chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose administered after 30-day Use by Date to 7 patients; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     The patient medical history or condition was not known by he HCP.     On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.  This case contains information for the 1st of 7 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721413, US-MODERNATX, INC.-MOD-2023-721426, US-MODERNATX, INC.-MOD-2023-721427, US-MODERNATX, INC.-MOD-2023-721428, US-MODERNATX, INC.-MOD-2023-721429, US-MODERNATX, INC.-MOD-2023-721430 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721429:Patient 6 out of 7 patients US-MODERNATX, INC.-MOD-2023-721413:Patient 2 out of 7 patients US-MODERNATX, INC.-MOD-2023-721430:Patient 7 out of 7 patients US-MODERNATX, INC.-MOD-2023-721428:Patient 5 out of 7 patients US-MODERNATX, INC.-MOD-2023-721427:Patient 4 out of 7 patients US-MODERNATX, INC.-MOD-2023-721426:Patient 3 out of 7 patients
This spontaneous report was received from a registered nurse via medical assistant and refers to a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 02-OCT-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
I have been tracking my menstrual/ovulation for years now and am alway have very regular ovulation between days 12-15, and a 24-27 day cycle. The cycle I got my second Moderna shot I had my first anovulatory cycle that I am aware of in my life, and my cycle was 45 days long.
Expired Flulaval administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 77AJ9, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's comments: The Healthcare Professional (HCP) had administered Flulaval expired dose to a patient. The reporter did not consent to follow-up. Additional supportive information: The patient had received an expired dose of FluLaval Quadrivalent, which led to expired vaccine used.
loss of smell; loss of taste; red eyes; covid-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19), ANOSMIA (loss of smell), AGEUSIA (loss of taste) and OCULAR HYPERAEMIA (red eyes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TREPROSTINIL SODIUM since an unknown date. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (covid-19). On an unknown date, the patient experienced ANOSMIA (loss of smell), AGEUSIA (loss of taste) and OCULAR HYPERAEMIA (red eyes). At the time of the report, COVID-19 (covid-19), ANOSMIA (loss of smell), AGEUSIA (loss of taste) and OCULAR HYPERAEMIA (red eyes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, COVID-19: (Inconclusive) Results unknown.         Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided   Reporter did not allow further contact
Pt. returned to pharmacy on 6/20/17 C/O red swollen bump on arm at inj. site, it was significantly red and warm to touch. Pt. was referred to PCP to rule out infection and for further treatment. Pt. stated was pink at time of inj. but has become more red over time.
cramps; headache; lower back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "cramps"; HEADACHE (non-serious), outcome "unknown", described as "headache"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain".  Additional Information: I was at withheld Hospital (withheld (Hospital address) to have bloodwork done (I'm fine it's just for a checkup). The doctor or nurse whom conducted this had a (Country name Withheld) accent / was originally from (Country name Withheld). I didn't catch her name. She told me that when she received the COVID vaccine (I think first dose) she had cramps, headache and lower back pain - she did have her period but hadn't had cramps during period for some time so chalked it up to the vaccine. She said her husband was sick for around 24 hours and threw up. She said for other doses / booster they were fine. Note even though she's originally from (Country name Withheld) my impression is both she and her husband are living here in the United states and would have received the vaccine here. They are both fine and it sounds like most of her family had the Pfizer vaccine which was encouraged by her and her husband. She was not seeking to complain or report - I just felt that I should relay. I'm just relaying what she said - she wasn't looking to complain or report it. In fact, after I told her I worked for Pfizer she said they had filled out some form after having the vaccine but it wasn't clear to me if both she & her husband filled it out and if it was the reactions to the dose she had relayed to me or another dose that she had no symptoms. I tried filling out this form Pfizer's Adverse Event Reporting Portal (withheld) but I'm presuming patient details is the person relaying this information and I don't have her name or date of birth etc.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient was given an adult dose of Pfizer that was diluted using 1.3mL of sodium chloride and drawn up to administer a 0.2mL dose. Patient was observed for 15 minutes with no signs of allergic reactions.
Had a high fever in the night & began having jerking p/fever went down; MD feels like had some focal type sz;
Patient reported swelling in throat (3/10) and dizziness (7/10) and headache approximately 7 minutes following vaccination. Patient received liquid diphenhydramine 40mL/100mg PO. Approximately 25min later, patient noted dizziness improved to (2/10), swelling and nausea resolved. Patient was discharged to household with mother.
Pt had significant swelling of the arm with warmth and erythema. Left arm circumference 23 1/2cm and right arm circumference 19cm. Redness over most of upper right arm 18cm X 14cm in size.
Shortly after administering vaccine, patient nearly fainted. Patient was sweating, pale, and BP was low. Patient advised he was nervous and only had a smoothie for breakfast. Gave patient water and protein bar. Monitored patients symptom and BP which normalized shortly after consuming water/food. Let patient leave after 30 minutes post incident after confirming patient had been feeling okay 15 minutes.
Overall body aches, fatigue, weakness, severe arm soreness, and headache beginning a few hours after vaccine and continuing still 48 hours later
muscle problems in one of his legs and one of his arms; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route, on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated my son is experiencing muscle problems in one of his legs and one of his arms. I think he got Pfizer as well, but I am not sure. You are coming out with a follow up shot but it makes me very uncomfortable getting it. It is a little bit frightening not knowing what is causing this. On an unknown date, patient was reported experiencing muscle problems in one of his legs and one of his arms. The outcome of the event was unknown.
11/2/07 tc from mom.  8 days after shots (10/25/07) child developed rash on chest, back, arms face.  On day 10 after shots, child developed diarrhea and fever of 100 degrees.  11/5/07 f/u phone call to mom.  Child getting better, rash fading.  She did not take child to MD.
03/29/05 arm pain, numbness, swelling. 03/31/05 chills, body aches, headache.
friends pregnant daughter lost her baby after the jab; friends pregnant daughter lost her baby after the jab; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION (friends pregnant daughter lost her baby after the jab) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION (friends pregnant daughter lost her baby after the jab) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (friends pregnant daughter lost her baby after the jab). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. lost her baby after getting the jab. At the time of the report, ABORTION (friends pregnant daughter lost her baby after the jab) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (friends pregnant daughter lost her baby after the jab) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported. Treatment information was not provided.  A friend pregnant daughter lost her baby after getting jab. COMPANY COMMENT: This is a Spontaneous case concerning an unknown-year-old female patient with no clinical history who experienced the unexpected events of  ABORTION and MATERNAL EXPOSURE DURING PREGNANCY The events occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed Authority report states the doses were given on same date (providing different lots). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2022-438341 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is a Spontaneous case concerning an unknown-year-old female patient with no clinical history who experienced the unexpected events of  ABORTION and MATERNAL EXPOSURE DURING PREGNANCY The events occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed Authority report states the doses were given on same date (providing different lots). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Injection site is swollen and red - approximately 2 inches x  1.5 inches in an oval shape. Hard to the touch and approximately 2 mm raised. Itches
Patient was given Pediatric Pfizer vaccine on 10/2/2022 with short-dated expiration (9/30/2022), notified by manufacturer 10/12/22. After administration, stability data provided stability through 10/19/22. Patient notification not required. No adverse event occurred. Reporting to VAERS was required by Home Office
This spontaneous report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-OCT-2014, the patients were vaccinated with improperly stored GARDASIL, 0.5 ml, intramuscular (strength, frequency and lot number not provided). Co-suspect or concomitant therapies were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
23 hour after the vaccination pt. was fatigued, temp. and had a tonic clonic seizure. T. max was 103.5 by EMT. Hospital evaluation was normal with Dx of febrile seizure. All Sx's resolved after seizure with no other illness. Pt. was quickly back to baseline. However, he did develop URI Sx's in the next 24 hours.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 2 patients. This is 2nd of 2 reports. A female patient of unknown age and race received TRUMENBA at single dose via unknown route of administration on an unspecified date for immunization. Relevant medical history and concomitant medication were unknown. The patient fainted after being vaccinated with TRUMENBA and other unknown vaccines. The patient recovered quickly with no further complications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017081609 same reporter/drug/AE, different patient.
19 year old male smoker, diaphoretic/SOB with acute chest pain at 2 AM 4/6/03 following 2 days of chest pressure. Received vaccinia vaccination 3/26/03. Diagnosed at medical center with myopericarditis and released 4/7/03. Has follow up appointment with attending doctor 4/21/03 at hospital.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 26-JUL-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX (lot # L011534, expiry date 03-JUL-2016), dose and route unknown. No adverse effect was reported. Additional information has been requested.
PATIENT RECEIVED DOSE ONE OF PFIZER COVID-19 VACCINE. AFTER 10-15 MINUTES, PATIENT APPROACHED PHARMACY STAFF TO ASK IF SHE COULD LIE DOWN IN THE PATIENT CONSULT ROOM. AS STAFF APPROACHED HER, SHE COLLAPSED TO THE GROUND. THE PATIENT WAS ROLLED ONTO HER BACK AND WAS UNRESPONSIVE WITH EYES OPEN FOR A PERIOD OF APPROXIMATELY 30-60 SECONDS. THIS APPEARED TO BE A SEIZURE, BUT THE PATIENT MAY HAVE HIT HER HEAD ON THE FLOOR DURING THE FALL. THE PATIENT SUDDENLY BECAME RESPONSIVE AND ABLE TO COMMUNICATE BUT DID NOT REMEMBER FALLING. 911 WAS CALLED AND EMS REMOVED THE PATIENT TO A LOCAL HOSPITAL FOR FURTHER EVALUATION. THERE WERE NO SIGNS OF ANAPHYLAXIS.
This spontaneous report was received from approximately a 71 year old male patient, regarding himself. The patient had no pertinent medical history, drug reactions and allergies. On 29-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose, lot # and other details unspecified). No concomitant therapy was reported. On 30-JUL-2014, the patient experienced big-red blotches on his legs, popped eye vessels and bleeding from his eyes after receiving ZOSTAVAX. The consumer also stated that he was seen and released, the same day (30-JUL-2014), from an unspecified emergency room, on an unspecified date. The consumer stated that, he received treatment for events with antibiotic (unspecified name, dose/frequency and manufacturer), allergy medication (unspecified name, dose/frequency and manufacturer) and steroids (unspecified name, dose/frequency and manufacturer). No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of events was reported as recovered on 13-AUG-2014. The causality was unspecified in the report. Additional information has been requested.
Patient presented to office on 04/07/21 with rash all over body that began on 04/06/2021.  On exam, Dr. noted generalized large papules all over with some confluent areas,  excoriated lesions on R forearm.  No focal lesions at injection sites.  Patient was diagnosed with generalized urticarial lesions and lab was obtained  for a total IgE level and and stinging insect allergy panel, including mosquito.  Patient treating symptoms with oral Benadryl and cortisone cream.
I got my shingles vaccinebut have had it/suspected vaccination failure; had it many times, some on my face; destroyed the Trigeminal nerve; I can't feel the right side of my face.; horribly painful; 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.   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), shingles, injury to trigeminal nerve, numbness facial and pain. On an unknown date, the outcome of the vaccination failure, shingles, injury to trigeminal nerve, numbness facial and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, injury to trigeminal nerve, numbness facial and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine but had shingles more times than he/she could count.  The patient stated it was horribly painful.  The patient got some on face and it had destroyed the trigeminal nerve. The patient could felt much on the right side of face. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
After 10 minutes of getting the vaccine I felt mildly light headed, which lasted 5minutes.  Then about eight hours after getting the vaccine I started with body aches, mild headache, and chills which all lasted for five hours - I did take Tylenol ten hours after getting the vaccine, (two hours after the first sign of chills).  When the chills resided I started with thick mucus production and post nasal drip.   Now, 21 hours after getting the vaccine I feel clammy and continue to have mucus production.
Gout flare - only one previous incidence of gout.   Generalized inflammatory response lasting 3 days.
Signs/Symptoms/Time Course - per patient, he starting having pain to his right side (arm/neck) for approximately 1 week and decided to go to the ER. Per patient, he received an injection in his buttocks and was discharged with (Cyclobenzaprine 1mg 1 tab 3x daily; Ibuprofen 800mg 1 tab every 8 hours for 7 days; Lidocaine Topical (5%) daily for 14 days).
2nd Covid booster administered 90 minutes after expiration time of 8pm.  Dose administered at 9:30pm, without adverse effects