chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEELING OF BEING DRUNK; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes, and smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had some mild symptoms and some strong symptoms but nothing awful as of yet. The patient experienced headaches, fatigue and almost a feeling of being drunk. He also felt tightness in chest and some shortness of breath. On 01-SEP-2021, the patient tested COVID-19 virus test which resulted positive (suspected clinical vaccination failure and suspected covid-19 infection). He was not consulted to any healthcare professional. He started taking unspecified flu and cold medication and ibuprofen as treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and feeling of being drunk was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210913259.; Sender's Comments: V0: 20210913267-COVID-19 VACCINE AD26.COV2.S - Suspected clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
red patch on arm (1st dose); swollen glands on injection site; continued fever that doesn't go away/elevated body temperature/fever of 100 F at most/fever for 2.5 to 3 weeks (1st dose); COVID arm (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm (1st dose)), ERYTHEMA (red patch on arm (1st dose)), LYMPHADENOPATHY (swollen glands on injection site) and PYREXIA (continued fever that doesn't go away/elevated body temperature/fever of 100 F at most/fever for 2.5 to 3 weeks (1st dose)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (COVID arm (1st dose)). On an unknown date, the patient experienced ERYTHEMA (red patch on arm (1st dose)), LYMPHADENOPATHY (swollen glands on injection site) and PYREXIA (continued fever that doesn't go away/elevated body temperature/fever of 100 F at most/fever for 2.5 to 3 weeks (1st dose)).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided by the reporter.   This case was linked to MOD-2021-325347 (Patient Link).
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Pain @ injection site Narrative:  Other Relevant History:
Lightheaded after vaccine.  Did not last long.  That is the only problem I had directly after the vaccine. Thirty-six hours later (Tuesday, 2/16/21) I had a rash on my left hand. My hand was very itchy, red and swollen.  I had a bump under the skin of my left  hand about the size of a dime.  I also felt some tingling from my waist down to my feet which went away after a few hours. The rash and the bump lasted 3 days.  Dr (primary) told me "Do not get the second shot."
My 13 year old daughter had her 1st dose of the Pfizer vaccine on 1/10/22. She started randomly experiencing whelps/hives that itch significantly on 1/30/22. Treatment: prednisone, benadryl, loratadine, and cetirizine.
pt recvd flu vax NOV92 & 1 wk later pt devel a sore throat & cervical lymphadenopathy; 2 wks following vax had fever & chills, & cough; anemic, myalgias;
Hospitalized (9.7.21 - still admitted);  COVID-19 positive;  fully vaccinated  HISTORY OF PRESENT ILLNESS: Patient is a 78 y.o. male with a history of permanent atrial fibrillation and type 2 diabetes who presents today as directed by his PCP due to fever and hypoxia.  Patient has COVID-19 infection.  He states he has had symptoms for at least 2 weeks.  It initially started with a dry cough and generalized fatigue and weakness.  He also states that he has been having issues with his eyes.  He says that they are dry and sometimes red.  He has great concern about his eyes in fact stating that he has a disease in their some kind, he is sure of it.  He denies vomiting or diarrhea.  He had not noted any fevers at home.  On arrival, he was hypoxemic and required supplemental oxygen which he does not use at baseline.  He was noted to have a low-grade fever.  His lab work and vitals were otherwise largely unremarkable.  He had radiographic evidence of COVID pneumonia.  On exam, he is lying on his side in no acute distress.  He does still require supplemental oxygen.  His biggest concern is about his eyes at this time.  Despite his elevated level of concern, he does struggle to be able to elaborate as to exactly what is wrong with them.  He states he received his 2nd dose of the Moderna COVID-19 vaccine in March of 2021. Plans are discussed for admission and he is agreeable.  He wishes to be listed as full code status. ASSESSMENT / PLAN: * Acute respiratory disease due to COVID-19 virus Assessment & Plan Admit to medicine-hypoxia secondary to COVID pneumonia Patient has noted symptoms for at least 2 weeks, outside therapeutic window for remdesivir Will initiate daily Decadron 6 mg, oxygen therapy, wean as able, does not use at baseline Will trend daily complete blood count, CMP, CRP, D-dimer, continuous pulse oximetry Encourage incentive spirometry and pronation COVID 19 Pneumonia Acute Hypoxic Respiratory Failure - improving Sepsis - improving Presenting symptoms: Hypoxia, Febrile, Cough SIRS criteria met 2: HR 76, RR 24, TEMP 38.1, WBC 8.64 COVID 19 detected by PCR: 9/7. Symptomatic day: 14 plus Removed from Covid isolation 9/8. CXR with findings of Covid Pneumonia Received Decadron and acetaminophen in ED. Not a Remdesivir candidate because 14 days symptomatic. Current oxygen saturation 97%, oxygen requirement increasing daily from 2L admission > 4L > 9L > 11L > 15L > 13L with oxymizer on 9/11. CRP improving 13L Intermediate NC on 9/13 Given 80mg lasix IV x1 9/14 - Give another 80mg IV lasix now - Dexamethasone 6 mg oral daily - 8 of 10 days, but can prolong this course per pulmonology consult - Daily labs CBC with differential, CMP, D-dimer  - Continuous pulse oximetry and telemetry  - Mucinex 600mg BID
Welts plus red developed rash on arm. Tx 4/16/06 4/17 had a rash on trunk that increased. rash erythematous macular rash, trunk, blanched, pressure over angle. Dx viral exanthem vs reaction to ProQuad.
itchiness to forearm; rippling to the skin- inside of right arm; pigmentation from wrist to elbow bright red; blotchy redness; stiff neck; headache; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red), RASH MACULAR (blotchy redness) and MUSCULOSKELETAL STIFFNESS (stiff neck) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red), RASH MACULAR (blotchy redness), MUSCULOSKELETAL STIFFNESS (stiff neck), HEADACHE (headache) and MYALGIA (muscle pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 20-Mar-2021, MUSCULOSKELETAL STIFFNESS (stiff neck), HEADACHE (headache) and MYALGIA (muscle pain) had resolved. At the time of the report, PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red) and RASH MACULAR (blotchy redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment drugs include Benadryl Topical Cream.
Following the injection, I (the patient) left the office feeling fine. This was not my first GARDASIL shot, but I am unsure of whether it was my 2nd or 3rd in the series. Within 4 hours of the shot, I began to feel sick and achy. I had a low-grade fever of 102 for the next two days. This is the same reaction I had had following the first GARDASIL shot. In addition to fever, I developed painful eczema within weeks of starting the GARDASIL series. I did not know at the time that eczema can be attributed to vaccines, but now I do. I still have mild eczema.
Client received vaccination and immediately reported feeling lightheaded and stated "I feel like I am going to black out and I feel nauseated". VS WNL. No other symptoms reported. A & O x3. Immediately had client lay down with feet elevated. Client also reported not eating all day. Lollipop given to help with possible low blood sugar. After laying down and lollipop client reported feeling better after 15minutes. Advised client to go home eat and rest. Called and spoke to client on 10/05/18 and she stated all of her symptoms resolved after she ate.
Influenza vaccination administered at 0650am 12/15/05 in left deltoid. 12/16 muscle aches, lower back cramping, lethargic, very tired, took Motrin for symptoms. 12/17 on awakening in early morning weak, very fatigued, nauseated-dry heaves, shaking uncontrollably--called EMS and was transported and treated in ER at hospital. Fever 103.7 was treated w/ IV fluids and d/c home. Continued with headache and nausea 12/18 & 12/19. Slowly began to feel better. Reported to me 12/20.
Muscle ache, fever, dizziness, extreme fatigue. Lasted throughout the day and into the following day.
PATIENT CAME IN ON 10/7 & STATED SHE WENT TO DR FOR SHINGLES. DR. ORDERED ACYCLOVIR 800MG TID.
Patient presented to COVID-19 vaccine clinic with CDC card. On the card it had dates of Moderna 2/19/2021 and Moderna 3/24/2021, making them eligible for first booster. Patient stated she did not receive these doses so registration noted them to be entered. When I went to enter them, multiple COVID-19 vaccine administrations appeared.
Patient contracted COVID-19 after being fully vaccinated. No booster documented. Muscle aches, congestion, runny nose and cough. Patient did receive monoclonal antibody treatment (Regeneron).
Confused, he could not move or speak and made strange guttural noises. Since I had COVID, I thought it was from the virus, but the second dose that was in November produced the same effects. On August 11 he was admitted to Hospital and then sent to a rehabilitation center to be able to walk again.
Shivering and stomach pain. Time 10:30 pm  2/16/21 - 5:00 am 2/17/21
24 hours after injections of PREVNAR 13 and PEDIVAX patient had hives on Right thigh near injection site.
Pt fainted in chair after receiving vaccination.  Transported to cot easily & feet elevated.   Pulse 72 Resp 24 Color improved & drinking apple juice.  Left w/o assistance with friends.
I am just shy of 10 weeks pregnant. I got the flu shot yesterday morning (not sure which kind), and since about 8pm yesterday, I have had bad cramping.  I have not experienced such bad cramps before when pregnant. I have no idea if it is related to the shot, but they started later that evening and have not slowed down yet. My EDD is 4/3/23.
I started having heart palpitations that came and went the first and second day. The third day they became constant and felt like a rapid heartbeat. I went to the hospital emergency. The EKG and pulse were normal. A blood test showed a slight inclination of a blood clot. I had a pain in my left leg calf. A CAT scan of my lungs and ultrasound of my left leg was done. There was no blood clot. I was referred to a cardiologist and advised to make an appointment in the next week. I was given no medicine. On the fourth day the heart palpitations began to ease up and each day since. They have not ceased completely, but are less and less.
received two doses on April 6th, 2021 / Havrix vaccine expired on March 6th, 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix) (batch number 37RY4, expiry date 6th March 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HBV (Engerix B).   On 6th April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 6th April 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device and an unknown time after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were received as follows: The reporter reported that the patient received the vaccine which was already expired on 6th March 2021. The reporter consented to follow up.
About one year after vaccination began having sore throat, coughing, congestion, and fever. Symptoms lasted about one week and were very mild. We gave her pseudoephedrine, TYLENOL, and OTC cough med and these all seemed to improve her symptoms.
Rash, severe itching, itching of eyes, swelling of face, hoarseness, swelling of eyelids, mild fever, sore throat for 3-4 days took Benadryl.
This spontaneous report as received from a nurse refers to a 15 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.
swelling of (R) thigh (moderately to knee) minimal warmth/ no tenderness/ no erythema no mass palpable-full ROM of knee. To apply heat to area and TID/Tylenol prn pain recheck in office if swelling increases or PRN
Left arm urticaria extending to scapula area.  No hives/rash. No respiratory symptoms.
Vaccines given Fri [04/29/11]; family went camping Sat & Sun [hiking, fishing]. Mon. started with low grade fever 100; 101 at 9pm then 103.4 ax at 11:30pm. Tues.: 5AM 103, 8AM 99 degrees - family checked for ticks & other bug bites or other problems - cont. to take fluids, now playful with low grade fever cont. IBP.
Swelling and severe pain occurred in upper right arm early evening after injection. Called pharmacist who advised using arm, and applying heat. Applied heat as instructed. On 12/09/2016 could not use arm due to severe pain. Continued heat as instructed by pharmacist. On 12/10/2016 awoke to redness and swelling in upper arm from injection site to elbow and around back of arm to elbow. Severe pain continued. Daughter took me to Hospital treatment center where I was diagnosed with cellulitis of the right arm. Heat treatment canceled and antibiotic started. Saw MD on 12/11/16 who continued antibiotic and will see MD on 12/18/16 for continued care.
COVID-19 infection; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 infection) in a 21-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Physician reported that a patient had first dose of Moderna COVID-19 vaccine. Developed COVID-19 infection on 13-Sep-2021 and received monoclonal antibodies.  No concomitant medications were reported.; Sender's Comments: This case concerns a 21-year-old, male patient, with no disclosed medical history, who experienced the non-serious, unexpected, event of Covid-19. Time interval between first dose of Moderna vaccine and event is unknown. The rechallenge is not applicable as patient only received first dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
joint aching, muscle pains, arms & knees; joints feel stiff to pt; no fevers, swelling, effusions; sx subsided p/1st inject, worsened again p/2nd; now better;
After both the 1st & 2nd dose my lower back was extremely stiff and panful.  For the week after each dose it was very painful to bend or in general move at the waste, activities like sitting down, standing up, getting in/out of bed were quite uncomfortable.  The pain gradually declined over the week but my lower back remains a bit stiff and sore.  Prior to the vaccinations I never had any similar issues with my back.
Morphea (confirmed by skin biopsy); This is a spontaneous report from a contactable physician. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on 29Jan2021 (Lot number EL9262) (at the age of 67 years old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination.  It was unknown If other vaccine in four weeks.  Medical history included Raynauds, dermatitis and sulfa allergies. Concomitant medications included MVI (multi-vitamin injection); ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took propylene glycol and experienced allergy.  The patient experienced morphea (confirmed by skin biopsy) on 09Feb2021. Event resulted in doctor or other healthcare professional office/clinic visit. Treatment included Taclonex ointment. It was unknown if patient had COVID prior vaccination and if covid tested post vaccination. The patient received the second dose via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EN6201). The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Started to feel clammy, and sweaty. Shortness of breath, cramps diarrhea and vomiting. Total weakness.
Received pfizer booster in left arm on 3/12/2022. The next day had symptoms of headache, dizziness, pain at injection site, rash at injection site that itches and is painful, fever, and pain when moving left arm. Tylenol is what is being taken to help improve symptoms as well as a rash cream that was prescribed by physician.  Symptoms have remained the same since they started.
Patient described an immediate sensation of the shot going to the heart. Since vaccine, she has noted that she has had an increase in heart palpitation sensation (states that frequency has doubled since vaccine), some dull chest pain, causing it to be uncomfortable to lie on left side.  Some noted SOB since vaccine.
Pain in injection site. Pulses with heart beat. Started at 6p.m. day of injection. Took 2 TYLENOL followed by 2 ALEVE 4 hours later with no relief.
Pfizer vaccine was diluted with NS 0.9% Bacteriostatic which is not recommended for use with this vaccines. Reported to Pfizer and CDC. As per recommendation from CDC, affected dose should be repeated. Pt was notified and all questions answered. Pt was scheduled to repeat on 9/15/21 and did not show. Have since attempted to reschedule.
Folded bowel movement, vomiting and diarrhea picky skin, dry up hair needed BENADRYL.
At my annual physical on Tues., 08/16/2022, my primary care physician and I made the decision that I should receive the Prevnar 20 vaccination because I suffer from various autoimmune diseases. Within two hours of receiving the vaccination, I immediately began feeling weak, tired, and general malaise. On Thurs., 08/18 my left eye became inflamed, red and painful. On Fri., 08/19/22, I went to see my eye doctor and was diagnosed with anterior uveitis flare. I was prescribed Prednisolone AC 1% Opthalmic Suspension, USP and instructed to instill one drop in my left eye every hour. I was diagnosed with anterior uveitis in February 2020 but it had been well managed and I was not having any flares until after I received to Prevnar vaccination. On Mon., 08/22/2022 I began experiencing painful joints including my elbows, knees, and right ankle. My sleep was disrupted for several night due to pain in my eye and joints. I was no longer able to do the things that I enjoy including go to work, prepare meals, exercise, and garden. On Sun., 08/28 I began feeling better and was able to resume many of my regular activities.
pt recv vax & pt exp 10 chicken pox like lesion mostly @ inj site;
Chills & Body Aches started at 11am  Stomach cramping / Nausea/ Diarrhea 5pm
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA93AA, expiry date February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included stem cell transplant.   On 23rd March 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 23rd March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's comment: The patient received an expired dose of Bexsero. The consent to follow up was given by email. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received dose of Bexsero that was already got expired in February 2022, which led to expired vaccine used.