chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: an inappropriate use due to the administration of QUADRACEL to a patient under the recommended age of 4 years old with no adverse event; 15 month old patient received QUADRACEL instead of the intended DAPTACEL with no adverse event; Initial information received on 14-Oct-2024 regarding an unsolicited valid  non-serious case received from Nurse.   This case involves a 15 months old female patient who had received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine [Quadracel (Vero)] instead of the intended Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] and inappropriate use due to the administration of quadracel to a patient under the recommended age of 4 years old with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine conj (tet tox) (Acthib) and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation.  On 14-Oct-2024, the 15 months old female patient who had received a 0.5 ml(dose 4) dose of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine Suspension for injection (Expiry date: 03-OCT-2025 and lot U7908AA, Frequency: once and Strength: standard) via intramuscular route in the right vastus lateralis instead of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine with no adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency; same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Sender's Comment:Reporter can be contacted by Sanofi: Yes
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administration of an extra dose of FLUBLOK within the same flu season, 5 days apart with no reported Adverse event; Initial information received on 14-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 85 years old female patient and is reported administration of an extra dose of influenza trivalent recombinant vaccine [Flublok TIV] within the same flu season, 5 days apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Oct-2024, the patient received an unknown dose (dose 1) of suspect Influenza Trivalent Recombinant Vaccine (expiry date, strength, lot number not reported) via unknown route in unknown administration site and On 09-Oct-2024 she also received a 0.5 ml dose (dose 2) of same vaccine of lot: TFAA2418 and expiry date: 31-May-2025 via intramuscular route in the left deltoid as Influenza within the same flu season, 5 days apart with no reported adverse event (extra dose administered) (latency: on same day) following the last dose of vaccine.  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: 13.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate use due to use of FLUBLOK to a pediatric patient with no reported adverse event; Initial information received on 14-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 13 years old male patient and reporter stated that inappropriate use due to use of influenza quadrivalent recombinant vaccine (Flublok) to a pediatric patient 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 COVID-19 vaccine.  On 13-Oct-2024, the reporter stated that inappropriate use due to use of  0.5 ml of influenza quadrivalent recombinant vaccine (unknown strength) with lot TFAA2421 and expiry date 31-May-2025 via intramuscular route in the left deltoid for immunization to a pediatric patient with no reported adverse event (product administered to patient of inappropriate age).  Reportedly, they recently participated in a local flu clinic. There one of their students administered a FLUBLOK vaccine to a 13 year old patient. The pharmacist knows the vaccine is only indicated for 18. Pharmacist stated that a student administered flublok to a 13 year old patient and they wanted to know how to proceed about it. Caller stated that they haven't called the patient about it yet   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: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: consumer received an expired daptacel with no ae; Initial information received on 14-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient who received an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Aug-2021 the patient received an expired dose once of 0.5 ml (dose 1) of diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for Injection) (lot: C5643AA; expiry date: 31-Jul-2021; strength: standard) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) (expired product administered) (latency: same day). On 10-Sep-2021 he also received a dose 2 of same vaccine. On 08-Oct-2021 he also received a dose 3 of same vaccine. On 08-Apr-2022, the patient received a dose 4 of same vaccine.  Reportedly, they had not performed any serological testing; that the  consumer started their series late due to the mother being anti vaccination.   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: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Caller states the physician put in the order for the Fluzone HD and then two separate nurses came in and administered a dose in each arm with no reported adverse event; Initial information received on 15-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 80 years old male patient whose physician put in the order for the influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] and then two separate nurses came in and administered a dose in each arm 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 a dose of suspect  influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe(dose, strength, frequency, batch number, expiry date, route was unknown) as prophylactic vaccination and the physician put in the order for the fluzone hd and then two separate nurses came in and administered a dose in each arm with no reported adverse event (extra dose administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: next day after the injection, she woke up with a lot of swelling on her hands and feet; Initial information received on 15-Oct-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 70 years old female patient who had next day after The Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD], she woke up with a lot of swelling on her hands and feet.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 11-Oct-2024, the patient received a dose of 0.5 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot U8519BA, Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in the left deltoid for Influenza  On 12-OCT-2024 the patient developed next day after the injection, she woke up with a lot of swelling on her hands and feet (peripheral swelling) (latency : 1 day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (next day after the injection, she woke up with a lot of swelling on her hands and feet).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event next day after the injection, she woke up with a lot of swelling on her hands and feet.
Age: 82.0
Sex: M
Vaccine: YF, YF
Symptoms: Hypotension, Intensive care, Liver function test increased, Neurological symptom, Thrombocytopenia
Clinical narrative: thrombocytopenia; hypotensive; got elevated LFTs; neurological changes; Initial information received on 22-Oct-2024 regarding an unsolicited valid serious case received from a physician.  This case involves a 82 years old male patient who experienced hypotensive, got elevated LFTs (liver function test), neurological changes and thrombocytopenia after receiving yellow fever vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mg dose of yellow fever vaccine - US Solution for injection with standard strength (lot number and expiry date not reported) once via subcutaneous route in unknown administration site for Immunization.  On an unknown date the patient was hypotensive (hypotension), got elevated lfts (liver function test increased), neurological changes (nervous system disorder) and thrombocytopenia (latency- 5 days) following the administration of yellow fever vaccine -.   Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Physician reported that patient had an adverse effect 5 days after receiving YF-VAX. Physician stated that  it seems like patient had got that visceral  Visceral Topic Disease from it. Now, the patient was in the ICU (Intensive Care Unit). Patient was hypotensive. Patient had got elevated LFTs, abnormal crowning function, and thrombocytopenia. Patient had neurological changes as well. Patient was hypotensive and mild [unconfirmed] lysis. Patient was still in the ICU right now as per physician. Physician said that patient got the YF-VAX in preparation because he was leaving the country. Patient was being treated by the Doctor.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.  Seriousness criteria: The patient was hospitalized for all the events and medically significant for thrombocytopenia.; Sender's Comments: Sanofi company comment dated 29-Oct-2024: This case involves a 82 years old male patient who experienced hypotensive, got elevated LFTs (liver function test), neurological changes and thrombocytopenia after receiving yellow fever vaccine -  [YF-VAX]. Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Age: 82.0
Sex: M
Vaccine: YF, YF
Symptoms: Systemic inflammatory response syndrome
Clinical narrative: thrombocytopenia; hypotensive; got elevated LFTs; neurological changes; Initial information received on 22-Oct-2024 regarding an unsolicited valid serious case received from a physician.  This case involves a 82 years old male patient who experienced hypotensive, got elevated LFTs (liver function test), neurological changes and thrombocytopenia after receiving yellow fever vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mg dose of yellow fever vaccine - US Solution for injection with standard strength (lot number and expiry date not reported) once via subcutaneous route in unknown administration site for Immunization.  On an unknown date the patient was hypotensive (hypotension), got elevated lfts (liver function test increased), neurological changes (nervous system disorder) and thrombocytopenia (latency- 5 days) following the administration of yellow fever vaccine -.   Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Physician reported that patient had an adverse effect 5 days after receiving YF-VAX. Physician stated that  it seems like patient had got that visceral  Visceral Topic Disease from it. Now, the patient was in the ICU (Intensive Care Unit). Patient was hypotensive. Patient had got elevated LFTs, abnormal crowning function, and thrombocytopenia. Patient had neurological changes as well. Patient was hypotensive and mild [unconfirmed] lysis. Patient was still in the ICU right now as per physician. Physician said that patient got the YF-VAX in preparation because he was leaving the country. Patient was being treated by the Doctor.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.  Seriousness criteria: The patient was hospitalized for all the events and medically significant for thrombocytopenia.; Sender's Comments: Sanofi company comment dated 29-Oct-2024: This case involves a 82 years old male patient who experienced hypotensive, got elevated LFTs (liver function test), neurological changes and thrombocytopenia after receiving yellow fever vaccine -  [YF-VAX]. Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Sex: U
Vaccine: FLUX
Symptoms: Injection site erythema, Swelling
Clinical narrative: Injection site redness; Slight swelling; This spontaneous case, initially received on 10-Oct-2024 (with additional information received on 17-Oct-2024), was reported by a health professional and concerns an patient of unknown and gender.  No relevant medical history was reported, and no concomitant medications were reported.  Administration of company suspect drug: On an unknown date, the patient received Influenza virus vaccine for Indication not reported, Route of administration: Not reported, Anatomical Location: Not reported, Dose: Not reported, Lot number: Not reported and would be requested on follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Injection site redness (outcome: Not Reported), Slight swelling (outcome: Not Reported).  Influenza virus vaccine action taken: Not Applicable  Reporter's assessment: The reporter did not provide seriousness and causality assessment for both events.; Reporter's Comments: All the events considered as related
Sex: U
Vaccine: FLUX
Symptoms: Injection site erythema, Swelling
Clinical narrative: Injection site redness; Slight swelling; This spontaneous case, initially received on 10-Oct-2024 (with additional information received on 17-Oct-2024), was reported by a health professional and concerns an patient of unknown age/gender.  No relevant medical history was reported, and no concomitant medications were reported.  Administration of company suspect drug: On an unknown date, the patient received Influenza virus vaccine for Indication not reported, Route of administration: Not reported, Anatomical Location: Not reported, Dose: Not reported, Lot number: Not reported and would be requested on follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Injection site redness (outcome: Not Reported), Slight swelling (outcome: Not Reported).  Influenza virus vaccine action taken: Not Applicable  Reporter's assessment: The reporter did not provide seriousness and causality assessment for both events.; Reporter's Comments: Causality was related for both events.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient came to pharmacy on 10/26/2024, regarding her post vaccination reaction to her left Arm . Patient was administered FLUAD vaccine on left arm and Prevnar 20 on right arm on 10/20/2024 at pharmacy. According to Patient, patient came to pharmacy on 10/25/2024 and spoke to RPh on duty regarding local reaction to her left arm -swelling, redness, tenderness and painful patch, that was spreading. Rph on duty recommended patient to seek medical care immediately. Patient went to emergency department on 10/26/2024. Patient was diagnosed with cellulitis in left arm and prescribed medications to treat cellulitis. RPh spoke to patient on 10/29/2024, according to her medication prescribed was not helping, so patient was hospitalized for emergency care  and discharged on 10/29/2024 after IV antiobiotic treatment. RPh on duty spoke to employee at ER. Dr and  also notified about the incident.   RPH at pharmacy
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells palsy
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Peripheral coldness, Pyrexia
Clinical narrative: I became very very cold in my hands and feet with a fever and extremely tired.  Took Advil to lower fever. I was not able to get out of bed for 6 hours
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cardioversion, Dizziness, Electrocardiogram abnormal, Fatigue, Heart rate increased
Clinical narrative: 10/24/24 Started with body aches and feeling nauseas and tired.  10/25 around 12.30 pm palpitations (svt) heart rate over 200 beats a minute. Could not slow it down. Feeling dizzy.  My daughter picked me up and took me to the emergency room . My elevated heart rate went on until around 4.30 pm.  Eventually doctors had to reboot my heart.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Palpitations, Supraventricular tachycardia
Clinical narrative: 10/24/24 Started with body aches and feeling nauseas and tired.  10/25 around 12.30 pm palpitations (svt) heart rate over 200 beats a minute. Could not slow it down. Feeling dizzy.  My daughter picked me up and took me to the emergency room . My elevated heart rate went on until around 4.30 pm.  Eventually doctors had to reboot my heart.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling, Myalgia
Clinical narrative: 48 hours after administration, localized swelling, erythema & induration at site of injection. Local symptoms resolved within 48 hours, followed by left arm muscle pain for 10 days & inability to abduct arm beyond 90 degrees without significant discomfort. Pain has not worsened or improved over time, has not implemented any home measures due to an inability to take NSAIDs while taking PPI.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient reports dizziness and nausea for 3 days after vaccination
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidently gave patient 12+ Covid vaccine as the 6 month- 11 years were misplaced by another staff member in the adult section, therefore not able to be seen by other staff.
Age: 47.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered
Clinical narrative: one to many Mpox vaccines administered to this patient.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidently gave patient 12+ Covid Vaccine as the 6month to 11 years were misplaced by another staff member and put on the adult shelf. Therefore the 6month to 11 years were not visible to other staff members.
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: none
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure, Syncope
Clinical narrative: Patient fainted then started to "seize" for about 10-15  seconds.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Patient reported that roughly an hour after she received the second dose of the Rabavert vaccine she began to feel left arm pain that radiated down to her finger tips. She reported that she continued to feel arm pain for the rest of the evening and broke out into chills with a fever. She self reports that she got a fever up to 102 degrees and had chills so severe that she was shaking. She reports that around 5 am on 10/22/24 her fever broke and she began to feel a lot better. She called today to report the incident to the pharmacy, and reiterated that she feels completely fine now and only had the one incident of side effects.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out after receiving the vaccination
Age: 2.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product preparation issue
Clinical narrative: Pt given covid 19 pfizer 6mth to <5  all 3 doses given and not reconstituted
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haematoma
Clinical narrative: Patient received vaccine on 10/23/24. On 10/24/24, the patient noticed a large hematoma beginning below the injection site and ending before her elbow. There was no pain or discomfort. The patient only noticed by sight. The patient reported to the pharmacy on 10/29/24 and the hematoma already looked to be healing on the upper portion but still looked darker toward the bottom.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT GOT A FLUSHOT ALREADY THIS SEASON ON 7-26-24 AND ANOTHER ONE YESTERDAY 10-28-24. INSURANCE PAID FOR BOTH AND THERE WAS NO WARNING THAT THIS WAS A DUPLICATE SHOT FOR THE SEASON. PATIENT HAS NO REACTION, WAS REALLY UNDERSTANDING .
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Bell's palsy, Blood glucose, Computerised tomogram head, Electrocardiogram, Magnetic resonance imaging head
Clinical narrative: Bell's Palsy     Prednisone 40mgx 5days, Valacyclovir TID for 7days
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Scan with contrast
Clinical narrative: Bell's Palsy     Prednisone 40mgx 5days, Valacyclovir TID for 7days
Age: 59.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a second dose of the 2024-2025 flu vaccine. No adverse symptoms reported.
Age: 0.75
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product preparation issue
Clinical narrative: Pt given covid 19 pfizer 6mth to <5  all 3 doses given and not reconstituted
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Patient was given Pediarix instead of single dose of Dtap. Provider was made aware and said to relay message that pt should be okay as vaccine are not vaccines that were given early. Mother of patient was called and made aware of the error and answered mother of child's question regarding if the child would need an additional vaccine. Let pt know that since his needed vaccine of Dtap was part of the combination vaccine given today that he did not need an additional dose.
Age: 44.0
Sex: F
Vaccine: COVID19, FLU3, HEPAB, TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site scab, Muscular weakness, Pain
Clinical narrative: patient stated that she developed pain, numbness that radiates down the arm into the hand. she complained her hand felt like she couldn't use it, hard to grip and hold onto things. also developed what appeared like a chemical burn under the sight of lower band aid on  the left arm. scabbed over on the skin
Age: 44.0
Sex: F
Vaccine: COVID19, FLU3, HEPAB, TDAP
Symptoms: Pain in extremity
Clinical narrative: patient stated that she developed pain, numbness that radiates down the arm into the hand. she complained her hand felt like she couldn't use it, hard to grip and hold onto things. also developed what appeared like a chemical burn under the sight of lower band aid on  the left arm. scabbed over on the skin
Age: 80.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient had already received a dose of Fluad 8/20/24
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is only 63, and therefore should not have received a dose of Fluad
Age: 1.08
Sex: M
Vaccine: HIBV, PNC15
Symptoms: Crying, Hyperhidrosis, Hypotonia, Pallor
Clinical narrative: :Pt had an episode of excessive crying, with subsequent sweating pallor and altered sensorium,6 hours after receiving routine shots , see video . Dx BRUE (Brief resolved unexplained event) r/o seizure . Pt has macrocephaly (father also has large head),and there does appear to have been a recent rapid increase in Head Circ. (see growth chart) physical exam otherwise unremarkable. 13 mo infant with macrocephaly , BRUE (brief resolved unexplained event) six hours after receiving vaccinations. Pt became pale , was sweating and then went limp. ? seizure r/o mitochondrial disease
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Patient reported possible infection due to vaccine
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after receiving the vaccine. No treatment was needed we just made sure patient was comfortable until she came too. Patient was okay after about 10 minutes and got up and walked out of store with her mom.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED A SECOND DOSE OF FLUAD 2024-2025
Age: 74.0
Sex: F
Vaccine: PNC21
Symptoms: Abdominal pain upper, Chills, Dry mouth, Headache, Injection site rash
Clinical narrative: PATIENT EXPERIENCED CHILLS, STOMACH ACHE, HEADACHE, FEVER, RASH AT INJECTION SITE AND DRY MOUTH 12 HOURS AFTER RECEIVING VACCINE.  PATIENT WAS PRESCRIBED CEFDINIR 300MG AND RECOMMENDED BENADRYL FOR RASH.
Age: 74.0
Sex: F
Vaccine: PNC21
Symptoms: Pyrexia
Clinical narrative: PATIENT EXPERIENCED CHILLS, STOMACH ACHE, HEADACHE, FEVER, RASH AT INJECTION SITE AND DRY MOUTH 12 HOURS AFTER RECEIVING VACCINE.  PATIENT WAS PRESCRIBED CEFDINIR 300MG AND RECOMMENDED BENADRYL FOR RASH.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Patient reports having a seizure with in 15-30 minutes of receiving a Shingrix shot.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling drunk, Nausea, Sensory disturbance
Clinical narrative: I had been having mild, normal side effects, but they had subsided enough for me to resume my usual exercise regimen. I had hiked 3 miles (with no issues) and had done about 10 minutes of Pilates when I became so dizzy I had to stop. (It was similar to feeling very drunk: off balance, room spinning, etc.). The dizziness mostly subsided after a minute, but not entirely. Even the next day, I felt a little woozy and ?off? (head feels weird and slight nausea). My face, scalp, and nape also broke out in mild hives over the same evening.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vertigo
Clinical narrative: I had been having mild, normal side effects, but they had subsided enough for me to resume my usual exercise regimen. I had hiked 3 miles (with no issues) and had done about 10 minutes of Pilates when I became so dizzy I had to stop. (It was similar to feeling very drunk: off balance, room spinning, etc.). The dizziness mostly subsided after a minute, but not entirely. Even the next day, I felt a little woozy and ?off? (head feels weird and slight nausea). My face, scalp, and nape also broke out in mild hives over the same evening.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Blindness, Disorientation, Dizziness, Dyspnoea, Dysstasia
Clinical narrative: 9:30 AM 10/25/2024 Dizzy, unable so stand, fell to floor, loss of consciousness, blacked out, loss of vision, disoriented, profuse sweating, nausea, shortness of breath, heart rate fluctuating, unable to stand or walk.  Ambulance called, IV administered, taken to ER.  Kept in ER for about 3 hours MRI Head,Chest, Spine, ABD/Pelvic.  Released I was told there were no rooms available.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Fall, Gait inability, Heart rate irregular, Hyperhidrosis, Loss of consciousness
Clinical narrative: 9:30 AM 10/25/2024 Dizzy, unable so stand, fell to floor, loss of consciousness, blacked out, loss of vision, disoriented, profuse sweating, nausea, shortness of breath, heart rate fluctuating, unable to stand or walk.  Ambulance called, IV administered, taken to ER.  Kept in ER for about 3 hours MRI Head,Chest, Spine, ABD/Pelvic.  Released I was told there were no rooms available.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Magnetic resonance imaging abdominal, Magnetic resonance imaging head, Magnetic resonance imaging pelvic, Magnetic resonance imaging spinal, Magnetic resonance imaging thoracic
Clinical narrative: 9:30 AM 10/25/2024 Dizzy, unable so stand, fell to floor, loss of consciousness, blacked out, loss of vision, disoriented, profuse sweating, nausea, shortness of breath, heart rate fluctuating, unable to stand or walk.  Ambulance called, IV administered, taken to ER.  Kept in ER for about 3 hours MRI Head,Chest, Spine, ABD/Pelvic.  Released I was told there were no rooms available.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Nausea
Clinical narrative: 9:30 AM 10/25/2024 Dizzy, unable so stand, fell to floor, loss of consciousness, blacked out, loss of vision, disoriented, profuse sweating, nausea, shortness of breath, heart rate fluctuating, unable to stand or walk.  Ambulance called, IV administered, taken to ER.  Kept in ER for about 3 hours MRI Head,Chest, Spine, ABD/Pelvic.  Released I was told there were no rooms available.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Myalgia, Pain
Clinical narrative: 10/20/24 pain and swelling at injection site, aching of muscles and joints. 10/21/24 pain and swelling at injection site, radiating or referred pain in wrist and thumb, ache in forearm. Felt like maybe the swelling at injection site was causing some blocking pressure on circulation, or on nerves. Vaccination itself was surprisingly painful, but no blood or bruising. Ibuprofen and aspirin did nothing for arm pain. But homeopathic arnica montana stopped the pain and swollenness.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: 10/20/24 pain and swelling at injection site, aching of muscles and joints. 10/21/24 pain and swelling at injection site, radiating or referred pain in wrist and thumb, ache in forearm. Felt like maybe the swelling at injection site was causing some blocking pressure on circulation, or on nerves. Vaccination itself was surprisingly painful, but no blood or bruising. Ibuprofen and aspirin did nothing for arm pain. But homeopathic arnica montana stopped the pain and swollenness.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Rhinorrhoea
Clinical narrative: Runny nose, stomach cramps, tiredness
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypertension, Hypoaesthesia, Neck pain, Paraesthesia
Clinical narrative: On 10/29/24,  Pt called pharmacy and complained having adverse reaction 1 week after getting Comirnaty Lot LM2222.  After getting the shot, pt was feeling normal for the first week. Starting 2nd week,  patient has chill, numbness, tingling from arm down to fingers.  Patient apply lidocain, patch, hot patches. Patient took aspirin and 800mg ibuprfen but it get works. Patient has high blood pressure, neck pain and swelling of arm. Patient planned to go to ER and will schedule appt with MD next week. Patient does not know what to do to help her feel better and hope someone from pharmacy can call her to explain what is going on with her. Informed pharmacy manager regarding adverse events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: On 10/29/24,  Pt called pharmacy and complained having adverse reaction 1 week after getting Comirnaty Lot LM2222.  After getting the shot, pt was feeling normal for the first week. Starting 2nd week,  patient has chill, numbness, tingling from arm down to fingers.  Patient apply lidocain, patch, hot patches. Patient took aspirin and 800mg ibuprfen but it get works. Patient has high blood pressure, neck pain and swelling of arm. Patient planned to go to ER and will schedule appt with MD next week. Patient does not know what to do to help her feel better and hope someone from pharmacy can call her to explain what is going on with her. Informed pharmacy manager regarding adverse events.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Developed rash down my left  arm the very next day. The rash was red, raised and painful.  Back at work on Monday 10/28/2024,  I went and sought advice from our school nurse who advised that I go to urgent care. I did so the same afternoon and was given a prescription of antiviral medication by the doctor.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Syringe issue
Clinical narrative: Where the needle attaches to syringe vaccine shot out the side when giving it. Stopped immediately and went to get another Hep B. That syringe was fine and patient did get vaccinated.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, MMR
Symptoms: Administration site wound, Injection site swelling
Clinical narrative: Pink swelling of upper (R) arm ends at elbow. No redness or induration around injection sites. Half moon shaped open sore, superficial on mid lateral arm where band aid was, no drainage or surrounding redness
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Immediate post-injection reaction, Magnetic resonance imaging head, Migraine
Clinical narrative: Extreme vertigo, migraine and nausea. Meds for migraine, nausea and vertigo. Rt. shoulder pain started immediately after vaccine give on 9-1. Migraines lasted a year. Shoulder pain continues
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Extreme vertigo, migraine and nausea. Meds for migraine, nausea and vertigo. Rt. shoulder pain started immediately after vaccine give on 9-1. Migraines lasted a year. Shoulder pain continues
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Embolism, Leg amputation, Pain in extremity, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: 2-1-24 Embolism and thrombosis of lower R. leg. Extreme pain (R) leg, sudden onset. Had (R) leg amputated 3 days later 2-4-24
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: none - pt. received wrong dose - no side effects noted
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Blood phosphorus decreased, Carbon dioxide decreased, Flushing, Herpes zoster
Clinical narrative: Sore spot on arm next day, then very bad bodyaches rash + pain at site states then having shingles flushing in face for few days after - face peeling hurt to put lotion on face- She was back to normal about 10/15/24
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Pain, Pain in extremity, Renal function test normal
Clinical narrative: Sore spot on arm next day, then very bad bodyaches rash + pain at site states then having shingles flushing in face for few days after - face peeling hurt to put lotion on face- She was back to normal about 10/15/24
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Tenderness
Clinical narrative: Sore spot on arm next day, then very bad bodyaches rash + pain at site states then having shingles flushing in face for few days after - face peeling hurt to put lotion on face- She was back to normal about 10/15/24
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Mouth ulceration, Oral discomfort, Oral disorder, Skin burning sensation
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tongue discomfort, Tongue disorder, Tongue ulceration
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report a TE with PROQUAD. Administered to 1 patient after being improperly stored; This spontaneous report was received from a nurse regarding a 4-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 23-OCT-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter, administered for prophylaxis (vaccination scheme frequency, anatomical site of injection and route of administration were not provided; lot number x018584 has been verified to be a valid number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live [PROQUAD], expiration date 05-JAN-2025). Mentioned vaccine was administered after a temperature excursion (TE) (Product storage error).   No additional adverse event was reported for the patient.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported/ No additional AE; a patient who was administered an expired dose of MMR-II on 22-OCT-2024; This spontaneous report has been received from a consumer referring a patient of an unknown age and gender.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 22-OCT-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, rHA, at a dose of 0.5 milliliter, administered for prophylaxis (strength, route and anatomical location of administration were not provided; lot reported as # X020654, which has been determined to be valid lot # for this vaccine, expiration date validated to be on 21-OCT-2024) (expired product administered). There were no symptoms reported/ No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Medical assistant reported patient was accidently administered an expired dose of VAQTA on Oct 25, 2024. Product expired on Oct 1, 2024. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC r; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender.  The patient's medical history, concurrent conditions, Concomitant therapies, past drug reactions and allergies were not reported.  On 25-OCT-2024, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, once, administered for prophylaxis (dose, anatomical site of injection and route of administration were not provided; lot number X006702 has been verified to be a valid number for hepatitis A vaccine, inactivated [VAQTA], expiration date 01-OCT-2024) (Expired product administered). It was reported that the product had no prior temperature excursions. No further information was provided.   No additional adverse event was reported for the patient.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received First Dose, and Second Dose Engerix; Initial report received on 03-Oct-2024.  A pharmacist reported that a patient (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and was given ENGERIX-B as the second dose.  Medical history and concomitant medications were not reported.   On an unknown date, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, and injection site were not reported, NDC # 43528-002-01)] from a pharmacist.   On an unknown date, the patient received the second dose of a hepatitis B vaccine [ENGERIX-B (lot #, expiration date, NDC #, route and site not provided)].  The reporter did not have any information on the incident, location, or patient.  No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Pharmacist Administered Heplisav-B Three TImes; Initial report received on 07-Oct-2024.  A pharmacist reported that an adult patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization three times.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date in Feb-2024, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported)] from a pharmacist. On an unspecified date in Mar-2024, the patient received the second dose of HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported) from a pharmacist. On an unspecified date in Aug-2024, the patient received the third dose of HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported) from a pharmacist. HEPLISAV-B was administered three times.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Injury associated with device, Syringe issue, Underdose
Clinical narrative: leaked around the needle luer during administration; second needle stick to the patient due to inadequate vaccine dose delivery; inadequate vaccine dose delivery; This non-serious case was reported by a other health professional and described the occurrence of incomplete dose administered in a 50-year-old female patient who received Flu Seasonal TIV Quebec (Flulaval) (batch number 2B3YJ, expiry date 06-JUN-2025) for prophylaxis.   On 30-SEP-2024, the patient received Flulaval .5 ml. On 30-SEP-2024, an unknown time after receiving Flulaval, the patient experienced incomplete dose administered (Verbatim: inadequate vaccine dose delivery). On an unknown date, the patient experienced syringe leak (Verbatim: leaked around the needle luer during administration) and accidental needle stick (Verbatim: second needle stick to the patient due to inadequate vaccine dose delivery). The outcome of the incomplete dose administered, syringe leak and accidental needle stick were unknown.   It was unknown if the reporter considered the syringe leak and accidental needle stick to be related to Flulaval and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the syringe leak and accidental needle stick to be related to Flulaval and Flulaval 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: 30-SEP-2024 The reporter reported that the several syringes from this reported lot had leaked around the needle luer during administration which resulted in a second needle stick to the patient due to inadequate vaccine dose delivery, which led to incomplete dose administered, syringe leak and accidental needle stick
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on abd + lower back. had rash about 3 wks. still have small rash controled with antihistames
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injury associated with device, Occupational exposure to product
Clinical narrative: Vaccine needle accidentally punctured medical assistants hand prior to administration to patient
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Contusion, Malaise, Muscle discomfort
Clinical narrative: chest pain, muscle discomfort in chest, malaise, bruising of chest
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client was given High Dose Flublock at age 61, should have been given fluzone non-high dose
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Electrocardiogram, Electroencephalogram, Fall, Head injury
Clinical narrative: Passed out Saturday for about 10 minutes at approximately 12 noon , hit head when fell taken to hospital
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Magnetic resonance imaging, Ultrasound Doppler
Clinical narrative: Passed out Saturday for about 10 minutes at approximately 12 noon , hit head when fell taken to hospital
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: developed hives, and shortness of breath 20 minutes after vaccine. took benadryl which improved symptoms.