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 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 1:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 1:36 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 66.39.  Concomitant products were not provided.  On 02-MAR-2021, Excursion time was 09 AM, 10 AM,11AM,12PM,2PM,3PM temperature was 27, 29,32,33,35.36total doses given for the day was 117, 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 30-MAR-2021, Excursion time was 09 AM temperature was 33 total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 13 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  On 02-MAR-202, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 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 Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pt recvd vax;awoke w/ red marks over stomach,legs & under arm pits;by pm red marks had spread to chest,back,neck & face ; hands & feet swollen;dph & apap;T 100.9;
100.5 temperature; Out of breath when "I" talk; Chills; Aches; Headache; DOSE 1: 29Mar2021/ DOSE 2:15Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic reaction to wasp sting (wasp sting allergy), penicillin allergy and contrast media allergy (Allergy to Gadolinium). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination and did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 08:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 04:30, the patient experienced 100.5 temperature, was out of breath when she talked, chills, aches and headache. On the same day at 04:30, the patient underwent body temperature test and the result was 100.5 (unspecified units).The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 100.5 temperature, out of breath when she talked, chills, aches and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Flat erythema in folds of skin wheezing began turning red all over & then began having trouble breathing; pt taken to ER; rx w/meds;
Vaccine was stored on refrigerator on 22-Sep-2021 and then administered on 01-Dec-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Sep-2021 and then administered on 01-Dec-2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Sep-2021 and then administered on 01-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Sep-2021 and then administered on 01-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. On 22-Sep-2021, the vial was placed in the refrigerator. The vial did not have any temperature excursion and the patient had no adverse event. No Treatment medication reported.
Myalgia lymphadenapathy cervical, selling left arm. Narrative:  Other Relevant History:
10/15 mins post vaccination experienced sudden onset of difficulty breathing followed by heaviness in chest then pain. Pain level fluctuates 2-3-5/10. Pain lasted 30 hours. Medical records state drug reaction, nausea, palpitaiton. msv
12 days after shot itching at injection site.  14 days after at injection site a red raised ring appeared. It is about 4 inches in diameter with itching and hot to the touch with some pain
Information has been received from a physician concerning an 82 year old male patient (180 pounds and 67 inches), who on 14-JUL-2009 was vaccinated with 0.65 ml of a dose of ZOSTAVAX (Merck) intramuscularly. On an unspecified date in July 2009 the patient experienced local severe swelling. Local severe swelling was considered as other important medical event by the physician. No further information is available.
Developed red and swollen R upper arm-immunizations given on 11/6/02. Arm swelling noted yesterday and worse 11/8/02. Arm today with induration 4.5cm around injection site-erythema 5cm above 7cm below 6cm medially and 5cm laterally-warm to touch.
Cardiac arrest five days after administration of the 2nd dose at 9pm, ambulance was called and EMTs attempted resuscitation, but no pulse was detected after 1 hour of compressions and CPR; time of death was recorded at 10:06pm
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administered Moderna vaccine on 19-Jul-2022) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administered Moderna vaccine on 19-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administered Moderna vaccine on 19-Jul-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported.
postherpetic neuralgia; herpes zoster; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The medical history, concurrent conditions and concomitant medications were not provided. On or around 26-JUN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the patient suffered a painful rash on her head from the right parietal area of scalp around the back of the head onto her left occipital region. She was diagnosed with herpes zoster and postherpetic neuralgia. As a direct and proximate result, her symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, she sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for herpes zoster and postherpetic neuralgia was not recovered.   The herpes zoster and postherpetic neuralgia were considered disabling events.
Light headed, fatigue,  numbness on lips - felt like swelling at first then had the numbness
Noticed double vision started 2 days after vaccine was taken. Right Eye would not track with Left Eye and get side by side double vision. Visited Opthamologist 9/7/21 and was first diagnosed on 9/13 diagnosis confirmed with my General Practitioner and second Opthamologist. No treatment available and must just wait until my vison and swelling of 6th cranial nerve subsides. Have MRI scheduled for 9/15 to confirm nothing else as an issue
Chills, nausea, vomiting , diarrhea   Then all day. Very ?deep? sleep. Then extreme dehydration. So to ER for fluids.   Don?t know how to go back. Original start of the event date was 01/14/2021. In am
Vx given without shaking at least 15s; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a 43-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 04-MAY-2023, the patient received the 1st dose of Twinrix. On 04-MAY-2023, an unknown time after receiving Twinrix, the patient experienced inappropriate reconstitution technique (Verbatim: Vx given without shaking at least 15s). The outcome of the inappropriate reconstitution technique was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-MAY-2023 The pharmacist reported that the patient received first dose of Twinrix dose without shaking it vigorously for at least 15 seconds prior to the administration as was indicated on the prescribing information, which led to inappropriate reconstitution technique. The reporter consented to follow up by email.
Soon after taking first dose, i noticed a change in my heart rate. It started beating rapidly and I am feeling sick.
Patient was seen 2 days after DTaP, MMR, and HIB given. The DTaP site was very red the day after, and increased in size and depth of redness 2nd day after. 4cmX4cm indurated purplish area surrounded by 6cmX11cm reddened area. Tender. Keflex given. No systemic fever but site warm to touch.
Extreme Pain, redness, swelling at injection site and up to 6 inches away.  Increasing over next 4 days.  Joint pain, body aches , increasing over next 3 days.  Headache, 4 days.  Asthma symptoms.  Slight fever day 1 -3.  Exhaustion.
Moderna Covid-19 vaccine administered 13 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered 13 hours after first puncture) in a 28-year-old male patient who received mRNA-1273 (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 28-Sep-2021,  after starting mRNA-1273, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered 13 hours after first puncture). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered 13 hours after first puncture) had resolved.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided. Patient had not experienced any adverse reactions after vaccination.
12/19/03: Friday at approximately 7pm, pt exhibited congestion, cough, fever-temperature unknown, and body aches, relieved with children's Motrin for cold, then intermittent relieved by more children's Motrin.  He's improving, but his fever is up and down.  Flu shot given Friday at 15:30.  Still febrile, recovering.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient who was vaccinated with a dose of QUADRACEL (Batch number: C5248AA and expiry date: 21-AUG-2019) via intramuscular route in the right thigh on 24-Jul-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and PREVNAR for Immunisation on an unknown date. It was a case of actual medication error due to drug dose administration interval too long because patient was behind in vaccine series and had no vaccine records. It was reported that QUADRACEL given early, patient had 2.5 weeks until 4 birthday. It was unknown if any adverse event was occurred or not following the vaccination. No reported symptoms or need for treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Within ½ hour I started feeling dizzy and the left side of my jaw started to ache.  I progressively felt worse as the day went on. a few hours after vaccination my upper left arm swelled up at the injection site.  upper left arm pain.  Then started to get headache and nauseated.  Around 10pm I was running a fever of 101.1.  Took Advil and went to bed.  Woke up around 130am sweating profusely, temperature down to 99.4, then had extreme chills and nausea and my whole body was shaking, nothing helped.  By 3am my fever was back up to 101.4, took more Advil and went back to bed.  At 8am the next morning my temperature was back down to 99.1.  checked temperature again around 11am and it was low, down to 96.1.  By mid-afternoon my temperature had finally returned to normal.  The next several days I felt tired and sluggish, dizzy off and on, and arm still hurts at injection site.  I have diabetes and have neuropathy and the neuropathy in my feet has intensified and comes on more frequently.
Patient experienced flushing, tingling, and itchy throat/tongue, rash within minutes of receiving first dose of vaccine.  Administered diphenhydramine 25 mg PO in vaccine clinic and called rapid response. Patient was taken to ED where they noted mild lip swelling. The itchy throat and rash resolved in the interval between vaccination and presentation to the ED. In the ED, she received famotidine IV and steroids. Epinephrine was deferred since patient had no shortness of breath or other respiratory symptoms. She was observed in the ED for 5 hrs and discharged with EpiPen and steroid taper.
Starting on the morning of April 2nd, 2021, injection site located on the left arm was noticeably swollen and red. It is currently still red and swollen around the area and below the area of the injection site, all the way down to the end of my bicep.
Information has been received from a nurse practitioner concerning a patient who in an unspecified year as a child, was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On an unspecified date, the patient underwent mumps titer test that was resulted as negative. It was indicated that no adverse events were related to this event. A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested.
At the injection site. Its been like this for 2-3 days. Very tender, felt some fatigue throughout the day but very mild. Redness.
Booster; severe back and sciatica pain; severe back and sciatica pain; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 32030BD), via an unspecified route of administration on an unspecified date in 2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration as dose 2, single both for covid-19 immunization. On an unspecified date in 2021, a couple days after the vaccine, the patient experienced back and sciatica pain. The patient received steroids as therapeutic measure to relieve the pain. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101578115 same reporter/drug, different patients.
Asthma reaction not reactive to albuterol. Continued to progress, secondary asthma attack at midnight following vaccine. Constant asthma since and exacerbations following each additional dose.
Chronic daily Headache from 2/4-- > 3/20/2021  work up negative for other cause, MRI normal
Pain in the joints, ankle, knee and elbows. The left elbow is the most painful and persistent
Patient is a 77 y.o. female with a history of HTN, osteoporosis, idiopathic gastroparesis who presented to emergency 11/26/2022 for rib pain without a fall or injuries. Found to have multiple acute bilateral rib fractures so she was transferred to ED for trauma evaluation. Urgent Care following since admission for medical management. Hospital course complicated by diagnosis of COVID-19, acute hypoxic respiratory failure and hypotension.   1. Multiple bilateral acute rib fractures started 1 day before admission, after being hugged by a friend. In setting of known osteoporosis . CT chest 11/26/2022 found anterior to anterolateral right 3-7 and left 4-7 rib fractures, grade 2 chest wall injury. Aggressive pulmonary toilet with I-S and vibratory PEEP.  Pain control. PT/OT followed. Trauma followed, f/u OP 12/15 in trauma clinic. 2. COVID-19: Vaccinated. Developed sore throat and test positive 11/29/22. CXR 11/29/22 with minimal bibasilar atelectasis, no consolidations. Initially without cough or sputum production but developed symptoms on 11/30/22 with hypoxia. Completed 6 days of dexamethasone with improvement to room air. Completed isolation. 3. Acute hypoxic respiratory failure: required 2L NC 11/30/22 AM.  Secondary to COVID-19 infection, rib fracture. Resolved 4. Osteoporosis: known h/o, likely directly contributed to fx above. Continued home vitamin D, calcium and Fosamax.  5. Solitary pulmonary nodule: noted incidentally on admit imaging with new 0.5cm cavitary nodule or cystic lesions with smooth wall thickening in RUL consider traumatic vs inflammatory vs neoplastic etiologies. Extensive secondhand smoke exposure. Outpatient follow up imaging per Organization at 1 year. 6. Incidental findings: noted questionable filling defect in CBD with no intra nor extrahepatic biliary lesion. Consider MRCP if were to develop symptoms of biliary colic. Also noted unchanged distal splenic artery aneurysm measuring up to 0.8cm, repeat imaging 1 year recommended per report. 7. HTN: home meds held briefly for hypotension as above. Improved. No med changes on discharge. 8. EtOH dependence: drinks 3 beers/day. Denied any h/o EtOH withdrawal in the past. Discharged on thiamine and folate supplement. Recommended outpatient follow-up.