chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing in both ears; Ear pressure, clogging and the feeling of water in the ears; Chest tightness; Sternum pain; Aches and pains throughout my upper body, exacerbated by exercise; Transthoracic Echo showed some abnormalities.; Blood pressure elevated; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 49-year-old male patient received first dose of bnt162b2 (Covid 19, Brand Pfizer, Solution for Injection, Lot Number: EN6202), via an unspecified route in the left arm on 27Feb2021 at 14:15 (age at vaccination: 49-year-old), as a single dose for covid-19 immunization. Medical history included high cholesterol. Concomitant medication included atorvastatin calcium (LIPITOR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 01Mar2021, 36 hours after vaccination, patient woke up at 03:00 am with ringing in both ears for the first time in his life. Patient have seen two ENTs and a chiropractor. Patient have had periods of ear pressure, clogging and the feeling of water in the ears. In addition, 13 days after vaccination on an unknown date, patient started experienced chest tightness, sternum pain, aches and pains throughout his upper body, exacerbated by exercise, transthoracic echo showed some abnormalities and blood pressure elevated, still. Therapeutic measures taken as a result of the events included nasal spray, allegra, chiropractor and acupuncture. Patient has received second dose of bnt162b2 (Covid 19, Brand Pfizer, Solution for Injection, Lot Number: EN6206), via an unspecified route in the left arm on 20Mar2021 at 12:45, as a single dose for covid-19 immunization. The patient underwent lab test and procedure which included hearing test was normal and showed no loss of hearing, pressure test was normal, Chest xray and stress test was normal, transthoracic echo showed some abnormalities, blood pressure elevated, PCR (SARS-CoV-2 test) nasal swab: negative on 10Mar2021 and 20Mar2021. The clinical outcome of periods of ear pressure, clogging and the feeling of water in the ears have diminished over the past 12 weeks and only now happen a few times a week, but the ringing in the ears persists. It was constant but he has gotten more used to it, and there are times when it is louder and times when it is less loud, chest symptoms have mostly resolved, blood pressure elevated, still, sternum pain, aches and pains throughout upper body, exacerbated by exercise was not recovered.  Follow-up attempts are completed. No further information is expected.
Breakthrough case admission after 3 vaccines Moderna 1/22/21 Lot#027L20A Moderna 2/20/21 Lot# 038K20A Moderna 11/4/21 Lot# 939905
cold sores; not feeling right; achiness; chills; fever; "Flu-like symptoms"; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 1st dose of Shingrix (intramuscular) 0.5 ml. On 19th April 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell, pain, chills, fever and influenza-like symptoms. On an unknown date, the patient experienced cold sores. On an unknown date, the outcome of the feeling unwell, pain, chills, fever, influenza-like symptoms and cold sores were recovered/resolved.   It was unknown if the reporter considered the feeling unwell, pain, chills, fever, influenza-like symptoms and cold sores to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in her left deltoid.   The next day, the patient was not feeling right and experienced achiness, chills, shivering, fever of 102.4 and flu-like symptoms. On an unknown date, less than a month, the patient also experienced cold sores.   The patient sought treatment at the local emergency room for fever.   The patient fully recovered from her symptoms.   The patient gave permission for safety to follow up with her physician.
Information has been received from a registered nurse concerning a 10 year old male who was vaccinated on 12/02/1997 with a doses of varicella virus vaccine live (Oka/Merck).  In October 2003 the patient was seen with a rash over his entire body.  The child was noted to have chickenpox breakthrough.  Unspecified medical attention was sought.  There was no product quality compliant.  The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed chickenpox breakthrough/shingles.  No further information is expected.
After first dose he was weak the first day and then was fine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (After first dose he was weak the first day and then was fine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included METFORMIN, AMLODIPINE and ATORVASTATIN for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced ASTHENIA (After first dose he was weak the first day and then was fine). At the time of the report, ASTHENIA (After first dose he was weak the first day and then was fine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It mentioned that the patient consumed concomitant medications for high blood pressure.  No treatment medications were reported.   This case was linked to MOD-2022-468644 (Patient Link).
Pt.'s Son states that after receiving the 2nd dose of Moderna 03/12/2021, started experiencing symptoms 03/30/2021 of suffering a Blood Clot in the right side of the Brain, Ischemic Stroke with loss of Mobility to the left side. Hospitalized for 7 days at Hospital, discharged to a Rehabilitation Center. PT for Follow-Up care after 1 month of Rehab.
Pain at injection site; Chills; Body aches; Diarrhea; Nausea; Extreme fatigue; Stabbing pain in right lower abdomen; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6200) via an unspecified route of administration in the left arm on 01Mar2021 at 12:30 (at the age of 69-years old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and COVID-19 (prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 02Mar2021 at 02:00, the patient experienced pain at injection site, chills, body aches, diarrhea, nausea, extreme fatigue and stabbing pain in right lower abdomen. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, chills, body aches, diarrhea, nausea, extreme fatigue and stabbing pain in right lower abdomen was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Chronic diastolic congestive heart failure (HCC)   Troponin level elevated   Coronary artery disease involving coronary bypass graft of native heart without angina pectoris -     CARDIAC REHAB PHASE II; Future   Ischemic cardiomyopathy   Herpes zoster without complication   Open wound of right knee, subsequent encounter   Other orders -     CARDIAC MONITOR; Standing -     STRICT INTAKE / OUTPUT (per unit routine); Standing -     WEIGH PATIENT; Standing -     ORTHOSTATIC VITALS; Standing -     CONTINUOUS OXIMETRY; Standing -     HEART FAILURE EDUCATION; Standing -     NOTIFY PROVIDER if need to titrate oxygen more than 2 L to maintain oxygen saturation greater than 90%; Standing -     CHF - NEW YORK HEART CLASS (NYHC); Standing -     BRAIN NATRIURETIC PEPTIDE; Standing -     TROPONIN I; Standing -     EKG; Standing -     XRAY CHEST PORTABLE -; Standing -     furosemide (LASIX) injection solution 40 mg -     CHF - No ACE inhibitor or ARB; Standing -     COMPREHENSIVE METABOLIC PANEL; Standing -     COMPLETE BLOOD COUNT WITH DIFFERENTIAL; Standing -     ceFAZolin (ANCEF) in D-4% 50 mL IV piggyback (DUPLEX) (premix) 1,000 mg -     SARS-COV-2, INFLUENZA A+B, AND/OR RSV NUCLEIC ACID TESTING PANEL; Standing -     DECISION TO ADMIT FROM ED; Standing  Hospital Course No notes on file patient was admitted to outpatient observation he has improved however is not back to baseline at this point time he still has dyspnea he will have an echocardiogram tomorrow and also see if cardiology can see him as they will be in this facility tomorrow             LabTests Pending at Discharge   Lab test were reviewed this morning they have improved but still show significant congestive heart failure he still shows a significant increase in BNP
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The medical history includes breast cancer. On 25-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration and lot#/batch# were not reported). Concomitant therapies included dexamethasone (manufacturer unknown) which was administered on 01-DEC-2013. The pharmacist reported that the patient has had breast cancer for an unspecified period of time and was diagnosed with breast cancer on an unspecified date before ZOSTAVAX was administered. The reported adverse event was cancer. The patient sought medical attention (went to unspecified physician). It was reported that she will be beginning chemotherapy to treat breast cancer soon. The outcome of breast cancer was unknown. Upon internal review the event breast cancer considered to be medically significant. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist. A patient, of an unspecified age and gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Patient felt "drunk" next morning after the vaccination. Unable to "get out of bed." Recovered by afternoon and able to go for a run. Event took place after use of product. Patient: fully recovered on an unspecified date. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
09-11-18 pharmacy, first Shingrix injection. Within a couple of days I began having pain at level 3 on scale of 1-10 with 10 being worst. I did not connect the pain to the injection at that time. 02-08-19 pharmacy, 2nd Shingrix injection. The next day my pain was up to level 6. 05-02-19 Dr OV for pain. 05-02-19 Medical Center for Echocardiogram, was normal. Electrocardiogram was normal. 05-09-19 Imaging for CT, was normal. 05-17-19 Dr for pain now level 8. 05-30-19 Imaging for MRI, pain now level 10. I was not able to lay down for MRI. 06-01-19 Stand Up MRI, I had to drive 90 miles to have MRI, was normal. 06-04-19 Neurological, Dr. He referred me to Rehabilitation Services for physical therapy. 06-12-19, 06-17-19, 06-19-19 Rehab. For physical therapy. 06-17-19 Dr for pain, continuing at level 10. He advised that condition could continue for a few weeks or for a very long time. Prescribed Gabapentin 300 mg, 1 three times daily. This medicine has brought my pain level down to a 6 and I am still unable to lay on my back. I have to sleep sitting in a recliner.
Symptoms started on 6/24 at 2:00am: chest pain difficulty breathing horrible cough  Per doctor request to take IB profrin and plenty of rest and asthma pump for lungs. As of today, he states the chest pain is minimum and his breathing is better.  However the cough is still around mainly in the mornings.
Events: Vision loss in right eye, loss of muscle function on right side, slurred speech, slow comprehension, high blood pressure, irregular heart beat, difficulty breathing, and vomiting. Taken to ER at 8 pm and given Zofran . Syptoms remained. Life flighted. Ct scan ran and normal. Released two days later with follow up to neurologist for stroke.
PATIENT IN QUESTION WAS GIVEN MISTAKENLY GIVEN THE FLUAD QUADRIVALENT EVEN THOUGH THERE WERE NOT OVER THE AGE OF 65. PATIENT WAS CONTACTED ONCE THE ERROR WAS DISCOVERED. PATIENT STATED THAT THEY HAD NO I'LL SIDE EFFECTS OTHER THAN A SLIGHTLY STRONGER REACTION TO THE SHOT THAT THE NORMALLY EXPERIENCE. PATIENT STATED THERE WERE NO LASTING SYMPTOMS OR ANY OTHER ISSUES TO REPORT AT THE TIME
Itchy bumps; Pain in the arm; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included headache. It was reported that the patient was allergic to a component of the pfizer vaccine. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) taken for unrelated headache. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Mar2021 at 10:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021, the patient experienced pain in the arm and itchy bumps. The patient reported that in the morning of April 6 hand starting feeling itchy but without bumps. However, around 5 pm the itchy bumps started coming out on left fore arm. It got worst as the night went on and had to take benadryl (MANUFACTURER UNKNOWN) to relieve it then went to sleep and woke up next morning (April 7) to more itching, he guesses the medicine has worn off. It got itchier and the bumps started showing in stomach, upper legs, but cheeks, a few on lower legs, and now also on the right arm. (fore arm and hands mostly). The patient bought CLARITIN, which was 4 times more expensive than benadryl (MANUFACTURER UNKNOWN) but did not work so went back to king benadryl (MANUFACTURER UNKNOWN) and it relieve it for around 6 hours and had to take another 50mg for another 6 hours of relief. On April 8 morning, the bumps have reduced and itchiness was only mild. So have not taken the medicine again yet and usually after 6 hours need to take another benadryl (MANUFACTURER UNKNOWN). Therapeutic measures were taken as a result of the event itchy bumps  which included treatment with benadryl (MANUFACTURER UNKNOWN) and CLARITIN. The clinical outcome of pain in the arm and itchy bumps was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
10 minutes after receiving the vaccine, I started to experience squeezing/pressure in my mid-chest under my sternum. I tried to attribute it to anxiety but after 1 hour of symptoms, I returned to the vaccine clinic site. They monitored my vitals which were stable. I returned to work thinking if I could keep my mind off of it, the sensation would go away. It didn't. 10 hours later, I was still experiencing chest pain. I went to a local ED and had a full work up including EKG, chest xray and labs. Nothing concerning was found. I am still having chest pain today.
Burning,itching, swelling, painful, hot to touch started a couple of hours after injection & continued to get worse til today -> 2 1/2 days post injection.
This spontaneous report was received from a registered nurse and refers to a 2 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 63 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
The vaccine was given past it?s refrigeration expiration date, the date on the vial was still within date.  Patient was revaccinated.
Patient was immunized with Fluzone HD (Lot# UI519AA, Exp 6/30/16) intramuscularly in his left arm on 11/28/15. Patient's wife reports to the pharmacy on 12/15/15 (17 days later) and states her husband is still experiencing soreness and limited range in mobility in his left arm. Patient received the immunization at around 5:10 P.M. and patient's wife states he did not experience any pain at the time of immunization. However, he began experiencing soreness the following evening on 11/29/15. She states there are no signs of redness or swelling, however he is unable to raise his left arm above his head and unable to move his arm too far backwards. She states he has not seen a doctor yet but plans to see his primary care physician soon.
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a patient who received BEXSERO. Concomitant products included HPV vaccine and Hepatitis A vaccine. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The shot was done concomitantly with HPV and Hepatitis A vaccines at the same day. A patient had swelling in the site of administration.
(R) deltoid - warm, red - lump - 30" additional small reddened area / 1" near site. Medically deferred permanently from further Anthrax. Will continue to monitor localized reaction.
patient felt light headed thought she would pass out. SHe laid on floor with feet up. BP did get low but improved after laying down. SHe never acutally lost conciousness
flu-like symptoms; felt like her heart was inflamed; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt like her heart was inflamed), PYREXIA (fever) and MYALGIA (body aches) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt like her heart was inflamed), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt like her heart was inflamed), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            Concomitant medication use was unknown Treatment information  was unknown   This case was linked to MOD-2021-255603 (Patient Link).
Patient developed 9-10 days after Dose 1 and Dose 2 of the vaccine a rash that involved both hands and forearms. Rash is vesicular, papular, erythematous with multiple painful petechiae. The rash also extends to the neck and mildly on the face. She consulted to an urgent care and was given prednisone for 5 days, rash resolved by Day 5 but patient continues with joint pain after rash resolved. The reactions was identical after both doses of the vaccine. Rash was the same as well as timing of the symptoms.
UNKNOWN ADMINISTRATION INFORMATION.  Patient presented to ED reporting hives and allergic reaction after receipt of Moderna vaccine earlier in the day. Given diphenhydramine, famotidine, methylpredinisolone and discharged home.
swelling, warm to touch, red at site of injection patient has been doing cool compressions to help with swelling. asked patient to monitor and if gets worse or no improvement to contact md
Had swelling and pain for a few days after, as well as body aches and fatigue, then redness developed on about day 5, along with pruritus.  The area of redness is getting bigger, and she has noticed warmth in the area.  She has tried taking Tylenol and applying topical hydrocortisone.  No other associated symptoms, no fever/body aches/chills, no N/V, no rash anywhere else or swelling of lips/tongue.  She denies any previous reaction to vaccines. Left deltoid: 5 cm x 3 cm area of light erythema, well-circumscribed, warm to touch, no TTP.  Full ROM of shoulder without pain.  No evidence of ascending lymphangitis.  PMS intact distally. Benign exam, vitals WNL.  Findings most consistent with localized reaction to her vaccine, appears to be self-limited.  Counseled patient she can try ice packs and over-the-counter antihistamine for the itching.
After 1-2 hrs, the patients had chills, shakes and felt lightheaded. The mom called our office and the patient vomited. The whole episode lasted about 1.5-2 hrs.
Arm hurt badly at injection site. Temperature of 100.5 for more than 24 hours.
Severe back pain, body tremors, leg weakness causing falls, loss of use of fingers and loss of all hand sensation making it impossible to pick up or grasp items, gout flare up, vision changes
Abrupt onset of a severe colitis attack requiring trip to ER; This is a spontaneous report from a contactable consumer. This 53-years-old female consumer (patient) reported for herself that:  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 16:45 (Batch/Lot Number: EP7533) as single dose at the age of for COVID-19 immunisation.  Medical history included endometriosis and ulcerative colitis (had been in remission over 20 years prior to this occurrence), allergy toTetracycline. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) within 2 weeks of vaccination included elderberry [sambucus nigra] (manufacturer unknown), ascorbic acid, zinc (manufacturer unknown), colecalciferol (VITAMIN D, manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced abrupt onset of a severe colitis attack requiring trip to ER on 16Apr2021 20:00. The patient was hospitalized for the event and has been treated with antibiotics and prednisone. Therapeutic measures were taken as a result of the event. Since the vaccination, the patient has not been tested for COVID-19.  The outcome of event was recovering.
Starting Friday evening severe rash and hives.   Treated with multiple Benadryl. Starting today (5/3) - swelling of the tongue.   Have tried Benadryl.   No improvement yet.