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 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:28 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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.   No Concomitant product use was reported.  The age of patient was provided as 37.39.  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 13-Feb-2021, Excursion time was 09 AM temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 13-Feb-2021 no hourly temperature recordings available.  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.
Client was given Pfizer as second dose COVID 19 vaccine after having Moderna for first dose.  Cleint was monitored for 30 minutes post vaccine.  No adverse reactions noted.
Information has been received on 14-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for the prevention of shingles. Instead, in June 2017, the vaccine caused the patient to suffer a heart attack. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a direct and proximate result of ZOSTAVAX the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. The patient has paid and has become liable to pay for medical aid, treatment, and medications and will necessarily incur further expenses of a similar nature in the future. The outcome of the events is not recovered. The causality of the events is related. Upon internal review, heart attack was considered to be medically significant. Heart attack was considered to be disabling. Additional information has been requested.
more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, on left arm, on 06Feb2021 15:30 (at the age of 50-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included type 1 diabetes and Raynaud's, patient had no known allergies. No COVID prior vaccination. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), and lansoprazole, all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration, on left arm, on 15Jan2021 15:30 (at the age of 50-year-old), at single dose, for COVID-19 immunization, and after receiving the first dose the patient experienced tingly sensation in her chin area. After receiving the second dose on 08Feb2021 13:00 (reported as "day three") patient experienced more intense tingling sensation around the chin area and extreme dizziness. Patient took diphenhydramine hydrochloride (BENADRYL) and meclozine hydrochloride (BONINE) as a result. On 09Feb2021 (reported as "day 4") patient still experienced the tingly sensation around chin and lower mouth area. Patient felt almost like a sensation of when, for example: your arm fell asleep. It was constant. No COVID tested post vaccination. The outcome of the events was not recovered.
SCRATCHY, GRAVELY THROAT; IRRITATION OF VOICEBOX; SOUNDS "FROGGY"; HARDER TO SPEAK AS DAY GOES ON, WORSE IN EVENING; HURTS TO TALK.  HAS HAD SIMILAR SYMPTOMS IN PAST BUT BROUGHT ON BY STRONG SCENTS/SMELLS (HAS HYPERSENSITIVITY TO SMELLS)  AND RESOLVES WHEN SHE IS ABLE TO GET FRESH AIR.  THESE SYMPTOMS STARTED ABOUT 24 HOURS AFTER VACCINE AND HAVE STILL NOT RESOLVED AS OF TODAY PER PATIENT.  HAS CALLED DR. 2 TIMES AND WAS SEEN ONCE IN HIS OFFICE. HAS TAKEN A ZPAK.
Weakness, dizziness, sore throat, swollen glands w/in 2d of vaccine.
Patient fainted from the seated position about 5 minutes after vaccine administration.  He was carefully placed on the floor and given an ice pack and some orange juice.  When he felt better, he was helped in to a chair and remained under observation for another 40 minutes.  Patient reported feeling normal before he left.  His mother states he did not have anything to eat or drink that morning prior to coming in.  She also reported that he has fainted in the past from seeing a papercut on his finger.  Patient was going to report to the urgent care to ensure there were not further issues.
The patient presented to the ED with complaints of fatigue. The patient was found to have an NSTEMI and suspected pneumonia on x-ray. The patient was started on a heparin drip, ceftriaxone, and azithromycin. BP was 176/101, pulse 93, O2 sat of 95% and temp 99.3 F. Patient is being admitted to the hospital for continued treatment of NSTEMI.
The client visited the clinic on 02/26/2022 to receive their booster dose of COVID-19 vaccine. The client was administered her vaccine by a student, who was observed by a nurse. During the 15-minute waiting period following her vaccination, the client was approached, who informed the client that the student who administered her vaccine had accidentally poked themselves in the hand with the needle prior to using the same needle to administer the booster dose. Informed this individual that ?the student is clean? and stated that the risk of infection was low, but eventually advised the client to visit an urgent care center after the client expressed significant concern about the contaminated needle. The client requested documentation of the incident or other paperwork to indicate what had happened, and refused; Did eventually write down her name for the client. The nurse observer, and the student were all wearing uniforms with logos and name branding during this event, denied that they were associated with other area. The client visited a Family Medicine on 03/01/2022 to follow up on this concern. After explaining her story, her MD gave her a hepatitis vaccine and advised blood testing following the potentially contaminated needle stick. The client was sent to Immediate Care, then to the Medical Center in order to have a blood sample collected. She received clear results from this lab on 03/19/2022, and had a telemedicine appointment on this date in which she was advised that she would have to continue to return for testing in another 3 months, as well as likely another 3 months after that. The client currently has appointments scheduled for the 11th and 14th of April to follow-up.   This client is very concerned about her own health and is distressed about the lack of follow-up and care shown by the clinic staff. She is receiving therapy due to the stress she is experiencing because of this incident. She is additionally concerned about the expense of the blood testing she is having to undergo as the result of this incident. She would like the clinic to be reprimanded to ensure that a similar issue will not be experienced by anyone else, and she would like to find out if anyone else can pay for her blood testing, as she does not feel she is at fault in this situation.   NOTE: This form was completed by proxy of (COVID Feedback Team) with permission from the client. The client only speaks Spanish; please be aware of this during any follow-up. If needed, feel free to also reach out to myself with any additional concerns or questions regarding this report.
Patient was given 2nd dose, however he had a severe delayed reaction after 1st dose. Eyes swelling 12 hrs past dose epipen. Doctor okied 2nd dose. He took allegra BID since Monday. Wife to monitor at home.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single and administered in arm left, administration date 27Mar2021 (Lot number: EK8730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lactose intolerance" (ongoing), notes: Verbatim: Lactose intolerance; "dry eyes" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing), notes: He started taking the Flonase within the last 3 years for seasonal allergies. Concomitant medication(s) included: HYDROEYE taken for dry eye, start date: 2021 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "sore arm".  Additional Information: The only other medical condition that he has, he doesn't know if it is medical, but he has lactose intolerance. Patient is on FLONASE started taking within the last 3 years at a dose of 1 to 2 sprays in each nostril, 50 mcg/ spray for seasonal allergy. Vitamin D has been taking for the last 2 to 3 years at a dose of 5,000 iU as regular supplement from unknown to Ongoing. Multi-vitamin has been taking for over 5 years as regular supplement from unknown to ongoing. Probiotic has been taking for the last 2 years as regular supplement from unknown to Ongoing. Hydroeye started taking two months ago from 2021 to ongoing for dry eyes. Patient received the first two doses of the Pfizer COVID vaccine and he also had the booster. He had the first two doses he thinks in Mar2021 and Apr2021. After each he had a sore arm and then he did just get the booster last month, Oct2021, and after the booster he had a sore arm as well which resolved in a few days and that's what happened after the first two doses, too. He confirms that they were all the Pfizer COVID vaccine and that his 1st dose was in Mar2021, 2nd dose was in Apr2021 and his booster dose was in Oct2021. No emergency room and physician office required for AE. Prior Vaccinations (within 4 weeks) if any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. AE(s) following prior vaccinations: After flu shots he will have a sore arm, but that's all. Family Medical History Relevant to AE(s) and Relevant Tests reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT WAS INADVERTENTLY GIVEN INTRADERMAL FLU VACCINE AND IT IS ONLY APPROVED FOR USE IN ADULTS AGED 18 THROUGH 64 YEARS OLD. PATIENT IS 14 YEARS OLD.
A report has been received from a Health Professional concerning a 46 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 28-Jan-2014. The patient received inadvertently expired FLUMIST QUADRIVALENT which started on 28-Jan-2014. The outcome of the event of inadvertently gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Initially vial was first punctured on 04-Mar-2022 at 8:15, but administered on 07-Mar-2022 at 8:10-Past the 12 hour post puncture; administered a booster shot past the 12 hour post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Initially vial was first punctured on 04-Mar-2022 at 8:15, but administered on 07-Mar-2022 at 8:10-Past the 12 hour post puncture) and EXPIRED PRODUCT ADMINISTERED (administered a booster shot past the 12 hour post puncture) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2022 at 8:10 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022 at 8:10 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a booster shot past the 12 hour post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially vial was first punctured on 04-Mar-2022 at 8:15, but administered on 07-Mar-2022 at 8:10-Past the 12 hour post puncture). At the time of the report, PRODUCT STORAGE ERROR (Initially vial was first punctured on 04-Mar-2022 at 8:15, but administered on 07-Mar-2022 at 8:10-Past the 12 hour post puncture) and EXPIRED PRODUCT ADMINISTERED (administered a booster shot past the 12 hour post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. It was reported that 30 day mark expiration date of Lot number 033K21-2A is on 04-Apr-2022, the vial did not undergo any temperature excursions, total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) No Treatments were reported.
A 20 Year old female with no previous medical conditions, received the 1st dose of Anthrax vaccine on 05/30/2001.  The patient was taking no concomitant medications at the time of the event. On 05/31/2001 the patient experienced erythema, induration, tenderness, slight warmness, and nausea of moderate intensity for approximately 12 hours.  Subsequently, on 06/05/2001, the patient developed a swollen, tender node on the left side of the neck.  The patient took one dose of Tylenol on 06/05/2001 for the soreness in the left neck.  As of 06/09/25001 all symptoms have resolved.
Towards the end of April - Beginning of May: Both legs started to become itchy.  May6th- May 8th: Started to notice mosquito- bite like bumps on both lower extremities, both legs started to swelled up. But the right leg was more swollen than the left to the point that I couldn?t sleep or walk on it.   May 9th- I went to Emergency Care around 5am to be checked out cause it was hurting me so much.  They couldn?t figure out what had happened and they discharged me a few hours later with an order of Prednisone to take once a day for 7 days and preferred me to my PCP.   May 10th - We went to go see my PCP which she advised us to stop taking the prednisone and doctors orders was to stay out of work for a week in order to be off my feet.   She advised us to cancel the second vaccine appointment until everything clears up.
Child was to receive 3rd dose of Merck Hep B ped/adolescent but instead received Heplisav B which is indicated for adults
Headaches; tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. This consumer reported for a male patient (her dad).  A 89 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional Information: Reporter asked questions about covid vaccine Question: Can you take your thyroid medication with the Covid vaccine. Question: Caller wanted to know about the efficacy of the Pfizer covid vaccine. Question: Caller wanted to know about will the vaccine protect against the (delta) variant. Question: Caller wanted to know about should she take or not take the Pfizer covid vaccine. Caller (65 years old female) wanted to know about the side effects for the Pfizer covid vaccine. She said some people have no side effect and some have Headaches and tiredness. Her 89 years old dad had headache and tiredness after the Pfizer covid vaccine. Caller wanted to know how safe it was got that vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt is a 58 y.o. male with a PMH of chronic lyme disease, HTN, atrial fibrillation and DVT on Eliquis, and metastatic high grade rectal NET with hepatic, mesenteric, and pelvic involvement s/p colostomy and pelvic wall resection currently on carboplatin/irinotecan presents to UK ED after being called for positive blood cultures.  Constitutional: Positive for chills and fever. Negative for fatigue and unexpected weight change.  Respiratory: Positive for cough. Negative for apnea, chest tightness, shortness of breath, wheezing and stridor.   Cardiovascular: Positive for chest pain. Negative for palpitations and leg swelling.   He tested positive for COVID-19 and was asymptomatic for COVID-19 other than the fever on his first ED visit 8/26 and didn't require any treatment.
Pt recvd vax & the day of vax exp pain in arm down to hand, abdo pain, GI hyperactivity, diaphoresis, malaise for 24-48 hrs; (temp unk);
Patient was given Hepatits A vaccine on 11/5/18.  Patient complained of soreness shortly after the vaccination (which I thought was normal).   I was unaware the patient was still having problems potentially related to the vaccine until his wife came into the pharmacy on 4/11/19.  I called the patient who said his arm still hurt and he was unable to lift his arm all the way up.  The patient also read online that Havrix could cause seizures and he said he had a seizure on 12/4/18.  The vaccine was given on 11/5/18.  He said he had been to physical therapy for 3 months (Dec, Jan, and Feb) but that did not resolve the pain and mobility problems of his arm/shoulder.  He said he also had an EMG scan done recently but did not have the results yet.
Nausea for 3 days, dizziness, change in vision, sweaty & chills
Temp 104.7 3/4/08 - received immunizations 3/3.  Taken to UC - leg swollen, red, hard - given Ceftriaxone.  Improved in 24 hours.
Redness, extreme itching, swelling, hardness from shoulder to elbow and under armpit. Used hydro-cortisone and benadryl in beginning. Then used anti-itch spray.
pt. recvd. vax & developed measles rash,coryza,cough,conjunctivitis,& Koplik spots.
Patient came to clinic requesting a flu shot. Patient was registered and vaccinated with a fluzone vaccine.  Patient had already been vaccinated for current  flu season on 11/15/2021 @ 0859 with Fluarix left deltoid lot# 7557A
This patient had an hyperglycemic episode, onset of insulin. Dependent diabetes, no previous history.
A mother reported that her son (now 13 years of age) received doses of Orimune, Tri-Immunol and HIB (Coww) vaccines on 4/20/89, when he was 18 months old. She indicated that her son "immediately" developed a fever, loss of speech and loss of balance. He was subsequently dx'd with autism. She indicated that her son was born "gifted" and was walking at 6 months of age. Post vax, he needed speech therapy to relearn words that he knew prior to immunization. He is presently receiving chelation therapy to remove mercury from his system and, according to his mother, he has made great progress. She also reported that her son developed redness at the Tri-Immunol site. Autism was considered "Medically Important". F/U 7/3/01 no updated info rec'd.
This case was reported by a physician via sales rep and described the occurrence of headache in a 16-year-old female patient who received BEXSERO. Previously administered products included BEXSERO with an associated reaction of headache (refer case US2016163459) and BEXSERO with an associated reaction of nausea (refer case US2016163459). On 2nd November 2016, the patient received the 2nd dose of BEXSERO. In November 2016, less than a week after receiving BEXSERO, the patient experienced headache, vomiting and abdominal pain. On an unknown date, the outcome of the headache, vomiting and abdominal pain were unknown. It was unknown if the reporter considered the headache, vomiting and abdominal pain to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in left arm. No further information was provided.
The day after the event or son began to have intrusive thoughts, loss of appetite, compulsive behavior such as excessive hand washing excessive double checking that he closed the door or did his homework. Loss of sleep and flat affect in mood and as well as mood swings at times. This has worsened in severity over time. We have seen the pediatrician and three therapists in the past three months.
Patient received first dose of Shingrix (herpes zoster vaccination) on May 19, 2023. The second dose was administered too early on June 7, 2023. The patient has been notified that their dose is invalid being that it is less than 4 weeks following the first administration. He has agreed to return in August 2023 to receive a valid second dose.
Donor received shot on 9/17/13 to right arm. Later that night arm was numb and both armpits turned black. Arm stayed numb for 2-3 days.