chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of abdominal distension (abdominal bloating), lower abdominal pain (pain in lower abdomen, almost like vaginal area), abdominal discomfort (looked like she was pregnant), pain in extremity (arm pain) and fatigue (felt tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031L20A) for COVID-19 immunization. The occurrence of additional events detailed below. Concurrent medical conditions included fibromyalgia and irritable bowel syndrome. Concomitant products included hydrocodone for an unknown indication (treatment medication). On Feb 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced abdominal distension (abdominal bloating), lower abdominal pain (pain in lower abdomen, almost like vaginal area), abdominal discomfort (looked like she was pregnant), pain in extremity (arm pain), fatigue (felt tired) and pyrexia (fever). At the time of the report, abdominal distension (abdominal bloating), lower abdominal pain (pain in lower abdomen, almost like vaginal area), abdominal discomfort (looked like she was pregnant), pain in extremity (arm pain), fatigue (felt tired) and pyrexia (fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-18.She states no issues with 1st dose on 2/12.0923 Pt report pain and HA has resolved now she feels sleepy. VS as follows 148/86, HR-68, 02 sat 98%, r-20. Pt grandaughter accompanied her here.0937 Pt allowed to go home with grandaughter she reports she feels much better. VS as follows 150/89, HR-77, 02 sat 96%, r-18. Pt instructed to f/u with MD as needed.
Father stated febrile very quickly. 106.0F. with ear thermometer. Nausea and Vomiting. Headache. Stated called Nurse line with insurance company. Nurse stated to take Tylenol and luke warm bath. Father stated temp went down to 104F within 30 min. and stated has had fever and headache since Sat. Night 6/2/12. Stated called Pediatrician office Sun. spoke with Dr. Informed Doctor that child received Tyhpoid Vi vaccine on the May 31, 2012.  Today father stated fever is down around 100F. States continuing to give Tylenol. Will be speaking with Pediatrician again this afternoon 6/4/12.
Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Patient reported severe body aches the next and no other complaints thereafter.
Expired vaccine booster dose administered dose/administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine booster dose administered dose/administered greater than 12 hours post puncture) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 0401321A and 002B12A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 24-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine booster dose administered dose/administered greater than 12 hours post puncture). On 24-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine booster dose administered dose/administered greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vial was opened on 23 DEC 2021 and was administered after 12 hours post puncture as booster dose on 24-DEC-2021 and it was given post 24 hours after it was opened. No concomitant and treatment information were reported by the reporter.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult 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 (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 19th of 40 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information available.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
localized soreness, redness & heat & swelling for 2 days; dizziness, nausea, flushing on the 1st day; No prior vax;
Pt. received the first dose of Pfizer vaccine on 2/24/21, and 2nd Moderna vaccine on 3/17/21 accidently. Pt. has been informed and consulted with the error. Pt. reported doing well with minimal soreness and pain on the injection on 3/18/21. An incident investigation revealed that there were some miscommunication with the pt. and the nurse. Pt. did not have his vaccination card with him for the 2nd dose, the nurse miss understood that was his 1st does of COVID vaccine. Staff communication and follow up has been provided by the nurse manager.
nurse only gave the DTaP-IPV portion of Pentacel with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 4 months old male patient for whom nurse only gave the DTAP-IPV portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine and pneumococcal vaccine for Prophylactic vaccination (Immunisation).  On 12-Oct-2023, the patient received a standard dose 2 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ840AA, expiry date- 16-FEB-2024) via intramuscular route in the left thigh for Immunization.  On 12-OCT-2023, the nurse only gave the DTAP-IPV portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine with no reported adverse event (single component of a two-component product administered) (latency- same day).   Reportedly, Site manager reports that a nurse grabbed PENTACEL, and she did not reconstituted the DTaP-IPV portion into the HIB portion; reports that the nurse only gave the DTaP-IPV portion. She asks what they should do? She asks how much 0.4% NaCl (sodium chloride) should be used to dilute the HIB portion of Pentacel? Site manager reports that the HIB portion of the PENTACEL has been left out of the refrigerator since yesterday around 3:30PM; reports that excursion lasted around 17 hours and reached a maximum temperature of 70F; she asks for stability information. This excursion is covered by the extended stability data. Site manager asks if she can order just the 0.4% NaCl saline diluent. Treatment -no treatment   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the Directive and Regulatory Authority 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.
On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid vaccine (DOSE 1, SINGLE), for Covid-19 Immunization; Janssen covid vaccine (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Aug2022, outcome "unknown"; ISCHAEMIC STROKE (medically significant) with onset 10Dec2022, outcome "unknown", described as "On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain".  Clinical course: Female consumer stated that she had previously had 2 doses of Janssen Covid vaccine and then on Aug2022 had a booster of the Pfizer Covid vaccine. She states at the time of the dose she did not have any side effects. On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain. She reports that it came out of no where and she did not have many risk factors. She described being an overall healthy individual. She stated that she saw on the news that there have been some reports of strokes linked to the vaccine. She would like to know if there is any information on this happening. She would like to know if she should have further vaccine doses since she had this stroke that may have been related.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information was received on 19-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, or concomitant medication was not provided. It was reported that the patient was vaccinated on an unreported date, with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-MAR-2015,  the patient was treated by a physician for the onset of a blistering vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed Lipoderm for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Information has been received from a nurse concerning three children, ages 7, 11 and 13 years old (age of patient not specified) of who on 23-JUN-2006 were vaccinated with Vaqta. Regarding this patient, the patient was administered the vaccine subcutaneously. The second dose of the regimen was administered on 28-Jul-2006, approximately 1 month after first dose. The patient also experienced redness of upper extremity. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Physician reported that patient received Prevnar, haemophilus B (manufacturer unknown), measles, mumps, rubella (manufacturer unknown), and varicella virus (manufacturer unknown) vaccines on 9/15/2000. On 9/18/2000 the patient developed a fever of greater than 102 deg. F. He recovered. This is 1 of 5 patients from this facility who experienced this event following receipt of 3 different lots of Prevnar.
Received 3rd vaccine on 11/5.  Mild to moderate asthma attack began on 11/11.  Stated 20 mg of prednisone on 11/14.  On 11/17, had ruptured appendix requiring emergency surgery.
she is currently experiencing aching, runny nose, and a lot of sneezing; she is currently experiencing aching, runny nose, and a lot of sneezing; she is currently experiencing aching, runny nose, and a lot of sneezing; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported that a patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: Not reported) dose 2, via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was experiencing aching, runny nose, and a lot of sneezing on Mar2021. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Approximately the evening of receiving MMR SQ and Tdap in Right deltoid arm and Hepatitis A in Left arm deltoid, 9/1/07. Patient developed a painful swollen-reddened Right arm from shoulder area down to 2-3 inches above the elbow. After using Ibuprofen/ice she finally saw pediatrician on 9/5/07 and was placed on antibiotics. 24 hours later symptoms mostly resolved and completely gone in 2-3 days. Temperature about 100 degrees.
This spontaneous report was received from a certified medical assistant via a company representative referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 10-OCT-2017, the patient was vaccinated with a properly stored, but expired dose of ZOSTAVAX lot number M032141 and expiration date of 02-OCT-2017 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse reaction were reported.
p/vax pt became pale, floppy & lethargic;pt was hosp;pt pallor & floppiness abated w/in 1hr;the lethargy resolved w/in 4hr;pt recovered w/in 4 days;
After receiving vaccine, bruise developed at site of injection that lasted months. Moderate pain at time of injection; has developed muscle atrophy at site of injection. No pain at this time. Bruise and muscle atrophy occurred in left arm.
Pt. described rash (extremely itchy) on lower extremities 1-2 wks after MMR vaccine. No other symptoms.
Moderna COVID-19 Vaccine EUA 7 days after the shot: itching, swelling, redness at the injection site. The pharmacist at the vaccine provider recommended using an anti-histamine and ice, which lessened the reaction.  There is still redness at 12 days after the injection.
49 year old male, history of hypertension and high cholesterol  3:15 Vaccinated 3:25 complained of feeling lightheaded and anxious, escorted to medical tent 3:35 BP 153/88, P 108, 02 96% now complaining of chest pain 6/10 O2 via nasal cannula, EMS notified One paramedic placed monitor  3:45 BP 153/88,  P 108 ? O2 100% 4:05 EKG  rate- 104, possible L atrial enlargement  4:12 Staff arrived and ordered transport to hospital  4:20 Transported
c/o chills, cough, neck pain, generalized body aches, increased tm 100-seen in ER at 4am 7-21-07 IV fluids given. Torodal given for pain Diagnosed with (1) Viral illness (2) poss. Vaccine reaction
Parent called from trip where patient developed symptons 10 days s/p vaccine administration of MMR, DTAP HIb, Varicella. Patient developed slight rash on abdomen on day 10, followed by fever of 99.9 axillary on day 11 with rash becoming raised and spreading over face, chest, back arms and legs. Became slightly itchy. Mother called from another state to ask if she should seek medical care. Dr. consulted since Dr. out, and mother informed it was probably MMR reaction which would require supportive care and close monitoring. Mother told to take child to Urgent Care if symptoms escalated or ER if any life threatening signs or symptoms developed.  Mother advised she could use Benadryl if itching was a problem. Child not experiencing any other problems. Eating and playing normally.
This spontaneous report as received from a medical assistant refers to an 18 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 11-MAY-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot number K021487 (dose and route were not reported) and a dose of improperly stored M-M-R II lot number K015374 (dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Diarrhea, NauseaVomiting, Facial flushing, shortness of breath, fatigue Narrative:
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with unspecified dose of improperly stored GARDASIL 9 (dose, route and dose number were not provided) (lot# K026247, expiry date 29-JAN-2017). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
1/12/07 had Rabies vaccine on Monday 1/8, Tuesday evening had fever but no thermometer, also joint and muscle pains, relieved with Ibuprofen, recurred Wednesday evening with same symptoms, rash and redness of face with itching, began Thursday, no trouble breathing, Calamine and Benadryl did not give relief. At this time T 98.5, P 66, R 14 BP 96/62. No apparent distress, fine non raised rash on face, ears, poss scalp, chest, arms, legs to feet, reports no other exposure - Food, soaps, etc, Eval per Dr and referred to PCP to determine if SX are related to vaccine. Recommended to defer vaccine #2 until cause of symptoms is evaluated. 1/15/07 spoke with pt. She reports eval by PCP who thought vaccine was the cause of the symptoms and recommended to continue the Benadryl. Symptoms were improved Saturday (1/13) but worsened last pm with hives on arms and thighs with itching. Recommended to continue the PCP's recommendations. Will come to clinic tomorrow to prepare VAERS report. 1/16/07 Pt did not return for further evaluation.
Initial report was received from a healthcare professional on 14 October 2013. A female patient had received an injection of Influenza Vaccine (manufacturer, lot number, route, site and exact date of administration not reported) 4-5 years ago and an unspecified amount of time later experienced hives, rash, itching and throat swelling. Treatment was a course of steroids and she was told not to receive the flu vaccine again. No additional information was provided. Outcome was recovered. Documents held by sender: None.
Information has been received from a consumer concerning her 13 month old son with no medical history and an allergy to amoxicillin who on 10-NOV-2007, was vaccinated with a dose of HIB. On 12-NOV-2007, the patient experienced a fever. He has a second fever a week after that and a third fever on 21-DEC-2007. Each time he was taken to local emergency room and was given TYLENOL and MOTIN. At his last visit, tests were done to identify the cause of the fever and to no avail. Laboratory diagnostic studies performed included unspecified blood work, a chest x-ray and a urine test. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a 20 year old female patient. On 24-JUL-2009, the patient was vaccinated with first dose of 0.5 ml GARDASIL, (lot number, expiry date was not reported and route was intramuscular). On 29-APR-2013, the patient was vaccinated with second dose of 0.5 ml GARDASIL, (lot number, expiry date was not reported and route was intramuscular). Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank and left breast. Severe swelling and joint pain at left knee and hives down left leg calf. Significant rash and swelling of both eyelids and allover body soreness.
Red and sore at site. Not cellulitis. 3 cm diameter over left deltoid, raised patch.
Patient refers feeling a metal flavor in the roof of the mouth. Vitals are taken B/P 125/80, pulse 67, Oxygen 99%, temp 97.3. Dr. is consulted, keeping patient until she is back to normal and discharge after being aware of location, time and place.
Before she left the pharmacy, her arm went numb. She had a medicine taste in her mouth. Numbness started on the right-side of her body. Her legs and lips went numb. Tiredness.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Pt broke out with hives/rash a day later after eating egg products. Had no history of egg allergy before vaccination.