chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Only adjuvant component administered; Only adjuvant component administered; 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 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-NOV-2024, the patient received Shingrix. On 14-NOV-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only adjuvant component administered) and inappropriate dose of vaccine administered (Verbatim: Only adjuvant component administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-NOV-2024 The patient received only adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Extra dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose in 2023).   In NOV-2024, the patient received the 2nd dose of Arexvy. In NOV-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-NOV-2024 The health care professional reported that a patient received 1 dose of Arexvy in 2023 and he again got another shot last week by mistake, which led to extra dose administered. The reporter want to know safety and efficacy data regarding repeat vaccine. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Dosing Schedule (Bexsero 1st dose, Trumenba 2nd dose); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Trumenba. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Dosing Schedule (Bexsero 1st dose, Trumenba 2nd dose)). The outcome of the interchange of vaccine products 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: 22-NOV-2024 Pharmacist called asking about advice regarding a male patient dosing schedule who received first dose of Bexsero and Trumenba as second dose. No specific vaccination dates and no vaccine details were provided from the Pharmacist.  No further information was provided. Patient received first dose of Bexsero and Trumenba as second dose which led to interchange of vaccine products.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Nervous system disorder, Quadriplegia
Clinical narrative: CNS system was not working/neurological problems; paralysis from the neck down/paralyzed; suffering from "5 auto-immune diseases/multiple autoimmune conditions; This spontaneous case was reported by a patient and describes the occurrence of NERVOUS SYSTEM DISORDER (CNS system was not working/neurological problems), QUADRIPLEGIA (paralysis from the neck down/paralyzed) and AUTOIMMUNE DISORDER (suffering from "5 auto-immune diseases/multiple autoimmune conditions) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In April 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NERVOUS SYSTEM DISORDER (CNS system was not working/neurological problems) (seriousness criteria hospitalization and disability). In 2021, the patient experienced QUADRIPLEGIA (paralysis from the neck down/paralyzed) (seriousness criterion medically significant) and AUTOIMMUNE DISORDER (suffering from "5 auto-immune diseases/multiple autoimmune conditions) (seriousness criterion medically significant). At the time of the report, NERVOUS SYSTEM DISORDER (CNS system was not working/neurological problems), QUADRIPLEGIA (paralysis from the neck down/paralyzed) and AUTOIMMUNE DISORDER (suffering from "5 auto-immune diseases/multiple autoimmune conditions) had not resolved.            No concomitant and treatment medications were reported.  The patient experienced an adverse event for the last 2 and a half years and stated that she became paralyzed after receiving vaccine and her CNS system was not working. The patient had many more diagnosis.  The patient experienced paralysis from the neck down and was suffering from 5 auto-immune diseases. The patient further indicated she had been to the clinic and well as numerous specialists about that matter. She had severe health issues after receiving Moderna's COVID-19 vaccines, including multiple autoimmune conditions and neurological problems. She was unable to get proper medical treatment and diagnosis from doctors who were unfamiliar with her condition.   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2024: Live significant follow-up received- Reporter details, patient details, suspect therapy details and events of paralyzed, CNS system was not working were added. On 10-Dec-2024: Live significant follow-up received- Reporter details, suspect therapy date, events of paralysis from the neck down and suffering from 5 auto-immune diseases were added. On 10-Dec-2024: Live non-significant follow up added. Event of neurological problems was added. On 10-Dec-2024: Live Follow-up  No New Information was added.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: a couple of her fingers turned purple; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN DISCOLOURATION (a couple of her fingers turned purple) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043029) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced SKIN DISCOLOURATION (a couple of her fingers turned purple). At the time of the report, SKIN DISCOLOURATION (a couple of her fingers turned purple) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were provided. No vaccines in past 4 weeks and no relevant medical history. Patient received the vaccine and a couple of hours after, a couple of her fingers turned purple. HCP stated he did not think it's all her fingers, just some. She did not have any itching or rash present. Did not mention any loss circulation. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2024: Live Follow Up contains no new significant information received. Reference number added.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Still in pain from my shoulder to my hand; muscle pain in my right arm constantly since the shot; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Still in pain from my shoulder to my hand) and MYALGIA (muscle pain in my right arm constantly since the shot) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 11-Sep-2024, the patient experienced PAIN IN EXTREMITY (Still in pain from my shoulder to my hand) and MYALGIA (muscle pain in my right arm constantly since the shot). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Still in pain from my shoulder to my hand) and MYALGIA (muscle pain in my right arm constantly since the shot) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       Concomitant product use was not provided by the reporter.  Patient had had muscle pain in her right arm constantly since the shot. She had tried muscle relaxants, Tylenol, physical therapy. Still in pain from her shoulder to her hand. It was unknown if the patient experienced any additional symptoms or events.
Age: 55.0
Sex: M
Vaccine: RSV
Symptoms: Device issue, Product container issue, Skin laceration
Clinical narrative: Received some cuts from the device broke on his hand / burst or broke on the providers hand and cost a bit of an issue because the plunger did not completely go through the first step; Received some cuts from the device broke on his hand / burst or broke on the providers hand and cost a bit of an issue because the plunger did not completely go through the first step; Received some cuts from the device broke on his hand / burst or broke on the providers hand and cost a bit of an issue because the plunger did not completely go through the first step; received some cuts from the device broke on his hand; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 11Dec2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from an Other HCP from product quality group.  A 55-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 25Nov2024 as dose 1, single (Lot number: LN5467, Expiration Date: 31Oct2025) at the age of 55 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE MECHANICAL ISSUE (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 25Nov2024, outcome "unknown" and all described as "Received some cuts from the device broke on his hand / burst or broke on the providers hand and cost a bit of an issue because the plunger did not completely go through the first step"; LIMB INJURY (non-serious) with onset 25Nov2024, outcome "unknown", described as "received some cuts from the device broke on his hand". Additional information: It was reported that Abrysvo actually burst or broke on the provider's hand and cost a bit of an issue because the plunger did not completely go through the first step. The plunger has to go down in order for the 2 items to mix and it wasn't going down so the doctor put a little bit more pressure on it and the vial broke on his hands.  Causality for "received some cuts from the device broke on his hand / burst or broke on the providers hand and cost a bit of an issue because the plunger did not completely go through the first step" and "received some cuts from the device broke on his hand" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 2.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling, Product administration error
Clinical narrative: developed Cellulitis on right thigh/ Its pretty swollen, derailed and painful; This is a spontaneous report received from an Other HCP from medical information team.  A 2-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Dec2024 as dose 3, 0.5 ml single (Lot number: HN2630, Expiration Date: Aug2025) at the age of 2 years intramuscular, in right thigh for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Prevnar 20 for Immunization, notes: DOSE 1, SINGLE; Prevnar 20 for Immunization, notes: DOSE 2, SINGLE. The following information was reported: CELLULITIS (non-serious) with onset 11Dec2024, outcome "not recovered", described as "developed Cellulitis on right thigh/ Its pretty swollen, derailed and painful". Therapeutic measures were taken as a result of cellulitis.  Additional information: Reporter stated "Its pretty swollen, derailed and painful. So I wanted to report it and also know if there was any other case if you guys had. looks like it was worsened since the pain was so bad the child had to be brought into the office today. Treatment was given to child ibuprofen in the office immediately and then sent the child home and advised to do warm and cold compresses. Nurse practitioner calling about Prevnar 20 for pediatric. Reporting she had a 2 year old child that received Prevnar 20 and developed cellulitis on her right thigh. First she has heard of this and wanted to report this and know if Pfizer has heard of any other cases. Causality was likely related to Prevnar 20 vaccine. Patient was a fairly healthy young child. She came in today for an exam.
Sex: U
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: The nurse reported two incidents where the patient was given Trumenba and they passed out. Both patients recovered in the clinic.; This is a spontaneous report received from a Nurse from a sales representative.  An adolescent patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "The nurse reported two incidents where the patient was given Trumenba and they passed out. Both patients recovered in the clinic.". It was unknown if therapeutic measures were taken as a result of loss of consciousness.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possibly contributory role of TRUMENBA in triggering the onset of 'passed out' occurred to the adolescent cannot be fully excluded, considering the temporal relationship.   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 ,Linked Report(s) : US-PFIZER INC-202400325906 same reporter/drug/event, different patient;
Sex: U
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: The nurse reported two incidents where the patient was given Trumenba and they passed out. Both patients recovered in the clinic.; This is a spontaneous report received from a Nurse from a sales representative.  An adolescent patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "The nurse reported two incidents where the patient was given Trumenba and they passed out. Both patients recovered in the clinic.". It was unknown if therapeutic measures were taken as a result of loss of consciousness.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possibly contributory role of TRUMENBA in triggering the onset of 'passed out' occurred to the adolescent cannot be fully excluded, considering the temporal relationship.   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,Linked Report(s) : US-PFIZER INC-202400325649 same reporter/drug/event, different patient;
Sex: U
Vaccine: COVID19, FLUX, PPV
Symptoms: Dizziness, Hunger
Clinical narrative: dizziness/dizzy; empty stomach; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as unk unk, single), in arm for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), as unk unk, single), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness/dizzy"; HUNGER (non-serious), outcome "unknown", described as "empty stomach".  Additional information: Patient reported would not have had these shots for the covid (Clarified as Pfizer COVID-19 Vaccine), flu (Unspecified Flu Shot) and pneumonia shot (Unspecified Pneumonia Shot), all at one time, two in one arm and the other one in the other arm  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chillblains
Clinical narrative: Increase chilblains on toes; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 12Dec2024 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: AJOVY [FREMANEZUMAB]; BACLOFEN; CRESTOR; CYMBALTA. The patient did not receive any vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The following information was reported: CHILLBLAINS (non-serious) with onset 14Dec2024 at 17:00, outcome "recovering", described as "Increase chilblains on toes". Therapeutic measures were not taken as a result of chillblains.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 24.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: reaction of site swelling; reaction of site redness; vaccine administered to the patient's subcutaneous tissue; This is a spontaneous report received from a Physician from medical information team.  A 24-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Dec2024 as dose 1, 0.5 ml single (Lot number: LG9827, Expiration Date: 31Oct2025) at the age of 24 years subcutaneous, in left arm for maternal immunisation. The patient was 34 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Dec2024, outcome "unknown", described as "vaccine administered to the patient's subcutaneous tissue"; VACCINATION SITE ERYTHEMA (non-serious) with onset 11Dec2024, outcome "recovering", described as "reaction of site redness"; VACCINATION SITE SWELLING (non-serious) with onset 11Dec2024, outcome "recovering", described as "reaction of site swelling".  Additional Information: It was reported that the vaccine was not given in the deltoid and site redness and swelling started the night before on 11Dec2024. Clarifies she came in on 12Dec2024 to see the provider.
Sex: F
Vaccine: COVID19, FLUX, RVX
Symptoms: Feeling abnormal
Clinical narrative: they felt like they got "knocked low" the next day; This is a spontaneous report received from an Other HCP, Program ID.  A 68-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; influenza vaccine (FLU VACCINE), in Dec2023); rsv vaccine (RSV VACCINE), in Dec2023). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "they felt like they got "knocked low" the next day". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: reactions to covid19 vaccines (soreness around the arm); reactions to covid19 vaccines (tiredness); This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-016955 (BioNTech), 2024SA321489 (Sanofi).  An 85-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since Nov2021 (ongoing)) at 300 mg (300 mg qow (strength 300mg/2ml)), subcutaneous for dermatitis atopic. The patient's relevant medical history included: "Dermatitis atopic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "reactions to covid19 vaccines (soreness around the arm)"; FATIGUE (non-serious), outcome "unknown", described as "reactions to covid19 vaccines (tiredness)". The action taken for dupilumab was dosage not changed. Additional information: On an unknown date, the patient developed a non-serious event "reactions to covid-19 vaccines" (soreness around the arm and tiredness) (unknown latency) following first dose intake of DUPILUMAB and COVID-19 Vaccine. Unknown if MD was aware. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome for the events was unknown.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Post-acute COVID-19 syndrome
Clinical narrative: developed Long COVID; contracted COVID-19; contracted COVID-19; This is a spontaneous report received from a Pharmacist, Program ID.  A male patient in his 40's received BNT162b2 (BNT162B2), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "contracted COVID-19"; POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "not recovered", described as "developed Long COVID". Clinical course: Male patient in his mid-40s, self-described as slightly overweight, received Pfizer's 2021 COVID-19 vaccine some time in Feb2021. In May or Jun (he wasn't sure which month) of 2021, he contracted COVID-19 and developed Long COVID. The single Long Covid symptom that he described Is loss of smell/reduction in sense of smell. That symptom persists today of interview (12Dec2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event drug ineffective based on the known safety profile and temporal association.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 11-Dec-2024 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves Adult male patient who experienced flu after receiving Influenza vaccine.  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 influenza 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 prophylactic vaccination.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On an unknown date the patient flu (influenza) (unknown latency). The patient was hospitalized for this event.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.; Sender's Comments: Sanofi Company Comment dated 17-Dec-2024: This case involves Adult male patient who experienced flu after receiving Influenza vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 100.0
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: flu shot killed him in 4 days; Initial information received on 11-Dec-2024 regarding an unsolicited valid Social Media serious case received from a patient's son.  This case involves a 100 years old male patient who was killed in 4 days after receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer (doe, formulation, strength, route, lot number and expiry: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious flu shot killed him in 4 days (death) (unknown latency).  Reportedly:-My last flu shot was in 71 in the workplace.  No choice. One buddy ended up in hospital and never returned to work. Last jab for me. 75 now, and take no meds,  prescription or OTC.  I do take 5 grams of Vitamin C and Iodine and Magnesium.  My goal is to live longer than my father  This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) flu shot killed him in 4 days.  Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the event (flu shot killed him in 4 days).  At time of reporting, the outcome was Fatal for the event flu shot killed him in 4 days.  The cause of death was reported as Death.; Sender's Comments: Sanofi company comment dated: 18-Dec-2024:- This case involves a 100 years old male patient who was killed in 4 days after receiving vaccine INFLUENZA VACCINE. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any family history patient past medical history and concurrent condition precludes comprehensive case assessment.; Reported Cause(s) of Death: death
Age: 27.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt came requesting second polio vaccine that she needed.  pharmacist did not realize until after the administration of the vaccine that the patient just had polio vaccine on 12/3/24.   pt did not fill out the form appropriately and did not indicate that she had just received vaccines less than 2 weeks ago.  pt did not experience any adverse effects or issues.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: Staff member administered Prevnar 13 that expired 11-30-2024.  Provider notified and Pfizer/Wyeth notifed.  Patient will need to get another Pneumoccal injection as the expired one may not be as effective as it should be.   Have been unable to reach patient as yet.  Will keep trying so patient can return to office to get the vaccine.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Pt stated after vaccine she has been experiencing  vomiting and diarrhea
Age: 20.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Patient is pregnant (32 weeks), patient came yesterday to received RSV 1st dose, Provider ask me to give another RSV, I didn't check the logs from yesterday so I give her another dose.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: 12/11/2024 @12:15 pm Per pt, reports experiencing severe pain at the site of Flu vaccine. States attempted to schedule appt but appts are months out. Requesting this message be sent to his PCP 12/14/2024 @ 3:34 pm RN Spoke with patient. He states he has been taking ibuprofen and it helps for about 40 mins. He reports pain is not as severe as it was but still present. Injection site is not red or swollen. Patient reports the pain is radiating up to his neck and down to his fingers. Appt scheduled with pcp 12/18/2024 for f/up. ED precautions given for worsening or new sx.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Chills, Decreased appetite, Injection site erythema, Injection site swelling
Clinical narrative: RN spoke to patient on 12/13/24 @ 0947. Pt stating she received shingles vaccine in R arm 2 days ago. Pt c/o site hot and swollen (about the size of an egg), started yesterday. Pt c/o fever (102.4F) and chills since yesterday, took water and tylenol. Pt still c/o fever and chills. Pt stating no h/o reaction. Pt hasn't eaten in 24H and c/o of nausea. Pt diabetic and stating BS 151 when she woke up this morning. RN notified DO and recommended pt being seen today at walk-in clinic. RN notified pt of this and stated limited availability at walk-in today. RN recommended pt going to urgent care. Pt went to urgent care on 12/13/24, was thought to be having a local reaction and outlined the area. On 12/14/24, redness spread past outlined area and pt went to ED. Due to concern for cellulitis, pt started on keflex.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: RN spoke to patient on 12/13/24 @ 0947. Pt stating she received shingles vaccine in R arm 2 days ago. Pt c/o site hot and swollen (about the size of an egg), started yesterday. Pt c/o fever (102.4F) and chills since yesterday, took water and tylenol. Pt still c/o fever and chills. Pt stating no h/o reaction. Pt hasn't eaten in 24H and c/o of nausea. Pt diabetic and stating BS 151 when she woke up this morning. RN notified DO and recommended pt being seen today at walk-in clinic. RN notified pt of this and stated limited availability at walk-in today. RN recommended pt going to urgent care. Pt went to urgent care on 12/13/24, was thought to be having a local reaction and outlined the area. On 12/14/24, redness spread past outlined area and pt went to ED. Due to concern for cellulitis, pt started on keflex.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Patient reported rapid, pronounced swelling of injection site immediately, as well as tenderness of injection site. Patient waited for 15-20 minutes for observation. Swelling reported to be decreased after ice pack applied. Patient also reported general dizziness, which was improved after the waiting period. After reaction, patient acknowledged that she suffered a torn rotator cuff in the right shoulder in the same arm that the vaccine was administered in, but the patient did not inform us at the time. The patient was counseled on what to do if any allergic reactions or adverse effects after departure.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Pt had previously received a Tdap shot at pharmacy on 08/21/2024, then another Tdap shot on 12/17/2024
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: Pharmacist only gave me paper on Tdap(tetanus, diphtheria,Peertussis
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Pt did not experience any adverse effects. I called his mother to notify.   it didn't let me skip the date of reaction. He had no reactions
Age: 77.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Chest discomfort, Fatigue, Heart rate increased, Tachycardia
Clinical narrative: tachycardia; This non-serious case was reported by a consumer via call center representative and described the occurrence of tachycardia in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 30-NOV-2024 11:00, the patient received Arexvy. On 30-NOV-2024 11:30, 30 min after receiving Arexvy, the patient experienced tachycardia (Verbatim: tachycardia). On 30-NOV-2024 14:30, the outcome of the tachycardia was resolved (duration 3 hrs).   It was unknown if the reporter considered the tachycardia to be related to Arexvy.     It was unknown if the company considered the tachycardia to be related to Arexvy.   Additional Information: GSK receipt date: 11-DEC-2024 The patient received Arexvy vaccine and 30 minutes after he started to experience tachycardia that lasted for 3 hours.
Age: 77.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Tachycardia
Clinical narrative: tachycardia; This non-serious case was reported by a consumer via call center representative and described the occurrence of tachycardia in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 30-NOV-2024 11:00, the patient received Arexvy. On 30-NOV-2024 11:30, 30 min after receiving Arexvy, the patient experienced tachycardia (Verbatim: tachycardia). On 30-NOV-2024 14:30, the outcome of the tachycardia was resolved (duration 3 hrs).   It was unknown if the reporter considered the tachycardia to be related to Arexvy.     It was unknown if the company considered the tachycardia to be related to Arexvy.   Additional Information: GSK receipt date: 11-DEC-2024 The patient received Arexvy vaccine and 30 minutes after he started to experience tachycardia that lasted for 3 hours.
Sex: U
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site pain/tendernessat the injection site and swelling after receiving a dose of GARDASIL 9.; Injection site pain/tendernessat the injection site and swelling after receiving a dose of GARDASIL 9.; This spontaneous report was received from a nurse referring to themselves as a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On 11-DEC-2024, the patient experienced injection site pain/tenderness and swelling at injection site (vaccination site pain / vaccination site swelling) following hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination. At the time of reporting, the outcome of the events was not reported.  No additional information provided.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report that an expired dose of PNEUMOVAX23 was inadvertently administered to a patient on 12/12/2024. Caller confirmed the product has no history of a temperature excursion. Caller was provided with the not supported statement from the; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 12-DEC-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23) lot # W027449, expiration date 25-SEP-2024 (dose and route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No symptomatic events reported / No additional AE; An adult patient who received a pediatric dose of VAQTA on 12/16/2024; This spontaneous report was received from a Licensed Practical Nurse, concerning an adult patient of unspecified age and unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 16-DEC-2024, the adult patient was vaccinated with a pediatric dose (1 dosage form) of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered as prophylaxis (exact dose, lot number, expiration date, route of administration, and anatomical location were not provided) (Product administered to patient of inappropriate age).  No symptomatic events nor additional information were reported.  Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No ae; Pharmacist reported that a patient who was born in 1995 received first dose of VARIVAX on 3/01/1997 and second dose on 7/2/2008.  The patient wanted to get the third dose for unspecified reason.  The patient did not get the third dose yet.  No ae/ no; This spontaneous report was received from a pharmacist referring to a patient of unknown gender that at the time of this report would be approximately 29-year-old. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 01-MAR-1197, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). Then, on 02-JUL-2008, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) (inappropriate schedule of product administration). It was reported that the patient wanted to get the third dose for unspecified reason. The patient did not get the third dose yet. No adverse event (AE) was reported.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Health care professional called to report a temperature excursion on PROQUAD, the PROQUAD was stored in the refrigerator and administered; This spontaneous report was received from an other Health Professional and refers to a 6-year-old patient of unknown gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 09-OCT-2024, the patient was vaccinated with a dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) injection,  lot #Y002099, expiration date: 09-JUL-2025, administered for prophylaxis (strength and route of administration were not provided), that underwent a temperature excursion (TE). The reporter stated that the measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator and administered to the patient. There were no reported signs or symptoms of adverse effects. No additional adverse events  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2412USA005703:
Age: 41.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Vaccination site swelling
Clinical narrative: Technician vaccinated the patient and noticed the area swelling rapidly after vaccination with second shot (Covid-19).  Immediately had the pharmacist check the patient.  Spacing of the vaccination was appropriate but the area was quite swollen so had patient sit for mandatory 15 minutes to monitor and gave ice pack for localized injection site reaction.  Patient did not complain of increased pain only slight dizziness but fine after observation period.  Notified patient to follow up with PCP if symptoms worsen or do not improve.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site warmth, Skin infection
Clinical narrative: REDNESS /WARMTH ON INJECTION SITE- LEFT ARM
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No reported signs/symptoms of adverse effects. No additional AE/no PQC; TE on PROQUAD; This spontaneous report was received from a medical assistant referring to an 8-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 29-AUG-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (lot#: Y002099, expiration date: 09-JUL-2025; strength and dose were not provided) for prophylaxis. The administered experienced temperature excursion (TE) before (product storage error). No additional adverse events (AE) were reported (no adverse event).
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired drug used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 08-NOV-2024, the patient received Havrix. On 08-NOV-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired drug used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-NOV-2024 The health care professional reported that expired vaccine was administered to a patient, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; 3 years later got shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 3 years later got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-DEC-2024  The patient self reported this case for himself. The reporter reported that he received GlaxoSmithKline shingles vaccine and 3 years later got shingles. The reporter wanted to know why since it's supposed to be good for a lifetime.  The reporter was in to see his physician day before reporting and was given medication for 10 days for shingles.  The reporter did not want to share anything further until he spoke to someone who could answer his question. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 16.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received a menquadfi vaccine instead of the MenB vaccine that was indicated in his records with no reported adverse event; Initial information received on 12-Dec-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves, a 16 years old male patient who received a MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] instead of the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was indicated in his records with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   List concomitant: no other vaccines.  On 21-Mar-2024, the patient received (dose 2) of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution for injection (unknown strength, dosage, expiry date, formulation, batch number and route) via unknown administration site for prophylactic vaccination. On 05-Dec-2024, the patient received 0.5 ml (Standard) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE  Solution for injection (once) (lot 08271AB, expiry date: 31-Jan-2028) via intramuscular route in unknown administration site for immunization instead of the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE that was indicated in his records with no reported adverse event (wrong product administered).  Reportedly, Nurse reported the Immediate side effects were not in question as this occurred a week ago and ''patient's fine''.   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: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Within few hours of receiving vaccine - pain on top of left hand, starting at wrist and continuing down to tips (nails) of fingers. No pain in palm of hand. Shot was upper left arm. Pain grew severe - continued for 2 1/2 days. Couldn't sleep or use left hand at all.