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 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 1:33 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:33 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient age was reported as 78.23 years.  It was reported that unknown number of patients were 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 time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 27-Oct-2021, At excursion time 09:00 AM, temperature was 29, at 10AM temperature was 32, total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccines were moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 2 and 4 vials were moved to clinic 29-Sep-2021 and 05-Oct-2021 respectively. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by 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.  No treatment information was provided.
Mother stated injection site was okay after appointment, two hours later the injection site formed a hard bump and took two weeks to go away.
Narrative: COVID infection following COVID vaccine series 03/18, Pfizer, dose #1 04/09, Pfizer # 2 08/26 COVID swab, result: not detected 10/21 LACTIC ACID: 1.01 10/21 COVID swab, result: detected 11/15 COVID swab, result: detected 11/15 pt cc: cough, fatigue, exposure: unknown 11/15 CTA PE impression: No pulmonary embolus to the subsegmental level. Equivocal central bronchial wall thickening which could reflect ongoing or resolving bronchitis. No definite pneumonia or pleural effusion. Equivocal findings of cirrhosis within the visible liver. If not already established, recommend outpatient HEPATOLOGY consultation for further investigation and risk stratification. 11/15 DDIMER: 0.81 11/15 ESR: 71 11/15 PROCALCITONIN: <0.05 11/15 HUMAN RHINOVIRUS: DETECTED
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Feb2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 03Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 26May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Anti viral product, Paxlovid, treatment start date: 06Jun2022 and treatment stop date: 11Jun2022. Indication: Treatment of COVID-19. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I ADMINISTERED PEDIATRIC VACCINE WHEN SHE SHOULD HAVE RECEIVED 12 AND OLDER VACCINE.    DISCUSSED WITH PATIENT.   WE WILL GIVE ADULT VACCINE NEXT VISIT
Redness and irritation around the injection site, feels warm to the touch, is sore and aches a little bit.
pain in neck; body aches; nausea; chills; drugged feeling; fever; redness around injection site; pain in hands; itching in hands; redness in hands; burning in hands; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included alpha-gal allergy. Concomitant products included montelukast sodium (Singulair), famotidine (Pepcid Ac) and fexofenadine hydrochloride (Allegra).   On 13th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2020, 1 days after receiving Shingrix, the patient experienced neck pain, general body pain, nausea, chills, feeling abnormal, fever, injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of. On 15th August 2020, the outcome of the fever was recovered/resolved. On 16th August 2020, the outcome of the neck pain, general body pain, nausea, chills and feeling abnormal were recovered/resolved. On an unknown date, the outcome of the injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, general body pain, nausea, chills, feeling abnormal, fever, injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on right arm.  The patient reported that on next day, had chills, nausea, body aches, pain in neck, and a drugged feeling that lasted until Sunday. The patient also experienced fever that resolved on 15th August 2020. The patient received Benadryl (NOS). The patient also developed redness around the injection site, burning in hands, redness in hands, itching in hands, and pain in hands and these are all still ongoing currently.  The reporter consented to follow up.
stuffy head; couldn't breathe through his nose; lost sense of taste and smell; lost sense of taste and smell; diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (stuffy head), DYSPNOEA (couldn't breathe through his nose), AGEUSIA (lost sense of taste and smell), ANOSMIA (lost sense of taste and smell) and COVID-19 (diagnosed with COVID) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CARVEDILOL, AMLODIPINE, OMEPRAZOLE, VITAMIN D NOS, FERRIC CITRATE (AURYXIA), SEVELAMER CARBONATE and Sensitar for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEAD DISCOMFORT (stuffy head), DYSPNOEA (couldn't breathe through his nose), AGEUSIA (lost sense of taste and smell), ANOSMIA (lost sense of taste and smell) and COVID-19 (diagnosed with COVID). On 02-Feb-2021, AGEUSIA (lost sense of taste and smell) and ANOSMIA (lost sense of taste and smell) had resolved. At the time of the report, HEAD DISCOMFORT (stuffy head), DYSPNOEA (couldn't breathe through his nose) and COVID-19 (diagnosed with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included guaifenesin.
Pain in right shoulder radiating to right hand. Continues to be painful and now I am having an MRI and treatment by an orthopedic surgeon.
States she had vomiting, dizziness, and a temp of 98.9 for 1 hr. on 10/16/08
DIZZINESS; OTHER SYMPTOMS; TINNITUS; DAILY HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, other symptoms, tinnitus and daily headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tinnitus, daily headaches, dizziness and other symptoms was not reported. This report was non-serious.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, chills, dizziness and nausea. On an unknown date, the outcome of the injection site pain, fever, chills, dizziness and nausea were unknown. It was unknown if the reporter considered the injection site pain, fever, chills, dizziness and nausea to be related to SHINGRIX. Additional details were reported as follows: This case was reported by an Office Manager. The age at vaccination was not reported. The patient experienced pain at the injection site, followed by fever, chills, dizziness and nausea that evening. The reporter agreed to be followed up.
Fever, chills, severe headache, vomiting, diarrhea for 2 days
Swelling and redness in the injection area. Arm was hurting all the way to wrist. Injection area felt warm.
Patient came in for second dose of Pfizer vaccine. During assessment patient verbalized having allergies to Sulfa, Penicillin and Ceftriaxone cause itching and hives. Patient also mentioned allergies to Taro which cause swelling of throat. Do to allergies patient was recommended to be monitored for 30 minutes which patient verbalized understanding.  Vaccine given by another nurse at 1438 to left deltoid. At 1510, patient notified LVN who was monitoring patients that she was feeling tightness to her chest and difficulty breathing. Patient was moved into room 8C for close monitoring and vital signs were taken. At 1511 first sets of V/S noted as following 121/79 HR 70 ,O2 Sat 100%, RR 24  MD notified at 1513 by Nurse. During close monitoring patient denied any itching, tightening of the throat but light coughing, patient denies smoking. Patient was alert, awake, oriented  X4 .  Patient stated that after first dose of vaccine she was having N/V. Patient stated had similar but milder symptoms a few hours after the first covid19 vaccination   As stated by patient she took a puff of her inhaler before getting the second dose of the vaccine, and took a second puff of her inhaler (Medication noted Albuterol Sulfate HFA 90mcg/ actuation inhaler) as soon as she sat down into the monitoring room.  Patient stated that she had never been diagnosed with Asthma. 1522 second set of V/S noted as BP 111/73, HR 69, O2 Sat 100%. At 1525 MD recommended Benadryl, and MD explained side effects of medication. Patient refused because she wanted to have the ability to drive. During the monitoring, patient disclosed already feeling anxious upon arrival to clinic. At 1531 MD told patient that he was observing that she was having more labored breathing, therefore patient was recommended to take the Benadryl and patient agreed. At 1532, crash cart was opened  and Benadryl was removed to give to patient. At 1533 Benadryl 25mg 1 Cap given PO to patient. 1535, V/S were taken again noted as follows BP 128/78, HR 66, O2 Sat 100%. Patient was monitored continuity. Patient stated that she felt better. Patient was offered to call family member to pick her up, but patient declined and stated she would be okay to drive. 1550 V/S noted as following BP 113/72, HR 66, O2 Sat 100%, RR 20. Patient was asked to stand, Denied any dizziness or feeling sleepy. Patient left from clinic at 1554.
had 2 doses of COVID vaccine > 4 weeks prior to a PCR test and had a positive PCR test via nasopharyngeal swab on 3.4.21.  Experiencing congestion/mild symptoms
Loss of appetite; I had fever and chills which lasted three days; headache a couple days; itching started and hasn't stopped - arms, back, body - it comes and goes away - there is one or to places there's a little red but that's from my scratching but otherwise don't see anything; Feeling more fatigued. Loss of appetite   - these lasted for at least a month; shortness of breath issues - continued for three or four weeks before it got to be a real struggle. I was going two or three steps and was having real bad shortness of breath. My son said it was called exertion something. ER - CAT scan- multiple blood clots on lungs - 4 of my 5 lobes were not functioning at the time - Bilateral Massive Pulmonary Thrombolism  - I got there just in time. They sent me to Catheter lab - two catheters with Antivase and multiple bags of Heparin and other blood thinner with three day stay. Eliquis - prescriptions - 5 mg - twice a day for 6 months minimum and maybe for the rest of my life. They put me on oxygen on three days  - 40's and 50's when I got to the hospital but within a day on oxygen it was back up to 90's. Kidney= Creatine levels were high when I got there but close to normal at release. Blood glucose levels were normal. Blood pressure was 120/80 when I left - laying down. When active it was 130 something over. They put me in Surgical ICQ and then they needed the bed and sent me home to rest. Six foot distance between me and the refrigerator - I do have my appetite back now 1200 calories a day in my diet. I am doing some light walking. Minimized stair climbing but I'm in a three story house so have to do it. Doing light construction work for my son so I'm banging nails. Not any running right now. Telephone follow with doctor - I don't have a primary because I hadn't seen a doctor for 35 years.
Information has been received from a physician concerning a 14 month old patient who on 02-MAR-2009 was vaccinated with a dose of VARIVAX (dose, route and lot number not provided). Ten days after vaccination on 12-MAR-2009, the patient experienced "a local reaction that looks like zoster". The physician stated there was "two centimeter raised area with brown crusts." The patient had not recovered from the event at the time of the report. The patient sought medical attention by contacting the physician. Additional information has been requested.
Pt received combination vaccine of DTAP, HEPB, & POLIO on 4/24/09.  Pt. had no fever or s/s of any illness @ time of vaccination.  Pt. returned to clinic on 4/27/09 with localized reaction of redness with minimal warmth to right deltoid.  Rx. was given for PEDIAPRED, ZYRTEC, AMOXIL @ this visit.  Returned to clinic with red, raised rash to entire body. on 5/4/09.
Patient suffered a subarachnoid hemorrhage (Hunt & Hess 5) on the evening of April 26 or the morning of April 27 that, after 3 cerebral angiograms, doctors have not been able to determine the cause of.  His son found him unconscious the afternoon of the 27th.  He spent 2.5 weeks in the ICU, 1 week in the step down unit, and 2.5 weeks in the rehab hospital.  He recently completed 18 weeks of outpatient therapy.  His recovery has been remarkable but he still has some short term memory issues.    I don?t know if the vaccine and subarachnoid hemorrhage are related but I?ve been seeking advice as to whether patient should get a booster and was told to make sure a VAERS report was filed.  It?s possible this is a duplicate since I?ve asked 2 doctors and the facility if a report was filed and have not gotten a definitive answer.
My left arm was sore for 3 days and my stomach was sore for one week.
Following vaccine administration, pt claimed to feel a little "dizzy." had him lie down on the floor. he refused a yoga mat. mother requested to put some paper towel that was wet to cool his forhead. patient was very communicative and cognizant the entire time. had his feet elevated. observed him for 20 minutes. Checked pulse and it  was 75. After sitting for approximately 15 minutes, he was able to sit up without problem. He was not dizzy and I observed  no restriction in movement to indicate hypotension.  While laying down he stated the inside of his mouth felt tingly which happens when he is nervous. At about the 15m mark, patient was able to drink fluids (mother purchased a drink from cafe) and felt immediately better.     Prior to administration, hestated that he has never had a vaccine reaction. He did state following injection that he felt the needle. He tensed his arm muscle as I was about to vaccinate. He said he felt the needle which made him feel a little nervous. I asked to observe him for another 15 minutes, but mother wanted to take him home. Offered to get him a scooter, but patient and mother refused. Techincian offered to walk him to the door to make sure he was safe and had no issues walking while mother brought car around. He was under constant observation.
This spontaneous report as received from a nurse practitioner refers to a male patient in his 60. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unknown date the patient developed a case of shingles after having ZOSTAVAX administered. The outcome of shingles was unknown. The patient saw a physician for medical attention. Additional information is not expected.
I developed fever of 102 degrees; extreme chills; intense muscle aches; diarrhea; fatigue; This is a spontaneous report from a contactable consumer (mother of the patient) or other non hcp. This consumer reported similar events for 2 patients. This report is for 2nd of 2 patients.   A 23-year-old male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in arm right on 14Apr2021 10:15 (at the age of 23 years) as dose 2, single for COVID-19 immunization. Patient medical history was reported as none. The patient had no known drug allergies. The patient did not receive other vaccine in four weeks. The patient's concomitant medications were not reported. On 14Apr2021 at 10:15, the patient experienced developed fever of 102 degrees, extreme chills, intense muscle aches, diarrhea, and fatigue that lasted 48 hours. The reporter added her 23-year-old son also suffered similar side effects and was forced to take a sick day from his job. Adverse events did not result in emergency room visit or physician office visit. Patient did not receive any treatment in response to the Adverse events. The patient underwent lab tests and procedures which included body temperature: 102 degrees on 14Apr2021 at 10:15 (she developed fever of 102 degrees). Outcome of the events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : 2021422101 same drug/reporter/event, different patient
suspected vaccination failure; I got it on my back but it was mild and no pain afterwards/I got it again on my face but it was a small case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (face was the first and the worst case). Concomitant products included valaciclovir hydrochloride (Valtrex) and gabapentin.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient reported that, his/her face shingles was the first and the worst case. The patient started Valtrex twice and till the time of reporting, he/she was still on Gabapentin since 2017.  The patient was told that since he/she got shingles he/she had to wait one year to receive the Shingles shot. Th patient received Shingles shot but then was told that, shingles laid dormant in the body and even though he/she got the shot it could be reoccurrences. After receiving Shingles vaccine, the patient got it on his/her back but it was mild and no pain afterwards. The patient got it again on his/her face but it was a small case.  This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR158719:Same reporter
Right deltoid pain and Right shoulder sharp, stabbing pain radiating into upper arm and elbow, limited ROM, pain getting progressively worse with arm abduction and arm rotation movements, alleviated with arm rest. Diagnosed with Rt brachial neuritis treatment neurontin 300 mg every 8 hours, Motrin 800 mg every 6 hours, ice/hot packs, arm resting. Also reported runny/stuffy nose, malaise, dry cough. Diagnosed with URI treatment symptomatic.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). On an unknown date, the patient experienced a painful rash, at the injection site, one week after receiving ZOSTAVAX. The patient saw unspecified physician who diagnosed the rash at the injection site as shingles. At the time of the report, the patient's outcome of shingles was unknown. Additional information has been requested (correspondence containing a request for additional information is scheduled).
Injection site was hot, red and inflamed for 2 weeks, redness continued for 4 weeks. As of 11/16/18 the injection site still looks bruised but no pain.