chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rhinorrhea, aches and pains, lethargy, sore throat, sinus pressure, productive cough of thick tan mucus. Flu shot obtained Monday. By Tuesday I was developing lethargy, aches and pains and sore throat. By Wednesday I had developed sinus pressure, rhinorrhea, productive cough.
She is still in the hospital, she is on high flow oxygen now, 50 Liters; COVID positive/tested positive; COVID positive/tested positive; elevated white blood cells; low sodium; Low chloride; high BUN; Low EGFR; This is a spontaneous report from a contactable physician. An 85-year-old female patient received the second dose of BNT162B2 (lot number: EW0162, expiration date: 31Jul2021), at the age of 85 years old, on 24Apr2021 and the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8730, expiration date: 30Jul2021) on 30Mar2021, both at single dose for COVID-19 immunisation. Medical history included cardiac failure congestive, chronic obstructive pulmonary (COPD), diabetes, hypertension, cholesterol and she was on 2 Liters oxygen as needed before COVID. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) at 81 mg, daily; furosemide at 20 mg, daily; amlodipine at 10 mg, daily; isosorbide at 60 mg, daily; losartan at 50 mg, daily; metoprolol at 25 mg, twice daily; insulin at 12 DF via intravenous; simvastatin at 20 mg, daily. The patient had BNT162B2 and was tested positive (COVID positive) on 17Jul2021. The reporter thought the lot number of three patient were actually different. Reporter assumed that it was a variant but did not know for sure. Public Health did not know for sure, so they were sequencing DNA sample. If it was like a privacy concern, reporter had already discussed all. She was also on home oxygen even before COVID. She was on 2 Liters oxygen as needed before COVID. She was still in the hospital, she was on high flow oxygen now, 50 Liters. After COVID, the patient was put on dexamethasone (treatment). It was originally 6 mg for 10 days and then they escalated it to 20 mg for 5 days and then 10 mg for 5 days, we did the high dose because of the oxygen. The patient underwent lab tests and procedures which included chloride: low, sodium: low, blood urea nitrogen (BUN): high, epidermal growth factor receptor (EGFR): low, complete blood count (CBC): significant for elevated white blood cell, everything else normal, basic metabolic panel (BMP): significant for low sodium, low chloride, high BUN and Low EGFR, all (except COVID-19 test) in 2021, COVID-19 test: positive on 17Jul2021. The outcome of the event high flow oxygen now, 50 Liters was not recovered. The outcome of other events was unknown.; Sender's Comments: The events Covid 19 and condition aggravated are assessed as possibly related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Macular papillary rash presented to ED 5/9/08. Afebrile during duration of illness. c/o fatigue.  In ED clinical signs of viral exanthem. Suspicious for liver disease, or occult hepatitis. 7/7/08-records received for DOS 5/9/08-DX: Viral syndrome. Elevated liver function test. Diarrhea. Viral exanthem, UTI, trichomonas vaginalis. Presented to ED with 4 day history of non-bloody diarrhea, malaise and arthralgias mostly located in neck and shoulder area. Irritability. Maculopapular rash this morning
Pain at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (Pain at injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q3720A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site). On 27-Jan-2021, INJECTION SITE PAIN (Pain at injection site) had resolved. Not Provided      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.   No concomitant medications reported by reporter. No treatment medications provided by the reporter.   This case was linked to MOD-2021-211483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: no new information for dose 1
1st dose in 2019 and not received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 19-Jul-2022 Reporter's comment: The pharmacist reported that the patient received his first dose of SHINGRIX in 2019 the exact date was unknown and did not receive his second dose. Provided information per content on agency recommendations for alternative dosing regimens. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
pharmacist administered flu vaccine L deltoid. Arm ached the next day-felt like normal vaccine soreness. No redness, swelling, heat or localized pain. Deep ache.  Next day pain worsened. Pain seemed to worsen until 10/29 unbearable. Contacted Virtual MD consult. Video consult instructed to take NSAIDs, ICE and follow up with Ortho.  No nerve pain, no fever, redness or other SEs. Deep joint pain persists in L shoulder. Follow up ortho unavailable until Nov.9 on waiting list. Passive ROM exercise with NSAIDs and ICE continue.
Redness/soreness at injection site. Pain started the night she received vaccine. Redness started two days later. Continued (redness/soreness) up to present.
rubbing his chest at boobs and went down to his knees. He said it was hurting bad; rubbing his chest at boobs and went down to his knees. He said it was hurting bad; has a brown oval spot at the injection site of both arms.  It is not black and blue.; has lost weight because of pain; This is a spontaneous report from a contactable consumer (Patient wife). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 16:30 (at the age of 66 year) as dose 2, single for COVID-19 immunisation at Hospital. Medical history included Leukemia (Diagnosed about 5 years ago). Concomitant medication(s) included ongoing nilotinib hydrochloride (TASIGNA) taken for leukaemia. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in right arm on 25Mar2021 (at the age of 66 year) for COVID-19 immunisation and experienced brown oval spot at injection site from first dose right arm. On an unspecified date in Jul2021, a week ago consumer stated that patient started rubbing his chest at boobs and went down to his knees. It was hurting bad. This has happened several times in the last 2 weeks. On an unspecified date in 2021, Patient has lost weight because of pain. They saw the doctor the other day and didn't know what to do. The doctor said he would give him some Tramadol. Patient (reporter husband) said he would get it for her (reporter) if she had pain because it doesn't do anything for him. Patient started having this pain about three weeks ago. Patient has leukemia. Patient was diagnosed prior to getting the vaccine. His numbers are going down. Patient arm was black and blue and was still there. Then clarified, on 19Apr2021 that patient has a brown oval spot at the injection site of both arms. It was not black and blue. Tramadol doesn't work for patient. The patient underwent lab tests and procedures on an unknown date in 2021 which included weight: lost weight. AE(s) require a visit to Physician Office. The outcome of event weight decrease was unknown while for rest events was not recovered.  Information about lot/batch has been requested.
Temperature 102.  Cold symptoms.  Advised Tylenol for temperature.  Call if symptoms change.
I did develop a sore arm that lasted for 48 hours. It was painful when he did the injection. Then, it was the sore arm, tiredness and fatigue the next day. The 24 hours after, I felt fatigued more than usual. Saturday morning on July 9, I noted that my legs were feeling itchy, and they were both below the calf area. The next day when I could actually look, I noticed that it started to look red and developed especially on the left leg. It was beet red color. It started itching more and I noticed that there was blistering forming on the back of my left leg on the lower portion. On the right side, on the inner part of my leg, I noticed more redness, itching, and burning. I still have it, but it?s not as intense now. As of yesterday, it seemed to start subsiding. I did see a NP on Monday, July 11 and he didn?t have any answers. He didn?t think it was related to the vaccine, but he wasn?t sure. I still think it could be related because that?s the only thing I did that was different. I didn?t eat anything different or take any new medications. The vaccine was the only thing that happened. He told me to use Kenalog ointment to use for the itching. I?ve been using some CeraVe over the counter anti-itching lotion and that seemed to help. I just get these intense urges to scratch and I refrain from that because they do blister. But they are super uncomfortable. The redness looks to be subsiding, but the itchiness hasn?t. If I touch it, it does begin to itch. However, it?s not as intense as it was. The legs also did feel tight, like swelling or irritation in the legs. The symptoms are improving, but not fully recovered at this time.
Symptoms:  Ringing in left ear and mild vertigo (date of onset shown previously is approximate) Diagnosis:  Sudden hearing loss diagnosed by hearing test;  Dr. stated likely a side effect of COVID vaccine (said they had seen a few other cases)  Treatment:  Tapered dosing of Prednisone (10 mg) over two weeks. Outcome:  Slight improvement in hearing but not enough to state full recovery
Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a public health as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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.
No symptoms or side effects reported by the patient; Medical Assistant called to report that a Patient received an expired dose of VAXNEUVANCE yesterday, 6/14/2023. HCP denies known temperature excursions on product. No symptoms or side effects reported by the patient. Operator of the device is a healt; This spontaneous report was received from a medical assistant referring to a 25-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 14-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) lot number U036156, expiration date 23-MAY-2023, 0.5 milliliter (route of administration) for prophylaxis (expired product administered). No adverse event was reported.  The vaccine did not underwent any temperature excursion.
no adverse effect reported; the patient was anadvertently administered a dose of Proquad, that had been improperly stored; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 24-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (exact dose and route of administration were not reported) for prophylaxis. There were two lot numbers involved: - lot # R030805, expiration date 22-APR-2020, therapy type recombinant human albumin (rha), - lot # S003326, expiration date 02-AUG-2020, therapy type rha. Concomitant therapies included sterile diluent, which was properly stored. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported. Administered dose of vaccine experienced the temperature excursion of 27.1 degrees Fahrenheit for 40 minutes.
Unclear where vaccine was administered. Unclear if patient received at medical facility or pharmacy as there is no documentation of the patient receiving the immunization at medical facility. Skin rash; Rash; Urticaria pruritus. Treatment Diphenhydramine 25 mg BID PO
Generalized fatigue; Injection site soreness; Severe headache for 3-4 hours a few hours after injection; Slight chills; Fever; This is a spontaneous report from a contactable non-healthcare professional reporting for a patient. A 40-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in right arm on 16Mar2021 at 16:15 (age at vaccination 40-years-old) for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID-19. The patient had known allergic to seasonal, pet dander, mold and dust. Medical history included severe asthma. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included SINGULAIR, LEXAPRO, SYMBICORT, VENTOLIN and allergy medication. On 16Mar2021, at 18:00 the patient experienced severe headache for 3-4 hours a few hours after injection, slight chills and fever. On 17Mar2021 patient experienced generalized fatigue and injection site soreness. The patient did not receive any treatment for the reported events. The clinical outcome of severe headache, slight chills, fever, generalized fatigue and injection site soreness was recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
This is a rash on (R) upper arm and middle arm measured 120 mm in width and 95 mm in length with blister in middle of rash measuring 20 mm in length and 30 mm in width. Pt put some ice wrapped in towel 03/14/08, blister appeared after ice application. Rx Benadryl 12.5 mg and HC cream 2.5%. Prescribed by physician.
Woke up at 5am with chills, muscle and joint aches and nausea (no vomiting). Symptoms lasted until 5pm.
state registry says 15 month old patient received full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (state registry says 15 month old patient received full dose) in a 15-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2022, the patient experienced ACCIDENTAL OVERDOSE (state registry says 15 month old patient received full dose). At the time of the report, ACCIDENTAL OVERDOSE (state registry says 15 month old patient received full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not reported.
pt recv vax & exp pain @ the inj site,& neurological disorder,characterized by severe sweating,arm jerking,muscle twitching & numbness in the inj arm;no other details were known @ the time of this report
On  5-15-2022, I woke up and my left inner thigh was very painful. There was an obvious very tender spot that I feared there was a blood clot. I do have a history of varicose veins and wear compression stockings every day of my life. When I put on my stockings, it helped the pain in that area but did not stop the pain completely. I then wrapped an ace bandage around my thigh to further compress the area. We had planned to leave home to go out of town on 5-17 so I went but elevated my leg and used an ace bandage on my left leg for travel. I noticed on this day, 5-17-2022, that the pain to my left leg had increased in intensity. I did purchase more bandages to wrap the leg for compression. I did stop several times to walk around during the trip. On 5-22, we were with family on vacation and I went into a swimming pool and noticed a painful area to my left calf and I suspected another blood clot. I did not go to an ER while on vacation due to previous experience. I kept using compression stockings, taking advil and walking but feel my leg was getting worse. On 5-27, I was in a restaurant and noticed pain behind my left knee. I concluded that I needed to see a vascular surgeon upon returning home. It took 3 days to drive back on 6-1-2022 due to frequently getting out to walk. On 6-3, I went to my primary care doctor's office and the Physician's assistant suggested to continue with advil. As I was leaving the office, I decided to stop by the medical imaging office to ask about an ultrasound. They told me that it showed a large  DVTs. I went back to my primary care doctor's office and the Physician's assistant prescribed an Eliquis starter pack. I began taking it on 6-3-2022 . On 6-20, I went to the vascular surgeon's office and the clinic technician did an ultrasound on my left leg and they told me that my DVT was resolved but that I needed to continue taking the Eliquis and that I needed to have a procedure on my right leg to prevent clots in it. On 7-8-2022, I saw a hematologist and she took blood samples at the office. I had mentioned to her that I had heard of friends having blood clots related to the vaccines and she told me that it was known to be related more to J and J vaccine, not Pfizer.  On 8-1, I went in for a Great Saphenous Ablation on my right leg. Sometime this fall, I will be getting a Great Saphenous Ablation to my left leg as well.
Hives and body rash Started in scalp and moved all the way down body Extremely red and itchy patches  Hives have started to fade but still active, going on 16 days now
I had a seizure about twelve hours after I received my vaccine. I was conscious for it and it involved both my legs and feet.
Two inch disc around the injection site on the left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Two inch disc around the injection site on the left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #002B21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sensitive skin and Rosacea. Concomitant products included DOXYCYCLINE (DOXYCLINE [DOXYCYCLINE]) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Two inch disc around the injection site on the left arm). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Two inch disc around the injection site on the left arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I had chills, muscle aches, 102 fever, fatigue, very sore at shot site
patient did not get full dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient did not get full dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .3 milliliter. On 10-Apr-2021, the patient experienced UNDERDOSE (patient did not get full dose). At the time of the report, UNDERDOSE (patient did not get full dose) outcome was unknown. Not Provided      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.   No concomitant medications were reported.  As the pharmacist was administering the vaccine to the patient the needle leaked out 0.1 - 0.2ml patient did not get full dose  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received: NNI
Large, red, warm, itchy rash at vaccination site on left arm appeared on about 2/12/21.  Contacted PCP, she suggested I see an allergist to be safe, met with Dr. on 2/18/21, he prescribed a cortisone cream to use immediateley.  He also prescribed prednisone to use after second vaccine if reaction was worse, and an epinephrine auto-injector in case of severe reaction.  He also suggested switching arms.  Redness and itch have finally faded to almost nothing as of 2/22/21.
1.  Arm Pain-intense pain in deltoid muscle, unable to move right arm, unable to sleep, in agony 2.  Shoulder Pain-shoulder pain when moving arm-felt like shot was given too high, pain so intense-unable to sleep 3.  Primary Physician-prescribed anti inflammatory, sent me to orthopedic 4.  Orthopedic Physician-prescribed prednisone,flector patches, return visit 5.  Massage Therapy-to help the shoulder and arm start to move 6.  Medications-tons of tylenol extra strength, advil, flector patches, prednisone, sleeping pills 7.  Agony which caused me to have only a few hours of sleep at night. Pain during the day