chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Health Care Department concerning at least 4 patients who over the past two months were vaccinated with a fourth dose of RECOMBIVAX HB (lot number not provided). It was unspecified if the patients sought medical attention. Follow up information has been received from an office manager concerning a female patient who after having received three doses of RECOMBIVAX HB, had an hepatitis B surface antibody test which was negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB (lot number was not available). The hepatitis B surface antibody was repeated a month after the fourth dose was given to the patient and the result was 80. The patient did not develop Hepatitis B. No other adverse events were reported. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information has been receive from an office manager via medical records concerning a 17 year old female patient who on 25-NOV-1992 was vaccinated with the first dose of RECOMBIVAX HB, on 07-APR-1993, received her second dose of RECOMBIVAX HB, on 18-AUG-1993 her third dose of RECOMBIVAX HB. On 19-APR-2010 the patient's hepatitis B surface antibody came back negative (<0.5). On 26-APR-2010, the patient received a booster dose of RECOMBIVAX HB. On 03-MAY-2010 the patient's hepatitis B surface antibody came back negative (<0.5). On 10-JUN-2010, the patient's hepatitis b surface antibody was 80. This is one of several reports received from the same source. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of influenza in a 77-year-old female patient who received FLUARIX QUADRIVALENT for prophylaxis. The patient's past medical history included penicillin allergy. Concurrent medical conditions included chronic obstructive pulmonary disease. On 24th September 2018, the patient received FLUARIX QUADRIVALENT. On 25th September 2018, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced influenza, blood pressure high, diarrhea, headache, fever, swelling arm, hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness. On an unknown date, the outcome of the influenza, headache and fever were unchanged and the outcome of the blood pressure high was unknown and the outcome of the diarrhea and swelling arm were recovering/resolving and the outcome of the hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness were not recovered/not resolved. It was unknown if the reporter considered the influenza, blood pressure high, diarrhea, headache, fever, swelling arm, hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient's historical conditions included asbestos in lung. The patient did not remember the word all the time, in her lungs, it was like somebody would get it. On Monday in afternoon the patient received FLUARIX QUADRIVALENT. On Tuesday morning, when the patient woke up, she was sick, very sick, she had the chills, she was hot, she was cold, and had a headache. The patient experienced flu like symptoms consisting of fever (body temperature: 102 degree F), chills, headache, diarrhea, and high blood pressure. The patient thought that the flu shot was supposed to not give her the flu, but it gave her the flu (she guessed) and she suffered from the flu symptoms which include a hoarse voice, fever, chills, hot and cold feeling, headache, jittery and shaky feeling. The patient did not go to her physician, and her arm was very swollen. And still on Tuesday she was not feeling well. The patient stated that she was not going to ever get a flu shot again, because even on the reporting date, she was not feeling well. The patient requested compensation from Legal for the side effects she experienced and would submit her request to Legal in writing. This case was one of the 2 cases, reported by the same reporter.
Information has been received from a registered nurse referring to her 14 year old son with asthma. The patient's medical history included acid reflux. The patient had an allergy to ORAPRED (caused irritability). On 03-OCT-2016 the patient was vaccinated with the first dose of GARDASIL 9 (intramuscular in the right arm, lot#, expiration date and dose unknown). The patient also received MENACTRA and influenza virus vaccine (unspecified in the left arm concomitantly). On the same day, the patient experienced burning at the GARDASIL 9 injection site while the GARDASIL 9 was being administered. On an unknown date in October 2016 (reported as unspecified time after vaccination) the patient experienced soreness at the GARDASIL 9 injection site as well as soreness at the sites of MENACTRA and influenza virus vaccine (unspecified). The reporter stated that the GARDASIL 9 injection site hurt worse. The patient did not seek medical attention and no lab diagnostics studies were performed. The patient received unspecified treatment for the events. At the time of reporting, the patient was recovering from the events. Causality was not reported. Additional information has been requested.
the patient developed joint stiffuess and soreness in the arm that had received the PNEUMOVAX injection; soreness in the arm; Then later that same day she developed a rash / the rash spread to the shoulders and back; a 3 inch lump at the site of PNEUMOVAX injection; This spontaneous report was received from a nurse concerning to a 46-year-old female patient. The patient's medical history included dysphagia, amnesia, myalgia, sleep apnoea syndrome, depression, chronic obstructive pulmonary disease, asthma, syncope, narcolepsy, hypertension, gastrooesophageal reflux disease, renal artery stenosis and back pain.  Concomitant therapies included bumetanide (BUMEX), clonazepam, dextroamphetamine, gabapentin, levalbuterol hydrochloride (XOPENEX), levothyroxine sodium, methylphenidate,  metoprolol succinate, morphine sulfate (MS CONTIN), omeprazole, potassium chloride, pravastatin, ranitidine, spironolactone, tramadol hydrochloride, triamterene, hydrochlorothiazide, and verapamil. The patient's drug reactions and allergies included amoxicillin, ciprofloxacin, prednisone, levofloxacin, sulfa and vancomycin (reaction: hives), olmesartan medoxomil(BENICAR) (reaction: anaphylaxis)(captured in marrs # 1910USA009138), codeine (reaction: hives, nausea, vomiting, and hallucinations).    On 07-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S012822 and expiration date 21-FEB-2021, intramuscular for prophylaxis (formulation, strength, and frequency were not reported). Then later at the same day, she developed a rash and a 3 inch lump at the site (injection site mass) of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection. On 08-OCT-2019, the rash spread to the shoulders and back (rash generalised), and the patient developed joint stiffuess (joint stiffness) and soreness in the arm (pain in extremity) that had received the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection. The patient started diphenhydramine hydrochloride (BENADRYL) (manufacturer unknown) on an unknown date. On 09-OCT-2019, the patient recovered from the events. The patient sought for medical attention. None laboratories or studies were performed.   The causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)was not provided.; Sender's Comments:  US-009507513-1910USA009138:
Information has been received from a medical assistant concerning a 4-month-old male who on 20-JUN-2006 was vaccinated by mouth with a dose rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  Unspecified medical attention was sought.  Additional information has been requested.
Pt. had local swelling, erythema & pain left deltoid, measuring, approx. 4"x4", along w/headache & mild nausea/chills, the day after vax. Had fever to 103 over next 2 days w/erythema extending over entire upper arm. Tx'd w/antibiotics,rest.
7/20:  Sore throat, headache, photo sensitivity, sore neck, lethargic, no appetite. 7/22:  In addition to the above symptoms, developed petechiae rash on cheeks, torso, back, groin, buttocks, and upper thighs. 7/26:  In addition to the above symptoms that occurred on 7/20 and 7/22, developed flare of petechiae rash and painfully, swollen left, cervical lymph node.
Developed a rash on my entire upper body, all down my arms, abdomen, reck. Creases in palms of hands dried, cracked and peeled.
Supraclavicular swelling began from day 2 (2/23/2021).; This is a spontaneous report from a contactable consumer (patient). A 45-Year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9266) via an unspecified route, administered left arm on 23Feb2021 at 17:30 (at the age of 45 years) as dose 2, single for covid-19 immunization at public health department. The patient's medical history was not reported. The patient's concomitant medications (other medications in two weeks) included vitamin D (VIATMIN D NOS). No other vaccine in four weeks. The patient took previously first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9265) via an unspecified route, administered left arm on 02Feb2021at 19:00 (at the age of 45 years) as dose 1, single for covid-19 immunization. There were no other vaccine in four weeks. No covid prior vaccination. The patient experienced supraclavicular swelling began from day two on 23Feb2021. The patient did not receive treatment for adverse event. No covid tested post vaccination. The outcome of event was unknown.  Follow-up attempts were completed. No further information was expected.
Jaundice (skin and sclera yellow) 2 days (10/29/99) post vax, clearing after 7 days. Had low-grade fever 99-100 on 10/29, fatigue on 10/30 and 10/31 and on 11/1, fever to 101F. Decreased appetite until 11/2/99
Presented to clinic an 18x16cm underation on right deltoid area - redness, warmth, Temperature of 98.9, generalized achiness, and nausea.  Given Zyrtec 10mg daily/ice packs
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 75 years old female patient who was vaccinated with the dose of INFLUENZA VACCINE (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date earlier this season. She was also vaccinated with a (0.5 ml) dose of FLUZONE HIGH DOSE (Batch number: L-UI994AA, Expiry date: 02-Apr-2019) via intramuscular route in the left deltoid on 02-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: None.
Vasovagal reaction. Syncope. Legs put into air. Patient regained consciousness.
have side effects to the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have side effects to the first 2 doses) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's disease, Thyroid disorder and Immunocompromised.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (have side effects to the first 2 doses). At the time of the report, VACCINATION COMPLICATION (have side effects to the first 2 doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient reported, she was on a lot of medications, but did not specify which ones. Treatment drug information was not given   This case was linked to MOD-2021-395759, MOD-2021-395849.
Large area of erythema, pain and swelling. Tx w/sulfamethoxazole 200 mg - trimethoprim 40 mg/5 ml.
reddened rash at injection site noted on 4/19/21. Itching.
During my pregnancy, I had the H1N1 shot at 12 weeks pregnant. I miscarried very soon afterwards. The doctor said that the baby died around 13 weeks. I just want to know if this is a result of the H1N1 shot. I have heard of at least 2 other cases of this happening ot others.
No adverse effects reported; a 16 year old male inadvertently administered one separate dose each of ZOSTAVAX; ZOSTAVAX administered were expired; Information has been received from a pharmacist referring to a 16 year old male patient. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent.  On 22-MAR-2019, the patient was inadvertently administered one dose of zoster vaccine live(ZOSTAVAX) 19400 plaque-forming unit (PFU) (lot # N025568, expiration date 08-DEC-2018; dose and frequency were not reported) subcutaneously for prophylaxis (inappropriate schedule of vaccine administered and expired product administered). No adverse effects were reported in patient.  This is one of two reports from the same reporter.; Sender's Comments:  US-1009507513-1903USA011073:
CT scan of the abdomen and pelvis revealed appendicitis with associated fat stranding. She was started on IV Zosyn and was transferred to hospital for further care. She underwent attempted laparoscopic appendectomy with conversion to open appendectomy.  A JP drain was placed in the OR. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
No adverse reaction from injection. Vaccine that was given was beyond use date by 5 days.
Constant Tinnitus in both years that sounds like a white noise machine or a fan and clogged ears beginning some time in April not precipitated by a cold or infection that I know of. 2nd Vaccine was March 15.
Vomiting and slight fever the next day (9/20). Redness adjacent to vaccine site, raised, warm, and tender on 9/21.
Onset type I diabetes mellitus  1/7/09 Reviewed hospital records for 10/18-10/22/2008. FINAL DX: new onset type 1 diabetes mellitus; DKA Records reveal patient experienced polyuria, polydipsia, nocturia & weight loss over 6 wk period.  Admitted to PICU on insulin drip for DKA.  Stabilized on sq insulin & d/c to home w/continued diabetes education & management in clinic.
Shaking chills, nausea, diffuse muscle aches and pains, headache, fatigue, mild sore throat
It's not really an adverse reaction I'm just worried my first shot was done down further on my arm the second one is way up top and .worried its.not gonna work to.protect me if it was done in the wrong spot and I've only had minor side effects like where the shot was given is only sore if it is touched or.pressed on I just.want to.make sure I'm going to get the full efficacy of the medicine and when he pulled the shot.out some of the medicine came out to
Arm Pain; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain) and ARTHRALGIA (Shoulder pain) in an 87-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 Ulcerative colitis.    The patient's past medical history included Urticaria, Formication and Dyspepsia. Previously administered products included for Drug use for unknown indication: KEFLEX [CEFALEXIN] (Urticaria with Keflex), CODEINE (Urticaria with Codeine), DOXYCYCLINE (Urticaria with Doxycycline), Flagyl (Dyspepsia with Flagyl), CORTISONE (Urticaria with Cortisone), CALCORT (Urticaria with Calcort), Prednisone (Formication with Prednisone) and Amoxiclav (Urticaria with Amoxiclav). Past adverse reactions to the above products included Dyspepsia with Flagyl; Formication with Prednisone; and Urticaria with Amoxiclav, CALCORT, CODEINE, CORTISONE, DOXYCYCLINE and KEFLEX [CEFALEXIN]. Concurrent medical conditions included Cigarette smoker (Tobacco Use/Five to six packs of cigarette a day) since 2012, Transient ischaemic attack since 2015, Sulfonamide allergy (Sulfa drug allergy manifested by Hives), Allergic urticaria, Pain, Anxiety and Ulcerative colitis. Concomitant products included LORAZEPAM for Anxiety, PARACETAMOL (TYLENOL) for Pain, VITAMIN D3 for Supplementation therapy.   In 2017, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain) and ARTHRALGIA (Shoulder pain). At the time of the report, PAIN IN EXTREMITY (Arm Pain) and ARTHRALGIA (Shoulder pain) had not resolved.            It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Patient stated that Humira was working for her initially but now medication was not working.  Treatment information was not provided.  The reporter's causality for the events of Arm Pain and Shoulder pain with Adalimumab Solution for Injection was No Reasonable Possibility.   This case was linked to MOD-2022-658030 (Patient Link).
Patient reports, on the afternoon after the vaccine, he started to feel weak, and had some discomfort  with blurry vision in both eyes with pain and discomfort in his right eye.  He continued to work. On 4-11-21, he went to work feeling weak with pain/discomfort in his right eye with blurry vision in both eyes. The pain was so much with blurry vision that he had asked someone else to take him to the airport to travel back home. He traveled back home via airplane.  On 4-12-21, his condition did not change. He consulted with his Commander and unit staff, and would go see an eye doctor.  He was seen by a civilian eye doctor on 4-15-21, 4-16-21, 4-27-21, and military doctor on 5-1-21. He was diagnosed with Anterior Uveitis,  pupils unequal, pupil bound.
Pt described considerable exhaustion within 30 - 45 minutes of getting the vaccine followed by headache, pain at the site of vaccine and by the early evening started having shortness of breath that was concerning enough that she contacted 911 and a medic came to evaluate her at her home, she was not taken to the ED. 72 hours later (today) she continues to have headache, some throat pain, considerable fatigue and now complains of bone pain in her thighs.
Severe exacerbations of systemic capillary leak syndrome;  entitled Severe exacerbations of systemic capillary leak syndrome after COVID-19 vaccination: A case series. The full publication has been requested.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CAPILLARY LEAK SYNDROME (medically significant), outcome "unknown", described as "Severe exacerbations of systemic capillary leak syndrome". Exacerbations of rare systemic capillary leak syndromes have been reported, but the patient had no evidence of a prior leak.; Sender's Comments: Based on possible temporal relationship the causal role of the BNT162B2 Vaccination cannot be excluded for reported event.  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
Nausea; Vomiting; Lightheadedness; Collapsing or losing consciousness. Positive LOC. vomiting x1. EMS was called at 1207 and refused further care. patient waited until a ride came and picked him up.
Information has been received from a physician concerning a child with no reactions after the first dose of VARIVAX (Oka/Merck) who on approximately 10-JUL-2008, two weeks ago, was vaccinated with the second dose of VARIVAX (Oka/Merck). The patient experienced severe swelling under arm, redness on the arm and nodules. The patient was taken to the emergency room but was not admitted. The patient's severe swelling under arm and redness on the arm and nodules persisted. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 29-MAR-2017, the patient was inadvertently administered an expired dose of GARDASIL 9 lot # L000610, expiry date 31-JAN-2017 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
small patch on lower back that become worse,was diagnosed for shingles; swollen right groin lymph node; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (small patch on lower back that become worse,was diagnosed for shingles) and LYMPHADENOPATHY (swollen right groin lymph node) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HERPES ZOSTER (small patch on lower back that become worse,was diagnosed for shingles) and LYMPHADENOPATHY (swollen right groin lymph node). The patient was treated with FAMCICLOVIR for Shingles, at a dose of 5mg and TEMAZEPAM at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (small patch on lower back that become worse,was diagnosed for shingles) had not resolved and LYMPHADENOPATHY (swollen right groin lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
pt reported having received only 1 vaccine of Moderna and dose was given, however, registry shows documented prior doses on 4/21/2021 and 5/25/2021.  No known clinical symptoms as of this date. will continue to monitor.
A few days following the shingles vaccination the patient developed a vesicular rash in a V1 and V2 dermatomal distribution on the right face. Right eye Ocular manifestation also occured, including; iritis, endothelialitis, and keratitis. Concern now is that cornea will have scarring resulting in permanent vision loss without surgery in the right eye.