chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: had a patient get 3 doses of the Shingrix Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 745JK, expiry date 19-JUN-2026) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 31st March 2022) and Shingrix (2nd dose received on 09 June 2022).   On 20-AUG-2024, the patient received the 3rd dose of Shingrix. On 20-AUG-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: had a patient get 3 doses of the Shingrix Vaccine). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-AUG-2024 A pharmacist started a chat and informed that patient had 3 doses of the Shingrix Vaccine which led to extra dose administered. The patient had a last name change, did not remember getting it, and the dose was not listed on the registry when checked. It had been over a week and patient had not reported any adverse events.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on 27 April 2021).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received). The outcome of the incomplete course of vaccination 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: 30-AUG-2024 The reporter stated that a patient that had his Havrix first dose in April 2021, never got the 2nd dose. The reporter cannot remember if he needed to restart the series or he just need the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Havrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received a Shingrix shot 2.5 years ago is questioning whether or not she should still get the 2nd shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 06-APR-2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received a Shingrix shot 2.5 years ago is questioning whether or not she should still get the 2nd shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-SEP-2024 The pharmacist reported that they had the patient who received an first Shingrix shot 2.5 years ago and she was questioning whether or not she should still get the 2nd shot, The reporter was assuming that they were not starting over but was been 2.5 years since the initial vaccination Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. This case is linked with US2024109560, reporter by same reporter.; Sender's Comments:  US-GSK-US2024109560:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic carcinoma
Clinical narrative: Pancreatic cancer; This spontaneous case was reported by a non-health professional and describes the occurrence of PANCREATIC CARCINOMA (Pancreatic cancer) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATIC CARCINOMA (Pancreatic cancer) (seriousness criterion medically significant). At the time of the report, PANCREATIC CARCINOMA (Pancreatic cancer) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported.  Patient had pancreatic cancer and had 5 Moderna shots for COVID.  No treatment medication was reported.  Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) event of pancreatic cancer. The event onset date is unclear. Vaccination dates are also not provided however it was stated that patient received 5 doses of Spikevax NOS. As reported, patient had pancreatic cancer and had 5 Moderna shots for COVID. No further information about the event was provided. Considering the nature of event and lack of biological plausibility for causality, the event of pancreatic cancer is assessed as not related. The benefit-risk relationship of Spikevax NOS is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Patient was so sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Patient was so sick) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer (All over body).    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient was so sick). At the time of the report, ILLNESS (Patient was so sick) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Dosage text was reported as unknown. No treatment information was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Plasma cell myeloma
Clinical narrative: multiple myeloma; he felt like he had the flu/muscle aches, pain, fatigue; This spontaneous case was reported by a patient and describes the occurrence of PLASMA CELL MYELOMA (multiple myeloma) in a 76-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (he has experienced certain side effects in the past with a previous Moderna COVID19 vaccine). Past adverse reactions to the above products included Vaccination adverse reaction with Moderna COVID-19 vaccine.    In 2024, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In April 2024, the patient experienced PLASMA CELL MYELOMA (multiple myeloma) (seriousness criterion medically significant). In 2024, the patient experienced INFLUENZA LIKE ILLNESS (he felt like he had the flu/muscle aches, pain, fatigue). In 2024, INFLUENZA LIKE ILLNESS (he felt like he had the flu/muscle aches, pain, fatigue) had resolved. At the time of the report, PLASMA CELL MYELOMA (multiple myeloma) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient was undergoing chemotherapy for Multiple Myeloma.  Company comment:  This is a spontaneous case concerning a 76-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Plasma cell myeloma. The event occurred after the administration the first dose of SPIKEVAX 2023-2024 vaccine. Latency could not be assessed due to lack of information on vaccination date. The patient also experienced flu like symptoms which lasted for less than 2 days. The patient is now under chemotherapy. No further information was provided. Age and gender are contributor risk factors for the event. The benefit-risk relationship of SPIKEVAX 2023-2024 Vaccine is not affected by this report.
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Headache, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: had a Home Covid test and came as Positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had a Home Covid test and came as Positive) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Aug-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 02-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced COVID-19 (had a Home Covid test and came as Positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (had a Home Covid test and came as Positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2024, Body temperature: fever of 102.5. On 02-Sep-2024, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient had headache and fever of 102.5. He mentioned that he had high fever with limited response to Tylenol along with headache, general Malaise, sore throat and nasal Congestion. On September 2nd he had a home Covid test and came as positive. Next day his PCP confirmed as Covid. The consumer also stated that he knows that vaccine did not cause him Covid but was wondering if vaccine could have contributed to the severity of the symptoms he was experiencing. However, he mentioned that he was currently doing better.
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: had a Home Covid test and came as Positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had a Home Covid test and came as Positive) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Aug-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 02-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced COVID-19 (had a Home Covid test and came as Positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (had a Home Covid test and came as Positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2024, Body temperature: fever of 102.5. On 02-Sep-2024, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient had headache and fever of 102.5. He mentioned that he had high fever with limited response to Tylenol along with headache, general Malaise, sore throat and nasal Congestion. On September 2nd he had a home Covid test and came as positive. Next day his PCP confirmed as Covid. The consumer also stated that he knows that vaccine did not cause him Covid but was wondering if vaccine could have contributed to the severity of the symptoms he was experiencing. However, he mentioned that he was currently doing better.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Chills, Feeding disorder, Headache
Clinical narrative: hair loss; stress; could not eat for 2 days; She was left very weak; chills; nauseated; terrible headache; low-grade fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALOPECIA (hair loss), STRESS (stress), FEEDING DISORDER (could not eat for 2 days), ASTHENIA (She was left very weak) and CHILLS (chills) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. 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 SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss), STRESS (stress), FEEDING DISORDER (could not eat for 2 days), ASTHENIA (She was left very weak), CHILLS (chills), NAUSEA (nauseated), HEADACHE (terrible headache) and PYREXIA (low-grade fever). At the time of the report, ALOPECIA (hair loss), STRESS (stress), FEEDING DISORDER (could not eat for 2 days), ASTHENIA (She was left very weak), CHILLS (chills), NAUSEA (nauseated), HEADACHE (terrible headache) and PYREXIA (low-grade fever) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated it took her cousin 2 days to recoup from the ordeal she went through that night.  She did not take anything for the symptoms. She stated that she believed it was a reaction from her body from the stress that the vaccine put her through. She had a good amount of hair loss with her first shower and washing her hair after the symptoms subsided. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773443 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773443:Patient 1 (Master case)
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Stress
Clinical narrative: hair loss; stress; could not eat for 2 days; She was left very weak; chills; nauseated; terrible headache; low-grade fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALOPECIA (hair loss), STRESS (stress), FEEDING DISORDER (could not eat for 2 days), ASTHENIA (She was left very weak) and CHILLS (chills) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. 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 SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss), STRESS (stress), FEEDING DISORDER (could not eat for 2 days), ASTHENIA (She was left very weak), CHILLS (chills), NAUSEA (nauseated), HEADACHE (terrible headache) and PYREXIA (low-grade fever). At the time of the report, ALOPECIA (hair loss), STRESS (stress), FEEDING DISORDER (could not eat for 2 days), ASTHENIA (She was left very weak), CHILLS (chills), NAUSEA (nauseated), HEADACHE (terrible headache) and PYREXIA (low-grade fever) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated it took her cousin 2 days to recoup from the ordeal she went through that night.  She did not take anything for the symptoms. She stated that she believed it was a reaction from her body from the stress that the vaccine put her through. She had a good amount of hair loss with her first shower and washing her hair after the symptoms subsided. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773443 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773443:Patient 1 (Master case)
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Ophthalmoplegia
Clinical narrative: Stroke; Internuclear ophthalmoplegia; This is a spontaneous report received from an Other HCP.  A 53-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: NURTEC ODT taken for migraine. The patient also took other concomitant therapy (reported taking an unknown inhaler). Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: OPHTHALMOPLEGIA (medically significant) with onset 02Nov2021, outcome "unknown", described as "Internuclear ophthalmoplegia"; CEREBROVASCULAR ACCIDENT (medically significant) with onset Nov2023, outcome "not recovered", described as "Stroke". The events "internuclear ophthalmoplegia" and "stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (Aug2024) Unknown results. Therapeutic measures were taken as a result of ophthalmoplegia, cerebrovascular accident. The patient reported that the week after her last vaccine, she had a neurological event called Internuclear ophthalmoplegia which happened on 02Nov2021. She never had one before and was hoping to never have one again. The patient also had a stroke in Nov2023 and still having symptoms. The patient reported she went to the emergency room for the events then has been given something, she does not quite recall.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events ophthalmoplegia, and cerebrovascular accident; and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Unable to sleep the night of the injection; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Sep2024 at 14:15 as dose 1, single (Lot number: LM2215) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INSOMNIA (non-serious) with onset 06Sep2024 at 23:00, outcome "recovered" (07Sep2024), described as "Unable to sleep the night of the injection". Therapeutic measures were not taken as a result of insomnia.  Additional information: Facility where vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. The patient was unable to sleep the night of the injection.  No follow-up attempts are possible.
Sex: U
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss; tinnitus; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00178.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss"; TINNITUS (non-serious), outcome "unknown". Clinical course: The patient was considering getting the vaccine in a week or whenever it comes out. The patient hasn't had a vaccine in two years because the last booster they got was mRNA (they think Pfizer). The patient got tinnitus and hearing loss; it was sudden onset. So, the patient has been rather paranoid on getting the vaccine and have not gotten COVID at this point, but patient felt like needed to get a vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Pyrexia
Clinical narrative: My Fahrenheit test cameup 100 points higher; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Aug2024 as dose 1, 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: PYREXIA (non-serious) with onset 30Aug2024, outcome "unknown", described as "My Fahrenheit test came up 100 points higher". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient called in with questions about the Pfizer Biotech COVID-19 vaccine. Patient received the COVID-19 on Thursday (29Aug2024). On 30Aug2024, Patient took a blood test, and Fahrenheit test came up 100 points higher.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: DTP, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: out of range for a cumulative time of 72 hours and provided the times the vaccines went out of range with no reported adverse event; Tdap vaccine have been administered post excursion,with no reported adverse event; Initial information received on 28-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to (2024SA254906).  This case involves an unknown age and unknown gender patient where reporter reported Polio Vaccine and diphtheria, tetanus and nos pertussis vaccine were out of range for a cumulative time of 72 hours and provided the times the vaccines went out of range with no reported adverse event and Tdap vaccine have been administered post excursion, 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 a dose of suspect diphtheria, tetanus and NOS pertussis vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for immunization and dose of suspect Polio vaccine not produced by Sanofi Pasteur lot number not reported for Immunisation (Product storage error) and (poor quality product administered) (latency-  same day).  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.
Age: 37.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: 3rd dose of Engerix B received longer than recommended scheduled; Engerix-B vaccine that was administered on 30AUG2024 that expired on 24AUG2024; 2nd dose received longer than recommended; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 37-year-old male patient who received HBV (Engerix B) (batch number FR334, expiry date 24-AUG-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received first dose on 24th March 2023).   On 30-AUG-2024, the patient received the 3rd dose of Engerix B. On 11-SEP-2023, the patient received the 2nd dose of Engerix B. On 11-SEP-2023, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received longer than recommended). On 30-AUG-2024, the patient experienced drug dose administration interval too long (Verbatim: 3rd dose of Engerix B received longer than recommended scheduled) and expired vaccine used (Verbatim: Engerix-B vaccine that was administered on 30AUG2024 that expired on 24AUG2024). The outcome of the drug dose administration interval too long and expired vaccine used were unknown and the outcome of the drug dose administration interval too long was not reported.   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: 30-AUG-2024 The licensed practical nurse requested extended expiration for Engerix-B vaccine that was administered to the patient on 30th August 2024 that expired on 24th August 2024,which led to expired vaccine used. The patient received 2nd and 3rd dose of Engerix B longer than recommended schedule, which led to lengthening of vaccination schedule.
Age: 72.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received two flu shots for the 2024 season- one administered on 9/8 and the other on 8/5. The patient feels fine otherwise.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation
Clinical narrative: Patient came in 5 days after getting her vaccination . She stated that her eyes were burning , when I asked if patient had any other problems she stated that her arm was sore after the shot , which I explained was normal. Patient did state to me that she was on dry eye therapy eye drops already. Told patient to follow up with her eye doctor if her current prescription eye drops are not working.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Scan, Seizure
Clinical narrative: I had a seizure on my drive home
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: The patient received a 2nd Arexvy vaccination. He stated that he had never received RSV vaccination in the past.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vascular pain
Clinical narrative: Symptoms started on Saturday evening with pain in the blood vessel around the left  arm, elbow, and the lower arm close to the hand and around the biceps area. The pain lasted over night and by Sunday morning the pain had subsided.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Local reaction
Clinical narrative: Local injection site reaction - redness and itching at injection site beginning on day after administration and continuing through Day 5
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: patient received fluzond HD On 8/12/24  and started to have adverse reactions 2 days later including headache, body aches, fever, and chills. Patient took some ibuprofen for the symptoms, and was fine a week later.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt states that 24 hours after the shot she began to feel light headed and dizzy and claimed she had fainting, but put her head between her legs to prevent this.  Pt did not go to any medical doctor or facility for any evaluation and was not transported by abulance
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Hypopnoea, Panic attack, Presyncope, Syncope
Clinical narrative: Patient received HPV vaccination while lying down on exam table, reported that he was nervous. Vaccine verified against provider order prior to administration by MA by RN (self). Initial dose of HPV was received by patient in 2023, no reported issue/adverse effects by parent.    Per parent - Patient got up and washed hands, no issue. Walked over to get hand sanitizer no issue, then collapsed, hit front of head against door.    1132: Parent opened door and called for help. RN, LVN, and MA responded immediately - stabilized patient's head as he was laying on the floor. Patient responsive, panicked.    Initial V/S @ 1135 while on floor NKDA 148/75, HR 75 SpO2 99% RR 24 rapid, shallow breathing   Providers entered exam room, LVN, parent, and RN (self) assisted patient to chair, he was able to stand on his own.    Repeat V/S @1139 in chair 123/75   Cold pack and wet towels placed on patients neck, per provider vasovagal reaction. Patient calmed down, provider checked pupillary response, no deficiency. Patient able to identify where he hit his head. Provided parent with ER precautions post-head injury, parent and patient verbalized understanding.    Patient asked to stand, able to stand without losing balance. Patient was offered but denied any soda/snacks. Per parent, child ate breakfast, but was reportedly very nervous about receiving vaccine today.    Patient able to respond to questions without issue. Sat back down without issue.   V/S @ 1149 in chair 131/82, HR 65, RR 16, normal non-labored breathing, able to take deep breaths without issue. SpO2 97%.    Patient responsive to questions, plays soccer, states his heart rate is usually around 65-70.    Patient ambulated in exam room without issue, denied any dizziness or nausea. No trouble with vision. Patient declined use of wheelchair to parent's vehicle.  Per provider, patient okay to d/c. Patient d/c at 1155. RN (self) walked alongside patient to outside curb, patient was ambulating without issue, stable. Reinforced ED precautions, parent verbalized understanding and agreed.
Age: 85.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Vomiting
Clinical narrative: chills and vomiting ~4 hours after injection
Age: 72.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient presented both arms with redness and swelling
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Skin discolouration
Clinical narrative: The patient has a history of cytokine storm following the initial first vaccine back in 2022. Given that information, she really wanted to receive her booster, as it had been over 2 years since the initial series she received, and she wanted immunity from the COVID-19 virus. Knowing this, the pharmacist had the patient wait 20 minutes following the vaccine to make sure that she was going to be okay. About 15 minutes after the vaccine, the patient's hand appeared a grayish color, and she was very lightheaded. The pharmacist did not want the patient to drive, but the patient did not want to go via ambulance to get looked at. She did not experience unconsciousness but was very lightheaded. The pharmacist checked her blood pressure, and it was normal at 119/74, and her pulse was 87. Eventually the patient felt okay, and a friend came to pick her up to go be seen by a medical professional. The pharmacist did not have to administer any other treatment to the patient
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This patient received two Flu shots (one on 7/26/24 and one on 9/8/24). The insurance covered both doses, and no alert occurred. I talked to the patient today and she has no symptoms.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Fatigue, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Within one hour of receiving vaccine started complaining of severe pain at injection site. Within 6 hours left thigh was very swollen. The next morning was crying inconsolably, unable to bear weight on left leg. Also started complaining of severe headache and neck ache. Fatigue. Vomited once. Neck pain is increasing 2 days after vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site swelling, Neck pain, Vomiting, Weight bearing difficulty
Clinical narrative: Within one hour of receiving vaccine started complaining of severe pain at injection site. Within 6 hours left thigh was very swollen. The next morning was crying inconsolably, unable to bear weight on left leg. Also started complaining of severe headache and neck ache. Fatigue. Vomited once. Neck pain is increasing 2 days after vaccine.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Sore throat, chills, muscle pain, headache, nausea, fever
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Sore throat, chills, muscle pain, headache, nausea, fever
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling, Skin irritation
Clinical narrative: Patient received her HPV and Men ACWY vaccine on 9/4. Mom states that two days later she developed redness and swelling around the injection site on her right arm. There was significant swelling and redness with some pain/itchiness for two subsequent days, which improved after using warm compresses and ice. There was no associated fever or other systemic symptoms, patient otherwise in her usual state of health. Today, the swelling has resolved, and patient complains of very mild residual irritation/stinging sensation around the area that was previously swollen.   Pictures provided by mom from yesterday show mild to moderate erythema and swelling starting from deltoid region extending a few inches proximal to patient's elbow.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Atrial fibrillation, Breathing-related sleep disorder, Condition aggravated, Dyspnoea
Clinical narrative: #1: The first night I started with respiratory distress, waking up every 30 to 45 minutes gasping for air. This lasted for 9 or 10 days. The MD had just started me on Tramadol for arthritis pain and I thought that was what was causing resp. distress since it is an opioid and stopped taking it immediately even though I had only taken two doses.  However when I had  the 2nd vaccine the same thing occurred starting that same night. Also I had an EKG late Oct./early Nov. and it showed no abnormalities.  I had  vaccines Jan 12 and Feb 2 and in early March I was diagnosed with A-fib. I do know that A-fib can happen at any time but I think it was "helped" in this case.  My health has declined ever since and I will have to live with this the rest of my life.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: General physical health deterioration, Middle insomnia, Respiratory distress, Therapy cessation
Clinical narrative: #1: The first night I started with respiratory distress, waking up every 30 to 45 minutes gasping for air. This lasted for 9 or 10 days. The MD had just started me on Tramadol for arthritis pain and I thought that was what was causing resp. distress since it is an opioid and stopped taking it immediately even though I had only taken two doses.  However when I had  the 2nd vaccine the same thing occurred starting that same night. Also I had an EKG late Oct./early Nov. and it showed no abnormalities.  I had  vaccines Jan 12 and Feb 2 and in early March I was diagnosed with A-fib. I do know that A-fib can happen at any time but I think it was "helped" in this case.  My health has declined ever since and I will have to live with this the rest of my life.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe itching armpits and groin the mostly just hands and feet
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria
Clinical narrative: Immediately following injection, developed a ~1cmx1.5cm red raised wheel at the vaccine site
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site bruising
Clinical narrative: Patient reports bruising at the injection site
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Abdominal pain upper, Anxiety, Balance disorder, Crying, Decreased appetite
Clinical narrative: On 6/1/23 mother presented with patient to report that following the 5/16/23 MMR/V vaccination  pt was very irritable, which became more significant as the week progressed. Pt then became "skiddish", and would "scream-cry" after looking down a hallway in her house. Sleep is disrupted at night and pt would "whine" in her sleep as well as throughout the day, which had never previously occurred. Per mom patient also experienced a regression in potty training behavior and will instead just go to the bathroom when she needs to instead of asking for help, mom has put her back in diapers. Patient is also experienced  a reduced appetite, stomach aches, and poor balance, often just falling over. Mom notes there was a similar reaction in patient's sibling. Mom states no recent changes at home or notable events or guest visits since receiving vaccine. No fevers. On exam, patient was growing well and had a normal neurological exam and specifically normal cerebellar function.  Normal VS. She is at baseline developmentally delayed and the urinary  toileting regression was felt to be age appropriate.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Developmental regression, Fall, Irritability, Neurological examination normal, Screaming
Clinical narrative: On 6/1/23 mother presented with patient to report that following the 5/16/23 MMR/V vaccination  pt was very irritable, which became more significant as the week progressed. Pt then became "skiddish", and would "scream-cry" after looking down a hallway in her house. Sleep is disrupted at night and pt would "whine" in her sleep as well as throughout the day, which had never previously occurred. Per mom patient also experienced a regression in potty training behavior and will instead just go to the bathroom when she needs to instead of asking for help, mom has put her back in diapers. Patient is also experienced  a reduced appetite, stomach aches, and poor balance, often just falling over. Mom notes there was a similar reaction in patient's sibling. Mom states no recent changes at home or notable events or guest visits since receiving vaccine. No fevers. On exam, patient was growing well and had a normal neurological exam and specifically normal cerebellar function.  Normal VS. She is at baseline developmentally delayed and the urinary  toileting regression was felt to be age appropriate.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Sleep disorder
Clinical narrative: On 6/1/23 mother presented with patient to report that following the 5/16/23 MMR/V vaccination  pt was very irritable, which became more significant as the week progressed. Pt then became "skiddish", and would "scream-cry" after looking down a hallway in her house. Sleep is disrupted at night and pt would "whine" in her sleep as well as throughout the day, which had never previously occurred. Per mom patient also experienced a regression in potty training behavior and will instead just go to the bathroom when she needs to instead of asking for help, mom has put her back in diapers. Patient is also experienced  a reduced appetite, stomach aches, and poor balance, often just falling over. Mom notes there was a similar reaction in patient's sibling. Mom states no recent changes at home or notable events or guest visits since receiving vaccine. No fevers. On exam, patient was growing well and had a normal neurological exam and specifically normal cerebellar function.  Normal VS. She is at baseline developmentally delayed and the urinary  toileting regression was felt to be age appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Pt reported the right side of her face feeling numb while being monitor after the vaccine.  She had Moderna vaccine before without any problem.  I told her it could be Bell's Palsy, chance is very rare but it's possible.  Pt went to see the Dr after and was diagnosed with Bell's Palsy.  I spoke to her in the evening, she said everything is fine.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Amblyopia, Asthenia, Blood test, Fine motor skill dysfunction, Gait inability
Clinical narrative: Per mother, he started not acting like himself shortly after the vaccines.  He presented to our office on 04/21/23 after a week of vomiting and was diagnosed with OM and PNA.   He returned to our office on 04/24/23.  I saw him at that time.  He no longer had OM or PNA but was listless and appeared dehydrated.  I transferred his care to Hospital ER.   He was discharged from the ER and presented to our office again on 04/26/23.  Once again he was transferred to Hospital ER.  He was diagnosed with Guillain Barre Syndrome and admitted to the ICU.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Gastrointestinal tube insertion, Guillain-Barre syndrome, Hypotonia, Immunoglobulin therapy, Inability to crawl
Clinical narrative: Per mother, he started not acting like himself shortly after the vaccines.  He presented to our office on 04/21/23 after a week of vomiting and was diagnosed with OM and PNA.   He returned to our office on 04/24/23.  I saw him at that time.  He no longer had OM or PNA but was listless and appeared dehydrated.  I transferred his care to Hospital ER.   He was discharged from the ER and presented to our office again on 04/26/23.  Once again he was transferred to Hospital ER.  He was diagnosed with Guillain Barre Syndrome and admitted to the ICU.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Intensive care, Lumbar puncture, Magnetic resonance imaging, Malaise, Mobility decreased
Clinical narrative: Per mother, he started not acting like himself shortly after the vaccines.  He presented to our office on 04/21/23 after a week of vomiting and was diagnosed with OM and PNA.   He returned to our office on 04/24/23.  I saw him at that time.  He no longer had OM or PNA but was listless and appeared dehydrated.  I transferred his care to Hospital ER.   He was discharged from the ER and presented to our office again on 04/26/23.  Once again he was transferred to Hospital ER.  He was diagnosed with Guillain Barre Syndrome and admitted to the ICU.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Muscular weakness, Musculoskeletal disorder, Nasopharyngitis, Rhinorrhoea, Social avoidant behaviour
Clinical narrative: Per mother, he started not acting like himself shortly after the vaccines.  He presented to our office on 04/21/23 after a week of vomiting and was diagnosed with OM and PNA.   He returned to our office on 04/24/23.  I saw him at that time.  He no longer had OM or PNA but was listless and appeared dehydrated.  I transferred his care to Hospital ER.   He was discharged from the ER and presented to our office again on 04/26/23.  Once again he was transferred to Hospital ER.  He was diagnosed with Guillain Barre Syndrome and admitted to the ICU.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Streptococcus test, Streptococcus test negative, Vomiting
Clinical narrative: Per mother, he started not acting like himself shortly after the vaccines.  He presented to our office on 04/21/23 after a week of vomiting and was diagnosed with OM and PNA.   He returned to our office on 04/24/23.  I saw him at that time.  He no longer had OM or PNA but was listless and appeared dehydrated.  I transferred his care to Hospital ER.   He was discharged from the ER and presented to our office again on 04/26/23.  Once again he was transferred to Hospital ER.  He was diagnosed with Guillain Barre Syndrome and admitted to the ICU.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Dehydration, Guillain-Barre syndrome, Intensive care, Listless
Clinical narrative: Per mother, he started not acting like himself shortly after the vaccines.  He presented to our office on 04/21/23 after a week of vomiting and was diagnosed with OM and PNA.   He returned to our office on 04/24/23.  I saw him at that time.  He no longer had OM or PNA but was listless and appeared dehydrated.  I transferred his care to Hospital ER.   He was discharged from the ER and presented to our office again on 04/26/23.  Once again he was transferred to Hospital ER.  He was diagnosed with Guillain Barre Syndrome and admitted to the ICU.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Otitis media, Pneumonia, Vomiting
Clinical narrative: Per mother, he started not acting like himself shortly after the vaccines.  He presented to our office on 04/21/23 after a week of vomiting and was diagnosed with OM and PNA.   He returned to our office on 04/24/23.  I saw him at that time.  He no longer had OM or PNA but was listless and appeared dehydrated.  I transferred his care to Hospital ER.   He was discharged from the ER and presented to our office again on 04/26/23.  Once again he was transferred to Hospital ER.  He was diagnosed with Guillain Barre Syndrome and admitted to the ICU.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 26-year-old patient received her first and only dose of GARDASIL 9 in 2021; No symptoms reported / No additional AE; This spontaneous report was received from a nurse practioner, concerning a currently 26-year-old female patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date in 2021, the patient was vaccinated with the 1st and only dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prophylaxis (exact dosage, lot number, expiration date, route of administration, and anatomical location were not provided). The reporter inquired if series needed to be repeated as the patient no received further doses (Inappropriate schedule of product administration). No symptoms nor additional adverse events (AE) were reported.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm sore; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm sore". Additional information: Consumer reports that on the previous administrations she only had an arm sore.