chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered to patient after more than 1 temperature excursion; Dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered to patient after more than 1 temperature excursion) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:40 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered to patient 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 51.11 years.  Concomitant products were not provided.  On 30-Mar-2021, the vaccine with batch number 030B21A was moved to fridge. On 03-Mar-2021, 20 vials were moved to the clinic. On the same day, at 09 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit.  The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Apr-2021.   It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  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 Fisherbrand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Keeps getting headaches around head ear to ear; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Keeps getting headaches around head ear to ear) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 08L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Keeps getting headaches around head ear to ear). At the time of the report, HEADACHE (Keeps getting headaches around head ear to ear) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: No specific follow-up information recorded.
Brought to the emergency department from the facility, after patient was found to be very lethargic, acutely altered, and diarrhea.  On admission patient was found to have sirs criteria (+) with leukocytosis and lactic acidosis (2.7).  Elevated troponin (82) which is above her baseline; EKG shows no ST segment changes or any T-wave inversions.  Found to have AKI on admission (creatinine 1.67; baseline creatinine and 0.76).  Hemodynamically stable on admission; saturating well on room air; found to have hyperkalemia and hypernatremia (161).  CT of the brain showed no acute infarct or hemorrhage.  Chest x-ray with No cardiopulmonary disease identified. In the emergency ICU physician was COVID Tested positive on 8/29/2021. 83-year-old female past medical history: dementia; advance, hypertension, history of CVA; hyperlipidemia, diabetes mellitus; type 2, depression; anxiety, chronic GERD, left bundle-branch block, lives at assisted living facility for the last 9 years, son is POA; -(+) COVID-19 2 weeks ago. Brought to the emergency department from the facility after patient was found to be very lethargic, acutely altered, and diarrhea. On admission patient was found to have sirs criteria (+) with leukocytosis and lactic acidosis (2.7). Elevated troponin (82) which is above her baseline; EKG shows no ST segment changes or any T-wave inversions. Found to have AKI on admission (creatinine 1.67; baseline creatinine and 0.76). Hemodynamically stable on admission; saturating well on room air; found to have hyperkalemia and hypernatremia (161). CT of the brain showed no acute infarct or hemorrhage.  Chest x-ray with No cardiopulmonary disease identified. In the emergency ICU physician was consulted who recommended to manage on PCU floor due to institutional limitations in the setting of COVID-19.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a non health care professional. This case involves a patient who was vaccinated with FLUBLOK QIV (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. It was also reported that, vaccine PNEUMOVAX, ADACEL (batch number, expiration date, dose, route and site of administration was not reported) was also delayed in transit and therefore no longer viable with vaccine. The patient's medical history and concomitant medications were not reported.  It was an actual medication error due to incorrect product storage as Flublok, Adacel and Pneumovax were delayed in transit and were no longer viable. Customer Service transferred call to Nurse Consultant as this Customer/Pharmacy tech is reporting that Flublok was given to a patient from the vaccine shipment that was delayed in transit and therefore no longer viable.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  List of documents held by sender: none.
I had a blurry vision and headache; sugar was off wack it was at 424; pounding headache; This is a spontaneous report from a contactable Consumer. This Female Consumer reported for herself.  A female patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 15Feb2021 09:15 am as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetic Mellitus and concomitant medications were not reported. On 15Feb2021 after the vaccination, around 14:00 the patient experienced pounding headache, her sugar was off whack it was at 424. she checked it again thinking it might be a mistake. It was still at 424.  In the morning she checked before getting the vaccine. It was stable at 106. she took her insulin and started drinking a lot of water. she couldn't't get sugar to come down by 3:00 clock it went up to 435. she never had her sugar this high. she had a blurry vision and headache. she called doctor and spoke to his R.N. She advised her to take humoral 4 units before dinner. she noticed around 7:00 pm, which is 5 hours later her sugar settled down to 205. she fairly believes the covid-19 vaccine brought her sugar skyrocketing. she took a fast-acting insulin 18 units and glyburide only then she was able to lower the sugar level. she was advised to not to eat carbs at night. Last night it got down to 169. In the morning was 197.  she still had headache. her arm felt like when she gets the flu vaccine. her concern was the high blood sugar, it took too long to come down. The patient lab data includes blood glucose levels on 15Feb2021 with a reading of 424 twice in back-to-back readings, and on same day patient glucose levels was 106 in the morning before vaccine. By 03:00pm it went up to 435. At around 07:00 pm sugar level showed a reading of 205. In the night it was 169 and in next morning it was 197. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (03Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up at-tempts have been completed and no further information is expected.
Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201287006 same reporter/event/products, different patient;
1/27 noticed redness at site, later that day noticed redness was spreading down arm and was about 3 inches long.  Called 24 hour nurse line and was advised to get some hydrocortisone cream.  Started cream on 1/28, was cleared up on 1/31.   2/4 arm started itching and later that evening noticed redness had returned.  2/5 called and got doctor appointment.  Was advised to continue cream thru weekend and if did not get better begin medrol pak.
Patient returned to pharmacy 30 min after injection complaining of generalized itching to head, neck, back and arms.  Denied SOB, dyspnea, facial swelling.  Observed x10 min.  Symptoms continuing.  Administered 50 mg diphenhydramine po.  Observed x15 min.  Symptoms continuing but not worsening.  Highly recommended pt get ride home.  Pt cannot get ahold of husband or daughter.  Offered to find ride home.  Pt declined as she lives close and doesn't want to leave car at store. Observed x15 min.  Itching somewhat better around head.  Preexisting TMJ pain starting.  Pt wants to drive home as it is close by.  Recommended to go to ER if she develops any facial swelling or difficulty breathing.  Pt left store and texted about 20 min later that she arrived home safe but itching is continuing.
Patient went unconscious after receiving these vaccine, hit his hand twice and went to ER to be checked out.
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of varicella virus vaccine live. On approximately 23-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/12/2006. Information has been received from a registered nurse concerning an elementary school-aged child on 23-JAn-2001 was vaccinated with a dose of VARIVAX (Merck). ON 02-MAR-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Patient was here for Pfizer booster, Patient recived Moderna dose, Rn spoke to patient and will follow up with PCP as well, No imedeate adverse reaction noted. Patient did not have the vaccine card to verify what was received for the 1st booster. Patient received the vaccine at another facility so staff was not able to review what was given for the 1st vaccine.
redness; hives; rash on back and clavicle; (rash) very itchy; Rash at the injection site in the left arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness), URTICARIA (hives), RASH (rash on back and clavicle), RASH PRURITIC ((rash) very itchy) and VACCINATION SITE RASH (Rash at the injection site in the left arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Benign prostatic hyperplasia. Concomitant products included AMLODIPINE for Blood pressure management, TADALAFIL for Enlarged prostate.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), URTICARIA (hives), RASH (rash on back and clavicle), RASH PRURITIC ((rash) very itchy) and VACCINATION SITE RASH (Rash at the injection site in the left arm). At the time of the report, ERYTHEMA (redness) and VACCINATION SITE RASH (Rash at the injection site in the left arm) outcome was unknown and URTICARIA (hives), RASH (rash on back and clavicle) and RASH PRURITIC ((rash) very itchy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication includes Benadryl, Steroid Ointment and Body Wash.   This case was linked to MOD-2021-037010 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up information was received: Added Patient Demographics, Reporter Information, Medical History Information, Concomitant and Treatment Medications, Events associated with vaccine.
Approximately 4 days post vax, the pt complained of redness and warmth on left lower deltoid area. The site was not raised. Approximate sized of an adult fist. No medical treatment was sought. The pt also experienced pain to the area. Suggested treatment of hot/moist pack to the site for 2-4 days for 20 minutes. Also educated client on signs of infection.
Information has been received from a physician concerning a female patient who on 01-JUN-2009 was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # 661528/0867X). On 03-JUN-2009 the patient developed edema at the injection site. On 04-JUN-2009, the patient went to emergency room and was given antibiotics and was "sent home". The patient was not admitted to hospital. Follow-up information was received from the physician who indicated that the patient did not report an adverse event to him, that the information came from the patient's husband. No further information is available.
Lymph nodes sore to touch can?t touch side whet ejnjection given did not occur in two previous
On 10/13/2021 I had a colonoscopy. I had pain for up to a week after the colonoscopy. I have had colonoscopies in the past and I have not had any pain before. There was no treatment. I called my doctor, they recommended to take a medication, that I never took. About a week after my vaccination, 09/24/2021, my left arm, at the site of the injection, has been significantly itching for the past 3 weeks, and even now 10/27/2021. I find myself unconsciously scratching. There is not any visible bump or anything. I have put cortisone cream to calm down the itching and it helps. I have not seen a doctor for it. I keep thinking it will go away. The pain after the colonoscopy has gone away, but the itching in my arm has not.
This is a 1 year old male concerning a possible measles contraction from an MMR vaccine. He received IV Solu-Medrol while at ER and was on a po steroid taper, finished 10/15/01. He received an MMR vaccine and had a fever to 104F the 3 days, following vaccination. He was in his usual state of health until 11/9/01, when he developed a temperature of 102F. A macular rash was noted on his face 11/9/01, and by 11/10/01, had spread to his legs and trunk. He was treated with Benadryl and Tylenol as an outpatient but 11/12/01, was noted by his paternal grandmother to have increased irritability and decreased po intake along with photophobia. He was sent to the ER and transferred to the hospital. He had mild rhinitis and a cough consistent with his asthma that was nonproductive. No other known contacts regarding measles. The infectious disease dept was consulted and felt that serology would not help in the dx as IgM would be positive both after vaccination and with a wild-type exposure. The pt was observed overnight and remained stable and was discharged on 11/13/01, in the care of his guardian, his grandmother. He was to continue his Pulmicort bid and his albuterol prn and was instructed to call MD's office for a follow-up appointment.
Pt developed pain in L deltoid immediately after injection of influenza vaccine that resulted in pain lasting 6 weeks following injection. Injection was given correctly in L deltoid IM at appropriate location. Pain completely resolved by 11/22/16. No subsequent pain or limitation in range of motion. Pt's examination was WNL.
Patient first felt like hands were swelling,  then heart palpitations   dizziness within 5 minutes of first reaction.  Patient thought throat felt scratchy.  Benadryl 50mg was administered by on site nurse.  EMS was called and responded within a few minutes.  The patient was assessed by EMS personnel.   She was considered stable.  Her husband was allowed to take her to the emergency department.  The emergency department said she had a strong reaction to the vaccination.  Her employer gave her the rest of the day off and tomorrow off.
Nausea, fever, headache, body aches, ringing in ears, severe chills. Not sure if related but I had my right ankle swell a month later and developed painful red bumps on both legs and then feet. Two rounds of antibiotics and it cleared up, except some lingering discoloration for several months.
Pt received two vaccines (flu vaccine and HepA vaccine) on 10-3-19 (one in deltoid of left arm, one in deltoid of right arm). The left arm is the arm concerned. Pt stated vaccination stung alittle, but seemed normal. Day after vaccine, injection site hurt alittle. Pt stated as weeks went on, still hurt. Pt stated she heard other people said their arm was sore after vaccine, so she thought hers was similar. However, it has gotten worse and pt states it is making everyday tasks difficult. Pt thought she would wait until her next scheduled doctor appointment to ask about it, however, she was having trouble sleeping due to the pain.Pt states she experiences periods of numbness in arm and sometimes has to use right arm to move left arm to roll over while trying to sleep. Pt states has taken tylenol and ibuprofen OTC and has used topical OTC cream/rubs, but pain continues. Pt had doctor visit on 11-14-19 for the problem. Doctor recommended MRI. Pt currently unsure or undecided what to do now. Pt states pain is in various parts of left arm and hand and the degree of pain varies and fluctuates.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old male patient received BNT162b2 (BNT162B2), on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR, stop date: 10May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Paxlovid Induced Rebound Covid 7 days after testing negative; Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The treatment has been received with Paxlovid, start date was 10May2022 and stop date was 15May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax & w/in 24hrs post vax exp back,shoulder,neck,arm pain;addl w/in 24hrs post vax exp earache,glandular pain,diff swallowing;sx were treated w/DPH
received the first does of Shingrix on last year on  9/18/2020 /  came in today (7/9/2021) with interest in getting the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th September 2020).   On 9th July 2021, the patient received the 2nd dose of Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: Pharmacist reported that the patient received the first does of Shingrix on last year but came in today (day of reporting) with interest in getting the second dose, which led to lengthning of vaccination schdeule. Pharmacist asked was it okay to give the second dose of Shingrix. The reporter did not consent to follow-up.
Intense headache, skin clammy and chills, no fever, pale, upset stomach. Uncomfortable and restless. Gave Tylenol and two hours later was better.
Patient did not have an adverse reaction. Filing this report due to patient's age and vaccine received. She received dose 3 of Pfizer booster at 15 years old.
Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 08-AUG-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M034780 with expiration date 15-APR-2019; dose and route were unknown, for prophylaxis) which were exposed to temperature excursion of 9 to 25 degrees Celsius for 1 hours 34 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010405: US-009507513-1708USA010404: US-009507513-1708USA010408:  US-009507513-1708USA010242: US-009507513-1708USA010407:
Fever, Redness at injection site, Chills, Blisters/Hives at injection site, body aches, Headaches,  Soreness in arms and swelling.