chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial did under went a temperature excursion; Patient received  a Dose administered  greater than 12 hours post puncture; Patient received a second booster  and are not immunocompromised or over 50 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received  a Dose administered  greater than 12 hours post puncture), EXTRA DOSE ADMINISTERED (Patient received a second booster  and are not immunocompromised or over 50 years of age) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vial did under went a temperature excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     The patient had no allergies. The patient never had COVID-19 positive test or diagnosis. The patient had no acute or chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: janssen for primary series and booster (primary series and booster). Past adverse reactions to the above products included No adverse event with janssen for primary series and booster.    On 03-May-2022 at 11:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022 at 11:15 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received  a Dose administered  greater than 12 hours post puncture). 03-May-2022 at 11:15 AM, the patient experienced EXTRA DOSE ADMINISTERED (Patient received a second booster  and are not immunocompromised or over 50 years of age). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial did under went a temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received  a Dose administered  greater than 12 hours post puncture), EXTRA DOSE ADMINISTERED (Patient received a second booster  and are not immunocompromised or over 50 years of age) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vial did under went a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient was not immunocompromised. Other vaccines given within 1 month prior to Moderna vaccine reported as no. The adverse event did not cause patient to go for office visit, urgent care, ER and hospital. The vial was initially stored in the refrigerator on 29 Apr 2022 and was first punctured  on 29 Apr 2022 at 8AM. The vial was stored in fridge post puncture and did undergo temperature excursion. The vial was exposed to room temperature range (8 to 25 degree Celsius or  46 to 77 degree F) for 3 hours. No treatment medications were reported.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. Nurse reported that she had unspecified patients that received on an unspecified dates, their first dose of GARDASIL (dose, route, lot# were not reported) and then came back a year later on unspecified dates and received their second dose of GARDASIL. No adverse effects was reported. No Product quality Complaint (PQC) was involved. Additional information has been requested.
After two weeks noted mouth sores that got worse and started to bleed the following days.  By Friday 11/4 gums were bleeding along with the mouth sores.
Information has been received concerning a 1 year old patient who on 02-APR-1997 was vaccinated with one dose of VARIVAX vaccine. On 11-OCT-1997 the patient developed an "extensive distribution of red splotchty rash in L2 distribution on the leg and ankle". Additional information has been requested.
55 year old female c/o slight fever and sore arm x 2 days. Patient feels better.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 18 years old adult patient and unknown gender. On 16-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient reported his body felt run down, like he had the flu, and his temperature rose to 100F 1 day after, followed by 99F 48 hours after.
5MAY t101 @ 9PM, temp inc to 104.8 w/in 3 hrs; seen @ ER; mom reports shakes & twitches; treated w/Motrin & APAP; temp dec; 24 hrs later temp to 102.5; to Er again dx OM, conjunctivitis & URI;
headache & what seems to appear like a bruise it doesnt hurt in the area where I had titanium inserted for back surgery.  I noticed a pain sensation 3 days after my second shot thought nothing of it seemed to be symptoms of back pain that for me occur when I've had the flu in years past.  I did find it interesting that it was localized in this area near my incision recall reaching around to my back to confirm that this was the location.
Tested negative on day 6, but rebounded 6 days later after taking several antigen tests; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 18Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Apr2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 16Dec2019, stop date: 28Jul2022. Past drug history included: Aleve, reaction(s): "Known allergies:Aleve". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 07Aug2022 at 12:00, outcome "recovering", described as "Tested negative on day 6, but rebounded 6 days later after taking several antigen tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Negative; (07Aug2022) Positive, notes: Rebounded 6 days later after taking several antigen tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included took Paxlovid for 5 days from 28Jul2022 to 01Aug2022. Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1548- Pfizer covid vaccine given in left deltoid, tolerated administration without issues. Patient left exam room to sit in waiting room with mother. 1555- Patient's brother came to get myself "I think my sister may pass out" Observed patient become very pale and vomit in garbage can. She was given a cold paper towel and bottle of water. She had a near syncopal episode. Mother present during event. 1632- Patient left ambulatory with mother and brother in no distress. Patient stated "I am feeling much better maybe it was my anxiety about getting a shot"
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Body Aches Generalized-Medium, Additional Details: Patient reported flu-like symptoms that developed with-in 24 hours of vaccine administration, on day 2 her arm "felt heavy" by day 3 rash developed that started at injection site and spread over the next days until she reported to pharmacy on 04/11/2023 in the afternoon. rash has spread on both side of injection site and down  the arm to the wrist, rash was warm to the touch, skin not affected by rash on arm was not warm. Patient was advised to seeek medical attention at nearby urgent care.
death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient has PMH significant for neoplasm of liver, stage 4 esophageal adenocarcinoma congestive cardiomyopathy, AF, htn. Seen 3/22, per not "states that for the past three days he has had constant chest heaviness and shortness of breath along with productive cough with dark sputum." Discharged 3/24. Deceased 4/2/2021 however no notation or death certificate noted.
Tachycardia (150?s), dizziness, shakiness, flushing beginning 5-10 min after injection. Lasted for approximately 45 min.   Approx 24 hrs after injection, developed a rash on torso?bilateral arms, chest, neck and back.
It was reported that a 30-year-old female patient received a TD Adult vaccination. Reportedly the patient experienced shortness of breath almost immediately post vaccination. Treated with epinephrine in emergency room. It has been determined that the patient had a reaction to the dry natural rubber latex vial stopper.
This spontaneous report as received from a pharmacist refers to a 54 year old patient (gender unspecified). The pharmacist reported that 54 year old patient possibly had been receiving PNEUMOVAX every 5 years because of emphysema. Administration dates and lot# were not reported. Outcome of the event was unknown. Additional information has been requested.
Report of swelling lip - reports this has happened in the past many times. Reports being able to breath well - only concerned about lip swelling.   She was provided 20mL of Geri-Dryl from the response bag. She drank the full 20mL with no issues. Vaccine recipient stayed for an additional 20 minutes for observation. No further swelling was witnessed. She continued home with her husband after the additional observation time.
Rash to entire body began Sunday 8MAR92 periorbital & facial edema 10MAR92;
Itchiness all over chest and arms 1 week later; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 05Apr2021 at 11:00 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unknown indication, started from unknown date, unknown if ongoing. The patient previously received clarithromycin (BIAXIN) on unknown date for unspecified indications and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On 09Apr2021, the patient underwent lab tests and procedures which included rapid nasal swab test, and the result was negative. On 11Apr2021 at 12:00, the patient experienced itchiness all over chest and arms 1 week later. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event itchiness all over chest and arms was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Headache on top of her head and vice-like pain 3-7/10. Pain sometimes alleviated with Tylenol - onset 2 days post Yellow Fever vaccine (Same as husband) but persists to this day.
This spontaneous report was received from a licensed practical nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ Vial, lot # M019707 with expiry date 25-OCT-2017 (dosing details unknown) for prophylaxis. Administered doses of ROTATEQ experienced a temperature excursion of 60.1 degrees Fahrenheit (F) for 14 hours and 15 minutes, 47.5 degrees Fahrenheit (F) for 30 minutes, 47.3 degrees Fahrenheit (F) for 30 minutes, 50.7 degrees Fahrenheit(F) for 30 minutes and 32.7 degrees Fahrenheit (F) for 2 hours and 15 minutes. There was no previous temperature excursion. The call was because of a data logger. No symptoms were reported. Product quality complain was not reported. Follow up information has been received on 01-DEC-2016 from a nurse, who stated that administered doses of ROTATEQ experienced also a temperature excursion of 33.1 degrees Fahrenheit (F) for 4 hours. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA005809: MERCK 1611USA005196:Mfr number.
Warm, red, indurated & ithcy at site of MMR injection site - lasted approx. 6 days. 10/02/2011 6:00 AM developed diarrhea which lasted approx. 4 days - improved for approx. 3 days and resumed on 10/9. Yellow stools - primarily liquid - has not checked temp - does not believe she is running a fever; has loss of appetite and "stomach rumbling" - does not know anyone else with similar symptoms; can keep small amounts of food and liquids down - does not think she is dehydrated.
Patient was given .2 ml of the dose for 12-18 year olds- No adverse reaction just reporting due to being COVID vaccine related
Diffuse urticaria developed 5 days after second dose of pfizer without other obvious source.  Treated with antihistamines and resolved within a few days.
Information has been received from a consumer concerning a 74 year old husband with penicillin allergy, peanut allergy, and allergies to SEPTRA, ENTEX LA, PRILOSEC, and REGLAN and a history of chicken pox (age 8) who on 18-OCT-2007 was probably vaccinated in left arm with a dose of ZOSTAVAX (Oka/Merck) instead of a dose of influenza virus vaccine (unspecified).  Concomitant therapy included primidone, propranolol HCl, PREVACID, finasteride (MSD), "baby" aspirin and vitamin B (unspecified).  On 19-OCT-2007 or 20-OCT-2007, 1 to 2 days after vaccination the patient developed shingles.  It was reported that the patient was there to receive the influenza shot which the office said they gave him but the reporter believed that the patient received ZOSTAVAX (MSD).  It was reported that the office was administering both vaccines at the time of patient's vaccination.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been received from the consumer concerning her husband who stated that the patient was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of a dose of influenza virus vaccine (unspecified).  She reported that he patient prior to her husband received a dose of ZOSTAVAX (Oka/Merck).  The patient developed rash under his left arm that moved to his back and a little on his chest.  The patient was seen by his physician and subsequently was diagnosed with shingles.  The nurse practitioner stated that the patient was vaccinated with flu vaccine and "they don't make mistakes".  The patient currently had a few large scabs and was starting to have a lot of pain.  Follow up information from a health care professional reported that 1-2 days after vaccination (Oct-19-2007), he developed symptoms of a rash at the injection site, a burning sensation under the arm accompanied by fatigue and pain (site not specified).  On 10-NOV-2007, a specimen was obtained (unspecified source) and sent for varicella zoster identification (results not reported).  It was reported that at the time of this report the patient had recovered.  It was also reported that there was no recent exposure to chickenpox or shingles.  Additional information has been requested.
Described by mother on (telephone call) 1) redness 2) swelling 3) tenderness at RT injection site.
L arm red from deltoid to elbow on 10/16/02. Pain is reported for the L arm as well as a "heavy" feeling in the arm. Will see PMD for those complaints 10/16/02.
Possible late second dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 18-JUL-2023, the patient received the 2nd dose of Shingrix. On 18-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible late second dose of Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 Physician via sales representative reported that patient was possibly late for administration of second dose of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Information was received on 08-FEB-2019 from a lawyer and a female consumer  and her husband regarding a case in litigation. On 04-DEC-2014 the patient was inoculated at a pharmacy with ZOSTAVAX (lot number and expiration not reported) for its intended purpose: the prevention of shingles. The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the vaccine the patient suffered a stroke which led to permanent vision loss in one eye. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages and required extensive medical care and treatment. The patient suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a result the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Stroke resulting in permanent vision loss in one eye was considered to be a medically significant event. Stroke, herpes zoster and vaccination failure were considered to be disabling. Additional information has been requested.
Client complained of feeling nauseous and dizzy after receiving 1st Pfizer Covid Vaccine(Lot# ER8734 Exp 3/31/21) at 1020. Client was walking out of restroom when she alerted EMT she was feeling dizzy and nauseous. Mother was present and had accompanied client to restroom. Per client could walk back to waiting room. Client was assisted by mother from restroom to walk to nearest chair. Fist assessment at 10:23: alert and oriented, blood pressure 130/100, pulse 83, oxygen 98. Per client no breakfast did morning and had not hydrated as well. Client given water and instructed to take small sips. Client denied headache, blurry vision, or vomiting in restroom. Client informed she would be observed for an additional 15 mins. Client asked if she could eat a snack as she felt she was feeling this way due to not having breakfast. Client advised to take small bites. Per client no history of allergies or reaction to vaccines and no current medication she takes. Within 5 minutes of sitting client stated symptoms were improving. Vitals at 1036: blood pressure 120/88, pulse 81, oxygen 98, alert and oriented. Client stated previous symptoms had resolved. Client advised to speak with provider prior to second dose. ER precautions given. Mother would drive client home. Client left facility at 1038 with a steady gait.
At injection site, pt developed induration with erythema measuring 4cm X 3cm, beginning on 4/13/00. Pt had been exposed to varicella about 2 weeks prior to vaccination and was asymptomatic at time of injection. Pt on exam on 4/17/00, also had a few very small red papules/vesicles, pin point on trunk. Still having symptoms.
Swollen lymph nodes above left collar bone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 09:45 (Lot number: EWO187) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; ALPRAZOLAM. Vaccination history included: Bnt162b2 (Dose number=1, Lot number: EWO185, Administration date= 17May2021, Administration time: 09:15 PM, Vaccine location= Left arm), administration date: 17May2021, when the patient was 45 years old, for Covid-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Jun2021 22:00, outcome "not recovered", described as "Swollen lymph nodes above left collar bone". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information- It was reported that patient did not receive any covid vaccine prior vaccination and did not undergo covid tested post vaccination. Patient had no known allergy.  No follow-up attempts are possible. No further information is expected.
15min p/vax left the clinic & exp shaking, problems speaking,heart racing, pressure in head;pt was taken to hosp ER & on arrival also had purple lips & blotchy face;blood test given DPH & sx went away w/in 10min;