chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that there was excursion from their freezer on 01-Oct-2021. Storage condition at the time of the excursion was frozen.   Maximum and minimum temperatures reached-Minimum-4.2 degrees F Maximum 5.7 degrees F.  Excursion duration-6 minutes.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received contains patient demographics, vaccine start date and dose details.
Body aches from head to toe, headache, pain in left foot where it is hard to walk.  It is since subsiding.  This came on fast once it started and is dissipating within a 30 hour period.
One of three children immun from the same vial & experienced an inject site rxn. Rxn described a induration; Tx included Tylenol & ice packs.
Information has been received from a physician concerning a 24 year old female who on 08-OCT-2007 was vaccinated IM with Gardasil vaccine. Concomitant therapy included Zoloft. On 10-OCT-2007, the patient experienced facial tingling. No additional information at this time. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. The physician noted that diagnostic tests should be performed to check for infection. The patient did not come into the office for an appointment. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
lethargy; dry cough; fatigue; chills; slight fever, 99.9; soreness in her left arm; hot, then cold; cant shake symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), LETHARGY (lethargy) and COUGH (dry cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), COUGH (dry cough), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight fever, 99.9). On an unknown date, the patient experienced LETHARGY (lethargy). At the time of the report, PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), LETHARGY (lethargy), COUGH (dry cough), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight fever, 99.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medicines were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07 May 2021 and updated lab test and patient email id.
presented to the ED with generalized weakness progressing to fever, cough, dyspnea, myalgia, pneumonia. admitted to  Hospital
No Adverse Reaction.  A letter was sent to patients parents from hospital to bring child in to get Covid-19 pfizer booster shot. Child is on prednisone. Vaccine was initiated and later we found out child is not Immunocompromised.
She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines; She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines; Gained weight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GJ377) at the age of 66 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL1284), in arm, on 25Jan2021 as dose 2, single (Lot number: EN538721), in arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 301558A), in arm and on 08Mar2022 as dose 4 (booster), single (Lot number: FJ5683), in arm for covid-19 immunisation. The patient's relevant medical history included: "Headache" (unspecified if ongoing); "Renal issue" (unspecified if ongoing); "Had MI due to spasm" (unspecified if ongoing); "Had MI due to spasm" (unspecified if ongoing). Concomitant medication(s) included: TIZANIDINE taken for headache; GABAPENTIN taken for headache; DILTIAZEM taken for headache; ACYCLOVIR [ACICLOVIR] taken for myocardial infarction, muscle spasms; BABY ASPIRIN taken for myocardial infarction, muscle spasms; SHINGRIX taken for immunisation as dose number unknown, single. The following information was reported: WEIGHT INCREASED (non-serious) with onset Feb2023, outcome "unknown", described as "Gained weight"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines". The patient underwent the following laboratory tests and procedures: Body temperature: 104.5 degree; Weight: 40 lbs, notes: gained in past 3 years. It was further reported that patient had a temp. of 104.5 degree F but did not lose her sense of smell and/or taste as she gained weight since having COVID. Patient was not prescribed with Paxlovid due to her renal issue.
This spontaneous report was received from a clinical medical assistant who refers to a patient of unknown age and gender. On 29-AUG-2013 the patient was vaccinated subcutaneously with 0.5 ml an expired dose of M-M-R II HSA (lot # 1293AA, exp. date 09-AUG-2013). No adverse effect reported. Additional information has been requested.
Covid Arm that had a lumpthat got larger over time/square odd arm; Covid Arm that had a rash; headache from hell; lymph node swelled on my left side all the way down to my collar bone, I couldn't even wear my seatbelt and went all the way behind my ears.; had a temperature of a 102 degree F fever the next day (04May2021), then 100 degree F on 05May2021, then 99 degree F on 3rd day (06May2021); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Covid Arm that had a lumpthat got larger over time/square odd arm), PYREXIA (had a temperature of a 102 degree F fever the next day (04May2021), then 100 degree F on 05May2021, then 99 degree F on 3rd day (06May2021)), VACCINATION SITE RASH (Covid Arm that had a rash), HEADACHE (headache from hell) and LYMPHADENOPATHY (lymph node swelled on my left side all the way down to my collar bone, I couldn't even wear my seatbelt and went all the way behind my ears.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), BEMPEDOIC ACID (NEXLETOL), METOPROLOL, SEMAGLUTIDE (OZEMPIC), FISH OIL, MULTIVITAMINS & MINERALS PLUS LUTEIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +) and CO-Q-10 for an unknown indication.    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (had a temperature of a 102 degree F fever the next day (04May2021), then 100 degree F on 05May2021, then 99 degree F on 3rd day (06May2021)), HEADACHE (headache from hell) and LYMPHADENOPATHY (lymph node swelled on my left side all the way down to my collar bone, I couldn't even wear my seatbelt and went all the way behind my ears.). On 05-May-2021, the patient experienced VACCINATION SITE MASS (Covid Arm that had a lumpthat got larger over time/square odd arm) and VACCINATION SITE RASH (Covid Arm that had a rash). On 07-May-2021, PYREXIA (had a temperature of a 102 degree F fever the next day (04May2021), then 100 degree F on 05May2021, then 99 degree F on 3rd day (06May2021)) had resolved. At the time of the report, VACCINATION SITE MASS (Covid Arm that had a lumpthat got larger over time/square odd arm), VACCINATION SITE RASH (Covid Arm that had a rash), HEADACHE (headache from hell) and LYMPHADENOPATHY (lymph node swelled on my left side all the way down to my collar bone, I couldn't even wear my seatbelt and went all the way behind my ears.) 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.   Treatment details were Naproxen 500mg twice a day, Caffeine and water to alleviate the symptoms experienced.   This case was linked to MOD-2021-114645 (Patient Link).
Systemic: Seizure-Medium, Additional Details: After receiving her 2nd covid dose, patient had a seizure. Patient has a history of seizures and was taken to urgent care by paramedics.
SICK ON 12-30-2021 WITH CHEST CONGESTION, FATIGUE AND COUGH. TESTED POSITIVE FOR COVID-19 AND INFLUENZA A ON 01-01-2022. ADMITTED TO SHC ON 01-01-2022 DISCHARGED 01-05-2022
tested positive greater than 14 days post 2nd vaccine Narrative:  tested positive greater than 14 days post 2nd vaccine
Numbness, Tingling, Pins & Needles in feet, legs, hands, arms, neck and face. Started one week after injection and still ongoing now after 2 weeks of symptoms.
Patient has had pain in arm at site of injection site since day of vaccine.  Describes it as a dull pain.
Pt given Td vax on 12/14/99. Dvlped rash on 12/17 and itching on 12/18. Clearing along spinal area; txed w/ Benadryl.
Patient developed a blister and rash on the left side of her neck a couple of day after the vaccine. Now the rash is moving to the left side of her neck on 1/24/18.
NEEDLE LEAKED FROM VACCINATION - PT RECEIVED SOME VACCINE AND SOME DRIPPED DOWN HER ARM.  IT WAS DIFFICULT TO TELL WHETHER OR NOT THE PATIENT RECEIVED A THERAPEUTIC DOSE
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. Approximately in July 2015 (one of the date of 13-JUL-2015, 14-JUL-2015 and 15-JUL-2015), the patients were vaccinated with improperly stored GARDASIL (unknown strength and dose) Lot # K006690 with expiry date of 19-FEB-2017 and lot # K004205 with expiry date of 12-JAN-2017. Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Vaccine site had reddened area radiating to the underside of his arm. Patient stated he is taking 200mg MOTRIN and the redness/pain is being reduced. Patient also has cold like symptoms for one week.
pt recv vax 4NOV96 & 830AM became nauseated p/2hr;then flushed, weak kneed, SOB, heart palpitations;taken to hosp ER;recv DPH;saw FNP 5NOV96;
This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose was received on 31st October 2018 (refer case US2019025047)). Concurrent medical conditions included drug allergy ( allergic to penicillin, iodine and sulfa). On 31st October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 5 hrs after receiving SHINGRIX, the patient experienced blood in stool (serious criteria GSK medically significant), fainting (serious criteria GSK medically significant), sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration. On an unknown date, the patient experienced fall and weakness. On an unknown date, the outcome of the blood in stool, fainting, sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration were recovered/resolved and the outcome of the fall and weakness were unknown. The reporter considered the blood in stool, fainting, sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration to be related to SHINGRIX. It was unknown if the reporter considered the fall and weakness to be related to SHINGRIX. Additional details were received as follows: At noon, the patient received SHINGRIX vaccine in the left arm but she was not sure. By the evening, 5 hours later, she was really sick, much worst than the first time she received the vaccine, very achy, shaking, weak, shivering, fever, was in bed for 2 to 3 days and did not want to get out of bed, nor did she want to eat or drink. The first night, she got up to use the bathroom, had diarrhea and while on the toilet, passed out twice. The patient was laying on the cool tile floor, but not hitting any body parts with force when she fell. She then crawled back to bed. She felt stronger after 3 days, started to eat small amounts of food and after her symptoms resolved, she drove back home. She went to home after her symptoms resolved. She was staying at her daughter's home when she was ill after the second vaccine. When she was at home, the following day she noticed some blood in her stool, went to her gastroenterologist and had two colonoscopies, one in the office, the second one under anesthesia, both were unremarkable and within normal limits. The patient's cardiologist was concerned she fainted twice, so she wore a heart holter monitor for 2 weeks and the results were essentially normal. The patient then had a Stress test done and that was essentially within normal limits . She believes she was very dehydrated after the second vaccine and that is why she fainted.  She is allergic to penicillin, iodine and sulfa. The reporter did not consent to follow up.
Received 2nd Covid vaccine on 2-1-21 at about 0900.  I took prophylactic measures (Tylenol, ibuprofen, ice to injection site, & increased fluids).  On 2-2 at about 0730, I began to experience nausea, light-headedness (in addition to the muscle & joint pain I was previously experiencing).  Felt slightly better after eating & continued to work.  Inquired of our Pharmacy Manager, who stated whether these side effects are considered ADR's is debatable at this time, but he recommended entering this report.  P.S. 1st Covid Vaccine was on 1-4-21 but only got a sore arm.
Pt recvd 3 doses of HEp B vax 4FEB91, 5MAR91, & 12AUG91 & on 12AUG91 following 3rd dose pt exp pain in arm @ inject site; a few hrs later eyes became swollen, itchy & watery; condition persisted until 14AUG91 & then recovered;
Provider ordered a KINRIX (DTaP/IPV) for a 10 year old and staff gave vaccine without realizing KINRIX is only indicated to ages up to 7 years.
Called at 8 am this morning to inform me of a reaction to her COVID vaccine. She received the vaccine on Tuesday, 1/19/21. The next day she noted the back of her tongue on the R side was swollen. On Thurs, 1/21/21, she reports she woke up with the back of her tongue swollen on both sides such that she had some trouble speaking and needed to be very careful with chewing so she would not bite her tongue. She stated she also had drippy sinuses and an earache which then woke her up several times during the night last night. Today she reports the tongue swelling is only to the back R side of her tongue. She continues to have ear pain. She states she had not reported the symptoms to anyone before her call because she had not felt the symptoms were life-threatening. I asked her if she had taken any benedryl, and she stated the only medication she had taken was her analgesic herbal supplement. She states she has never had a vaccination reaction in the past. I advised her to call her PCP and be seen, which she was able to do. After she was seen, she called and stated while the clinician was looking at her tongue, it started to have shooting pains when she moved it to the right. The clinician stated her tongue and throat were not visibly swollen, noted no swollen lymph nodes, and noted no ear abnormalities.
worsening rosacea symptoms of the face, and diffuse hives 2 days later
Starting around 15th day after the Moderna COVID Booster shot, I developed hives with itching and rash all over my body including head and forehead and once around the eyes. They appear and cause lot of itching occasionally burning sensation and disappear after 1 hour and reappear at a different place.  During sleeping they tend to be lot aggressive in the lower body especially in the groin area.  I never had any allergy reaction my whole life and never had any rash.  Please help me . I am a healthy person working out 300 out of 365 days. I eat healthy and home made food.  I am not sure how long I should bear this suffering. Please help me
eye swelling and tearing, increased pulse rate, nausea, abdominal cramping, runny and stuffy nose; redness, pain, itching at injection site;  foggy headedness and lethargy. Symptoms started the day of injection 1/21/21 and have continued to this day 1/24/21
I24.8 DEMAND ISCHEMIA 5/6/2022 METABOLIC ENCEPHALOPATHY J96.00 ACUTE RESPIRATORY FAILURE 5/20/2022 METABOLIC ENCEPHALOPATHY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/6/2022 METABOLIC ENCEPHALOPATHY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/27/2022 METABOLIC ENCEPHALOPATHY I24.8 DEMAND ISCHEMIA 5/6/2022 HTN (HYPERTENSION) J96.00 ACUTE RESPIRATORY FAILURE 5/20/2022 HTN (HYPERTENSION) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/6/2022 HTN (HYPERTENSION) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/27/2022 HTN (HYPERTENSION) I24.8 DEMAND ISCHEMIA 5/6/2022 DO NOT RESUSCITATE STATUS J96.00 ACUTE RESPIRATORY FAILURE 5/20/2022 DO NOT RESUSCITATE STATUS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/6/2022 DO NOT RESUSCITATE STATUS J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/27/2022 DO NOT RESUSCITATE STATUS I24.8 DEMAND ISCHEMIA 5/6/2022 METABOLIC ENCEPHALOPATHY J96.00 ACUTE RESPIRATORY FAILURE 5/20/2022 METABOLIC ENCEPHALOPATHY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/6/2022 METABOLIC ENCEPHALOPATHY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/27/2022 METABOLIC ENCEPHALOPATHY
feeling very tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling very tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was given.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feeling very tired). At the time of the report, FATIGUE (feeling very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was received by the patient  No Treatment was received by the patient.   This case was linked to MOD-2021-124118 (Patient Link).
Arm sore, swollen, placed ice pack on arm.  By 11:30 PM had chills, nausea.  Took ibuprofen, slept until am. By 1:30 PM 6/14/11 again arm very sore, red, chills, nausea, fever 101.4.  Took more ibuprofen, called Employee Health Clinic. Advised to see medical provider but wanted to wait to see if symptoms would improve. Arm swollen and red on 6/15/11. Went to see doctor and was placed on antibiotics.
Redness, swelling, hotness to LUE. Placed on clindamyacin for cellulitus. Problem resolved.
ActHIB is mixed with a sterile diluent instead of the supplied 0.4% Sodium Chloride; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA186114 and 2019SA188109 (same reporter).  This case involves a 18 months old male patient who was vaccinated with a 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot U1919AA and Exp. Date 04-Jun-2019) via intramuscular route in the right thigh (reported as right leg) on an unknown date of March or April 2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong solution used in drug reconstitution. It was reported that, ActHIB is mixed with a sterile diluent instead of the supplied 0.4% Sodium Chloride diluent that was in the box.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
Subconjunctival hemmorage in sclera of eye, hidden under the lid. Red bleed just under the surface of the white of the eye. After 4 days of observation bleed had spread in terms of area covered, so went to ugent care. Urgent care recommended no treatment and that hemmorage would dissipate. Urgent care suggested correlation with Pfizer vaccine. Thus I chose to file this report.
Muscular aches/pains in legs and groin area; dizziness; weakness in walking.
7/1/00 with Hep-A vaccine #1, developed rash at injection site; 3 weeks later, resolved. Progressive myalgias and heliotropic rash 9/00 to 10/00. Dx'd with dermatomyositis and ATN (acute tubular necrosis).
Patient received flu vaccine on 10/10/15 at clinic. Gradually upper arm begin to swell up and redness noted. Mother works for my office since pediatrician only asked to use ice and child complained more pain she brought him in.
Dizziness and pressure in ears at 30 min after shot.  16 hours later, nausea, fever 101, chills from 8:30am -4am, heart pounding in ears. Tuesday May 11 heart palpatations and elevated blood pressure - to currently