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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 10:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 10:29 AM, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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 57.48 years. Concomitant products were not provided. On 02-Mar-2021, Excursion time was 09 AM,10 AM,11 AM,12 PM, 2PM and 3PM temperature was 27,29,32,33,35 and 36, total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 02-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 PM: 33, 1PM: 36, 2 PM: 35, 3 PM: 36, 4 PM: 37 and 5 PM: 37. 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 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.
According to patient:  Approximately 24 hours after receiving the first dose of the Moderna COVID vaccine this patient reported difficulty breathing, swelling of the wrists, ankles and tongue.  She was treated at the ED for anaphylactic adverse reaction with good effect.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: PATIENT CONTACTED PHARMACY 03/19/2021 AT 11:05 AM TO DESCRIBE HER SYMPTOMS, SHE STATES THE SYMPTOMS ARE NOT MODERATE, BUT WOULD LIKE TO REPORT THE ADR. PHARMACIST ADVISED PATIENT TO TAKE BENADRYL AND ICE THE AREA TO DECREASE REDNESS AND ITCHINESS.
Patient had diffuse swelling/erythema of right upper extremity (shoulder to elbow) with blistering 1-2 inches distal to infection site. This was noted the morning after vaccination. Progressed to tense edema of entire upper arm extending onto shoulder.  Pain difficult to assess as patient has hemiparesis.  Onset was quick and resolved within 48-72hrs. 3/16/06 Received D/C Summary from JHH which revealed patient experienced cellulitis w/arm swelling/pain/erythema.  Hx of severe congenital neutropenia./ss
15 mins p/inject c/o pain @ inject site, weakness, n/v, diaphoresis, BP initially 94-80-76 w/HR 80, IV fluids begun; pt sent to ER: no wheezing/rash;
When I woke up on 02/15/2021 I went to the bathroom I had again the burning sensation when urinating and also I could smell a foul odor. I went to my doctor's office again on 02/19/2021 and was diagnosed with an UTI again just like the 1st dose.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 11-JUL-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Local reaction; This case was reported by a nurse via sales rep and described the occurrence of local reaction in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown.   It was unknown if the reporter considered the local reaction to be related to Kinrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced local reaction after receiving Kinrix. The reporter consented to follow up This case has been linked with US2020AMR030159, reported by same reporter.
Patient was scheduled for second dose.  patient was given pfizer vaccine and after was discovered patient had the J&J.
This spontaneous report was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with doses of ROTATEQ oral, lot # L025598, expiration date on 13-JAN-2017 and lot #: L035508, expiration date on 12-MAY-2017 (dose and anatomical location were not reported); which were improperly stored as underwent a temperature of 30.7F during 20 hours. Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
arthralgia, brachial plexus neuropathy, muscle pain, fever and chills
Pt administered Pfizer COVID-19 vaccine 0.3mL, IM, Right Deltoid. Pt had Hx of Anaphylaxis to Coumadin, 30 minute wait period recommended after vaccination. Appx 15 minutes after vaccination, Pt states they were experiencing "hot/flushed feeling", "rapid heartbeat", "general weakness". No prior reactions to vaccines. Vital signs taken at 0949, B/P-178/114 Left Arm, seated position, Pulse-102, SPO2 on Room Air-99%, Temp-98.5 degrees F. Pt moved to supine position, given ice pack and water. Dr. contacted to evaluate Pt. Pt taking 30mg Adderall, last taken 0600. Hx of blood clot in 2013, and 2 cesarean section births. Last oral intake 0800, "normal breakfast". Vital signs repeated at 0954, supine position, B/P-154/105 Left Arm, Pulse-91, SPO2 on Room Air-98%. Pt transferred to observation room vial wheelchair, Pt care transferred to Dr.
Initial physician report received on 15 Sep 2010: This patient was vaccinated with only the Men A lyophilized conjugate component of MENVEO (batch number not reported) that was reconstituted with a sterile diluent. The patient did not receive the MenCWY-135 liquid conjugate component of MENVEO.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Jul2021 12:30 (Lot number: ER8729) at the age of 67 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Graves Disease both with Antibodies", start date: 2008 (ongoing); "APS Syndrome", start date: 2006 (ongoing); "Osteoarthritis all joints/ Neck", start date: 2009 (ongoing); "Degenerative spine - Thoracic", start date: 2000 (ongoing); "Osteopenia", start date: 2016 (ongoing); "Invasive Breast cancer", start date: 13Oct2013 (ongoing); "Lumpectomy", start date: 13Oct2013, stop date: Apr2020; "2nd surgery lymph nodes removed", start date: 26Oct2013 (ongoing); "APS" (ongoing); "HP" (ongoing); "DVT" (ongoing); "PE" (ongoing); "Inflammatory" (ongoing); "Osteo/ Degenerative arthritis" (ongoing); "Fibromyalgia" (ongoing). Family history included: "Cancer/ Bone/ Breast" (unspecified if ongoing); "Parkinson's" (unspecified if ongoing); "RHA" (unspecified if ongoing). Concomitant medication(s) included: XARELTO taken for antiphospholipid syndrome, hypersensitivity pneumonitis, deep vein thrombosis, pulmonary embolism (ongoing); IBUPROFEN taken for inflammation (ongoing); TRAMADOL taken for inflammation (ongoing); GABAPENTIN taken for osteoarthritis, spinal osteoarthritis (ongoing); TIZANIDINE taken for osteoarthritis, spinal osteoarthritis (ongoing); VIT. D3 taken for fibromyalgia (ongoing); TYLENOL taken for fibromyalgia (ongoing); BENADRYL taken for fibromyalgia (ongoing). The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 26Jul2021 14:00, outcome "recovered" (2021), described as "Rt Arm Red inj. site". Therapeutic measures were taken as a result of vaccination site erythema. Additional information: Vaccine was not administered at military facility. The patient was not administered with prior vaccinations. The patient stated that the listed conditions for arthritis etc., are ongoing several years the side effects were seriously painful then what she usually experience often. So, she would recommend physicians to review with patients to expect SE with Auto immune conditions as she was listed with meds on hand. As she doubled upon dosages and time. Cool compress in safe. The reporter considered "rt arm red inj. site" not related to bnt162b2. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the close temporal association the possibility of causal association between the event vaccination site erythema and the suspect drug BNT162B2 cannot be ruled out.
sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient used to work in the medical field and they required for all employees to get the flu shot. Every time the patient got the vaccine, the patient got sick. The patient had not gotten the flu shot in three years and had not exerienced the flu.
I was feeling really cold and was having chills then was so tired that I just laid down on the floor. My nose started running and also got stuffed up. I then started having a fever and then having a sore throat, with pressure in my ears. Thursday, I woke up and I could not breath and this brought on a panic attack, and I went into the clinic and there they tested me for Strep and COVID-19 and I was positive for COVID-19. They gave me an inhaler and put me on Paxlovid as well. I did have the weird metal taste taking the Paxlovid, bad diarrhea and my stomach hurt, on Saturday I was not able to walk. It was like my legs did not work and I had to learn how to walk again, and my symptoms had not improved, and I went back to the clinic and learned this was common with the Paxlovid.  I have tested negative, but I am still tired and fatigued,
Pt received vaccine 12-11-16. 12-19-16 - red, swollen, no pain.
SORENESS; FEVER; SWELLING AT INJECTION SITE; FATIGUE; CHILLS; NAUSEA; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (SORENESS), PYREXIA (FEVER), VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE), FATIGUE (FATIGUE) and CHILLS (CHILLS) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced NAUSEA (NAUSEA). On an unknown date, the patient experienced PAIN (SORENESS), PYREXIA (FEVER), VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE), FATIGUE (FATIGUE) and CHILLS (CHILLS). At the time of the report, PAIN (SORENESS), PYREXIA (FEVER), VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE), FATIGUE (FATIGUE), CHILLS (CHILLS) and NAUSEA (NAUSEA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Persistent pain in upper left arm at sight of injections.  Increased pain when moving the arm.   Several months later and the pain has not subsided at all.  Nothing works to relieve the pain - heat, ice, Tylenol or Advil are all unsuccessful in alleviating the pain.
Swelling in the left armpit large and painful enough on the second night to wake me up  Minor body aches
My fingers became stiff and really hurt about an hour after I got my vaccine. Also, my neck hurt, but my my biggest complaint is my fingers. My neck stopped hurting about a week later, by my fingers are still the same, and it is 12/22/21. My fingers hurt to pick anything up, type, or write.  It almost feels as if I have arthritis now.
Rash in vaccine site, began as small itchy red spot on 1/26/21; expanded threefold in 24 hours. No treatment at this point aside from taking a couple of Tylenol at bedtime each night. Watching to see if anything else happens.
Diagnosed covid the day I was suppose to get second dose 23Aug2021; Diagnosed covid the day I was suppose to get second dose 23Aug2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single and administration date 01Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "CHF" (unspecified if ongoing); "PAH" (unspecified if ongoing); "DM2" (unspecified if ongoing); "CKD stage 3" (unspecified if ongoing); "non - smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Aug2021, outcome "unknown" and all described as "Diagnosed covid the day I was suppose to get second dose 23Aug2021". The patient underwent the following laboratory tests and procedures: antibody test: (unspecified date) got monoclonial antibiodies; sars-cov-2 test: (23Aug2021) diagnosed covid; (03Feb2022) diagnosed covid. Therapeutic measures were taken as a result of covid-19.  Clinical course: She got her first dose in Jun2021. Diagnosed covid the day she was suppose to get second dose 23Aug2021. Got monoclonial antibiodies. Received 2nd dose 01Dec2021. Diagnosed covid again 03Feb2022. Had CHF, PAH, DM2, CKD stage 3. 62 year old non - smoker, female. Maybe info could help with studies. Could not get booster until Jun2022. She was a retired nurse and keep a mask on in, public and wash her hands, most of the time she wear gloves. Follow safety protocols.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events  "Drug ineffective" and "Covid-19" and the administration of the vaccine cannot be excluded
Seizure, loss of consciousness, fever of 99 degrees for one week, rash from head to toe, watery/red eyes, not eating, not drinking, runny nose, after a week fever of 104 for 5 days, seizure (followed by brief hospitalization) eczema on hands, feet and elbows (he has never had eczema or dry skin prior).
Was given tetanus/pertussis vaccine for possible employment. Immediately swelled and hurt. Continued pain for weeks with swelling and could see the injection site. Now have pain in the muscle that was injected and can't lift over shoulder height.
my daughter had the Pfizer vaccine and didn't have any problems with the first dose but was kind of out of it and felt back the next day but it wasn't too bad.; This is a spontaneous report from non-contactable consumer (Patient's mother). This Non-contactable consumer reported for her daughter (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient didn't have any problems with the first dose but was kind of out of it and felt back the next day, but it wasn't too bad. The outcome of the event was reported as unknown.  No follow-up attempts are Possible. No Further information is expected.
Pt reports she "passed out" after vaccines admin. Skin cool and pale. Lethargic, c/o nausea, c/o HA. Per Dr. - no injury. Monitored in office and dc'd to father at 1035.
Information has been received from a nurse concerning a 16 month old male who on 17-JUN-2009 was subcutaneously vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot #663541/0335Y).  Concomitant vaccination included DTAP (unspecified) and IPV (unspecified) given on the same day.  On approximately 17-JUN-2009 ("within a day or 2 of the injection") the patient developed redness and warmth at the injection site.  Subsequently, the patient recovered on an unspecified date.  The patient sought unspecified medical attention.  This is one of several reports from the same source.  Additional information has been requested.
pain at injection site swollen & tender lymph nodes in underarm where injection given shortness of breath extremely weak & tired
Narrative: On 02/19/21, patient received first dose of COVID-19 immunization  at the hospital. At the 05/28/21 primary care appointment, the patient reported  that they had an episode of Bell's Palsy temporally related to getting said vaccine  and inquired about receiving the second dose in the series. ID was consulted to  assist in answering the question. ID responded that Per CDC: Cases of Bell's  palsy were reported following vaccination of participants in the COVID-19  vaccine clinical trials. Available data were insufficient for FDA to conclude that  these cases were causally related to vaccination. Post-authorization safety  surveillance will be important to further assess any possible causal association. In  the absence of such evidence, people with a history of Bell's palsy may receive  any FDA-authorized COVID- 19 vaccine. Any occurrence of Bell's palsy  following COVID- 19 vaccination should be reported to VAERS. This has now  been entered into VAERS. Patient presented to the hospital ED on 03/21/21 and  received methylpred IV, Toradol IV and discharged on Medrol dose pak and  valacyclovir.
UrticariaPruritus, lymphadenopathy axillary 1/21, redness at injection site with itching 1/19/21 - lost time from work Narrative: advised to use benadryl by PCP - less axillary soreness 1/22 and less redness and itching- lost time from work
Morning after vaccine red area around injection site approximately 3 inches in diameter, swollen, hot, hard mass. Fever, sleepiness, irritability, loss of appetite, pain in leg. Saw Dr at pediatric urgent care Sunday 11/4/2012 received antibiotics for possible infection. Unable to say for sure if it is an infection or vaccine reaction. Told to follow up with Dr this wed 11/7/2012.
paralyzed totally; pneumonia; gbs; Initial information was received on 25-Dec-2022 (processed as a non-case) and follow up information regarding this unsolicited valid social media serious case received from a consumer/non-hcp on same day.  This case involves male patient who experienced paralyzed totally, pneumonia and GBS  (guillain-barre syndrome) after receiving influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic Vaccination (Immunisation).   On an unknown date patient got GBS (guillain-barre syndrome) from flu shot which left him paralyzed totally(paralysis) for 10 months. He would get better - boom pneumonia (onset and latency: unknown). On and on for 10 months. He finally took himself off of life support. There are many lawsuits now. Searched Guillian Barre Syndrome related to the flu shot. COVID shot is having the same effect.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for all the events.  Seriousness criteria: Medically Significant for all events.; Sender's Comments: Sanofi company comment dated 28-Dec-2022: This case involves male patient who experienced paralyzed totally, pneumonia and GBS  (guillain-barre syndrome) after receiving influenza vaccine. Additional information regarding condition at the time of vaccination, concomitant medication, medical history would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
78-year-old man with past medical history of hypothyroidism, dementia, and mood disorder who came to the emergency department with altered mental status, decreased appetite, and acute kidney injury.  Given fluid hydration, procalcitonin was positive, renal function improved with IV fluids, started on ceftriaxone and azithromycin for diagnosis of community-acquired pneumonia, remains on room air.  He was COVID-positive but he did not have COVID-19 pneumonia, therefore after discussion with ID he did not require remdesivir or Paxlovid.  Hemoglobin baseline is probably between 1011.  It was 12.2 upon admission but probably hemoconcentrated.  No signs of gastroenterologic bleeding.  Discharged home with daughter in stable condition.  Discharged with Augmentin to complete total of 5 days for CAP
No adverse event, but patient was given expired vaccine from the BUD, by 3.5 hours. PFizer was contacted and the ended stability per Pfizer allowed for an additional day, which makes the vaccine ok per the excursion