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 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 10:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced 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). 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.   No concomitant medications were reported. Age of patient was reported as 74.31 for dose administered on 03-Mar-2021 and 74.31 for dose administered on 31-Mar-2021.  Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 degrees Fahrenheit at 9 AM, 34 degrees Fahrenheit at 10 AM and 35 degrees Fahrenheit at 1 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. 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-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
6 year old received Dtap; TDap at 7 year old, now 10 year old 2nd dose not yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included TDap (1st dose received on an unknown date at 7 year old).   On an unknown date, the patient received Boostrix and the 2nd dose of Tdap Vaccine. On an unknown date, an unknown time after receiving Boostrix and not applicable after receiving Tdap Vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: 6 year old received Dtap) and incomplete course of vaccination (Verbatim: TDap at 7 year old, now 10 year old 2nd dose not yet). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The healthcare professional reported that for a patient on a catch up schedule, given a Dtap at 6 years old, and then TDap at 7 years old.  The reporter wanted to verify TDap is appropriate to give again at the age recommended at 10 years old however centers for disease control catch up schedule states 7 year old can get TDap. The patient received a dose of Boostrix at an inappropriate age, which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive 2nd dose of TDap, which led to incomplete course of vaccination.
Patient who is allergic to sulfur received flu vaccine on 9/05/2012.  Patient states that at 10:30 PM sneezing, awoke at 3:30 AM with horrible headache at the top of head. Felt pressure, spasm like pain.  Patient took Claritin at 5:00 AM. Went back to sleep, got up at 10:30 AM still had a headache. Took a Bentyl. Had diarrhea  X 1 at 2:00 PM (odor of sulfur).
Pt complained dizziness, headache, double vision 1 day after receiving MMR and Td. Pt was seen in ER and MRI was done. Pt was seen by neurology and was treated for migraine. Not related to immunizations.
About an hour after patient was checked out, she was waiting in the front waiting room, when she reported her throat feeling swollen and numb.  Especially on the left side, and she was brought into the room, and I was asked to reexamine the patient.  She reported that it was just her throat, did not have any breathing troubles, or tongue or lip swelling.  Her mask was taken out, and was carefully examined multiple times, she did not have any swelling, nor any hives.  Her blood pressure was stable, pulse ox was normal, heart rate was slightly elevated at 108.
Patient brought into clinic on 04/05/13 with complaints of red, itchy, rash on both arms at site where vaccines were given. No treatments necessary, home care was advised.
Itchy; Rash at the site; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash at the site) and VACCINATION SITE ERYTHEMA (Red) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash at the site) and VACCINATION SITE ERYTHEMA (Red). The patient was treated with PETROLATUM (CERAVE HEALING OINTMENT) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash at the site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.
Patient was 3-4 weeks pregnant, but unaware of her pregnancy at time of vaccination.
Pt developed symptoms on 9/17/21 and tested positive for COVID 19 as did her husband on 9/20/21.  Patient presented to the ED on 9/25 with continued symptoms and wished to have evaluation and treatment.
Horrible shooting/stabbing pains at the base of my esophagus/rib cage. Constant stOmach cramps and nausea. Almost like heartburn or acid reflux but not quite. Back pain from the middle of my back and up. Drowsiness, headaches. Sore muscles. All of this started either in the day after or two days after, it's hard to remember.
Woke up middle of the night with severe pain in left shoulder radiating down to hand. Developed redness of entire bicep/deltoid area of left arm. Hot to touch.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 7 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 7 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
020910- E.R. visit - Begin to have aching @ site 1930 - 2000 hours - Followed by erythema/edema entire L upper arm into axilla ET L scapular area - DX : Local-reaction to vaccine - Given BENADRYL 50mg PO in ER -Instructed to take QID x 3 day -ice to site Q3-4H PRN, TYLENOL. 021010 - DR. office visit - LT- upper arm still painful, edematous with erythema entire length ET circumference - T- 100.4 degrees F (T=97.1 degrees F on 020910)---Given Prednisone burst/taper.
I only know these facts. Per school nurse, pt. received Menactra (date and place are unknown), developed Guillain - Barre` syndrome.  Was treated at hospital and is now home Per 60 day follow up report-Although patient was 'cleared' by the doctor to resume wrestling, he has not been able to since he still notes tingling in his hands and feels fatigue when attempting to condition. Thus, he has not resumed sports.  Student has graduated and is no longer at high school.  Therefore, no furhter contact with student is maintained.
Severe hives reaction starting in left arm (shingrix, heplisav site) and then spreading to entire abdomen, torso, trunk.  Required visit to ED to receive prednisone, antihistamines and monitoring.  Pt did not report and other symptom and was discharged without any other incidents.  Will finish steroid course and antihistamines at home.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; however, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Itchy rash that started on my arms (left arm was worse than right arm.  Spread down arms, with a few patches on  my back, and starting at the top of my legs.
Patient pretreated with diphenhydramine. Patient expressed nausea and abdominal cramping along with need to vomit.  Cramping and nausea subsided by 09:29am.  Patient treated with diphenhydramine 25mg/10ml cup.  Patient ate package of graham crackers to subside nausea.  Expressed metallic taste in mouth.  Patient notes GI side effects have subsided but now has headache at 9:33am- pain at a  5 on a scale of 1-10 with 10 being worst.   Patient monitored until 9:46am with no other noted effects.  Patient provided 4x10ml diphenhydramine cups (25mg/10ml, NDC 68084-0024-59, Lot 502935, EXP 02/28/22)upon discharge from clinic
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced FATIGUE (Tired). In August 2021, FATIGUE (Tired) had resolved.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-024870, MOD-2022-455203 (Patient Link).
Moderate Sore Arm; Fatigue; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2021 17:00 (Lot number: EN6198) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Environmental allergy" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PRISTIQ; LOSARTAN; BUSPAR; ALPRAZOLAM; TRAZODONE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "Moderate Sore Arm"; FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "Fatigue"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "Chills". Therapeutic measures were taken as a result of pain in extremity, fatigue, chills.  Additional information: A 56-year-old non-pregnant female patient received first dose via an unspecified route of administration. This is the first of the two case reports. Concomitant medications included BUSPAR, trazodone (MANUFACTURER UNKNOWN), alprazolam (MANUFACTURER UNKNOWN), PRISTIQ and losartan, (MANUFACTURER UNKNOWN) were received for unknown indications from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Feb2021, the patient experienced moderate sore arm, fatigue lasted for about 36 hours and chills for about 12 hours. The patient called nurse and was advised to apply ice and take ibuprofen. The clinical outcome of pain in arm was unknown while that of fatigue and chills were recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
patient with rash that developed 10+ hours after vaccination with Hep A, Hib-PRP-OMP, and PCV13 while ill with presumed viral URI. Description of rash and pictures provided appear to be purpura, non-urticarial, and non-life-threatening. Mother reports rash was not responsive to Tylenol, Decadron, Benadryl, Orapred, or Claritin. This is not consistent with an IgE-mediated reaction due to vaccination. Rather, rash may be related to an alternative immune-mediated process most likely associated with his concurrent illness, and less likely but possibly associated with vaccination.   Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Tested positive for Covid-19 on 7/22/2021.  Admitted with difficulty breathing, SOB, and hypoxic
USING EXTRA DOSE OUT OF VIALS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date and vaccination site were not reported for prophylactic vaccination. The batch number and expiry date were not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced using extra dose out of vials. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of using extra dose out of vials was not reported. This report was non-serious.
My arm was sore and swollen after the vaccine. I ended up with a really sore throat two days after the vaccine I couldn't swallow or eat anything. I went to the doctor, she said I had lesions in my throat and prescribed magic mouth wash ( LID/MAAL/BENAD ). I also now have COVID-19.
PATIENT RECEIVED JANSSEN VACCINE ALTHOUGH, HE IS UNDER THE APPROVED AGE
Person completed their vaccination series by getting the Janssen COVID-19 vaccine in March.  Was then vaccinated Pfizer, completed the Pfizer series.
Received only the adjuvant; Received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA729A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comment: The reporter was clinical supervisor.  The reporter reported, one of their patient received only the adjuvant, instead of the reconstituted vaccine.  The reporter reported not being certain of whether this patient was the one who received only the adjuvant, as they had narrowed it down to two possible patients. The reporter consented to follow up.  Additional Supportive Information: The reporter reported, one of their patient received only the adjuvant, instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022184441:Same reporter
Given MMR immunization (L) upper arm SQ 3-9-11. Developed "lump" in area w/in 2-3 days. Two weeks later area became more erythematous with pain/itching developing over the next week. Was seen in occupational health 3-31-11 and diagnosed with delayed hypersensitivity reaction localized. Treated with cold packs & topical hydrocortisone cream.
Large red blisters at admin site 3 days after admin. Worsened to day 7. Patient had to go to Md for prednisone and VALTREX rx. Day 7 still unresolved.
This spontaneous report as received from a consumer refers to a 37 year old female patient. On 20-OCT-2014 the patient was vaccinated with GARDASIL, subdermal. The outcome of the patient currently 37 years old and received her first dose of GARDASIL which was given subdermal is unknown. Additional information has been requested.
Patient hospitalized for lumbar stenosis with neurogenic claudication within 6 weeks of receiving covid vaccination.
BLOOD CLOT IN LEG; This spontaneous report received from a consumer concerned a 73 year old female unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13- MAY-2021, the patient was taken to the emergency room (ER). On 14-MAY-2021, she was hospitalized with a clot/clots in her leg(s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210551429 - Covid-19 vaccine ad26.cov2.s-Blood clots in leg. This case concerns with 73 years old female. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Lightheadedness, numbness across face, sweating without fever, general malaise. Complained of excessive alcohol effects after 1 glass of wine. Constant headache. None of the effects relieved by OTC meds.
Patient received Janssen COVID vaccine on 7/20/21 and he has been living  in a congregate setting. On 11/2/21, patient admitted to our facility (med/surg unit) for acute hypoxemic respiratory failure due to COVID19 pneumonia (tested positive the day before). On 11/4/21, patient transferred to CCU for intubation. As of today (11/5), patient is still in CCU intubated.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-JUL-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 09-FEB-2018 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient saw down in the chair and was very nervous to get vaccinated. Father was present. Vaccine was given and nurse had patient stay in the chair for a few minutes. School cafeteria where the clinic was held was very hot; did not have air condition but fans were blowing. Cold water was given to patient. After approx 3 minutes patient stated she was feeling better and wanted to go to the waiting area. Nurse walked patient to seating area and on the way she stated she was going to vomit and then she dropped slowly to the floor and asked to lay down. Cold compress and ice pack provided. Patient never lost consciousness. EMS was called due to both siblings incident/ After approx 10 minutes school principal came with wheelchair and patient was moved to nurse office that had air conditioning. EMS checked patient and cleared to go home. Patient walked out with father and 2 siblings. Father and patient stated that she passed out after flu shot last fall as well.