chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered expired ACT-HIB to a patient with no adverse event; Initial information received on 31-Mar-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and gender patient and reporter reported that an expired HIB (PRP/T) vaccine [ACT-HIB] was administered to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection (expiry date: 11-Mar-2023) (With unknown strength, route, lot number and at unknown administration site) for immunization.     On an unknown date, an expired act-hib was administered to a patient with no adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: 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 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.
Started with cough on 10/30/09, next day had cough and headache, then next day had fever and cough.
After my first dose, I felt fatigued for about three days. After the second dose (3/5/21), I had a fever and felt sick (dizzy, nauseous, achy) for about a day; ever since then I've felt very fatigued.
Soreness, redness 3 cm x 7 cm, swelling at injection site, warm to touch-no fevers.
Patient hospitalized from 3/13/2022 to 3/21/2022 for prolonged postictal state & hyponatremia. Neurology was consulted on 3/14 which switched her home carbamazepine to lacosamide due to her not be able to take oral medications. Palliative care was consulted given her cachetic state & they recommend starting Escitalopram 10 mg until 3/23 & then going to 20 mg daily. Palliative also recommends staring Olanzapine 4 mg at bedtime & megestrol 800 mg daily for appetite stimulation. Discharged. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Pneumonia due to COVID-19 virus  ED to Hosp-Admission Discharged  4/14/2021 - 4/22/2021 (8 days)    Last attending ? Treatment team Maxillary fracture  Principal problem     Final Summary for Deceased Patient      Admission Date: 4/14/2021     Discharge Date: 4/22/2021   Final Diagnosis Principal Problem:   Maxillary fracture (CMS/HCC) Active Problems:   Pneumonia due to COVID-19 virus   Demand ischemia (CMS/HCC)   Dyslipidemia   Essential hypertension   Acute kidney injury (CMS/HCC)   Glomerulonephritis, IgA   Lactic acidosis   Septic shock (CMS/HCC)   Cytomegalovirus (CMV) viremia (CMS/HCC)   Acute respiratory failure with hypoxia (CMS/HCC)   Left femoral vein DVT (CMS/HCC)   Malnutrition (CMS/HCC)   Hypothermia     DETAILS OF HOSPITAL STAY   Presenting Problem/History of Present Illness/Reason for Admission Hypoxia [R09.02] Acute respiratory failure with hypoxia (CMS/HCC) [J96.01] Fall, initial encounter [W19.XXXA] COVID-19 [U07.1] COVID-19 virus infection [U07.1]     Hospital Course Patient is a 72-year-old female with past medical history of hypertension, hyperlipidemia, recent hospitalization due to CMV viremia and an AKI and myelosuppression.  Who presented to the emergency room after a fall in her house on 4/14.  She had significant face pain and was hypoxic with an O2 saturation of 68% on room air on presentation.  She was then found to be Covid positive.  Initially admitted to the medical floor however required increasing amounts of oxygen and was ultimately transferred to the ICU on 4/16.  She was maintained on nonrebreather oxygen until the evening of 4/21 when she was intubated and increasing vasopressor requirements.  Given her worsening condition, her husband elected to palliatively extubate and pursue comfort care.  Time of death was 10:02 AM on 4/22/2021.     Disposition of the body: morgue
Generally occurring and resolving within 36 hours: Generalized neuropathic pain that turned gradually into generalized nociceptive pain / soreness; Pounding headache at the base of the brain; Tachycardia; Sensation of pounding heartbeats; Nausea; Sensitivity to light; Loss of appetite and thirst; Low-grade fever  Still occurring at 48-53 hours: Nausea Light headache; Sensitivity to light; Some sensation of heart racing; Localized pain in different areas of the body
Erythematous area anterior right thigh extending from hip joint almost to knee, mainly inner portion of thigh, warm to touch and swelling. Asymmetrical around injection site. Treatment with Septra Suspension 40mg/5ml 2 tsp po tid x 10 days and Amoxicillin 15ml one tsp tid x 10 days.
Low grade fever, 101, moaning, unconsolable crying, sleeplessness, loss of awareness and motor function esp. facial expression.
Father reports acute onset diffuse urticaria on approx. 7 hrs post receiving 1st dose of inactivated flu vaccine 1400 today. REcommended appropriate dose antihistamine product available at home, close observation resp. changes (EMS/ER if occur). Avoid subsequent dosage.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 156 hours with the lowest recorded temperature of -3 Fahrenheit degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient had received Pfizer series (2 shots) at another location; date unknown to us.  Patient claimed that her antibody test showed negative after her second shot so her doctor recommended her to redo the series. She made appointment at our pharmacy for Moderna shot 7/1/21 first dose.  On her consent form, she checked NO to question "Have you received a vaccine for COVID in the past".  We gave her the shot then billed insurance afterwards.  Insurance came back with rejection that patient had Pfizer series.  We contacted patient and she confirmed she already had Pfizer series.  The case was reported to pharmacy manager and regional supervisor.  We were advised to fill out this report for CDC future use.  Patient had NO adverse effects but this form had to be filled out so some of the questions would not be relevant regardless of the answers.
Shorntess of breath; Stuffy nose; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shorntess of breath), NASAL CONGESTION (Stuffy nose) and MYALGIA (Sore left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-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 13-Jul-2021, the patient experienced NASAL CONGESTION (Stuffy nose) and MYALGIA (Sore left arm). On 16-Jul-2021, the patient experienced DYSPNOEA (Shorntess of breath). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 16-Jul-2021, NASAL CONGESTION (Stuffy nose) and MYALGIA (Sore left arm) had resolved. At the time of the report, DYSPNOEA (Shorntess of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Heart rate: increased (High) Fast heartbeat..         Concomitant product was not provided.   Reporter did not allow further contact
Large Itchy/Painful Rash developed over site where vaccine received just over 24 hours of receipt of shot. Tachycardia (264 bpm) began same time and is continuing as I document this agent. While I thought this should be reported, I do not plan to contact my doctor as I am assuming this if non-emergent.
Arm swollen red, hot to touch, itchy. MD gave po BENADRYL at office.
Myalgia, NauseaVomiting, TENDERNESS TO THE INJECTION SITE, FATIGUE Narrative:
Pt recvd 2nd dose of DTP/HIB/OPV 4OCT91; first dose given in MD office; p/immun both legs red @ inject site, erythema 50mm diameter rt leg (DPT) and 20mm lt leg (HIB); cool & warm compresses to inject sites; given APAP every 4 hrs;
About 7-8 hrs after injection I started puking and had a bad headache which lasted al most 24 hrs and yesterday morning I woke up really sore. My body feels like I got hit by a truck and I?m so tired
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # K021487, expiry date: 03-NOV-2016; lot# L024250, expiry date: 30-JUN-2017; lot# L019128, expiry date: 27-MAY-2017 and lot# L042266, expiry date: 27-OCT-2017 (route, dose# and site of administration not reported). Concomitant medication was not mentioned by the nurse. The vaccine was started at -2.0 degree centigrade for a time frame of 12 hours and 10 minutes. There was no previous temperature excursion. The call was a result of a "data logger". No adverse effects were reported. No additional information was provided. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the three reports received from the same reporter.
Pt came in on 5/15/19 reporting a red, sore, painful rash that he didn't get with the first dose of the series. Upon follow up with patient on 5/16/19, pt said that the injection site has improved over 24 hours. Pt also noted that he had received the first dose exactly 60 days before his 2nd dose.
Less than 24 hours after receiving vaccine, child became listless and febrile up to 104.7F.
Immediate full body  heat rush and heart racing upon injection.  Right arm went numb down to elbow, numbness then radiated up to neck & side of face into ear, up back of head, back toward shoulder blade and then down lateral torso. Numbness turned into intense pins and needles with intermittent jolts the day after the vaccine and slowly began to diminish. Most intense first 5 days, and  lasted in a significant manner a little over 2 weeks. Now is barely noticeable shoulder blade and side of neck. Chest tightness nearly immediately after vaccine. Used albuterol inhaler 30 minutes after vaccine which helped. Chest tightness reappeared 6 hours later, took Benadryl and inhaler. Required inhaler in the evening for 2 more days following vaccine.  Diarrhea began day after vaccine, lasted 2 days Neck muscles felt too weak to hold up head, began shortly after vaccine and recurred each afternoon for about 5 days.  Day 11 developed a sudden rash/redness with heat and swelling over the injection site. Took Benadryl and called PCP when rash worsened the next day. Visit to PCP 13 days post vaccine due to rash. MD unsure if allergy or infection, recommended antibiotics, but by day 14 after taking Benadryl for 3 days, the rash dissipated without beginning any antibiotics.
On Tuesday evening I experienced chills. The following day I had a fever and felt flu like symptoms along with a slight fever. In the middle of the night my fever broke. However, this morning I am really weak, I have a headache and I am nauseous.
Right arm, neck warmness after injection of typhoid vaccine to her right upper arm. Subsided 13:30.
No adverse effects reported.; patient was administered a dose of improperly stored MMR II, ROTATEQ or PEDVAX HIB; This spontaneous report as received from a medical assistant refers to a 9 week old male patient. The patient's pertinent medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent.  On 07-NOV-2019, the patient was vaccinated with a dose (1 dosage form) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot #R033252, expiration date 29-JUN-2020 (anatomical location was unknown) for prophylaxis (product storage error). The vaccine was exposed to above 47 Fahrenheit scale (52F) for the time frame of 1 hour 15 minutes. There was previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was filed.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA003851: US-009507513-2005USA003275: US-009507513-2005USA003277: US-009507513-2005USA003150: US-009507513-1911USA003851:
period immediately following vaccination had more blood clots; more cramps; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (period immediately following vaccination had more blood clots) and DYSMENORRHOEA (more cramps) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (period immediately following vaccination had more blood clots) and DYSMENORRHOEA (more cramps). At the time of the report, HEAVY MENSTRUAL BLEEDING (period immediately following vaccination had more blood clots) and DYSMENORRHOEA (more cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This is a spontaneous case concerning a 41-year-old female patient with no reported medical history, who experienced the non-serious  unexpected events Heavy menstrual bleeding and dysmenorrea . The events occurred on the same day after receiving the first  dose of mRNA-1273. Rechallenge is positive, since patient experienced the same symptoms after second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. No relevant concomitant medications were reported. Treatment information was unknown. It was stated that after all 3 Moderna doses, patient period immediately following vaccination had more blood clots, darker blood and she had more cramps.   This case was linked to MOD-2021-405167, MOD-2021-405201 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 41-year-old female patient with no reported medical history, who experienced the non-serious  unexpected events Heavy menstrual bleeding and dysmenorrea . The events occurred on the same day after receiving the first  dose of mRNA-1273. Rechallenge is positive, since patient experienced the same symptoms after second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
On 4/21/2021 patient consented to receive initial Pfizer dose at facility. When RN documented vaccine administration into database she found previous record of 2 Pfizer vaccine administration at pharmacy first dose on 2/12/2021 and second dose on 3/5/2021. After receiving what we thought of as the first dose based on communication with the patient, he was monitored in facility with no adverse reaction.
throat was kind of sore; little light headedness; feeling pain in arm; tongue was sore; feeling a heat of rash where I had a surgery in the abdominal area; Ear ache; rash on my groin area; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in arm right on 29Mar2021 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension, diabetes mellitus, and surgery in the abdominal area. Concomitant medications included glipizide taken for diabetes mellitus. On an unspecified date, the patient experienced throat was kind of sore, little light headedness, feeling pain in arm, tongue was sore, feeling a heat of rash where patient had a surgery in the abdominal area, earache, and rash on groin area. Treatment (cream) was received for the event rash. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
A health professional reported the non-serious spontaneous event of administration to patient over 49 years of age involving an 82-year-old male patient. Neither medical history nor concomitant medications were provided. FLUMIST was administered on 26-Oct-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
This spontaneous report was received from a pharmacist via company representative regarding 1 of two patients and this report concerns a female patient of unknown age. No information about medical history, concurrent conditions were reported. The pharmacist had provided the consumer, the patient's husband with the Merck Global Safety phone number and directed him to call regarding  his wife and her shingles experience following vaccination with ZOSTAVAX. The Consumer was provided the Privacy disclosure statement and was asked if Merck would be able to send him/his wife correspondence to obtain wife's treating physician full contact information for which the consumer agreed. He stated that on an unknown date in 2015, his wife received ZOSTAVAX (lot# and expiry not reported). Since receiving that vaccination his wife has had shingles twice on an unknown date approximately in 2015. She was currently under the care of her physician (current treatment for her Shingles was unknown) and the condition was ongoing. The outcome of first occurrence of shingles was unknown. Causality was not reported. This is one of 2 reports from the same reporter. Additional information has been requested.
DIZZY FOR 24 HOURS; TIRED FOR 24 HOURS; INK BLOB TYPE THINGS FLOATING IN VISION, ESPECIALLY RIGHT EYE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 07-MAR-2021, the patient received series 1 dose of Janssen covid-19 vaccine ad26. cov2.s (dose number in series 1) for prophylactic vaccination and had normal feeling like trash for 24 hours.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 03-NOV-2021, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-NOV-2021, the patient was dizzy and tired for 24 hours. In NOV-2021 (for 2-3 days following booster vaccination), the patient experienced ink blob type things floating in vision, especially right eye.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy for 24 hours, and tired for 24 hours on 04-NOV-2021, and had not recovered from ink blob type things floating in vision, especially right eye. This report was non-serious. This case, involving the same patient is linked to 20211164183.
Since having my Covid-19 Vaccine shot, my periods have been always delayed, lasting more than 8 days with huge blood clots. I have never ever experienced delayed periods despite having PCOS or endeometriosis as well as never ever having large clots passing. As a result of this, i have began taking Ferrous sulphate daily to boost my iron levels, as i had felt very weak, lethargic after my first period after the inital vaccine. I have been waiting each month since vacination for my periods to return to normal 5 days, with minimal bleeding, but they have not returned to baseline.
Light headed and room spinning and foggy feeling in the head. Felt like his eyes were dilated. Back pain went away.
Information was received on 06-FEB-2019 from a lawyer and a female consumer regarding a case in litigation. On 14-JUN-2016 the patient was inoculated at a pharmacy with ZOSTAVAX (lot number and expiration not reported) for its intended purpose: the prevention of shingles. Shortly after receiving the vaccine the patient suffered intermittent horizontal diplopia and was later diagnosed with diplopia and esotropia. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages and required extensive medical care and treatment. The patient suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a result the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX.   Dlplopia and esotropia were considered to be disabling. Additional information has been requested.
Itchy red bumpy rashes appear randomly on body and disperse after about 30 minutes.   They have occurred on torso, hands, feet, legs, arms, neck and scalp.   Started on 7/1 and continue to appear.  First occurrence was on underside of left forearm.  Most frequent occurrences have been on lower torso (hips), neck and scalp.  Changes to temperature and humidity do not seem to impact when and where they occur.   Exercise and diet do not appear to have any impact on occurrences.   There do not seem to be any other side effects.  The day after the injection, there were no different side-effects than previous doses (all Moderna), sore arm and slight sluggishness.
Chills; Vomiting; Diarrhea; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a male 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 chills, vomiting and diarrhea. On an unknown date, the outcome of the chills, vomiting and diarrhea were unknown.   It was unknown if the reporter considered the chills, vomiting and diarrhea to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination not reported. The reporter stated, the patient had same reaction after unspecified shingles vaccine as she did. The reporter did not want to fill adverse event report form.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073609:same reporter
Pt phoned in & said had a local rxn to ZOSTAVAX shot, 3 days post injection. Pt. treated & no apparent sequelae. Rxn - red/itching at injection site.
Immediately got a shooting pain in arm with light headness. Got pale within 30 seconds. Started to have a seizure with uncontrollable arm and leg movement. Arms went limp broke out in a clammy cold sweat. Pupil got enlarged and were unresponsive. Patient blacked out and this continued off and on for 15-20 minutes post injection.  Had very labored breathing. EMS arrived and attended to patient