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 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 3:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 3:32 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced 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). 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.   Age of patient was reported as 53.04 for dose administered on 14-Feb-2021 and 53.14 for dose administered on 21-Mar-2021.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 2 PM, 3 PM temperature was 32, 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine date was 10-Mar-2021.On 21-Mar-2021, Excursion time was 09 AM, 10 AM, 11 AM, temperature was 32, 34 total doses given for the day was 94, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vials were sent to clinic. Vaccine date was 15-Apr-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 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.
Narrative: Patient arrives with mild rash, after vaccination. He also reported some slight flank tenderness that seemed to start just prior to arrival, but this went away in the ER, he has no microscopic hematuria. He was observed, treated with Toradol and loratadine, and did not progress to severe allergic reaction. We discussed plan of care including antihistamines, returning here for any worsening symptoms or concerning increased to do so.
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer Inc.) concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, and codeine allergy. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: unknown) dose was not reported, 1 in total was administered on 03-MAR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 69 years old. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine included Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 25-OCT-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with tozinameran (dose number in series 2). The patient received non-company suspect vaccine included Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin and route of admin were not reported, batch number: 065K21A, expiry: unknown) dose was not reported, administered on 01-APR-2022 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with elasomeran (dose number in series 3). The patient receive non-company suspect vaccine included Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 4) (form of admin and route of admin were not reported, batch number: GH97206, expiry: unknown) dose was not reported, administered on 19-SEP-2022 to right arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 4). On 11-APR-2023, the patient experienced covid-19 infection (suspected covid-19 infection) (dose number in series 4). The patient received treatment with non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (route of administration and form of admin were not reported, batch number:GF7861, expiry: unknown) dose and frequency were not reported administered from 14-APR-2023 to 19-APR-2023 for covid-19 treatment. On 23-APR-2023, the patient again experienced cold symptoms similar to the original covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (dose number in series 2), elasomeran, and tozinameran (dose number in series 4) was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. On 20-AUG-2014, 2 patients were vaccinated with a dose of GARDASIL (lot number, expiration date, dose and route were not reported) that was improperly stored at 48F for 39 minutes. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever of 102.8 deg F,  Headache,  Tachy at 108 bpm,  left sided chest discomfort at 4/10.
Information has been received from a health professional concerning a 77-year-old male with a history of atrial fibrillation and chronic lymphocytic leukaemia who on 06-DEC-2007 was vaccinated subcutaneously with a 0.65 ml dose of Zostavax (Oka/Merck). No list of medications or allergies were available. On approximately 13-DEC-2007 the patient developed a large area of redness and swelling at the injection site. The patient was seen in the office on 13-DEC-2007, no treatment was required and no lab or diagnostic studies were required. Subsequently, the patient recovered from the redness and swelling at the injection site. No product quality complaint was involved. Additional information has been received. The patient received an injection of Zostavax (Oka/Merck) and approximately 24 hours later (on approximately 07-DEC-2007) he noticed a redness, tenderness and swelling at the injection site that peaked in 2 days and gradually subsided over a 3 week period of time. The patient was reported recovered as of the end of December 2007. Additional information is not expected.
the vial was initially stored in the refrigerator on 11Jan2023 and administered on 16Mar2023; No adverse event; Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11Jan2023 and administered on 16Mar2023) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 16-Mar-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. On 16-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11Jan2023 and administered on 16Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11Jan2023 and administered on 16Mar2023) 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 (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11Jan2023 and administered on 16Mar2023).    No concomitant medication details was reported. Vial size was reported as 2.5ml. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720507 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720507:
Information has been received from a physician concerning two patients, who were vaccinated with varicella virus vaccine. Subsequently, the pts developed herpes zoster. The first pt developed a rash on the back, and the second pt developed a rash on one leg. The pts sought unspecified medical attention due to symptoms. The reporting physician believed there was no association between the pts symptom and the vaccine.
dark red rash that was very itchy; dark red rash that was very itchy; itchy; Skin peeling at injection site; This spontaneous case was reported by a nurse and describes the occurrence of   in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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) (Intramuscular) 1 dosage form.        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 medications were reported.   The patient was recommended to use a topical antihistamine for treatment of the events.
Within 20 minutes I experienced extreme shortness of breath that continued throughout the weekend and into the following week.  Within 36 hours I developed a "rash" that was later diagnosed as petechiae. Labs were ordered immediately and my platelet level was 66,000. The hematologist that was consulted with had me report to the emergency room for further tests. I was informed not to injure myself in anyway with a count that low or I could hemorrhage and die.
5:00 PM chills, felt freezing,  arm sore, muscle aches , headache,  congestion, tired. 11:00 pm same symptoms and nausea. 1:30 am dizzy,  temperature 97.8, other symptoms slightly better.  8:45 am arm sore, muscles sore, thirsty, nausea, dizzy, mucus.
Pt came into pharmacy on 4/18 to discuss with the pharmacist that her are is still red, warm and slightly swollen area around injection site which she received from our pharmacy on Friday, 4/15/22.
Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwell, weakness, brain fog, lasted 40 hours.
pt walked at age 14 mon, walked w/ lt foot nl & on toes of rt foot; postured w/rt arm; on 8/13/99 was dx w/cerebral palsy w/o any apparent reason; has cast on rt leg; will wear brace; physical therapy; occupational therapy & possible shots
Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  It was reported that doses were administered to 20 patients from these expired vials .  The vials expired on 8OCT2021 and were left in the refrigerator past that date. All 20 patients were given the full 3rd dose of the Moderna COVID-19 vaccine as it was a clinic for immunocompromised patients Caller states that no adverse reactions have been reported by any patients from the 3rd dose.
Severe inflammation and pain around heart and lungs, joint pain, nerve pain, vivid malar rash. Looked like a full blown Lupus flare up. I've never had that before.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 29-NOV-2011, a healthcare provider administered the ZOSTAVAX to the patient. On an unknown date in 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not  limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was taking allergy medicines. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine was not applicable. The outcome of chills was not reported. This report was non-serious.
Headache, HYPERtension & Tachycardia Narrative:  Pt received 3rd dose of Moderna vaccine on 10/28/21 at 6pm. By 6am the following day, pt was complaining of severe headaches that started at the top of the head and radiated down the neck. No NSAIDs given at that time. Vitals at 0930: BP 124/84 mmHg. At 0950: BP 132/93, temp 98.1, O2 sat 98%, HR 103 bpm. At 1015, pt called PCP to see if could be seen that day. PCP recommended taking OTC pain relief meds and to present to clinic if no improvement. Pt was picked up from site by mother. At 1030: BP 136/88, temp 98.1, O2 sat 99%, HR 108, RR 18. Of note, pt does report a reaction after receiving 2nd dose of Moderna vaccine, for which she was hospitalized for 1 week. (No information provided on that event.) No follow up information found.
flat, itchy, red spots on arms, legs and they moved to her abdomen; fever; redness and swelling around the injection site; redness and swelling around the injection site; redness and swelling around the injection site; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 22 years old female patient who experienced flat, itchy, red spots on arms, legs and they moved to her abdomen, fever and redness and swelling around the injection site, while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included LORAZEPAM (LORAZEPAM).  On 13-May-2019, the patient received a dose of suspect RABIES (HDC) VACCINE lot N1K303M and expiry date: 29-Oct-2019 via unknown route in the left deltoid.  On an unknown date, following the vaccination the patient experienced hives (urticaria), fever (pyrexia), vaccination site inflammation with symptoms of vaccination site swelling and vaccination site erythema.  (Other relevant tests included no lab data.)  Final diagnosis was hives, fever, vaccination site inflammation with symptoms of vaccination site swelling and vaccination site erythema.  The patient was treated with PREDNISONE (PREDNISONE) for Product used for unknown indication and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Product used for unknown indication.  The outcome of the events was unknown at the time of reporting.  List of documents held by sender: none.
Upper lip itched and was slightly puffy. Next day it returned to normal but bottom lip became itchy and felt 2 little bumps underneath. I assume it was hives.
Tachycardia/heart rate was above 100 upon waking up on 08sep, mostly 115-120 until about 1:00, then around 100 for remainder of the day (currently ongoing).; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH99694) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Other Medical History: Hypothyroidism" (unspecified if ongoing); "Other Medical History: Past hx of severe Covid 19 (Feb2021)", start date: Feb2021 (unspecified if ongoing), notes: Other Medical History: Past hx of severe Covid19 (Feb2021), if covid prior vaccination: Yes. Concomitant medications included: LEVOTHYROXINE; ZOLPIDEM. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: TACHYCARDIA (non-serious) with onset 08Sep2022 at 07:00, outcome "not recovered", described as "Tachycardia/heart rate was above 100 upon waking up on 08sep, mostly 115-120 until about 1:00, then around 100 for remainder of the day (currently ongoing).". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia.  Additional information: the patient had no other vaccine within four weeks. She had COVID prior to vaccination, and was not tested for COVID post vaccination.
Arm/shoulder area extremely sore from flu shot, having difficulty sleeping due to discomfort. Went to Dr after approximately 3 weeks. Dr suggested muscle damage and would heal over time.
ARM JUST BEEN TENDER, LITTLE ACHE, AND SORE ON TOUCH; This spontaneous report received from a patient concerned an 88 year old female. The patient's height, and weight were not reported. The patient's past medical history included: periods of depression, and other pre-existing medical conditions included: her blood goes half way in the right side of the neck. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced arm just been tender, little ache, and sore on touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm just been tender, little ache, and sore on touch. This report was non-serious.
Summary: Extremely long and heavy menstrual cycle, resulting in anemia,  after the covid vaccine.  I received the second dose of my vaccine on 02/14/2021. I was fully immunized on 02/28/2021. I should have started my period on the next day, or the day after. My cycle is usually 25-26 days.  My period started on 03/14/2021 instead (38 day cycle) and lasted for two weeks. It was extremely heavy during those two weeks, interfering with my daily life and preventing me from leaving home.  I started feeling dizzy and lightheaded and was still dealing with extremely heavy bleeding, so I went to the ER on 03/29/2021. My uterus had an extremely thick lining, identified on an ultrasound, and I was quite anemic. I was told I nearly needed a blood transfusion. Since 03/29/2021, I have been on daily birth control and progesterone to get control of the bleeding. I have only had a few days without bleeding in that time. I am now scheduled for a D&C and uterine ablation to manage my bleeding.
Pt received Covid 19 Vaccine on 12.18.20 at 10:46am in Right Deltoid.  Pt presented to the ED at 1:50pm with suspected throat swelling. Denies itching, redness or tongue swelling.  Treatment:  Epinepherine 0.3mg SQ- 1:55p Benadryl 50mg/IV- 2pm Methylprednisolone 125mg IV- 2:02p Pepcid 20mg IV- 2:06p Discharged at 3:53pm with all symptoms resolved. Pt prescribed an epi-pen