chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash, Throat tightness
Clinical narrative: Rash; Itching; Throat closed up; This spontaneous case (out of a cluster of 2 cases), initially received on 30-Oct-2024, was reported by a health professional and concerns a female patient of unknown age.  At the time of the event the patient had alpha-gal.  Further information regarding concomitant medication and medical history was unknown.  Administration of company suspect drug: On 29-Oct-2024, the patient received Flucelvax (TIV) for Influenza immunization, Dose regimen: 0.5 ml, Route of administration: Not reported, Site of administration: Not reported, Lot number: Not reported and requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Rash (outcome: Recovered / Resolved), Itching (outcome: Recovered / Resolved), Throat closed up (outcome: Recovered / Resolved).  Physician reported that had a couple of patients with alpha-gal. They came in on 29-Oct-2024 and received their flu vaccines with the Flucelvax. The mother had a rash, itching and reported that her throat closed up; she took her epi which relieved her symptoms. Her daughter broke out in hives, and felt better on a course of low dose steroids.  Treatment medication: Epinephrine  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the events as non-serious and causality assessment was not provided.  Linked Case ID(s): US-BEH-2024183689, US-BEH-2024183689 (same reporter); Reporter's Comments: Causality was assessed as related.
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Broke out in hives; This spontaneous case (out of a cluster of 2 cases), initially received on 30-Oct-2024, was reported by a health professional and concerns a female patient.  At the time of the event the patient had alpha-gal.  Information regarding medical history and concomitant medications was unknown.  Administration of company suspect drug: On 29-Oct-2024, the patient received Flucelvax (TIV) for Influenza immunization, Dose regimen: 0.5 ml, Route of administration: Not reported, Site of administration: Not reported, Lot number: Not reported and requested upon follow-up..  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Broke out in hives (outcome: Not recovered / Not resolved).  Physician reported that had a couple of patients with alpha-gal. They came in on 29-Oct-2024 and received their flu vaccines with the Flucelvax. The mother had a rash, itching and reported that her throat closed up; she took her epi which relieved her symptoms. Her daughter broke out in hives, and felt better on a course of low dose steroids.  Treatment medication: unspecified steroids  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the event as non-serious and causality assessment was not provided.  Linked Case ID(s): US-BEH-2024183687 (same reporter); Reporter's Comments: Causality was assessed as related.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Insomnia
Clinical narrative: Shortness of breath; couldn't sleep; tiredness; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (hospitalization), outcome "recovering", described as "Shortness of breath"; INSOMNIA (hospitalization), outcome "recovering", described as "couldn't sleep"; FATIGUE (hospitalization), outcome "recovering", described as "tiredness". The patient was hospitalized for dyspnoea, insomnia, fatigue (hospitalization duration: 5 day(s)). Therapeutic measures were taken as a result of dyspnoea, insomnia, fatigue and included treatment with heart medications and iv drip.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received COVID-19 Moderna vaccine and high dose influenza Fluzone on 11/15/2024. Pt did not recall that she had received both of these same vaccines at a local pharmacy on 9/9/2024.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Nausea
Clinical narrative: constant nausea, still current.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Chills, Decreased appetite, Injection site swelling, Pain
Clinical narrative: Patient stated her symptoms started the day after the injection and included pain and swelling at the injection site, chills, body aches, and loss of appetite for three days. Provider recommended OTC pain medication and antihistamines to manage symptoms.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Mistakenly gave patient Fluzone high dose instead of regular fluzone or Flublok
Age: 96.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash broke out on both arms and her chest and didn't go away after 3 days. Went to dr and got medrol dose pak, Started pack on 11/18.
Age: 71.0
Sex: M
Vaccine: COVID19, UNK, UNK, UNK, VARZOS
Symptoms: No adverse event
Clinical narrative: No adverse effects
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given 2 days past the BUD.  No adverse reaction noted in patient.  Mom declines revaccination.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain
Clinical narrative: Chest/heart pain - starting day after injection and ongoing
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medication error: wrong vaccine was given. Pt was due for RSV but received Shingrix.  No adverse events noted when pt left clinic. Pt waited 7 minutes after getting Shingrix vaccination. Pt received influenza and Covid vaccines on 11/1/24.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given 2 days past BUD.  No adverse reaction noted in patient.  Mom declines to revaccinate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Headache
Clinical narrative: Patient reports symptoms starting the morning after receiving the  vaccine. Per patient portal message on 10/26/24, "Very bad reaction.  Crushing headache.  Couldn?t function; to speak a sentence or articulate.  Went back to bed and 4-5 hours later; I was better.  Wanted to be sure it?s in my record.  I felt like what I?ve imagined a stoke would be like.  My Covid shot was on Oct 17th and I seem to be fine now". Patient further elaborated on the phone that she had word finding difficulty(resolved). Denies any facial droop/paralysis, no weakness in arms or legs, no numbness/tingling.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Diagnosed Shingles 2/20/2024. Symptoms began three days prior. Two week recovery. Prescribed course of Acyclovir antiviral for shingles, and liquid ophthalmic steroids for Herpes Zoster Opthalmicus. Dr continued treatment with Valacyclovir and low-dose liquid ophthalmic steroid for one year treatment.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest X-ray abnormal, Cough, Pneumonia, Respiratory tract congestion
Clinical narrative: I was sick the week before I got the shot. Started feeling better and decided to get it.  After 2 days, sickness back, coughing, congestion, no fever.  After 2 weeks went to urgent care, got antibiotics.  They took X-rays.  Not quite better after a week, went to my doc for follow up.  Got more antibiotics and inhaler.  Feeling a little better not yet 100%. Still coughing and some congestion.  Will wait till I finish antibiotics before do a follow up.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HD given to age 59 and less inadvertently.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: First time she's had a skin reaction to covid vaccine.  Vaccine administered on 11/14. Rash started under deltoid, moved down to bicep. Painful rash Pain improving today.  Itchy, burning pain.  Wider than width of hand, about 3-4 " long Denies CP, difficulty breathing, facial swelling, palpitations, fever, n/v. Hx of urticaria, looks similar, Red, prickly raised skin, diffuse, non-bordered recommended treatment options:  trial PO benadryl or topical OTC steroid cream prn for itching And continue to monitor. Call clinic for worsening of s&s, spreading, redness, heat, pain, fever, n/v
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction
Clinical narrative: the FLU vaccine - large local reaction to the left deltoid- site of injection
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received their second influenza injection of the season in error.  The system did not flag for a duplication of therapy and nor did their insurance flag the claim as a duplicate.  Patient has not experienced any side effects thus far, but is aware of the duplication.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received their second influenza injection of the season in error.  The system did not flag for a duplication of therapy and nor did their insurance flag the claim as a duplicate.  Patient has not experienced any side effects thus far, but is aware of the duplication.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: patient received initial Fluad dose on 08/04/2024, then received a second Fluad dose on 11/18/2024 (she should have only received one dose).
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient developed a red itchy rash on arm directly superficial to location of vaccination. Rash was improving at time patient presented (8 days post-vaccination). Patient denies any other symptoms, and states this happened with the COVID vaccine recently as well, but not as severe.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Electrocardiogram, Facial paresis, Upper respiratory tract infection
Clinical narrative: Pregnant when received COVID-19 booster. Three days prior I had received a Tdap booster. The week following the vaccinations I had an upper respiratory infection. It was  relatively mild (no fever) and  recovered in just over 7-8 days. A few days after recovery (and 2 weeks after COVID-19 vaccination), I experienced facial weakness and sought care in ER, was diagnosed with Bell's Palsy.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was erroneously given a second influenza vaccine within the same season. No patient reported adverse effects.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient originally received the first dose of Fluad on 08/17/2024 and received another dose of Fluad again on 11/18/2024. He's doing great, no adverse reaction.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine accidentally administered to patient.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Biopsy lymph gland, Biopsy lymph gland normal, Blood test
Clinical narrative: Enlarged Lymph nodes under clavicle. First - attempt to aspirate cells to diagnose Lymphoma; Inconclusive. 2nd - surgical removal of lymph nodes to diagnose possible lymphoma. Pathology - negative for Lymphoma.      Onset of cardiac arrhythmia - May 2022 post positive Covid 19 February 2022. Chest Angiogram with contrast, EKG, Stress test, Stress test with iodine tracers. Diagnosis: irregularities due to Covid 19 from February.    Onset of Atrial Fibrillation 2024 post positive Covid 19 test. EKG, 7 day Cardiac monitor,  Echocardiogram, cardiac CT w contrast.  Still trying different treatments as paroxysmal Afib still present occasionally.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac monitoring, Computerised tomogram heart, Echocardiogram, Electrocardiogram
Clinical narrative: Enlarged Lymph nodes under clavicle. First - attempt to aspirate cells to diagnose Lymphoma; Inconclusive. 2nd - surgical removal of lymph nodes to diagnose possible lymphoma. Pathology - negative for Lymphoma.      Onset of cardiac arrhythmia - May 2022 post positive Covid 19 February 2022. Chest Angiogram with contrast, EKG, Stress test, Stress test with iodine tracers. Diagnosis: irregularities due to Covid 19 from February.    Onset of Atrial Fibrillation 2024 post positive Covid 19 test. EKG, 7 day Cardiac monitor,  Echocardiogram, cardiac CT w contrast.  Still trying different treatments as paroxysmal Afib still present occasionally.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenectomy, Lymphadenopathy, SARS-CoV-2 test positive, Scan myocardial perfusion, Scan with contrast
Clinical narrative: Enlarged Lymph nodes under clavicle. First - attempt to aspirate cells to diagnose Lymphoma; Inconclusive. 2nd - surgical removal of lymph nodes to diagnose possible lymphoma. Pathology - negative for Lymphoma.      Onset of cardiac arrhythmia - May 2022 post positive Covid 19 February 2022. Chest Angiogram with contrast, EKG, Stress test, Stress test with iodine tracers. Diagnosis: irregularities due to Covid 19 from February.    Onset of Atrial Fibrillation 2024 post positive Covid 19 test. EKG, 7 day Cardiac monitor,  Echocardiogram, cardiac CT w contrast.  Still trying different treatments as paroxysmal Afib still present occasionally.
Age: 43.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Angiogram cerebral, Arteriogram carotid, Computerised tomogram head, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Perimesencephalic nonaneurysmal subarachnoid hemorrhage.
Age: 43.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Scan with contrast, Subarachnoid haemorrhage
Clinical narrative: Perimesencephalic nonaneurysmal subarachnoid hemorrhage.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID 31 days after getting the vaccine.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hive outbreak around 48 hours after vax. The patient has started having hive episodes after getting Covid vaccinations. On 11/3/23 patient also had hives, on same day as vaccine. The hives recurred at night sporadically for several weeks after  getting the vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Neuralgic amyotrophy
Clinical narrative: Right Shoulder  pain, weakness - diagnosed as Parsonage Turner syndrome
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Non-Hodgkin's lymphoma
Clinical narrative: We?re seeing a spike in cancer cases including myself. I got diagnosed with non-hodgkin?s lymphoma and I didn?t have any risk factors. I?m reporting this in case you need to investigate.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Child has large swollen area on arm about the size of a racquetball. Child reports tingling in the arm with swelling.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: none
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring, Dyspnoea, Electrocardiogram, Feeling hot, Flushing
Clinical narrative: 7 mins after vaccine administration, feel flushed and hot, within a few minutes, throat constricted, labored breathing, difficult to talk, feet tingling then numbed. PCP then administered benadryl 25mg x2. Also received Epi pen x1. Was then sent to ER for 4  hours observation. In the ER, received pepcid and decadron 10mg
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: 7 mins after vaccine administration, feel flushed and hot, within a few minutes, throat constricted, labored breathing, difficult to talk, feet tingling then numbed. PCP then administered benadryl 25mg x2. Also received Epi pen x1. Was then sent to ER for 4  hours observation. In the ER, received pepcid and decadron 10mg
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given FLU vaccine upon parent and patient request. Patient had already received FLU vaccine on 9/23/24. Both provider and I (MA) overlooked this on the report.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: rash around both under arm areas/rash spread to trunk, back, forearms, thighs and top of feet; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Oct2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 28Oct2024 as dose 1, single), in right arm for immunisation. The patient's relevant medical history included: "Tree nut allergy" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; PANTOPRAZOLE; FAMOTIDINE; VALSARTAN; FLONASE [MOMETASONE FUROATE]; DIGESTIVE PROBIOTICS ADVANCED; METOPROLOL; VITAMIN D [COLECALCIFEROL]. The following information was reported: RASH (non-serious) with onset 03Nov2024, outcome "recovering", described as "rash around both under arm areas/rash spread to trunk, back, forearms, thighs and top of feet". Therapeutic measures were taken as a result of rash.  Additional information: Approximately 5 days following the vaccine, the patient developed a rash around both under arm areas. Over the next days, the rash spread to trunk, back, forearms, thighs and top of feet. Treatment for the adverse event included Prednisone, topical steroid cream and Benadryl.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain injury, Cytokine increased, Immune system disorder, SARS-CoV-2 test
Clinical narrative: sick; pain and suffering your vaccine has caused her; pain and suffering your vaccine has caused her; she passed away; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 24-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 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: DEATH (death, medically significant) with onset 10Nov2024, outcome "fatal", described as "she passed away"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), EMOTIONAL DISTRESS (non-serious), outcome "unknown" and all described as "pain and suffering your vaccine has caused her". The patient date of death was 10Nov2024. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: Reporter had already submitted multiple paperwork and medical files regarding their daughter who became sick after receiving the Pfizer covid vaccine back in Apr2021. Their daughter had passed away on 10Nov2024 from these complications and it needs to be known the pain and suffering the vaccine had caused her and their family. Her name was (withheld) and she was only 24 years old when she passed away. Her life was ripped away from her, robbed and she was undeserving of this.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: she passed away
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Encephalopathy, Immune system disorder
Clinical narrative: sick; pain and suffering your vaccine has caused her; pain and suffering your vaccine has caused her; she passed away; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 24-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 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: DEATH (death, medically significant) with onset 10Nov2024, outcome "fatal", described as "she passed away"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), EMOTIONAL DISTRESS (non-serious), outcome "unknown" and all described as "pain and suffering your vaccine has caused her". The patient date of death was 10Nov2024. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: Reporter had already submitted multiple paperwork and medical files regarding their daughter who became sick after receiving the Pfizer covid vaccine back in Apr2021. Their daughter had passed away on 10Nov2024 from these complications and it needs to be known the pain and suffering the vaccine had caused her and their family. Her name was (withheld) and she was only 24 years old when she passed away. Her life was ripped away from her, robbed and she was undeserving of this.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: she passed away
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Emotional distress, Illness, Pain
Clinical narrative: sick; pain and suffering your vaccine has caused her; pain and suffering your vaccine has caused her; she passed away; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 24-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 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: DEATH (death, medically significant) with onset 10Nov2024, outcome "fatal", described as "she passed away"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), EMOTIONAL DISTRESS (non-serious), outcome "unknown" and all described as "pain and suffering your vaccine has caused her". The patient date of death was 10Nov2024. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: Reporter had already submitted multiple paperwork and medical files regarding their daughter who became sick after receiving the Pfizer covid vaccine back in Apr2021. Their daughter had passed away on 10Nov2024 from these complications and it needs to be known the pain and suffering the vaccine had caused her and their family. Her name was (withheld) and she was only 24 years old when she passed away. Her life was ripped away from her, robbed and she was undeserving of this.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: she passed away
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: chills; fever; pain in the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "latex allergy", start date: 2014 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2), administration date: 09Feb2021, when the patient was 66-year-old, for covid-19 immunization, reaction(s): "Pain in extremity"; BNT162b2 (DOSE 2), administration date: 09Feb2021, when the patient was 67-year-old, for covid-19 immunization, reaction(s): "chills", "malaise"; BNT162b2 (DOSE 3 (booster)), administration date: 10Sep2021, when the patient was 67-year-old, for covid-19 immunization, reaction(s): "pain in extremity", "chills", "malaise"; BNT162b2 (DOSE 4 (booster)), administration date: 01Apr2022, when the patient was 68-year-old, for covid-19 immunization, reaction(s): "chills", "malaise"; moderna (DOSE  5 (booster)), administration date: 06Sep2022, when the patient was 69-year-old, for covid-19 immunization, reaction(s): "extrasystoles"; Bnt162b2 (DOSE 1), administration date: Jan2021, when the patient was 66 years old, for covid-19 immunization, reaction(s): "chills"; Bnt162b2 (DOSE 1), administration date: Jan2021, for covid-19 immunization, reaction(s): "malaise". The following information was reported: CHILLS (non-serious) with onset 2023, outcome "unknown"; PYREXIA (non-serious) with onset 2023, outcome "unknown", described as "fever"; VACCINATION SITE PAIN (non-serious) with onset 2023, outcome "unknown", described as "pain in the injection site". Additional information: The Consumer reports that she had symptoms with the administration of the Comirnaty vaccine on 2023 like chills, fever, pain in the injection site, but again all those were normal symptoms.  Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: chills; fever; pain in the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "latex allergy", start date: 2014 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2), administration date: 09Feb2021, when the patient was 66-year-old, for covid-19 immunization, reaction(s): "Pain in extremity"; BNT162b2 (DOSE 2), administration date: 09Feb2021, when the patient was 67-year-old, for covid-19 immunization, reaction(s): "chills", "malaise"; BNT162b2 (DOSE 3 (booster)), administration date: 10Sep2021, when the patient was 67-year-old, for covid-19 immunization, reaction(s): "pain in extremity", "chills", "malaise"; BNT162b2 (DOSE 4 (booster)), administration date: 01Apr2022, when the patient was 68-year-old, for covid-19 immunization, reaction(s): "chills", "malaise"; moderna (DOSE  5 (booster)), administration date: 06Sep2022, when the patient was 69-year-old, for covid-19 immunization, reaction(s): "extrasystoles"; Bnt162b2 (DOSE 1), administration date: Jan2021, when the patient was 66 years old, for covid-19 immunization, reaction(s): "chills"; Bnt162b2 (DOSE 1), administration date: Jan2021, for covid-19 immunization, reaction(s): "malaise". The following information was reported: CHILLS (non-serious) with onset 2023, outcome "unknown"; PYREXIA (non-serious) with onset 2023, outcome "unknown", described as "fever"; VACCINATION SITE PAIN (non-serious) with onset 2023, outcome "unknown", described as "pain in the injection site". Additional information: The Consumer reports that she had symptoms with the administration of the Comirnaty vaccine on 2023 like chills, fever, pain in the injection site, but again all those were normal symptoms.  Batch/lot number is not provided, and it cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, FLU3
Symptoms: Dermatitis atopic, Urticaria
Clinical narrative: Delayed-onset urticaria following vaccination on both elbows; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for COVID-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 15Oct2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "central sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 22Oct2024, outcome "recovering", described as "Delayed-onset urticaria following vaccination on both elbows". Therapeutic measures were taken as a result of urticaria. Additional information: The patient did not receive other vaccines within 4 weeks prior to the vaccine(s). It was unknown if the patient was taking any other medications within 2 weeks of the event starting. Treatment received included Triamcinalone acetonide cream 0.5%.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: Delayed-onset urticaria following vaccination on both elbows; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for COVID-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 15Oct2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "central sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 22Oct2024, outcome "recovering", described as "Delayed-onset urticaria following vaccination on both elbows". Therapeutic measures were taken as a result of urticaria. Additional information: The patient did not receive other vaccines within 4 weeks prior to the vaccine(s). It was unknown if the patient was taking any other medications within 2 weeks of the event starting. Treatment received included Triamcinalone acetonide cream 0.5%.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Product lot number issue
Clinical narrative: No additional AE; HCP called to report a GARDASIL 9 box was labeled with a separate lot number than what was listed on the products inside. Caller states the box has a lot of X024727 EXP: 05/15/2026 but the syringes inside are labeled Y007322 exp: 08/18/202 for one co; Poor quality vaccine administered; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The reporter informed that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection box was labeled with a separate lot number than what was listed on the products inside. The box had the valid lot number X024727, expiration date reported and confirmed as 15-MAY-2026 but the syringes inside were labeled with the valid lot number Y007322 expiration date reported and confirmed as 18-AUG-2026 for one container (3 doses were administered on unknown day to the patients as prophylaxis [dose: 0.5ml; strength, route of administration, and anatomical location were not provided]) (Product lot number issue/Poor quality product administered) and the second container had the correct lot and corresponding syringes inside with a matching lot number. In total, caller states 5 pre-filled syringes out of the 10 had the incorrect lot according to the product package and the other 5 were correct.   In addition, the reporter verified no damages to package upon current inspection but was not the one who opened the package upon product arrival to the facility and could not verify if any other damages or issues were noted upon receipt of product. It was also informed that the suspect vaccine was store in the fridge and in its original carton; multiple people had access to the product and it was not verified if they could have inadvertently caused the mix. No additional adverse events (no adverse event).  This is a non-valid case due to unspecified number of patients and lack of patients' identifiers.  Follow up information was received from the medical assistant on 18-NOV-2024.  The case referred to a 16 year old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant vaccines included influenza seasonal vaccine. It was reported that the patient was taking over the counter dextroamphetamine-amphetamine (ADDERALL XR) 10 mg and clonidine 0.1 mg. On 25-OCT-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # Y007322, expiration date: 18-AUG-2026, administered intramuscular in the left arm. It was reported that the lot # did not match with the one in the box (lot # X024727). This discrepancy was noted during weekly immunization Audit.  This case was previously considered as non-valid since there was not patients' identifiers, upon follow up information patient's identifiers were provided.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Product label issue
Clinical narrative: No additional AE; HCP called to report a GARDASIL 9 box was labeled with a separate lot number than what was listed on the products inside. Caller states the box has a lot of X024727 EXP: 05/15/2026 but the syringes inside are labeled Y007322 exp: 08/18/202 for one co; Poor quality vaccine administered; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The reporter informed that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection box was labeled with a separate lot number than what was listed on the products inside. The box had the valid lot number X024727, expiration date reported and confirmed as 15-MAY-2026 but the syringes inside were labeled with the valid lot number Y007322 expiration date reported and confirmed as 18-AUG-2026 for one container (3 doses were administered on unknown day to the patients as prophylaxis [dose: 0.5ml; strength, route of administration, and anatomical location were not provided]) (Product lot number issue/Poor quality product administered) and the second container had the correct lot and corresponding syringes inside with a matching lot number. In total, caller states 5 pre-filled syringes out of the 10 had the incorrect lot according to the product package and the other 5 were correct.   In addition, the reporter verified no damages to package upon current inspection but was not the one who opened the package upon product arrival to the facility and could not verify if any other damages or issues were noted upon receipt of product. It was also informed that the suspect vaccine was store in the fridge and in its original carton; multiple people had access to the product and it was not verified if they could have inadvertently caused the mix. No additional adverse events (no adverse event).  This is a non-valid case due to unspecified number of patients and lack of patients' identifiers.  Follow up information was received from the medical assistant on 18-NOV-2024.  The case referred to a 16 year old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant vaccines included influenza seasonal vaccine. It was reported that the patient was taking over the counter dextroamphetamine-amphetamine (ADDERALL XR) 10 mg and clonidine 0.1 mg. On 25-OCT-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # Y007322, expiration date: 18-AUG-2026, administered intramuscular in the left arm. It was reported that the lot # did not match with the one in the box (lot # X024727). This discrepancy was noted during weekly immunization Audit.  This case was previously considered as non-valid since there was not patients' identifiers, upon follow up information patient's identifiers were provided.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Product lot number issue
Clinical narrative: No additional AE; HCP called to report a GARDASIL 9 box was labeled with a separate lot number than what was listed on the products inside. Caller states the box has a lot of X024727 EXP: 05/15/2026 but the syringes inside are labeled Y007322 exp: 08/18/202 for one co; Poor quality vaccine administered; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The reporter informed that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection box was labeled with a separate lot number than what was listed on the products inside. The box had the valid lot number X024727, expiration date reported and confirmed as 15-MAY-2026 but the syringes inside were labeled with the valid lot number Y007322 expiration date reported and confirmed as 18-AUG-2026 for one container (3 doses were administered on unknown day to the patients as prophylaxis [dose: 0.5ml; strength, route of administration, and anatomical location were not provided]) (Product lot number issue/Poor quality product administered) and the second container had the correct lot and corresponding syringes inside with a matching lot number. In total, caller states 5 pre-filled syringes out of the 10 had the incorrect lot according to the product package and the other 5 were correct.   In addition, the reporter verified no damages to package upon current inspection but was not the one who opened the package upon product arrival to the facility and could not verify if any other damages or issues were noted upon receipt of product. It was also informed that the suspect vaccine was store in the fridge and in its original carton; multiple people had access to the product and it was not verified if they could have inadvertently caused the mix. No additional adverse events (no adverse event).  This is a non-valid case due to unspecified number of patients and lack of patients' identifiers.  Follow up information was received from the medical assistant on 18-NOV-2024.  The case referred to a 14 year old male patient. The patient's concurrent conditions included allergy to latex. It was reported that the patient was taking over the counter cetirizine (ZYRTEC) and fluticasone (FLONASE). On 29-OCT-2024, the patient was vaccinated with the  second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # Y007322, expiration date: 18-AUG-2026, administered intramuscular in the left arm. It was reported that the lot # did not match with the one in the box (lot # X024727). This discrepancy was noted during weekly immunization Audit.  This case was previously considered as non-valid since there was not patients' identifiers, upon follow up information patient's identifiers were provided.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Poor quality product administered
Clinical narrative: No additional AE; HCP called to report a GARDASIL 9 box was labeled with a separate lot number than what was listed on the products inside. Caller states the box has a lot of X024727 EXP: 05/15/2026 but the syringes inside are labeled Y007322 exp: 08/18/202 for one co; Poor quality vaccine administered; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The reporter informed that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection box was labeled with a separate lot number than what was listed on the products inside. The box had the valid lot number X024727, expiration date reported and confirmed as 15-MAY-2026 but the syringes inside were labeled with the valid lot number Y007322 expiration date reported and confirmed as 18-AUG-2026 for one container (3 doses were administered on unknown day to the patients as prophylaxis [dose: 0.5ml; strength, route of administration, and anatomical location were not provided]) (Product lot number issue/Poor quality product administered) and the second container had the correct lot and corresponding syringes inside with a matching lot number. In total, caller states 5 pre-filled syringes out of the 10 had the incorrect lot according to the product package and the other 5 were correct.   In addition, the reporter verified no damages to package upon current inspection but was not the one who opened the package upon product arrival to the facility and could not verify if any other damages or issues were noted upon receipt of product. It was also informed that the suspect vaccine was store in the fridge and in its original carton; multiple people had access to the product and it was not verified if they could have inadvertently caused the mix. No additional adverse events (no adverse event).  This is a non-valid case due to unspecified number of patients and lack of patients' identifiers.  Follow up information was received from the medical assistant on 18-NOV-2024.  The case referred to a 14 year old male patient. The patient's concurrent conditions included allergy to latex. It was reported that the patient was taking over the counter cetirizine (ZYRTEC) and fluticasone (FLONASE). On 29-OCT-2024, the patient was vaccinated with the  second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # Y007322, expiration date: 18-AUG-2026, administered intramuscular in the left arm. It was reported that the lot # did not match with the one in the box (lot # X024727). This discrepancy was noted during weekly immunization Audit.  This case was previously considered as non-valid since there was not patients' identifiers, upon follow up information patient's identifiers were provided.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Product lot number issue
Clinical narrative: No additional AE; HCP called to report a GARDASIL 9 box was labeled with a separate lot number than what was listed on the products inside. Caller states the box has a lot of X024727 EXP: 05/15/2026 but the syringes inside are labeled Y007322 exp: 08/18/202 for one co; Poor quality vaccine administered; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The reporter informed that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection box was labeled with a separate lot number than what was listed on the products inside. The box had the valid lot number X024727, expiration date reported and confirmed as 15-MAY-2026 but the syringes inside were labeled with the valid lot number Y007322 expiration date reported and confirmed as 18-AUG-2026 for one container (3 doses were administered on unknown day to the patients as prophylaxis [dose: 0.5ml; strength, route of administration, and anatomical location were not provided]) (Product lot number issue/Poor quality product administered) and the second container had the correct lot and corresponding syringes inside with a matching lot number. In total, caller states 5 pre-filled syringes out of the 10 had the incorrect lot according to the product package and the other 5 were correct.   In addition, the reporter verified no damages to package upon current inspection but was not the one who opened the package upon product arrival to the facility and could not verify if any other damages or issues were noted upon receipt of product. It was also informed that the suspect vaccine was store in the fridge and in its original carton; multiple people had access to the product and it was not verified if they could have inadvertently caused the mix. No additional adverse events (no adverse event).  This is a non-valid case due to unspecified number of patients and lack of patients' identifiers.  Follow up information was received from the medical assistant on 18-NOV-2024.  The case referred to a 12 year old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 29-OCT-2024, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # Y007322, expiration date: 18-AUG-2026, administered intramuscular in the right arm. It was reported that the lot # did not match with the one in the box (lot # X024727). This discrepancy was noted during weekly immunization Audit.  This case was previously considered as non-valid since there was not patients' identifiers, upon follow up information patient's identifiers were received.