chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen; arm was very itchy; redness, going from her shoulder down to her elbow; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen), VACCINATION SITE PRURITUS (arm was very itchy), VACCINATION SITE ERYTHEMA (redness, going from her shoulder down to her elbow) and HEADACHE (severe headaches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swollen), VACCINATION SITE PRURITUS (arm was very itchy), VACCINATION SITE ERYTHEMA (redness, going from her shoulder down to her elbow) and HEADACHE (severe headaches). At the time of the report, VACCINATION SITE SWELLING (swollen), VACCINATION SITE PRURITUS (arm was very itchy), VACCINATION SITE ERYTHEMA (redness, going from her shoulder down to her elbow) and HEADACHE (severe headaches) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Narrative: 94yo male patient died on 12/20/2021. No info as to cause of death or any events leading up to pt's death in medical record. Pt died at home. Pt had received vaccines on 3/9/21 & 4/7/21. Pt's problem list below: PROBLEM LAST MOD PROVIDER Abnormal breath sounds (SCT 301273002) 07/24/2020 (ICD-10-CM R06.89) Chronic rhinitis (SCT 86094006) (ICD-10-CM 08/14/2017 J31.0) Cough (SCT 49727002)(ICD-10-CM R05.) 08/14/2017 Dizziness (SCT 404640003) (ICD-10-CM R42.) 08/14/2017 Pneumonia (SCT 233604007) (ID-10-CM J18.8) 08/14/2017 Abnormal gait (SCT 22325002 (ICD-10-CM R26.9) 03/18/2017 Laceration of hand (SCT 284549007) (ICD-10-CM 10/17/2016 S61.411S) Asthenia (SCT 13791008) (ICD-10-CM R68.89) 04/07/2016 Lower respiratory tract infection (SCT 50417007) 03/31/2015 (ICD-9-CM 519.8) Lower urinary tract symptoms (SCT 307541003) 03/31/2015 (ICD-9-CM 788.99) Idiopathic Pulmonary Fibrosis (SCT 700250006) 12/18/2017 (ICD-10-CM J84.112) Other dyspnea and respiratory abnormality (SCT 11/27/2015 60845006) (ICD-10-CM R06.09) Dyschromia (ICD-9-CM 709.00) 04/24/2014 Edema (ICD-9-CM 782.3) 04/24/2014 Thrombocytopenia (ICD-9-CM 287.5) 04/24/2014 Other specified disease of white blood cells 03/10/2017 (SCT 165509000) (ICD-10-CM D72.828) 1. Count elevated and he is being seen in hematology 2. Lab report again (ICD-9-CM 592.0); Calculus of Kidney (ICD-9-CM 10/15/2010 592.0) (ICD-9-CM 388.30); Tinnitus * (ICD-9-CM 388.30) 02/18/2010 (ICD-9-CM 715.98); Osteoarthritis involving the 04/27/2007 spine (ICD-9-CM 715.98) Sensorineural Hearing Loss (SCT 194424005) 07/24/2020 (ICD-10-CM H90.3) Diverticulosis, Colonic (ICD-9-CM 562.10) 12/10/2001 FOS 7-01 (ICD-9-CM 715.90); Osteoarthritis * (ICD-9-CM 12/10/2001 715.90) (ICD-9-CM 726.32); Epicondylitis * (ICD-9-CM 06/12/2001 726.32) Chronic rhinitis (ICD-9-CM 472.0) 06/12/2001 Other and unspecified hyperlipidemia (SCT 07/24/2020 55822004) (ICD-10-CM E78.5) Acute upper respiratory infections of 05/11/1999 unspecified site (ICD-9-CM 465.9) Chronic ischemic heart disease (ICD-9-CM 414.9) 02/23/2001 CABGx4 vessel 6-00 This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
5/1/19 5:20 PM Pt received his HPV (9) Lot # R028762 Exp 6/21 at around 5 PM 10 minutes later while walking to have his blood drawn (routine) for his check up his cheeks got rosy and then his forehead felt very warm and throat felt dry like crushed mints in his throat After drawing of blood he became very pale (? vasovagal) but responded to liquids + chocolate  was given Zyrtec 10 mg Did well and went home  7.21PM called Mom, pt is doing fine
A few minutes after being vaccinated I started to feel abdominal pain in the lower part of the belly, in the lower back and hips, as the hours passed the pain intensified. My Dr. diagnosed it as colic, I am 18 weeks pregnant, the pregnancy is still normal and everything is fine. The pain lasted 36 hours and diminished little by little until it disappeared.
10/24 6pm. Patient said she had a red, warm, and swollen area 5-6 inches below the injection site. The area was 4&1/2 inches wide and 5 inches in length. She had slight fever and body aches as well. 10/24 7:30/8pm. She took BENADRYL and ibuprofen. 10/25 3:58pm The area has improved and is now pink and no longer red. She is having no body aches or fever.
About 30 hrs after getting MMR, V, Hep A, Flu vaccine, pt has brief period of altered level of consciousness while bathing, possible mild seizure (mom reported some brief shaking), f/b vomiting and then promptly fell asleep. Responsive at time of mom's call with NL breathing and temp.
Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
First vaccination, 2.11.21 I only had sore arm for about 5 days. Second vaccination on 03.04.21, about 10hours later I had fever, aches, diareeah, and overall fatigue. Also the pain in my arm lasted more than a week, with that second shot. Shortly after that, I was having symptoms but did not relate them to the shot. Since August of 2021, I have had not received the booster at that time. In August, I was told that my aortic valve needed to be replaced. Prior to August, in April, my cardiologist stated that I wont need a valve replaced until two years. I asked was this related to the shot, he said could be. It jumped from needing a valve in 2 years, to needing one in 6 months. Then I started getting UTI. I have had at least 4 since August, this is not an occurrence for me. I also have diverticulitis, I never had this before. Because of the antibiotics , I developed C-diff. I got my booster shot in October 11, 2021. After that, things got really bad. During that timeframe, nothing stands out to what I mentioned.  I attended Hospital.
This spontaneous consumer report (initial receipt: 30-Sep-2011) concerns a female patient. On an unknown date the patient received a flu shot and experienced 'vertical double vision in her right eye'. She believed the flu shot contained mercury which may have caused the reaction. The event outcome was not reported.
Patient reported lightheadedness, minor throat swelling, "foggy" feeling. Reported some dizziness. Advised patient to lay down and monitored them. Offered snacks and drinks. Patient reported feeling better after an hour and left on own will with no symptoms.
Pt received seasonal flu vaccine on 10/13/09 in left deltoid IM. On 12/1/09 patient reported that arm pain began in left upper arm 24 hours after vaccination. Denied redness or swelling or injury from physical cause. Stated pain was a constant 30 on a scale of 0-10. Tried ibuprofen/heat and ice with no relief. States that pain is now a 5 with movement only. Denies swelling or redness. Instructed to follow up with personal physician on 12/1/09 and after visit to follow-up with me.
Information has been received regarding a case in litigation, via a physician, concerning a 50 year old female with stress incontinence, asthma and hypertension and a history of total abdominal hysterectomy, Marshall Marchetti Krantz operation, menometrorrhagia, tonsillectomy and cholecystectomy who on an unknown date was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included LOTREL, estrogens, PREMARIN, imipramine HCl, NASOCORT, CELEBREX and a "B-Agonist" (manufacturer unspecified). Following the vaccination, the patient developed a rash and induration. The reporter felt that rash and induration were an allergic reaction to therapy with PNEUMOVAX 23. No further information is available.
Narrative:  COVID infection following COVID vaccine series 03/08, Pfizer, dose #1 03/29, Pfizer, dose #2 06/21 COVID swab, result: not detected 11/24 COVID swab, result: not detected 12/22 COVID swab, result: detected 12/21 pt cc:  cough, fever, headache, sore throat, exposure: Church function
Nausea, tremors, and decrease in HR.  Patient taken to ED.  No epinephrine injection administered.
Adverse event: I had shingles one week after I received my first shot Actions: After the second day to have the first reactions I set up an appointment with my family doctor and when I went they told me that I had shingles as a reaction. Outcome; - Originally had 4 shingles on my face, after the 4-5 day was spread  all over my face, neck (front and back), behind the ears,  torso (including chest), back, (upper and lower), legs, glutinous,  genitals, everywhere. They were many. - The front neck area was full of shingles, that they even connected with each other. - Swollen body  More actions after spread;  - Took cold showers and baths almost every hour for around 35 hrs. of constant pain - Use Cortizone, aloe vera, Calamine, Cooling itch relief spray and creams. - Did not sleep well for 2 nights - My body is all swollen and I needed anti-inflammatory, other than Ibuprofen. Started around 3/29 and ended in 4/28 - Still have marks all over the body and my front neck skin became flexible and aged significantly
patient returned to pharmacy with flushing.  pt took a Benadryl,  during observation patient's face became bright red and tight.  Also presented with a petechial rash on neck.  Patient refused off of epipen and  patient would not allow us to call 911 but patient agreed to let her husband take her to the doctors care near by.  patient had no trouble breathing and no swelling of tongue or lips. pt said she would keep us posted.
Heart-attack 3/23/03. Vaccinated 3/21/03. No known history of cardiac problems. Severe indication of some hx of chest discomfort. MMWR weekly April 4, 2003/52 (13); 278-282. Case #3. An active man aged 64 years with a history of dyspnea on exertion and productive cough for 3 months and eight previous smallpox vaccinations was revaccinated on 3/21. On 3/23, he sought medical care for chest "fullness" and dizziness. Blood tests indicated elevated troponin I and CK-MB levels. ECG demonstrated inferior ST segment depression and T wave inversion. Echocardiography indicated moderate inferior wall hypokenesis with a normal ejection fraction. Coronary arteriography showed three vessel atherosclertic disease with development of some collateral circulation. THe pt underwent cardiac catheterization with ballon arthrotomy, and two coronary artery stents were placed. The clinical course and laboratory findings are consistent with acute myocardial infarction in a pt with chronic coronary artery disease. He returned to work on 3/31.
Pt recvd MMR/HIB vax 6NOV91 & 7NOV had t104 & 2 episodes of sz; pt was otherwise fine on exam; 8NOV still had a fever;
loss of all ability to move body, pain to touch, at times a burning sensation. can no longer move due to extreme weakness. My mother is in assisted living and was able to transfer from chair to wheelchair and feed herself as well as move her body independent of help. The same day she had her COVID shot she complained of severe pain in her right arm, within days she was no longer able to move and was rushed to the emergency. After routine tests, they were not able to determine the cause of pain and problem. I did ask if there could be a connection to the vaccine but they didn't know.
Presented about 60  hours after 2nd moderna vaccine with crushing chest pain and was found to have  acute pericarditis and a troponin of 10.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EP6955), on 13Oct2021 as dose 3 (booster), single (Lot number: EW0217) and on 27Apr2022 as dose 4 (booster), single (Lot number: FL3197) for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "past mini-stroke" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2022) Negative, notes: Negative antigen test on 30Dec2022; (01Jan2023) Positive, notes: Antigen test positive again on 01Jan2023; (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID Treatment).
This resident of the assisted living facility received his Covid-19 Moderna (1st) vaccination and he  has a leaking Aortic Aneurysm which resulted in hospitalization  and he entered into  Hospice care on 1.30.2021 and passed away on  1.30.2021.
Pt received influenza, Tdap, and Herpes zoster. presenting with [moderate] dizziness characterized as a spinning sensation that began [4 hours ago].  Since then, the dizziness has been [constant].  The patient [is] feeling unsteady and off-balance when attempting to walk. The sense of movement is [distinct] and [not] associated with any feeling of near syncope. The sense of movement [is] worse with movement of the head
Left upper extremity cellulitis developed over a 4-5 day period following the injection.
Pruritic morbilliform skin rash. Treated with oral corticosteroid & topical corticosteroids.
Patient presented with chicken pox 1 day after administration of vaccine, had negative varicella titer prior to admin; was treating shingles lesions on his wife prior to vaccine administration.
One day after immunization patient developed a red, itchy rash at injection site. It is about 4 inches wide.
This spontaneous report was received from a medical assistant and refers to a 3 months old patient. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was provided. On 05-AUG-2016 12:06, the patient was vaccinated with an improperly stored first dose of ROTATEQ lot # L023870 (expiration date and dose were not reported), via oral. It was reported that the vaccine was exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The medical assistant also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. Patient's concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of the several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Pt. C/O swelling in her throat and nausea. On assessment she was verbal, A$O x4. V/s - BP 134/87, RR 16, HR 85, Temp. 97.6, Psox 99% RA. Pt. offered 500 mls of water and 125 mls of apple juice and she finished all.  No S/S of respiratory distress notde and pt denied  any pain. Further observation was initiated until pt. said she felt  better and ready to leave. She left the observation hall at 2:55p m to her home.
Have ringing in my ears. Dr. diagnosed me with tinnitus. I never had ringing in my ears before; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfur antibiotic, gold and sunscreen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took nickel sulfate (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. The patient received other vaccines within 4 weeks prior to the COVID vaccine and included tetanus vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 28Jan2021 for an unknown indication. Concomitant medications included estrogens conjugated (PREMARIN) and muscle relaxer (MANUFACTURER UNKNOWN), both for unknown indications on unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9267) via an unspecified route of administration in the left  arm on an unknown date, as a single dose for COVID-19 immunisation. On 08Mar2021, the patient experienced ringing in ears and the doctor diagnosed the patient with tinnitus. The patient reported that she never had ringing in the ears before. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and was reported as cleaned ear wax out of ear. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 08-Jan-2014. The patient was given accidentally FLUMIST. The patient was not reporting any symptoms. The patient experienced accidentally gave expired FLUMIST which started on 08-Jan-2014. The outcome of the event of accidentally gave expired FLUMSIT is unknown. The report was considered to be non-serious by the reporter.
Rec'd call from patient states had reaction post vaccination of Flu High Dose & Pneumococcal vaccines. C/O left arm swelling, redness, chills & fever of 101.7 F 15 hours after receiving the vaccine. Took TYLENOL & ADVIL. States symptoms dissipated 11/3/12.
Developed  ITP for which he was admitted to the hospital on 8/22/23, received IVIG and started on steroids. Will follow-up with Heme/Onc.
Developmental achievement normal until after 4 month vaccines. Baby had DTAP, HEP-B and IPV at 2 months, at another facility. Child now dx'd with encephalopathy and global developmental delay.
Information has been received from an office manager concerning a 19 year old female with no pertinent medical history or no known drug reactions/allergies who on 11-SEP-2007 was vaccinated with GARDASIL (654539/0742U) in the left deltoid. Concomitant therapy included ORTHO TRI-CYCLEN. On 11-SEP-2007 the patient passed out, fell off the table and hit her head. The patient was sent to the hospital via ambulance. Medical attention was sought. No further information is available. Follow-up information was received from an office manager. It was reported that the patient fell and was sent to the ER where a head computed axial tomography was performed. The scan was negative and the patient was discharged. The patient had a lump on her head with swelling and bruising. The patient is recovering at this time and has decreased swelling. Additional information has been requested.
_ Patient came to me on 9/23 20 with a fever of 101.3 on .  He does not feel well.  Did not tell his father that he does not feel well.   Patient says he is very tired. Does not want food ?.  Sept 22 Patient Tdap Vaccine #2 Sept 23  Patient Did not feel well, Fatigue, fever 101.3 at 6 pm.  Temp 99.5 at 9:30 pm.  Left arm very painful to touch, swollen tennis ball size redness.  Patients facial and neck Tics begin to  increase Sept  24 Temp 98.6.  Arm very red, swollen, painful to touch, Lump still present Friday Sept 25?.Redness is reducing, however large lump is still present and painful to touch
Pfizer-BioNTech COVID-19 Vaccine  Shortly after recieving the dose 1 of the Covid vaccine, the patient became slightly nauseated. After 15 minutes, the nausea became worse. Patient vomited a small amount of mucus. Patient was observed for an additional 15 minutes then taken to walk-in clinic for observation or about 1.5 hours. Nausea went away and patient went back to work at COVID vaccination clinic. It is difficult to tell if this was perhaps nausea with vomiting associated with anxiety surrounding the COVID vaccination or this may have been potentially a COVID vaccination side effect.  It occurred relatively quickly but there are no signs of anaphylaxis. She was observed in the clinic for approximately 1.5 hours with no ill effects. Pt was strongly encouraged her to discuss the 2nd vaccination with her primary care physician as side effects may be more intense with the 2nd shot.  1/10/21: Pt received 2nd dose with no adverse effects.
Fri. Nov 18, Shot was given around noon. 2:00 to 3:00 started feeling tired. 3:30 achy, increased malaise, sore arm, sinus drainage, rapid and labored respiration. 5:30 totally exhausted, chills, very achy, tightness and pain in throat and lower ribs, queasy, no appetite so no dinner; went to sleep, could hardly rise to the bathroom, slept for 12 hours. Sat. Nov 19, Still extremely tired, achy, queasy. Ate meals, but food did not taste good. Sun. Nov 20, Still tired, achy, queasy. Felt better in afternoon so was more active. Did not sleep well. Mon. Nov 21, Felt lousy again-very tired and achy. Tue. Nov 22, basically back to normal.
Headache with intermittent nausea throughout the day (4am until asleep at 10pm) that limited my daily activities. The headache was severe enough to wake me from sleeping at 4am, kept me from going back to sleep, made me feel intermittently nauseous, and was not completely relieved by a 650 mg dose of Tylenol taken in the afternoon.  I didn't feel well enough for my daily tasks, and took a 2 hour nap without headache relief.  I was 22 weeks 4 days pregnant the day of the headache/nausea, estimated due date 06/13/2021.  This is my first pregnancy that is considered low-risk with a healthy course so far (and regular prenatal care).  I had nausea the first 12 weeks of pregnancy, followed by about 6 weeks of daily mild headaches (weeks 12-18).  This headache was more severe than I had experienced thus far during my pregnancy, but still manageable.  This event was unusual as I have been feeling well since week 19 of pregnancy.
Significant change in immune system. I typically get sick once or maybe twice a year. I have been sick 5 times since receiving the vaccine.
Received Flu vaccine 10-13-2006 3p left deltoid at health department, localized soreness at injection site next morning, pain started that night below injection site to elbow, pain radiated up left arm to back of neck.  Relief with heat not cold, TYLENOL at 5 no relief.  Relief with heat only, pain stayed in left arm, shoulder and neck area till 10-28-06.  Pain for 15 days.