chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling, redness, itchiness, pain at injection site.  Fever, sinus congestion, lethargy.
pt started to exp excruciating pain in hips to point he could not walk & to carry pt was extremely painful;pt spiked fever @ hosp & vomited;pt hosp for 3 days & no definite dx was made. Discharge summary states final diagnosis to be myalgias secondary to hepatitis vaccine.
Symptoms/adverse effects: itchiness, sneezing, asthma Treatment: NasalCrom and futicasone in each nostril Outcome: need to continue treatment as symptoms returned
Blood Pressure; Cough; Horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), HEADACHE (Horrible headache) and BLOOD PRESSURE MEASUREMENT (Blood Pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Protentil as needed for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced COUGH (Cough) and HEADACHE (Horrible headache). On 06-May-2021, the patient experienced BLOOD PRESSURE MEASUREMENT (Blood Pressure). At the time of the report, COUGH (Cough) and HEADACHE (Horrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information provided was Tylenol and Benadryl.
This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 17-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Initial HCP (health care professional) report was received on 02 Nov 2010: This patient was vaccinated with MENVEO (batch number X100027) on an unspecified date. The patient received only the menCYW-135 liquid conjugate component of MENVEO. Patient did not receive MenA lyophilized conjugate of MENVEO. No adverse event occurred.
Possible SIRVA injury. Patient stated difficult to move arm and tingling sensation. Pain is radiating throughout shoulder and arm. Was told to self treat with Tylenol and ibuprofen until recovery by provider.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. On 04-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # 671021/0747AA, expiration date 18-AUG-2012) (dose, route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information is not expected.
Felt flu-ish but no fever; General malaise / Felt crappy for the first 24 hours; A spontaneous report was received from a consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, felt flu-ish but no fever / influenza like illness, general malaise and felt crappy for the first 24 hours / malaise.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events, felt crappy for the first 24 hours, felt flu-ish but no fever and general malaise.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 18 Feb 2021, the outcome of events, felt crappy for the first 24 hours, felt flu-ish but no fever and general malaise was resolved.
Patient contacted clinic after patient reported to work post 15 minute wait period after vaccine administration. Reported body numbness, nausea, and hot flashes. Local dispatch/EMT responded to patient who was in her work and transported patient to local ER. Patient was administered Benadryl in route to ER. No Epi.
Chief Complaint:  Fever   Source of Information:  Available medical record   History of Present Illness:  This is a 63y.o. male with past medical history significant for COPD, diabetes, hyperlipidemia, hypertension, urinary tract infection, frontotemporal dementia.  He presents to Hospital on 1/18/2022 for evaluation of fever and possible sepsis.  He presents via EMS.  Facility reports that he has been febrile at home and notes that he has a chronic Foley with dark and "infected" urine.  Per reports patient is nonverbal at baseline.  History is severely limited.     In the ED, Vitals on arrival of T 97.6°F, BP 149/105, HR 113, RR 18, SpO2 98% on room air Labs remarkable for white blood cell count 11.6, hemoglobin 12.9, platelets 295.  Sodium 142, potassium 4.7, chloride 110, bicarb 18, BUN 60, creatinine 1.42, calcium 9.5.  Alk phos 127, AST 15, ALT 11.  Lipase within normal limits.  Lactic acid 3.3 originally now 1.3.  Procalcitonin 9.12.  Magnesium 2.2.  Phosphorus 4.2.  TSH 0.81.  Troponin 0.01x3.  Flu, RSV negative.  COVID-positive.  Blood culture pending.  Urinalysis positive for nitrites, 3+ leukocyte Estrace, 4+ bacteria. Patient received Tylenol, sepsis fluid bolus 30 mL/kg.  Vancomycin and cefepime. Imaging: Chest x-ray no pneumothorax or pleural effusion.  No focal consolidation.  The cardiomediastinal silhouette is unremarkable. EKG consistent with sinus tachycardia, no significant ST segment changes indicative of ischemia.
Patient has a rare autoimmune syndrome called Aicardi-Goutieres, in which the body attacks DNA and potentially RNA in the patients body. Therefore, his primary care neurologist and immunologist have recommended that he get the Janssen vaccine as they feel it will pose less of a risk of side effects in regards to his conditions. The decision to give the patient this vaccine although he is under the age at this time was discussed with MD, MD, MD and the DH safety committee.
I still have headaches; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0187), dose 1 via an unspecified route of administration, administered in arm left on 21Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included high blood pressure and vitamins (over the counter vitamin B, C). In Jun2021, the patient experienced "I still have headaches". The patient asked if she should take Tylenol. When probed whether the patient need any medical assistance, she reported that "not really just light headache that I am having since I took, well I should take Tylenol or something will it go away". It was not bad. She was about to go to store to get something maybe to stop the headache. The outcome of the event was not resolved.
Severe nausea and patient became pre-syncopal with significant pallor and tachycardia.
Ischemic stroke.  At this time, the stroke is cryptogenic and no underlying cause/condition has been identified. I am a mix and match patient having received J&J in 03/2021 and Pfizer in 11/2021. Reporting this event out of caution. Given that no underlying cause is presently identified and mix and match data is still limited.
PATIENT RECEIVED DOSE 1.  ON 3/3/2021 IN THE LEFT UPPER ARM, PFIZER, LOT NUMBER EN 6202. DOSE 2 GIVEN 3/24/2021, LEFT UPPER ARM, PFIZER, LOT NUMBER ER 8733 DOSE 3. 12/14/2021 LEFT DELTOID, PFIZER, LOT NUMBER FJ 1620  HAD ONSET OF UPPER RESPIRATORY SYMPTOMS IN JULY 2021 WITH STUFFY NOSE, HEAD CONGESTION, WHEEZING AND SHORTNESS OF BREATH.  PROGRESSIVE SYMPTOMS, SEEN IN URGENT CARE OCTOBER 2021.  AT THAT TIME, CHEST X-RAY SHOWED CARDIOMEGALY AND PULMONARY EDEMA CONSISTENT WITH HEART FAILURE.  STARTED ON MEDICAL THERAPY.  DUE TO PROGRESSIVE, SEVERE SYMPTOMS, HAD TO QUIT HER JOB.
20 minutes post vax the pt had a weak, pale, syncopal episode which lasted two seconds. The pt recovered and Engerix B was discontinued. The physician felt that this episode was unrelated to Engerix B and the pt was probably hypoglycemic. The mother stated that the pt did not have breakfast. Physician does not feel comfortable re-vaccinating the pt to complete the series. The most recent information received reports the condition of the pt is recovered.
patient fainted minutes after receiving the vaccine.  He was unconscious for 3-5 seconds and regained consciousness.  he then felt dizzy and threw up.  ems was called and they evaluated him and he left on his own all within 35 minutes.
Patient noted to have redness and swelling to site that night. Mom put hydrocortisone on it, and it seemed bigger. Itches and hurts. Mom brought child in on 7/26 because area is now approx. 4cm x 4cm in size, warm to touch, tender
Myopericarditis requiring hospitalization. Chest pain symptoms started 4 days after patients COVID Pfizer booster. Initial vaccination series was 12/17/2020 and 1/8/2021. Patient's substernal chest pressure, positional with improvement sitting forward as well as EKG changes showing diffuse ST elevations all support pericarditis. Chest pain improve with colchicine and ibuprofen.
Problem # 1:  Allergic contact dermatitis (ICD-692.9) (ICD10-L23.9) Diffuse erythematous plaque-like allergic appearing rash on face trunk arms and scalp.  Timeline suggest it is a reaction to her second Covid vaccine injection.  Only other new exposure was going to be pewter day prior to symptoms and eating popcorn but she has had this in the past with no problems Suggest we stated before that this is a reaction to Moderna Covid vaccine I would suggest she not get it in the future if able to We will treat with oral prednisone and continue antihistamines.  Also use ice packs , oatmeal baths and calamine to help with itching She will call or portal if symptoms or not improving.
HCP combined two adjuvant vials, product was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 2-Nov-2022 Reporter's comment: The pharmacist reported that the product was not administered. Nothing else was reported. The reporter did not consent to follow-up. Additional supportive information: The pharmacist  mistakenly combined two Shingrix adjuvant vials rather than an adjuvant and antigen vial, which led to wrong solution used in drug reconstitution.
Patient came in with a migraine headache. He was given an injection of toradol by CMA and observed for 20 minutes. He tolerated this well. He returned to exam room for TD booster, lot Number U1879BA because he was over due. He was observed for additional 10 mins when he began itching and turning red. He was examined by PA and given an injection of Benadryl. He was observed an additional 20 mins and then released to his wife to be driven home.
Information has been received from a clinical laboratory director concerning a 12 month old male patient who on an unspecified date was vaccinated with "the standard dose" of VARIVAX (Merck) injection (Lot# not provided). It was reported that 2 months after receiving the vaccination shot, the patient developed a zoster rash. It was reported that a pediatric Vaccine HSA who works with the laboratory director had an isolate with a vaccine type virus. The lab director reported that the sample was DFA positive and PCR positive for varicella zoster virus (VZV). The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the mild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Zoster rash was considered to be disabling for the physician. Additional information has been requested.
pfizer pediatric (5-11) vaccine was given approximately 29 hours after the vial was mixed.  It was mixed on 1/3/22 at 8:55am.  Pfizer manufacturer was contacted and told us that the stability was known for 24 hours after mixing, but is unknown beyond that.  The CDC advised that when stability is unknown to revaccinate.  The patient's parent was notified and elected to repeat the dose at a later time.
2nd dose was on Saturday at 10a.  Felt body aches and headache that evening and the next day.  Arm was sore at the injection site.  Treated with ibuprofen (400 mg).  Was able to go to school on Monday.  Tuesday morning at 3a woke up not feeling well with chest pain and headache.  Treated with ibuprofen.  Still felt a little unwell in the morning, but by afternoon was feeling normal.
Swelling and erythema at injection site bilat on lateral aspect of leg swollen adipose and warmth no discharge no Lymphadenopathy
This spontaneous report as received from a pharmacist refers to an unkonwn number of patients of unkonwn age. On an unkonwn date the patients were vaccinated with ZOSTAVAX, VARIVAX (Merck) and PNEUMOVAX 23 (lot#, expiration date, dose and frequency were unknown). In July 2014 (reported as for the last 2 months) there were multiple excursions occurred with vaccines PNEUMOVAX 23, ZOSTAVAX and VARIVAX (Merck) and most likely they were administered to patients. The reporter did not provide actual excursion information. No adverse event reported. Additional information has been requested.
shot made me sick as hell; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: shot made me sick as hell). The outcome of the sickness was recovered/resolved (duration 2 days).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by the patient via interactive digital media. The second Shingles shot made the patient sick as hell for 2 days but stated that it was worth it. The patient reported that just a heads up to plan your next day accordingly after the second shot and stated hopefully you would be okay. Follow-up would not possible as no contact details were available.
At 11:30 pm I woke up not being able to move any extremities except for my finger tips. I was fully awake but my body would not follow any brain commands regarding any thoughts about moving any part of my body. I dozed back off to sleep and at  4 am I woke again only this time feeling pain all over my body. This time after heavy concentration my body began to follow thoughts of moving starting from my toes up to my neck. I had bad body aches and headache the next day and took Tylenol for it.
Within one hour of the shot I got very cold, I started sneezing and got a sore throat.  I also miscarried.  This all happened within one hour of receiving the shot 12/4/09 Medical records received for date 11/25/08 and 11/2/09. DX: annual gyn exam WNL. OV 11/2/09 infertility consult. Pt denies knowledge of any prev. pregnancies seek consult for no conception over past year.
Hives covering full body. Diphenhydramine given ay 6:15 pm 11/12/14, pharmacy called by mother approx 6:45 pm. Advised mother to provide another dose at 10:15 pm and to go to urgent care/ER if worsening at second dose. 2nd dose given at 10:15 pm. 11/13 pt was recovered in am, broke out again in evening after shower. 3rd dose given approx 8 pm.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 59-year-old female patient who received SHINGRIX (batch number 9277N, expiry date unknown) for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site cellulitis, intramuscular formulation administered by other route and wrong injection technique. On an unknown date, the outcome of the injection site cellulitis, intramuscular formulation administered by other route and wrong injection technique were unknown. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the reporter's fellow pharmacist. The age at vaccination was reported. The pharmacy administered SHINGRIX to a patient too low in the left arm, which led to wrong injection technique. The pharmacy thought that, the dose was given subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. After vaccination, the patient experienced cellulitis in the left arm, which the pharmacist believed that was related to the injection technique, but could not be sure of causality. The reported batch number (92779) for SHINGRIX did not exist and was updated to 9277N, according to sales datasheet.
Info has been received from a physician concerning a pediatric pt who on approx. 8/26/05 "two weeks ago" was vaccinated, SC, with an 0.5 ml dose of MMRII. On 9/7/05, the pt developed a measles-like rash. Unspecified medical attention was sought. The pt's outcome was unknown. No product quality complaint was involved. Additional info has been requested.
Pt recvd vax & the next morning exp t102.7 & diaper had been dry all noc; refusing liquids; adm to hosp CXR showed some congestion; hypothermia;
I got the monkeypox vaccine. The site was sore and itchy for 3 weeks.
Phantosmia (smelling smoke that isn't there). I  had COVID-19 in late December. I had phantosmia from January thru early March but  it slowly disappeared. But now after getting  the vaccine in April, the phantosmia (smoke  smell) is back. It isn't as intense as during January/February and is getting better but I still "smell" smoke occasionally.
Several weeks after receiving the shot my blood pressure went up to almost 200 over 89/94 - which has never happened before. I got shortness of breath, my heart kept sleeping bits and it was hard to talk for too long or to walk up a block.  I went to urgent care where I was told to go to the emergency room if my condition doesn't improve. The next day they sent me to the cardiologist and since then I've done ECO, cardiograms, stress test.
Employee states she had her vaccine 1545 and after sitting in chair 'a little more than 20-25 minutes,' she began to feel faint, dizzy, sweaty, cold and clammy hands but felt sweaty. Developed ringing in her ears and vertigo; like she is drunk and spinning, off balance. Taken to ER, BP up at 152/80's and HR in the 90's. Testing completed; all normal per employee. Went home and felt extreme fatigue, and as of 1/18/2021 her arm is still achy, running down her arm to her fingertips and down her backside on the left side in the upper part of the back. Has no PCP, discussed f/u with an Urgent Care or other Health Care Provider if lost any sensation or developed further symptoms.
This literature marketed report as received from a healthcare professional, refers to a 17 year old male patient with recurrent intermittent abdominal pain and diarrhea 4 years ago, since 2008, and eczematous skin rash. The patient's pertinent medical history included perennial allergy, seasonal allergic rhinitis, eczema, vernal conjunctivitis, recurrent herpetic infection and drug allergy. It was reported that patient's symptoms worsened with milk. Gluten and milk avoidance improved symptoms but reintroduction caused exacerbation. Physician reported that a stool culture in the past (date not specified) grew Blastocystis hominis. On an unknown date, previous PNEUMOVAX 23 vaccination, the patient underwent a serotype test which revealed only 1 positive serotype. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (lot # and expiration date were not reported). Concomitant therapies included montelukast sodium (manufacturer unknown). On an unknown date, a post vaccination test was performed which revealed only 9 out of 23 positive serotypes. On unspecified dates the following lab tests were also performed: Physical examination (date not reported): normal, except for boggy nasal turbinates and patches of eczema. Allergy skin test (date not reported): positive to various molds and slgE=class I positive to corn, soybean, wheat and peanut. Class II to potato, but negative to egg white and milk. Elevated lgG: gliadin antibody>100 units/ml tTGIA.lgG: negative, decreased lgG: 456 mg/dL, IgA: 50 mg/dL. Healthcare professional reported that childhood hypogammaglobulinemia may be secondary to cow milk allergy since immunoglobulin and cells leak through the inflamed mucosa. Progression from lgAD to common variable immunodeficiency (CVID) with impaired antibody response could occur with immune mediated gastrointestinal disease such as nodular lymphoid hyperplasia or atrophic gastritis. Common variable immunodeficiency (CVID) was associated with poor response to PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. The patient's antibody test negative was reported to be related to PNEUMOVAX 23. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX. On 28th February 2018, the patient received the 1st dose of SHINGRIX. On 28th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 1st March 2018, the patient experienced fever, feeling cold, nausea and vomiting. On an unknown date, the outcome of the injection site pain, fever, feeling cold, nausea and vomiting were unknown. It was unknown if the reporter considered the injection site pain, fever, feeling cold, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: The reporter was reporting for wife who received a first dose of SHINGRIX vaccine yesterday on 28th February 2018. The patient had pain at the injection site. At the time of reporting she had a fever and feels cold. The patient also had nausea and vomited on the morning of reporting date. The reporter asked that whether she had a worse reaction on her next shot and should she stop receiving the second shot. The representative stated that for this type of concern, they need to had one of our product specialists call to accurately discuss this concern. The product specialists just need to get a few bits of information and they could have call the reporter to discuss the reactions.
Rash, chills, diarrhea, drowsiness, achy joints; started evening of injection, rash spreading 1 week later; treated with BENADRYL.