chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started noticing heart palpitations when I would get in bed at night. My heart would pound very hard. I have a finger pulse reader and it was showing that it was in the low 40s. It would stop and then happen sporadically for a span of two weeks. I only had them at night. I had high blood pressure occasionally when I would check. I went to the ER and they did an EKG and admitted me. I had an ECHO, stress test. They ended up letting me go home and gave me a 30 day monitor for my heart. I did see the cardiologist then because my heart rate was really high and he put me on a beta blocker, metoprolol, and told me to take a baby aspirin. Then I started having tingling in my toes and lower legs on April 21st. Two nights before that the numbness and tingling started to go up my left side up into my face. I went to the same ER and they admitted me and did different test to rule out brain bleeds and clots in my lungs. When I left I was referred to a neurologist that I won't be able to see until September. Everyday since my second hospital visit I have had some numbness on some part of my left side.
Per patients mother the patient did not express any kind of discomfort at the site that the injections were given. After a day at the beach is when the redness, and swelling was noticed. Patients mother called on 06/28/2018 @ 8:30 to report the reaction. Patients mother stated that the arm did have direct sun exposure and sun tan lotion was not put on the site of the redness. Patients mother gave the patient MOTRIN to help with the swelling and did cool compresses to the area. Patients mother states that the patients arm was red and swollen from the shoulder to the elbow. Patients mother states that the patient has improved 100%, and does not have any further concern at this time.
This spontaneous report as received from a Medical Assistant refers to an unknown number of patients of unknown gender and ages. On unspecified dates, since 06-FEB-2015, the patients were vaccinated with an inappropriate storage of M-M-R II 0.5 ml, intramuscular, (lot# and expiration date were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Myalgia, Arthralgia, Palpitations, Angina, SORE THROAT Narrative:
Patient presented to the vaccination site on 11/07/21. The client notified RN that she received the complete series of Janssen COVID vaccine. First dose was given on 4/04/21 and second dose was given on 4/27/21. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Janssen. Per CDC guidance, Dr approved to proceed with COVID vaccine Janssen was obtained from medical consult team via text message from, RN, Vaccine Operations Lead. Client received COVID vaccine Janssen Lot# 1855194 on 11/07/21. The client did not report any symptoms during the 15 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 1501 unassisted and with a steady gait.
Patient is a 55-year-old male with past medical history of type 2 diabetes treated with insulin, CKD 4, hypertension who presents to the ED complaining of nausea, vomiting, headache, fever for the last week.  Patient states that 1 week ago he began having nausea and vomiting twice a day.  He states that any time he attempts to eat immediately vomits.  He has had decreased oral intake over the last week.  Patient also states that he has had diarrhea.  Patient also admits to fevers and headaches, fatigue, weakness, abdominal pain, lightheadedness, body aches, nasal congestion, sore throat, cough with sputum production (yellow), decreased urine output.  Patient cannot recall any sick contacts.  Patient states he has CKD and has an appointment with a nephrologist in 1 month.  Currently in COVID Step down unit on 01/17/2022.
2 days after receiving anthrax vaccine, pt p/w significant itching of right arm where shot administered.  On exam, erythema measuring 9x12 inches in the area with (+) warmth to the touch.  Pt provided with education, reassurance.
I had shot and sat to be observed at 8:30 am.  After about three minutes I felt a wave of adrenaline type feeling wash over me and my heart raced and I felt really out of it/fearful.  I sat for a minute hoping it would pass, and it didn't so I asked for help.  EMT gave me pulse check and blood pressure, both were very very high (don't know what) and irregular so they brought ECG.  The ECG was also irregular.  I felt disoriented and had waves of heat/blood racing/pulse racing.  I was taken by ambulance to  Hospital.  Within 2.5 hours I was feeling better, not recovered but not as acute.  They did another ECG, still irregular and did some blood draws which seemed to satisfy the Dr.  that nothing was acute.  Once I had returned to a more normal level they released me.  Tonight at home I still have a bit of a racy clammy feeling but have felt more stable thus far.  It was an awful, scary feeling and it come on in just two or three minutes after shot.
This spontaneous report was received from a female patient of approximately 74 years of age. The patient's current condition included allergy to sulfa. Approximately on an unknown date in 2006 (reported as seven and a half years ago) the patient was vaccinated with ZOSTAVAX (lot number and expiration dates were not reported) (dose number, strength, dose and route of administration were not reported). No concomitant medications were reported. On an unknown date in February 2013 the patient developed shingles. The patient stated that it was the worst pain imaginable. The patient was referred to an unspecified neurologist for the treatment. The patient was treated with VALTREX, Prednisone, Gabapentin, oxycodone and another unspecified medication. At the time of the report the patient still had affected nerves in the right arm and she could not use her right arm like she could in the past (disability). There were no lab diagnostic studies performed. The patient was not hospitalized. There was no product quality complaint involved. The patient also reported that the doctor stated to her that 5 patients had developed shingles after receiving ZOSTAVAX 7 years ago (approximately in 2007) (MARRS ID 1404USA005449). The patient and the physician wanted to know if there should be a booster dose of ZOSTAVAX given to the patients after a certain period of time. The outcome of the events was reported as recovering. The causality of the events was unknown. This case is linked to case # 1404USA005449 via the same reporter link. Additional information has been requested.
breasts enlarged and swollen as well as tender; breasts enlarged and swollen as well as tender; breasts enlarged and swollen as well as tender; body and joint pain; Fatigue; body and joint pain; headache; fever; pain at injection site; chills; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EW0217 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 09Jun2021 12:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation in Pharmacy or Drug Store. Medical history included COVID-19. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. The patient experienced fatigue, body and joint pain, headache, fever, pain at injection site, chills, swollen lymph nodes, breasts enlarged and swollen as well as tender on 10Jun2021 04:00. Reporter considered the events as non-serious. The patient underwent lab tests and procedures which included COVID-19 antigen test via nasal swab: negative on 07Jul2021. Patient visited Doctor or other healthcare professional office/clinic visit due to the events. Patient did not receive any treatment for the events. The outcome for the events was not recovered. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number ER8730 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 30Jun2021 13:00 (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation.
I went to the vaccination site to get the second dose of the Moderna COVID-19 vaccine.  During the vaccine injection by the technician, the needle and the syringe disconnected and the vaccine went over the car and my arm.  We were unable to determine how much of the dose may have been administered into my arm.  The needle definitely went into the injection site, but I don't know how much of the dose I had gotten.  I talked with the technician and supervisor on-site and they did not know what to do.  Their best recommendation was to get tested by my PCP for the anti-bodies in a couple of weeks.  I was not comforted by what I felt was ad-hoc answers to my questions, so I did not get an additional dose.  When I returned home, I called the CDC and looked online for what to do.  The official guidance is that an additional does of the vaccine should have been administered into my other arm.  I was not given an additional dose, so I do not know what I'm supposed to do.  I waited a couple of hours to see if I had the sore arm like the first dose, but I have not (as of yet) felt any affects from the vaccine injection.
Throat swelling, which developed gradually by the evening on the day patient received Pfizer 1 injection COVID 19 vaccine on Feb25. Patient did not report reaction until appointment today March 2. Patient reported slight improvement, but still had hoarseness and dyspnea during phone interview. Prescribed Medrol DosePak.
Patient received Pediatric vaccination without diluent at 0.2ml, patient reported to be feeling normal on 5/28  and on 5/29 reported having fatigue, increased heart rate, slight fever overnight into today.  Patient spoke with 24 hour nurse line about symptoms DR office stated to monitor symptoms
Rapid heart rate right after the shot. Waited in the waiting area for five minutes, then I felt normal so I didn?t mention the symptom to the practitioner.
This case was reported by a nurse and described the occurrence of fever in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 09Aug05 the subject received the 5th dose of Infanrix in the right thigh (lot AC14006BA-incorrect lot number). On 09Aug05, the subject also received vaccination with inactivated poliomyelitis virus vaccine (Ipol) and measles, mumps and rubella virus vaccine (MMRII) in the right arm. On 11Aug05, 2 days after vaccination with Infanrix, the parents of the subject called the physician's office and reported that the subject experienced a fever of 100 degrees F and large swelling at the Infanrix injection site that was 7 inches long by 5 inches in diameter, slightly elevated, and was red, warm and painful to the touch. The events resolved on 16Aug05. The nurse considered the events to be related to vaccination with Infanrix.
CG received the Moderna vaccine on 12/23/2020 at 1700 had mild arm pain for two days then was fine. On 12/28/2020 noticed the pain was back and I now have a medium sized lump in my armpit that was causing pain. On 12/31/2020 began to have a rash around the injection site that was increasing in size and limiting arm mobility. PCH EH sent CG to WorkMed and CG was given Rx for Keflex which was completed on 01/07/2021--CG stated symptoms are greatly improve.
high pitched screaming beginning @ 3PM to 330PM & then q 2 hrs for 30 min lasting till 930PM & arching back;
patient had one dose of influenza vaccine administered on 10/26/2022 . Patient did not recall and second dose was given on 12//19/2022. Patient denied feeling ill, short of breath, dizzy, with fever or any ill symptoms.
Pulmonary Fibrosis; Shortness of breath that required oxygen; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PULMONARY FIBROSIS (Pulmonary Fibrosis) and DYSPNOEA (Shortness of breath that required oxygen) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urothelial carcinoma.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath that required oxygen) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced PULMONARY FIBROSIS (Pulmonary Fibrosis) (seriousness criterion hospitalization). The patient was hospitalized on 12-Apr-2021 due to DYSPNOEA and PULMONARY FIBROSIS. At the time of the report, PULMONARY FIBROSIS (Pulmonary Fibrosis) and DYSPNOEA (Shortness of breath that required oxygen) outcome was unknown.        The action taken with 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.   Concomitant medications included were many medications for underlying urothelial cancer. Treatment included for the events was oxygen high flow nasal cannula.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was inadvertently given Moderna as a second dose at the vaccination site instead of Pfizer.  He was given Pfizer EL9269 on 2/5/2021
Systemic: Allergic: Itch (specify: facial area, extremities)-Mild, Systemic: Allergic: Rash (specify: facial area, extremities)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Fever-Mild
Lot # is accurate. I am not certain re: manufacturer though it was "Meningococcal MVC4" circled on his form. The Health Dept said mnfr started w/ 'geni...' but I did not see that listing. Symptoms were very similar to meningitis. SEVERE headache worsening w/ any position change, photophobia, nausea, stiff neck but no increased pain flexing lower spine. Low grade fever (<100). Lasted 3 days despite symptomatic treatment w/ rest and alternating Ibuprofen / Acetominophen round the clock. (this is a 'never sick kid' and I am an acute care NP and this was worrisome enough to me I called Head of Peds Dept at my facility on Sat to discuss case as my ped office was closed. We discussed again 24h later to insure improvement. I am marking 'office visit below since the exams I did & conversations had were consistent w/ an office visit.)
This spontaneous report as received from a other health care professional refers to a female patient of age of approximately 14 years old.  No information about medical history, concurrent conditions and concomitant medications were reported. On 22-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot #J006957, expiration date 05-JUN-2015 in the left arm (reported as left deltoid) that was out of temperature. The outcome of event reported is unknown. This is one of several reports received from the same source. Additional information has been requested.
Site: Redness at Injection Site-Mild, Systemic: Dizziness/Lightheadedness-Mild, Systemic: Hypertension-Severe, Systemic: Tachycardia-Medium.
Pt arm at injection site is red and swollen. Injection site is warm/hot to touch. More than 8cm diameter.
Information has been received from a physician concerning a 22 year old female patient who was vaccinated with the series of GARDASIL, 0.5 ml and developed "CIS 2" after completing the vaccination series. No information regarding the time frame for the first, second and third dose of GARDASIL. No lot number was provided. Unspecified medical attention had been sought. Upon internal review, "CIS 2" was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Pt given Hepatitis B injection 02/17/2005, was sitting in chair, looked dazed, stated feeling lightheaded, approximately 3 minutes after injection given, pt passed out at 11:00 AM, Pt came to immediately to voice and gently tactile stimuli. Pt continued to c/o feeling lightheaded and vision going dark, denied SOB, pain, nausea, or any other problem.  Immediately passed out again, and aroused very quickly to voice and gently tactile stimuli. I called for RN Director. We gently assisted the patient off the chair onto the floor and had him lay down. Pt repeatedly fainted then woke up easily to voice and tactile stimuli, but could not stay conscious for more than approximately 20 to 45 seconds at a time. Each time pt able to respond appropriately to questions and simple commands example, could state name, explain how he was feeling, could appropriately identify number of fingers shown to him by RN, and could appropriately hold up 1to 3 fingers as requested by RN. BP taken at around 11:05 AM and repeated approximately every 5 minutes stayed around 120's/80 to systolic of 115/??. Apical pulse ranged 80's slowed when passing out to speeding up when awakened. Respirations slowed when passed out to normal around 16 per minute while awake. Ammonia ampule used and patient woke up readily whenever used. Pt around 11:10 AM began to complain of a severe occipital Headache. Continued to pass out very frequently, every one to three minutes. Mother present, discussed with mother having child go to ER room to get checked out by MD as heart rate noted to be regularly irregular, and child could not be kept awake and was at this point c/o very severe occipital HA. Mother agreed and 911 called at 11:18 AM. Once ambulance staff member in the building responded immediately, rest of ambulance crew here in approximately 5 minutes. Pt at that time seemed to be more awake and could maintain wakefulness for much longer periods of time, still seemed dazed, c/o "HA and lightheaded", responded appropriately to questions. PT taken to ER Room at 11:45 AM. Note that mother did state that child never reacted this way to any prior vaccines. This was child's third Hepatitis vaccine of the series. During the first 20 to 25 minutes of this episode, child passed out multiple times, estimated to be over 25-30 times. ER room nurse called around 1:00 PM to let staff know that pt was diagnosed by MD as having a vasovagal response. Pt was released to go back home with parents and reportedly doing fine when left. The next day the school that the child attends, called Office Manager at the Health Dept. asking if child received vaccine. They reported the child was back in school. RN had called patients home the next day (02/18/2005) left message asking for parents to call Health Dept back for a report on child's condition, No answer back. The following week on Monday and Wednesday RN again called and left messages, but received no answer.
Flumist given at 6:46pm appr. 20 mins after receiving vaccine pt had complaints of blotchy redness on back of neck and complaints of throat swelling. Assessed by Dr and 2 tsp of Benadryl given. No difficulty breathing. Assessed every 5 minutes until 7:35. No symptoms at this time.  Follow up on 10/13/04 states: "information obtained from the reporter indicated that <20 minutes after FluMist pt had hive-like rash in neck (4-5 reddish spots 2cms in diameter), itching in neck, plus sensation of throat swelling which lasted for approximately 45 minutes. Pulse was 96/min, O2 saturation 99%. Given Benadryl 2 tsp's (presentation 12.5mgs/5ml) 5 min after symptoms onset. The only history of allergy was dermatitis after poison ivy."
Felt sick; Left arm is sore; Nauseous; Tired; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt sick), PAIN IN EXTREMITY (Left arm is sore), NAUSEA (Nauseous) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 immunization.    Co-suspect products included non-company products TREPROSTINIL inhalation powder for Pulmonary arterial hypertension and TREPROSTINIL SODIUM (TYVASO) inhalation powder for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included CALCIFEDIOL MONOHYDRATE (RAYALDEE), FUROSEMIDE, APIXABAN (ELIQUIS), POTASSIUM CHLORIDE, RIOCIGUAT (ADEMPAS), SPIRONOLACTONE, OXYGEN, ALBUTEROL SULFATE, FAMOTIDINE (PEPCID [FAMOTIDINE]), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA), GUAIFENESIN, PARACETAMOL (TYLENOL), MACITENTAN (OPSUMIT) and PREDNISONE for an unknown indication.   On 24-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL (Inhalation use) at an unspecified dose and TREPROSTINIL SODIUM (TYVASO) (Inhalation use) 32 microgram. On an unknown date, TREPROSTINIL SODIUM (TYVASO) (Inhalation use) dosage was changed to 48 microgram four times per day. In October 2023, the patient experienced MALAISE (Felt sick), PAIN IN EXTREMITY (Left arm is sore), NAUSEA (Nauseous) and FATIGUE (Tired). At the time of the report, MALAISE (Felt sick), PAIN IN EXTREMITY (Left arm is sore), NAUSEA (Nauseous) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered MALAISE (Felt sick), PAIN IN EXTREMITY (Left arm is sore), NAUSEA (Nauseous) and FATIGUE (Tired) to be related.    No treatment medications were reported.  The current dose of Tyvaso DPI was reported as 48 µg, four times a day (QID) via inhalation (IH) route.   Reporter did not allow further contact