chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very pale; Vertigo; nauseated; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (very pale), VERTIGO (Vertigo), NAUSEA (nauseated) and FATIGUE (fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     The patient's past medical history included Pancreaticoduodenectomy (For pancreatitis). Concurrent medical conditions included Iodine contrast media allergy, Osteoporosis (worsening, now on Prolia (every 6 mos. injections).) since June 2014, Seasonal allergy, Acute pancreatitis (Recurrent) since May 2009, High cholesterol since December 2014, Carotid artery disease (Blocked carotid artery) since December 2014 and Asthma. Concomitant products included ATORVASTATIN for High cholesterol, DENOSUMAB (PROLIA) for Osteoporosis.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PALLOR (very pale), VERTIGO (Vertigo), NAUSEA (nauseated) and FATIGUE (fatigue). On 18-Feb-2021, PALLOR (very pale), VERTIGO (Vertigo), NAUSEA (nauseated) and FATIGUE (fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2021-271984 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added patient demographics, medical history and concomitant medications.
Swelling at and around injection site - 1 week Soreness at injection site - 2 weeks Fever - 2 days  Injection site heatness 1 week Bruising that has lasted over 2 weeks Body Aches -1 week Headache - different from my migraines
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and known drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot # and expiry date were not reported) for prophylaxis. On an unknown date, reported as later on, the patient got pneumonia. The reporting pharmacist wanted to know if the patient needed another dose of PNEUMOVAX23. The outcome of the event was unknown. The reporter did not provide the causal relationship between the event and PNEUMOVAX23. Upon internal review, the event of pneumonia was considered to be medically significant. Additional information has been requested.
Heart problems, eventually it went away months later; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problems, eventually it went away months later) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart problems, eventually it went away months later). At the time of the report, CARDIAC DISORDER (Heart problems, eventually it went away months later) had resolved.     No concomitant medications were reported. No treatment details were reported. It was reported that, after all the testing, nothing was found wrong and attributed to vaccination. The event eventually went away after months later.
Lightheadedness, chest pain/pressure, flushed skin of chest, tingling BLE > BUE.  Taken to ED from vax site. Improved but still with lightheadedness and rash of upper chest. Given IVF and benadryl injx. Observation x 3 hours.
Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA728A, expiry date 31st October 2023) for prophylaxis.   On 15th November 2022, the patient received Menveo. On 15th November 2022, unknown after receiving Menveo, 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: 21-Nov-2022 Reporter's comment: The registered nurse called to inquired that the whole dose should be repeated. The reporter confirmed that the dose was administered in their facility. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered Menveo lyophilized powder component reconstituted with sterile water instead of the supplied Menveo diluent, which led to wrong solution used in drug reconstitution.
I'm a surgeon therefore I was working that week. I believe with my working hours the side affects may not be adverse events. It may lack of sleep and stress could be factors. On 12/19 exp chills  on 12/20 chills, muscle aches, and nausea.12/21 muscle aches, low grade fever 100.1 to response to Tylenol around the clock. On 12/21 I had severe lymphangitis(tonsils). I got a rapid Covid test results negative. Since then I continue to wear N-95 mask and not able to attend church. I dint miss any days of work.
Patient developed intermittent right-sided pleuritic chest pain about 10 days following vaccination as well as lower leg pain. Patient started taking aspirin and stopped smoking and pain in leg resolved but still had intermittent chest pain. Last couple weeks patient stopped taking aspirin and started smoking again and 2 days ago noticed an increase in pleuritic chest pain that brought him to the emergency department.
6PM pt woke up mom tried to feed pt but was too sleepy to eat; 715AM woke up having convuls & fever of 102; 810PM arrived, went to ER no further problems;
Myalgia, Arthralgia, SkinRash, Rash, UrticariaPruritus, Palm of left hand numb Narrative:
I had my COVID booster on Nov. 18 and am still ill :  lethargy, achiness, a bad cough and cold, and severe pain in my left arm.
Pt recvd 3 doses of Engerix-B & was found to have no response;
Information has been received from a physician concerning a 68 year old female with breast cancer (2006) and rhinitis allergic and a history of deep vein thrombosis (resolved), pulmonary embolism, benign brain stem tumor, gastroesophageal, reflux disease, pancreatitis, peptic ulcer disease, benign pulmonary nodule and kidney surgery for a benign tumor who in June 2008, was vaccinated with ZOSTAVAX (lot #659267/1836U). Concomitant therapy included Astelin, Coumadin, Flonase, Lovastatin and Tamoxifan Citrate. Three weeks later she developed dizziness and left ear pain. The patient has been following up with a neurologist and an otolaryngologist (the reporting physician had not received dictation reports from these physicians). The patient had been placed on Amoxicillin (+) Augmentin and was beginning to show improvement. Additional information has been requested.
Patient reported that her right arm after injection was sore, which said was least of her symptom.  About 9 pm  after she received her vaccine(at 3:22 PM ) on 7/22/2019 she began to experience total body aches and chills.  She did not check for a temperature.   She was uncomfortable enough that she did take Naprosyn 220 mg 1 tablet andit did help.  On 7/23/2019 she reports that her arm is sore but the other symptoms have gone away
Cellulitis and lymphangitis with tender left axillary LA; major reaction to first vaccinia vaccination.
1443 Patient reported feeling dizzy and nausea. 1445 Report to staff. Snack at 1446, reported feeling zero symptoms at 1455. Observed for an additional 10 mins. Pt. left at 1505 on her own accord.
Narrative:  Patient received first vaccination with JYNNEOS series on 09/27/22 and returned to clinic for second dose in series on 10/25/22. At this time, patient reported about 3 days after vaccination he developed raised, itchy, non-painful red lesions on arms, legs, and back. At time of second dose, still had some lesions popping up. Denied ulceration, fevers, shortness of breath, or throat swelling. Second dose of vaccine series was delayed until Allergy could consult. on 10/26/22, allergy completed a thorough consult concluding that the rash is likely to represent an immune response to the vaccine (not an IgE mediated response). Allergy states if there is no disseminated features to suggest general vaccinia, the rash described is general not considered to be a contraindication and administration of the second dose should be made in discussion with the patient. As the rash was delayed, increased acute monitoring will not change the outcome for the patient. If the patient decides to receive the second dose, steroids or antihistamines may be administered. No decision has been made at this time on second dose administration.
thighs started itching and getting blotchy; Thighs started itching; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration on 09Mar2021 at 18:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included progesterone 200 mg (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received oxycodone; paracetamol (PERCOCET) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 11:30, two weeks after the vaccination, the patient was sitting in the sun with her legs uncovered. Her thighs started itching and got blotchy. Her calves did not experience the same. She had not tried sunning her torso or arms yet. On 24Mar2021 (reported as this morning), she went out again and experienced same thing. She had photos of her legs during and after she came back inside. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events itching and blotchy. The clinical outcomes of the events itching and blotchy were recovered with sequelae (reported as recovered with lasting effects) on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
10/14/15, 3PM, significant swelling and pain left upper arm, chills/diaphoresis. 10/15: no chills/diaphoresis. Pain increased, pt unable to lift arm or perform ADLs for 4 days. Significant improvement by 10/20.
Pt given 2nd Covid vaccine. Stated she had lip tingling/numbness and left sided facial numbness. No SOB, no difficulty breathing or airway issues. 25 mg IM benadryl given at 17:33. Currently at 18:13 pt states it is not getting worse and the numbness is currently over her left eye brow and chin. Pt stated she feels comfortable to leave but pt was advised to wait.Pt stated that after her first vaccine she had some numbness on right side of face that lasted 3 days post injection but no difficulty breathing or with airway. She had read on line that 1% of people may get numbness so felt comfortable getting second dose since she had no airway problems. At 18:29 pt left, refused to go to ER per clinic recommendations.
Received Lymerix shots(3). 9/26/99, 10/27/99, 09/18/00. Developed rheumatoid arthristis. Am now being treated with Embrel.
No Adverse Event; bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. On 28-Dec-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient).    No concomitant drug information was provided. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.
diarrhea; This is a spontaneous report from a contactable Physician. This reporter reported 3 cases. This is 3rd of the 3 cases. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced diarrhea on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034918 same reporter, drug and different pateint;US-PFIZER INC-2021034919 same reporter, drug and different pateint
Had difficulty and pain with urination; Urine color brown/reddish; Klebsiella infection; Fever of 100 degrees; Chills; Nausea; Loss of appetite; Fatigue; Lethargy; This is a spontaneous report from a non contactable Nurse.  A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 06Mar2021 09:30 (Batch/Lot Number: EN6199) age at vaccination of 71-years-old, as single dose, for covid-19 immunisation. Medical history included benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medication included celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported.  The patient previously took tamsulosin and experienced drug hypersensitivity, silodosin and experienced drug hypersensitivity.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021 (evening) the patient experienced a fever of 100 degrees Fahrenheit, chills, nausea, loss of appetite, fatigue and lethargy. On 07Mar2021 the patient had difficulty and pain with urination, urine color brown/reddish. The events resulted in doctor or other healthcare professional office/clinic visit. Antibiotics were given for Klebsiela infection. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The association between the event Klebsiella infection with BNT162b2 can not be fully excluded based on temporal relationship.  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.
Tenderness at injection site Elevated temperature of 100.4 Treated with Tylenol 500 mg and  Cooling Measures
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: anxiety and ptsd attacked trigered by the vaccine-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: 5 minutes after the dose, pt started having headache, sweating and shriveling, anxiety and ptsd attacked trigered by giving the vaccine, gave 1 dose of tylenol 500mg, called 911, pt was transfered to the hospital
Diagnosed by NP at Urgicare Center with shingles on  21 June 2019 after two doses of Shingrix given by pharmacist (27 Dec 2018 and 15 May 2019).
rash (warm to touch and sore) that started as one spot and has grown to three spots across arm overnight
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/27/2021 and 2/22/2021, and 8/31/2021. Patient presented to ED on 10/15/2021 with complaints of cough & SOB x 2 weeks - diagnosed with covid PNA 2d prior prescribed doxycycline. Pt presents today because he reports he was coughing and had sharp pain at center of chest/ xiphoid process. Pt transferred to the ICU due to increasing oxygen requirements from COVID pneumonia. Pt also found to be anemic at that time and transfused 1 unit w/ improvement in Hgb levels. Pt had a history of aortic stenosis so a TTE was performed which revealed severe aortic stenosis, which significantly increased his chances of a difficult intubation due to poor cardiopulmonary reserve. Pt subsequently began developing worsened respiratory status and required intubation. Pt then developed worsening renal failure requiring CRRT. CRRT caused pt to become extremely hypotensive despite being on 3 pressors and near max. Pt also developed afib w/ RVR and had to be started on amio gtt. CRRT was paused and initially BP recovered without use of pressors, however over the course of a few hours pressors had to be added back. Pt also began having elevation of lactic acid, low temperatures, and elevated WBC so was re-cultured at that time. Family decided at that time they would like to allow patient to have comfort care, and patient expired on 10/26/2021
On Day 6, patient reported axillary lymphadenopathy plus erythema and soreness at site.  On day 9, nurse noted extensive axillary lymphadenopathy as well as supraclavicular lymphadenopathy.  Erythema was present on the upper (vaccinated) arm and extended to the clavicle.  The patient reported soreness at the site and malaise.  The patient was referred to MD.  MD examined the patient that day, and believed the reaction to be vaccine-associated.  He prescribed Duricef and told the patient to start the medication the next day if there was no improvement.  The patient started the Duricef the next day (Sunday, February 23rd) since there was no improvement.  The Health Department learned of this on Monday, February 24th.  Since the patient was not at work (she wasn't scheduled to work), Employee Health asked the patient to report to the Health Department for digital photos.  The patient came to the Health Department and photos were made.  Consent was obtained to share this information with the state Health Department.  Minimal erythema was noted today.  The patient said the erythema began to subside late Sunday, and stated she is feeling better today.   Her left clavicular area appears slightly swollen when compared to her non-vaccinated side.
Patient noticed small "zit" like mark underneath injection site a few weeks after receiving vaccine. Patient popped it and noticed it got more swollen and inflamed. Patient came into clinic to have it looked at. Provider gave strict return precautions and strict self care to prevent spreading further.
Left deltoid paint no redness, warmth, swelling. No fever, sweats/chills. Pain seems to be slowly increasing.
fever; crying for 3 hours; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (MI) (Reference number- 00899754) and transmitted to Sanofi on 15-Dec-2021.  This case involves Child and unknown gender patient who had fever (pyrexia) and crying for 3 hours (crying) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C576b5A, expiry: 28-Aug-2022) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious fever (pyrexia) and crying for 3 hours (crying) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "Secretary states that a child had a reaction and was crying for two hours and also had fever after receiving DAPTACEL. The doctor wanted to know what else can be given other than Daptacel. Caller states that she would have the doctor call back with adverse event (AE) information and receive recommendation."  No laboratory test was reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of events with suspect.
This case was reported by a consumer via call center representative and described the occurrence of eye pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th December 2021, the patient received the 1st dose of Shingrix .5 ml. In December 2021, less than a week after receiving Shingrix, the patient experienced back pain. On 20th December 2021, the patient experienced eye pain. On an unknown date, the outcome of the eye pain was not recovered/not resolved and the outcome of the back pain was unknown. It was unknown if the reporter considered the eye pain and back pain to be related to Shingrix. Additional details were provided as follows: The patient stated that almost immediately after administration of the Shingrix vaccine she got a pain in left eye on the socket part towards the outer corner of the eye. The pain was still present at the time of reporting, but the patient stated she wasn't having any vision loss or blurriness. She also reported back pain, but was not sure if it could be attributed to the vaccine entirely. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021264521:Same reporter. US-GLAXOSMITHKLINE-US2021264519:Same reporter.
This spontaneous report as received from a Registered Nurse concerning an unknown number of patients who on an unknown date were vaccinated with a dose of LIQUID PEDVAXHIB exposed to -1 degrees C for 24 hours (dose, route and lot number not provided). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 08-JAN-2016, the patient was vaccinated with a dose of ROTATEQ (lot # L013192 and expiration ate January 2017, oral), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccinee rec'd 1st dose of Engerix-B on 30SEP90 & experienced pain @ inject site. 24 hrs p/she rec'd 2nd dose of vax 30OCT90 had total body joint pain & was difficult to move. Treated @ ER w/local anesthetic/Orudis. Lower body pain resolved