chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2022 and was forwarded to Moderna on 04-Mar-2022.    This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that patient's facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients.  Treatment information was not provided.
Patient came to vaccine pod and received Moderna, there was Pfizer and Moderna at the site and she was given Moderna in error. Patient mother notified and our regional department of health. Patients mother states she had no ill effects as of note. Mild headache and fatigue as expected for vaccine.
Coughing, mucus, fever x 12 hours exposed to Flu / Mom. Positive Flu A / Binax test kit. Rx TAMIFLU 75 mgm po BID x 5 days.
pt had area of swelling around injection site.  he reported no pain in area of swelling except tenderness at injection site.  swelled area is about 4 inches in diameter and about 1/2 inch high at the highest point.  he says the swelling appeared the morning after the vaccination (this morning 9/23/20).  he showed us the site at about noon today and said it had not changed when I checked on him at 4pm
Increased Fatigue on day one after 1st dose.  mild Left axillary lymphadenopathy.  Axillary swelling, and tenderness radiating into left breast and very mild into left anterior neck. . 2/10 on pain scale. Constant Dull discomfort. Not really worse with movement.  Axillary lymphadenopathy and tenderness more noticeable on day 2 after receiving 1st dose of vaccine. NO SOB, dyspnea, fever, change in heart rate.
Red, swollen, warm to touch and painful at injection site 3-4 inches circ. Advised MOTRIN - cool compress.
Pt experienced injection site reaction characterized by redness and swelling and was painful to move leg. Given Keflex for infected immunization site but was later reassessed as vaccine reaction.
Needle leaked (Not sure if any of the dose got in to the patient's muscle); Needle leaked (Not sure if any of the dose got in to the patient's muscle); A spontaneous report was received from a healthcare professional concerning a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following:  needle leaked (device connection issue), not sure if any of the dose got into the patient's muscle (vaccine underdose)  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot #: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, while administering the vaccine to the patient, the nurse noted that the needle was not attached properly.  The vaccine leaked and the reporter was not sure if the patient received any of the dose.    Action taken with mRNA-1273 in response to the event was unknown.  The event, needle leaked and not sure if any of the dose got into the patient's muscle, was considered resolved.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273.  There were no reported adverse events associated with this case.
Approx 2 wks following vax, lab eval revealed serum GGT 75; No further details were provided;
Patient was inadvertently given FLUZONE 0.25 mL IM by intranasal route. PCP/Health dept. have been notified, response in process. Patient's mother notified.
Hot on the outside; Fatigue; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot on the outside), FATIGUE (Fatigue) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FEELING HOT (Hot on the outside), FATIGUE (Fatigue) and CHILLS (Chills). On 09-Feb-2021, FEELING HOT (Hot on the outside), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were provided.  No treatment information was provided.   This case was linked to MOD-2021-046408.
~12 hours after 2nd dose I experienced severe muscle aches, chills, headaches, nausea and exhaustion/brain fog. 2-3 days later, the muscle aches got better, and the chills diminished greatly, but the other symptoms have been recurring since. Sometimes mild or moderate, but sometimes severe, where I can't work or go after regular daily activities. I hope this isn't a chronic condition, it's day eight now.
Seizure.  Lasted approximately 5 minutes. Outcome was positive and no lingering effects.
bleeding; my skin on my hands and the bottom of my feet started to peel off; very painful in the fingers and the feet; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249, expiration date not reported) via unspecified route of administration in the arm right on 21Jan2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. The patient previously took iodine and experienced drug allergy; also received first dose of bnt162b2 (Lot number: EJ1685) via unspecified route of administration in right arm on 30Dec2020 14:00 for COVID-19 immunization. Facility type vaccine: clinic. It was reported that on 23Jan2021, couple of days after the second shot, patient experienced skin on hands and the bottom of my feet started to peel off and bleeding and very painful in the fingers and the feet.  The events resulted in both: Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was unknown if treatment received for the events. Outcome of all events was recovering.; Sender's Comments: Based on plausible temporal relationship and known drug profile, a contributory role of the suspect BNT162B2 cannot be excluded in the development of bleeding, skin exfoliation and pain in extremity.  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.
Patient is fully vaccinated. 61-year-old male presents to the ED following a positive covid test 5 days ago. Patient complains of increasing shortness of breath, weakness, coughing, general malaise and fatigue. Patient states that he presented to a urgent care with pneumonia was prescribed azithromycin and steroids. Patient states that his fatigue and shortness of breath had progressively gotten worse over last week. Patient currently denies any fevers, chills, nausea, vomiting and chest pain. Complains of mild shortness of breath. Treatment:  referred to clinic for monoclonal antibChest x-ray was ordered and reviewed. Bilateral patchy opacities doing the lower lobes. On examination patient had in no distress.  Pt discharged. Returned to the  hospital 6 days later. He reports worsening shortness of breath, dry cough.On arrival to the emergency department patient's oxygen saturation 88% on room air. Patient was placed on 4 L nasal cannula and oxygen saturation improved to 100%. Treatment:  oxygen therapy,  bronchodilator treatment, decadron, remdesivir, baricitinib, IV heparin for acute pulmonary empolism and switched to Lovenox. Patient discharged.
Swelling, erythema, fever and chills 2 days after vaccine given. Gave Keflex 10 day course for possible cellulitis.
Pt recvd 2 doses of Engerix-B on 4FEB91 & 4MAR91 for the prevention of Hep B; 3APR91 infused w/clotting factor IX concentration; 21JUN91 tested positive for Hep B core antibody;
Pt became nauseated, dizzy and diaphoretic minutes after vaccine.  He was layed down in clinic, given ice pack and juice, vitals monitored.  Pt able to leave clinic in stable condition. Evaluated by Dr. before leaving.
At 12:39 pm (while under post vaccination observation), staff asked the observer if her neck was red as it was itching. No erythema noted in the neck. Denied difficulty of breathing or swallowing. Remained verbally responsive, with no other symptoms noted.
Developed wheals at injection site right after injection given. Cleared after 30 mins observed in clinic (MMR site).
Joint aches, cold feet and hands, lack of energy, followed by slight fever and headache.
EXTREME FATIGUE. MUSCLE & JOINT PAIN, NAUSEA & VOMITING and MIGRAINE HEADACHE
Starting the day after the vaccination, the patient developed a large bruise at the injection site, bigger than the size of a softball. The patient experience some soreness in the arm for a few days. The bruise was still sore when pressure was applied as of 1/8/18.
Pt presented to medical with complaint of "itching" along arms and chest region. Upon assessment, pt was found with hives along arms and chest region. Pt given Benadryl 50mg IM at 7:38 PM. Intravenous therapy: 20g left AC 0.9% NS (KVO) and O2 via NRB at 10LPM. Pt given second dose of Benadryl 50mg IM at 10:18 PM. Pt spent the night in medical ward and was released in the AM with Bendaryl 25mg PO.
Redness with warmth in the vaccination site area.  Started itching on the third day, but not to the point of intense scratching.  Later the same day started feeling a muscle pinch by the right shoulder blade.  Applied a pain patch which dulled the pain which was gone by morning.  Began again in the afternoon of the next day.
Pt reported today for one week of pain and swelling of the injection sight, and night sweats after injection, right shoulder visibly swollen, denied any rashes, throat tightening, or shortness of breath (out of norm, he has chronic copd) Pt instructed to take Tylenol for fever and pain and to ice the arm on/off for 15 min for next 3 days
My arm was sore for the first 48 hours but then the adverse reaction started eight days after the 1st injections.  I woke up with a red, swollen, itchy, and painful hard lump at the injection site and has not resolved.
Two days after vx started having heartburn and her body felt numb, she periodically couldn't stand. Went to her PCP and they referred her to a Cardiologist, where they then gave her an EKG test and ultrasound. They diagnosed her with having Afib. Is currently wearing a heart monitor.
Initial report received from a consumer who is also the patient on 24 May 2013. A female patient of unspecified age, whose medical history and concomitant medications were not reported, had received a dose of ADACEL, lot number C4311AA in right arm (deltoid) on an unknown date. On an unknown date, the patient had a golf size swelling and soreness at the vaccination site. The patient applied cold packs. The swelling flattened into broader area but the soreness remained. Stayed swollen for 6 week. Corrective treatment and laboratory investigations were not reported. The patient's outcome was recovered. Documents held by sender none.
Felt a little bit sluggish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BRADYPHRENIA (Felt a little bit sluggish) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 25-Feb-2021, the patient experienced BRADYPHRENIA (Felt a little bit sluggish). On 26-Feb-2021, BRADYPHRENIA (Felt a little bit sluggish) had resolved.            This case was linked to MOD-2021-030380 (Patient Link).   Reporter did not allow further contact
48 hours after receiving immunizations, patient reports 100 + temp for 36 hours, a 2.5" Hive at injection site where she received Hep B and PNEUMOVAX vaccines. Reports moderate to severe pain in arm muscles, ache all over, including head, muscles and joints and reports heart rate resting around 100 bpm.
Migraine-Headache, toes hurt, hard to walk, eyes hurt, feels weak
Developed acute pancreatitis about 1 month after second dose. Was hospitalized and am still having some symptoms (abdominal pain)
Patient reported fever, chills, a walnut-sized lump in her injection arm, and tremors in her hand. The fever, chills, and lump went away within a couple of days, but she still occasionally has tremors in her hand.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 15:45 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Hormone replacement" (unspecified if ongoing), notes: Other medication in 2weeks product = Hormone replacement. Concomitant medication(s) included: STRESS B COMPLEX [AMINOBENZOIC ACID;ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;ROSA CANINA;THIAMINE MONONITRATE] taken for hormone replacement therapy, start date: 04Jan2021. Past drug history included: Cefzil, reaction(s): "Known allergies: Cefzil", notes: Known allergies: Cefzil. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 15Dec2022 to 20Dec2022 for Covid-19.
shot given at 1045 am. arm soreness at injection site. ltook two 500 mg tyleno at 1 pm and  laid down for a nap, woke up at 1:30 pm with heavy headache at top of head about 3 inches in circumference. at 4:30 pm began to have body aches, more in my legs but generally all over. temp went up 1 degree. had these symptoms till the next day which began lessening about noon and by 4 pm they were gone except I had arm soreness and I have continued to have heavy headaches every day which is somewhat relieved by scalp massage and tyleno.. lingering effects of vaccinenone
Vagal response - dizziness, trouble seeing, nausea, called EMT's after pt sat for several mins. was ok and walked out without help & was cleared by EMT's.
Rash, hives, swelling, generalized. Arrived at ED at 10:53 on 06/04/02. Had four baby shots at 09:45. Had Benadryl 12.5 po and Solumedrol 12.5 mg.
Received vaccination yesterday. Fever to 103.2 deg began last night and became very fussy. Pt recovered 2/6/04.
Fever up to 102.5, rhinorrhea, and erythematous rash that began on cheeks and spread to neck, trunk then extremities. Further details can be obtained from mother at home number.
sick all year; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be possibly related to Flu vaccine.  Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment:  This case was reported by a consumer via interactive digital media. The reporter reported younger sister had the shot and was sick for a long period of time. Totally agree. Absolutely not. The patient got the flu vaccine and was sick all year. Not exaggerating either. The reporter reported what needs to be pushed is making these vaccine companies liable for vaccine injuries and see how fast they push their products on people.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2022 at 12:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Feb-2022 at 12:32 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Patient describes area as slightly red below injection site and that it is about 2 inches in diameter.  He reports slight numbness and that the area is slightly warm and raised.
Hives began on the right arm under the injection site, traveled down the right arm, left arm, back of neck, back, torso, and legs all had hives which lasted until the next afternoon around 4 pm   Hives went down by Saturday 1/16/21
pt reported on 6/13/19 that she was clinically diagnosed with cellulitis following the Prevnar 13 imz in 09/2016 due to the vaccine being given too low on the arm.
Ischemic Stroke left side of brain.  Right side of body initially paralyzed and speech slurred.  Received TPA within 1 hour in emergency room.  Full recovery, no lasting deficits.
Nausea, vomiting, dry heaves, headache, sore throat, burning cheeks, ear pain
chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 05May2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8729 and expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and experienced very tip of tongue was tingly and a little bit dizzy. The patient experienced side effects with chills and fatigue in May2021. The patient had a COVID test on 10May2021 and it was negative. The outcome of these events was recovered on 11May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling, soreness, hot to touch. 3 quarter sized red, non-raised blotches or patches.
Fatigue, aches, pains, shortness of breath, sensitivity to sound, anxiety, severe depression, suicdal, diarrehae, head aches, sinus issues, phantom smells, short term memory loss, lack of concentration, wake up not knowing where I am, personality changes, mood disorders, unable to spell, unable to do simple math, unable to do physical work without crashing afterwards. unable to remember other symptons because of dementia and cognitive impairment. This has been a migrating illness. I seem to do better in some ways only to relapse in other ways. Has been going on for over 2 years. I want my life back. please help