chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 97.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient and his wife came to the pharmacy this afternoon requesting for us to check what vaccines they were due for. My RPH used converge to check and had a conversation with the woman that she could get 3 vaccines today (flu tetatnus and covid) and she told his wife that He was due for covid-19 vaccine today. I was in the back of the pharmacy doing some converge cases so I did not overhear this conversation but I usually administer vaccines at the pharmacy as the grad intern. I came up front to grab  after she was done filling them out (she filled out for both of them)  and handed it over to one of our technicians to process them as there were many patients at will call during this period.  The issue from this point was that his pt's form was checked off to receive an influenza vaccine, not the covid-19 vaccine that was discussed with him and my RPH and since I didn't hear their conversation, I grabbed a fluzoneHD vaccine and put the sticker on the consent form and I also failed to verify the name of the vaccine when I was in the admnistration room and about to give the vaccine. His wife was with me in the administration room and she received her vaccines first and then he did as well. they asked for a receipt of the vaccines they got which I printed that out and handed to her outside as we were closed for lunch. I realized this error when I was in the process of checking to see if the backtag  for his vaccine was printed  on his prescription profile. Then I notcied that he already received a Flu vaccine in 9/30/2024. I retrived his consent form to double check what vaccine he requested and what was administered to him and I was confused when I saw that the flu vaccine was indeed requested. I brought this to the attention of my Pharmacist and she attested that she spoke with the couple about their pending vaccines, mentioning specifically that Patient was due for a covid vaccine but she did not check off the 'vaccine requested ' portion of the consent form. I remember that when I grabbed the form from the wife after signing it, the form was marked off as flu vaccine requested and the technician who processed it also attested to this. We tried to reach the couple to inform them about this error, and tell Patient to come back for his Covid-19 vaccine as well as to see if there might have been a misunderstandig when she was filling out his consent form. We were unable to reach the couple via the phone number on the form and their profile, so we will inform them of this when they come in next to pick up their prescriptions.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain, Pain in extremity
Clinical narrative: I?m a nurse with experience giving IM injections and when the pharmacist injected the shot, it felt too high. Within a few hours of the injection, my arm was very sore. My arm is normally sore after a vaccine, but this felt worse and more painful than usual. For about a week I was in a lot of pain now it has been over a month and I am still in pain especially when lifting my arm. I have notified my PCP (appt in 2 weeks) and saw a physical therapist. The physical therapist said this is likely an inflammation of the rotator cuff. I have been doing light exercises, which help somewhat. Advil offers some relief. PCP told me to apply heat, which hasn?t helped.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given 2 doses of flu vaccine, once on 11/18/2024, and once on 11/25/2024. pt was monitored in clinic shortly after vaccine was given and error was found. denies chest pain, shortness of breath, injection site redness or reactions
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased, X-ray
Clinical narrative: patient developed severe right shoulder pain < 24-48 hours after vaccine and has decreased range of motion.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Rash, Rash pruritic, Skin warm
Clinical narrative: Redness covering most of the left arm. hot to the touch and itchy rash all over the arm.
Age: 54.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Arm still painful, swollen and limited range of motion more than 1 month after injection.
Age: 61.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injected limb mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Pt was given injection on Sunday.  Per pt, experienced pain a few hours after injection that was different from previous vaccinations.  She talked to her PCP who then referred her to the ER.  Pt received steroids  from ER on Monday.  Patient has been unable to lift left arm.  Patient came back to pharmacy to discuss incident and still had bandaid on upper arm/shoulder that confirmed injection was too high on shoulder.
Age: 61.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Arthritis, Arthritis reactive, C-reactive protein, Full blood count
Clinical narrative: Pt was given injection on Sunday.  Per pt, experienced pain a few hours after injection that was different from previous vaccinations.  She talked to her PCP who then referred her to the ER.  Pt received steroids  from ER on Monday.  Patient has been unable to lift left arm.  Patient came back to pharmacy to discuss incident and still had bandaid on upper arm/shoulder that confirmed injection was too high on shoulder.
Age: 61.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injected limb mobility decreased, Injection site pain, Metabolic function test, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt was given injection on Sunday.  Per pt, experienced pain a few hours after injection that was different from previous vaccinations.  She talked to her PCP who then referred her to the ER.  Pt received steroids  from ER on Monday.  Patient has been unable to lift left arm.  Patient came back to pharmacy to discuss incident and still had bandaid on upper arm/shoulder that confirmed injection was too high on shoulder.
Age: 61.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Red blood cell sedimentation rate, Sleep disorder, X-ray limb
Clinical narrative: Pt was given injection on Sunday.  Per pt, experienced pain a few hours after injection that was different from previous vaccinations.  She talked to her PCP who then referred her to the ER.  Pt received steroids  from ER on Monday.  Patient has been unable to lift left arm.  Patient came back to pharmacy to discuss incident and still had bandaid on upper arm/shoulder that confirmed injection was too high on shoulder.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, sore arm
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood test normal, Computerised tomogram thorax abnormal, Factor V Leiden mutation, Injection site pain
Clinical narrative: My husband had a heart attack in 2022 after his fourth shot of Pfizer.  I requested test I was worried that I may have some hidden issues that blood test can't see.  My routine blood work checked out fine.  I was scheduled for a CT scan and found I had two blood cloths in my lungs.  My doctor's name is (redacted).  I asked him was it as a result of the vaccine he would not answer yes.  He referred me to doctor where I was told I have Factor 5.  I have been on this medication for two years.  Now Dr. asked me to get a second opinion to see if I can get off this medication.  Dr. ask me today was I on birth control which I have not taken since 2002.  I realized this was a result of taking the vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Pyrexia
Clinical narrative: My husband had a heart attack in 2022 after his fourth shot of Pfizer.  I requested test I was worried that I may have some hidden issues that blood test can't see.  My routine blood work checked out fine.  I was scheduled for a CT scan and found I had two blood cloths in my lungs.  My doctor's name is (redacted).  I asked him was it as a result of the vaccine he would not answer yes.  He referred me to doctor where I was told I have Factor 5.  I have been on this medication for two years.  Now Dr. asked me to get a second opinion to see if I can get off this medication.  Dr. ask me today was I on birth control which I have not taken since 2002.  I realized this was a result of taking the vaccine.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Wrong technique in product usage process
Clinical narrative: Patient reported that the vaccine was administered into her bone or joint.  When asked for more detail or explanation, she explained that it seemed as if the pharmacist administered the vaccine almost on top of her shoulder rather than on the deltoid muscle on the side of the shoulder.  She described pain in her arm which has lasted since the vaccine was administered, making it difficult to function, or raise her arm above her shoulder.  She also reports that she feels that the vaccine may not have worked, because she did not experience other side effects that she typically feels when vaccines are administered, such as fatigue, malaise, low grade fever, etc.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Hallucination, Panic attack, Paranoia
Clinical narrative: Panic attack, hallucinations, paranoia
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Vomiting
Clinical narrative: Pt threw up three times in quick succession at 9:30pm. He had the flu shot around 7pm. He also complained of a headache from the time of his flu shot until he threw up.
Age: 1.08
Sex: M
Vaccine: PNC20
Symptoms: Fatigue, Insomnia, Pyrexia, Rash, Urticaria
Clinical narrative: Rashes with hives appearing in random body locations at random times of day that started 9 days after injection. Exhibited fever, fatigue, and lack of sleep starting 9 days after getting injection.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Axillary pain, Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Immediate pain in right armpit, upper area, size of golf ball. Pain persisted in right armpit, then progressively traveled over several days from armpit through upper arm to elbow, then forearm and wrist into base of thumb. Pain decreased in armpit but became intense in elbow, firearm, and wrist. Experienced with feeling of tightness, increased pain with touch/pressure, and reduced range of motion of arm with increased pain if attempting certain movement.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity, Skin tightness, Tenderness
Clinical narrative: Immediate pain in right armpit, upper area, size of golf ball. Pain persisted in right armpit, then progressively traveled over several days from armpit through upper arm to elbow, then forearm and wrist into base of thumb. Pain decreased in armpit but became intense in elbow, firearm, and wrist. Experienced with feeling of tightness, increased pain with touch/pressure, and reduced range of motion of arm with increased pain if attempting certain movement.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Swollen, erythema, tender wheel 4 cm x 4 cm at injection site
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: erythema, 6x7 cm wheel
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Disorientation, Lethargy
Clinical narrative: Lethargy, disorientation (above baseline) anorexia.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Erythema, Tenderness, Urticaria
Clinical narrative: erythema tenderness wheel 3 x 4 cm
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: the first vaccine in which she had a "bad allergic reaction"; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 26Mar2021 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: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "the first vaccine in which she had a "bad allergic reaction"".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 51.0
Sex: U
Vaccine: FLU3, UNK
Symptoms: Lacrimation increased, Nasal congestion, Pain, Pruritus, Skin irritation
Clinical narrative: Itchy, copious watery eye with exudate; Irritated oropharynx; Base of tongue/sublingual swelling; Painful oropharynx; Nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath); Itchy oropharynx; Hive on Face/jaw line; This spontaneous case, initially received on 05-Nov-2024, was reported by a non health professional via health authority Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2799287-1) and concerns an adult patient of unknown gender.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 14-Oct-2024, the patient received Afluria (TIV) for an unknown indication., Dose regimen: Not reported, Route of administration: Intramuscular, Anatomical site: Right Arm, Lot number: AW1619A. CSL Seqirus Batch number to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 14-Oct-2024, the patient experienced Itchy, copious watery eye with exudate (outcome: Recovered / Resolved), Irritated oropharynx (outcome: Recovered / Resolved), Base of tongue/sublingual swelling (outcome: Recovered / Resolved), Painful oropharynx (outcome: Recovered / Resolved), Nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath) (outcome: Recovered / Resolved), Itchy oropharynx (outcome: Recovered / Resolved), Hive on Face/jaw line (outcome: Recovered / Resolved).  Irritated/itchy/painful oropharynx; Hive on Face/jaw line; Itchy, copious watery eye with exudate that was clear; significant nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath); Base of tongue/sublingual swelling  Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: The events were considered as related to the administration of Afluria (TIV).
Age: 51.0
Sex: U
Vaccine: FLU3, UNK
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Itchy, copious watery eye with exudate; Irritated oropharynx; Base of tongue/sublingual swelling; Painful oropharynx; Nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath); Itchy oropharynx; Hive on Face/jaw line; This spontaneous case, initially received on 05-Nov-2024, was reported by a non health professional via health authority Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2799287-1) and concerns an adult patient of unknown gender.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 14-Oct-2024, the patient received Afluria (TIV) for an unknown indication., Dose regimen: Not reported, Route of administration: Intramuscular, Anatomical site: Right Arm, Lot number: AW1619A. CSL Seqirus Batch number to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 14-Oct-2024, the patient experienced Itchy, copious watery eye with exudate (outcome: Recovered / Resolved), Irritated oropharynx (outcome: Recovered / Resolved), Base of tongue/sublingual swelling (outcome: Recovered / Resolved), Painful oropharynx (outcome: Recovered / Resolved), Nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath) (outcome: Recovered / Resolved), Itchy oropharynx (outcome: Recovered / Resolved), Hive on Face/jaw line (outcome: Recovered / Resolved).  Irritated/itchy/painful oropharynx; Hive on Face/jaw line; Itchy, copious watery eye with exudate that was clear; significant nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath); Base of tongue/sublingual swelling  Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: The events were considered as related to the administration of Afluria (TIV).
Age: 51.0
Sex: U
Vaccine: FLU3, UNK
Symptoms: Dyspnoea, Eye pruritus, Lacrimation increased, Nasal congestion, Oropharyngeal pain
Clinical narrative: Itchy, copious watery eye with exudate; Irritated oropharynx; Base of tongue/sublingual swelling; Painful oropharynx; Nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath); Itchy oropharynx; Hive on Face/jaw line; This spontaneous case, initially received on 05-Nov-2024, was reported by a non health professional via health authority Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2799287-1) and concerns an adult patient of unknown gender.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 14-Oct-2024, the patient received Afluria (TIV) for an unknown indication., Dose regimen: Not reported, Route of administration: Intramuscular, Anatomical site: Right Arm, Lot number: AW1619A. CSL Seqirus Batch number to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 14-Oct-2024, the patient experienced Itchy, copious watery eye with exudate (outcome: Recovered / Resolved), Irritated oropharynx (outcome: Recovered / Resolved), Base of tongue/sublingual swelling (outcome: Recovered / Resolved), Painful oropharynx (outcome: Recovered / Resolved), Nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath) (outcome: Recovered / Resolved), Itchy oropharynx (outcome: Recovered / Resolved), Hive on Face/jaw line (outcome: Recovered / Resolved).  Irritated/itchy/painful oropharynx; Hive on Face/jaw line; Itchy, copious watery eye with exudate that was clear; significant nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath); Base of tongue/sublingual swelling  Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: The events were considered as related to the administration of Afluria (TIV).
Age: 51.0
Sex: U
Vaccine: FLU3, UNK
Symptoms: Swollen tongue, Throat irritation, Urticaria
Clinical narrative: Itchy, copious watery eye with exudate; Irritated oropharynx; Base of tongue/sublingual swelling; Painful oropharynx; Nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath); Itchy oropharynx; Hive on Face/jaw line; This spontaneous case, initially received on 05-Nov-2024, was reported by a non health professional via health authority Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2799287-1) and concerns an adult patient of unknown gender.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 14-Oct-2024, the patient received Afluria (TIV) for an unknown indication., Dose regimen: Not reported, Route of administration: Intramuscular, Anatomical site: Right Arm, Lot number: AW1619A. CSL Seqirus Batch number to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 14-Oct-2024, the patient experienced Itchy, copious watery eye with exudate (outcome: Recovered / Resolved), Irritated oropharynx (outcome: Recovered / Resolved), Base of tongue/sublingual swelling (outcome: Recovered / Resolved), Painful oropharynx (outcome: Recovered / Resolved), Nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath) (outcome: Recovered / Resolved), Itchy oropharynx (outcome: Recovered / Resolved), Hive on Face/jaw line (outcome: Recovered / Resolved).  Irritated/itchy/painful oropharynx; Hive on Face/jaw line; Itchy, copious watery eye with exudate that was clear; significant nasal congestion acutely to where I couldn't move air through nose (I could easily mouth breath); Base of tongue/sublingual swelling  Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: The events were considered as related to the administration of Afluria (TIV).
Age: 16.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Dizziness, Pallor, Presyncope, Unresponsive to stimuli
Clinical narrative: And staring off into the distance and not responding to his mother or me; Vasovagal reaction; He was pale in color; About 5 minutes (or less) later, his mother sat him down in a chair in the waiting area due to him feeling faint; This spontaneous case, initially received on 05-Nov-2024, was reported by a non health professional via  health authority from Vaccine Adverse Event Reporting System (VAERS) (reference number 2800175-1) and concerns an adolescent male patient.  No medical history or concomitant medications were reported.  Administration of company suspect drug: On 16-Oct-2024, the patient received Flucelvax (TIV) for indication not reported, dose regimen reported as Not specified, Route of administration: Intramuscular, anatomical location: left arm, batch number reported as 388532. CSL Seqirus Batch number unable to be matched.  Non-company suspect drugs: On 16-Oct-2024, the patient received Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), for COVID-19 Immunization, Dose Regimen: 0.5 ml, Route of administration: Intramuscular, anatomical location: left arm, batch number reported as 6024MF012  Adverse reactions/events and outcomes: On 16-Oct-2024, the patient experienced And staring off into the distance and not responding to his mother or me (Medically Significant, outcome: Recovered / Resolved, stop date: 16-Nov-2024), Vasovagal reaction (outcome: Not Reported), He was pale in color (outcome: Not Reported), About 5 minutes (or less) later, his mother sat him down in a chair in the waiting area due to him feeling faint (outcome: Not Reported).  Patient had left vaccination room after another pharmacist administered 2 vaccines. About 5 minutes (or less) later, his mother sat him down in a chair in the waiting area due to him feeling faint. Reporter responded to patient and when got to him he was pale in color and staring off into the distance and not responding to his mother or to the reporter. He was breathing and rubbed his sternum and he began to respond after a minute or so. Following the vasovagal reaction, his mother gave him sips of soda and his color began to return and he began to speak with us. He continued to sit for 15 minutes or so before they felt ready to leave. No additional issues were reported.  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment: The reporter considered the event as non serious and related to the suspect drug.  Follow-up (14-Nov-2024) received from reporter: New reporter added, non company suspect indication added, outcome updated (and staring off into the distance and not responding to his mother or me), stop date added, causality updated to related from not reported, narrative updated.; Reporter's Comments: Causality: Related due to close temporal relationship of same day of the vaccination(about 5 minutes later).Covid19 vaccination is likely a confounding factor.
Sex: U
Vaccine: COVID19, COVID19, FLU3
Symptoms: COVID-19, Drug ineffective
Clinical narrative: a lot of pain; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 04Sep2024 as dose number unknown, single), in left arm. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Pfizer vaccine (DOSE NUMBER UNKNOWN, SINGLE; Intramuscular, Right or left arm), for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 2024, outcome "not recovered", described as "a lot of pain".  Additional information: It was reported that the patient was taking Aspirin within 2 weeks prior to the event onset and that did not received any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient mentioned that she and her husband received several vaccines beginning around Mar2020, every 6 months in the right or left arm. Also she reported that this was the first time vaccine did not work. The patient reported that just got sleepy for a few days following this vaccination. The patient was not allergic to any previous vaccination, medications, foods or other products and there are not other diagnosed  illnesses/medical history/chronic health conditions.
Sex: U
Vaccine: COVID19, COVID19, FLU3
Symptoms: Pain
Clinical narrative: a lot of pain; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 04Sep2024 as dose number unknown, single), in left arm. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Pfizer vaccine (DOSE NUMBER UNKNOWN, SINGLE; Intramuscular, Right or left arm), for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 2024, outcome "not recovered", described as "a lot of pain".  Additional information: It was reported that the patient was taking Aspirin within 2 weeks prior to the event onset and that did not received any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient mentioned that she and her husband received several vaccines beginning around Mar2020, every 6 months in the right or left arm. Also she reported that this was the first time vaccine did not work. The patient reported that just got sleepy for a few days following this vaccination. The patient was not allergic to any previous vaccination, medications, foods or other products and there are not other diagnosed  illnesses/medical history/chronic health conditions.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Off label use, Product availability issue
Clinical narrative: No additional AE; HCP reported that an adult patient was administered two 0.5mL doses of RECOMBIVAXHB on 10/29/2024 to equal the full dosage of 1.0 mL due to the office not having the full dosage in stock. No additional information was provided. No patient demographic; the office not having the full dosage in stock; This spontaneous report was received from a nurse referring to an adult patient of unknown age and gender. Information about the patients' pertinent medical history, concurrent conditions, concomitant medications or drug reactions/ allergies was not provided.  On 29-OCT-2024, the patient was vaccinated with two pediatric doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) dose of 0.5 mL (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported) as prophylaxis (Off label use). This procedure was done to equal the full dosage of 1.0 mL due to the office not having the full dosage in stock (Product availability issue). No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; PNEUMOVAX 23 expired on 10/7/2024 and was inadvertently administered on 11/7/2024; This spontaneous report was received from a certificated medical assistant (C.M.A.) and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On 07-NOV-2024, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe injection (lot # X018273 has been verified to be a valid lot number, expiration date reported as 07-OCT-2024 00) administered for prophylaxis at a dose of 0.5mls (strength, route of administration and anatomical location were not reported)  (expired product administered). No additional adverse events reported.
Age: 1.17
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: A 14 months old male patient received an adult dose of Havrix. Was his first dose of Havrix.; A 14 months old male patient received an adult dose of Havrix. Was his first dose of Havrix.; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 14-month-old male patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 15-DEC-2025) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: A 14 months old male patient received an adult dose of Havrix. Was his first dose of Havrix.) and adult product administered to child (Verbatim: A 14 months old male patient received an adult dose of Havrix. Was his first dose of Havrix.). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-OCT-2024 The reporter called to report that they administered an adult dose of Havrix to a 14 months old patient and was there a contraindication for this, which led to overdose and adult product administered to child. The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered only the DTAP-IPV liquid portion of PENTACEL, it had not been reconstituted with the ACTHIB powder portion with no reported adverse event; Initial information received on 18-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to US-SA-2024SA344353  This case involves an unknown age and unknown gender patient who was administered only the DTAP-IPV liquid portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], it had not been reconstituted with the ACTHIB powder portion 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 was administered only the dtap-ipv liquid portion of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot UK046AA, expiry date- 31-AUG-2025) via unknown route in unknown administration site for Immunization; it had not been reconstituted with the ACTHIB powder portion with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, Caller would like to know how to proceed. Can the ACTHIB powder portion be administered separately to these patients with a separate diluent.  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-2024SA344353:patient #2.
Sex: F
Vaccine: FLU3, HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: mistakenly injected with FLUZONE instead of the intended Hep B vaccine with no reported adverse event; Initial information received on 14-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 day old female patient who mistakenly injected with influenza USP trival A-B subvirion NO preservative vaccine [fluzone] instead of the intended hep B vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On 14-Nov-2024, the patient mistakenly injected with 0.5 ml od influenza USP trival A-B subvirion NO preservative vaccine [fluzone] Suspension for injection standard (unknown lot and expiry date) once via unknown route in unknown administration site for immunization instead of the intended hep B vaccine with no reported adverse event (wrong product administered) (Latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, She did not have information on whether it was specifically fluzone NP or T. She inquired about any potential concerns they should be aware of when the patient is transferred to them, including possible side effects or any they could do regarding this situation. She reiterated that this did not happen in their facility.  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: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached: 9C Duration out of labelled range: 54 minutes and product was administered with no adverse event; Max/low temperature reached: 9C Duration out of labelled range: 54 minutes and product was administered with no adverse event; Initial information received on 15-Nov-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] max/low temperature reached: 9C duration out of labelled range: 54 minutes with no adverse event and max/low temperature reached: 9C duration out of labelled range: 54 minutes and product were administered with no adverse event.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect IPV (VERO) Suspension for injection (unknown strength) with lot W1C7311 and expiry 18-Nov-2025 date via unknown route in unknown administration site for prophylactic vaccination (immunization) with no adverse event (poor quality product administered) (Latency same day).  On 05-Nov-2024 the suspect IPV (VERO) exposed to max/low temperature reached: 9C duration out of labelled range: 54 minutes and product was administered with no adverse event (product storage error)  Reportedly, Caller stated that all of the products were also involved in a previous excursion in September and were out of range for 5 hours and 21 minutes and reached 11C. Human error not involved.   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-2024SA339656:02307666
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE QIV used post temperature excursion with no reported AE; Initial information received on 15-Nov-2024 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves an unknown age female patient who received influenza quadrival A-B vaccine [fluzone QIV] post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received influenza quadrival A-B vaccine Suspension for injection (unknown strength) with lot UT8488LA and expiry date 30-Jun-2025 via unknown route in unknown administration site for prophylactic vaccination (immunization) post temperature excursion with no reported adverse event (poor quality product administered).  Reportedly, Human error was not involved. There were no previous excursion. temperature reached: 5.180 F Low (temperature confirmed with HCP to be sure)  (negative) -14.9 C  High Temperature reached: 33.22 F (0.6 C)   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-2024SA342579: US-SA-2024SA342856:02307917
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: one of the spoiled FLUZONE HD dose was administered to a patient (with no reported adverse event); Initial information received on 15-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 65 years old male patient who had one of the spoiled Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] dose was administered to a patient (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.  On 15-Nov-2024, the patient received a dose of 0.5 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot U8532BA, Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in the left deltoid for Immunization and one of the spoiled fluzone hd dose was administered to a patient (with no reported adverse event) (poor quality product administered) (latency : same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Low temperature reached: 5.180 F Low (temperature confirmed with HCP to be sure)  (negative) -14.9 C   High Temperature reached: 33.22 F (0.6 C) was administered to the patient wih no adverse event; Initial information received on 15-Nov-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case- US-SA-2024SA342978  This case involves an unknown age male patient and low temperature reached: 5.180 f low (temperature confirmed with hcp to be sure)  (negative) -14.9 c   high temperature reached: 33.22 f (0.6 c) was administered to the patient wih no adverse event with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UT8473BA expiry-30-Jun-2025 via unknown route in unknown administration site for prophylactic vaccination (Immunisation) (strength, dose unknown)low temperature reached: 5.180 f low (temperature confirmed with hcp to be sure)  (negative) -14.9 c   high temperature reached: 33.22 f (0.6 c) was administered to the patient wih no adverse event (poor quality product administered) (same day latency).   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-2024SA342978:
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: FLUZONE (syringes) was administer a week earlier/patient was supposed to take the dose at 4 weeks with no reported adverse event; Initial information received on 15-Nov-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 9 months old male patient who received influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] a week earlier/patient was supposed to take the dose at 4 weeks with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2024 the patient received 0,5 ml of dose 1  influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength0- unknown, lot UT8459JA and expiry date- 30-Jun-2025) and on 07-Nov-2024, the patient received 0.5 ml of dose 2  of same vaccine (lot UT8459JA) both via intramuscular route in unknown administration site as Immunization which was administer a week earlier/patient was supposed to take the dose at 4 weeks with no reported adverse event (inappropriate schedule of product administration) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Burning sensation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: feeling like a sunburn; did experience on the day of the injection sharp pain like the joints having a zapping pain; being red; being tender, and burning a bit; area swelled the first day and has gotten smalle; Initial information received on 18-Nov-2024 regarding an unsolicited valid  non-serious case received from a Patient.  This case involves a 30 years old female patient who experienced feeling like a sunburn, did experience on the day of the injection sharp pain like the joints having a zapping pain, being red, being tender, and burning a bit and area swelled the first day and has gotten small after receiving elasomeran [Spikevax] and influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pain.   On 14-Nov-2024, the patient received an unknown dose of Spikevax not produced by Sanofi Pasteur (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization) and received 0.5 ml of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection  with standard strength (expiry date- 30-Jun-2025 and lot UT8415NA) via unknown route in the left deltoid for immunization.   On 14-Nov-2024 the patient developed feeling like a sunburn (burning sensation), did experience on the day of the injection sharp pain like the joints having a zapping pain (arthralgia), being red (injection site erythema), being tender, and burning a bit (injection site pain), and area swelled the first day and has gotten small (injection site swelling) (latency- same day) following the administration of influenza USP TRIVAL A-B subvirion no preservative vaccine and Spikevax.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.