chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) 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 37.00.  Concomitant products were not reported.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42, 5 PM: 42.  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 Fisher brand 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report was received from a registered nurse regarding a pediatric patient of unknown age and gender. Pertinent medical history, drug reaction/allergies were not provided. On an unknown date, the patient received a first dose of VAQTA (Lot number and expiration date were not provided). Co-suspect therapy and concomitant medication were not provided. On an unspecified date, a second dose of VAQTA was recently administered at a 5 month interval from the first dose. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The day after the vaccine she had a horrible back ache. On March 6th the starting getting a red raised rash around injection site which ended being 6 inches in diameter.
Persistant watery diarrhea after 1st dose of Rotateq-0.25 lb wt loss in 1 month.
Pale, dizzy, rapid and irregular heart beat, sensitivity to light and sound, disoriented.
This infant had a fever of 103 (2 hours after his vaccine temp 102), he cried for 6 hours, and the fever persisted for 24 hours. The patient was treated with Motrin at home he was very irritable.
The vaccine was mixed with the incorrect diluent. The nurse used sterile water instead of 0.9 Sodium Chloride. There have been no side effects reported by the parent or child.
I contracted COVID-19. My symptoms include tiredness, coughing, left shoulder pain, neck & back soreness/achiness, knee pain, and numbness on my left leg. I don't have much of an appetite either. I took Paxlovid for five days to treat my symptoms. I've also been taking Mucinex. I was prescribed cough tablets as well.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 68-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment was made.  There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  Reporter stated that no adverse reactions were reported by any patients. No treatment medication were provided.
patient was given orange cap 5-11 pfizer as a booster instead of Bivalent. Staff as been educated on updated protocol and Provider was notified.
Systemic: shortness of breathe, 100-120 bpm,150/80bpm-Medium
I had my 1st shot of the Pfizer vaccine on Aug 16 around 11:30am. My appointment  was at 11am, but with paper  and others ahead of me. My right arm was swore  a few hours later, and my body began to ache as well. The next day my body ached pretty bad. Those things I expected. WHAT I didn't expect was my lymph nodes in my right armpit to swell to the size of a golf ball. I couldn't raise my arm above shoulder height. I couldn't get into an urgent care till 6pm that evening. The DR told me to rest a few days, and it should go away. He also told me that I needed to report this event, so it could be tracked.  Item 20 on form, I am still recovering now.
Patient called at 10:51am. She stated that she had questions about vaccine. Patient states she received 2nd Covid19 vaccine on 03/26/2021. The next day, om 27th of March, she awoke with bumps and swelling on arms. Right side was worse than left arm. (The vaccine was administered in left arm). She denies having fever, shortness of breath, dizziness, chest pain, or any other distress symptoms. The bumps are irritating and causes her to scratch. Because of the scratching , her skin has holes where the bumps are. As of today , the bumps are still there but she noticed a spreading rash on breast, chest,  and neck. Patient states the rash/hives on her breast , chest,and neck area are not the same as the bumps on her arms.  Patient states that she does not have insurance and has not seen a physician in 2 years. Was refused a Gold Card because her lack of a permanent resident. She has PO Box listed as her resident.  Encouraged/advised patient to seek medical attention to be assessed by a healthcare professional. (Suggested going to clinic ,will see walk-in patients without insurance).
Injection site: swollen red sore.  Fever, headache, fatigue, pain.  Felt like I had a horrible flu.  Arm is STILL red and swollen and spread although slightly minimized each day.
injection site was hard and swollen; injection site was hard and swollen; headache; nausea; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 52 (unit not specified) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date in Feb2021 as dose 1, single for COVID-19 immunisation. The patient was immunocompromised (taking an immunosuppressant). Concomitant medication included an unspecified immunosuppressant. On an unspecified date in 2021, the patient reported that the injection site was hard and swollen (described as "size of a quarter and looks like a huge hive"), headache, and nausea. The patient was concerned as the events has lasted over a week and the patient was taking an immunosuppressant. The outcome of the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed insidious onset erythema, induration, and rash maximum diameter 5 cm around vaccine injection site.
Systemic: Vaccine stored out of range-Mild, Additional Details: Vaccine stored out of range
Chills began 2 hours after vaccine was given.  Chills resolved 48 hours after receiving vaccine. Subjective low-grade fever and feeling weak.  Denies HA or other symptoms at this time.
Pt recvd 3 doses of Engerix-B vax on 6JUN90, 5JUL90, & 26NOV90 & was found to be a non-responder;
This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. On 20-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) which had expired on 10-APR-2014. No adverse effects were reported. Additional information has been requested.
I had an oral sensation like I was tasting something cold.; This is a spontaneous report from a consumer. A 65-year-old male patient received first dose bnt162b2 (COVID 19, Pfizer, EN 5318), via an unspecified route of administration, Left arm on 27Jan2021 15:15 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine was administered in four weeks. On 27Jan2021 at 16:15, approx. an hour after injection, the patient had an oral sensation like he was tasting something cold. No treatment was given for the event. Outcome of event was recovered on 2021.  No follow-up attempts are possible. No further information is expected.
Received Varivax within minutes developed 2 large hives at site of vaccine, respiratory symptoms. Given 3/4 tsp Benadryl, has known milk allergy.
intense burning in my neck side of face and side of head; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (intense burning in my neck side of face and side of head) 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 BURNING SENSATION (intense burning in my neck side of face and side of head). At the time of the report, BURNING SENSATION (intense burning in my neck side of face and side of head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Headache, Myalgia, NauseaVomiting, CHILLS Narrative:  Other Relevant History:
On Saturday, 12.4.05, mother noticed 2 large red welts on pt right deltoid - area warm to touch. Pt c/o of itching.  Caladryl applied. Pt temp not taken, but mother says pt felt warm and was given tylenol on Monday, 12.5.05.  Today, 12.6.05, mother noticed fluid filled blister on pt left foot, right upper lip.  Red welt on right side of neck.  Pt c/o areas itching - Caladryl applied.
Vaccine recipient developed covid like symptoms three days after receiving vaccine #2.  She tested positive on 1/19/2021. She is currently self isolating
Big knot first sized after injection and bruised; Big knot first sized after injection and bruised; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (Big knot first sized after injection and bruised) and INJECTION SITE BRUISING (Big knot first sized after injection and bruised) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2022, 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 ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced INJECTION SITE NODULE (Big knot first sized after injection and bruised) and INJECTION SITE BRUISING (Big knot first sized after injection and bruised). At the time of the report, INJECTION SITE NODULE (Big knot first sized after injection and bruised) and INJECTION SITE BRUISING (Big knot first sized after injection and bruised) had not resolved.            No concomitant information was reported. Reporter causality for the events Injection site nodule and Injection site bruising with Humira was reported as probable. No treatment information was reported. It was unknown if the patient was enrolled in a Covid -9 vaccine trail.
pt found deceased (@ home) 29AUG95; ER MD states is SIDS death; family has not obtained final autopsy report
pt rcvd vax; pt devel sore throat & myalgias, fatigue;
Saturday 12/26/2020 received Moderna vaccine dose #1 of 2 at 12:00pm. 15 minute observation required (no symptoms) was able to leave. At 12:30 pm - 30 minutes post vaccine: experienced lip & tongue tingling & numbness, throat felt weird. Jaw line became itchy. Self-resolved 15-20 minutes after. At 2:00pm experienced severe migraine & lightheadedness - unable to perform daily routine due to pain & feeling of passing out. At 3:15 pm tongue became  itchy & throat feeling weird again. Self-resolved 15 minutes later. Today 12/27/2020 only symptom is severe pain in left upper arm (where injection was) feels like solid mass & difficulty raising arm due to pain & tight feeling (this is very different than just having sore arm post flu vaccine). Pain in arm constant throbbing heavy pain.
Lethargic 4 days; headache, weak legs (knees buckled),  odd pains various locations, tingling in hands and wrists, dizzyness, weakness, sore throat two weeks,
5-10% infarction on the placenta.  No issues during the pregnancy.  Low birth weight of 5lbs 4.5oz.  Mother gained normal weight, non smoker, no alcohol, health diet and regular light exercise.
Patient reports, shaking uncontrollably for a period of time in the evening. Also states, developing joint and muscle pain several days later not including the localized pain in the arm.
Hives; This is a spontaneous report from a contactable other health professional reporting for himself. A 57-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK4176), via an unspecified route of administration in arm left, on 19Jan2021 at 06:30 AM, at single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and hypothyroidism. Allergies to medications, food or other products: no. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included metformin (unknown manufacturer), insulin glargine (LANTUS), levothyroxine sodium (SYNTHROID). Previously the patient received the 1st dose of BNT162B2 for COVID-19 immunisation, on 29Dec2020, lot# EK9231, in left arm, at 04:00 PM. The patient experienced hives on 21Jan2021 with outcome of recovering. No therapeutic measures were taken as a result of the event. The patient was not tested for COVID-19 since vaccination.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD lot # M004897, expiration date: 26-JUL-2017, 0.5 ml. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
stroke during surgery; TIA; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 70 year-old female patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), administered in arm (unsure if in the left arm), administration date 30Mar2021 (Lot number: ER8733) at the age of 70 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "She is a heart patient" (unspecified if ongoing); "TAVR Surgery, Heart Valve Replaced", start date: 12Apr2021 (unspecified if ongoing). The patient had no allergies. The patient had unspecified concomitant medications (reported as "No, any medication she has had is a daily medication that she has been taking"). Vaccination history included: BNT162B2 (Lot number: EN6205, administered in the arm), administration date: 02Mar2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 12Apr2021, outcome "unknown", described as "stroke during surgery"; TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset of 2021 (reported as either in Jun2021 or Jul2021) outcome "unknown", described as "TIA". The patient did not have testing for what just happened, but for the scans and stuff that she had would have been back in Apr2021, she also had a stroke then, but the stroke was during the surgery on 12Apr2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101647058 Same patient, different events, different vaccine dose
redness warmth extension 2/3 upper arm No fever Rx as cellulitis at urgent care
Pt states that on 6/25/21 she noticed a bump on her neck, by the next day she formed a spotty rash on forehead, temple, and upper back areas. The rash began to get worse and formed a blister like rash and on the morning of 6/28/21 the blisters began to pop. Patient took benadryl to help with the rash and had a virtual appointment with PCP office where she was advised not to receive the 2nd dose. States no difficulty breathing or scratchy throat.
Blood pressure elevated to 245/125, at ER.  Stayed elevated for several hours. I was not previously on any blood pressure meds, but am now.
Developed alopecia areata around end of aug 2021 for the first time. There is no family history or previous history of this condition. Have been treated with monthly steroid injection since nov 2021, yet the affected area keeps growing.
Shaking cold chills, body soreness, headache, chest pain and fever. Taking Tylenol for it
pt seemed well then went to sleep;pt did not eat lunch;refused juice;@2hr p/vax pt seemed warm & sitter noted mild twitching of hands & ? grunting resp;
2 days after administration, patient noticed a 4 inch red circular rash around site of injection. It was slightly warm and itched a little.
Followed up with the patient closely as possible.  Not sure if patient utilized V-safe or other means. 7/12/22 at 457pm no known issues 7/13/22 at 126pm reported she feels like she was hit by a bus, and everything hurts.  Didn't go to work. 7/14/22 at 1219pm reported she's not dead but how long does the body aches last and has a migraine 7/14/22 at 103pm reported day before had really bad pain in her right rib cage 7/14/22 at 552pm reported she heard mandating the booster dose by her employer group and still feels achy and overly hot and taking temperature. 7/15/22 at 1016am reported she is still terrible like she's dying. She will call her Dr. Nothing over the next 2 days were reported (sat and sun = weekend) 7/18/22 at 321pm reported her left arm has been numb and tingling.  Asking if its normal or go to ER.  Couldn't advise for or against and suggested contacting her PCP versus waiting the ER for hours.  She states she had other symptoms and chose to ignore them and has an upcoming appt with DR and see what they say 7/19/22 was told physician said she had an allergic reaction and can no longer get the COVID vaccine.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021 at 4:14 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient received the expired vaccine. The patient was administered with the vaccine past the published expiry.  It was also reported that patient had 2/2 COVID received+ 1 additional dose.  No Concomitant product use was reported. No treatment information was provided.  id reported- 108630234
Pt called 2/8/11 to report reaction. Lt. upper arm was swollen the size of a grapefruit, thinks he had a fever, had diarrhea and unable to eat or get out of bed on Sat.-2/5. Stated that it is getting better every day since and he is on the mend. Fever, Diarrhea and swelling, loss of appetite.
Patient was given half the dose of 0.25 ml rather than the 0.5 ml dose
Took 1st oral typhoid pill AM 5/6/2010. After noon same day developed "patch" of rash on left elbow and some "bumps" that itched mildly. Also spread to back of legs, knees and back. Relieved with CALADRYL lotion. 1 wk later developed a few more areas before it fully dissipated.
Patient received Janssen COVID vaccine on 3/11/21 (lot #1802070) and Pfizer COVID vaccine on 12/6/21 (lot # FJ1620) at the medical center. On 8/9/22, patient admitted to our inpatient facility with acute hypoxemic respiratory failure due to COVID-19 pneumonia and pulmonary embolism. On 8/16/22, patient was transferred to the med/surg unit and still admitted here as of today (8/18/22).