chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red swollen area, pain and hot at injection site the day after shot; Red swollen area, pain and hot at injection site the day after shot; Red swollen area, pain and hot at injection site the day after shot; Red swollen area, pain and hot at injection site the day after shot; Next day itchy instead of pain, still red & hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jun2022 at 12:00 as dose 1, single (Lot number: 0238761-18090) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Liver cirrhosis" (unspecified if ongoing); "deep vein thrombosis" (unspecified if ongoing); "poor circulation" (unspecified if ongoing), notes: poor circulation; "varicose veins" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "ascites" (unspecified if ongoing); "damaged spleen" (unspecified if ongoing), notes: damaged spleen. Concomitant medication(s) included: PROPRANOLOL; OMEPRAZOLE; FUROSEMIDE; SPIRONOLACTONE. Past drug history included: Cipro, reaction(s): "allergy". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 13Jun2022 at 12:00, outcome "not recovered" and all described as "Red swollen area, pain and hot at injection site the day after shot"; VACCINATION SITE PRURITUS (non-serious) with onset 13Jun2022 at 12:00, outcome "not recovered", described as "Next day itchy instead of pain, still red & hot". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pain, vaccination site warmth, vaccination site pruritus.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received other medications within 2 weeks of vaccination: Propranolol, Omeprazole, , Furosemide, Spiranolact. Reported Event: Red swollen area, pain & hot @ injection site the day after shot. Next day itchy instead of pain, still red & hot.
Information had been received on 09-OCT-2016 from a registered nurse who reported that four unspecified patients received improperly stored GARDASIL 9 (lot# M007764, expiration date 30-JAN-2018) on 21-SEP-2016 and one unspecified patient received improperly stored GARDASIL 9 (lot# M007764, expiration date 30-JAN-2018) on 14-OCT-2016. No adverse effects were reported. No further information was provided. Additional information has been requested.
Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine.  Blood pressure was high on taking 183/91.  Patient reports History of "White Coat Hypertension".  Symptoms resolved.   MOnitored for at least 15 minutes and released to home. Recommended patient follow-up with PCP regarding potential underlying hypertension..
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Previously administered products included for Product used for unknown indication: CODEINE. Past adverse reactions to the above products included No adverse event with CODEINE. Concurrent medical conditions included Psoriasis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had soreness in arm around injection area due to covid-19 vaccine.  The reporter's causality for the event of Vaccination site pain was reported as no reasonable possibility for Skyrizi.  No treatment medication were provided.  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.
Patient reported to registrar and nurse that she had not been previously vaccinated for COVID. Computers lost connectivity at an offsite outreach and staff were unable to verify patient's vaccination status. Patient was given dose of Janssen vaccine.  She had previously received two doses of Pfizer vaccine (on 3/4/2021 and 3/25/2021)
Small bumps on forehead under the skin. Bumps on  eyebrow bones   Eyebrow bones becoming more pronounced at corners  and sensitive to the touch  , also itchy . Also, before this  (1st booster) shot , I experienced  itchy face and eyes for about 3 or 4 weeks up until the shot .
This spontaneous report as received from a mother concerning her 13 year old daughter. In June 2012, the patient was vaccinated with GARDASIL dose 1, intramuscular. On October 2012, the patient was vaccinated with GARDASIL dose 2, intramuscular. Concomitant therapy  included birth control and allergy medication. In June 2012, "soon after receiving her first dose of GARDASIL", the patient experienced various symptoms including nausea and vomiting, stomach cramping with severe stomach pain which was "constant and debilitating", joint pain, intermittent swelling around eyes, intermittent rashes and shortness of breath. The mother stated that her daughter was "significantly incapacitated due to the constant pain". The patient was unrelieved of these symptoms at this time and there was no diagnosis or resolution to her symptoms post-testing, including "multiple" hospitalizations. Ultrasound, x-ray and blood work were performed with no result provided. The hospital's name and lengths of stay were undisclosed. The events were considered to be other important medical events. Stomach cramping with severe stomach pain which was "constant and debilitating" and joint pain were considered disabling. Additional information has been requested.
inc fever 101.5, local swelling & redness;10cm x 10cm;tx APAP, Keflex;
Worst ast, wheezing and coughing and increased post nasail drip in my life. worse when trying to go to bed. Wheezing cough, shallow breaths.  went on for almost 3 months.  I have noticed other people coughing quite a lot.  Used rescue inhailer Ibuterol, nebulized with Ibuterol, Pumacort inhaile, Triligy, inhailer and Delsun cough syrup. On worst nights I had to take all above TWICE in a seriesover a 1.5-2 hour period to finally subdue the wheezing and coughing. Novenber 20th seems quite a bit better and have not been using the nebulized.
fever, congestion, mild cough, severe body aches and pains, muscle cramps, nausea, sensitivity to temperature
Pt received 2 shots on the same day in same arm (per pt request). Next day she had 104 fever, then continued for 3 days w/no relief from OTC products. Seeked medical assistance, at which she was admitted for PNA.
Left arm redness, swelling. C/O neck and head pain, "not feeling right".
Wheezing, Swelling of mouth, uvula, Headache,Fever, Body aches.  Please note although I have mild intermittent asthma wheezing is a very rare occurrence for me. This wheezing episode felt more like an allergic reaction.
Pt's mother states pt had softball sized swelling that was red and warm 2-3 days after injection.
Information has been received from a physician concerning a 12 yr old pt who in Feb 2005, was vaccinated with a dose of varicella virus vaccine live. It was reported that 24 days following the vaccination, in approx Mar 2005, the pt experienced a rash with 50 lesion and a low grade fever. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
A lump formed slightly larger than a quarter that felt like a fluid sack right above the injection site on my left arm. It stayed about the same over the next 3 months until I finally  had  an ultrasound completed last week.  They indicated its a lipoma ( a cyst with fat inside). My doctor said it can't be drained so I would need to remove it with surgery. I haven't decided what I want to do about it yet.
pt recv vax; to clinic w/ painful swelling around inject site at rt leg;T 100; keflex;resolved but knot still palpable;
This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (feeling agitated) and EMOTIONAL DISORDER (very emotional) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 045A21A) for COVID-19 vaccination. No medical history was provided by the reporter.  On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced AGITATION (feeling agitated). On 21-Apr-2021, the patient experienced EMOTIONAL DISORDER (very emotional). At the time of the report, AGITATION (feeling agitated) and EMOTIONAL DISORDER (very emotional) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 34 years old female patient who experienced received expired MENACTRA (lot number: U5766AE expiry date: 02-Dec-2018) on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ADACEL on 03-Dec-2018 and AFLURIA QUADRIVALENT on 03-Dec-2018 for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown if the patient had any adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
diluent only without lyophilized powder component; administered liquid diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number BE24A, expiry date 19th March 2023) for prophylaxis.   On 7th November 2022, the patient received the 1st dose of Shingrix. On 7th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The medical assistant called to inquire for any side effects to look for and reported they inadvertently administered the Shingrix liquid diluent only without the lyophilized powder component to a patient in the left deltoid. The medical assistant confirmed diluent administered in their facility and was the attempted first dose of Shingrix. The reporter did not consent to follow up. Additional Supportive Information: The reporter reported that they inadvertently administered the Shingrix liquid diluent only without the lyophilized powder component to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Pt recv vax on 12/29/98; on 12/31/98 pt exp fever (101) & lethargy
Patient had swelling in leg, fever, and was limping. During follow up visit with provider on 10/13/2023, leg swelling had decreased and was no longer limping. Benadryl administration was discussed if swelling returns.
It started with a bad cough I am pretty sure I got it around 9/9/2022 I knew was getting something I only had the cough. Then I went to the doctor on 10/3 and I was positive because the cough wouldn't go away, and my lungs kept running. They prescribed antibiotic doxycycline, benzonatate and inhaler. I had to go back on the 17th, and they gave more benzonatate and a cough medication. I tested at home, and it was negative. My lungs had stop burning I and still on the inhaler and I also take cough drops. I didn't test until the 28 and 30 and they were both negative.
In the ER she tested positive for COVID with no hypoxia and no findings of acute infiltrate on CXR.  She was also noted to be septic with tachycardia, fever and leukocytosis with a UA showing a UTI.  She was admitted on COVID isolation.  COVID was treated with daily Remdesivir but no steroids as no hypoxia.  She will need COVID isolation through 12/27/22.  For her UTI she was treated with IVF and ceftriaxone.  Her WBC normalized on 12/19.  Fever resolved after admission.  Mental status improved daily and for the last several days of hospital stay she was at her baseline MS.  Urine culture grew mixed flora but she improved on ceftriaxone so she was changed to Vantin to complete a full course - last day is 12/27/22.  PT saw the patient and she was transferred to on 12/22/22.  Hospital course otherwise without complication.
this pt devel a pruritic rash on the trunk & extremities 24-36 hr p/vax;following a skin biopsy MD dx viral rash;pt was treated w/DPH & topical corticosteroid;
Hep A given without inudent, within 5-10 minutes after injection.  On walking out of office, became dizzy and passed out, struck head on wall, taken to room and layed down.  While recovering after several minutes, pale, regular rhythm, BP 88/54.  Color improved after 15 minutes.  Complained of headache, blood pressure up 92/60.
pt devel papular rash consisting of 6 lesions on trunk, 20 days p/vax secondary to negative varicella titer;over next 48hr pt devel 3-4 more lesions, more vesicular, 2 on shoulder, 2 on face;crusted & evolved;
shingles; This is a spontaneous report from a contactable Pharmacist (patient) reported for herself via Medical Information Team. A 63-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry Date, NDC number: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 (at the age of 63 years-old) as DOSE 2, SINGLE for prevention of COVID-19. Time the Vaccination was given in the afternoon. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date in Feb2021 (at the age of 63 years-old) as DOSE 1, SINGLE for COVID-19 immunisation. No medical history (including any illness at time of vaccination) and other products were reported. Had no family medical history relevant to adverse event. For US Only: Vaccination Facility Type was Fairground, Vaccine was administered at Military Facility/national guard, the patient took no Prior Vaccinations (within 4 weeks). The patient stated that In Jun2021 she was diagnosed with shingles and was calling to know if the diagnosis is related to the vaccine, was wondering if she gets the booster, would she get shingles again. Seriousness criteria of event shingles was reported as Other medically important condition/ Medically significant. The Adverse event did not require a visit to Emergency Room but require a visit to Physician Office. The patient had no adverse event following prior vaccinations. No relevant tests and no Investigation Assessment were reported. Outcome of event was recovered (took about 2.5 months) on an unspecified date in 2021. Relatedness of drug to reaction(s)/event(s): Reaction assessed: Shingles, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Herpes zoster and the suspect drug bnt162b2 cannot be excluded. 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
Immediate pain at injection site followed in 2 hours by, chilly feeling, headaches and lethargy. She took 1 dose of Tylenol. Complete recovery within 12 hours. No rash or wheals.
Approximately 1.5 years after receiving one dose of varicella virus vaccine live the pt developed chickenpox characterized by 30-50 lesions with some pustules and scabbed.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 21-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
ORAL THRUSH; WHOLE BODY IS INFLAMED; EYE TWITCHING; LEG JERKING; PRESSURE UNDER HER RIB CAGE; HOT TO TOUCH; RASH ON UPPER ARM, CHEST, STOMACH; LEFT ARM SORE; UNEXPLAINED BLUE/PURPLE BRUISING ON FRONT AND BACK LEG; BAD TASTE; LOSING TASTE; BURNING IN THE MOUTH; SWOLLEN TONGUE; ITCHINESS ALL OVER THE BODY; SKIN FELT LIKE IT'S BURNING AND HOT TO TOUCH; LIPS NUMBING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known health condition and was taking supplements only. the patient never had allergy medications (never get seasonal allergies).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin felt like it's burning and hot to touch. On APR-2021, the subject experienced lips numbing. On 08-APR-2021, the subject experienced itchiness all over the body. On 20-APR-2021, the subject experienced burning in the mouth. On 20-APR-2021, the subject experienced swollen tongue. On 20-APR-2021, the subject experienced bad taste. On 20-APR-2021, the subject experienced losing taste. On MAY-2021, the subject experienced unexplained blue/purple bruising on front and back leg. On MAY-2021, the subject experienced left arm sore. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) normal white blood cells and iron level low, Platelet count (NR: not provided) normal, Serum iron (NR: not provided) low, and White blood cells (NR: not provided) Normal. On an unspecified date, the subject experienced oral thrush, whole body is inflamed, eye twitching, leg jerking, pressure under her rib cage, hot to touch, and rash on upper arm, chest, stomach. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from skin felt like it's burning and hot to touch, and rash on upper arm, chest, stomach, was recovering from pressure under her rib cage, had not recovered from swollen tongue, and burning in the mouth, and the outcome of itchiness all over the body, unexplained blue/purple bruising on front and back leg, eye twitching, leg jerking, left arm sore, whole body is inflamed, bad taste, losing taste, lips numbing, hot to touch and oral thrush was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534998.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
This study case was received from the investigator in the trial on 03 July 2013. A 41 year-old male subject whose past medical history included high blood pressure, elevated cholesterol, chest pain, chest pressure, abnormal ECG, dizziness/fainting spells, shortness of breath and headaches was found to have other, chest pain 16 days after the subject had received the following vaccines on 09 April 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI vaccine (lot number, route and site of administration not reported) and Anthrax 3 (manufacturer, lot number, route and site of administration not reported). On 25 April 2013, Troponin I was normal and the subject's ECG was abnormal. Results of an echocardiogram were not available. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non interventional) study. Documents held by sender: none.
Approximately 12 hours post vaccination EE reported red mark 2x1" warm to touch.  Severe pain radiated up neck and to head causing headache.   Went to office clinic for assessment 1/6/2021  ee states diagnosis was local reaction.