chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; could barely lift it up; body ache; very tender; swollen under arm; feels like she's getting the flu; joint pain; tired; Muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DYSKINESIA (could barely lift it up), PAIN (body ache), TENDERNESS (very tender) and PERIPHERAL SWELLING (swollen under arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DYSKINESIA (could barely lift it up), PAIN (body ache), TENDERNESS (very tender), PERIPHERAL SWELLING (swollen under arm), INFLUENZA LIKE ILLNESS (feels like she's getting the flu), ARTHRALGIA (joint pain), FATIGUE (tired), MYALGIA (Muscle aches) and CHILLS (chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), DYSKINESIA (could barely lift it up), PAIN (body ache), TENDERNESS (very tender), PERIPHERAL SWELLING (swollen under arm), INFLUENZA LIKE ILLNESS (feels like she's getting the flu), ARTHRALGIA (joint pain), FATIGUE (tired), MYALGIA (Muscle aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
BODY GOT INFLAMED; CHEST TIGHTNESS/CHEST FELT PAINFULLY TIGHT WHEN COUGHING; PERSISTENT COUGH; ARM PAIN; RINGING IN THE EARS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had surgery years ago. The patient was using rescue inhaler. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 30-SEP-2021) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. Age at time of vaccination 61 years old. No concomitant medications were reported.  On 20-AUG-2021, the patient experienced arm pain, and ringing in the ears. On 27-AUG-2021, the patient experienced chest tightness/chest felt painfully tight when coughing, and persistent cough. On an unspecified date, the patient experienced body got inflamed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain on 01-OCT-2021, had not recovered from chest tightness/chest felt painfully tight when coughing, ringing in the ears, and persistent cough, and the outcome of body got inflamed was not reported. This report was non-serious.
Dose #3: Left Subclavian swelling and palpable lymph node with pain/tenderness to site. This happened with dose 1 given in left arm as well and lasted 3 weeks.
Influenza was mistakenly administered subdermal instead of PPD. Forearm became red, swollen, itchy, warm at site of injection. Treated with triamcinolone 1% cream. Symptoms subsided after 2 days. Small residual red "nickel" size spot remains today.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 12-Mar-2021, VACCINATION SITE PAIN (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided patient took acetaminophen to treat her symptoms
Information has been received from a doctor of pharmacy concerning a male patient who on approximately 04-NOV-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX (lot # 662662/0979X). It was not known if the patient had been previously vaccinated with PNEUMOVAX. The pharmacist reported that the patient developed cellulitis and received antibiotics and supportive care and is recovering. Additional information has been requested. This is one of three reports received from the same source.
Quadracel was administered to a 7 years old/no AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 23-Aug-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5635AA via intramuscular route in the right deltoid.  It was a case of actual medication error due to Inappropriate age at vaccine administration.   Patient experienced no 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.  List of documents held by sender: none.
This case was reported by a nurse via call center representative and described the occurrence of injection site discomfort in a patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number M73CE, expiry date June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On an unknown date, less than 3 weeks after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site discomfort, injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site discomfort, injection site swelling, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site discomfort, injection site swelling, injection site erythema and injection site pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information was reported as follows: The age at vaccination was not reported. The nurse reported that the patient experienced injection site discomfort, swelling, pain and redness after vaccination with the same batch number of FLUARIX. The patient was the staff member of the reported facility. This is 1 of the 10 cases reported by the same reporter.
Titre Dropped; Initial Report Received on 26-Jan-2022 and 07-Feb-2022  A registered nurse reported that a patient (age, gender, race and ethnicity unknown) received 2 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient's titer dropped.  No medical history was reported.   No concomitant medications were reported.  On 19-Jul-2021, the patient received the first dose of HEPLISAV-B (Lot # 934967, expiration date 11 APR 2022, NDC # 43528-003-01) intramuscularly in the right deltoid by the nurse reporter.   On 09-Aug-2021, 3 weeks after having received the first dose of HEPLISAV-B vaccination, the patient received the second dose of HEPLISAV-B (Lot # 934967, expiration date 11 APR 2022, NDC # 43528 003 01) intramuscularly in the right deltoid by the nurse reporter.   On 14-Jan-2202, the patient's titers dropped from 27 on 05-Oct-2021 to 9. No adverse reactions were reported. No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
His daughter is helping with history.  She states that they called and stated that he was acting somewhat confused.  He had an episode similar to this on last Thursday where his eyes looked ?glazed over?.  The decision was made for patient to come to the emergency room.  Upon arriving to the emergency room patient was found to be hemodynamically stable.  He did have a temperature of 99.1°.  He is oxygenating on room air.  A chest x-ray and CT of his chest was obtained and patient had findings consistent with a COVID pneumonia.  During the time of examination patient's O2 saturation appear to have dropped to 90 when he was talking.  He denies any shortness of breath, dyspnea upon exertion, fever chills, body aches, nausea or vomiting, no diarrhea.  He states that his appetite is intact.  He denies any headache.  He had a CT of his head that did not reveal any acute intracranial abnormalities.  He had routine labs and was found to have an elevated D-dimer at 2.81.  He had an ABG performed and was found to have a PO2 of 68.7, pCO2 of 30.5, pH of 7.512, bicarbonate of 24.5.  The remainder of patient's labs were within normal limits. Admitted on 9/20/21. Started on ceftriaxone, azithromycin. Noncontrast CT of the head was negative.  CT angio of the chest did show evidence of COVID pneumonia.  He is not significantly hypoxic, not needing any oxygen.  He has been  vaccinated against COVID since 7 months ago. Patient was also noted to have T8 compression fracture, however as per Radiology, this compression fracture has been present since at least since 2/2018. In any case patient is not having any pain and denies recent falls.  Patient received IV antibiotics.  Switched to cefdinir and doxy at discharge.  Will continue Lasix.  Hemodynamically stable for discharge. Dishcarged on 9/22/21
About 7 days after my shot, my left arm developed a large rash at the injection site which was hard, swollen, and EXTREMELY ITCHY.
This spontaneous report as received from a pharmacist refers to a 32 year old female patient. The patient's relevant medical history, current conditions, concomitant medications and past drug history were not reported. On 14-OCT-2016 the patient was vaccinated with an expired dose of M-M-R II lot # K016154, expiration date: 24-SEP-2016. The patient has not reported any adverse effects. It was unknown if there was any relevant lab work. As of 15-OCT-2016, it was unknown if the patient would continue on the M-M-R II. The outcome of receiving an expired dose of M-M-R II was unknown. There was no product quality complaint involved. Additional information has been requested.
Extreme head ache, irritability, dry mouth, numbness and tingling of my left arm, my tongue feels tingly. I feel like I drank about ten red bulls my heart feels like its racing!
I get my period one to days after my sugar pill, end 2021, my period was 6 days late and there was other symptoms just late. Apr2021, I got my period 5 days early. May2021 it was one full week late. In June 2021 it was a full week early and it was light and lasted a long time for 2 weeks. This continued till the beginning of Sep. 2 Sep2021 and got a physical and couldn't find anything.  I had sinus infections but I do feel good.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from Physician Assistant. This case is linked to cases 2018SA269762, 2018SA274507, 2018SA274519, 2018SA274520, 2018SA274523, 2018SA274521, 2018SA274525 and 2018SA274522 (same reporter). This case involves a 70 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 24-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that vaccine shipment took 3 days and temp indicator in shipping container did not show a change in temperature- that doses were not viable from shipping excursion, doses were given to nine patients. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
pt recv vax 28AUG95 & 29APR96 pt exp 20-30 lesions (described by pt father as flea bites) on the torso & legs;pt was dx w/chickenpox & treated symptomatically;
Pt received HPV#3 and Hep A adult #2 vaccines 032912. Pt had nausea, vomiting, body aches.
Vaccine was given in right upper arm. Patient had fast spreading hive on R inside forearm. Entire left arm became reddened. Extreme swelling noted on left hand and wrist. One hive noted on left side of neck/throat area. Patient also had some complaints of shortness of breath without wheezing.
Pain at injection site and numbness, tingling, and weakness to 4th and 5th digits of left arm.
The medications that were reconstituted on Friday were administered on Saturday; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, or concomitant medications was not provided.  On Friday 09-OCT-2020, the patient was in the nurse's office and was supposed to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX). The vaccines were reconstituted with sterile diluent (dose, route of administration, lot number and expiration date were not reported) and were ready to be administered that day; however, the reporter mentioned that the patient had to leave abruptly and the vaccines were not administered.  On 10-OCT-2020 (also reported as "on Saturday"), the patient returned for the vaccinations that were already reconstituted, and had administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) 0.5 milliliter (lot number reported as S013536 and expiration date 02-MAY-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot number reported as R35226 was an invalid lot number for varicella virus vaccine live (oka/merck); expiration date reported as 04-DEC-2020) (for both vaccines frequency was reported as "once", routes of administration were not reported) administered as prophylaxis (out of specification product use).
Patient seemed to be a healthy baby until late October of 1999. He developed a series of ear infections and by November he regressed. His ability to speak words stopped and he displayed autistic behaviors such as repetitious play, toe walking, lack of comprehension, sensitivity to noise and light, etc. 10/15/07-records received-office visit notes from 7/15/98-10/27/04-well baby visits with occasional otitis media, URI, viral illness. 5/5/99-scratch left eye. 9/19/02-seen for poor speech, delayed, also very active at school , does not sit still. ADHD. Fractured clavicle 6/16/03-Parents felt child developed normally until about 16-18 months of age seemed to lose some of his vocabulary words. Seen in speech therapy, very short attention span and bursts of energy. Sing song voice, echolalia. Performance test responses slow. Tests showed scores in the mentally retarded range on standardized measure of intelligence and appears to meet diagnostic criteria for ADHD and Autistic Disorder
severe headache radiating to neck; unable to sleep last night; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache radiating to neck) and INSOMNIA (unable to sleep last night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-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 HEADACHE (severe headache radiating to neck) and INSOMNIA (unable to sleep last night). At the time of the report, HEADACHE (severe headache radiating to neck) and INSOMNIA (unable to sleep last night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
At approximately the 30 minute mark, patient began complaining of hot and itchy palms. Palms and fingers developed redness and there were faint red areas bilaterally on both arms.  Patient's PCP consulted and 25 mg of Benadryl was given. PCP saw patient and determined she was safe to go home.
Extreme body aches, painful at site and painful swelling  inside armpit.  24hr Fever 102 that won?t go away with Tylenol, Nausea, chills, headache and lethargy.  Heaviness when breathing.  Flank pain.
This case was reported by a consumer via GSK Access and described the occurrence of not feeling well in a 61-year-old female subject who was vaccinated with influenza unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma. Since 2004, the subject took ADVAIR for asthma. In 2005, the subject had a quadruple bypass and her asthma seemed to get worse afterwards. On 17 September 2014, the subject received a dose of influenza vaccine unspecified (administration site and route unknown, batch number not provided). On 18 September 2014, 1 day after vaccination with influenza vaccination unspecified, the subject didn't feel well. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified.
first dose 16FEB2021 Red, indurated and swollen - no fever no chills Right arm Lot EN6201 I have photos  second dose 10MAR2021 Red indurated and more swollen, significant fatigue set in Left arm. EN6208 I have photos
About 13 hours after vaccines we're given son woke up screaming crying of high fever and complained of knee and hand pain.
Patient states sore arm that progressed to a burning sensation that has gradually gotten worse. Patient states she has spoke with her doctor and she will be getting a mri.
swollen redness 2 in in diameter around injection site, day 2-4 after swollen redness 1/2 in in diameter around injection site, day 8 after
Syncope after vaccination, within 5 minutes. Afterwards had nausea and dizziness, was flushed and sweating. Nurse observed me, had me lie down, raised my feet, and gave me juice and cookies, continued to observe me until symptoms subsided, about 15 or 20 minutes.
Adhesive capsulitis of left shoulder. Pain, stiffness, loss of range of motion; physical therapy treatment.
Pt walked into immunization clinic and reports he had small pox vaccine about 12 days ago, on Sunday he woke up with sudden appearance of rash on his upper chest, back and upper arms. No fevers/no chills, aysmptomatic except for rash.  Vaccine tech reported member stated he had shaved his chest, unsure if that was prior to small pox or after vaccination.  Visible shaving bumps present on chest. Attending physician spoke with infectious disease physician advised that keep covered and place on convalescent medical leave for 7 days. Diagnosis of Vaccinia in medical record, DoD Milivax policy states VAERS must be completed if loss more than 1 duty day.  Delay in completing VAERS staff was not aware of requirement to complete.
vaccination site movement impairment; Pain in arm of the injection after 1st dose,had pain in the arm of the injection starting first day; pain is from her shoulder down into her arm; Pain from shoulder into arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment), VACCINATION SITE PAIN (Pain in arm of the injection after 1st dose,had pain in the arm of the injection starting first day), PAIN IN EXTREMITY (pain is from her shoulder down into her arm) and ARTHRALGIA (Pain from shoulder into arm after 1st dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment), VACCINATION SITE PAIN (Pain in arm of the injection after 1st dose,had pain in the arm of the injection starting first day), PAIN IN EXTREMITY (pain is from her shoulder down into her arm) and ARTHRALGIA (Pain from shoulder into arm after 1st dose). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment), VACCINATION SITE PAIN (Pain in arm of the injection after 1st dose,had pain in the arm of the injection starting first day), PAIN IN EXTREMITY (pain is from her shoulder down into her arm) and ARTHRALGIA (Pain from shoulder into arm after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-189035, MOD-2021-189035, MOD-2021-169696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up appended
1/2/2021 vaccination. Observation for 15 min. Felt light headed, feverish. Lasted for about a couple days.  1/2/2021 ER; administered saline  / 3 hours
I hit my head, I got vertigo, visual blurriness, headache. I went to the local emergency room five or six days later when the migraines would not go away. I had a CT scan that came back normal. They told me that I would be fine. The migraines did not go away, I made an appointment with my doctor. He did a concussion screening that found that I had, had a concussion, he referred me to physical therapy for vestibular therapy. In February I saw I Neurologist who did concur with my primary care physician that I had suffered a concussion, but I was improving. I am mostly recovered; I am getting better every week.
Gave first shot, Engerix-B and patient was fine, he stated it hurt but that was all.  Then I wend to give the shot in his left arm, and when I was done he stated that it hurt.  I was going to give him a MMR shot as well but he said his arm hurt and wawnted to wait for a minute.  I asked him if he wanted to sit on the bench but he was beginning to turn pale and stated he felt like he was going to get sick and pass out. I asked a technician to get a cold compress and a wet paper towel.  At this point he passed out and we has the compress on is neck and the wet papertowels on his arms.  His mother came over to try to wake him up, he slowly came around for about a minute and then he passed out again.  At that point we called 911.  When the EMT arrived they checked his blood sugar and it was 66.  I spoke with the patient Monday and he stated he was not admitted to the hospital and that he had blood drawn and he had elevated WBC but everything else was normal.
H/A, Fever, Chills, Dizzy, Body Aches x 3 days.  Loss of appetite.  Swollen lymph nodes under arm.