chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
A group of nurses were vaxed in the hip & had subtherapeutic titer levels;
It was reported that a pt received a Fluzone SV '99-'00 vaccination on 10/5/99. The vaccination "was given SQ instead of IM". Reportedly, that same day, the pt experienced local (injection site) reaction, nausea and vomiting. The pt reportedly, recovered from this experience. "Reviewed, no additional information at this time, 11/17/99."
I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/25/2022 ELEVATED PSA I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/25/2022 HTN (HYPERTENSION) I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/25/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/25/2022 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/25/2022 HTN (HYPERTENSION)
pt recvd vax;p/ dose 1 exp a localized rash w/ redness & swelling;p/ dose 2,rash intensified & flu like sxs were exp;reporting MD states pt recvd vax at another facility;
Long red streak, swollen also.  Very tiny itchiness.  Used ice but not till the following day.
I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 10/30/2021 BLEEDING
Information has been received from a 76 year old female consumer who on 11-JAN-2007 was vaccinated with Zostavax (Oka/Merck).  Three months after getting the vaccine in first week of April 2007, the patient developed shingles.  Medical attention was sought.  The patient's shingles persisted.  No product quality complaint was involved.  Additional information has been requested.
On the arm he received the shot, from top of shoulder to elbow: Red/Swollen skin with hard tissue underneath the size of a baseball. Skin was very hot a smelled of latex/rubber.
1-2 hours after vaccine left arm became swollen and red twice its size. Ice applied, Benadryl.
Hospitalization for COVID symptoms on dates 6/24/2022- 6/26/2022.  Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Rt. deltoid area where injection was given became extremely swollen (the entire deltoid area up to the shoulder and down towards to the elbow. Hot to touch and very painful.
Day after booster- Soreness, minor rashes, nausea, tight throat, headache , pain in chest, rapid heart, swelling in face and lymph nodes. Wheezing and heartbeat sent us to ER. Given Prednisone, Cephalexine, Ondansetron 2nd day- repeat of same symptoms by evening, return to ER. 3rd day- fatigue, minor swelling in face, headache, tight throat. Visit to allergist for bloodwork. 4th day- exhaustion, dizzy, headache behind eyes, tight throat.
Patient recievd her first dose of the Moderna Covid 19 mRNA vaccine on 3/25/2021 at another facility.  She was 16 years 4 months of age at that time.  According to the EUA of the Moderna vaccine, she was underage at that time.  After consultation with our Medical Director Dr., the second dose of Moderna was administered without incident at the facility (5/3/2021).  Parental consent from her mother was obtained prior to the second dose.
Headache, nausea, dizziness, chills, fever, runny nose, watery eyes
This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP IN HIP) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP IN HIP) (seriousness criterion medically significant) and PERIPHERAL SWELLING (SWOLLEN HAND). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP IN HIP) and PERIPHERAL SWELLING (SWOLLEN HAND) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication was reported. Reportedly, the patient's right hip to keep hurting, thinking it was the rheumatoid, no pain since Aug until now and hand was swollen, no pain all last week but now feeling better. The reporter causality for an events of RHEUMATOID ARTHRITIS and PERIPHERAL SWELLING with the RINVOQ was no reasonable possibility. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company Comment: This is a spontaneous case concerning an adult male patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up), after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning an adult male patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up), after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a registered nurse concerning a 72 year old Caucasian male with asthma, heart disease, a morphine allergy, an intolerance to lorezapam (Ativan), poor circulation and a history of bypass to leg. On 11/6/01 at 10:00 am the patient was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot # 640744/0994L), in the right deltoid. Concomitant therapy that day included a flu vaccine. There was no illness at the time of vaccination. It was reported that on 10/11/94 the patient received the first dose. The second dose does not comply with the recommended dosage schedule. The patient reportedly within one to two hours, after the second dose, felt weak and had chills with receipt of the vaccine. The patient also had chest tightness and thought a heart attack. He took two aspirin and the chest pain went away. Later that night, his arm was very sore and swollen, also described as tightly swollen. The patient developed a severe local reaction at the injection site described as red, tender, swollen and painful. It was reproted that the symptoms started to get better the next day. However, the arm began to swell and he had more painful discomfort, described as very sore. The discomfort gradually diminished over 4 days. It was reported that the entire episode lasted for two weeks. The patient sought unspecified medical attention and recovered on 11/20/01/ It was noted that when flu shots first came out the patient became very ill after the first dose of the two dose series. No further information is expected.
immature granulocytes noted on CBC drawn on  1/27/2022 and 7/28/2022
1 day after vaccination, patient experienced pain in both arms from shoulder to elbows, headache, and overall felt sick causing patient to lay in bed for several days. Majority of symptoms resolved on 7/21/21. Patient does complain of lingering headache still today (7/22/21). Patient did not take any medications to treat symptoms
Severe pain in both shoulders affecting mobility. Diagnosed initially as bilateral shoulder bursitis, but following an MRI, impingement syndrome, tendinosis and joint arthrosis was also diagnosed. This condition has continued for five months and I have been treated with cortisone injections and continuing physical therapy.
patient was given Pfizer vaccine as second dose but we later realized that she should have received moderna as her second dose
3/1/2023 I was going to bed and I had a sore throat, it got really bad quickly. I also had a headache and did not sleep well at all that night. I felt bad the next morning. I had a headache, my eyeballs hurt, sore throat, a cough and chills. I assumed I felt bad because I slept so poorly. I was out of the country and did not see a doctor. I wasn't feeling so sick that I was afraid, so I just kept going. That evening, I took a shower and went to bed earlier. The next day, I felt a little better, but did not feel good. On 3/5/23 I had a positive at home COVID test. I called my doctor the next morning and had a telehealth appointment. I was prescribed PAXLOVID and began taking it that day. I am feeling better, but am still congested.
24hr p/vax pt devel warm, red area size of silver dollar w/even border that lasted for 2 days that faded to pink;redness returned 5 days later to a lesser degree;30hr post vax pt devel nausea & it hurt to breath;t101-102 & chills;lighthead
has had a hard time going to the bathroom.  (Asked what that meant: urination or defecation and he said defecation/the lady he spoke to referred him to Pfizer and said she had the same problem, too; This is a spontaneous report from a contactable consumer. An unspecified age of female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had a hard time going to the bathroom.  (Asked what that meant: urination or defecation and he said defecation) He has only gone twice in the last 5 days. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for [vaccine BNT162B2], F/UP closure to be managed as significant.
I agree with the resident plan of discharge.  The patient did have findings of COVID-pneumonia on his CT scan in addition to pulmonary edema.  We diuresed him and his oxygenation improved notably from when he was on nasal Oxymizer on admission and was discharged on low flow nasal cannula.  Patient was profoundly concerned about his ability to afford being in the hospital.  He did have a home O2 evaluation that showed that he desatted to 86% when he was on nasal cannula.  However he recovered when his nasal cannula was turned up from 2 L to 5 L within 30 seconds to goal O2 of 91%.  We discussed extensively at the bedside what his home O2 accesses.  He states that at home he has an oxygen concentrator that can range from 2 L at 93% concentration up to 5 L at a 79% concentration.  He did not have oxygen to go home with however and so he did require a face-to-face completion for an O2 tank to be dispensed to him for discharge.  We will continue Decadron to complete a total of 10 days.   Of note, he was noted to have an A1c of 5.2% and it does not appear that the patient is aware of if he does have any episodes of low blood sugar.  He was placed on 10 units of Lantus with his metformin and Trulicity being held and he was controlled on this.  The patient states that he takes 31 units of Basaglar in the home setting in addition to his metformin and Trulicity.  Given that he will be receiving Decadron, I recommended that he continue his home insulin regimen and then after he finishes steroids may reduce his Basaglar to 10 units daily in addition to metformin and Trulicity as the patient is well below his goal A1c given his age for which she should be likely closer to 7.5%.
that it hurt like heck getting the (Prevnar) shot; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age (reported as 60, without unit) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunisation.  The patient's medical history and concomitant medications were not reported. The patient said that it hurt like heck getting the (prevnar) shot on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was to receive new Pfizer Covid 19 Bivalent Booster but instead received Primary Pfizer Covid 19 Vaccine. Patient had no reaction, tolerated well, and released home.
Shingles-across left back/shoulder-down left arm-all fingers and hand-severe blistering/pain. I now have scaring and pain and no feeling in tips of fingers on left hand. Antiviral med taken.
arm pain; light headedness; cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), DIZZINESS (light headedness) and NASOPHARYNGITIS (cold symptoms) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (light headedness) and NASOPHARYNGITIS (cold symptoms). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) had resolved and DIZZINESS (light headedness) and NASOPHARYNGITIS (cold symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    Reporter did not allow further contact
vaccination site pain; headache; tiredness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and FATIGUE (tiredness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Colitis ulcerative.    No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and FATIGUE (tiredness) was resolving.        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.   On an unknown date, post vaccination, the patient reported that she experienced symptoms of headache, fatigue, and injection site pain.   No relevant concomitant medications were reported  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Email response
Fatigue, headache. Muscle pain, joint pain, chills, nausea, dizziness, weakness
High fever. Erythema maculopapular, vesiculopustular exanthem.
I  had sharp pain from my shoulder blade to the back of my head 2 weeks after getting the vaccine. I still feel the pain sometimes.
Patient had swelling, erythema, and bruising about 2 inches above her left elbow
Individual stated she has hives. No visible signs of raised red areas, She states she felt itchy.
Four hours after receiving vaccine, patient began to feel faint; Went to the bathroom and had onset of extremely heavy vaginal bleeding; Not consistent with the timing of cycle, 1 1/2 week early menstrual cycle, lasting 9 days and usually it only last 4-5 days; Menstrual cycle lasting 9 days and usually it only last 4-5 days; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 02Aug2021 at 10:30(at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified probiotic capsules from wholefoods for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Aug2021 at 14:30, 4 hours after receiving vaccine, the patient began to feel faint, went to the bathroom and had onset of extremely heavy vaginal bleeding and was not consistent with the timing of cycle. 1 1/2 week early menstrual cycle which lasted 9 days and usually it only last 4-5 days. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events  began to feel faint, went to the bathroom and had onset of extremely heavy vaginal bleeding and was not consistent with the timing of cycle, 1 1/2 week early menstrual cycle which lasted 9 days and usually it only last 4-5 days was resolved on an unknown date in Aug2021.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown. Not Provided          No concomitant medication were reported. The reporter did not mention any treatment information.   Reporter did not allow further contact
Pt was suppose to receive Menveo and HPV vaccine. Pt was given Menveo and Bexsero at the time of the visit. Pt did not have any allergic reaction to vaccines. Pts mother was notified as was Dr. Dr. stated that there is no harm with giving both of the vaccines that were given at the time of visit and that pt can receive HPV at next well child check.
Facial flushing, bright red and itchy splotches over the face, arms and chest. Had diarrhea for 24 hours. She took a Benadryl and got relief of symptoms.
Patient said his vaccinated arm (left arm) only started hurting five days after first dose. He said he has a hx of partial torn rotator cuff, but the pain post-vaccination continues. Patient discussed with PCP last week at physical. He has not experienced a decrease in mobility, but certain movements make it worse. He said it hurts all the time. Sometimes it aches and sometimes he experiences piercing pain. He uses Naproxen, "Hydrocodone", and Gabapentin for other indications, and he said this helps the pain. The pain "doesn't keep [him] from doing anything."
15 minutes after immun. tingling lips and (L) cheek - BENADRYL 25 mg given - pt. states takes 75 mg BENADRYL HS QD. Symptoms not abating - takes 25 mg BENADRYL - 20 minutes later feeling hot, throat swelling, EMS called to hospital at 11 AM.
SEVEN HOURS AFTER VACCINE ADMINISTRATION PATIENT DEVELOPED FACE EDEMA AND RESPIRATORY PROBLEMS. WAS ADMITTED TO HOSPITAL AND WAS GIVEN ACETAMINOPHEN AND STAYED FOR OBSERVATION FOR 5 HOURS.
Per family phone call within 24 hours of vaccination patient developed fever, sore arm with a red raised area around the injection site. No respiratory/airway issues discussed. 48 hours later she had fevers and was pale with continue red raised area around the injection site.
Shakes/chills, Fever, Headache, Body ache, Extreme fatigue.
Patient is a 72 yo F w/ PMH of  DM, HTN, CKD, and asthma who presents to the ED for shortness of breath and myalgias. She reported cough for the past week with worsening difficulty breathing. Positive covid exposure as she recently had two aunts pass away 2/2 Covid. Previously received the J&J vaccine. Patient was initially hesitant to be evaluated in the ED but daughter was able to convince her to be evaluated today due to her worsening symptoms.    In the ED, patient had SpO2 of 60% on RA. She was placed on supplemental O2 and eventually BiPAP 100%. She remained tachypneic with increased work of breathing despite BiPAP. Covid swab positive. Inflammatory markers elevated. ABG showed 7.31/36/69/17. Heparin gtt started due to d-dimer >10,000 but unable to obtain CTA PE 2/2 AKI. Patient also found to be hyperkalemic w/ K 6.0. Medical management for hyperkalemia started with insulin and albuterol. Was unable to give lokelma as patient could not tolerate taking off BiPAP for PO intake.
Tachycardia, Fatigue, Dizziness, Headache, Diarrhea, Chills, Vasculitis, Face Rash.
Mother report fit of rage in The evening after immunization apt. Biting, knawing her teeth, Hitting, kicking & screaming for an hour. Next day 1/2 as bad. Mother stated she isn't herself & acts as if she isn't sure what is going on. No fever. Hard to fall asleep at night.
Itching  on arms and chest began Jan 30 approximately 4pm.  Got progressively worse throughout the night. Hives covered 95% of body,  including eyes which began to swell shut.  Took 50mg Benadryl with little relief.  Went to Urgent Care and was given:  01/31/2021 0836 famotidine (PEPCID) injection 40 mg 40 mg Intravenous   01/31/2021 0836 diphenhydrAMINE (BENADRYL) injection 25 mg 25 mg Intravenous   01/31/2021 0836 methylPREDNISolone sodium succinate (Solu-MEDROL) injection 125 mg 125 mg Intravenous  01/31/2021 0840 EPINEPHrine (EPIPEN) injection 0.3 mg 0.3 mg Intramuscular  Raised lesions started to flatten 1.5 hours after medications were administered  Dx to home with prescription for Epi Pen, prednisone PO 60mg 1dose/day and instructed to continue taking 50 mg Benadryl q4-6 hours and Pepcid OTC 1 dose per day.  Instructed to follow up with PCP in 1 week.