chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started in arms - heaviness in muscle's - went to legs - (not joints). heaviness in center of chest & tightness in neck.
81-year-old male patient of MD who presented with poor appetite, weakness, diarrhea and cough.  He tested positive for COVID-19. His background history include CKD stage IV/V, diabetes mellitus, CAD, chronic anemia, BPH, hyperlipidemia and skin cancer.   Diarrhea resolved  Colitis resolving  Noncontrast CT of the abdomen/pelvis with diffuse colonic thickening suggestive of colitis. In the setting of COVID-19 infection. C. difficile testing neg Loose stool is improved. He was on Zosyn, now discontinued. Imodium as needed.   Covid-19 Virus Infection COVID pneumonia Chronic respiratory failure - 2L Date of onset of symptoms: 2-26-2023 Symptoms present on admission: Cough, weakness, poor appetite. Date of covid positive test: 3-8-2023 Vaccination status: 2 shots and 1 booster Imaging: CXR with left lower interstitial opacities. Current oxygen requirements: 2 liters  Medical therapy: steroids stop dexamethasone Consultants following:ID Anticipated special isolation end date: 3/8/23 - d/w ID - now off Isolation. CXR on 3/8 with left lower lobe interstitial opacities suspicious for pneumonia.  Repeat CXR today.  .  Discussed with ID. No need for further antibiotics   CKD stage IV/V Had renal biopsy in 9/2022 with finding of advanced chronic changes in the setting of severe vascular disease with obliterative microvascular changes. No need for renal replacement therapy at present. Cr improved to 2.60 Nephrology following.as an OP   Generalized weakness Consult PT/OT and CM   Anemia of CKD and iron deficiency Follows with hematology and receives Venofer. Monitor Hb closely.   HTN He has a history of left renal artery stenosis status post stent. Also history of right subclavian stenosis. BP is now higher. Repeat CXR BP remains persistently elevated. Continue Norvasc and Coreg, increase dose of lisinopril. Increasing amlodipine to 10 mg Hydralazine as needed   Diabetes mellitus II Fluctuations in BG since yesterday. Likely component of IV steroid. Adjusted Lantus and SSI. Continue to monitor, avoid hypoglycemia.   Chronic respiratory failure Continue O2 support and bronchodilators. He uses O2 at home. Currently on 2 L.
About one week after the vaccine, she developed some itching, redness, swelling and firmness of skin just below the vaccine site. This spread over the next day or so, was stable, and then a couple days later started to improve.  I will note that this is the same reaction that two of my coworkers had, also 7-8 days after their first moderna coronavirus vaccine. I saw a news article describing it as "COVID arm"
Approximately 30 hours after vaccination I felt sick; I had a fever of 101.2 and chills; I had a fever of 101.2 and chills; I felt incredibly nauseous and lost my appetite; I felt incredibly nauseous and lost my appetite; I was pale and felt weak; I had a severe headache; I'm left with a sore right arm; I was pale and felt weak; Approximately 2 hours after vaccination I was very tired and slept about 6 hours; This is a spontaneous report received from a contactable Other Health Professional. A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 00:45 as (At the age of 21-year) DOSE 1, SINGLE for covid-19 immunisation. Medical history included granuloma annulare, migraine and autoimmune thyroiditis from an unknown date. The patient's concomitant medications were not reported. Patient had No known allergies. No covid tested post vaccination. No covid prior vaccination. Patient did not receive Other medications in two weeks. It was unknown if patient was pregnant at the time of vaccination. Patient took Other vaccine 4 weeks include HPV vaccine dose number 2 in Left arm on 15Jan2021 and Tdap booster in Right arm on 15Jan2021. It was reported that Approximately 2 hours after vaccination patient was very tired on 09Feb2021 and slept about 6 hours. Patient felt great afterwards. Approximately 30 hours after vaccination patient felt sick. Patient had a fever of 101.2 and chills. Patient felt incredibly nauseous and lost his appetite. patient was pale and felt weak. Patient had a severe headache. Approximately 48 hours after vaccination most side effects have been resolved and I'm left with a sore right arm on 10Feb2021. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 101.2 on 10Feb2021. The outcome of event i'm left with a sore right arm was not recovered, and outcome of all other events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Started with pain is the area of the shot and the fatigue, muscle pain, chills, nausea then fever, vomiting and now a big read rash on the injection site that is very hot.
Information has been received from a registered nurse referring to a patient of unknown age and gender Information about medical history and concurrent condition was not reported. On 19-JAN-2015 the patient was vaccinated with improperly stored PNEUMOVAX23 lot # K010465 with expiration date of 23-MAR-2016; dosage and route unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tinnitus in right ear that is nonstop. It worsens at night. Exam by physician found ear canal is clear. Also had MRI of brain and right ear canal. It was also clear.
Day 7 post injection left arm injection area itchy, slightly red, swollen,  mild pain.  Area covering 2 inches by 2 inches.
Reddened area approx. 8 1/2 x 5 cm, warm to touch surrounding injection site of left thigh.
Initial report received from a healthcare professional on 18 Nov 2014. A male patient (age not reported), whose concomitant medication were not reported, had received a dose of DAPTACEL, manufacturer: Sanofi Pasteur Ltd (batch number: C4630AA, expiry date: 28-OCT-2016) dose and route of vaccination were not reported) in left thigh on an unspecified date, a dose of Flu vaccine, manufacturer: Unknown, batch number, dose and route of vaccination were not reported in right thigh, on an unspecified date and fourth dose of DTAP, manufacturer: Unknown, batch number, dose and route of vaccination were not reported on an unspecified date. Medical history of the patient was reported as, he had mild allergy to eggs and nuts. On an unspecified date, patient had papular vesicular lesions in left thigh. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. List of documents held by sender: none.
Positive warm slightly raised erythema at site of injection. Local reaction (palm size) to Dtap
Wednesday Dec. 11: late afternoon low grade fever with intense headache began; Dec. 12th awoke w malaise; began to dress for work; series of violent dry heaves; out of work all day; saw his intrenist  late afternoon for pre-arranged visit and 99.2 temp; Dec. 13th went to work for X-Mas Party; left at 2;30, 1 hour into party.  From  Dec.13th through Dec.16th  patient has been at home, in bed, with fever 100° to 101,8°; imbalance; occasional disorientation; malaise; mild diarrhea; significant fatigue, sleeping easily 16-18 hours.  On 12/17 patient worked half day with 99.6 temperature;  fell asleep for 5 1/2 hours; awoke in full sweat; temperature at 98.4 !
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: En6201), in left arm, on 14Mar2021 as dose 2, single (Lot number: En6206), in left arm and on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood sugar" (unspecified if ongoing); "Melanoma" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 24Jan2022; LIPITOR, start date: 01Jan2017, stop date: 18May2022. Past drug history included: Bacitracin, reaction(s): "Known allergies: Bacitracin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Still testing positive using at home antigen test 5 days after onset of second set of symptoms; Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks. COVID 19 Treatment: Paxlovid, treatment start date: 18May2022 and stop date: 22May2022. On 26May2022, reoccurrence of nasal congestion and fatigue 4 days after completing 5 day course of Paxlovid. Still testing positive using at home antigen test 5 days after onset of second set of symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection site became "itchy" 1 hour after vaccination. Redness, warmth and swelling came 3 days later. Turned into cellulitis 11/9/10.
Pt presents to clinic with right arm redness and swelling. Received DTaP in RUA and IPV in RLA on 05/05/2003. Diagnosed: localized DTaP reaction. Tx: Treat symptomatically
Extreme shaking, low grade fever. I took 800 mg ibuprofen. Symptoms lessened but went away after 2-3 days.
Onset of raised blotchy body rash with itching x 30 min.- then disappeared. Asymptomatic since that time.
This spontaneous report as received from a consumer refers to an 80 year old female patient with drug reactions/allergies, but details not specified. The patient stated that she had shingles 10 times before having had the ZOSTAVAX vaccine. In 2008 (reported as "about a year ago" at the time of report) the patient experienced a light case of shingles. On 12-FEB-2014 (reported as "about a week ago" at the time of report) the patient experienced another case of shingles that was severe and included a rash with blisters and pain. Patient explained that she had been given unspecified pain medication and nerve medication for her shingles associated nerve pain. patient also stated that she had been prescribed FAMVIR antiviral to be taken as soon as she feels pain. Patient had taken the FAMVIR for 8 days. The outcome of the events was unknown. Additional information has been requested.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 47-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 have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the 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.   It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because her facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patient. Reporter confirmed that patients had administered doses while the temperature excursion assessment was ongoing.  No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2022-501575 (Patient Link).
Rash appeared 3 days after vaccine, with no associated signs or symptoms.  Rash consistent with erythema multiforme.  Coincided with day 7 of AMOXICILLIN for otitis media
she is now blind; paralized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "she is now blind"; PARALYSIS (medically significant), outcome "unknown", described as "paralized".  The lot number for bnt162b2 was not provided and will be requested during follow up.
after recv vax pt devel approx 30 lesions, fever 101, sore throat. m.d. dx was chickenpox
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. The reporter considered the injection site pain and in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported to the physician. The age at vaccination was not applicable. The reporter indicated that approximately 12 SHINGRIX vaccinations have been administered at his pharmacy. At least 80% of the consumers that received the vaccine have reported experiencing pain during the administration of the vaccination. Also these patients report experiencing a sore arm for and extended period of time (at least 4-5 days) after receiving the injection. The reporter was unable to provided patient specific information.
Soreness in arm; Body aches; This is a spontaneous report received from a contactable (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced soreness in arm and body aches on 15Jan2021. The patient wanted to know if she can take Tylenol or ibuprofen. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Redness (about 2 inches diameter) soreness, swelling and itching at the site of injection for about a week. Joints (injected arm) were also sore.
Information has been received from a Registered Nurse concerning a 47 year old male with benign prostatic hyperplasia and no drug allergies who on 20-FEB-2009 was vaccinated subcutaneously with a 0.5 ml dose of MMR II vaccine (660202/0451X). Concomitant therapy included finasteride (MSD). The patient had a negative measles titer after receiving the vaccine. The patient sought unspecified medical attention. The result of measles titer was negative. No further information is available.
Initial information was received on 02 December 2008 from a health care professional.  A 40 year old female patient with a nut allergy received an intramuscular right deltoid injection of FLUZONE No preservative 2008-2009 (lot number UT2758AA) on 20 November 2008.  On 24 November 2008 the patient called her physician to report she had pain at the injection site.  She took IBUPROFEN without relief.  On 26 November 2008 she was seen by her physician.  The physician stated that "nothing appeared to be at the site".  The patient was prescribed VOLTAREN.  The patient continued to have pain at the time of the report.  No other symptoms were reported.  The recovery status was not provided.  List of Documents held by Sender:  None.
Fever and body aches for one day the day after.  Then 2/26 got large swollen area in underarm of arm where got shot and it is extremely painful.
Patient describes "a tiny red itchy area with one bump that looks like a bug bite" in the area where vaccine was given. She is unsure if it is vesicular or just an elevated bump.
PERIPHERAL NEUROPATHY HYPOTENSION 5/22/2022 -- RECURRENCE OF SAME SYMPTOMS
Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old male patient who received 0.5 ml dose of suspect DAPTACEL lot C5101A via intramuscular route in the deltoid expiry date: 26 Nov 2018 instead of ADACEL (lot number and expiry date not reported) on 23-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong drug administered and inappropriate age at vaccine administration. It was unknown if any adverse event was occurred. 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 the documents held by sender: none.
I don't feel good; 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 FEELING ABNORMAL (I don't feel good) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I don't feel good). At the time of the report, FEELING ABNORMAL (I don't feel good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs were reported.
On Monday, March 15th patient experienced a muscle tightening in her right leg, similar to a Charlie horse. Then on Thursday, March 18th patient experienced a lump, tightening sensation on the inner side of her right inner elbow.
feels like a big boil under his left arm; his whole body is itchy; has a very bad headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Feb2022 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Pfizer BioNTech Covid vaccine), administration date: Jul2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02, Pfizer BioNTech Covid vaccine), administration date: Jul2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: FURUNCLE (non-serious) with onset 08Feb2022, outcome "unknown", described as "feels like a big boil under his left arm"; PRURITUS (non-serious) with onset 08Feb2022, outcome "unknown", described as "his whole body is itchy"; HEADACHE (non-serious) with onset 08Feb2022, outcome "unknown", described as "has a very bad headache".  Additional information: Reported as he noticed the boil yesterday evening, his whole body itching he noticed last night and the headache since yesterday morning. Patient did not administer any vaccine in last 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got the shot at 6:30pm. Drove, went to the grocery store, came home, did chores. Around 9:45 started preparing for the next day (getting coffee pot ready, etc.) up until this moment I had no side effects except pain in my arm.  Then at 9:45PM I began feeling light headed, ringing in my ears and fell unconscious. I woke up on my kitchen floor in a small pool of blood and disoriented. I do believe this reaction is related to the vaccine. I DO NOT have a history of fainting. I ate food and drank plenty of water throughout the day and after my vaccine injection. Everything about my day was typical except for the vaccination and losing consciousness.
Patient received Prevnar vaccine at around 10:00 a.m.  Patient presented back to the clinic at 5:00 p.m. with altered sensorium.  Patient had vomiting once at home.  Patient was admitted to hospital.  Patient developed seizures around 8:00 p.m. that lasted for about 10 minutes.  She was treated with Valium and Phenobarbital.  Patient had another seizure at 8:15 p.m. that was treated with Phenobarbital.  Patient did not have any further seizures.  Nurse follow up on 06/18/04 states: "ADD: pneumonia, depressed reflexes, irritable, fever, shaking."
pt doing well until 10PM the day p/vax;pt observed to have bright red cheeks & ears;children motrin given by mom 830PM;pt observed @ 10PM to be breathing funny & was limp;911 called & taken to ER t103R;dx w/febrile illness;? sz activity
Right after shot- lightheartedness  Day after and 2 days after- headache, fever, chills, body ache, fatigue  august 9th itchy rash on arm at injection site
Received Menactra 5/23/07. (R) Arm with raised Blotchy Bumps-Warm to touch
approximately 8 hours after injection patient's hands, face and feet began to swell/itch
Neck pain followed my eye orbital pain and swollen left eye soreness to the touch. Sore when I blink. Bone around eye socket is sore. Nothing injury related. No recent accidents.
Leg Muscles sore No Appetite Joints sore loose stools Upset stomach--but did not Vomit Very uncomfortable all over
Moderate muscle and joint soreness and pain throughout entire body for over 24 hours.  Also have more acute pain at the injection site in my left arm.  The pain is not debilitating, but it is very uncomfortable and makes it difficult to function in a normal capacity.