chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Fatigue
Clinical narrative: Developed fatigue; Abdominal pain that lasted for the day; This spontaneous case, initially received on 21-Oct-2024 ((including additional information received on 02-Nov-2024) was reported by a health professional and concerns adolescent female patient.  Administration of company suspect drug: On 12-Oct-2024, the patient received Flucelvax (TIV) for Influnza vaccination, Dose regimen: .5 ml, route of administration: not reported, Lot number: 946578. CSL Seqirus Batch number unable to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 13-Oct-2024, the patient experienced Developed fatigue (outcome: Recovered / Resolved, stop date: 13-Oct-2024), Abdominal pain that lasted for the day (outcome: Recovered / Resolved, stop date: 13-Oct-2024).  On 13-Oct-2024 (Sunday), the reporter daughter at an age of 13 developed fatigue and abdominal pain that lasted for the day.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter assessed the seriousness for the event as non-serious and the causality was not reported; Reporter's Comments: The events was considered as related due to close temporal relationship
Sex: F
Vaccine: UNK
Symptoms: Head injury, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Fainted; Start sweating a lot; This spontaneous case, initially received on 26-Oct-2024, was reported by a non health professional and concerns an elderly female patient.  Administration of company suspect drug: On 26-Oct-2024, the patient received Flucelvax (TIV) for Influenza immunization, Dose regimen: 0.5 ml, Lot number: No batch number available and would be requested with follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 26-Oct-2024, the patient experienced fainted (Medically Significant, outcome: Unknown), start sweating a lot (outcome: Unknown).  Patient took a regular flu shot on 26-Oct-2024, patient takes the regular flu shot because of medical recommendation. And this time patient went to other facility, normally doesn't go there, but this time went, and after the flu shot patient always has to seat and wait 15 minutes, but facility didn't have any chairs, so patient decided to walk around the store before taking his car, and then started sweating, it was a hot day, but patient started sweating a lot, so patient rolled up his sleeves, and then fainted. When patient woke up, vaccine facility took patient to the hospital because patient had hit his head on the floor. They checked patient in the hospital, and nothing had happened. Patient was feeling better, it was just this episode, patient never had a reaction before, but like patient said, she always seats after taking the flu shot. So patient was calling to check if there's something different in the vaccine, because she took every year and never had that, also asks are those reactions common.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide the seriousness and causality of the events.; Reporter's Comments: Causality: Related for the events considering plausible temporal and biological relationship (same day of vaccination).
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Alanine aminotransferase, Blood calcium, Blood chloride, Blood creatinine, Blood glucose
Clinical narrative: Patient presented to clinic with left earlobe swelling,  redness & increased warmth on 11/08/24 and as the day progressed, the right ear swelled up as well and later with rash to different areas in the head as seen in the emergency room as well.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Blood immunoglobulin A, Blood magnesium, Blood potassium, Blood sodium, Blood urea
Clinical narrative: Patient presented to clinic with left earlobe swelling,  redness & increased warmth on 11/08/24 and as the day progressed, the right ear swelled up as well and later with rash to different areas in the head as seen in the emergency room as well.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: C-reactive protein, Ear swelling, Erythema, Full blood count, Glycosylated haemoglobin
Clinical narrative: Patient presented to clinic with left earlobe swelling,  redness & increased warmth on 11/08/24 and as the day progressed, the right ear swelled up as well and later with rash to different areas in the head as seen in the emergency room as well.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Rash, Red blood cell sedimentation rate, Skin warm, Vitamin D
Clinical narrative: Patient presented to clinic with left earlobe swelling,  redness & increased warmth on 11/08/24 and as the day progressed, the right ear swelled up as well and later with rash to different areas in the head as seen in the emergency room as well.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Epistaxis, Malaise
Clinical narrative: Pt received vaccine, 12/29/23 , she called the pharmacy on 11/6/24  (almost a year later), stating that she did not know if she should report or not. She told us about 6 days after receiving the RSV she had "snort" and bleeding from her nose. She also claimed she was sick for 4 and 1/2 months. No further information was provided.
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: called home and spoke with Mom about a vaccine error on 11/9/2024 where VZV was given in error. VZV is given at the 15 mo wcc, but due to a delay in the visit due to insurance criteria and patient scheduling, an interim MMRV vaccine was given at an urgent care follow up visit on 09/28/2024.  VZV dose #2 given at this time is considered early.  mom states understanding.  discussed with mom the increased immunity from getting the booster. Education on typical side effects of VAV. Discussed mom's question if there are other things that can cause harm. Reassurance provided.  discussed next steps of reporting to our organization and to VAERS.  Mom states agreement. she will contact us with any other questions.
Age: 62.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Patient described swelling of her arm to the size of her whole hand.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hypoacusis
Clinical narrative: Patient stated they felt dizzy, lightheaded, and couldn't hear well. Patient also received the influenza and COVID vaccine during same visit in left arm one inch apart. Patient was given a water and I, the Pharmacist, sat with the patient until symptoms were resolved. Patient felt better after about 5 - 10 minutes and left the pharmacy.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Been to hospital twice  sick with reactions for over 2 weeks missed 2 weeks and 2 days of work chills nauseous no appetite fatigue fever dizziness shakiness extreme headache
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Impaired work ability, Malaise, Nausea, Pyrexia, Tremor
Clinical narrative: Been to hospital twice  sick with reactions for over 2 weeks missed 2 weeks and 2 days of work chills nauseous no appetite fatigue fever dizziness shakiness extreme headache
Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Oral mucosal blistering, Pain, Pyrexia, Vomiting
Clinical narrative: Fever all day right after the vaccine,  vomiting's  , mouth blisters on tongue , pain all over the body
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Asthma, Cough, Fatigue, Pneumonia, Upper respiratory tract infection
Clinical narrative: Cough, asthmatic bronchitis, upper respiratory infection, fatigue, pneumonia
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: X-ray
Clinical narrative: Cough, asthmatic bronchitis, upper respiratory infection, fatigue, pneumonia
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Condition aggravated, Pain in extremity, Restless legs syndrome
Clinical narrative: Bilateral Leg pain and exacerbation of RLS without relief from common symptom relief modalities
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Glioblastoma
Clinical narrative: Glioblastoma
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received pediatric moderna vaccine (ages 6 mo to 11yrs) instead of age appropriate 12 YO+ spikevax vaccine. contacted moderna help number and after researching cdc guidelines gave pt correct age appropriate spikevax vaccine on same day. pt did not report any side effects as of today 11/11/24
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Electroencephalogram, Full blood count, Magnetic resonance imaging head
Clinical narrative: About 5 1/2 hours after receiving the vaccine I experienced the beginning of a 5 1/2 hour episode of transient global amnesia.  My son took me to the emergency room.  By the time we got home about 6 hours later I was beginning to be able to remember recent events.  I had never had this happen before.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Transient global amnesia, Urine analysis
Clinical narrative: About 5 1/2 hours after receiving the vaccine I experienced the beginning of a 5 1/2 hour episode of transient global amnesia.  My son took me to the emergency room.  By the time we got home about 6 hours later I was beginning to be able to remember recent events.  I had never had this happen before.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: NOT an adverse vaccine reaction, I don?t think. I just caught Covid, except I don?t know how, when or where. The Vsafe app linked me here.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Electromyogram, Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Complaints of L arm pain after receiving a flu shot. Pain lateral proximal humorus at site of injection. Worsening. Patient now unable to move her arm in any capacity at the GH joint. She denies tingling or weakness, only pain. PRICE/heat/massage/brace  Continue meloxicam/medrol dose pack/ flexeril  ROM exercises as tolerated to prevent frozen shoulder Further studies ordered as she c/o numbness , muscular pain, AC joint pain
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Magnetic resonance imaging, Myalgia, X-ray
Clinical narrative: Complaints of L arm pain after receiving a flu shot. Pain lateral proximal humorus at site of injection. Worsening. Patient now unable to move her arm in any capacity at the GH joint. She denies tingling or weakness, only pain. PRICE/heat/massage/brace  Continue meloxicam/medrol dose pack/ flexeril  ROM exercises as tolerated to prevent frozen shoulder Further studies ordered as she c/o numbness , muscular pain, AC joint pain
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: Pain in joints and muscles all over the body even 2 weeks after administration.
Age: 87.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient called earlier complaining that the injection area was still red, burning and hot to the touch. I advised pt to go to urgent care and get some antibiotics as it sounded like it was infected. Patient was given cephalexin 500mg bid x7 days . dx code on script : L03114 t50a95a.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient reported itchy red rash at and around the injection site
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Skin warm
Clinical narrative: Pt got her 1st Shingrix shot on 10/17 at 4:37 pm.  I recall pt told me a couple of hours later her arm was feeling warm and possibly pain and it didn't go away. (I say I recall as we tried to complete this VAERS on 10/24 and the website logged me out as we were wrapping up. I have a hard time getting hold of the pt since then.) Pt mentioned she went to ER twice. I can't recall the time line. But the weekend after the shot she called the pharmacy ask if it was common to get such reaction from Shingrix vaccine and what she should do.  She was told to monitor that injection site and if the redness, tenderness and warmth (and pain) don't go away to go to ER. And that was what she did.  ER told her it was cellulitus and they gave her keflex on 10/21.  When I spoke with her to do the VAERS on 10/24 she said she was getting a little better.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Erythema, Injection site erythema, Reaction to previous exposure to any vaccine, Swelling face, Urticaria
Clinical narrative: Swelling of face, especially around eyes (primarily eyelids); redness of hands (hives), large red spot around covid injection site
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red, swelled area where injection occurred; provider said it was warm to touch; sent over keflex 500mg 1 cap qid for 5 days #20 caps
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Syncope
Clinical narrative: Syncope onset ~10 min after vaccination, including nausea, light headedness, sweating, and pale skin. We had Pt lie on floor with feet propped up for ~10 minutes with wet napkins on face and neck. When symptoms resided within about 5 minutes, Pt sat up and was monitored for another ~10 minutes with no symptoms recurring, and after having a sip of water and some coconut water, she and father felt she was well enough to leave. At 830pm, I called father to check on Pt, and she had eaten dinner and had no further symptoms.
Age: 88.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Dysstasia, Fall, Gait disturbance, Syncope
Clinical narrative: Patient reported that he experienced syncope, dizziness and has fallen multiple times beginning 3 days post vaccination. Patient has reported these complaints to his doctor, but no correlation has been determined for cause. After 3 weeks, patient states that he is still experiencing syncope and dizziness and has to use assistance to stand/walk.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Administered live vaccine, Varivax, approximately 48 hours after another live vaccine given, MMR. No side effects reported per patient.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Sinus congestion, Sinusitis
Clinical narrative: Increasing sinus congestion beginning approximately 4 days later. Sinuses not responsive to normal home treatment (nasal flushing, decongestants, nasal sprays) and eventually decided to pursue antibotic treatment for sinus infection.
Age: 44.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered live vaccine, Varivax, 48 hours after another live vaccine administered, MMR.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Pain
Clinical narrative: Had the shots before noon on Friday and woke early Saturday at2:30 with chills and fever of 101 F. Stayed in bed Saturday.  Woke up early Sunday about 3:00 am with fever of 102 F.  Aching all over, hard to get out of bed, headache that lasted through Monday. It?s Monday and I still feel utterly exhausted. I took aspirin on Saturday but switched to DayQuil on Sunday.  Have been drinking lots of water and resting.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pyrexia
Clinical narrative: Had the shots before noon on Friday and woke early Saturday at2:30 with chills and fever of 101 F. Stayed in bed Saturday.  Woke up early Sunday about 3:00 am with fever of 102 F.  Aching all over, hard to get out of bed, headache that lasted through Monday. It?s Monday and I still feel utterly exhausted. I took aspirin on Saturday but switched to DayQuil on Sunday.  Have been drinking lots of water and resting.
Age: 14.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Nervousness, Pallor
Clinical narrative: Patient nearly passed out due to nervousness from receiving the shot.  She questioned to her mom why she had to get the shot or not get it.  She turned pale so the pharmacist asked her to get the heart rate monitored and it showed 50.  She stayed seated and put the head down on the lap to stay calm and put the cold water bottle on the forehead.  After resting for 15 minutes, her heart rate turned back to normal range from 60 to 78.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Brain fog, Fatigue, Joint injury, Magnetic resonance imaging joint
Clinical narrative: Extreme fatigue?could fall asleep standing up Unexplained brain fog This is also recurrent. I had these symptoms last year Around the same time After the flu shot This year, I just so happen to have an incident with a dog and incurred knee injury
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pallor, Vomiting
Clinical narrative: After after her vaccine administration, patient felt light headed.  I told her to sit back down on the chair.  When I  observer her face she started to turn pale and she felt nauseous.  After about a minute, she started to vomit.  When she completed couple cycle of vomiting, she felt better.  But, couple minutes later she started to vomit again.  Few minutes later, paramedics arrive to assess her.   She did not experience any problem with breathing  or soreness in her arm.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Biopsy skin, Madarosis
Clinical narrative: Loss of eyebrow hair, upper eyelashes, and strip of hair on scalp. Various steroidal shots in scalp and eyebrow, and cream. No hair regrowth.
Age: 40.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: soon after vaccination, pt developed redness, itchiness and mild rash in area of right deltoid. was managed with diphenhydramine 25mg single dose.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Swelling, Hot to touch. swelling, itching, rash, and soreness.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria (face, neck)
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Aldolase, Antinuclear antibody, Blood creatine phosphokinase, Borrelia test, C-reactive protein
Clinical narrative: Patient came to clinic as a new patient on 05/06/2022. Patient reports rash and redness on bilateral hands which spread up to her elbows. She states this happened about 1 month after getting her COVID booster shot in January 2022. She reports itching and more bothersome at night.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Red blood cell sedimentation rate
Clinical narrative: Patient came to clinic as a new patient on 05/06/2022. Patient reports rash and redness on bilateral hands which spread up to her elbows. She states this happened about 1 month after getting her COVID booster shot in January 2022. She reports itching and more bothersome at night.
Age: 47.0
Sex: F
Vaccine: UNK, FLU3, FLU3
Symptoms: Corneal opacity, Eye discharge, Ocular hyperaemia
Clinical narrative: redness, itchiness, soreness, blurred vision in eyes, swelling of eyelid, headache for about 24 hours
Age: 47.0
Sex: F
Vaccine: UNK, FLU3, FLU3
Symptoms: Eye pain, Eye pruritus, Headache, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: redness, itchiness, soreness, blurred vision in eyes, swelling of eyelid, headache for about 24 hours
Age: 47.0
Sex: F
Vaccine: UNK, FLU3, FLU3
Symptoms: Vision blurred, Visual acuity tests
Clinical narrative: redness, itchiness, soreness, blurred vision in eyes, swelling of eyelid, headache for about 24 hours
Age: 47.0
Sex: F
Vaccine: UNK, FLU3, FLU3
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia, Swelling face
Clinical narrative: redness, itchiness, soreness, blurred vision in eyes, swelling of eyelid, headache for about 24 hours
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FBE calling on behalf of HCP. PNEUMOVAX 23 administered to a 4 month old. No additional AE/PQC.; No additional AE; This spontaneous report was received from a nurse practitioner and referred to a 4-month-old patient of unspecified gender.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the 4-month-old patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, .5 ml, administered for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional information reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had a positive Covid result.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had a positive Covid result.) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 204H232A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Atrial Flutter, Osteopenia, Osteoporosis, SVT (controlled), all diagnosed prior to this dose.  The patient's past medical history included Atrial flutter and Supraventricular tachycardia. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Had received a booster every time the CDC had suggested it but and did not know the exact number of doses received); for Product used for unknown indication: Pfizer vaccine (Dose 2) and Pfizer vaccine (Dose 1). Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Osteopenia and Osteoporosis.    On 10-Aug-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 09-Sep-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (had a positive Covid result.). At the time of the report, COVID-19 (had a positive Covid result.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) positive Covid result.         It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that patient received a 2023-24 Spikevax booster sometime around early Aug-2024 prior to leaving the country. While abroad, patient began to feel Covid symptoms on 09-Sep-2024 but, patient reports the symptoms were relatively mild. Patient went to a clinic and had a positive Covid result.  Treatment information was not provided.  Reporter causality was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2024: Upon internal review on 11-Nov-2024, significant correction was performed to update country
Sex: U
Vaccine: COVID19
Symptoms: Pancreatitis
Clinical narrative: pancreatitis; This is a spontaneous report received from a Physician from a sales representative.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COVID-19 VACCINE OMICRON KP.2-MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATITIS (life threatening (reported as: immediate risk of death from the event)), outcome "unknown".   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Considering the implied temporal relationship and since the contributory role of the suspect product BNT162b2 omicron (kp.2) cannot be excluded with certainty, the event pancreatitis has been considered as possibly related to the suspect drug. Information on details surrounding patient complete medical history,concomitant medications and clinical course would aid in comprehensive medical assessment. Case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine was administered with no adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to US-SA-2024SA305245 (master case).   This case involves 74 years old and unknown gender patient who was administered expired influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no 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 09-Oct-2024, the patient received an expired  dose of 0.7 ml once of suspect influenza quadrival A-B high dose HV vaccine (Strength- High-dose) (unknown formulation) (lot UT8131C, expiry date- 30-JUN-2024) via unknown route in the left arm for Immunization; with no adverse event (expired product administered) (latency- same day).  Reportedly, A Medical Assistant reported that they received expired 2023-2024 FLUZONE QUADRIVALENT High-dose and the vaccines were administered before realizing the issue to 3-people.  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.; Sender's Comments:  US-SA-2024SA305245:02259596 (master case)
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: given at least 3 doses of High Dose Fluzone to patients under 65 years of age, with no reported adverse event; Initial information received on 21-Oct-2024 regarding an unsolicited valid  non-serious case received from a unknown reporter.  This case involves an unknown age and gender patient who experienced given at least 3 doses of high dose fluzone to patients under 65 years of age, with no reported adverse event while after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  (unknow strength, dosage , formulation, expiry, lot number and route) in unknown administration site for prophylactic vaccination was given to patients under 65 years of age, with no reported adverse event (product administered to patient of inappropriate age) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly,they have given at least 3 doses of High Dose Fluzone to patients under 65 years of age.   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: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: red rash about 2 inches by 3 inches in size; upper arm is swollen just below the injection site; red rash about 2 inches by 3 inches in size; Initial information received on 30-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare.  This case involves a 5-year-old female patient who had red rash about 2 inches by 3 inches in size, upper arm is swollen just below the injection site and red rash about 2 inches by 3 inches in size after receiving influenza USP trival A-B subvirion NO preservative vaccine [FLUZONE] and diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [quadracel].  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On 28-Oct-2024, the patient received unknown dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection (unknown strength, lot and expiry date) total via intramuscular route in the left arm and unknown dose of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (unknown strength, lot and expiry date) via intramuscular route in the left arm for vaccination (immunization).  On 29-Oct-2024 the patient developed red rash about 2 inches by 3 inches in size (injection site rash), upper arm is swollen just below the injection site (injection site swelling) and red rash about 2 inches by 3 inches in size (injection site erythema) (Latency 1 day) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine and 1 day following the administration of influenza USP trival A-B subvirion NO preservative vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Injections were administered to the left arm. The upper arm is swollen just below the injection sites. There is also a red rash about 2 inches by 3 inches in size    Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for all the events.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE HD was administered to one patient post excursion with no reported Adverse event; Initial information received on 28-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient (unknown age and gender) who recieved Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] post excursion with no adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose Of Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe post excursion with no reported adverse event (poor quality product administered) (latency: same day), (dose, strength, administration site, route: unknown) with lot UT8463DA and expiry 30-JUN-2025 for Influenza.  Human error: No  Product used : Used   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.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: the products have been administered post excursion since they recently discovered the excursion with no reported adverse event; Initial information received on 29-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA315829 and 2024SA315801.  This case involves an unknown age male patient who received  poor quality IPV (VERO) [IPOL] vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of IPV (VERO) Suspension for injection (dose, strength, route, administration site : unknown) for Immunization, administered post-excursion (poor quality product administered) (latency: same day) with lot X1C891M and expiry 20-OCT-2026.   Reportedly "Previous Excursion? No. Human error? UNKNOWN. 6 patients have received IPOL post excursion. These products were supported by the extended stability information post excursion. The remaining inquiries were submitted to PV since the products were not supported by the extended stability information post excursion and had been administered to patients."   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.; Sender's Comments:  US-SA-2024SA315801:Patient 1 US-SA-2024SA315829:Master case US-SA-2024SA316535:master case US-SA-2024SA316609:
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: the products have been administered post excursion since they recently discovered the excursion with no reported adverse event; Initial information received on 29-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA315643 (Master case).   This case involves a unknown age and gender patient who received poor quality  IPV (VERO) [IPOL] since they recently discovered the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient  received IPV (VERO),Suspension for injection ( lot X1C891M,expiry: unknown)(dose, strength, route, administration site: unknown)for immunization, administered post excursion(poor quality product administered)(latency: same day) with no reported adverse event.  Reportedly "Previous Excursion? No. Human error? UNKNOWN. 6 patients have received IPOL post excursion. These products were supported by the extended stability information post excursion. The remaining inquiries were submitted to PV since the products were not supported by the extended stability information post excursion and had been administered to patients."  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.; Sender's Comments:  US-SA-2024SA316535: US-SA-2024SA316609: US-SA-2024SA315643: US-SA-2024SA315801: US-SA-2024SA315829:
Age: 1.0
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered TYPHIM VI to a patient under 2 years old with no reported adverse event; Initial information received on 30-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12-month-old male patient who was administered typhoid VI polysaccharide vaccine [Typhim VI] (patient under 2 years old) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel); Hepatitis a vaccine (Hepatitis A); Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck) (Proquad); and Pneumococcal Conjugate Vaccine for Immunisation.  On 23-Oct-2024, suspect Typhoid Vi Polysaccharide Vaccine Solution for injection of lot X2A421M and expiry date: 30-Apr-2026 frequency: once, strength: standard via intramuscular route in the left thigh for immunization administered to a patient under 2 years old with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient inadvertently received two doses of FLUZONE HD today, 30OCT2024, with no reported adverse event; Initial information received on 30-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 year old female patient who received two dose of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Oct-2024, the patient received a two dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (dose: 0.5 ml) with no reported adverse event  (extra dose administered) (latency: same day) (lot: UT8409DA and expiry : 30-JUN-2025) via intramuscular route in the left arm for Influenza.   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: 15.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally given FLUBLOK, with no reported adverse event; Initial information received on 30-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old male patient who was accidentally given INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2024, the patient was accidentally given INFLUENZA TRIVALENT RECOMBINANT VACCINE Solution for injection, dose 0.5 ml Frequency = once, strength- standard lot TFAA2408 expiry-31-May-2025 via intramuscular route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Reportedly, Nurse states 4 under age18 patients were accidentally given FLUBLOK.   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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram head, Magnetic resonance imaging head, Vertigo, Vestibular neuronitis
Clinical narrative: Woke with extreme vertigo, vomiting, extreme difficulty walking.  Eventually firmly diagnosed at clinic with Vestibular Neuritis by Dr. on 11/8/2024.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Woke with extreme vertigo, vomiting, extreme difficulty walking.  Eventually firmly diagnosed at clinic with Vestibular Neuritis by Dr. on 11/8/2024.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hypoaesthesia, Lymphocyte count decreased, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal
Clinical narrative: Progressive weakness of legs thatled  to fall on floor for 3 hours and hospitalization. Improved after 3 doses IV Solumedrol but weakness returned 2days after last dose. Now using walker. Hands now numb as well
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Walking aid user, White blood cell count decreased
Clinical narrative: Progressive weakness of legs thatled  to fall on floor for 3 hours and hospitalization. Improved after 3 doses IV Solumedrol but weakness returned 2days after last dose. Now using walker. Hands now numb as well
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hyperhidrosis, Pain, Tearfulness
Clinical narrative: I'm in a lot pain all over my whole body, woke up sweating (soaked the bed in sweat) and then immediately shivering violently.    Worst pain is in my joints, pain causes me to tear up
Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Asthenia, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Tired  Achey Weak Headache High blood pressure Rapid Heart Rate Difficulty Breathing Chills
Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Heart rate increased, Hypertension, Pain
Clinical narrative: Tired  Achey Weak Headache High blood pressure Rapid Heart Rate Difficulty Breathing Chills
Age: 70.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Dysgeusia
Clinical narrative: Starting the day after these 2 vaccines, my food has tasted "funny". This has now continued for nearly 4 months, with only small temporary remissions. Even without eating, I get a strange taste in my mouth. No longer can enjoy my food.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle spasms, Pain, Pyrexia, Rash
Clinical narrative: Morning of 10/30/24 became bedridden due to extreme achiness all over body. Intermittent low-grade fever during the next 48 hours with disturbed sleep. Between 10/30 and 11/3 experienced intermittent but severe leg cramps with milder achiness overall. Rash appeared on face on 10/31, and by the next day the rash had spread to neck and trunk.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Morning of 10/30/24 became bedridden due to extreme achiness all over body. Intermittent low-grade fever during the next 48 hours with disturbed sleep. Between 10/30 and 11/3 experienced intermittent but severe leg cramps with milder achiness overall. Rash appeared on face on 10/31, and by the next day the rash had spread to neck and trunk.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received shingrix first dose 5 years ago, shall they repeat the dose?I need to administer the shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received shingrix first dose 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received shingrix first dose 5 years ago, shall they repeat the dose?I need to administer the shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-OCT-2024 The patient received shingrix first dose 5 years ago, shall they repeat the dose. The patient did not receive the second dose in the time frame. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: possible blood clots from covid vaccine; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number were not reported) dose series 1, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced possible blood clots from covid vaccine(dose series 1). It was reported that the patient has a history of blood clots that he thinks started after receiving a COVID vaccine.  Patient never specified the manufacturer of the COVID vaccine he received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible blood clots from covid vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Thrombosis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.