chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Injection site mass
Clinical narrative: Bump about 1 inch across swell up on arm; This spontaneous case initially received on 05-Nov-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2794391-1), and concerns an elderly male patient.  Drug history included lisinopril (Reaction: Allergy), lagevrio. At the time of the event the patient had Hypertension, Benign Prostatic Hyperplasia, anxiety.  Administration of company suspect drug(s): On 29-Sep-2024, the patient received Fluad (TIV) for Unknown indication., Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Left Arm, Lot number: 388497.   Adverse reactions/events and outcomes: On 29-Sep-2024, the patient experienced Bump about 1 inch across swell up on arm (outcome: Recovered / Resolved).  Vaccinated patient in middle of deltoid using the C technique, used a 1 inch length needle to get deep enough IM, needle was completely in deltoid. after needle was removed, pt had an anithistamine based reaction (bump about 1 inch across swell up on arm. Monitored patient very closely for 20 minutes. Swelling went down significantly (down to less than 1/4 inch) all by itself. Patient asked if they could leave, they acknowledged to me that they felt completely fine (no s/sx of breathing issues or fainting at all). Will follow up myself with patient on Monday 30-Sep-2024. Advised patient if condition worsens to seek emergency care. Patient verbally acknowledged.  Fluad (TIV) action taken: Not Applicable Treatment: unspecified antihistamines  Reporter's assessment: The reporter assessed the event as non-serious and did not provide the causality assessment.; Reporter's Comments: The event was considered as related to the administration of Fluad (TIV).
Age: 58.0
Sex: F
Vaccine: FLU3, PNC20, PNC20, UNK
Symptoms: Fatigue, Induration, Injection site erythema, Injection site paraesthesia, Injection site warmth
Clinical narrative: Feels fatigue; Fever 100; Next day noted redness around injection site; Next day noted warmth around injection site; Left arm soreness; Induration; Feels tingling in upper arm to elbow; This spontaneous case, initially received on 05-Nov-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2794405-1), and concerns an adult female patient.  Drug history included Erythromycin (Reaction: Allergy). At the time of the event the patient had mild persistent asthma, chronic rhinitis, esophageal reflux, Penicillins, cough. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 23-Sep-2024, the patient received Flucelvax (TIV) for unknown indication., Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Right Arm, Lot number: 946581.   Non-company suspect drugs: Prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)), Indication: unknown, Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Left Arm. Batch/Lot number: HR3649  Adverse reactions/events and outcomes: On 23-Sep-2024, the patient experienced Feels tingling in upper arm to elbow (outcome: Not recovered / Not resolved), Left arm soreness (outcome: Not recovered / Not resolved), Induration (outcome: Not recovered / Not resolved). On 24-Sep-2024, the patient experienced Next day noted warmth around injection site (outcome: Not recovered / Not resolved), Next day noted redness around injection site (outcome: Not recovered / Not resolved). On 26-Sep-2024, the patient experienced Feels fatigue (outcome: Not recovered / Not resolved), Fever 100 (outcome: Not recovered / Not resolved).  Left arm soreness and felt firm after injection was given. next day noted redness and warmth around injection site. Feels tingling in upper arm to elbow. Feels fatigue, fever 100 on 26-Sep-2024.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter assessed all events as non-serious except for Fever did not provided the seriousness and for all events did not provide the causality assessment.; Reporter's Comments: The events were considered as related to the administration of Flucelvax (TIV).
Age: 58.0
Sex: F
Vaccine: FLU3, PNC20, PNC20, UNK
Symptoms: Pain in extremity
Clinical narrative: Feels fatigue; Fever 100; Next day noted redness around injection site; Next day noted warmth around injection site; Left arm soreness; Induration; Feels tingling in upper arm to elbow; This spontaneous case, initially received on 05-Nov-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2794405-1), and concerns an adult female patient.  Drug history included Erythromycin (Reaction: Allergy). At the time of the event the patient had mild persistent asthma, chronic rhinitis, esophageal reflux, Penicillins, cough. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 23-Sep-2024, the patient received Flucelvax (TIV) for unknown indication., Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Right Arm, Lot number: 946581.   Non-company suspect drugs: Prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)), Indication: unknown, Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Left Arm. Batch/Lot number: HR3649  Adverse reactions/events and outcomes: On 23-Sep-2024, the patient experienced Feels tingling in upper arm to elbow (outcome: Not recovered / Not resolved), Left arm soreness (outcome: Not recovered / Not resolved), Induration (outcome: Not recovered / Not resolved). On 24-Sep-2024, the patient experienced Next day noted warmth around injection site (outcome: Not recovered / Not resolved), Next day noted redness around injection site (outcome: Not recovered / Not resolved). On 26-Sep-2024, the patient experienced Feels fatigue (outcome: Not recovered / Not resolved), Fever 100 (outcome: Not recovered / Not resolved).  Left arm soreness and felt firm after injection was given. next day noted redness and warmth around injection site. Feels tingling in upper arm to elbow. Feels fatigue, fever 100 on 26-Sep-2024.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter assessed all events as non-serious except for Fever did not provided the seriousness and for all events did not provide the causality assessment.; Reporter's Comments: The events were considered as related to the administration of Flucelvax (TIV).
Age: 58.0
Sex: F
Vaccine: FLU3, PNC20, PNC20, UNK
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site paraesthesia
Clinical narrative: Feels fatigue; Fever 100; Next day noted redness around injection site; Next day noted warmth around injection site; Left arm soreness; Induration; Feels tingling in upper arm to elbow; This spontaneous case, initially received on 05-Nov-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2794405-1), and concerns an adult female patient.  Drug history included Erythromycin (Reaction: Allergy). At the time of the event the patient had mild persistent asthma, chronic rhinitis, esophageal reflux, Penicillins, cough. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 23-Sep-2024, the patient received Flucelvax (TIV) for unknown indication., Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Right Arm, Lot number: 946581.   Non-company suspect drugs: Prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)), Indication: unknown, Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Left Arm. Batch/Lot number: HR3649  Adverse reactions/events and outcomes: On 23-Sep-2024, the patient experienced Feels tingling in upper arm to elbow (outcome: Not recovered / Not resolved), Left arm soreness (outcome: Not recovered / Not resolved), Induration (outcome: Not recovered / Not resolved). On 24-Sep-2024, the patient experienced Next day noted warmth around injection site (outcome: Not recovered / Not resolved), Next day noted redness around injection site (outcome: Not recovered / Not resolved). On 26-Sep-2024, the patient experienced Feels fatigue (outcome: Not recovered / Not resolved), Fever 100 (outcome: Not recovered / Not resolved).  Left arm soreness and felt firm after injection was given. next day noted redness and warmth around injection site. Feels tingling in upper arm to elbow. Feels fatigue, fever 100 on 26-Sep-2024.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter assessed all events as non-serious except for Fever did not provided the seriousness and for all events did not provide the causality assessment.; Reporter's Comments: The events were considered as related to the administration of Flucelvax (TIV).
Age: 58.0
Sex: F
Vaccine: FLU3, PNC20, PNC20, UNK
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Feels fatigue; Fever 100; Next day noted redness around injection site; Next day noted warmth around injection site; Left arm soreness; Induration; Feels tingling in upper arm to elbow; This spontaneous case, initially received on 05-Nov-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2794405-1), and concerns an adult female patient.  Drug history included Erythromycin (Reaction: Allergy). At the time of the event the patient had mild persistent asthma, chronic rhinitis, esophageal reflux, Penicillins, cough. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 23-Sep-2024, the patient received Flucelvax (TIV) for unknown indication., Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Right Arm, Lot number: 946581.   Non-company suspect drugs: Prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)), Indication: unknown, Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Left Arm. Batch/Lot number: HR3649  Adverse reactions/events and outcomes: On 23-Sep-2024, the patient experienced Feels tingling in upper arm to elbow (outcome: Not recovered / Not resolved), Left arm soreness (outcome: Not recovered / Not resolved), Induration (outcome: Not recovered / Not resolved). On 24-Sep-2024, the patient experienced Next day noted warmth around injection site (outcome: Not recovered / Not resolved), Next day noted redness around injection site (outcome: Not recovered / Not resolved). On 26-Sep-2024, the patient experienced Feels fatigue (outcome: Not recovered / Not resolved), Fever 100 (outcome: Not recovered / Not resolved).  Left arm soreness and felt firm after injection was given. next day noted redness and warmth around injection site. Feels tingling in upper arm to elbow. Feels fatigue, fever 100 on 26-Sep-2024.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter assessed all events as non-serious except for Fever did not provided the seriousness and for all events did not provide the causality assessment.; Reporter's Comments: The events were considered as related to the administration of Flucelvax (TIV).
Sex: F
Vaccine: FLU3, UNK
Symptoms: Injection site mass, Injection site rash
Clinical narrative: She has a small lump at the site of injection; She has a rash at the site of injection; This spontaneous case, initially received on 05-Nov-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2794468-1), and concerns an elderly female patient.   Administration of company suspect drug(s): On 28-Sep-2024, the patient received Fluad (TIV) for indication not reported, dosage regimen: not reported, Route of administration: Intramuscular, Anatomical site: Right Arm, batch number reported as 388459.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 29-Sep-2024, the patient experienced She has a small lump at the site of injection (outcome: Unknown), She has a rash at the site of injection (outcome: Unknown).  Patient received vaccine on 28-Sep-2024. Patient came to pharmacy and was very tight clothes and couldn't remove them to access the ideal deltoid location. She rolled up the sleeves and the vaccination were administered as high as possible. On 30-Sep-2024 the patient called and stated that she had rash and small lump at the site of injection and believe it was administered subcutaneously and was wondering how long it would take to resolve. Reporter advised the patient to contact her physician and explained that local site reactions at the injection site were possible following influenza vaccination and were typically self-resolving.  Fluad (TIV) action taken: Not Applicable   Reporter's assessment: The reporter assessed the events as non-serious and did not provide the causality assessment. ; Reporter's Comments: The events were considered related to the administration of Fluad (TIV).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Fall, Nausea
Clinical narrative: headache; fell; nausea; weakness; dizzy spell; couldn't eat or drink; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 31Aug2024 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing), notes: 24 years ago; "high cholesterol" (unspecified if ongoing), notes: 20 years ago; "uterine cancer", start date: Oct2009 (unspecified if ongoing), notes: successfully treated with hysterectomy; "hysterectomy", start date: Dec2009 (unspecified if ongoing); "lymphedema" (unspecified if ongoing), notes: lymph nodes removed during hysterectomy; "lymph nodes removed" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ROSUVASTATIN; CALCIUM. Vaccination history included: Comirnaty (received all prior COVID-19 vaccines from Pfizer), for COVID-19 immunization; Shingrix (2nd dose, had similar reaction but not as severe), for immunization, reaction(s): "allergic to vaccine". The following information was reported: DECREASED APPETITE (non-serious) with onset 01Sep2024, outcome "unknown", described as "couldn't eat or drink"; DIZZINESS (non-serious) with onset 01Sep2024, outcome "unknown", described as "dizzy spell"; FALL (non-serious) with onset 01Sep2024, outcome "recovering", described as "fell"; NAUSEA (non-serious) with onset 01Sep2024, outcome "recovering"; ASTHENIA (non-serious) with onset 01Sep2024, outcome "unknown", described as "weakness"; HEADACHE (non-serious), outcome "unknown". The events "weakness" and "dizzy spell" required physician office visit. The events "falling" and "nausea" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of fall. Therapeutic measures were not taken as a result of asthenia, dizziness.  Additional information: patient reported that when she woke up she had all the symptoms and stayed in bed all day, couldn't eat or drink and at night she went to the bathroom got dizzy, weak, and fell. On the emergency room visit an X-ray was ordered by the walk in clinic for the fall and was given pain medication, and muscle relaxant. Nausea has improved at the time of emergency room visit.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fall, Headache
Clinical narrative: headache; fell; nausea; weakness; dizzy spell; couldn't eat or drink; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 31Aug2024 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing), notes: 24 years ago; "high cholesterol" (unspecified if ongoing), notes: 20 years ago; "uterine cancer", start date: Oct2009 (unspecified if ongoing), notes: successfully treated with hysterectomy; "hysterectomy", start date: Dec2009 (unspecified if ongoing); "lymphedema" (unspecified if ongoing), notes: lymph nodes removed during hysterectomy; "lymph nodes removed" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ROSUVASTATIN; CALCIUM. Vaccination history included: Comirnaty (received all prior COVID-19 vaccines from Pfizer), for COVID-19 immunization; Shingrix (2nd dose, had similar reaction but not as severe), for immunization, reaction(s): "allergic to vaccine". The following information was reported: DECREASED APPETITE (non-serious) with onset 01Sep2024, outcome "unknown", described as "couldn't eat or drink"; DIZZINESS (non-serious) with onset 01Sep2024, outcome "unknown", described as "dizzy spell"; FALL (non-serious) with onset 01Sep2024, outcome "recovering", described as "fell"; NAUSEA (non-serious) with onset 01Sep2024, outcome "recovering"; ASTHENIA (non-serious) with onset 01Sep2024, outcome "unknown", described as "weakness"; HEADACHE (non-serious), outcome "unknown". The events "weakness" and "dizzy spell" required physician office visit. The events "falling" and "nausea" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of fall. Therapeutic measures were not taken as a result of asthenia, dizziness.  Additional information: patient reported that when she woke up she had all the symptoms and stayed in bed all day, couldn't eat or drink and at night she went to the bathroom got dizzy, weak, and fell. On the emergency room visit an X-ray was ordered by the walk in clinic for the fall and was given pain medication, and muscle relaxant. Nausea has improved at the time of emergency room visit.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: headache; fell; nausea; weakness; dizzy spell; couldn't eat or drink; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 31Aug2024 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing), notes: 24 years ago; "high cholesterol" (unspecified if ongoing), notes: 20 years ago; "uterine cancer", start date: Oct2009 (unspecified if ongoing), notes: successfully treated with hysterectomy; "hysterectomy", start date: Dec2009 (unspecified if ongoing); "lymphedema" (unspecified if ongoing), notes: lymph nodes removed during hysterectomy; "lymph nodes removed" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ROSUVASTATIN; CALCIUM. Vaccination history included: Comirnaty (received all prior COVID-19 vaccines from Pfizer), for COVID-19 immunization; Shingrix (2nd dose, had similar reaction but not as severe), for immunization, reaction(s): "allergic to vaccine". The following information was reported: DECREASED APPETITE (non-serious) with onset 01Sep2024, outcome "unknown", described as "couldn't eat or drink"; DIZZINESS (non-serious) with onset 01Sep2024, outcome "unknown", described as "dizzy spell"; FALL (non-serious) with onset 01Sep2024, outcome "recovering", described as "fell"; NAUSEA (non-serious) with onset 01Sep2024, outcome "recovering"; ASTHENIA (non-serious) with onset 01Sep2024, outcome "unknown", described as "weakness"; HEADACHE (non-serious), outcome "unknown". The events "weakness" and "dizzy spell" required physician office visit. The events "falling" and "nausea" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of fall. Therapeutic measures were not taken as a result of asthenia, dizziness.  Additional information: patient reported that when she woke up she had all the symptoms and stayed in bed all day, couldn't eat or drink and at night she went to the bathroom got dizzy, weak, and fell. On the emergency room visit an X-ray was ordered by the walk in clinic for the fall and was given pain medication, and muscle relaxant. Nausea has improved at the time of emergency room visit.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient was given the ADULT dose of the Pfizer vaccine. He is a child and was there for the pediatric dose. We were not notified for 9 days. He did have a very sore arm for two days, but so far, no other symptoms. I'm here to report the vaccine error.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the ADULT dose of the Pfizer vaccine. He is a child and was there for the pediatric dose. We were not notified for 9 days. He did have a very sore arm for two days, but so far, no other symptoms. I'm here to report the vaccine error.
Age: 68.0
Sex: M
Vaccine: RSV, UNK, COVID19
Symptoms: Death, Mobility decreased, Pain, Pyrexia
Clinical narrative: The patient was reported as deceased by his sister to the pharmacy on 11/25/2024. She reported that he had been feeling unwell from the time of vaccination to his passing 10 days later.
Age: 68.0
Sex: M
Vaccine: RSV, UNK, COVID19
Symptoms: Death, Malaise
Clinical narrative: The patient was reported as deceased by his sister to the pharmacy on 11/25/2024. She reported that he had been feeling unwell from the time of vaccination to his passing 10 days later.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Atrial fibrillation
Clinical narrative: Immediately after, typical injection site pain.  24 hrs after the injection, typical aching, feeling tired and slight headache.  About 32 hrs after the injection (11pm), I went to bed and noticed a rapid heart rate. I have a Mobile device (since my Mother-in-Law has A Fib) so I ran an EKG which read out as A Fib. Since I am a retired PA-C and had no other symptoms, and a rate of 80 - 90 and not 120, I elected to relax and keep monitoring rather than going to the ED.  The rhythm transitioned to SInus Rhythm with Supraventricular Ectopy @  12:41am.  The following day, the device alternated between AFib and Sinus Rhythm with SVE.  I sent these readings to a friend/retired Cardiologist who read more as rapid and irregular atrial response since the rate never breaks 93 with any readings. Monday morning, AF continued as did the SVE.  Monday afternoon (@ 36 - 40 hrs post onset) the readings were NSR.  Tuesday @ 9:45am I saw my PCP for f/up of Low B12. She ran an EKG which was Nl but ordered a 30 day event monitor and f/up w/ Cardiologist. While awaiting the monitor, all readings have been NSR.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Atrial fibrillation, Cardiac monitoring, Electrocardiogram abnormal, Fatigue, Headache
Clinical narrative: Immediately after, typical injection site pain.  24 hrs after the injection, typical aching, feeling tired and slight headache.  About 32 hrs after the injection (11pm), I went to bed and noticed a rapid heart rate. I have a Mobile device (since my Mother-in-Law has A Fib) so I ran an EKG which read out as A Fib. Since I am a retired PA-C and had no other symptoms, and a rate of 80 - 90 and not 120, I elected to relax and keep monitoring rather than going to the ED.  The rhythm transitioned to SInus Rhythm with Supraventricular Ectopy @  12:41am.  The following day, the device alternated between AFib and Sinus Rhythm with SVE.  I sent these readings to a friend/retired Cardiologist who read more as rapid and irregular atrial response since the rate never breaks 93 with any readings. Monday morning, AF continued as did the SVE.  Monday afternoon (@ 36 - 40 hrs post onset) the readings were NSR.  Tuesday @ 9:45am I saw my PCP for f/up of Low B12. She ran an EKG which was Nl but ordered a 30 day event monitor and f/up w/ Cardiologist. While awaiting the monitor, all readings have been NSR.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Heart rate increased, Injection site pain, Pain, Sinus rhythm, Supraventricular extrasystoles
Clinical narrative: Immediately after, typical injection site pain.  24 hrs after the injection, typical aching, feeling tired and slight headache.  About 32 hrs after the injection (11pm), I went to bed and noticed a rapid heart rate. I have a Mobile device (since my Mother-in-Law has A Fib) so I ran an EKG which read out as A Fib. Since I am a retired PA-C and had no other symptoms, and a rate of 80 - 90 and not 120, I elected to relax and keep monitoring rather than going to the ED.  The rhythm transitioned to SInus Rhythm with Supraventricular Ectopy @  12:41am.  The following day, the device alternated between AFib and Sinus Rhythm with SVE.  I sent these readings to a friend/retired Cardiologist who read more as rapid and irregular atrial response since the rate never breaks 93 with any readings. Monday morning, AF continued as did the SVE.  Monday afternoon (@ 36 - 40 hrs post onset) the readings were NSR.  Tuesday @ 9:45am I saw my PCP for f/up of Low B12. She ran an EKG which was Nl but ordered a 30 day event monitor and f/up w/ Cardiologist. While awaiting the monitor, all readings have been NSR.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional Adverse events reported; an expired dose of PNEUMOVAX 23 was given to a patient.; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender.  The patient's medical history, concomitant therapies and concurrent conditions were not reported.   On 25-OCT-2024, the patient was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #x018273, expiration date: 07-OCT-2024, administered as prophylaxis (strength, and route of administration were not provided).  Pharmacist reported that this dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was expired (Expired product administered). This was patients second dose in a series. The first dose was not expired. The pharmacist did not provide lot number for the first dose. No additional adverse events were reported.
Age: 36.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/asymptomatic; an expired GARDASIL 9 vaccine was inadverntly administered to a patient on 10/29/2024; This spontaneous report has been received from a medical assistant (MA) (vaccine provider) and a health business professional (HBP) referring to a 36-year-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.   On 29-OCT-2024, the patient was inadvertently vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W004648, expiration date: 06-OCT-2024, administered intramuscularly (IM) in the left deltoid (LD) for prophylaxis by the MA (first dose; strength and dose were not provided) (Expired product administered). The vaccine did not have any prior temperature excursions (T.Es). It was reported that the patient was asymptomatic both at time of vaccination and after vaccination (no adverse event). The event was reported to doctor previously. No additional adverse event (AE)/product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; HCP reports patient was given PROQUAD earlier than recommended.  Patient received MMR II and VARIVAX on 10/25/2024 and PROQUAD today 11/18/2024.  No other information was provided. No additional AE. No PQC.; This spontaneous report was received from nurse and refers to a patient os unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-OCT-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 18-NOV-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No additional adverse event was reported.
Age: 4.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain
Clinical narrative: pain at the injection site.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 4-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21-OCT-2024, the patient received Menveo (intramuscular, unknown thigh). In OCT-2024, less than a week after receiving Menveo, the patient experienced injection site pain (Verbatim: pain at the injection site.). The outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Menveo.     It was unknown if the company considered the injection site pain to be related to Menveo.   Additional Information: GSK Receipt Date: 24-OCT-2024 Caller was the mother of the patient who reported that the travel Healthcare professional gave her two sons (ages 4 and 5) the one vial presentation of Menveo (pink cap), in their thighs. The boys stated there was pain at the injection site. The travel Healthcare professional called the mother to report the wrong presentation of Menveo was given to both boys. Caller wanted to know next steps.
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pruritus
Clinical narrative: sore at the injection site; legs were itching; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number g7cy7, expiry date 30-JUN-2025) for prophylaxis.   The patient's past medical history included mercury sensitivity.   On 22-OCT-2024, the patient received Fluarix 2024-2025 season (intramuscular, left deltoid). In OCT-2024, less than a week after receiving Fluarix 2024-2025 season, the patient experienced injection site pain (Verbatim: sore at the injection site) and itchy legs (Verbatim: legs were itching). The outcome of the injection site pain was unknown and the outcome of the itchy legs was not resolved.   The reporter considered the injection site pain and itchy legs to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the injection site pain and itchy legs to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   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: 24-OCT-2024 The reporter was a retail pharmacist who reported that patient received Fluarix trivalent 2024-2025 intramuscularly ,via prefilled syringe, in the left deltoid on 22 October 2024. The patient's husband returned to the pharmacy on 25 October 2024 saying that his wife (the patient) had a sore arm (sore at the injection site) and also informed him that both of her legs were itching. The husband did not know if there were any bumps/rash on her legs he just knew that they itched. The husband was asking if there was any mercury in the Fluarix vaccine because the patient has a history of reaction to mercury and the symptoms she was experiencing was similar to what she had experienced in the past.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 29-OCT-2024 The reporter was a friend calling on behalf of a patient that received her first dose of Shingrix in September 2021 (no specific date provided), and stated that the patient received her second dose of Shingrix two weeks later. No date was provided for the second dose.  No Lot/Expiry/NDC/Location or Route of Administration were provided for either dose.  No Date of Birth was provided for the patient.   The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Incorrect dose administered
Clinical narrative: pregnant 37 weeks 3 days received a fluzone high dose vaccine by mistake with no reported adverse event; Initial information received on 14-Nov-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age 37 weeks 3 days female pregnant patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] by mistake with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant 37 weeks 3 days received a fluzone high dose vaccine by mistake with no reported adverse event occurred at 37 Weeks of pregnancy. the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE formulation : Suspension for injection in pre-filled syringe, strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and pregnant 37 weeks 3 days received a fluzone high dose vaccine by mistake with no reported adverse event (exposure during pregnancy) (latency: same day)   Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Temperature excursion: negative disposition and product used with no reported adverse event; Max/low temperature reached: 9CDuration out of labelled range: 54 minutes with no reported adverse event; Initial information received on 15-Nov-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case was linked to 2024SA341644.  This case involves an unknown age and unknown gender patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] post max/low temperature reached: 9 Celsius duration out of labelled range: 54 minutes and temperature excursion: negative disposition and product used with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Nov-2024, the patient received a dose of suspect punctured INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE Suspension for injection (lot U8435BA, expiry: 30-JUN-2025) (unknown strength, dosage and route) in unknown administration site for prophylactic vaccination.  On an unknown date the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] post max/low temperature reached: 9 Celsius duration out of labelled range: 54 minutes temperature excursion: negative disposition occurred on 05-Nov-2024 (latency-same day) and product used (latency unknown) with no reported adverse event.  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. No human error.  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-2024SA341644:02307664
Age: 71.0
Sex: F
Vaccine: FLU3, TDAP, FLU4
Symptoms: Dizziness, Headache, Impaired driving ability, Impaired work ability, Laboratory test
Clinical narrative: Extreme vertigo, dizziness, headache, blurry/fuzzy vision, and nauseous. It started on the Friday after the shot on Thursday and has lasted through today, Sunday, 11/24/2024.  Treatments have been to take clear ear ways and neck movements/PT to release the inner ear problems to help with vertigo and dizziness.  Gensying gum to help with nausea, as I tried pepto bismol, which only made me sicker. Reduced use of the computer (I'm a college professor who teaches online, needing to also grade papers) and other screens, such as my handheld and TV, simultaneously to help with focusing better.  I was asked to change my glasses to see if that would help, went through 3 pairs and it did for a day or two, and then it started all over again, so now I am back to my original glasses. Now,am only useing the computer for about 20 minutes at time, but still having problems with focusing and not quinting for viewing the screen, as I get headaches still.  When I go to get up I have to do it slowly, so I don't get dizzy. When I go to get up from bed, lots of vertigo, and have to still wait about 45 minutes before I can get it calmed down before I get up. I wanted to try driving, and it was not good, after I went down the street about 5 blocks, so I came back, because of both dizziness, and blurry vision happening.
Age: 71.0
Sex: F
Vaccine: FLU3, TDAP, FLU4
Symptoms: Nausea, Vertigo, Vision blurred
Clinical narrative: Extreme vertigo, dizziness, headache, blurry/fuzzy vision, and nauseous. It started on the Friday after the shot on Thursday and has lasted through today, Sunday, 11/24/2024.  Treatments have been to take clear ear ways and neck movements/PT to release the inner ear problems to help with vertigo and dizziness.  Gensying gum to help with nausea, as I tried pepto bismol, which only made me sicker. Reduced use of the computer (I'm a college professor who teaches online, needing to also grade papers) and other screens, such as my handheld and TV, simultaneously to help with focusing better.  I was asked to change my glasses to see if that would help, went through 3 pairs and it did for a day or two, and then it started all over again, so now I am back to my original glasses. Now,am only useing the computer for about 20 minutes at time, but still having problems with focusing and not quinting for viewing the screen, as I get headaches still.  When I go to get up I have to do it slowly, so I don't get dizzy. When I go to get up from bed, lots of vertigo, and have to still wait about 45 minutes before I can get it calmed down before I get up. I wanted to try driving, and it was not good, after I went down the street about 5 blocks, so I came back, because of both dizziness, and blurry vision happening.
Age: 71.0
Sex: F
Vaccine: FLU3, TDAP, FLU4
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Extreme vertigo, dizziness, headache, blurry/fuzzy vision, and nauseous. It started on the Friday after the shot on Thursday and has lasted through today, Sunday, 11/24/2024.  Treatments have been to take clear ear ways and neck movements/PT to release the inner ear problems to help with vertigo and dizziness.  Gensying gum to help with nausea, as I tried pepto bismol, which only made me sicker. Reduced use of the computer (I'm a college professor who teaches online, needing to also grade papers) and other screens, such as my handheld and TV, simultaneously to help with focusing better.  I was asked to change my glasses to see if that would help, went through 3 pairs and it did for a day or two, and then it started all over again, so now I am back to my original glasses. Now,am only useing the computer for about 20 minutes at time, but still having problems with focusing and not quinting for viewing the screen, as I get headaches still.  When I go to get up I have to do it slowly, so I don't get dizzy. When I go to get up from bed, lots of vertigo, and have to still wait about 45 minutes before I can get it calmed down before I get up. I wanted to try driving, and it was not good, after I went down the street about 5 blocks, so I came back, because of both dizziness, and blurry vision happening.
Sex: F
Vaccine: TDAP
Symptoms: Dysgraphia, Multiple sclerosis, Tremor
Clinical narrative: can't draw like this anymore because my hand shakes from the multiple sclerosis I got from your AdacelTdap vaccine; can't draw like this anymore because my hand shakes from the multiple sclerosis I got from your AdacelTdap vaccine; Initial information received on 11-Nov-2024 regarding an unsolicited valid serious case received from a consumer (Patient).  This case involves Adult female patient of an unknown age who reported that she can't draw like this anymore because her hand shakes from the multiple sclerosis after receiving Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel].  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 unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On an unknown date the patient can't draw like this anymore because her hand shakes from the multiple sclerosis (multiple sclerosis) and (tremor) (unknown latency).   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both events.  At time of reporting, the outcome was Unknown for both events.  These events were assessed as medically significant.; Sender's Comments: Sanofi company comment dated on 19-Nov-2024: This case involves Adult female patient of an unknown age who reported that she can't draw like this anymore because her hand shakes from the multiple sclerosis after receiving Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel]. Further information regarding tolerance medical history or family history, concurrent condition and concomitant medication laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 35.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dosage for age.  gave infant dose over 11 lbs.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Wrong dosage for age gave infant dose over 11bs
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Brain fog, Chest pain, Chills
Clinical narrative: Brain fog, bad headache numbness in fingers and toes, chills, shaking muscle (pain, nausea, faint, weakness, anorexia. Lasted 9-12 hours, chest pain for 3 days. Coughing, wheezing, nasal discharge for 3 days. Asthematic attacks for 3 days.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Decreased appetite, Headache, Hypoaesthesia
Clinical narrative: Brain fog, bad headache numbness in fingers and toes, chills, shaking muscle (pain, nausea, faint, weakness, anorexia. Lasted 9-12 hours, chest pain for 3 days. Coughing, wheezing, nasal discharge for 3 days. Asthematic attacks for 3 days.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Rhinorrhoea, Tremor, Wheezing
Clinical narrative: Brain fog, bad headache numbness in fingers and toes, chills, shaking muscle (pain, nausea, faint, weakness, anorexia. Lasted 9-12 hours, chest pain for 3 days. Coughing, wheezing, nasal discharge for 3 days. Asthematic attacks for 3 days.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Paraesthesia oral, Throat tightness, Tongue disorder
Clinical narrative: Tingling mouth, tongue felt thick, throat, throat feels like someone is grabbing when she swallows. A little SOB with chest heaviness.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine increased, Mental status changes
Clinical narrative: Background: - 11/18 office visit with Transplant, assessed to be A&OX3             - No mention of why patient was A&OX3 vs 4             - Patient received influenza and COVID vaccines             - Furosemide was increased to 80mg QAM and 40mg QPM - 11/19 admitted to hospital with AMS             - H&P assessed to be oriented to person, place, and time             - Empirically started Vancomycin and Cefepime             - AKI on CKD (Baseline creatinine 1.61, admitted at 2.74) - 11/20 patient assessed to be A&OX4 on ER handoff to floor and AM RN
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Redness, swelling, pain, fever
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Death, Hypotension, Vomiting
Clinical narrative: Vomiting, starting 11/20/2024. Abdominal pain 11/22/2024, Sent to ER on 11/22/2024 R/T low BP and increased pain. Death date 11/23/2024 14:43
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: On Thursday Nov 21st, I took my 4 month old son to get his Respiratory Syncytial Virus vaccine  (RSV vaccine) at dr's office. The clinic injected my son with a Flu vaccine instead of the RSV vaccine. My son was not supposed to get a Flu vaccine until he was older than 6 months. Clinic had no procedure in place to check and make sure they were giving out the right vaccines to babies.
Age: 1.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product preparation issue
Clinical narrative: This is a report of a medication error ONLY. No adverse events have occurred. It was realized today that the covid vaccine vial that was indicated for this child's age needed diluent added. This was inadvertently overlooked and the entire vial was drawn up and given as one single dose. The Mother was called and informed of this mistake today. She informed that the child has NOT had any adverse effects to occur and stated that "he has been completely fine". Mother was informed that this dose still counts and per CDC/ACIP guidelines she should proceed with dose number 3 at the recommended time. Mother verbalized understanding.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after realization of temperature excursion. Temp Excursion happened on 11/14/2024, patient was vaccinated on 11/18/2024. The vial was punctured prior to temp excursion, per manufacturer, must the vaccine is no longer viable. Patient's parent was called and educated, appointment for revaccination rescheduled.