chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My adverse event started on 12/2022 in the evening. I had chest pains. It was on my  left side between my heart and shoulder. The pain quickly spread to upper chest to bottom of throat. The pain lasted for 10-25minutes. It shows up all of a sudden. It can happen in the morning , afternoon and more in the evening after 9:00pm. I couldn't relate this to stress or anything else. I went to my Pulmonologist 02/24/2023  on who did all kinds of tests including  asthma . Pulmonary function test was done on 03/17/2023 which  negative and also a Methacholine  test which was negative.  She also referred me to a cardiologist.  I went to the Cardiologist on  02/17/2023 it was a consultation she didn't believe it was a cardio issue. She said it might from acid reflux or musculoskeletal. She ordered a Stress EKG which I did  today 03/17/2023. They said the result will come in by next week. On late January  25/2023. in the evening and I started getting   terrible  itching/ rash on my hands and feet. It started in my feet then to my hands. It's like a burn. It usually more at night. It  itches and I feel like a burning sensation and getting bit by a bug. It stared getting worse now it became hives. It's on my hands, feet and my chest.  This is an ongoing issue. I went to a Dermatologist for the Hives on 01/21/2023 they prescribe me Ivermectin ( 1 week ) , Hydroxyzine HCL, Betamethasone Propionate,  and Zyrtec. The Dermatologist  diagnosed me with 2 things what are Urticaria and Dermatographias.  She said it could be triggered by a virus, reaction to Amoxicillin, allergy or chronic hives.   I had a follow up with my Dermatologist on 03/08/2023 . I  went to my regular doctor  03/09/2023 who I also  shared this information with him. He said it could be a reaction to Amoxicillin, possibly to Mono, allergies or chronic hives. He agreed on the medication the Dermatologist prescribed and advised me to continue. On 02/09/2023 in the morning I had a sore throat, low grade fever, and cough.  I went to the walk-in clinic they determined that it was a upper respiratory infection. They told me to take Dayquil and Nyquil for few days to see if I get better or not. Since, It  got worse I went to another walk-in clinic I told them that cough was getting worse and nothing was helping . They diagnosed me as Acute Upper Respiratory and   Sinusitis. They prescribe me with 2 medication for my symptoms which are Amoxicillin,  ( 10 days) and Methyl prednisone ( 6 days) . When I finished taking the Methyl Prednisone I had hives all over my torso. My doctor thinks I have reaction to Amoxicillin.  As of today the hives has been improved but hasn't recovered fully yet. The chest pains I still have but not as much as before. The upper respiratory issues has resolved.
Soreness around the injection site; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness around the injection site), CHILLS (Chills) and HEADACHE (Headache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness around the injection site), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Soreness around the injection site), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2022-560043, MOD-2022-560044 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow-up information contains no new information.
Information has been received from a nurse practitioner concerning a 16 year old female patient with penicillin allergy, who on 14-JAN-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # 661530/0575X). On 15-JAN-2009 the patient experienced a rash on her wrist and up her arm. The patient sought unspecified medical attention. There were no laboratory or diagnostic tests performed. The patient recovered on 16-JAN-2009. Follow up information received from the medical assistant on 26-JAN-2009. It was reported that the 16 year old female patient with penicillin allergy that caused rash, on 14-JAN-2009 was vaccinated into the left deltoid with the first 0.5 mL dose of GARDASIL. On 15-JAN-2009, the patient experienced a mild rash to hands and lower forearm areas bilaterally, slight erythema that had pruritis. The symptoms started to resolved and then returned after shower. The patient denied any changes to medication, powders, soaps, lotions and/or detergents. The patient did not require treatment. Additional information is not expected.
an expired vaccine was given to a patient with no adverse event; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from other health professional and consumer/ non health care professional. This case involves a male patient (unknown age) who received an expired TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient had no other vaccines as a concomitant medication(s).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 18-Oct-2021, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot RIS772M and expiration date: 18-Sep-2021) via intramuscular route in the deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "The caller stated that an expired vaccine was given to a patient. What is their next step?"  At time of reporting, no adverse event 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 the 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.
Found by EMS on back in her crib.  Pt was intubated and given 6 doses of epi in route to ER.  Pt had no pulse on arrival.  Pt received a larger ET tube and bicarb.  Resucitation unsuccessful, pt expired.
Sweats, body aches, headache on the day of vaccination.  Next day the patient experienced regional lymphadenopathy and arm weakness.
Developed red rash around injection site on thigh within hours of vaccines (8 cm X 8 cm in doctors office) man reported prior to arriving @ doctors office left leg was purple from injection site to toes
Sore throat, nasal drip, sinus pressure, lethargy/malaise, joint pain.
Pt received covid vaccine #1 on 11JAN2021 in left deltoid. 48-72hrs later pt reports noticing a small spot or bump on her left arm. The size increased to the size of a dollar bill. Pt denies any fever. Pt developed an irregular urticarial rash that was raised, mildly erythematous to her left deltoid.
Patient reports onset of chest pain three days after his second Pfizer COVID vaccine. In the following three days after his vaccine, he had headache, decreased appetite, and mild nausea. However was still taking in fluids, decreased solid food intake. He also experienced insomnia and generalized malaise. At midnight on 07/02 he began to experience 9/10 substernal chest pain that was sharp, burning in sensation and located in the middle of the chest, non-radiating, pleuritic which lasted for several hours. Patient has had no fevers, vomiting, diarrhea, congestion, sore throat or cough. Denies any  SOB, dizziness, syncope, palpitations, edema, orthopnea. There has been no trauma to the chest. No recent URIs. He was seen at a hospital where he was found to have a trop of 1251 ng/L (converting to ~1.5 in our system) then one hour later up to 1500mg/L. His EKG at the hospital demonstrated lateral ST elevations. Had a normal CXR. He was given Maalox which was not helpful. He was transferred to another medical facility after 3 hours at the hospital.   Upon presentation to the emergency department, his vitals were stable. He had elevated CRP to 7.69, troponin was 1.0. CBC and Chem were normal. BNP normal at 15. Bedside ultrasound showed no pericardial effusion. Cardiology was consulted and ECHO showed mild left ventricular dysfunction with EF 47%. Repeat EKG here showed ongoing ST elevations in lateral leads, though mild. His pain has since improved to a 2/10. He has not required any medication for his pain. He is COVID/flu/RSV negative.   On arrival to the floor, his chest pain had completely resolved. Patient reports the pain was pleuritic, worse with exertion and improving on rest.   PMH: idiopathic urticaria  Allergies: NKDA  Family history: none reported, no cardiac disease or sudden cardiac death  Hospital Course:  Patient was admitted to the cardiology floor for continued monitoring of his troponin levels and EKG. He was then treated with IVIG 2g/kg and started on methylprednisolone IV x 2 doses. He initially had some very mild chest discomfort that improved by day 2 of admission. An echocardiogram was performed which showed improvement in his EF to 54%. Given his dysfunction, he was started on Enalapril 2.5mg twice daily. He was transitioned over to PO steroids which he tolerated well. On day of discharge, his troponin levels were trending down, and EKG was WNL. Cardiac MRI was performed and showed late gadolinium enhancement in the left ventricle. He had occasional PVCs but no arrhythmias. Viral myocarditis studies were sent and all negative.  By time of discharge, patient was well-appearing, vitals stable, demonstrating good PO intake. Prescriptions sent to preferred pharmacy. Follow up with cardiology in place. Discharge instructions and return precautions reviewed with patient and parent, who expressed good understanding and agreement with plan.  Patient will follow up in cardiology clinic next week with a repeat MRI 3-6 months.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Arm swelling at the site then getting worse-- hot, red and swelling spreading to encompass a large area of upper arm. Then developed a hive below the swelling.
Patient reports first dose on 8/23 and second dose on 9/20. Patient experienced shortness of breath and severe chest pain resulting in an Emergency Department visit on 9/22.
Whole arm numbness, mild pain, tingling. Mental fog for half a day on day two. Mild nausea.
Information has been received from a physician A clinic via relief system for sufferers from adverse drug reaction concerning a 72 year old male patient with hypertension, no allergy and a history of left eye fundal hemorrhage who on 22-OCT-2009 was vaccinated with pneumococcal vaccine injection (lot number 9MK04R), 0.5 mL into left upper arm at A clinic (indication, and injection route were not reported). Suspect therapies included COUGHCODE tablet, 2 tablet, BISOLVON tablet, 1 tablet, OMSEN tablet, 1 tablet, LOXONIN tablet, 1 tablet, BANAN tablet, 1 tablet, all of these were administered three times a day and started on 23-OCT-2009 for the treatment of "cold?". On 22-OCT-2009, at around 11:00, the patient was vaccinated with pneumococcal vaccine into left upper arm. On 23-OCT-2009, the patient visited B clinic because of flu symptoms. Diprophylline_dihydrocodeine combined drug, bromhexine, serrapeptase loxoprofen sodium, cefpodoxime proxetil were prescribed for 5 days. On 25-OCT-2009, in the morning, the patient experienced unrest and did not open his eyes. The patient developed injection site (left upper arm) cellulitis/cellulitis-like reaction. The patient was admitted to C hospital due to "worsening of consciousness condition with pyrexia". On 03-NOV-2009, the patient recovered from injection site (left upper arm) cellulitis/cellulitis-like reaction and "worsening of consciousness condition with pyrexia", and was discharged from C hospital. During the course, no test was performed at A clinic. The physician's comment (A clinic): It was unknown whether the cause was vaccine or cold medicines which prescribed at B clinic. It might be just symptom from pyrexia. The reporting physician considered that injection site cellulitis/cellulitis-like reaction was non-serious and "worsening of consciousness condition with pyrexia" was serious due to hospitalization. The reporting physician felt that the causal relationship between injection site cellulitis/cellulitis-like reaction and "worsening of consciousness condition with pyrexia" to pneumococcal vaccine and other suspect therapies was unknown. No further information is available.
No adverse effects reported; multiple unspecified patients may have been administered improperly stored VARIVAX; This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported.  Since 27-SEP-2019, multiple unspecified patients may had been administered improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S019463 and expiration date 24-JUN-2021 (strength, dose, frequency and anatomical location were not provided) for prophylaxis. The administered doses of the vaccines were stored with the temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit (mainly at 8 degrees Fahrenheit) for 38 minutes. The previous temperature excursion was 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 40 minutes. There was a digital data logger involved. No adverse effect reported.
blurred vision; lot of pain the arm (R arm, injection site; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision) and VACCINATION SITE PAIN (lot of pain the arm (R arm, injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (lot of pain the arm (R arm, injection site). On 25-Feb-2021, the patient experienced VISION BLURRED (blurred vision). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (blurred vision) and VACCINATION SITE PAIN (lot of pain the arm (R arm, injection site) outcome was unknown.            No concomitant product use was reported   This case was linked to US-MODERNATX, INC.-MOD-2020-077981 (E2B Linked Report). This case was linked to MOD-2021-089499 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Added Batch No as 028L20A. Also added injection site as Right arm and vaccination place  On 28-May-2021: Non Significant Follow up - contact info updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2020-077981:
body aches; Pregnant patient who recieved first dose of the Moderna COVID 19 vaccine; Lightheadedness; Dizziness; headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient who recieved first dose of the Moderna COVID 19 vaccine), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), HEADACHE (headache) and MYALGIA (body aches) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 035C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 02-Jan-2021 to an unknown date for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 19-Jan-2021 and the estimated date of delivery was 26-Oct-2021. On 30-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient who recieved first dose of the Moderna COVID 19 vaccine), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness) and HEADACHE (headache). On 29-May-2021, the patient experienced MYALGIA (body aches). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 30-Apr-2021, EXPOSURE DURING PREGNANCY (Pregnant patient who recieved first dose of the Moderna COVID 19 vaccine) outcome was unknown. On 30-May-2021, MYALGIA (body aches) had resolved. At the time of the report, DIZZINESS (Lightheadedness), DIZZINESS (Dizziness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment was unknown.  Patient provided consent to follow up with her by e-mail and with her physician by phone, if necessary.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up appended on 3-jun-2021 :Race , Ethnicity , Second dose , and  New Event Updated.
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-OCT-2012, at age 62, the patient was administered the ZOSTAVAX vaccine by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Very painful golf ball sized swelling in armpit the day after treatment.; Very painful golf ball sized swelling in armpit the day after treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 at 13:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "known allergies: Kiwi" (unspecified if ongoing). Concomitant medication(s) included: BIOTIN; TURMERIC [CURCUMA LONGA]; VITAMIN B12 [VITAMIN B12 NOS]; VITAMIN D3; VITAMIN C [ASCORBIC ACID]; PROBIOTICS. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 03Jun2022 at 07:00, outcome "not recovered", described as "Very painful golf ball sized swelling in armpit the day after treatment"; SWELLING (non-serious) with onset 03Jun2022 at 07:00, outcome "not recovered", described as "Very painful golf ball sized swelling in armpit the day after treatment.". Therapeutic measures were not taken as a result of swelling, axillary pain. Additional information: Patient did not had other vaccine in four weeks. Patient did not have prior vaccination. Patient did not have covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
extreme fatigue; palpitations; Fast heart rate; Initial information was received on 03-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 25 years old female patient who experienced extreme fatigue, palpitations and fast heart rate after receiving vaccine influenza quadrival A-B multidose vaccine preserved [Fluzone].  Pre-existing conditions: Asthma, Attention deficit hyperactivity disorder, Drug hypersensitivity and Food allergy.The patient's past medical history included COVID-19. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included loratadine (Claritin [loratadine]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (adderall) and levosalbutamol hydrochloride (Xopenex) and covid-19 vaccine (covid-19 vaccine) for covid-19 immunization.  On 14-Oct-2022, at 14:45 hours the patient received dose 1 of suspect influenza quadrival A-B multidose vaccine preserved lot GJ375 via unknown route for prophylaxis.   On 17-Oct-2022 at 07:15 hours (latency: 2 days) the patient developed non-serious events of extreme fatigue , palpitations and fast heart rate (heart rate increased) following the administration of influenza quadrival A-B multidose vaccine preserved.  Action taken : Not Applicable.  No corrective treatment was received for the events (extreme fatigue, palpitations, Fast heart rate).  At time of reporting, the outcome was Recovering / Resolving for all the events.
The medical assistant gave the patient  the 0.25mL but the patient should have received the 0.5mL dose.
Began not feeling well on 11/30. Chest tight, congested, and just feeling poorly. As the day went on I began feeling much worse and symptoms worsening. Went straight to bed. Woke up 11/31 feeling worse and running low grade fever. Symptoms continued to worsen. 12/4 Fever of 102 and symptoms maintained. 12/5 was prescribed PAXLOVID and began to see an improvement in symptoms. Tested negative and returned to work 12/12. Still having congestion and cough but they are improving.
Patient had Bell's Palsy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jul-2021 and was forwarded to Moderna on 08-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Patient had Bell's Palsy) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced BELL'S PALSY (Patient had Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Patient had Bell's Palsy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was on oral medications to relieve the symptoms. She denied to provide the name of drug.  Company Comment : Very limited information regarding the events has been provided at this time.  Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is expected.