chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: received the DTap/IPV portion of Pentacel but not the lipophilic HiB component (with no reported adverse event); Initial information received on 09-Dec-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 15 months old and unknown gender patient who received only dtap/ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] but not the lipophilic hib component (with no reported adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received only dtap/ipv portion of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (dose, strength, route lot and expiry: unknown) but not the lipophilic hib component (with no reported adverse event) (single component of a two-component product administered) (latency same day) in unknown administration site for prophylactic vaccination.  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  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: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: consumer was late for day 7 and would be getting the dose on day 13 or 14 with no reported adverse event; Initial information received on 10-Dec-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient, as consumer was late for day 7 and will be getting the dose on day 13 or 14 with no reported adverse event with RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, consumer was late for day 7 of suspect RABIES (HDC) VACCINE  Powder and solvent for suspension for injection via unknown route in unknown administration site for immunization (strength, dose, batch and expiry date unknown) and would be getting the dose on day 13 or 14 with no reported adverse event (routine immunisation schedule not administered) (unknown latency).  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.   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: 14.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion when the fridge was opened/highest temp was 9.76° with no reported adverse event; unsuitable product administered with no reported adverse event; Initial information received on 10-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA367885.  This case involves a 14 years old female patient who had received IPV (VERO) [IMOVAX POLIO] of temperature excursion when the fridge was opened/highest temp was 9.76° with no reported adverse event and unsuitable product administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella zoster vaccine (Varicella vaccine) for Immunisation; and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for Immunisation.  On 14-Nov-2024, the patient received a dose 2 of 0.5 ml of suspect IPV (VERO) (Suspension for injection) lot W1A191M. Expiry date: 16-Dec-2025, Frequency: Twice, strength was unknown via subcutaneous route in the right arm for Immunization and temperature excursion when the fridge was opened/highest temp was 9.76° with no reported adverse event (product storage error) (unknown latency) and unsuitable product administered with no reported adverse event (poor quality product administered) (latency : same day).  Reportedly "Previous Excursion? None Human error? Yes. Administered post-excursion? Yes, she said that the (punctured) IPOL. Does extended stability data cover the excursion? No."   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-2024SA367885:
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given only the DTaP-IPV component of PENTACEL, but not the HIB component (with no reported adverse event); Initial information received on 11-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient was given only the dtap-ipv component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)], but not the hib component (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 10-Dec-2024, the patient received a dose 2 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine  (Suspension for injection) lot UK045AA, Expiry date: 31-Aug-2025, strength was unknown via unknown route in unknown administration site for Immunization and patient was given only the dtap-ipv component of pentacel, but not the hib component (with no reported adverse event) (single component of a two-component product administered) (latency: same day).  Reportedly "She inquired whether they should still administer the HIB component separately or if they need to revaccinate the patient with the full PENTACEL dose."   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: 8.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD has been given to patients aged 8 (with no reported adverse event); Initial information received on 11-Dec-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 8 years old and unknown gender patient who received influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] (with no reported adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Dec-2024, the patient received 0.5 ml of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- high dose, expiry date- 30-Jun-2025 and lot UT8454AA) via intramuscular route in unknown administration site as Immunization at the age of 8 years (with no reported adverse event) (product administered to patient of inappropriate age) (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: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: cold after getting flu shot; Initial information received on 11-Dec-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves an unknown age male patient who experienced cold after getting Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Insulin glargine (Lantus Solostar).  On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer formulation, strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On an unknown date the patient developed cold after getting flu shot (nasopharyngitis) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (cold after getting flu shot).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event cold after getting flu shot.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Hypersensitivity
Clinical narrative: allergic reaction; feeling weak; fatigue; Initial information received on 11-Dec-2024 regarding an unsolicited valid  non-serious case received from a consumer/Non-Healthcare Professional.  This case involves an unknown age female patient who experienced allergic reaction, feeling weak and fatigue after receiving Influenza USP trival A-B high dose subvirion vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Dec-2024, the patient received unknown dose of suspect Influenza USP trival A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 11-Dec-2024 on same day the patient developed allergic reaction (hypersensitivity). As a result, she spent the day in the emergency room. On unknown date In Dec-2024 the patient feeling weak (asthenia) and fatigue (unknown latency).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events (allergic reaction, feeling weak, fatigue).  At time of reporting, the outcome was Unknown for all the events.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Pt states having injury from vaccine. suspect rotator cuff injury.
Age: 0.17
Sex: M
Vaccine: PNC20, RV1
Symptoms: Erythema, Infantile spitting up, Tremor
Clinical narrative: Mother had an appointment with Community Health worker around 3:15pm, child was asleep in mother's arms, woke up spitting milk, just a little, mother positioned child upwards, and that's when she noticed the child shaking from head to toe, turned red within minutes.  PCV20 and Rota was given around 3 pm, and child had a reaction around 3:15-3:20pm.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cluster headache
Clinical narrative: Cluster headache.
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Foetal growth restriction, Pre-eclampsia, Ultrasound foetal abnormal
Clinical narrative: Patient hospitalized with pre-eclampsia with severe features and fetal growth restriction. Received Abrysvo at 32 weeks; the following day, the fetus was noted to have worsening umbilical artery dopplers necessitating delivery.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Mobility decreased, Pain in extremity
Clinical narrative: Arm on fire; arm very sore (difficult to raise over head); hip, knees, and ankle aches (like you're having covid)
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Dizziness, Mobility decreased, Nausea
Clinical narrative: Arm on fire; arm very sore (difficult to raise over head); hip, knees, and ankle aches (like you're having covid)
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm on fire; arm very sore (difficult to raise over head); hip, knees, and ankle aches (like you're having covid)
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Mobility decreased, Pain in extremity
Clinical narrative: Nausea, extreme aches in the hips, knees, and ankles, dizziness, sore arm (difficult to lift over head), and arm on fire.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Dizziness, Mobility decreased, Nausea
Clinical narrative: Nausea, extreme aches in the hips, knees, and ankles, dizziness, sore arm (difficult to lift over head), and arm on fire.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Nausea, extreme aches in the hips, knees, and ankles, dizziness, sore arm (difficult to lift over head), and arm on fire.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Extra dose administered, Injection site erythema
Clinical narrative: Patient was given a second dose of Arexvy although that is not recommended. She received another dose in another state so it did not show on state shots and she did not tell the pharmacist. She said she did get some redness at the site and red lines on her arm but getting better on their own.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Raised, hard, painful egg-sized lump appeared 10 hours after injection.  Site then became red and hot. She had joint pain and a stabbing pain in left side under rib cage.  Patient took benadryl orally and applied ice every 20 minutes.  She came in to pharmacy 48 hour after injection and site was still red, hot, dollar-bill sized.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth, Musculoskeletal chest pain
Clinical narrative: Raised, hard, painful egg-sized lump appeared 10 hours after injection.  Site then became red and hot. She had joint pain and a stabbing pain in left side under rib cage.  Patient took benadryl orally and applied ice every 20 minutes.  She came in to pharmacy 48 hour after injection and site was still red, hot, dollar-bill sized.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Hyperhidrosis
Clinical narrative: Chills with profound shivering. Fever and sweating. Nausea. Loss of appetite. Headache. Muscle and joint soreness.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Chills with profound shivering. Fever and sweating. Nausea. Loss of appetite. Headache. Muscle and joint soreness.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site urticaria, Lip swelling
Clinical narrative: Within 5-10 minutes of receiving 3 vaccines (MMR, Varicella and Hepatitis A), patient started developing hives on her face, head, redness of face and slight swelling of lips.  No wheezing or trouble breathing.  The area in which the Varicella vaccine was administered turned red, swollen with hives and she also developed a few hives down that right arm.  We gave Zyrtec 2.5mL and monitored her for 20-30 minutes.  The hives resolved, her face was less red.  No trouble breathing.  Mom then took her home.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Within 5-10 minutes of receiving 3 vaccines (MMR, Varicella and Hepatitis A), patient started developing hives on her face, head, redness of face and slight swelling of lips.  No wheezing or trouble breathing.  The area in which the Varicella vaccine was administered turned red, swollen with hives and she also developed a few hives down that right arm.  We gave Zyrtec 2.5mL and monitored her for 20-30 minutes.  The hives resolved, her face was less red.  No trouble breathing.  Mom then took her home.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Head injury, Heart rate increased, Hypertension, Malaise
Clinical narrative: After about 10 - 15 minutes of receiving the flu shot  patient went to the restroom , he returned to the lobby and notified the staff that he fell and hit his head.  The pharmacist on duty took his blood pressure and gave him some water; both blood pressure and pulse were elevated. patient stated he was not felling well and the staff asked if he wanted to have the paramedics called and he said yes.   Paramedics were called to assist the patient and the patient was taken away.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pruritus, Rash, Rash macular, Scar
Clinical narrative: blotches on legs and skin/growth on hands and skin; discoloring in the hands; Scars; rashes on my feet and on the side of my left foot; itching; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2022 as dose number unknown (booster), 0.3 ml single (Lot number: FK9729, Expiration Date: 31May2022) at the age of 73 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: SCAR (non-serious) with onset 2022, outcome "recovering", described as "Scars"; RASH MACULAR (non-serious) with onset 2022, outcome "not recovered", described as "blotches on legs and skin/growth on hands and skin"; SKIN DISCOLOURATION (non-serious) with onset 2022, outcome "not recovered", described as "discoloring in the hands"; PRURITUS (non-serious) with onset 2022, outcome "not recovered", described as "itching"; RASH (non-serious) with onset 2022, outcome "recovering", described as "rashes on my feet and on the side of my left foot". The events "blotches on legs and skin/growth on hands and skin", "discoloring in the hands", "scars", "rashes on my feet and on the side of my left foot" and "itching" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash macular, skin discolouration, scar, rash, pruritus. Additional information: Patient had a reaction, some growths, discoloring in the hands, growth on hands and skin. She has growths on her skin: growth like "growing of hives", growth like "growth on the skin". The skin discolored on her hand and there were blotches on legs and skin as well. Blotches were like different colored spots. Patient said that she got the vaccine on 22Jan2022 and she has not got any another dose since then. That was her last dose. Patient did not know the actual date but it happened after she had taken the vaccines seems like a couple of month later. It was in March or April and things started growing on her and blotches. Just recently, patient went to a dermatologist and she just had scars and some of rashes on her feet and on the side of her left foot but they calmed down that a lot. Patient has some discoloration on both of her chin. Treatment for event: Opzelura.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: blotches on legs and skin/growth on hands and skin; discoloring in the hands; Scars; rashes on my feet and on the side of my left foot; itching; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2022 as dose number unknown (booster), 0.3 ml single (Lot number: FK9729, Expiration Date: 31May2022) at the age of 73 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: SCAR (non-serious) with onset 2022, outcome "recovering", described as "Scars"; RASH MACULAR (non-serious) with onset 2022, outcome "not recovered", described as "blotches on legs and skin/growth on hands and skin"; SKIN DISCOLOURATION (non-serious) with onset 2022, outcome "not recovered", described as "discoloring in the hands"; PRURITUS (non-serious) with onset 2022, outcome "not recovered", described as "itching"; RASH (non-serious) with onset 2022, outcome "recovering", described as "rashes on my feet and on the side of my left foot". The events "blotches on legs and skin/growth on hands and skin", "discoloring in the hands", "scars", "rashes on my feet and on the side of my left foot" and "itching" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash macular, skin discolouration, scar, rash, pruritus. Additional information: Patient had a reaction, some growths, discoloring in the hands, growth on hands and skin. She has growths on her skin: growth like "growing of hives", growth like "growth on the skin". The skin discolored on her hand and there were blotches on legs and skin as well. Blotches were like different colored spots. Patient said that she got the vaccine on 22Jan2022 and she has not got any another dose since then. That was her last dose. Patient did not know the actual date but it happened after she had taken the vaccines seems like a couple of month later. It was in March or April and things started growing on her and blotches. Just recently, patient went to a dermatologist and she just had scars and some of rashes on her feet and on the side of her left foot but they calmed down that a lot. Patient has some discoloration on both of her chin. Treatment for event: Opzelura.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Computerised tomogram, Delusion, Dysgraphia, Fine motor skill dysfunction, Laboratory test
Clinical narrative: Fine motor skill dysfunction; Mental status changes; Sepsis; delusion; Dysgraphia; This spontaneous report has been received from a consumer via other company on 11-DEC-2024, referring to a 79-year-old female patient.   The patient's past medical history included Rheumatoid arthritis. The patient's past medical treatment(s), vaccination(s) and famify history were not provided. The patient's past concurrent condition included Drug hypersensitivity. Concomitant medications included ethylprednisolone aceponate and leflunomide.  On 16-SEP-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #X027348, expiration date: 24-JAN-2026, administered for prophylaxis (strength, dose and route of administration were not provided); influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), lot #U8249CA, administered intramuscularly for immunisation (strength, formulation, dose, and expiry date were not provided); covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE) (lot # 6024MF013, strength, formulation, dose, expiry date, route of administration, and indication were not provided); rsv vaccine (RSV VACCINE) (lot # HN3801, strength, formulation, dose, expiry date, route of administration, and indication were not provided); and  varicella zoster vaccine rge (cho) (VARICELLA ZOSTER VACCINE RGE (CHO)) (lot # T4HR9, strength, formulation, dose, expiry date, route of administration, and indication were not provided).  On 16-SEP-2024, the patient experienced delusion, dysgraphia, fine motor skill dysfunction, mental status changes, sepsis (also reported as "patient was admitted to Medical Center emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a CT (Computerized tomogram) scan was performed on 16-SEP-2024 (results not reported)"). The patient was hospitalized for all the events during 2 days from an unknown date in 2024. The outcome was unknown for all events.  The causal relationship between the events and suspect products was not reported.  All events were reported as medically significant.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Mental status changes, Sepsis
Clinical narrative: Fine motor skill dysfunction; Mental status changes; Sepsis; delusion; Dysgraphia; This spontaneous report has been received from a consumer via other company on 11-DEC-2024, referring to a 79-year-old female patient.   The patient's past medical history included Rheumatoid arthritis. The patient's past medical treatment(s), vaccination(s) and famify history were not provided. The patient's past concurrent condition included Drug hypersensitivity. Concomitant medications included ethylprednisolone aceponate and leflunomide.  On 16-SEP-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #X027348, expiration date: 24-JAN-2026, administered for prophylaxis (strength, dose and route of administration were not provided); influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), lot #U8249CA, administered intramuscularly for immunisation (strength, formulation, dose, and expiry date were not provided); covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE) (lot # 6024MF013, strength, formulation, dose, expiry date, route of administration, and indication were not provided); rsv vaccine (RSV VACCINE) (lot # HN3801, strength, formulation, dose, expiry date, route of administration, and indication were not provided); and  varicella zoster vaccine rge (cho) (VARICELLA ZOSTER VACCINE RGE (CHO)) (lot # T4HR9, strength, formulation, dose, expiry date, route of administration, and indication were not provided).  On 16-SEP-2024, the patient experienced delusion, dysgraphia, fine motor skill dysfunction, mental status changes, sepsis (also reported as "patient was admitted to Medical Center emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a CT (Computerized tomogram) scan was performed on 16-SEP-2024 (results not reported)"). The patient was hospitalized for all the events during 2 days from an unknown date in 2024. The outcome was unknown for all events.  The causal relationship between the events and suspect products was not reported.  All events were reported as medically significant.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Delusion, Dysgraphia, Fine motor skill dysfunction, Mental status changes, Sepsis
Clinical narrative: Fine motor skill dysfunction; Mental status changes; Sepsis; delusion; Dysgraphia; This spontaneous report has been received from a consumer via other company on 11-DEC-2024, referring to a 79-year-old female patient.   The patient's past medical history included Rheumatoid arthritis. The patient's past medical treatment(s), vaccination(s) and famify history were not provided. The patient's past concurrent condition included Drug hypersensitivity. Concomitant medications included ethylprednisolone aceponate and leflunomide.  On 16-SEP-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #X027348, expiration date: 24-JAN-2026, administered for prophylaxis (strength, dose and route of administration were not provided); influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), lot #U8249CA, administered intramuscularly for immunisation (strength, formulation, dose, and expiry date were not provided); covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE) (lot # 6024MF013, strength, formulation, dose, expiry date, route of administration, and indication were not provided); rsv vaccine (RSV VACCINE) (lot # HN3801, strength, formulation, dose, expiry date, route of administration, and indication were not provided); and  varicella zoster vaccine rge (cho) (VARICELLA ZOSTER VACCINE RGE (CHO)) (lot # T4HR9, strength, formulation, dose, expiry date, route of administration, and indication were not provided).  On 16-SEP-2024, the patient experienced delusion, dysgraphia, fine motor skill dysfunction, mental status changes, sepsis (also reported as "patient was admitted to Medical Center emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a CT (Computerized tomogram) scan was performed on 16-SEP-2024 (results not reported)"). The patient was hospitalized for all the events during 2 days from an unknown date in 2024. The outcome was unknown for all events.  The causal relationship between the events and suspect products was not reported.  All events were reported as medically significant.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Computerised tomogram, Delusion, Dysgraphia, Fine motor skill dysfunction, Mental status changes
Clinical narrative: Fine motor skill dysfunction; Mental status changes; Sepsis; delusion; Dysgraphia; This spontaneous report has been received from a consumer via other company on 11-DEC-2024, referring to a 79-year-old female patient.   The patient's past medical history included Rheumatoid arthritis. The patient's past medical treatment(s), vaccination(s) and famify history were not provided. The patient's past concurrent condition included Drug hypersensitivity. Concomitant medications included ethylprednisolone aceponate and leflunomide.  On 16-SEP-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #X027348, expiration date: 24-JAN-2026, administered for prophylaxis (strength, dose and route of administration were not provided); influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), lot #U8249CA, administered intramuscularly for immunisation (strength, formulation, dose, and expiry date were not provided); covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE) (lot # 6024MF013, strength, formulation, dose, expiry date, route of administration, and indication were not provided); rsv vaccine (RSV VACCINE) (lot # HN3801, strength, formulation, dose, expiry date, route of administration, and indication were not provided); and  varicella zoster vaccine rge (cho) (VARICELLA ZOSTER VACCINE RGE (CHO)) (lot # T4HR9, strength, formulation, dose, expiry date, route of administration, and indication were not provided).  On 16-SEP-2024, the patient experienced delusion, dysgraphia, fine motor skill dysfunction, mental status changes, sepsis (also reported as "patient was admitted to Medical Center emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a CT (Computerized tomogram) scan was performed on 16-SEP-2024 (results not reported)"). The patient was hospitalized for all the events during 2 days from an unknown date in 2024. The outcome was unknown for all events.  The causal relationship between the events and suspect products was not reported.  All events were reported as medically significant.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Sepsis
Clinical narrative: Fine motor skill dysfunction; Mental status changes; Sepsis; delusion; Dysgraphia; This spontaneous report has been received from a consumer via other company on 11-DEC-2024, referring to a 79-year-old female patient.   The patient's past medical history included Rheumatoid arthritis. The patient's past medical treatment(s), vaccination(s) and famify history were not provided. The patient's past concurrent condition included Drug hypersensitivity. Concomitant medications included ethylprednisolone aceponate and leflunomide.  On 16-SEP-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #X027348, expiration date: 24-JAN-2026, administered for prophylaxis (strength, dose and route of administration were not provided); influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), lot #U8249CA, administered intramuscularly for immunisation (strength, formulation, dose, and expiry date were not provided); covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE) (lot # 6024MF013, strength, formulation, dose, expiry date, route of administration, and indication were not provided); rsv vaccine (RSV VACCINE) (lot # HN3801, strength, formulation, dose, expiry date, route of administration, and indication were not provided); and  varicella zoster vaccine rge (cho) (VARICELLA ZOSTER VACCINE RGE (CHO)) (lot # T4HR9, strength, formulation, dose, expiry date, route of administration, and indication were not provided).  On 16-SEP-2024, the patient experienced delusion, dysgraphia, fine motor skill dysfunction, mental status changes, sepsis (also reported as "patient was admitted to Medical Center emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a CT (Computerized tomogram) scan was performed on 16-SEP-2024 (results not reported)"). The patient was hospitalized for all the events during 2 days from an unknown date in 2024. The outcome was unknown for all events.  The causal relationship between the events and suspect products was not reported.  All events were reported as medically significant.
Sex: U
Vaccine: RSV, RSV
Symptoms: Throat tightness
Clinical narrative: figure out what she/he was allergic to; throat got very tight; difficulty breathing; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Dec2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (hospitalization, medically significant) with onset Dec2024, outcome "unknown", described as "difficulty breathing"; DRUG HYPERSENSITIVITY (hospitalization) with onset Dec2024, outcome "unknown", described as "figure out what she/he was allergic to"; THROAT TIGHTNESS (hospitalization, medically significant) with onset Dec2024, outcome "unknown", described as "throat got very tight". Therapeutic measures were taken as a result of throat tightness, dyspnoea, drug hypersensitivity. Patient was given the Abrysvo vaccine yesterday (11Dec2024). Patient had a reaction. Her/his throat got very tight and then patient started having difficulty breathing. Patient was treated with an EpiPen at the pharmacy and then taken to a hospital.  Patient received treatment in the ambulance as well as at the hospital.  Patient would like to know the ingredients so that she/he could figure out what she/he was allergic to.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: RSV, RSV
Symptoms: Allergy to vaccine, Dyspnoea, Throat tightness
Clinical narrative: figure out what she/he was allergic to; throat got very tight; difficulty breathing; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Dec2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (hospitalization, medically significant) with onset Dec2024, outcome "unknown", described as "difficulty breathing"; DRUG HYPERSENSITIVITY (hospitalization) with onset Dec2024, outcome "unknown", described as "figure out what she/he was allergic to"; THROAT TIGHTNESS (hospitalization, medically significant) with onset Dec2024, outcome "unknown", described as "throat got very tight". Therapeutic measures were taken as a result of throat tightness, dyspnoea, drug hypersensitivity. Patient was given the Abrysvo vaccine yesterday (11Dec2024). Patient had a reaction. Her/his throat got very tight and then patient started having difficulty breathing. Patient was treated with an EpiPen at the pharmacy and then taken to a hospital.  Patient received treatment in the ambulance as well as at the hospital.  Patient would like to know the ingredients so that she/he could figure out what she/he was allergic to.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 40.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse event; Caller reported pediatric dose of VAQTA administered to an adult.  No other information reported.  No additional AEs or PQC reported.; This spontaneous report was received from a Health Professional and refers to a 40-year-old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-DEC-2024, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 mL, intramuscularly (IM), lot #X025163, expiration date: 12-MAY-2025, administered for prophylaxis (Underdose) (strength, and anatomical location were not provided). No adverse event was reported.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A nurse practitioner called and reported that a dose of PROQUAD was administered to a 13 year old patient. The caller provided the patient's initials and said there were no symptoms or adverse effects noted after the dose was administered. No; there were no symptoms or adverse effects noted after the dose was administered; This spontaneous report was received from a nurse practitioner concerning  to a 13-year-old patient of unspecified gender.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the 13-year-old patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical locations, albumin status, and route of administration were not provided) along with sterile diluent (STERILE DILUENT) solution for injection/infusion (strength, dose, frequency, lot #, expiry date, route of administration, and indication were not provided) (Product administered to patient of inappropriate age), but said there were no symptoms or adverse effects noted after the dose was administered. No additional information provided to further clarify the details.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: after each and every shot my mother wound up in the hospital for at least 2-3 weeks.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "after each and every shot my mother wound up in the hospital for at least 2-3 weeks."; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "after each and every shot my mother wound up in the hospital for at least 2-3 weeks."; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "after each and every shot my mother wound up in the hospital for at least 2-3 weeks.". The following information was reported: WOUND (hospitalization), outcome "unknown", described as "after each and every shot my mother wound up in the hospital for at least 2-3 weeks.". Clinical course: Reporter's mother received all 5 of the Covid-19 shots (Name withheld) they first came out even though reporter begged her not to. 2-3 days after each and every shot reporter's mother wound up in the hospital for at least 2-3 weeks.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400161742 same patient and reporter, different dose;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Headache, Laboratory test, Pain, Pain in extremity
Clinical narrative: Severe pain in right arm, ringing in ears, eye sight blurred, shooting pain from spine to brain,  swelling in face, feet, and breast
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Scan, Spinal pain, Swelling face, Tinnitus
Clinical narrative: Severe pain in right arm, ringing in ears, eye sight blurred, shooting pain from spine to brain,  swelling in face, feet, and breast
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual acuity tests
Clinical narrative: Severe pain in right arm, ringing in ears, eye sight blurred, shooting pain from spine to brain,  swelling in face, feet, and breast
Age: 50.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Decreased appetite, Dizziness, Somnolence
Clinical narrative: Dizziness at night.... dizziness while doing yogas.... dizziness while sitting sometimes .. daily....  reduced appetite.... and sleepiness....
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called regarding T/E for MMR II, VARIVAX, PROQUAD, GARDASIL-9, and VAQTA; This spontaneous report was received from an other health professional referring to unknown number of patients.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).   On 31-OCT-2024, the patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #Y010373, expiration date: 05-JUN-2026, administered for prophylaxis (strength, and route of administration were not provided); hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #Y011643, expiration date: 25-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (therapy type: recombinant Human albumin) (PROQUAD) injection, 0.5 milliliter, lot #Y008283, expiration date: 21-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided) after temperature excursion (TE) with 20.5 degree Fahrenheit (F) in the freezer for 33 minutes and 49.3 F in the fridge form 35 minutes (date of temperature excursion: 31-OCT-2024). The reporter denied any symptomatic events. No additional adverse event (AE). Measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) was not reported as vaccine was found to be in recommended range. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported because TE was within product disclaimer limits per the prescribing information.   Follow-up information received from a nurse on 09-DEC-2024, referring to a 4-year-old female patient.  On 31-OCT-2024, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #Y008283, expiration date: 21-OCT-2025 has been exposed to temperature excursion, 20.5 F for 33 min. On 01-NOV-2024, the patient was vaccinated with the improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, the first dose, 0.5 milliliter, administered subcutaneously on right arm for prophylaxis (strength was not provided). It was reported that temperature excursion occurred as a result of a reading from a Digital Data Logger. The outcome of product storage error was reported as resolved.   The event was considered as medically significant by the reporter.
Sex: U
Vaccine: RVX
Symptoms: Ear pain, Product administered to patient of inappropriate age
Clinical narrative: Ear pain; 45 years patient received RSV vaccine; This non-serious case was reported by a consumer and described the occurrence of ear pain in a 45-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced ear pain (Verbatim: Ear pain) and inappropriate age at vaccine administration (Verbatim: 45 years patient received RSV vaccine). The outcome of the ear pain was not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the ear pain to be related to RSV vaccine.     It was unknown if the company considered the ear pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-DEC-2024 The patient received RSV vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration.