chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 18 hours after the vaccine was administered patient experience arthralgias, fatigue, nausea and a rapid onset of fever with rigors with a t-max of 102. Patient remained febrile for approximately 18 hours after presentation of symptoms in which patient's fever resolved and symptoms improved. Patient did require to take sick leave during time of experiencing symptoms. Patient medicated with ibuprofen and acetaminophen as well as hydrated. No other treatments were required.
Patient was found deceased in her home by her daughter 9+ hours after receiving the vaccine.  The was no indication of how long the patient had been deceased prior to being discovered.
circular rash on leg at the administration site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (circular rash on leg at the administration site) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced VACCINATION SITE RASH (circular rash on leg at the administration site). At the time of the report, VACCINATION SITE RASH (circular rash on leg at the administration site) was resolving.        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.   Concomitant medications were not reported.  It was soft and non-painful. On 11 July 2022, the rash was almost resolved. Treatment medications were not reported.
On 12/30/2021, I started getting symptoms of breathing issues and coughing. I also experienced tiredness. I got a positive COVID-19 at home test. I called my doctor and did a telehealth visit and was prescribed  2 round of  steroids, cough medication, and inhaler. I also lost my of sense of taste which is not back all the way. I also got a positive COVID-19 on 5/3/2022. I have symptoms of congestion, mild headache, mild cough that feels like allergies. I contacted my doctor and was prescribed Paxlovid.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 84-year-old male patient who received SHINGRIX. Concomitant products included ramipril. On 17th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 18th April 2018, 1 days after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on left arm. The patient received CREON as concomitant drug.
Constant, pounding headache upper left quadrant of skull for months.  Deep fatigue.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2018SA279494 and 2018SA279808.(same reporter). This case involves a male patient (patient: 02) who experienced reactions between the injection site and elbow, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medication were not provided. On 10-Mar-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ004AB via intramuscular route. On an unknown date, The patient developed a non-serious reactions between the injection site and elbow (vaccination site reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab tests reported.) Final diagnosis was reactions between the injection site and elbow. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovering / Resolving for reactions between the injection site and elbow.
Began to feel malaise several hours after the second dose of the vaccine.  By 12 hours post injection began to feel ongoing malaise, myalgias, and low grade temps (max 100.2 F) with chills.  These symptoms lasted for about 24 additional hours and then resolved
Pt. called to ask about some blisters that appeared on skin a few days after vaccination. Pt. was instructed to seek medical attention for evaluation. Pt. was educated about most common ADE/SE of vaccines and the precaution he should have.
C/o muscle stiffness, leg numbness - (Rhabdomyolysis/elevated CPK).
In day one I felt a little off and weak after the injection. This was a few minutes later and lasted about 2 hours. I took a Tylenol PM to sleep, but didn?t sleep well at all. On the second day, in the morning when I woke up the arm where the injection was administered was extremely sore and I couldn?t lift it. It felt almost numb, but I was in pain. I took Advil late morning and felt better but still couldn?t lift my arm above my chest. Around 4-5pm that evening, I was feeling tightness in my chest. Felt like something heavy was sitting on top of me and I developed a headache at this point. I felt super tired so I took an Advil PM to comfortably take a nap. When I woke up I still had a headache and chest tightness. At this point my body started to feel sore. The next day, 1/31/21, I am still feeling fatigued. Headache did not go away or subside. My body still feels sore especially my back, top area (I would say around shoulder blades). I still have chest tightness and had a fever of 101 today. I have taken an Advil for headache and body soreness - after an hour of taking Advil, still feeling the same.
anaphylaxis; This is a literature report.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "food and drug allergies" (ongoing); "food and drug allergies" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis ".  The initial vaccination with COVID-2019 vaccines with emergency use authorization began in December 2020, less than a year after the SARS-CoV-2 RNA sequence was known. Global alarm is raised with the first two cases of anaphylaxis suffered by two female healthcare workers aged 40 and 49 years after receiving the Pfizer- BioNTech mRNA vaccine, 24 hours after the start of mass vaccination. Both patients had a history of food and drug allergies and carried epinephrine auto-injectors.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded. The case will be reassessed after Full Publication will be received.,Linked Report(s) : US-PFIZER INC-202200902646 Same article/drug/event; different patient;
Limpness in my hands, shoulder and neck area. Tightness in my chest. Fluttering heart beat. Hard to get enough air.
A report has been received from a Health Professional concerning a 37 year old, male subject, who had been receiving nasal FLUMIST. FLUMIST started on 17-SEP-2013. The patient was administered two full doses of FLUMIST, one in each nostril which started on 17-SEP-2013. The outcome of the event of two full doses of FLUMIST, one in each nostril is unknown. The report was considered to be non-serious.
Patient seen 9/12/22 with several-week history of abdominal pain and bloody stools.  Diagnosed with Stage 4 rectal cancer October 2022.
Fatigue  5 days Shoulder across back 1 day Headache dizziness nausea  21!!! Days
sat 9;30 am when tried to get out of bed horrible pain in my bones. it hurt so bad i screamed with each step. sun .a.m. the bone pain was bad and I could not walk or move. without screaming  mon pain less but sick to stomach and bones still hurt
Symptoms started within 2 hours of 2nd vaccine when I started getting really tired. I slept off and on for hours. By the evening, I started getting chills and body aches. The following day, I had chills, body aches throughout my body to include into my fingers and ankles, a headache, a fever of 101, and heaviness in my chest. I was advised my the pharmacist who gave the vaccine that I couldn?t take Tylenol or ibuprofen so I hadn?t. When my fever got up to 102.2, I took Tylenol, which was around 2pm. The fever broke later that night. On 5/24, the body aches, chills, and headache subsided. The only thing that lingered was the heaviness/chest pain. It is 5/29, and I still have it. I came across this information and site while trying to research why I still feel this way.
Moderna COVID-19 Vaccine EUA.  I had my 2nd vaccination around 5pm. in the evening.  I woke up in the middle of the night and when I went to look at something with a small flashlight, the light hurt my eyes and I had to turn the flashlight off. I was unable to even focus on what I was trying to look at it was so bad and my eyes were so sensitive.  Fortunately, that sensitivity did go away.
This case was reported by a healthcare professional and described the occurrence of chest tightness in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included ventricular dysfunction. On 14 September 2010 at 11:20 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 14 September 2010, within minutes of vaccination with FLULAVAL, the subject experienced mercury taste. Approximately 40 minutes later, on 14 September 2010, the subject experienced chest tightness. At the time of the report, the subject's vital signs were good. On 14 September 2010, the chest tightness and taste abnormality were resolved. The nurse reported two additional patients, see cases A0882705A and A0882706A.
Migraines; Tight headiness; Racing heart; Cold; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), TENSION HEADACHE (Tight headiness), PALPITATIONS (Racing heart), NASOPHARYNGITIS (Cold) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced MIGRAINE (Migraines), TENSION HEADACHE (Tight headiness), PALPITATIONS (Racing heart), NASOPHARYNGITIS (Cold) and PYREXIA (Fever). At the time of the report, MIGRAINE (Migraines) and NASOPHARYNGITIS (Cold) had not resolved and TENSION HEADACHE (Tight headiness), PALPITATIONS (Racing heart) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of MIGRAINES, TIGHT HEADINESS, RACING HEART, COLD and FEVER with RINVOQ(UPADACITINIB) was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
A spontaneous, non-serious report of administration of expired product has been received from a certified medical assistant concerning an 11-year-old male patient subsequent to FLUMIST. On 13-Mar-2009, the patient received FLUMIST with an expiration date of 25-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 09-Apr-2009 that included the results of a lot investigation. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.
Pt developed maculopapular rash originally b/l neck and hips and then spread to her trunk and arms. At same time developed sore throat and cough. Strep test negative.
Fluid build up in left ear causing pressure, hearing loss, ringing in ear, and vertigo.
SWELLING, REDNESS AND PAIN AROUND THE ARM. THE SWELLING SIZE IS 15X 15CM
Wed, 7 Jan afternoon, shut van sliding door on my left hand.  Went to ER due to severe pain, possible broken hand.  Had a tetanus shot during ER treatment.  Left shoulder has been very tender to the touch since second day.  Painful to move since second day.  Ache radiates across to other (right) shoulder.  Active Saturday cleaning house, had bath Sat night which gave some relief, but woke up with severe pain, applied heat for relief.  Took Percocet Wednesday, Lortab Wednesday evening, Tylenol PM Thursday night and Darvocet during the day through Saturday.  (Lortab caused inability to sleep at night).
Rec'd. routine imm. on 3/13/18. Seen 3/14/18 for S/S - (LT) arm with erythema and edema; non-painful. Have decreased at time of visit, afebrile. Tx with BENADRYL at H.S.; Ibuprofen every 6 hours prn. Return if S/S worsen.
pm of inj-pt states nausea & itching @ site of inj; next am approx 20 hrs later redness, swelling, hard, hot to approx 2in below inj site of pneumovax;
No additional adverse event; one dose of improperly stored VARN AX was administered to the patient; This spontaneous report has been received from an office manager and refers to a patient of an unknown age and gender. Information about concomitant medications, pertinent medical history and drug reactions or allergies was not provided. On 11-MAR-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot# S028926 was verified to be a valid number, expiration date reported and validated as 16-SEP-2021 (strength, dose, vaccination scheme and route of administration were not provided) as prophylaxis. Sterile diluent (STERILE DILUENT) which was used to reconstitute the vaccine had been properly stored. The administered dose of vaccine had temperature excursion of -8.3 degrees Celsius (C) for 24 minutes. There was no previous temperature excursion. Digital data logger was involved. No additional adverse event was reported. The outcome of the events was unknown.
administered the DTAP-IPV component of the PENTACEL to a patient without the HIB with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 1 years old female patient who was administered the DTAP-IPV component of the pentacel to a patient without the HIB with no reported adverse event for diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ853AB, expiry date: 13-APR-2024) (with an unknown dose and strength) via unknown route in unknown administration site for Immunization.  On an unknown date the patient was administered the DTAP-IPV component of the pentacel to a patient without the HIB with no reported adverse event (single component of a two-component product administered) (latency- same day) for diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  Reportedly, Pediatrician called stating that one of the nurses administered the DTAP-IPV component of the PENTACEL to a patient without the HIB. He just wants to know if the DTAP component is a valid dose  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  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 the 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
Patient received a Flu shot in one deltoid and Pneumonia in the other.  Both arms were red and swollen.  Arms were slightly pink and had raised sores.  Patient was treated with ice packs. Chest Heavy- Heart jumping out of chest. Discharge summary states neck pain, nausea, vomiting, headache, urinary tract infections, gastroenteritis. msc
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored ROTATEQ (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse events were reported. The outcome of events was unknown. No further information ws provided.  This is one of several reports received from the same reporter. Additional information has been requested.
Pt called pharmacy questioning if and when he should receive the 2nd dose as he is scheduled this Friday to receive it. However, he claims about 6 to 8 hours after 1st vaccination, he had experienced extreme shooting pain all over his upper torso and head, which resulted in an ER visit. Pt is still experiencing this pain, but not to the degree as before. He states he is enrolled in a clinical trial for a new medicine treating amyloidosis, which had just began 4 days prior to his vaccination on 3/5.
pt recvd vax; high pitch cry since noc of vax; fever of 102 each noc since vax;
45 minutes after vaccination, left shoulder began to twitch, toes curled. Been 3 weeks and my core , legs are having spasms. Appears symptoms Exacerbated, medication has reduced effectiveness.
24 hrs non-stopping crying, High-pitched for more than four hours. Fussiness for 2-3 days, Not sleeping well, Sleeping for 10-15 minutes at a time then would cry again.
Shortness of breath felt like I was about to pass out it felt like something comes over me and I feel like passing out less of energy but once it passes I be good call end and they said get some rest and take tylenol for the headache
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L003227 exp date 13-OCT-2016). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
meniere's disease; dizziness; vertigo; This is a spontaneous report from a contactable other hcp (nurse). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 57-years-old) as dose number unknown, single dose for covid-19 immunization. Patient received tofacitinib citrate (XELJANZ XR) tablet via orally from unspecified date in 2019 (Batch/Lot number was not reported; Expiration Date: 30Jan2023) to an unspecified date, at 11 mg, 1 daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced dizziness, vertigo and Meniere's disease. Reporter stated behind one week on therapy (Xelianz XR) due to receiving covid vaccine. Patient reported currently being tested for vertigo and meniere's by ENT. The action taken for tofacitinib citrate was unknown. The outcome of the event dizziness was not recovered and for remaining events it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Meniere's disease and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the product is evaluated as part of 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.
Breakthrough case admission after 2 vaccines  Moderna 3/26/21 Lot# 017B21A; Moderna 4/3/21 Lot# 025B21A
Headache, chills, body ache the night of vaccine. Continued body ache 2 days later. Swollen red rash about 4  inches round at injection site.
Sudden onset of erythematous maculopapular exanthema, some lesions are clustered (some confluent) - thick appearance on trunk. No facial or lower limbs involvement. Has temperature 101.3 F and bilat. retroauricular soft adenopathies.
Patient received flu vaccine 10/21/21 in fast track clinic. Patient then received this vaccine 1/27/2022. Did not need another vaccine until next flu season
Patient received 2nd dose of Pfizer COVID vaccine. Blanching, erythematous, somewhat serpiginous rash to L arm and hand with blister present on medial aspect of proximal forearm. Not pruritic, not painful. Area with blister is tender to the touch. Rash is not present on the L shoulder, R arm, or back. Denies fevers. 2nd dose of COVID vaccine to L arm last Thursday. The rash seems to originate from the vaccination site and does not extend upwards. The rash was noticed only today during an office visit. Patient has an intellectual disability, and very independent. always wears a long sleeve and her caregivers had not noticed it until today when rash extended down to her hands below the long sleeve.
Changes in hearing, faint, aches in hips and neck, tight chest. Faintness was within 10 minutes of administration of vaccine. And last about 2-3 minutes. Aches lasted 2 days.  Ears felt strange next day: felt as if plugged, seemed both like a loss of hearing and exaggerated hearing at same time. Roaring in ears.
p/vax pt arm at inj site was sore; red & warm; recommended APAP & heat
Information has been received from a consumer concerning her 15 month old son with no allergies or drug reactions who on 23-FEB-2005 was vaccinated SC with a dose of Varivax. There was no concomitant medication. The reporter indicated that 18 days after vaccination, on approximately 13-MAR-2005, the pt was diagnosed with cellulitis. He also had some breathing difficulties (not further specified) and was administered a 10 day antibiotic. It was noted that the pt was in the ER for 12 hours. A white blood cell count was performed (results not reported). Therapy with Varivax was discontinued. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Cellulitis and difficulties breathing were considered to be disabling by the reporter. Additional information has been requested. The reporter also indicated that the pt had a rash after vaccination with a dose of MMR (WAES0503USA05169)