chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 10:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 10:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 89.69.   Concomitant products were not provided.  On 11-Jan-2021 Excursion time was reported at 09.00 am with  temperature as 34 degrees Fahrenheit, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 01-Jan-2021 , vial was moved to clinic on 08-Jan-2021. 2 vials were sent to clinic. Vaccine BUD date was 04-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt had a syncopal episode shortly after receiving vaccinations. Pt received vaccines at 1505, syncopal episode at 1515 on 8/14/15. Elevated feet, cool compress, pt responded to treatment.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 23-DEC-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site soreness), PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness) and ADMINISTRATION SITE WARMTH (arm Warm to touch) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical records). On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site soreness). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness) and ADMINISTRATION SITE WARMTH (arm Warm to touch). At the time of the report, INJECTION SITE PAIN (injection site soreness), PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness) and ADMINISTRATION SITE WARMTH (arm Warm to touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Left arm bicep swollen; Left armpit swollen; Painful to light touch down to breast; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 17Sep2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin b complex (MANUFACTURER UNKNOWN) as over the counter (OTC) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the right arm on 25Aug2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 19Sep2021, the patient experienced left arm bicep swollen, left armpit swollen and painful to light touch down to breast. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events left arm bicep swollen, left armpit swollen and painful to light touch down to breast were not resolved at the time of this report.
PATIENT REPORTED CHILLS, FEVER, SHORTNESS OF BREATH, RED FACE AND CHEEKS. SHE SAID SHE USED "AN INHALER SHE HAD AT HOME" FOR THE SHORTNESS OF BREATH. SHE SAID SHE STILL FELT WEAK TODAY, BUT FEVER BROKE LAST NIGHT AND SHE WOKE UP WET WITH SWEAT. THIS WAS THE PATIENT'S SECOND DOSE OF SHINGRIX AND SHE DID NOT HAVE ANY PROBLEMS THE FIRST TIME.
Redness/swelling at injection site 24hrs from administration. Redness and swelling dissipated and then patient developed swelling from shoulder to below elbow over next 48hrs. Swelling was treated with steroid and resolved.
Patient received vaccine on 03/16/21 at 440pm, woke up on 03/17/21 with bumps on her left arm where the vaccine was given. She then woke up on 03/18/21 having chest tightness and shortness of breath.
pt recv vax;21jun95 n & v;c/o tightness in chest,feeling hot all over;to er;HA,red splotches on chest,itching;chest clear;prescription for pred;22jun95 T 103 last noc;still feels tired,itching, burning inside body;HA
Chest pain on right side when attempting to take a deep breath; shortness of breath - doesn't always feel like I can take a deep breath
Took advil due to her sore arm after shot.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a  contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unspecified), via an unspecified route of administration in the arm on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced sore arm. It was reported that patient took Advil due to her sore arm after shot and inquired if that would have an effect on the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Right arm began to itch at vaccination site. Patient later notified staff that she was allergic to latex
Received vaccine on 5/13/02. On 5/22/02, had temperature of 105F; at office, it was 105.6F (R) and Motrin was given. Exam was normal. Repeat temperature check 104.5F (R) 1/2 hour after Motrin. Follow-up phone on 5/24/02-doing well with a few papules scattered.
Nausea; Dizziness; Fatigue; Pain at injection site; Muscle aches; Chills; Irritability; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 15:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included mild traumatic brain injury, fibromyalgia, spinal stenosis, a known allergy to penicillin, casein and lactose. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), desvenlafaxine succinate monohydrate (PRISTIQ), pramipexole dihydrochloride monohydrate (MIRAPEX), methylphenidate hydrochloride (RITALIN) and rosa canina; urtica dioica; tanacetum vulgare (NEUROTEC); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 20:00, the patient experienced nausea, dizziness, fatigue, pain at injection site, muscle aches, chills and irritability. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, dizziness, fatigue, pain at injection site, muscle aches, chills and irritability was resolved on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 27Apr2021 at 15:00 hours (at the age of 49-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
pt tested positive in nursing home for COVID; hx of dementia, HTN; brought to hospital due to worsening respiratory failure; dx with COVID pneumonia, AKI; made a DNR/DNI; comfort care measures; pt's condition declined and she expired in the hospital
Passed 42 days mark to receive the 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Passed 42 days mark to receive the 2nd dose) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Passed 42 days mark to receive the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Passed 42 days mark to receive the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.
Bell's palsy; experienced sudden flushing; tachycardia; the left side of my tongue became numb and tight. The numbness and tightness radiated to my left cheek, ear, jaw, and neck; the left side of my tongue became numb and tight. The numbness and tightness radiated to my left cheek, ear, jaw, and neck; the left side of my tongue became numb and tight. The numbness and tightness radiated to my left cheek, ear, jaw, and neck; The numbness lasted for approximately 45 minutes with resulting jaw and ear pain for 3-4 days after injection; The numbness lasted for approximately 45 minutes with resulting jaw and ear pain for 3-4 days after injection; New lymph node tenderness at day 4.; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on left arm at 11:30 AM on 18Dec2020 at single dose for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medication included fluticasone propionate (FLONASE), loratadine (CLARITIN) both for seasonal allergies. The patient had sudden generalized flushing, tachycardia, and the left side of her tongue became numb and tight. The numbness and tightness radiated to her left cheek, ear, jaw, and neck at 11:45 AM on 18Dec2020. She hadn't found any similar reports/reactions documented. Spoke briefly per document below regarding Bell's palsy. The numbness lasted for approximately 45 minutes with resulting jaw and ear pain for 3-4 days after injection. New lymph node tenderness at day 4 in Dec2020. No shortness of breath, dysphagia, or facial drooping associated. All events were reported as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was unknown. Explained that Pfizer would not be able to provide treatment recommendations and referred to her HCP to discuss the 2nd dose.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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.
A lump where I got the shot; It's red all around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A lump where I got the shot) and VACCINATION SITE ERYTHEMA (It's red all around the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (A lump where I got the shot) and VACCINATION SITE ERYTHEMA (It's red all around the injection site). At the time of the report, VACCINATION SITE MASS (A lump where I got the shot) and VACCINATION SITE ERYTHEMA (It's red all around the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  The patient had no problem with the first 2 Moderna shots.
A report has been received from a Health Professional concerning a patient born on 22-Feb-1999, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started 21-Jan-2014. Office manager reported that they inadvertently administered expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) to forty two patients. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by reporter.
Pain tenderness in left axillary lymph nodes and a soft, tender lump about the size of a tennis ball in circumference and about an inch or two high in the left clavicle area.  I just noticed these two symptoms today, 10/27/2021 but they may have been there yesterday and I may not have noticed because my entire shoulder was sore and it was all the way into my scapula on the left as well as my axillary area on the left side too.
w/in 4 hr of vax pt found sallow in color & minimally responsive; pt became more alert & cried when awoken; no evidence of apnea or blue in face; upon arrival to ofc pt w/blue/mottled lower extremities-nl color returned spontaneously;
Headache, body aches, naseaua, vomiting, exhaustion, fever, chills
Per pt's description via email - "arm swelled & was extremely painful". Pt stated that she couldn't use the arm for 4 days. Also she states that she had a red rash from the inj. site to her elbow. All sxs resolved.
Narrative:  COVID infection following COVID vaccine series 4/15 COVID vaccine dose #1 05/13 COVID vaccine dose #2 11/14 COVID vaccine dose #3 12/13 1st visit at new clinic, new onset afib, sent to ED due to afib/RVR, found to be COVID positive, admitted to hospital, CXR WNL 12/15 discharge from hospital, remained asymptomatic for COVID
no adverse event; received an unknown number of doses of GARDASIL-9 following a temperature excursion; Information has been received from a medical assistant regarding an unknown number of patients of unknown age and gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On unknown date, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number R029515 with expiration date in 08-JUL-2021 (strength, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a lowest temperature range below 36 degrees Fahrenheit (°F)/ 2°F (34.3F)  (multiple excursions) for the time frame of 13 days, 21 hours and 45 minutes. It was unknown if any previous temperature excursion had occurred and the digital data logger was involved.  No adverse effects were reported in any patients.  This case is non-valid due to lack of patient identifiers.  As of 12-JUN-2020, the medical assistant provided the patient's identifiers for the patients that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that underwent a temperature excursion.  The patient was a 5-years-old female patient, that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 09-DEC-2019.  This case is one of 4 cases received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1912USA004231: US-009507513-2006USA005346: US-009507513-2006USA005345:
Patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, ATORVASTATIN, METFORMIN, INSULIN GLARGINE (BASAGLAR), EZETIMIBE (ZETIA), TAMSULOSIN, PREGABALIN and PIOGLITAZONE for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-369137 (Patient Link).
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL dose and route were not reported (lot # K008931, expiration date: 04-MAR-2017; lot # K007828, expiration date:03-MAR-2016; lot# H021861, expiration date:09-OCT-2015; lot # J008423; expiration date:21-JAN-2016). The temperature excursion was supported with in-house stability data. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
dizziness; vomiting; blinding headache; slight fever of 99.3 F; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness), VOMITING (vomiting), HEADACHE (blinding headache) and PYREXIA (slight fever of 99.3 F) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Dose number 1, lot number is 030L20A) on 15-Jan-2021, Moderna (Dose number 2, lot number is 024M20A) on 12-Feb-2021, Moderna (Dose number 3, lot number is 019F21A/039F21A) on 03-Nov-2021, Moderna (Dose number 4, lot number is 004M21A) on 05-May-2022, Moderna (Dose number 5, lot number is 057F22A) on 02-Oct-2022, Moderna (Dose number 6 and lot number is AF7184B) on 06-Sep-2023; for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot, Moderna, Moderna, Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Vertigo.    On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced HEADACHE (blinding headache) and PYREXIA (slight fever of 99.3 F). On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DIZZINESS (dizziness) and VOMITING (vomiting). At the time of the report, DIZZINESS (dizziness), VOMITING (vomiting), HEADACHE (blinding headache) and PYREXIA (slight fever of 99.3 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Body temperature: 99.3 F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
I had a cough and body aches that led to chest pain eventually. I still have chest pain and body aches today. They started to go away but didn't completely go away.
A 15-year-old male patient mistakenly received a booster with the Moderna action vaccine, which does not comply with the CDC guidelines.