appears to be reinfected.
Pt recvd vax 24SEP92 & shortly following vax pt exp weakness, prespiring & malaise; MD felt that sx were consistent w/hypotensive episode;
immediately upon vaccination, vaccinator noted flush to arm, redness on anterior surface which hadn't been red before;  noted slight bleeding from site;  brought to observation area;  left and right arm both red; no itching, no breathing issues, not warm at first.  Patient observed for ten minutes and then the area was becoming red, warm to touch and slightly raised, looking like hives.  Patient given benedryl and continued observation for 20 more minutes.  No changes, not worsening, let leave and advised to return if any spread or further problems.  Noted to have no breathing, itching, palpitations, nausea or other side effects.   Advised to not take the second vaccine.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA Rapid Heart Beat
swelling in armpit; Passed out; fatigue; arm has been sore all time; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling in armpit), LOSS OF CONSCIOUSNESS (Passed out), VACCINATION SITE PAIN (arm has been sore all time) and FATIGUE (fatigue) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced VACCINATION SITE PAIN (arm has been sore all time). On 19-Nov-2021, the patient experienced SWELLING (swelling in armpit), LOSS OF CONSCIOUSNESS (Passed out) and FATIGUE (fatigue). On 19-Nov-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. At the time of the report, SWELLING (swelling in armpit) and VACCINATION SITE PAIN (arm has been sore all time) had not resolved and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  Company comment: This is a Spontaneous case concerning a 23-year-old, male patient with unknown medical history, who experienced the unexpected non serious event of loss of consciousness. The event occurred approximately one day after the first dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 23-year-old, male patient with unknown medical history, who experienced the unexpected non serious event of loss of consciousness. The event occurred approximately one day after the first dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Following vaccine, the pt developed soreness, redness, hot to the touch, swelling from shoulder to elbow, nausea. Symptoms continued for 2 days.
pt recv vax 6AUG96 & 24hr p/vax pt exp a red raised rash;tx w/atarax;
Moderna 4/15/21, 6/24/21, 1/13/22. Positive on 8/8/22
Due to these reactions, the patient has opted not to get their second dose of the vaccine; three bouts of SVTs (rapid heart beats); delayed injection site bruising that looked like a bull's eye around the injection site; asymmetrical rash from the injection site to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (delayed injection site bruising that looked like a bull's eye around the injection site), VACCINATION SITE RASH (asymmetrical rash from the injection site to the elbow), SUPRAVENTRICULAR TACHYCARDIA (three bouts of SVTs (rapid heart beats)) and INTENTIONAL PRODUCT USE ISSUE (Due to these reactions, the patient has opted not to get their second dose of the vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE BRUISING (delayed injection site bruising that looked like a bull's eye around the injection site) and VACCINATION SITE RASH (asymmetrical rash from the injection site to the elbow). On 22-Feb-2021, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (three bouts of SVTs (rapid heart beats)). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Due to these reactions, the patient has opted not to get their second dose of the vaccine). At the time of the report, VACCINATION SITE BRUISING (delayed injection site bruising that looked like a bull's eye around the injection site), VACCINATION SITE RASH (asymmetrical rash from the injection site to the elbow), SUPRAVENTRICULAR TACHYCARDIA (three bouts of SVTs (rapid heart beats)) and INTENTIONAL PRODUCT USE ISSUE (Due to these reactions, the patient has opted not to get their second dose of the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.   Treatment information were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up included updated address information for the reporter/patient.
A pharmacist reported that 10 to 14 nursing home pts received an injection of flu shield and subsequently, developed a rash with "small blood blister appearance" on the trunk and some pts developed this rash on their scalps. As of the date of this report, no further info was available. The reporter indicated that 10-14 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided.
Vaccine site representative called me 12/1/21 to tell me my child was accidently given the adult dose instead of the pediatric dose of the COVID19 vaccine.
they were not suitable for use due to extended shipment/no AE; they were not suitable for use due to extended shipment/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA271944, 2019SA278134, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278140, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received Deteriorated dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On Oct-2019, patient received a multi-dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) (no dosing details were reported.  It was of actual medication error case due to Deteriorated drug administered (Poor quality product administered) and Product shipment delay (Product distribution issue).  It was unknown whether adverse event was noticed or not.  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.
Swelling up at the base of my neck on the left side; Neck pain; Don't feel good; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), SWELLING (Swelling up at the base of my neck on the left side), NECK PAIN (Neck pain) and FEELING ABNORMAL (Don't feel good) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and FEELING ABNORMAL (Don't feel good). On 26-Apr-2021, the patient experienced SWELLING (Swelling up at the base of my neck on the left side) and NECK PAIN (Neck pain). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) on 25-Apr-2021 for Adverse event, at a dose of 2 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm pain), SWELLING (Swelling up at the base of my neck on the left side), NECK PAIN (Neck pain) and FEELING ABNORMAL (Don't feel good) outcome was unknown. Not Provided          No relevant concomitant medications were reported.
mild erythema & edema of lt thigh appeared w/in 5 mins p/vax; DPH given;
About 24 hours after administration the patient reported a visibly swollen, red and hot to the touch patch of skin located near the bicep area. The patient was allergic to erythromycin and said she was informed of a possible reaction. She also reported she has had similar reactions with the pneumonia vaccine and the shingles vaccine.
Had shot a little after 6 p.m. Friday evening, 11/3/2017. To bed about 10. Awoke in pain just before 4 a.m.--could barely move arm due to pain. From mid humerus to elbow arm was swollen, hot, tender to touch. By 9 a.m. had husband get me ice bag, TYLENOL, and an ace bandage for gentle compression. By night, slight improvement in motion. Continued ice, TYLENOL and gentle ace bandage--swelling seemed to slide down arm slowly. Sunday, 11/5/17, clear hot red area on outer arm, swelling persisted, so I went to urgent care, saw APN--she said it was a classic bacterial infection of the tissue in the arm--prescribed Cephalexin 500 MG oral caps 4x day for 7 days. Started this morning 11/6/2017. But between getting the shot and being awakened by the pain, I kept on the same clean shirt, didn't touch the Bain-Aid--could the bacteria have been in the serum? Doesn't make sense.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Upon waking the next day after the administration of H1N1 vaccine, he described a numbness on the left side on his body. Upon further questioning this is more like paresthesias and has not diminished.