chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Patient got dizzy with second Moderna injection.
patient who is over 65 received Fluzone Quadrivalent instead of the Fluzone HD, No AE; Initial information was received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves over 65 years old patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported via unknown route in unknown administration site on an unknown date instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
RIGHT BRACHIAL PLEXOPATHY SYMPTOMS WITH WEAKNESS FINGER EXTENSORS. SYMPTOMS ARE IMPROVING. 50-60% BETTER ALMOST A MONTH LETTER
Heart palpatations; dry mouth; dry lips; very thirsty; body aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07May2021 at 11:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism. The patient had allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) for unknown indication from an unknown date and unknown if ongoing. The patient previously took vancomycin (MANUFACTURER UNKNOWN) and experienced drug allergy.  On 08May2021, the patient experienced heart palpitations, dry mouth, dry lips, very thirsty and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event heart palpitations, dry mouth, dry lips, very thirsty and body aches was not recovered at the time of this report.      No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms around right eye; Weakness in arms and legs; Feels tugging in the back of her head and symptoms around right eye; Neuropathic Symptoms on Right Side of Face; Numbness on Right Side of Mouth; she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her Bell's Palsy, and the corner of mouth started to have numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 41-year-old) as single dose for covid-19 immunization. Medical history included facial paralysis from 1998 to an unknown date, Bells palsy at age 18 , ongoing temporomandibular joint syndrome , asthma exercise, depression, pain, hypoaesthesia, Numbness in face in the past (June 2020 tele-visit with neurologist), fatigue, headache, anxiety. Concomitant medications included gabapentin (GABAPENTIN) taken for neurological symptom, hydroxyzine (HYDROXYZINE) taken for anxiety. The patient experienced she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her bell's palsy, and the corner of mouth started to have numbness on 01Mar2021 with, neuropathic symptoms on right side of face on 01Apr2021 with, numbness on right side of mouth on 01Apr2021, weakness of right eye numbness in right eye, feels tugging in the back of her head and symptoms around right eye, weakness in arms and legs, feels tugging in the back of her head and symptoms around right eye. Caller states basically she had Bell's Palsy years ago and was left with cranial nerve damage. She stated she noticed after the first Pfizer vaccine, that in that area of the face that she had Bell's Palsy, she started having neuropathic symptoms. and stated that it started thursday. States it has been there for a couple of days and she still has a little bit of neuropathic symptoms but not as great as when the onset began. The outcome of the events was recovering.   Information about batch/lot number has been requested.
head congestion; chest congestion; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head congestion), CHEST DISCOMFORT (chest congestion) and DYSPNOEA (shortness of breath) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEAD DISCOMFORT (head congestion), CHEST DISCOMFORT (chest congestion) and DYSPNOEA (shortness of breath). At the time of the report, HEAD DISCOMFORT (head congestion), CHEST DISCOMFORT (chest congestion) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
patient developed covid-19 infection on 8/11/21. positive test 8/16/21
12/26/08 1520 client fainted 5-10 secs., did not fall, no injuries noted, B/P 90/60, R14, P60, no SOB noted, push/grips strong, perria intact, skin u/d appropriate for face, A10 x 3, able to follow commands, answered appropriately, denied pain, client drank fluids, legs raised while lying down 15 mins, stated "feeling better, did not drink a lot of fluids, got up late, don't like shots".  Encouraged dad to follow-up physician.
Inflammation characteristics; Left arm was tender, red and warm at the injection site / Tender, pain; Left arm was tender, red and warm at the injection site; left arm was tender, red and warm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced injection site inflammation, injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site inflammation, injection site pain, injection site erythema and injection site warmth were recovering/resolving.   It was unknown if the reporter considered the injection site inflammation, injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and noticed after the injection, that her left arm was tender, red and warm at the injection site, but she reported that it looks better every day.  The tender, pain, warm and red, inflammation characteristics.  The reporter did not know HCP information. The reporter did not consent to follow up.
Patient fainted and felt from the bed to the floor had a head concussion and a seizure. Patient will be refer to neurologist.
About an hour and a half after the inoculation, my throat and mouth started to get extremely itchy.  By mid evening I had a rash on my face and moving down my neck.  The rash has spread over my entire face, on my stomach, backs of legs, and my back.  It is extremely itchy and uncomfortable.  I am able to take Clairtin during the day and Benadryl at night.  They haven't seemed to ease the symptoms.
Mom reports child cannot move without shaking. Has not checked temp but gave TYLENOL. Counseled to give ibuprofen and see PMD.
Store technician administered 1st COVID-19 Moderna vaccine shot into left arm of "Patient".  Upon disposing the syringe in the Sharps container, employee shortly notifies patient that the syringe was empty with air and says that she needs to administer again.  Patient was uncomfortable with any possibility of potentially getting a second dose of the vaccine by accident since Patient not only reported feeling sensations in her body shortly after the first administration but more so because employee already disposed and delayed momentarily before notifying the Patient of the error.  Patient considered that the only way to confirm for a fact that the shot was empty or not was to look through each of the syringes within the Sharps container to check for evidence of residue (or lack thereof).  Employee managed to retrieve a few syringes and stopped further inspection upon finding a syringe without any evidence of residue from the vaccine.  Employee then proceeded to administer the shot a second time.  Witnesses (store Employees) were present.  Patient proceeded to file a report with the pharmacy manager who stated that she will file a (same day) Quality Assurance report to document the event which will go into their files and a copy will also go to store Corporate.  Patient mentioned to  Manager about retrieving and inspecting each syringe for evidential confirmation and peace of mind that employee had not given any other empty shots that day.  However, after Manager spoke to her supervisor Patient was told it was not possible without the proper tools to handle the biohazardous materials.  Patient remained past her monitoring/observation time for side effects around 12:00PM.
Patient states the injection site started itching the night after the vaccine was administered. Subsequently, a rash (scaly and red) formed within 3 days after administration. The size of the rash was approximately 1.5 cm x 1 cm.
on 5/4/23 pt woke up with redness, warmth and itching of injection site,  redness has cont to increase over last several day
Severe headache, muscle pain from neck up, sore throat, constant cough, diarrhea, shortness of breath, muscle paralysis, pain in liver, pain in kidney, weight loss, night TMJ, lock jaw, physically weak. Have been under doctor's care since inception, Seeing multiple medical specialists. Taking numerous tests.
Hives to site of injection & legs, neck, thigh, abdomen 2 days after injection.
diagnostic with Lichen Planus; This is inconvenient; This spontaneous case was reported by a consumer and describes the occurrence of LICHEN PLANUS (diagnostic with Lichen Planus) and FEELING ABNORMAL (This is inconvenient) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A and 004F21A) for COVID-19 vaccination.     Patient never had COVID positive test. No history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. Patient did not have similar events in the past.  Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Amoxicillin). Concomitant products included VITAMINS NOS for an unknown indication.   On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, 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 experienced LICHEN PLANUS (diagnostic with Lichen Planus) and FEELING ABNORMAL (This is inconvenient). At the time of the report, LICHEN PLANUS (diagnostic with Lichen Planus) and FEELING ABNORMAL (This is inconvenient) had not resolved.            It was reported that after getting the second dose of the Moderna covid19 vaccine a month and half later patient got red marks in her stomach, forearms, back and chest. She went to the dermatologist and was diagnosed with Lichen Planus, she also reported that lot of articles stated that is in correlation with the vaccine, the rash was going to take months to get away and she had to take steroids. It was inconvenient and was itching all the time. Patient no office visit. It had been 3 months so far and was not giving signs of getting better and it had worsened.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Follow up received contains no new information.
For 24 hours expereinced headache, body aches, and nausea.  Took Tylenol.
Slight bump underneath injection site; arm warm to touch at site of injection; chills; sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Slight bump underneath injection site), VACCINATION SITE WARMTH (arm warm to touch at site of injection), CHILLS (chills), MYALGIA (sore arm) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, CLONIDINE and LABETALOL for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE MASS (Slight bump underneath injection site), VACCINATION SITE WARMTH (arm warm to touch at site of injection), CHILLS (chills), MYALGIA (sore arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 09-Mar-2021, CHILLS (chills), MYALGIA (sore arm) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE MASS (Slight bump underneath injection site) had not resolved and VACCINATION SITE WARMTH (arm warm to touch at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As reported patient experienced chills, arm was sore, and headache. Took Tylenol 8Mar2021overnight after getting first dose. Also experienced slight bump underneath injection site..
get the shots and get sick; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who reported get the shots and get sick after receiving  influenza vaccine.  The patient's past medical history, medical treatment(s),concomitant medication,  vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site (form, strength, batch number, expiry date: unknown) for Prophylactic vaccination. Information for batch and expiry date was requested.  On an unknown date the patient had a non-serious event of get the shots and get sick (illness) (latency: unknown) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: unknown.
I have very swollen lymph node in my armpits at the same arm where I receive the vaccine
Injection pain, entire upper arm swollen, painful to move or lift.  Fever began two hours after vaccine was administered  still currently at 101.5 with Tylenol. Extreme fatigue, muscle aches, chills. No change when taking Tylenol or Ibuprofen.
Lymph nodes swollen in neck for over  a week , extreme spine pain, muscle pain in arms bilateral, extreme joint pain in bilateral hips , fatigue
Narrative: COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/06, Pfizer, dose #2 10/10 pt admit to medicine cc: fall dx: Diziness, COVID + LOS: 3 days 10/10 pt cc: exposure: unknown 10/10 COVID swab, result: detected 10/10 CXR Impression: Clear lungs without acute findings 10/11 CTA PE Impression: 1. No large pulmonary embolism identified. Small area of subtle low attenuation area within a subsegmental pulmonary artery to the left lower lobe, favored to reflect artifact from patient respiratory motion given associated findings. Small pulmonary embolism is difficult to entirely exclude in the setting of high clinical suspicion. 2. Two new small ground glass opacities in the left upper lobe and a new focal ground glass opacity in the left lower lobe, which may reflect an infectious/inflammatory process. Focal opacity in the inferior left upper lobe reflects atelectasis. Attention on follow-up imaging to confirm resolution. 10/11 FIBRINOGEN: 264 10/11 DDIMER: 0.99 10/11 ESR: 300 10/12 DDIMMER: 1.01 10/12 ESR: 5 10/13 FIBRINOGEN: 281 10/13 DDIMER: 0.98 10/13 ESR: 11
This case was reported by a healthcare professional and described the occurrence of diaphoresis in a 20-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  Concurrent medical conditions included asthma and smoker.  There were no concurrent medications.  On 10 October 2008 at 10:00 the subject received a dose of FLULAVAL at 0.5 ml in the left arm.  On 10 October 2008, 45 minutes after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue.  The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention).  The subject was taken to the emergency room and treated with epinephrine.  Approximately four hours and fifteen minutes following onset, the symptoms were improved.  The health professional reported that she had five other subjects with similar, but less severe symptoms.  She did not have specific information regarding these subjects at the time of reporting.  Linked cases include: A0751890A, A0751892A, A0751893A, A0751894A and A0751895A.
On 1/12/2022 I started feeling like I had bronchitis, I had some chills, fever, and wet coughing. I was coughing up phlegm. I did a teleconference with a doctor and she prescribed antibiotics and cough medicine and asked me to do a Covid-19 test. I did the Covid-19 test on 1/13 but the sample size was not sufficient. I had to retest on 1/18 and it came back positive. I did 2 tests on 1/24, negative antigen immediate test and the PCR came back positive. When I had the second test I did not have any symptoms except the cough. I still have the cough and I am still coughing up phlegm.
Fever; Fussiness; Poor sleep; Elevated INR / coagulopathy, bleeding from PIV sites.
nose bleed; body aches; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced MYALGIA (body aches). On 09-May-2021, the patient experienced EPISTAXIS (nose bleed). At the time of the report, EPISTAXIS (nose bleed) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information provided was Tylenol
Breakthrough COVID-19: Patient is a 92-year-old female with past medical history of known in dysphagia, unspecified lower back pain, history of esophagitis, history of paroxysmal AFib not on anticoagulation. Was brought in by EMS, from local Nursing Home, EMS was called. Patient denies any chest pain, vital signs stable. CBC mild leukocytosis, mild neutrophilia, CMP mostly unremarkable. Chest x-ray was done, patient showed bibasilar infiltrates likely pneumonia, possible aspiration pneumonia. First Dose 8/26/21.
WITHIN A FEW MINUTES OF RECEIVING THE VACCINE, PT BECAME PALE AND EXPERIENCED NAUSEA, HEADACHE, DIZZINESS, VISION CHANGES (STATED SEEING RAINBOWS/DOTS), AND RINGING IN THE EARS. ADMINISTERED BENADRYL. MONITORED PULSE AND BP. PT DRANK SOME WATER.
The dose for the Moderna vaccine is .5 mL. This patient inadvertently received an overage of 0.01 to 0.02 mL.  The manufacturer instructed us to contact the patient to inform  them that the increased dosage could potentially lead to side effects that could be local or systemic. No serious adverse events were reported by the patient.
ZOSTAVAX given instead of varicella. Contacted CDC & they requested that VAERS form be submitted.
Information has been receoved from a health professional concerning an 83 year old female with no known allergies who on 15 OCT 2001 was vaccinated with one dose of pneumococcal vaccine 23 polyvalent (lot #640744/0994L). Within hours post-vaccination the patient developed redness, warmth and swelling at the injection site and arm. The patient sought unspecified medical attention. Additional information has been requested.
Patient presented to ED reporting received PNEUMOVAX day previously. Complained of redness, warmth, edema and decrease ROM shoulder and arm.