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 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 2:57 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 3:33 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced 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). 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.   Age of patient was reported as 39.32 for dose administered on 14-Feb-2021 and 39.41 for dose administered on 21-Mar-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021, 13-Feb-2021 and 14-Feb-2021 with temperature 35 degrees Fahrenheit from 10:00 AM to 02:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021.  Batch number 003B21A underwent temperature excursion on 20-Mar-2021 with temperature 32 degrees Fahrenheit from 10:00 AM to 02:00 PM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient given her second dose at our facility.  We only had  Moderna.  Patient received her first dose from other facility.  Patient did not have her vaccination card.  System was not used until after the Moderna shot was administered.  Then it was revealed that the Patient's first shot was Pfizer.  Thus the patient received a first shot of Pfizer and then a second shot of Moderna injection.  Patient DID NOT HAVE any adverse reactions from receiving the Moderna injection.
Fever began later that night, stiffness, trembling the next day noon, 9pm the day after 7am. Lasted 3 days, no other sx. Gave Tylenol no hospital needed.
Father states patient reported left arm at the site of the injections was red, swollen to the size of a baseball, tender to touch, itching and burning, hot to touch and a rash around the injection site.  Denies fever.  Symptoms began 6/14/2016, went to ED night of 6/15/2016.  Per father, MD in the ED diagnosed patient with a staph infection.  Prescribed Bactrim for 10 days and instructed patient to wear a sling to help with swelling.
Approximately 5 minutes after vaccine was given, child was noted to have urinated on himself while sitting in a chair, and then began to have a seizure.  Child has no previous history of seizure activity.
Information has been received from an office manager concerning a 45 year old female patient with a drug allergy to "ALLOVERA" (therapy unspecified), neoplasm of kidney and ureter, mixed high lipidemia, migraines, gastrooesophageal reflux disease (GERD), mild facial pain syndrome, obesity, sciatica and depression, who on 25-AUG-2009 was vaccinated IM in the left arm with the first dose of PNEUMOVAX 23 (Lot number 663936/0508Y). Concomitant therapy included PERCOCET, SEROQUEL, vitamins (unspecified), iron (unspecified), BIATON (therapy unspecified) and tizanidine hydrochloride. The patient was seen originally on 25-AUG-2009 for a bladder infection and was given CIPRO and then was administered the vaccine. Two hours after the dose, the patient called the office and mentioned that left arm had swollen up and she could not move it. The patient was instructed to apply ice to the area. During the evening "the swelling got worse" and the patient was seen in the emergency room. Emergency room treatment was not specified. It was noted that the patient was hospitalized (clarified as not hospitalized in follow up). The patient had a follow up appointment in the office on 28-AUG-2009. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. Follow up information has been received from the office manager on 01-SEP-2009, who stated that on 25-AUG-2009, the patient did not received any concomitant vaccinations when the PNEUMOVAX 23 was administered.  On 25-AUG-2009, the patient called the office and mentioned that her left arm was swollen and she could not move it. The patient was instructed to apply ice to the area. On the evening of 25-AUG-2009, the patient went to the Emergency Room. The patient was treated with prednisone and BENADRYL. The patient was not admitted to the hospital. On 28-AUG-2009, the patient cancelled her follow up visit to see the physician. The patient reported that she felt better. The patient was recovering. Additional information has been requested.
A territory representative reported that several children received an injection of Acel-Imune and subsequently developed an injection site reaction characterized by "severe" swelling, redness and warmth.
Attending Physician:  DO;*     Date of Admission:  1/27/2022   Chief Complaint:  Cough, Loose stools, Vomiting    Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 71y.o. female past medical history significant for permanent atrial fibrillation (pacemaker in place and on Coumadin), essential hypertension, type 2 diabetes mellitus, breast cancer s/p left mastectomy and in remission, hypothyroidism, CKD stage III. Patient presented to the ED today with complaints of cough, loose stools and vomiting. Patient stated since this past weekend (approximately 5 days ago) she's been having coughing, sneezing, nausea and vomiting, and diarrhea. Patient stated that her diarrhea was occurring more than 5 times a day, nonbloody. She states she's also been having a headache for which she is taking Tylenol at night to help her sleep, but states that her headache has not went away. Patient also stated that she has had some shortness of breath, more so with exertion. She also notes that she has had decrease in appetite. Patient was informed she tested positive for COVID 19 in the ED. She stated she was babysitting children this past weekend and wonders if she could have gotten it from them. She stated she has had Pfizer vaccine x2 (last dose in march 2021) but has not received booster. During the time of my encounter patient states she is still having a headache, denied shortness of breath, chest pain, abdominal pain. Patient states that she has not had an episode of nausea or vomiting since receiving Zofran in the ED.    ED Course - Vitals on admission: BP 116/37, HR 112, RR 20, SPO2 92%, temp 97.3 - EKG: Atrial fibrillation with RVR, rate 112 BPM Labs - CBC w diff: WBC 3.2, Hgb 11.9, platelets 154 - BMP: Sodium 141, potassium 4.1, chloride 106, bicarbonate 23, glucose 199, BUN 21, creatinine 1.27 - Magnesium 1.3 - Troponin negative ×2, ×1 pending - HFP: Albumin 3.1, otherwise remaining values wnl Imaging - CXR: Multifocal airspace disease concerning for pneumonia Meds given - Patient given 2 g mag sulfate, Zofran ×2, normal saline bolus 500 mL
6 weeks persistent left deltoid pain (injection site). Cannot exclude underlying rotator cuff syndrome. No visible/palpable exam findings.
Patient received both doses of Pfizer vaccine. Patient reports around 5 days after the vaccine, experienced shortness of breath, generalized weakness. On admission (about 10 days after completion of vaccination), patient is diagnosed covid-19 pneumonia with covid pcr positive and chest x ray consistent with pneumonia.
On March 23, about 2 1/2 weeks after my first dose, I woke up with sweats, chills, fever and vomiting that lasted about 24 hours.  Note: This happened again 7 days after my second dose for which I have filled out a second form.
Developed tactile fever and became fussy at 1pm. Premedicated before shots with Tylenol apprx. 9am and given Tylenol again at 1pm. By 3pm., child had temp 103.2 degrees, was screaming an inconsolible (screaming/crying for 1 1/2 hours straight). Then became "limp" per mom at 3pm. No seizures witnessed. Went to ER. Given motrin and all symptoms improved. Normal now.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 1st February 2019, the patient received the 2nd dose of SHINGRIX. On 1st February 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine into the left shoulder bursa, which led to vaccine administered at inappropriate site and experienced a lot of pain. The reporter was unable to provide lot number or expiration for SHINGRIX.
Within 25 minutes of administration itching started in injection arm and moved to  whole body.  Benadryl 50mg taken PO X2 with 4 hours, no relief.  Layed down and felt throat constricting so went to ER first time.  Rec'd benadryl 50 for third dose, prednisone 60, pepcid, and went home with an epi pen.  Symptoms worsened 2 days later and returned to ER with difficulty swallowing and facial and neck swelling.  Dizzy for 1 week after, inability to concentrate, neck pain.
Pentacel was administered to a patient without being mixed properly with no reported AE; Initial information received on 21-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient who was administered the vaccine without being mixed properly with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Jun-2022, the patient received a  dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine ( lot U6970BA and expiration date: 31-Jan-2023) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On 17-Jun-2022 , it was reported that the Pentacel was administered to a patient without being mixed properly with no reported ae (product preparation error)(latency: same day). It was also reported that the patient was only administered the liquid component of Pentacel.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event (Pentacel was administered to a patient without being mixed properly with no reported AE).  At time of reporting, the outcome was Unknown for the event pentacel was administered to a patient without being mixed properly with no reported ae.  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 the guidelines. 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.
Dose / reconstituted with sterile water instead of the supplied adjuvant; Dose / reconstituted with sterile water instead of the supplied adjuvant; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number F4234, expiry date 3rd April 2022) for prophylaxis.   On 1st July 2021, the patient received the 2nd dose of Shingrix. On 1st July 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that the patient had received 2nd dose of Shingrix which was reconstituted by using sterile water instead of the supplied adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with US2021151598, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151598:Same reporter.
Total / Sudden Sensorineural Hearing Loss - Right Ear,   Tinnitus
shingles; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: On unspecified date, the patient developed shingles On25th April the patient taken unspecified antiviral. At the time of reporting the patient had no rash and no symptoms. The health care professional did not have the lot number since the 1st dose was not given at his pharmacy. The reporter consent to follow up.
Information was received from a registered nurse concerning an unspecified number of patients (demographics not provided). On unknown dates, 15 doses of improperly stored PROQUAD (Merck) (dosage and route of administration not provided) were administered to an unspecified number of patients. No adverse symptoms were reported. The temperature excursion for PROQUAD (Merck) was found to be supported with in-house stability data. Follow up information has been received from the nurse on 19-DEC-2014. The nurse was available at the time of the report and was able to provide lot numbers, expiration dates, number of doses affected by the temperature excursion and remaining doses. The nurse provided that the approximate ages of the patients who received the vaccinations were 1 year old and 4 years old.  Additional walk in patients received the vaccinations were older from other countries. There have been no adverse reported since administration of the vaccinations and there was no need for revaccination. The nurse also reported that 20 doses of PROQUAD (Merck) (lot # reported as 5014800, expiration date: 12-MAR-2016) were affected and 3 doses with same lot number were remaining. Follow up information was received on 02-JAN-2014. Lot 5014800 is NOT a valid lot number for PROQUAD (Merck). Product information and narrative were updated. This is one of several reports from the same reporter. Additional information has been requested. Product information and narrative were updated.
arm pain for 3 days at injection site. Shivers and chills in first 24 hours. Mild fever first 24 hours Ongoing persistent lymph node inflammation in neck for 7 days and counting
Varicella vaccine breakthrough.  Had varivax x2.  Diagnosed in our office on 6/30/09 with varicella.  Had over 100 lesions.
Patient requested a flu shot after receiving his Covid vaccine.  Paper work was obtained from the office which was filled out in the exam room.  A second Covid injection was administered in error.
COVID 19 Treatment; COVID 19 Treatment; Dose 3: Moderna: Dose 2 Pfizer/Dose 1 Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: en6204), in left arm and on 01Apr2021 as dose 2, single (Lot number: er8737) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Dec2021 as dose 3 (booster), single (Lot number: 067HZ1A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic bronchitis" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Dec2021, outcome "unknown", described as "Dose 3: Moderna: Dose 2 Pfizer/Dose 1 Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Nov2022) Positive, notes: Tested positive covid 13Nov PM; (15Nov2022) Negative, notes: Tested negative 15Nov AM and asymptomatic at that time; (19Nov2022) Positive, notes: 19Nov similar, tested positive COVID later that morning. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included, vaccine received was noted as yes. Other medical history was noted as chronic bronchitis and depression. Known allergies was not reported. The anti-viral details included product COVID 19 Treatment with brand Paxlovid. The treatment started on 08Nov2022 and stopped on 13Nov2022, Lot number was GD5282. Indication was treatment of COVID-19. It was reported that patient took Paxlovid ending 13Nov2022 AM dose. All doses taken on time. Symptoms were down to very mild by 3rd dose. Tested positive covid 13Nov2022 PM. Tested negative 15Nov2022 AM and asymptomatic at that time. 18Nov2022 AM, patient woke up to heavy sinus drainage and slight (99) fever, some tiredness during day. 19Nov2022 similar, tested positive COVID later that morning.
Patient had localized swelling about the size of a quarter in diameter around the injection site starting almost immediately to a couple of minutes after PREVNAR 13 vaccination. Patient also had mild bleeding that resolved with compress with a cotton swab. I then applied a cold compress to the injection site for approximately 15 minutes -17 minutes and the swelling went down. Patient was contacted later that evening (approximately 3.5 hours after administration) and patient still had a little bump at the site per patient.
This spontaneous report was received from a nurse prescriber, who was also the female patient of unknown age, reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On unknown dates, the patient was vaccinated with dose 1 and dose 2 of VAQTA 0.5 ml Injection, (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. The patient reported, she believed that she received the wrong dose VAQTA, due to it was documented that she received two doses of the adolescent 0.5 ml. The patient wanted to confirm the lot numbers of the doses she received of VAQTA mentioning that the dosage might have just been documented incorrectly as opposed to actually receiving the wrong dose. No adverse reactions were reported.
Approx. 24 hours after 2nd Pfizer shot, large hives developed all over my scalp and spread down my forehead and onto my ears.  They also began spreading to various parts of my body - side of hips, knee, butt crack, tops of arms.   Benadryl controlled the itching, but not the swelling or spread.  I went to my doctor 48 hours after the shot and he immediately prescribed a steroid shot and Prednisone pills. It has been 3 hours since I received the steroid shot and there is very minor improvement.
Two days following injection site the right thigh began to look more red and a lump was felt at the injection site. By the following morning, the thigh looked much worse, larger area of redness, warm to touch.
some pain in the joints and in mussels; some pain in the joints and in mussels; This case was reported by a consumer and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2020, the patient received Shingrix. On 30th December 2020, less than a day after receiving Shingrix, the patient experienced joint pain and muscle pain. On an unknown date, the outcome of the joint pain and muscle pain were unknown.   It was unknown if the reporter considered the joint pain and muscle pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and on the same day, experienced some pain in the joints and in muscle.
No patient adverse event occurred, suboptimal dose administered due vaccine leakage from syringe tip and needle hub.
Lots of bleeding vaginally for less than 24 hrs. Not period bc I?m regular bc on thr pills for years.
Vaccines administered on 11-9-15. Received the flu vaccine in the (R) arm and the HPV in the (L) arm. Each vaccine given in deltoid. Lesion appeared in (L) deltoid. Flesh colored but increasing in size to form quarter size hard knot (2 1/2 cm x 4 cm).