chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site hard; Hand stiff; Hand swollen; Pain at the injection site; Body aches; Dizzy; Headache; Bitter vomit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Hand stiff), PERIPHERAL SWELLING (Hand swollen), DIZZINESS (Dizzy), VACCINATION SITE INDURATION (Injection site hard) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced DIZZINESS (Dizzy), HEADACHE (Headache), VOMITING (Bitter vomit), CHILLS (Chills) and MYALGIA (Body aches). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Hand stiff), PERIPHERAL SWELLING (Hand swollen), VACCINATION SITE INDURATION (Injection site hard) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Hand stiff), PERIPHERAL SWELLING (Hand swollen), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE PAIN (Pain at the injection site) and MYALGIA (Body aches) was resolving, DIZZINESS (Dizzy), HEADACHE (Headache) and CHILLS (Chills) had not resolved and VOMITING (Bitter vomit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include cholesterol medication.
MILD VIRAL EXANTHUM NOTICED 16 MARCH 0230, 11 DAYS AFTER INOCULATION.  NO TREATMENT NEEDED.
Patient experienced numbness and tingling in legs and arms.  A massive loss of muscle strength in legs occurred as well as the onset of fatigue.  Within a few days of receiving the shot the  Patient was in the emergency room at the hospital for these symptoms.  After a week these symptoms still persist.
Patient presented with SOB, nausea, and vomit. Patient was positive for COVID and fully vaccinated.
I received the Pfizer booster along with the flu shot in the same left arm (bicep location) on 12/30. I had the usual soreness in the arm on 12/30. However on 12/31 when I awoke, my entire collarbone was swollen, lumpy and extremely painful.  The swollen supraclavicular lymph nodes were inflamed and at least 1-2 inches. The entire left side of the collarbone to the neck was swollen and extremely sore. Anything touching the collarbone & lymph nodes and area near the carotid artery resulted in discomfort and extreme pain. I was more alarmed on how huge my lymph nodes had swelled to.  It was impossible to get any rest the night of 12/31-1/1 since the arm and lymph nodes were giving me so much pain.  I was extremely nervous that this could be a clot but after checking out the collarbone and touching it in various areas, I felt it was lymphnodes. I did an internet search and saw that this was a normal effect response so didn't seek urgent care. It is 1/4 and my collarbone is still swollen but not painful. The lymphnodes are not as huge as they were on 12/31 through 1/3.  I feel you should know about this reaction I had. I didn't have any  adverse extreme side effect with my Pfizer vaccines1  & 2. Only the booster.
Approximately 14 hours after injection, experienced severe shivering with elevated temp 99.8, headache and muscle/joint aches. Took Ibuprofen 400 mg and shivering & fever subsided within 3 hours.  Muscle aches subsided in about 6 hours. Headache persisted for about 12 hours and required additional Ibuprofen. Experienced malaise, fatigue (which necessitated bed rest, sleep), loss of appetite until 8pm .....19 hours from onset. Also left arm, site of injection painful, seemed swollen, and was red/hot to touch a hands width below the injection site. The redness/hotness persists 48 hours later....slight cellulitis?
only received one dose of the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-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 PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
smal palpaple cyst on rt thigh non tender, no redness; afebrile;
99 y.o. F w PMH of HTN, IPF with chornic hypoxic resp failure on 1 L NC, obesity, CKD III who lives independatnly presents to ER with facial droop and word finding difficulties. Her symptoms started this afternoon and last known normal was 1500. There was mention of body weakness on ER triage, but her NIH was 1 on arrival. CTOH  were unremarkable, CTA was pending but reportedly normal after Neurology evaluation. ER discussed with Neurology and decision to not pursue tpa. She was given loading doses of aspirin and plavix. She denies any fevers, chills, sob, chest pains, abd pains, rash, weakness, or other symptoms.
Arthralgia CHILLS, FATIGUE, PAIN/SWELLING INJ SITE,  LOCAL LYMPH NODE TENDER/SWELLING, Narrative:
Systemic: Dizziness/lightheadedness-Medium. Systemic: Sweating, flushed, low HR (39 bpm)-Medium. Systemic: Shakiness-Medium. Additional Details: Pt reported being lightheaded and wanted to lie down. Tried to assist him to our breakroom so he could lie down in private, but he lost strength and slowly went down. 2 pharmacists were on either side of him and gently laid him to the ground. He was alert and responsive but extremely bradycardic. The ambulance came and took him away.
Bruise at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at the injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site). At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site) outcome was unknown.
Initial misuse report received from a healthcare professional on 26 September 2013 and at agency on 21 March 2014. The patient had only received DTaP/IPV component from PENTACEL. No adverse event was reported. List of documents held by sender: none.
Fainted after receiving vaccinations. Rested and drank water. Patient left with mother at approximately 11:10.
Within a few days, I was having bone pain.  I have had this bone pain after the 1st and 2nd vaccines too.  I have NEVER had bone pain in my life ever. It's a strange feeling.    I still, 2 months later, sometimes wake up with bone pain, especially in my lower leg bones.   I wake up 1-2X a week with this pain.   I have no idea whether  it is causing lasting problems.
I was in a specific location so I was around a lot of cigarette smoke. I am kind of allergic to it. My sinuses got really inflamed form that. I got kind of achy. I took some Sudafed. We flew out on the 26th. The pressure from the plane made it worse and my ears weren't popping. Usually, Sudafed is enough to take care of it. I texted my mom and asked I f I should go to the urgent care, and she called me in some antibiotics.
hospitalized 9/17/21, tested positive for SARS-CoV-2 on 9/15/21. Found unconscious at home by his caretaker. Severe COVID 19 Pneumonia requiring intubation.
A month or so later I noticed that my arm was still slightly swollen and  painful to lift.  I have an appointment with my doctor on 12/20/21.
Patient given Pfizer booster dose 1 day too early. No AE noted. Pt aware.
Received DTaP, IPV, MMR and PPD 1/19/05.By that evening pt developed mild rash on both cheeks. By 1/20/05 rash had spread all over. Non pruritic lacey type rash on extremities and torso. Where pt received DTaP, rash was solid red around injection site. Rash is macular. No malaise, joint pain or neuropathy. Pt rechecked 1/24/05 and rash had resolved.
A report was received from a health care professional on 11/20/03 concerning a female vaccinee in her 50's who experienced a redness at the site of injection 2 days after inadvertently receiving Fluvirin via a needleless injector on 10/20/03. On 10/22/03 the vaccinee experienced redness at the site of injection after inadvertently receiving Fluvirin via a needleless injector. The redness lasted a few days and had resolved at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Caller called to inquiere about components in the PNEUMOVAX23 vaccine and wether or not the COVID 19 vaccine has the same components due to an allergic reaction she experienced when the caller received PNEUMOVAX23 in 2013; This spontaneous report had been received from a female consumer of unknown age regarding herself. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On unspecified date in 2013, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (dose, anatomical location, vaccine scheme, lot number, and expiration date were not provided), as prophylaxis.  On an unspecified date, the reporter called to inquired about components in the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) vaccine and whether or not the COVID 19 vaccine had the same components due to an allergic reaction she experienced when she received Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) in an unspecified date in 2013 (Drug hypersensitivity). Therefore, she sought medical attention due the event.   The outcome of the event Drug hypersensitivity was not provided.   The causal relationship between the event Drug hypersensitivity and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was related.
Headache, fatigue, neck stiffness, full boy muscle aches, and chills. Symptoms started at 7pm. Ibuprofen 8mg taken at 1am.
The patient had a breakthrough covid diagnosis on 9/27/2021 despite having  received covid vaccination on 8/19/21 and 9/16/21
Patient woke up with a rash all over her body the morning of 6/23/2021.
I have a rash on my stomach and skin sensitivity all across my left side. This started on April 20, 10 days after inoculation. I have not deviated from my normal routines in any other way than receiving the vaccine.  The rash is small and the pain is minimal, it feels like the kind of pain that directly precedes a muscle spasm, only it's been constant since onset. I am not personally concerned, but wanted to add to all data that is being collected.
patient stated 7-8 inch burning round rash at site of injection 3 days after administration, symptoms resolved on their own
Information was received from a health professional regarding a patient, demographics unknown, who on an unknown date, was vaccinated with VARIVAX (Merck) lot # J003221, expiration date 15-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination is unknown. "This is a corrected report. On 30-OCT-2013, it was reported that a Registered Nurse, who stated that the doses of VARIVAX (Merck) lot # J00321, expiration date on 15-MAR-2015 were exposed to unknown temperatures for 5 hours during interoffice transport. All vaccines are unsupported and were possibly administered to patients. No adverse symptoms reported. Nurse was unable to provide further temperature excursion details or dates of administration. All patients were revaccinated. No symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a nurse refers to currently 7-year-old patient. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On 29-JAN-2018, the patient was vaccinated with improperly stored PROQUAD (Lot # N020618 and expiration date 22-JAN-2019), (Lot# N025923 and expiration date 18-MAR-2019) for prophylaxis. The nurse stated that she has spoken to someone at Merck who determined that PROQUAD (lot # N020618) could still be used.  Temperature excursion details were provided. Temperature/Time frame was -14 degree Celsius to -10 degree Celsius (-14.3 degree Celsius) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of the six reports linked via same reporter link. Sender's Comments: US-009507513-1802USA007855.
Fainting episode upon rising from a chair; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on May2021 (Batch/Lot Number: EW0183) as 1st dose, single dose for covid-19 immunisation. The patient received the vaccine in a Public Health Clinic.   Medical history included juvenile idiopathic arthritis from an unknown date and unknown if ongoing (Previously diagnosed with JIA, but resolved with diet change), mold, gluten and lactose intolerance from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took gluten for food allergy and experienced food allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fainting episode upon rising from a chair on May2021. No treatment was received in response to the event. The patient was recovering from the event.    Follow-up attempts are needed. Additional information has been requested.
Info has been received from a health professional concerning a pt who in approx Oct 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot 3643251/0445M). Additional therapy given at the same time, in the opposite arm included influenza virus vaccine, "flu vaccine". The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently, in approx Oct 2002, the pt developed soreness in the arm, and it was warm to touch 6 days after the injection. It was also noted, the pt had enlarged axillary lymph node with soreness. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.
RAPID HEART RATE 150-160, SHAKY FEELING 10 MIN POST VACINATION
SORE THROAT MORE ON THE LEFT SIDE OF THROAT; 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 no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced sore throat more on the left side of throat. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from sore throat more on the left side of throat. This report was non-serious.
mistakenly gave a 2nd dose of Fluzone 3 days from the first one on a 5 year old, no AE; Initial information received on 18-Sep-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5-years-old male patient who received a 0.5 mL first and second dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 3 days from the first one (lot: UT7041MA, expiry date: 30-Jun-2021) via an unknown route at an unknown administration site as prophylactic vaccination.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation at the time of first dose.  It was an actual medication error due to Drug dose administration interval too short (Inappropriate schedule of product administration) on same day.  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.
None stated. Medical record and discharge summary received for DOS 10/270/09-10/29-09. Final DX: Diabetic Keto acidosis, Probable Viral Syndrome, Attention Deficit Disorder.  S/P vaccine presented in ED with nausea, vomiting. hyperglycemia, DKA. CO2 17. (+) serum acetone. Sugars in 200s.  Dropped to 58 before D/c. Resolved. D/C to home. Follow up with endocrine.  ICD9 codes: 799.9
Initial report received from a consumer on 29 September 2014. A 68-year-old male patient, who had medical history of anemia and insulin dependent diabetes and whose concomitant medications were not reported, received an intramuscular dose of FLUZONE (Lot number, Anatomical site of administration was not reported) on 11-SEP-2013. On 12-SEP-2013, within 24 hours, the patient developed a sore throat and had sore arm at injection site. The corrective treatment and laboratory details were not reported. The patient recovered from the events within 2 days. Documents held by sender: none.
headache, chills,  muscle ache....... took 1 Tylenol........symptons gone the next morning except for sore arm at site of injection......
pt recvd 4th dose of vax & exp diarrhea/cramping;
Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history or drug reactions/allergies, who about six months ago (approximately in March 2008) was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Reporter's daughter developed a fever, chills, nausea, hives, and became seriously ill after getting the first dose of GARDASIL. Patient has been hospitalized 4 times since then. Lab diagnostics studies performed included numerous tests. Therapy with GARDASIL was discontinued. At time of report, the patient had not recovered. Additional information has been requested. 1/7/09-records received for DOS 5/23-5/26/08-Admitted with C/O pain unable to get out of bed without any discomfort. History of polyarthralgia admitted for increased symptoms. first degree heart block. 11/2/08 C/O hair loss, weight gain.
parents noted noisy respiration, sx saliva mouth & tongue moving; no sz or LOC;
I tested positive for COVID-19 on 7/7/22. I was headed on vacation 6/24/22, when I started feeling ill. I felt like I had a bad cold. I am still having cold symptoms at this time.
Dizziness, headache, rash on inner left arm and neck, swelling/fluid accumulation on neck on the left side
After tolerating flu vaccine administration on 10/2/2019, pt developed mild pruritic rash, described as itchiness on back, stomach and chest where a small raised rash appeared. Pt reports symptoms onset one day after flu vaccine administration. SkinRash & Rash DIPHENHYDRAMINE 25 MG PRN, TRIAMCINOLONE small amount MG PRN
I experienced discomfort in the arm in which I received the shot.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOMFORT (I experienced discomfort in the arm in which I received the shot.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 037F21A, 023M20A and 032L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high since 2018. Concomitant products included DILTIAZEM for Blood pressure high.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (I experienced discomfort in the arm in which I received the shot.). At the time of the report, VACCINATION SITE DISCOMFORT (I experienced discomfort in the arm in which I received the shot.) outcome was unknown.            No acute illnesses at the time of vaccination. Patient was never diagnosed or tested positive for COVID-19.  After both the boosters patient experienced discomfort in the arm in which she received the shot. No treatment medication were reported.   This case was linked to MOD-2022-644263, MOD-2021-024267 (Patient Link).
First vaccine given on July 9, 2019, the second vaccine  on Aug 6, , 2019  Lot 1621926.. One week after 1st shot - developed severe back pain. Some relief after treatment.  After 2nd - developed severe back and all over joint pain. No relief to date.  Consulted primary care and chronic pain management doctor.  Prior to pregnancy in January, 2020, took muscle relaxant, a prescription NSAID, glucosamine chondritin, medical grade CBD oil . Tried, low impact cardio, sauna, hot yoga, aquatherapy - minimal relief.  As of January 2020, all medications ceased except for tylenol.  Pain is severe in mornings, and significantly impacts my daily work as Nurse Anesthesist and daily routine.
dizzy for 3 days; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine and Influenza vaccine.     Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's Comments: The patient self-reported this case. The patient stated that after getting the Flu shot and Shingle shot, he/she had been dizzy for 3 days and wanted to know what should be done and why he/she was dizzy after healing shingle shot. Additional Supportive Information: The follow-up would not be possible as no contact details were available.