chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.   Age of the patient was reported as 52.29. On 30-Mar-2021, the vaccine with batch number 030B21A was moved to fridge. On 03-Apr-2021, 20 vials were moved to the clinic. On the same day at 09 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit.  The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Apr-2021.   It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. 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 traceable temperature monitor at every hour. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degrees Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
pt recv vax & devel an inj site rxn characterized by edema, pain, warmth & redness which extended to fingers;4 inch to 6 inch area of induration formed @ inj site;pt also exp sl SOB;
Information has been received from a pharmacy intern concerning a patient who in 1999, was vaccinated with a dose of PNEUMOVAX 23 and in 2009, was vaccinated with a dose of PNEUMOVAX 23. The pharmacy intern reported that the patient developed local reactions after received the second dose of PNEUMOVAX 23. It was reported that the reactions involved soreness and swelling that lasted 3 to 5 weeks. At the time of the report the patient had not recovered. It was unknown if the patient experienced a reaction after the dose given in 1999 and if the patient sought medical attention for the soreness and swelling in 2009. Additional information has been requested. This is one of several reports received from the same source.
DIZZINESS, NAUSEA, VOMITING, HEADACHE, VERY TIRED, LETHARGIC. THIS LASTED FOR FOUR DAYS HITTING ME REALLY HARD. I STILL GET NAUSEOUS NOW AND DIZZY BUT ITS FADING. I HAVE A HUGE LUMP ON MY ARM STILL THAT'S VERY PAINFUL.
Syncope immediately following vaccine administration-Vital signs remained stable and patient was alert/oriented and talking within seconds and fully recovered (no dizziness, etc.) within 20 minutes.  BP L arm lying: 110/60, pulse 82 regular, Sitting: 104/60, pulse-84 regular.
This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Breast cancer) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, received 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 BREAST CANCER (Breast cancer) (seriousness criterion medically significant) and OSTEOARTHRITIS (Osteoarthritis). At the time of the report, BREAST CANCER (Breast cancer) and OSTEOARTHRITIS (Osteoarthritis) had not resolved. Concomitant product use was not provided by the reporter. Dosage text was reported as First Dose (1 in 1 Once) on 04-Mar-2021 and Booster Dose (1 in 1 Once) on 22-Aug-2021 dose. The reporter's causality for the events of Breast cancer and Osteoarthritis with Rinvoq (Upadacitinib) was reported as no reasonable possibility and the opinion was that the event of Breast cancer was not assessable and there was no reasonable possibility for the event Osteoarthritis was related to Rinvoq (Upadacitinib).  It was unknown if the patient was enrolled in a COVID-19 vaccine trial. Treatment information was not provided. Company Comment: This spontaneous case concerns a 55-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Breast cancer and non-serious event of Osteoarthritis unspecified days after a dose (booster) of mRNA-1273 vaccine. No further details on clinical course, other lab test results and treatment received were reported. The outcome of both events was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 55-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Breast cancer and non-serious event of Osteoarthritis unspecified days after a dose (booster) of mRNA-1273 vaccine. No further details on clinical course, other lab test results and treatment received were reported. The outcome of both events was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Localized swelling in tricep (injection site) to at least twice size, duration 7 days. 4 days post injection pain and swelling in shoulder and elbow. Pain in shoulder resided 2 weeks post injection, elbow/joint/tendon pain continues and requires NSAIDs daily (currently 27 days post injection).
Difficulty Breathing; Shakiness; Extremely Tires; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: EP7534), expiration date: unknown) as SINGLE DOSE for covid-19 immunisation. Age at vaccination was 34 years. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient had difficulty in breathing, shakiness and extremely tires. Events were treated however details were not reported. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Received vaccine 1/31/22 at 12:45PM. Became ill starting Tuesday evening around 5PM. Awakened by extreme cold chills around 1:30AM Wednesday morning. Dealt with extreme chills, headaches, crippling body pain, skin/nerves on right leg sensitive to touch, rash like sores in middle of chest, back, shoulders and forehead, loss of strength, unable to pass bowel during duration of feeling ill, left arm soreness but right arm used for shot and eye irritation when looking left to right. Symptoms started to subside Thursday evening but still felt lightheaded with headaches in left temple area. Unable to sustain energy for short periods of time. Scheduled appointment with PCP on 2/18/22 - unable to be seen sooner. After discussing incident with provider, he recommended that I send a report to VAERS and to suspend 2nd shot until we review labs to try and determine why I had a strong adverse reaction to vaccine. Also explained that I have continued to have mild headaches (currently speaking) but have been taking headache medicine since the onset of events.
3 days following first Pfizer Covid vaccine, I developed sudden onset of feeling as if I was being thrown but was actually sitting still. This was followed by dizziness and balance issues for 30 minutes to 1 hour.  This occured multiple times/week for 4-5 weeks. I was evaluated by my ENT who ordered MRI which was normal. He ordered balance test and I was found to have a "vestibular injury" which he described as often caused by viral infection. Symptoms have gradually lessened in severity and frequency but I do continue to have brief episodes of imbalance. This was very early after vaccinations started and he did not think it related to the vaccine.
This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is the fourth of eight report. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration, on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine.
Vaccine was initially stored into refrigerator on 04-May-2023 and vaccine was administered between 6-Jun-2023 to 9-Jun-2023.; No adverse event; 9 patients received vaccine after the 30-day BUD between 6-Jun-2023 to 9-Jun-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30-day BUD between 6-Jun-2023 to 9-Jun-2023.), PRODUCT STORAGE ERROR (Vaccine was initially stored into refrigerator on 04-May-2023 and vaccine was administered between 6-Jun-2023 to 9-Jun-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30-day BUD between 6-Jun-2023 to 9-Jun-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored into refrigerator on 04-May-2023 and vaccine was administered between 6-Jun-2023 to 9-Jun-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30-day BUD between 6-Jun-2023 to 9-Jun-2023.), PRODUCT STORAGE ERROR (Vaccine was initially stored into refrigerator on 04-May-2023 and vaccine was administered between 6-Jun-2023 to 9-Jun-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30-day BUD between 6-Jun-2023 to 9-Jun-2023.) and PRODUCT STORAGE ERROR (Vaccine was initially stored into refrigerator on 04-May-2023 and vaccine was administered between 6-Jun-2023 to 9-Jun-2023.).    Concomitant product use was not provided by the reporter.  Suspect dosage text was reported as unknown.  No additional doses medications or treatments administered in response.  Treatment information was not provided.  This case contains information about patient 9th out of 9 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729624 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729624:Master case
Nausea, vomiting, diarrhea, headache, low grade fever 11/14 - 11/18/05 No treatment
irritability & crying inconsolable, weak, falling,t102.4 noc p/shot, 103.4 3 nights p/shot; local swelling (1x2x3cm @ 1 wk), urticarial rash, local papular rash over inject site; OM; oral thrush;
Received Tdap 7/13/16 at 11:15am. Awoke 2am 7/14/16 with headache (severe), fever, feeling hot and cold. Developed joint aches upper body, nausea. No vomiting, rash, or hives. Vaccine site not particularly sore. Seen by our site to evaluate sx - 7/14/16 at 3:30pm - consulted with ID - NAPROSYN - PHENERGAN for nausea.
persistent soreness at site of injection (deltoid) with shoulder movement, soreness is mild and not noticeable at rest
Employee states the day she received injection "it was very sore then it became swollen, warm with redness and itching."  The reporting day was 5 days after injection. Area of injection is still red and warm measuring 4 x 4"
SMALL PLAQUE PSORIASIS FLARE-UP; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the patient experienced small plaque psoriasis flare-up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small plaque psoriasis flare-up. This report was non-serious.
THE PATIENT RECEIVED THE SHINGRIX VACCINE ON 1/29/20 AND STATED THAT SHE DEVELOPED A SHINGLES RASH WHICH SPREAD INTO HER EYE ON 2/1/20. SHE RECEIVED MEDICAL ASSISTANCE AND WAS PRESCRIBED VALACYCLOVIR AND IS BEING CLOSELY MONITORED. SHE HAS A FOLLOWUP APPOINTMENT ON 2/8/20 WITH A PHYSICIAN.
Shoulder soreness, malaise; Shoulder soreness, malaise; This is a spontaneous report from a non-contactable physician reported for himself. A 46-year-old male patient received bnt162b2, lot:  EH9899, via an unspecified route of administration at 11:00am on 24Dec2020 at a single dose for covid-19 immunization. The patient's medical history included gout from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 24Dec2020, the patient experienced shoulder soreness and malaise. The outcome of the event was recovered on an unknown date. It was reported that the vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was given to the patient for the events. Patient was not diagnosed with COVID-19 prior to vaccination and patient have not been tested for COVID-19. Patient has no allergies to medications, food and other products.   No follow-up attempts are possible. No further information is expected.
This spontaneous case, was initially received on 06-Oct-2017 reported by a pharmacist and concerns a 90-year-old, elderly female patient. Patient's medical history was not reported. The patient's concomitant medication included blood thinners. On 10-Mar-2017, FLUCELVAX QIV was administered to the patient (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195212, expiry date: 31-Mar-2018). On 10-Mar-2017, after administration of FLUCELVAX QIV, the patient experienced bruising after receiving vaccine, beyond injection site, up and down all the way down to elbow. Color changed to dark purple. The outcome of the event was not recovered. The reporter assessed this case as non-serious. Follow-up received from the reporter on 16-Oct-2017: The patient's route of administration and anatomical location were updated. Narrative amended accordingly. Non-significant case correction received 06-Oct-2017: Batch number (195212) was added on the screen and updated expiry date. The narrative was amended accordingly.
UNCONTROLLED ITCHING; PAINFUL LEGS; HEAVY LEGS; PAIN INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: CU516151, and  expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced pain injection site. On 01-MAY-2021, the subject experienced painful legs. On 01-MAY-2021, the subject experienced heavy legs. On 04-MAY-2021, the subject experienced uncontrolled itching. The action taken with covid-19 vaccine was not applicable. The patient recovered from painful legs, and heavy legs on MAY-2021, and pain injection site on 02-MAY-2021, and had not recovered from uncontrolled itching. This report was non-serious.
Head does not hurt but it feels heavy; High temperature; Sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (High temperature) and HEAD DISCOMFORT (Head does not hurt but it feels heavy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 14-Apr-2021, the patient experienced PYREXIA (High temperature). On an unknown date, the patient experienced HEAD DISCOMFORT (Head does not hurt but it feels heavy). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (High temperature) and HEAD DISCOMFORT (Head does not hurt but it feels heavy) 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.
Nurse further stated that they administered a 1st dose of the Moderna vaccine to one of their patients 24 hours after vial was pierced. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse further stated that they administered a 1st dose of the Moderna vaccine to one of their patients 24 hours after vial was pierced.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse further stated that they administered a 1st dose of the Moderna vaccine to one of their patients 24 hours after vial was pierced.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse further stated that they administered a 1st dose of the Moderna vaccine to one of their patients 24 hours after vial was pierced.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Flare up of psoriasis as per patient's complaint. Pt is being treated with clobetasol, ATARAX, doxycycline, betamethasone. Flare was mentioned to pt's dermatologist on 9/15/2011.
Caller said that one of her daughter developed a bloody nose when she is just lying in bed last night around 9pm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. The following information was reported: EPISTAXIS (non-serious) with onset 18Nov2021 21:00, outcome "unknown", described as "Caller said that one of her daughter developed a bloody nose when she is just lying in bed last night around 9pm.".  Additional information: Caller was a consumer calling for her twin daughters who received their Pfizer BioNTech COVID19 vaccine for the 5-11 years old. Caller said that one of her daughter developed a bloody nose when she is just lying in bed last night around 9pm. Caller wants to know if anyone has reported this. The pediatrician that she used to see is retired so she got a new pediatrician but at the same place. The caller hasn't called them yet but she was going to call them next. The caller did give her Tylenol after she had the vaccine, the pediatrician said to go ahead and give Tylenol afterwards so that's all she did. She took 7.5 mL.  No follow-up attempts are possible. No further information is expected.
Pt was given injection and complained immediately that she was lightheaded and that this usually happens. She passed out with her eyes open and was unresponsive w/difficulty breathing. 911 was called she was taken to hospital. She returned to normal w/in a few minutes.