chrisvoncsefalvay/vaers-outcomes huggingface dataset:
face swelling on the left side of her jaw below her ear / taken to the emergency room; got her first / vaccine 6/22/2021 / got her second vaccine this morning; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 22nd June 2021 and had swelling in arms, chills and redness for tolerance refer linked case US2021165601).   On 3rd August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd August 2021, 20 min after receiving Shingrix, the patient experienced facial swelling and drug dose administration interval too short. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the facial swelling was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient husband. The patient received 2nd dose of Shingrix vaccine and 20 minutes after developed face swelling on the left side of her jaw below her ear also  2nd dose of Shingrix received within a 2 month, which led to shortening of vaccine schedule. The patient was taken to the emergency room, given a 5 day course of steroids, and discharged. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165601:Same reporter
patients received a dose of a vial after 12 hours of initial puncture; Vial stored in refrigerator once punctured, in freezer prior to puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial stored in refrigerator once punctured, in freezer prior to puncture) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator once punctured, in freezer prior to puncture). On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture). On 07-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial stored in refrigerator once punctured, in freezer prior to puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications provided. There are two different lot numbers involved in this event. Lot numbers involved: lot 939902 with expiry (manufacturer) 17-Jan-2022,lot 047C21A with expiry (manufacturer) 07 Nov 2021. No adverse events reported after the vaccine.   This case was linked to MOD-2021-423398, MOD-2021-423397, MOD-2021-423357, MOD-2021-423048, MOD-2021-423373, MOD-2021-423320, MOD-2021-423437 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Patient demographics, Dose information, Event information was updated. On 21-Dec-2021: Follow up received on 21-Dec-2021 contains Non significant information.
Pt recvd vax & 1 hrs later exp body numbness & muffled hearing which lasted 3 hrs;
Upper respiratoryinfection, laryngitis.; Fatigue; Sore throat; Severe migraine; Slight cough; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 07:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included heart murmur, pituitary adenoma, hearing impaired and exercise induced asthma. Concomitant medications were 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 13:00, the patient experienced severe migraine and slight cough. On 28Mar2021, the patient experienced cough, sore throat, fatigue and on 31Mar2021, the patient experienced upper respiratory infection, laryngitis. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient received unspecified antibiotics, steroids and inhaler as a treatment for the events. The clinical outcome of the event migraine, cough, sore throat, fatigue and upper respiratory infection, laryngitis were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Extreme shivers, Headache, fever (100.4), body ache and soreness at vaccine site
My menstrual became irregular by April 11, 2021 was light and scanty. Then in July 2021 heavy and skipped menstrual months of September, October and December 2021. In February 2022 I got my menstrual three times.  Since I got my menstrual so close together the doctor wants to test same for cancer of my endometrial lining in March 2022.
fever; aches; chills; headache; This is a spontaneous report from a contactable other healthcare professional, the patient. This 51 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EJ1686, dose 2, single dose via unknown route of administration in the left arm on 19Jan2021 at 09:15 AM (at the age of 51 years-old) for COVID-19 vaccination. Medical history included gastroesophageal reflux disease (GERD). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EH9899, dose 1 via unknown route of administration in the left arm on an unknown date at 09: 45 AM. The patient was not pregnant at the time of vaccination. The patient had no known medication allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MOTRIN), dextromethorphan, doxylamine, ephedrine, ethanol, paracetamol (NYQUIL) and omeprazole. On 19Jan2021 at 20:00, about twelve hours following the second injection, the patient developed a fever, aches, chills and headache that  lasted for approximately 24 hours. The clinical outcome of fever, aches, chills and headache was recovered on an unknown date in Jan2021. Treatment received for fever, aches, chills and headache included an unknown over the counter medication without relief. Since the vaccination, the patient has not been tested for COVID-19.
Patient presented to ED on 7/20/21 with a fever, worsening non-productive cough, congestion, nausea and malaise. Patient had covid exposure and fully vaccinated. Patient was treated for covid and was discharged on 7/25/21.
Patient stated on 02/21/2017 she developed a rash on both hands, fever, chills, and decreased appetite. She went to the urgent care and received anti itch medications. She is fully recovered.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with breast cancer and treatment with unspecified chemotherapeutic agent more than one year ago and hepatitis C. On 13-JUN-2014 the patient ws vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, indication, route not reported). The patient's medically history included diverticulitis. On 14-JUN-2014, the patient went to an unspecified healthcare providers office due to suspected infection at the injection site, which was sore and reddened. The unspecified healthcare provider prescribed AUGMENTIN  On 19-JUN-2014, the patient had an area of redness and soreness surrounding the injection site described as "the size of a golf ball, and getting progressively worse". The patient also developed an unspecified rash, on an unspecified date in June 2014, which the reporter believed was still present. The outcome of the events was reported as not recovered. Additional information has been requested.
pt recvd vax & had swelling & arthralgia of lower limbs & joints on the rt side; approx 2 wks later had swelling of the rt foot & ankle;
Pain to shoulder area 15 minutes after injection.Pain escalated to 9/10 and inability to use arm with pain continuing for months.
the patient was well (including the day of the vaccine) until the day of this report / encounter.  parents noted that the left armthat had a red swelling, warmth, and itchiness reported by the patient.  The vaccine associated soreness had faded by this point.no cough, shortness of breath, wheezing, or fever reported .vital signs were within normal limits and the patient had an otherwise nonfocal exam.  The exam itself discloseda11 x 15 cm area of soft tissue induration and "faded" red hue, which was NONtender to touch.
Intermittent lymph node swelling for the past 6 months after 2nd dose of pfizer. Comes and goes. No history of this before vaccine.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unspecified age and gender. No medical history and concurrent conditions of the patients were reported. Since 25-JUL-2015 (exact dates unspecified), the patients were vaccinated with doses of GARDASIL (lot number: K011562, expiry date: 08-Apr-2017) (dose, route and site of administration not reported) which were exposed to temperature outside of the recommended range. No concomitant medications were reported. No adverse experience was reported. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. No additional information was provided. This is one of the two reports of the same reporter. Additional information has been requested.
shortness of breath for a few weeks and slight heart pain and then moderate heart pain and went to hospital. I have myopericarditis (1.3cm inflammation to inside of my heart)  Test included blood tests, echo, CTCA, MRI, Chest xrays among others and am on colchicine
Severe muscle and joint pain.  Treated with Tylenol and Ibuprofen.
warm and hot like cellulitis with a lot of fluid under the skin; lot of fluid under the skin; localized redness; swelling of the entire upper left arm; Initial information received on 22-Aug-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 10 years old male patient who experienced localized redness, swelling of the entire upper left arm and warm and hot like cellulitis with a lot of fluid under the skin, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Two other vaccines were given at the same visit. One was a vaccine containing tetanus. The mom was unable to remember the other vaccine.  In 2011, the patient received a first 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a serious localized redness (erythema), swelling of the entire upper left arm (extensive swelling of vaccinated limb) and warm and hot like cellulitis with a lot of fluid under the skin (cellulitis and discharge) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. All the events were assessed as Medically significant.  Other relevant tests not reported.  Final diagnosis was erythema, discharge, extensive swelling of vaccinated limb and cellulitis.   There was no treatment for the reaction. No antibiotics were given.  The reactions resolved on its own after two or three days.  Information on the batch number was requested.  Documents held by the sender: none.; Sender's Comments: Patient developed cellulitis after vaccination. Time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
I became very hot, sweating through my clothes within seconds, all the blood rushed from my limbs And I became clammy and turned pale. I had tunnel vision before losing consciousness. My whole body - all limbs, trunk, head/ face, everywhere, was in extreme discomfort. I had ?pins and needles? throughout my body, and I was nauseous (did not vomit). After about 15-20 minutes, I felt better enough to leave the clinic. My boyfriend was with me. On the way home, I had intense muscle cramps in my legs and feet, but also a strange indescribable feeling of discomfort bordering on pain, and also stomach cramping. When I arrived home (15 min) I defecated violently. I also fainted after my first Moderna shot but did not have the added symptoms (just feeling hot, tunnel vision, and fainting - no muscle cramps or whole-body torturous discomfort) and also felt genuinely better after 15 min. and drove myself home.
A month after the second shot I started having heart problems. Later I started having a hard time catching my breath. If I did anything I was out of breath. As each month  passed it seemed to get worse. My heart function continued to drop each month. I am now wearing a life vest.
At injection site patient has quarter sized hard lump under skin and a quarter size red spot that is hot to touch on skin. Redness spread over the next few days.
Wrong needle length used on SQ injection.  A 25 gauge 1" needle was accidentally mixed in with 25 gauge 5/8" needles. Injection given at 45 degree angle in outside, upper right arm but needle went in and came out other side of fatty tissue and leaked out on arm.  Child was upset and being held by parent.  Patient's arm was being held but still moving slightly, which made administration more difficult.  Vaccine readministered using correct 7 Rights of Medication Administration.  Pt. comforted by parent and tolerated well with no adverse effects.
It kind of seems like there is water in my ear; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (It kind of seems like there is water in my ear) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 17-Aug-2021, the patient experienced EAR DISCOMFORT (It kind of seems like there is water in my ear). On 16-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, EAR DISCOMFORT (It kind of seems like there is water in my ear) had not resolved.            No concomitant medication provided. No treatment information mentioned. After the second shot, the patient had 3 rounds of steroids plus 3 injections to treat the symptom. After six months the hearing started to get better, like 30% better, until the third dose was given and the problem started again.   This case was linked to MOD-2021-103664.
Moderna COVID-19 Vaccine EUA Patient received two doses of Moderna Vaccine at a Facility on the reported dates of 3/16/21 and 4/14/21. On 7/5/21 patient presented to ED with complaints of breathing difficulties and was diagnosed with multifocal pneumonia and COVID Positive with symptom onset of 7/1/21.  Patient subsequently developed acute renal failure.Patient expired on 7/19/21 from complications of acute hypoxic respiratory failure due to COVID-19.
About 5 hours after receiving my third dose, my tongue started to swell. It was swelling so much that I couldn't keep it in my mouth. I took two Benadryl, but it did not help at all. I consulted with my doctor and he told me to go to a local hospital ER. I had some tests completed and they hooked me up to a monitor. I wasn't given anything to help me, they just monitored me for about 5 hours. I was not even given an IV drip, like recommended from my PCP. The care there was horrific. Recently, I have noticed that my blood pressure drops about 20 points when I go from lying down to standing. I will have moments where I feel faint. I also have moments where I'm so fatigued that I cannot get out of bed. I've started seeing an acupuncturist for some relief.
Coughing, chest and throat tightness, nausea, vomiting, dizziness, fatigue, muscle and joint soreness, sporadic tingling in fingers and toes, on-and-off low grade fever, and temperature regulation issues ; home care and rest as well as 1 virtual visit with MD ; outcome pending
DONOR BECAME HOT, CLAMMY AND NAUSEATED ABOUT 5 MINS AFTER VACCINATION. DONOR WAS GIVEN COLD PACKS AND EMESIS BAG. GIVEN GATORADE AFTER NAUSEA SUBSIDED.
Went to get out of the car and was extremely dizzy; Could not remember any words/had trouble remembering words; Pain at injection site; Had tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain injection site in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 30th May 2023) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 6th April 2022, less than a day after receiving Shingrix, the patient experienced pain injection site and tiredness. On 8th April 2022, the patient experienced dizziness and forgetfulness. On 8th April 2022, the outcome of the dizziness and forgetfulness were recovered/resolved. In April 2022, the outcome of the pain injection site and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain injection site, tiredness, dizziness and forgetfulness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022099905   Additional Information: GSK Receipt Date: 29-JUN-2022/ 29-JUN-2022 Reporter's comments: This case was reported by the patient herself. The patient stated that she received her Shingrix vaccine in the Left deltoid and later that day she had pain at the injection site and had tiredness both of which resolved a day or two later. After 2 days on 8th April 2022, she went to get out of the car and was extremely dizzy and could not remember any words. The pharmacist said, the patient had trouble remembering words. Both the symptoms resolved in less than 30 minutes. The pharmacist stated that patient had not yet received the second dose of Shingrix. The patient would like to talk to safety herself. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022099905:FU1 - Deleted
The patient presented 3 weeks post injection with cardiac arrest from home.  She had a 1 hour downtime.  The day previous she had worsening leg swelling and SOB +DOE.  Post arrest she was diagnosed with massive PE.  She was treated for PE with thrombolytics and improved hemodynamically.  She unfortunately at this time has anoxic brain injury.
6/30/21, 20 minutes after headache and fatigue. More tired that usual over next few days and hard to concentrate.  7/2/21-7/13/21 twitching in my legs upon  waking (think activated bartonella bacteria from lyme co-infection), 7/3/21-7/8/21- circulation poor in lower legs-had to move  around a lot, veins protruding from lower legs-which I've never had before and some swelling in ankles, feet and fingers, 7/1/21 heart beating fast going up flight of stairs but quickly went back to normal  also got menstrual cycle 10 days early- was heavier with blood clots (typically 28 day cycle), bruise under area received vaccine
Information has been received from a 65 year old female registered nurse, who is the consumer, with hypersensitivity and allergic reaction to antibiotics and a history of flu which she had on October 2008, who on 26-NOV-2008, "a day before thanksgiving" was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# not provided). Concomitant therapy included influenza virus vaccine (unspecified) and glucosamine sulfate (unspecified). On 26-NOV-2008 the patient experienced rash above the belt buckle. On approximately 27-NOV-2008 the patient's rash appeared across her abdomen up her left side and across the back of her rib cage. The consumer is unsure if the rash was caused from ZOSTAVAX (Oka/Merck). The consumer saw her physician who gave her prednisone and BENADRYL to help with the rash, which she described as "blotchy red dots like measles", since she could not sleep. No lab diagnostics studies performed. After two doses of prednisone her rash went away. The consumer reported that she also had a cold that she developed on 24-DEC-2008, "Christmas eve", and she had an itchy throat, breathing difficulties and chest tightness. At the time of this report the patient had recovered. No further information is available.
Information has been received from a licensed practical nurse concerning a 77 year old female with hypothyroidism, hypertension, no known drug allergies, and unknown if history of asthma who on 03-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651404/0619F) 0.5 ml intramuscularly right deltoid. Concomitant therapy included policonsanol, SYNTHRODI, aspirin, albuterol and "propanolol". On 05-NOV-2006, 2 days post vaccination, the patient sought medical attention and went to the emergency room with cellulitis, was treated with oral antibiotics and released from the emergency room. She was not hospitalized. The cellulitis and redness was 1 to 2 inches under the right axilla, but not near the injection site. No laboratory diagnostic tests were performed. Subsequently, the patient recovered. Additional information has been requested.
It has been 8 weeks since the patient received the 1st dose; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been 8 weeks since the patient received the 1st dose) and PYREXIA (Fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been 8 weeks since the patient received the 1st dose). On 16-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been 8 weeks since the patient received the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included unspecified birth control medications.   At the time of this report, the patient did not get her second dose.  The patient did not take any medication to treat her symptoms.
Overcome with extreme dizziness to the point where I almost lost balance as I was making dinner in my kitchen.  Same episode happened about an hour later, although not as extreme and I was sitting down holding my baby. Now feeling mildly dizzy and need to lay down. I ate and drank water since the event happened.