chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a vaccine error with PENTACEL and did not mix the Dtap-IPV component and gave the HIB component separately with no reported adverse event; Initial information received on 25-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter reported that nurse had a vaccine error Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] and did not mix the dtap-ipv component and gave the hib component separately with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose total (1 X) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (Strength: standard) (Frequency: once) (With an unknown expiry date, lot number) not reported via unknown route in unknown administration site.  On an unknown date, the reporter reported that nurse had a vaccine error Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] and did not mix the dtap-ipv component and gave the hib component separately with no reported adverse event (single component of a two-component product administered) (latency: same day).  It was reported, One of the nurses, had a vaccine error with PENTACEL and did not mix the Dtap-IPV component and gave the HIB component separately. Nurse on the line wanted to confirm if it's considered a valid HIB dose. Nurse did not have any information thus questionnaire is blank. Nurse called to ask if it's considered a valid HIB dose if not mixed the Dtap-IPV component of PENTACEL.   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.
Pt states about 2 hours after vaccine was given, she developed numbness and tingling in her arm which lasted for about 2 days.  Later that same afternoon, she developed chest pain with a pounding sensation in her heart.  Denied tachycardia.  Chest pain seemed to come and go for a few weeks.  Last episode was end of last week.
mom called clinic to report t104 ax p/speaking w/MD giving APAP & sponge baths; Ibuprofen;
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with improperly stored VARIVAX (Merck) (dose strength, route unspecified). No adverse effects reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the case 1507USA009809 via same reporter link. Additional information has been requested.
The evening after receiving vaccine (4/12) I had fatigue, extreme tiredness, fever, muscle aches, left arm pain, and extreme chills.   Today (4/13) all the side effects are gone, except for left arm pain, muscle aches, and fatigue.
This spontaneous report was received from a registered nurse refers to a 65-year-old female patient. On 08-OCT-2012 at 2:30 p.m. the patient was vaccinated with a dose of ZOSTAVAX (lot # H012578, expiration date not reported) in the left arm subcutaneously. No concomitant medications were reported. On 15-JAN-2013 call was placed to the registered nurse. The nurse stated that the patient was hypersensitive to injections. Approximately on 08-OCT-2012 (reported as the day after she received ZOSTAVAX) she had a 4 inch by 6 inch area that was red and inflamed. Approximately on 10-OCT-2012 (reported as the following day) she saw her physician as it had spread to her entire arm. She then went to the Emergency Room (ER). The patient had not followed up with her physician since that time. It was unknown if the patient had recovered. Additional information is not expected.
ear infection; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she had many comorbidities and was due for her second dose of BNT162B2 in a few days. She reported she had an ear infection and her doctor was out of town, so she was taking hydrastis canadensis (GOLDENSEAL) to treat. She inquired if there would be any interactions between hydrastis canadensis and BNT162B2. The clinical outcome of ear infection was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) 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. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    No relevant concomitant medications were reported. It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medication reported.   This case was for 18th patient out of 77 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Health care professional (HCP) mentioned that there was incident because of miscommunication as a coworker said that there were some lot numbers whose expirations dates have been extended.  On 07 Apr 2022, the patient received 2nd booster expired dose from the lot number 059H21A.  Treatment information was not provided
stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "unknown", described as "stroke".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received my first Pfizer COVID-19 booster on 12/3/2021. On 2/13/2022, I began to experience sinus congestion. On 2/14/2022, I took a home antigen test and got a positive result. On 2/15/2022, I went to the local office of the facility I work for and underwent a rapid test, which also yielded a positive result. During the first two days, I had sinus congestion and fatigue. On the third or fourth day, I lost my senses of taste and smell. The loss of taste and smell lasted for maybe a little over a week. The worst symptom was the fatigue, because I would get exhausted just walking across the room. During my illness, I took a vitamin C-zinc combination supplement. The sinus congestion lasted for about two weeks, and the fatigue ultimately lasted for over a month. I was finally able to return to work on 3/3/2022.
p/1st series of vax pt devel high pitched screaming, poor appetite devel, ear infect began p/vax;
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted post-vaccination while sitting in a chair during her observation time.
On 10/1/2008 clinic visit for vaccines, mom stated that patient had 101 degrees fever 1 week after 8/6/08 vaccines given.  Taken to Emergency. Was teething at that time also.
This case was reported by a physician and described the occurrence of lump injection site in a 45-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). On 8 February 2011 the subject received 3rd dose of ENGERIX B adult (unknown route, left arm). On 8 February 2011, less than one day after vaccination with ENGERIX B adult, the subject experienced lump injection site, injection site pain and limited range of motion. The subject complained of pain in her arm by phone call to physician's office in April 2011 and again in July 2011 in person at her physical appointment. The subject was referred for physical therapy and an x-ray of the site with unremarkable results. At the time of reporting the injection site pain was unresolved. The limited range of motion improved on an unspecified date. The lump at injection site resolved on an unknown date in February 2011. The physician considered the events were probably related to vaccination with ENGERIX B adult. Follow-up information was received on 27 September 2011 via a physician. It was reported that the events of lump injection site, injection site pain and limited range of motion occurred the same day of vaccination with ENGERIX B, 08 February 2011. The events were unresolved and were considered probably attributable to vaccination with ENGERIX B. The subject was considered to be healthy with no relevant medical history or concurrent illness. There was no history of alcohol or tobacco use. This vaccination with ENGERIX B was confirmed to be the last of 3. No concurrent medications were reported. A diagnostic test of AP and Lateral views of the left humerus was performed on 26 July 2011. Findings were: No fracture. The bones were in anatomic alignment. Impression: There was no fracture.
Swelling, erythema right arm at injection site. No temperature. Denies signs or symptoms of other distress.
Patients were administered with expired vaccine on 29-Apr-2022- 5 doses; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered with expired vaccine on 29-Apr-2022- 5 doses) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered with expired vaccine on 29-Apr-2022- 5 doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered with expired vaccine on 29-Apr-2022- 5 doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial did not undergo any temperature excursions.  The vial was initially not stored in the refrigerator they directly thaw them from the freezer before administration.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow up received and contains significant information included patient demographics.
Injection Site: Light pain, tenderness, swelling and redness from 20:00h for roughly 24 hours.
Firmness,  extreme soreness,  painful muscles at injection site,  redness,  swelling at injection site, warm/hot to touch. Started about 10 minutes after the vaccine, but since none of these symptoms were mentioned, I believed they were normal. First dose was the same and lasted about a week - a week and a half
Had a headache several days after vaccines. Also developed a rash on left arm 9 days after receiving the vaccine. It is warm to touch, very tender and very sore arm
mom reports pt cried for 2 days; MD contacted fever 103 (by forehead; dec to 100-101 w/non Aspirin product fever cont to reoccur for 2 days;
Severe vertigo, entire room spinning with nausea for 24 hours. Went to urgent care for treatment. Had very difficult time getting there. Had to crawl on the ground. Not much in the way of dx/treatment. Dx vertigo and gave me anti nausea meds. Tried epley, but didn't help. Spinning episodes subsided by early evening, but still felt awful. Laid in bed/slept in upright position.  2nd day: woke with no vertigo, but still not feeling well at all. Feeling like hung-over/brain fog/poor balance, couldn't do any work at computer.   3rd day: woke with slight vertigo. Turn head and objects would shift 10 degrees back and forth, but would stop if I kept my head still.    No more vertigo by middle of 3rd day, but continued feeling off, like hung over, with trouble doing work at computer for long periods. Slight dizziness constant. Severe dizziness if I move my head down fast. Don't feel I should drive a car or ride my bike until it resolves. It has now been one week since symptoms started. Probably 80% gone.
Recipient received the vaccine. While she was in the observation period, she started to have an itch. It started with the top of her head and then spread to the rest of her body.  EMS was onsite and checked her vital signs, which were normal. She took benadryl, 50 mg by mouth. She was observed for 30 more minutes. Her symptoms resolved and she went home.
booster; soreness under the arm; Swelling under the arm/Swelling on the arm after receiving the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Memory loss", start date: May2021 (unspecified if ongoing), notes: daughter may start with memory loss at 26 years old. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Exp: Unknown , NDC :Unknown), for COVID-19 immunization, reaction(s): "headache", "soreness in the arm"; Bnt162b2 (Second dose), for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; AXILLARY PAIN (non-serious), outcome "unknown", described as "soreness under the arm"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swelling under the arm/Swelling on the arm after receiving the booster dose".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101780739 same vaccine, different patient and AE
Patient is a 80 y.o. female patient of local MD with history of alzheimer's dementia, CVA, GERD, HTN and HLD presented to Medical Center with altered mental status.   Acute Metabolic Encephalopathy secondary to Covid Infection with baseline Alzheimer's Dementia Patient with decreased level of responsiveness for several hours  Family concerned for recurrent CVA  Workup including head CT generally unrevealing  Patient has not tolerated MRI previously As she has rapidly returned to normal further testing would be unlikely to alter prognosis/management  Presume due to waxing/waning of dementia, expectations discussed with family  Delirium precautions Cont home Aricept, Seroquel, Depakote, Remeron Recommend polypharmacy minimized outpatient as this may contribute Palliative care for support and goals of care, will require ongoing follow up opt. 1/17: Remains clinically stable for discharge to SNF.   Covid-19 Virus Infection Date of onset of symptoms: likely 1/6 Symptoms present on admission: covid likely source of patient's confusion Date of covid positive test: 1/9 Vaccination status: vaccinated Imaging: NA Oxygen requirements on admission: none Current oxygen requirements: none Medical therapy: not indicated Consultants following: none Anticipated special isolation end date: 1/17   Pyuria  No fever, no reports of dysuria  Culture contaminated  No plans for further abx as is clinically stable    Hx of TIA/CVA Nonfocal exam  Cont asa, statin  Normocytic Anemia Chronic, stable from prior Monitor   Hypertension BP poorly controlled in ED in setting of agitation Continue home Coreg, amlodipine, lisinopril   AV Stenosis Lower Extremity Edema Noted on TTE 10/4 BNP 450, with lower extremity edema TTE (10/4): EF 62%, moderate sclerosis of AV leaflets and mild AV stenosis Outpatient Cardiology follow-up recommended during previous admission   T2DM No current medications A1c 7.4% on 10/10 Did not require insulin last admission Monitor on serial BMPs
Pt presented 9 days post vaccine complaining that she experienced local redness and swelling in the vaccinated arm. She provided a photo showing a bruised area lower than midway below her right arm, several inches above the elbow. She stated that the bruised area was due to an improperly administered vaccine. I explained that vaccines are given in the thickest part of the upper deltoid area, which is approximately six inches away from the area she was complaining of the bruise. I stated that the bruising she showed was unlikely caused by the vaccine, and asked if she bruised the arm in a different way perhaps. She said that she was certian that the vaccine was given in the area of bruising and that the cause was without question. I apologized and said that I truly was sorry that she experienced this and that our primary concern was her well being. I asked if she brought the concern of possible improper vaccine technique at the time of vaccination and she said no, she did not. I then asked her if there was anything else I could do to address her concerns and she said that she was sastified with the apology and was currently having no other symptoms related to the vaccine.
Pt states began feeling pain immediately upon injection.  shoulder pain and limited shoulder motion.  pain began to improve after approximately 1 week, but still painful.  spoke with provider approximately 5 weeks later and diagnosed as SIRVA.  no labs/tests done.  diagnosis based on symptoms, location, and time of symptom onset.  Pt still feeling pain, though says is much improved and now has full range of motion.
Pt recvd 3 doses of Engerix-B & was determined to be a non-responder; pt recvd a booster dose of Engerix-B; again determined to be a non-responder; another booster will be given;
Patient felt like vomiting and could not stand up. Patient had to lay down on the floor. 911 was called EMT arrived to treat patient.
Lower leg pain, confirmed clot about 4 inches long via an ultrasound on 4/9
Patient had onset of generalized tonic clonic seizures evening 2 days after immunizations. Patient had 3 days of URI's x 1 and fever prior to immunizations. Patient hospitalized for continued seizures. Patient received Dilantin and Heparin.  5/22/07 Received hospital clinic medical records which reveal patient experienced congestion, rhinorrhea, cough, vomiting, fever for 3 days prior to vax on 2/23/07.  Dx w/viral URI & treated symptomatically.  Vax record confirms that reported on VAERS form.  7/31/07 Received medical records from hospital which reveal patient experienced cough, runny nose & cold s/s.  Had seizures x 3 on 2/25/07.  Temp 99.4.  Tx w/dilantin. FINAL DX: convulsive epilepsy; acute URI; acute sinusitis; developmental delay.
Prolonged crying for about 9 hours, following 1st series of immunization. Mom gave tylenol which seems to help.
Inadvertently mixed 1.8mL 0.9% sodium chloride into Pfizer vial 5y to 12y. Vaccine given to a adult male 25yrs. per Pharmacy director consult with Pfizer manufacture, patient to return to clinic and administer a adult Pfizer vaccine. Vaccine given to patient at 12:15pm. 12/15/2021.
patient was inadvertently given only the liquid portion of Menveo on 05May2023; patient was inadvertently given only the liquid portion of Menveo on 05May2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 05-MAY-2023, the patient received Menveo. On 05-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient was inadvertently given only the liquid portion of Menveo on 05May2023) and inappropriate dose of vaccine administered (Verbatim: patient was inadvertently given only the liquid portion of Menveo on 05May2023). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-MAY-2023 The reporter did not had liquid component lot available but provided the lot number and expiry date for powder portion in case that helps safety (LOT AMVA798A and expiry date: January 2024). The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient inadvertently received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.