chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist via a company representative regarding a 60 year old male patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 02-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, route, anatomical location, lot number and expiration date were not reported). The patient's concomitant therapies included an unspecified flu shot a few days prior to the PNEUMOVAX 23. On 05-OCT-2015 (reported as three days and six hours after receiving PNEUMOVAX 23), the patient presented with an unspecified welt on his back (urticaria). Additionally, on an unspecified date described as "couple of weeks" the patient felt as he had fluid on his lungs. The patient sought medical attention by went to the physician office and the physician prescribed an unspecified albuterol, no lab diagnostics were performed. At the time of the report, the outcome of the patient presented with an unspecified welt on his back was recovered described as the welt lasted four days and the outcome of the patient felt as he had fluid on his lungs was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Pt experienced burning and itching. Within 24 hours post vax pt developed swelling and erythema and area increased to 4 X 6 cm within 48 hours.
At time of injection, patient noted that the administration was not deep or via the IM route, rather subcutaneous. Patient received dose at 1/07/2021 and 1/28/21
Throat feels different from normal; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) and OROPHARYNGEAL DISCOMFORT (Throat feels different from normal) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat feels different from normal). At the time of the report, COVID-19 (Tested positive for Covid) and OROPHARYNGEAL DISCOMFORT (Throat feels different from normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
sore arm which ended in 48 hours  nausea which ended in 48 hours  exhaustion which has not ended  swollen lymph glands which has not ended
A non-serious report of an 18-month old female who received FluMist by accident was received from a consumer.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical history nor concomitant medications were provided.  The patient received FluMist on 14Dec2007.  The 18-month-old patient was inadvertently administered FluMist.  No other events were reported.  No outcome for the event was provided by the reporter.  No dechallenge or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
While pt was walking out of clinic after receiving the 3 vaccines below, mother stated pt was pale, requested to sit down, and while sitting up pt began shaking uncontrollably (mother stated not violently), pupils were dilated, pt unresponsive to mother calling his name. This episode lasted about 30 seconds. Nurse was called afterwards, pt c/o stomach hurting but feeling fine, juice/granola bar given, VS WNL, pt's color returned to normal, pt aware of surroundings able to verbalize needs. UC/ER precautions given.
My periods have become unpredictable, more painful; Experiencing new symptoms with my period like breast pain; My periods have come 7-10 days early 3 times, and right now I'm 4 days late; My periods have come 7-10 days early 3 times, and right now I'm 4 days late; I am spotting and cramping between my periods as well; I am spotting and cramping between my periods as well; Periods are lasting longer it used to be 5 days long, now its 8-9 days long; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8730) via an unspecified route of administration in left arm on 22Mar2021 at 10:00 (at the age of 34-years-old), as a single dose for COVID-19 immunisation and also the patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0153) via an unspecified route of administration in the left arm on 12Apr2021 at 10:00 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, liver adenoma and known allergies to shrimp. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received tetracycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 10Apr2021, the patient experienced that her periods had become unpredictable, more painful, last longer, experienced new symptoms with period like breast pain. Her periods had come 7-10 days early 3 times, and right now she was 4 days late. Periods were lasting longer it used to be 5 days long, now it's 8-9 days long. She was spotting and cramping between her periods as well. It was reported that before the vaccine she was very regular. The events resulted in doctor or other healthcare professional office/clinic visit. On 18May2021, the patient underwent nasal swab test and the result was found to be negative. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events ''my periods have become unpredictable, more painful''; ''experiencing new symptoms with my period like breast pain''; ''my periods have come 7-10 days early 3 times, and right now I'm 4 days late''; ''I am spotting and cramping between my periods as well''; and ''periods are lasting longer it used to be 5 days long, now its 8-9 days long'' was not resolved at the time of this report.
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and unknown age. On 20-JUN-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 10 vials of 1, lot # H012972, expiration date 09-MAR-2014, 0.5 ml, intramuscular injection (indication not reported). No adverse effects were reported. Additional information has been requested.
PATIENT CALLED ON 11/2/2020 TO REPORT THAT SHE HAS HAD CONTINUED ACHING IN LEFT ARM AND PAIN ON LIFTING IT SINCE 3 DAYS AFTER HER FLU VACCINATION ON 10/16/2020. SHE WAS ADVISED TO CONTACT HER PHYSICIAN AND HAVE AN ASSESSMENT DONE. SHE STATED SHE HAD AN UPCOMING APPT. IN A FEW DAYS AND WOULD LET US KNOW THE OUTCOME.
Hives and fever continuing til today. Controlled for a few hours with BENADRYL and ibuprofen. Further w/o pending.
Patient has a bruise a little larger than a 1/2 dollar 5 1/2 inches below right shoulder. Patient states she has no pain.
Patient was given 1st dose at age 6 1/2 months today 5/17/16.
Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Sep-2022 at 4:55 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 18-Sep-2022 at 4:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.   It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  The vial(s) moved from freezer to refrigerator on 07-Sep-2022.   It was reported that the vaccines had undergone several temperature excursions in Aug 2022.   Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment information was provided.
?Covid arm? Very itchy, hard, red, sore around the injection site. Started approximately 7 days after first dose.
Evening of vaccination, felt a knot in throat. Did not have any trouble breathing, eating or drinking. The next day on 1/29/2021 felt body aches, headache, nausea, diarrhea.
This case was reported by a nurse and described the occurrence of hives in  19-month-old female patient who received DTAP (batch number AC14B154B. expiry date unknown). On 14th August 2012, the patient received DTAP vaccine (intramuscular). On 14the August 2012, an unknown time after receiving DTAP vaccine, the patient experienced hives. On 18th August 2012, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to DTAP vaccine. Additional information: The onset of the hives occurred within several hours of administration. The nurse stated the patient was seen in the emergency, where it was thought the hives were a result of the band-aid. No information available regarding the batch or expiration date of the vaccine.
ITCHY THROAT, FEELING OF THROAT TIGHTENING, PRODUCING A LOT OF PHLEGM. GIVEN OXYGEN, ALBUTEROL NEBULIZER, EPINEPHRINE, BENADRYL. FELT DIZZY AND LIGHTHEADED. TRANSPORTED VIA AMBULANCE TO ER IN STABLE CONDITIONS WITH VITALS WITHIN NORMAL LIMITS EXCEPT FOR RESPIRATORY RATE OF 21, SLIGHTLY ELEVATED.
chills; sore arm; arm slightly swollen; rash but on my arm and chest (the rash is not welts); This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 26th April 2021, the patient received the 2nd dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced chills, pain in extremity, swelling arm and rash. On an unknown date, the outcome of the chills, pain in extremity, swelling arm and rash were unknown.   It was unknown if the reporter considered the chills, pain in extremity, swelling arm and rash to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient had experienced chills ,sore arm that was slightly swollen and rash on arm and chest. The patient asked whether he/she need to call the doctor because the rash was not welts. No other information was reported.
within a few mins of receiving 1st dose of Moderna vaccine, patient started c/o throat tightness -- 25mg po benadryl given -- provider, called to area to assess/listen to patient , throat feeling tighter after 5 more mins -- 0.30mg epi-pen auto-injector administered --- 911 called for ER transport -- according to provider, patient was wheezing -- approximately 5-8 mins passed and throat still feeling tight  -- 50mg IM benadryl administered -- patient transported via EMS to local Er
Patient is a 74 y.o. male patient with history of Hypertension, diabetes, morbid obesity, OSA presented with shortness of breath.  He was found to be COVID positive and briefly required BIPAP and was able to be quickly weaned back to his home O2.  He was seen by Pulmonology and is stable for discharge from their standpoint.  He also was noted to have HAGMA, LA and AKI which all resolved with IVF.  PT and OT were consulted and family requesting HHC.  He is otherwise stable for discharge home and outpatient follow-up as above.  All questions and concerns answered at bedside with patient and his wife present.     Sepsis present on admit Covid-19 Virus Infection SIRS on admit, lactate 3.1, with AKI Hemodynamics stable and given CHF/COVID will avoid 30 ml/kg bolus Will hydrate with maintenance IVF and follow lactate, hemodynamics, and SCr closely Date of onset of symptoms: 10/3/22 Symptoms present on admission: cough, dyspnea Date of covid positive test: 10/4/2022 Vaccination status: vaccinated and 1 booster Imaging: CXR nonacute but low lung volumes. No definite focal consolidation Oxygen requirements on admission: 4LNC home O2 baseline Current oxygen requirements: Was on BiPAP now back to home O2 at 4 L NC Medical therapy: decadron remdesivir, albuterol MDI, guaifenesin/dextromethorphan Consultants following: None  Anticipated special isolation end date: 10/14/2022 CRP 64 Procalcitonin wnl Discharge on dexamethasone to complete 10 days steroid course   Lactic acidosis, resolved Lactic acid 4.3 now down to 3.4 Resolved with IVF   Acute renal failure, resolved SCr 1.68 from baseline 0.8-1.0 Due to COVID infection and home diuretics, ACEi Held home lasix, bumex, and lisinopril Avoid nephrotoxins, and provide gentle IVF hydration, encourage PO intake SCr normalized with IVF Can resume home regimen on discharge  Acute on Chronic respiratory failure Obesity hypoventilation syndrome Obstructive sleep apnea Chronic HFpEF 55% On 4LNC at baseline, clinical dehydrated CXR nonacute but low lung volumes Held home bumex, lasix, lisinopril; continue ASA metoprolol CHF meds COVID positive, started decadron and albuterol MDI Weaned back to home O2 Recommend outpatient sleep medicine follow-up for CPAP adjustment/titration   DM type 2 Peripheral neuropathy HbA1c 7.4 Started diabetic diet and decadron for COVID On gabapentin for neuropathy Follow glucose closely Continue lantus 65 units nightly as at home with scheduled Humalog with SSI TIDAC   CAD Elevated troponin Denies chest pain, trop 26>22 Suspect elevated trop due to poor renal clearance with AKI Checking EKG Continue home ASA, lipitor, and metoprolol   History of DVT/PE Chronic anticoagulation with Coumadin Pharmacy consulted for daily dosing Continue home coumadin regimen  Dementia Continue home aricept   Depression Continue home zoloft and wellbutrin   Morbid obesity BMI 44.60 Lifestyle modification recommended
Large pink rash in shape of a 3/4 moon with the large round edge down her right extensor upper arm in deltoid region measuring 8.5 x 7 cm. Site is warm to the touch & slightly swollen.
INJECTION SITE WAS RED, HOT, AND SWOLLEN. DAD NOTICED REACTION 1-2 DAYS AFTER INJECTION. RED, SWOLLEN AREA ABOUT 3" IN DIAMETER.
Patient has a raised pink area in the circumference of three inches around the injection site.  This has continued to be red even after a week.
BODY ACHES HEADACHE FEVER UP TO 103.8  STARTED AT 8PM LASTED TILL 6PM NEXT DAY SEVER TIRDNESS LASTED TILL 1/11 GONE WHEN WOKE UP
About  just after one this morning  my whole body began to convulse violently.  I  am sure it lasted for more than  a  minute or two.  I woke up feeling very tired. I woke up feeling that I ma have had  a heart attack.
Liquid leaked from the side of the product during administration, no AE; Liquid leaked from the side of the product during administration, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 55 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe) lot QFAA1912, Exp. Date 28-Jun-2020 via intramuscular route in the left deltoid on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and syringe leak.  It was reported that they gave a patient Flublok yesterday but it started leaking while giving vaccine to patient.  At the time of reporting, no adverse reactions were reported (symptoms- None reported)  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
I had the Vaccine Monday but the rash did not start till Friday. I have a red rash all over my body, Light headed , weak,
Dizzy within an hour of vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 07Apr2021 at 10:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included was not reported. Patient had no allergies to medications, food, or other products. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) 25 mg, daily, from an unknown date for an unspecified indication and unknown if ongoing. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 11:15 within an hour of vaccine, the patient became dizzy. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of dizzy was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658177/1012U). It was reported that a series of parents have been calling since the administration of the second dose of varicella virus vaccine live (Oka/Merck) to report that the children are experiencing local non-systemic reactions. The parent of the child sought medical attention via a phone call to the child's physician. Subsequently, the patient recovered at an unspecified date per the nurse "because no parents called back after initial call". A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
3:00 am 9-8-21 Pain swelling and fever at site of injection, along with body aches, headache and fever 99.9,  began taking ibuprofen 200 mg x2 , took tepid bath to bring fever down.   Same day after another round of ibuprofen still had all above symptoms after 2nd round of ibuprofen fever jumped to 103.  Switched to Tylenol500 mg x2 more baths (Husband took a picture on 9-9-21) Swelling in arm bigger and site still feverish but head temperature coming back to normal. 9-10-21 mild headache at waking continued tylenol to ward of fever and ease headache and body aches  arm still swollen but less red still have knot underneath injection site Husband took another picture of site of injection.
pt recvd vax; exp small round rxn w/ halo at inject site w/in 24 hrs;
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 7/9/2021 FEMALE BREAST CANCER, UNSPECIFIED SITE OF LEFT BREAST
Severe diarrhea and vomiting for 10 hours. Chest pain. No temperature.
Accidentally gave 2 patients a second dose from vials that were expired past the 12 hours mark this morning 21Aug2021 at 8:25am (vial was open since yesterday 20Aug2021, punctured at 1:35pm); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally gave 2 patients a second dose from vials that were expired past the 12 hours mark this morning 21Aug2021 at 8:25am (vial was open since yesterday 20Aug2021, punctured at 1:35pm)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021 at 8:25 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally gave 2 patients a second dose from vials that were expired past the 12 hours mark this morning 21Aug2021 at 8:25am (vial was open since yesterday 20Aug2021, punctured at 1:35pm)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally gave 2 patients a second dose from vials that were expired past the 12 hours mark this morning 21Aug2021 at 8:25am (vial was open since yesterday 20Aug2021, punctured at 1:35pm)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.