chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: 1805USA009899:Original Case : 1805USA006787; 1805USA009900:Original Case : 1805USA006787; 1805USA009901:Original Case : 1805USA006787; 1805USA009902:Original Case : 1805USA006787; 1805USA009903:Original Case : 1805USA006787; 1805USA009904:Original Case : 1805USA006787; 1805USA009905:Original Case : 1805USA006787; 1805USA009906:Original Case : 1805USA006787; 1805USA009907:Original Case : 1805USA006787; 1805USA009908:Original Case : 1805USA006787; 1805USA009909:Original Case : 1805USA006787; 1805USA009910:Original Case : 1805USA006787; 1805USA009911:Original Case : 1805USA006787; 1805USA006787:Original Case : 1805USA006787; 1805USA009913:Original Case : 1805USA006787; 1805USA009914:Original Case : 1805USA006787; 1805USA009915:Original Case : 1805USA006787; 1805USA009916:Original Case : 1805USA006787; 1805USA009917:Original Case : 1805USA006787; 1805USA009918:Original Case : 1805USA006787; 1805USA009919:Original Case : 1805USA006787; 1805USA009920:Original Case : 1805USA006787; 1805USA009921:Original Case : 1805USA006787; 1805USA009922:Original Case : 1805USA006787; 1805USA009923:Original Case : 1805USA006787; 1805USA009924:Original Case : 1805USA006787; 1805USA009925:Original Case : 1805USA006787; 1805USA009926:Original Case : 1805USA006787; 1805USA009927:Original Case : 1805USA006787; 1805USA009928:Original Case : 1805USA006787; 1805USA009929:Original Case : 1805USA006787; 1805USA009930:Original Case : 1805USA006787; 1805USA009931:Original Case : 1805USA006787; 1805USA009932:Original Case : 1805USA006787; 1805USA009933:Original Case : 1805USA006787; 1805USA009934:Original Case : 1805USA006787; 1805USA009935:Original Case : 1805USA006787; 1805USA009898:Original Case : 1805USA006787.
Rash - macular papular not changing over arms legs trunk. Itches <24 hours after receiving HPV #3. Saw allergist.
Was taking Ibuprofen on day vax rec'd.  Following day arm was red and swollen with hard nodule forming, vax site was sore to touch.  This remained for a few days, and then progressed into deep tissue ache at the vax site and itching on upper arm - these symptoms persisted for one week and have slowly tapered off.   Nodule approx size 3/4 inch diameter is present today.
w/in 24hr of vax pt devel fever of 101, shaking, tremors & an inj site rxn characterized by redness, swelling & induration;tx symptomatically & recovered p/5 days;
The pt experienced redness at the injection site for 5 days. The pt also experienced an elevated temperature for 7 days.
Individual started to c/o dizziness about 15 minutes post vaccine.  He was monitored for about 25 minutes but was not improving so EMS was called to transport to local ED
Hive-like rash on neck and chest. Rash was itchy, burning, and tingling. Also throat fullness, No chest pain or SOA. Took Benadryl at 3:15am with improvement in symptoms. Symptoms returned between 8:30-9:00am on 9/11/2011. Went to ER. Was told rash was likely a reaction to flu shot. Given Prednisone x 10 days and Benadryl.
10 minutes after the injection mouth tasted like metal, heart racing,  body shakes, cold limbs, feeling of being hot and cold, sheer panic. Symptoms were very strong for the first few hours after injection. Jittery, shaky, uneasy feeling persisted for about 48 hours.
Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from a Pharmacist via phone. This case is linked to case 2019SA021433. This case involves an 85 years old female patient who experienced pain moved to her shoulder, then her neck into her ear and head, soreness and a knot in arm, muscle spasms and redness in her arm at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Aug-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number UI993AB and Exp. Date 18-MAR-2019) not reported via intramuscular route in the arm nos. On an unknown date, the patient experienced non-serious pain moved to her shoulder, then her neck into her ear and head, soreness and a knot in arm (radiating pain), muscle spasms and redness in her arm at the injection site (vaccination site erythema) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Details of lab data not provided. Final diagnosis was redness in her arm at the injection site, muscle spasms and pain moved to her shoulder, then her neck into her ear and head, soreness and a knot in arm. The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Muscle spasms. The patient had not recovered from the events. List of documents held by sender: none. Follow up information received from non healthcare professional on 22-Jan-2019. Vaccine details added (lot number and Exp. date). List of documents held by sender: none.
Swelling and fluid on left elbow. The fluid decreased by 70% within 3 or 4 days but is still some fluid left. It is small mass on corner of elbow slightly sensitive to pressure. Is this a side effect and should I be concerned?
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 7th December 2018, the patient received SHINGRIX. On 7th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 15th December 2018, the patient experienced nausea, dry mouth, tremor and chills. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the nausea, dry mouth, tremor and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, nausea, dry mouth, tremor and chills to be related to SHINGRIX. Additional details were reported as follows: The patient was the caller's mother in law. On 15th December 2018, 8 day after vaccination the patient experienced nausea, dry mouth, tremor and chills. The patient experienced side effects. This case has been linked with US2018230517, reported by same reporter.
Severe muscle pain, join pain, headache, injection site pain, chills, tiredness, sore throat and overall unwell feeling. Worst pain I have ever felt. Similar to growing pains when one was younger but 100 times worse, pulsating continuously, and all over the body.
Passed out roughly 4 minutes after injection; Low bpm afterwards when paramedic showed up (30-40); sweating; EKG showed PVC of heart; dizziness; disorientation; low energyand weakness; This is a spontaneous report from a contactable consumer (patient).   A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 10:30 at age of 24 years old, (Lot Number: W01768721) as 1st dose, single for covid-19 immunisation. Medical history included known allergies: Augmentin.  Any other medications the patient received within 2 weeks of vaccination was none. Clinical course reported that: Passed out roughly 4 minutes after injection. Woke up after 2 minutes sweating. Low bpm afterwards when paramedic showed up (30-40). 2 IV bags administered. EKG showed PVC of heart. Still have dizziness and disorientation as well as low energy and weakness 4 days later. Adverse events onset date reported as 20May2021 10:30 AM. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome for events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Information on Lot/Batch number was available. Additional information has been requested.
Left deltoid with 1 x 3in area of redness; 1cm area of induration.
Provider reported an anaphylactic reaction after administration of Moderna. Patient started developing symptoms within 4-5 minutes of injection. She reported tingling of throat and manifested into swelling of the tongue and difficulty breathing. Provider administered EpiPen x 2 until she stabilized. She was treated with antihistamines and steroids and monitored to ensure stability. She was discharged back to quarters with precautions. PSR and VAERS report being completed as we speak.
lower back pain; fatigue; swollen lymph nodes in left armpit which kept her up all night; low grade fever for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), FATIGUE (fatigue), LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night) and PYREXIA (low grade fever for 3 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back pain), FATIGUE (fatigue), LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night) and PYREXIA (low grade fever for 3 days). At the time of the report, BACK PAIN (lower back pain), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night) outcome was unknown and PYREXIA (low grade fever for 3 days) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medication was reported.     No treatment information was reported.   This case was linked to MOD-2022-563382, MOD-2022-563381 (Patient Link).
I had diagnosed pancreatitis last year after I had my first shot of Pfizer. Now I have similar, but less severe pancreatitis symptoms: Upper abdominal pain day after shot. Pain when taking deep breaths. Slight fever. Headache. Loss of appetite.
After having the vaccine I had a local reaction consisting of (at various times and in varying degrees) pain, redness, swelling, and itching near the site of the injection. (The majority of the reaction was lateral to the injection site, on the side toward the body.) This lasted until 2/23/21 (6 days after injection). Then I was without symptoms until the evening of 2/27/21, when I noted an area of about the same size in the same location with pain to touch, redness, swelling, and itching. The area increased in size and was measured in the a.m. of 2/28/21 at 6.5 cm across and 3 cm up and down. This morning (~24 hours later), the area is more symptomatic and has increased in size again to 8 cm x 4 cm.
I have body itching; she still has mild itching and a fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I have body itching) and PYREXIA (she still has mild itching and a fever) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031895) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 20-Nov-2023, the patient experienced PRURITUS (I have body itching) and PYREXIA (she still has mild itching and a fever). At the time of the report, PRURITUS (I have body itching) and PYREXIA (she still has mild itching and a fever) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The patent had body itching, also had it before but took antihistamine.   No concomitant and treatment medications were reported.
Felt stinging sensations in foot, felt like bee stings on the foot; Having eyesight/vision problems lost sight for a period of time and relying more on eye glasses; Feeling confused; Lightheadedness and dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt stinging sensations in foot, felt like bee stings on the foot), VISUAL IMPAIRMENT (Having eyesight/vision problems lost sight for a period of time and relying more on eye glasses), CONFUSIONAL STATE (Feeling confused) and DIZZINESS (Lightheadedness and dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVETIRACETAM (KEPPRA XR) and OXCARBAZEPINE for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PAIN (Felt stinging sensations in foot, felt like bee stings on the foot), VISUAL IMPAIRMENT (Having eyesight/vision problems lost sight for a period of time and relying more on eye glasses), CONFUSIONAL STATE (Feeling confused) and DIZZINESS (Lightheadedness and dizziness). On 26-May-2021, PAIN (Felt stinging sensations in foot, felt like bee stings on the foot), VISUAL IMPAIRMENT (Having eyesight/vision problems lost sight for a period of time and relying more on eye glasses), CONFUSIONAL STATE (Feeling confused) and DIZZINESS (Lightheadedness and dizziness) had resolved.        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.   No treatment information was provided by the reporter.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-NOV-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On unknown dates, the patient was vaccinated with the first two doses of GARDASIL 0.5 ml, intramuscular, On 20-JUN-2014 and 14-OCT-2014, the patient was respectively vaccinated with the third and fourth dose of GARDASIL 0.5 ml, intramuscular. No adverse effect reported. Additional information has been requested.
No Adverse event; administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; Question:Is Moderna authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification?Answer:Yes;Question:Does our Safety team have your consent for follow-up with you?Answer:Yes;Question:Please describe all safety information associated to the adverse event(s) you experienced by the vaccine recipient (signs & symptoms, possible causes and progression).Answer:HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date. Patient identifiers for patient are documented in this case. No AEs were reported.
Approximately seven hours after receiving immunizations, patient had 7-10 minute episode of unresponsiveness and being "limp". Episode followed prolonged crying and inconsolable period. Resolved before arriving at ED. Normal exam at ED evaluation. Subsequent evaluation diagnosed hypotonic, hyporesponsive event.
pt recv vax 12JAN98 & 22JAN98 pt exp jaundice, n/v, fever & chills;on 22JAN98 to MD office;lab eval revealed serum hepatitis A antibody test = IgM negative;serum hep b core antibody test = IgM positive;serum hep B surface antigen=positive;
Patient started getting "nerve pain" one day after the vaccine was given and after normal arm soreness went away. The pain is triggered by certain movements of her arm and causes a tingling or shooting pain in her shoulder. The patient said it  seemed like the shot was given kind of toward the back of her arm and toward the top of the deltoid. Patient still gets this pain sometimes triggered by certain movements, but it's not reproduceable She did not see a doctor regarding this matter because  she said it doesn't bother her that much.
chills; fatigue/severe fatigue; subjective cold; myalgias; felt feverish, but always below normal temperature; This is a spontaneous report from a contactable physician for herself. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248) on 11Jan2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization in the hospital. Patient's medical history included hyperlipidaemia from an unknown date and unknown if ongoing. The patient previously had erythromycin and had allergies. Concomitant medication included Lipitor (Atorvastatin calcium). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 16Dec2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient did not have any other vaccine within four weeks. The patient did not receive COVID-19 vaccine prior to vaccination. The patient experienced chills, fatigue/severe fatigue, subjective cold, myalgias, felt feverish and but always below normal temperature in Jan2021. The patient was underwent COVID-19 (Nasal Swab) on 18Jan2021 which was negative. The patient didn't receive treatment. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Limited motion in arm, shooting pain, joint swelling, stiffness, tightness in shoulder
No additional adverse event reported; HBP reported an adverse event. Caller stated VARIVAX was administered after a temperature excursion. No additional AE or PQC reported. No additional information provided.   ?    Names of vaccines involved (including lot/exp): VARIVAX Lot U039726, E; This spontaneous report has been received from an office manager, regarding an identified patient of unknown gender and age. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   On unspecified dates, the varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U039726 experienced a temperature excursion of -11.5 Celsius degrees (C) for a timeframe of 2 hour 40 minutes and 0 seconds; with a previous temperature excursion of -14 C for a timeframe of 1 hour 0 minutes and 0 seconds, and another of -13.5 C for a timeframe of 1 hour 0 minutes and 0 seconds. If a digital data logger was involved was not reported (product storage error).   Consequently, on 27-JUN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U039726 confirmed to be a valid lot with expiration date reported and stablished as 15-DEC-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: testing negative for 2 days following Paxlovid course; Negative, notes: testing negative for 2 days following Paxlovid course; Positive, notes: The test came back with the FAINTEST positive one day after finishing course; Positive, notes: a STRONG positive line two days following; Positive, notes: a STRONG positive line two days following. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Patient did not receive and other medication in 2 weeks. Anti-viral details: Product was COVID 19 Treatment, Brand was Paxlovid. Treatment start date was 07Jul2022 and treatment Stop date was11Jul2022, indication was treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient has been lethargic, excessive sleep, inability to stay awake 4-8 Jan 03
Patient reported trouble breathing , soreness in arm, denied rash, or any signs of anaphylaxis. Patient reported feeling cold, but did not seem to have fever. Recommended patient go and be seen by medical provider for evaluation, and to keep checking temperature in case fever develops. Patient acknowledged understanding and will follow up with patient on 10/28/19