chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Initial insomnia
Clinical narrative: extreme tiredness/like he was zapped; He can never fall asleep; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old male patient received BNT162b2 omicron (kp.2) (COVID-19 VACCINE OMICRON KP.2-MANUFACTURER UNKNOWN), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE; Lot number: unknown), administration date: 2021, for Covid-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 2, SINGLE; Lot number: unknown), administration date: 2021, for Covid-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), administration date: 2022, for Covid-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 4 (BOOSTER), SINGLE; Lot number: unknown), administration date: 2022, for Covid-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 5 (BOOSTER), SINGLE; Lot number: unknown), administration date: 2023, for Covid-19 Immunization, reaction(s): "No adverse event". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme tiredness/like he was zapped"; INITIAL INSOMNIA (non-serious), outcome "unknown", described as "He can never fall asleep".  Additional information: Patient stated that when the covid broke out, they gathered everybody and said that you must get these vaccines. The first couple of years, they got two each year, and the last couple of years, he just has been getting one. He started getting extremely tired in the afternoon, he doesn't know if that was from Pfizer covid-19 vaccine, or he was getting old. He had 6 of the covid-19 vaccines. He would get up in the morning and do his normal stuff and around lunch time, it would seem like he was zapped. He can never fall asleep, but he had to lay down and rest for a while. It has been going on for couple of weeks and he doesn't know what was going on. He was going to see his heart doctor. Per patient, he got his last vaccine last fall in October. First couple of years, they got couple of them a year and then that tapered off so that would have been 4, then in 2023 and 2024 he just got one. He thinks he might have gotten 6 of them and the last one was October 2024. Later, the patient stated that the last one they gave him may have been Moderna. He did not specify the last one to the pharmacy which one he wanted but until then everything was Pfizer. He wanted to continue with Pfizer but that last one may have been different. He got that one in October and he never had any problems until a couple of weeks ago. He was querying if he did not have any problems right away, it probably does not have anything to do with the Pfizer vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Hypoacusis
Clinical narrative: complete hell as her ears have swelled up 3 times the size; couldn't hear; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR SWELLING (non-serious), outcome "unknown", described as "complete hell as her ears have swelled up 3 times the size"; HYPOACUSIS (non-serious), outcome "unknown", described as "couldn't hear".  Additional Information: Caller stated that she took Comirnaty last November and had "used Moderna all of the way through, and she will ever again use a Pfizer product. She has been through complete hell as her ears have swelled up 3 times the size, she couldn't hear, and she was home alone. It was the perfect storm. This is what happenings to human beings, had she known it had a horrific rash, because that's hard to find and you can't really find out anything, it's just a little thing that says you might get hives or rash, it doesn't say how long it's going to last." Caller stated that she is on the 8th day and is asking how much longer will the rash last?.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: vials somethings cracked and broken; The initial case was missing the following minimum criteria: [specify criteria adverse event. Upon receipt of follow-up information on [19Feb2025], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), 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: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "vials somethings cracked and broken".  Additional information: It was stated, "I'm a Pfizer vaccine sales representative I'm calling because I have an office that received Prevanar 20 and one of the pens, vials somethings cracked and broken and I spoke with the doctor and he said all of the vaccine Is still intact inside but there's something that's cracked and he tried to explain to me and I said is it still something that you can administer and he said he would have to use another needle so I said let me get medical on because I was told by customer service that the medical department needs to make a decision on weather they can use it or not."  The reporter considered "vials somethings cracked and broken" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "vials somethings cracked and broken" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". Clinical course: the reporter stated, the patient (her husband) tested positive for COVID, and he received the "Pfizer shot." The doctor prescribed nirmatrelvir and ritonavir (PAXLOVID)." The reporter also stated that the patient received "some cough medicine."  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Frostbite, Nerve conduction studies, Pain, Pain in extremity
Clinical narrative: Back of hand feels like pins and needles like coming out of frostbite, when this first happened with the very first vaccine hand felt so cold and they hurst; Painful hands; Aches/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing; Dizziness; Fever/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-782572 (Moderna).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FROSTBITE (non-serious), outcome "not recovered", described as "Back of hand feels like pins and needles like coming out of frostbite, when this first happened with the very first vaccine hand felt so cold and they hurst"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Painful hands"; PAIN (non-serious), outcome "unknown", described as "Aches/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing"; DIZZINESS (non-serious), outcome "not recovered"; PYREXIA (non-serious), outcome "unknown", described as "Fever/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of frostbite, pain in extremity, pain, dizziness, pyrexia.  Additional Information: Concomitant medication use information was not provided by reporter. Patient had no concomitant disease or risk factor. Patient developed adverse event after the first vaccination with covid vaccines. So far patient had received 8 vaccines, most of them were Moderna but a couple were Pfizer. Patient had already consulted to doctor, and he advised to use vitamin b, but it gave no results. As per patient it was sure the events were caused by the covid vaccine. The patient was treated with Vitamin b complex (Vitamin b) at an unspecified dose and frequency. At the time of the report, the events frostbite, pain in extremity and dizziness had not resolved; pain and pyrexia outcome was unknown  Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Back of hand feels like pins and needles like coming out of frostbite, when this first happened with the very first vaccine hand felt so cold and they hurst; Painful hands; Aches/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing; Dizziness; Fever/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-782572 (Moderna).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FROSTBITE (non-serious), outcome "not recovered", described as "Back of hand feels like pins and needles like coming out of frostbite, when this first happened with the very first vaccine hand felt so cold and they hurst"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Painful hands"; PAIN (non-serious), outcome "unknown", described as "Aches/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing"; DIZZINESS (non-serious), outcome "not recovered"; PYREXIA (non-serious), outcome "unknown", described as "Fever/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of frostbite, pain in extremity, pain, dizziness, pyrexia.  Additional Information: Concomitant medication use information was not provided by reporter. Patient had no concomitant disease or risk factor. Patient developed adverse event after the first vaccination with covid vaccines. So far patient had received 8 vaccines, most of them were Moderna but a couple were Pfizer. Patient had already consulted to doctor, and he advised to use vitamin b, but it gave no results. As per patient it was sure the events were caused by the covid vaccine. The patient was treated with Vitamin b complex (Vitamin b) at an unspecified dose and frequency. At the time of the report, the events frostbite, pain in extremity and dizziness had not resolved; pain and pyrexia outcome was unknown  Batch/lot number is not provided, and it cannot be obtained.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Heart rate increased
Clinical narrative: Patient states that on the same day after the shot and for at least two weeks following that he suffered from a general state of feeling "bad" and that his resting heart rate was elevated above normal.  He states that after about two weeks that feeling and the heart rate went back to normal.  Patient doesn't wish to get the second dose of the vaccine because he is worried that the same thing will happen again
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: whelp on shot area, itchy
Age: 12.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose of Tdap given 1 month too early. Misread catch-up chart in standing orders and thought she needed one more dose after this one, based on previous vaccination history.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient presented to the pharmacy in the evening on 2/24 reporting that she experienced redness below the injection site the day after administration (2/19) that progressed to swelling and heat the following day (2/20). She reports these adverse effects improved through the weekend, but she developed a painful, red, itchy, swollen, warm to the touch, almost bruised area the following Monday (2/24) even farther down the arm from the injection site (a bit above the elbow). She wanted to know if what she was experiencing was typical following Shingrix administration. Pharmacy advised patient to reach out to her doctor for assessment and for advisement on second dose administration given the length of time involved in the incident and the fact that the patient's symptoms improved and then quickly worsened days later. Pharmacy advised patient that symptoms could potentially be attributed to a delayed sensitivity/mild allergic reaction to the vaccine and that if symptoms worsened (spreading rash, hives, swelling of the face, difficulty breathing, etc.) she should seek immediate medical attention. Pharmacy followed up with patient by phone on 2/26. Patient reported that she had some mild, lingering itchiness in the area, but that the rash and bruising were gone. Patient further reported that while she had contacted her doctor, they never got back to her and she sought no other medical attention for the issue. Pharmacy advised patient to still follow up with her doctor on second dose advisement.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient has not reported any side effects or issues. When running reports for last months shots, I noticed that this patient received a 3rd dose in Feb 6th of Shingrix and guidelines only recommend 2 doses
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Angioedema, Arthralgia, Brain fog, Burning sensation, Chest discomfort
Clinical narrative: Immediate Reaction Post-Vaccination: The patient experienced brain flush, unilateral facial and eye burning with blurred vision (caused her to have to get a new prescription) with muscular incoordination of the eyes (8 days post vaccine) with facial drooping, R facial and eye swelling,  within 10 minutes of receiving the pneumococcal vaccine.  Jaw dropping started 2-3 hours after the vaccine (unable to close her mouth), the tongue was swollen, throat was swollen and all the lymph nodes in the neck were enlarged, and later the angioedema worsened to the point the eyes were swollen to halfway and the nose was swollen to shift.   Was having chest pressure and palpitations, headaches by 3:40 PM and lost the hearing as well around that time.  Buzzing muffled sound (like someone vacuuming behind her.) The L side of her body was also swollen and inflamed after the vaccine.  With severe burning searing pain in the R arm started 8:15 PM last x 2 weeks, then waxed and waned x 2 weeks, then started being able to be use the arm in the next month.   Aching pain in the B shoulders.  Then B arms with neuropathy 72 hours (tip of the shoulders into the hands buzzing, burning, tingling pain) which progressed and lasted x 2 weeks.  Cognition was decreased with brain fog x 2 weeks.  The facial swelling went through to  20 d later Still is experiencing facial flushing.  9 days after with some possible skin reaction with back swelling to the point of shininess that lasted 4 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Deafness, Dizziness, Eye irritation, Eye movement disorder, Eye swelling
Clinical narrative: Immediate Reaction Post-Vaccination: The patient experienced brain flush, unilateral facial and eye burning with blurred vision (caused her to have to get a new prescription) with muscular incoordination of the eyes (8 days post vaccine) with facial drooping, R facial and eye swelling,  within 10 minutes of receiving the pneumococcal vaccine.  Jaw dropping started 2-3 hours after the vaccine (unable to close her mouth), the tongue was swollen, throat was swollen and all the lymph nodes in the neck were enlarged, and later the angioedema worsened to the point the eyes were swollen to halfway and the nose was swollen to shift.   Was having chest pressure and palpitations, headaches by 3:40 PM and lost the hearing as well around that time.  Buzzing muffled sound (like someone vacuuming behind her.) The L side of her body was also swollen and inflamed after the vaccine.  With severe burning searing pain in the R arm started 8:15 PM last x 2 weeks, then waxed and waned x 2 weeks, then started being able to be use the arm in the next month.   Aching pain in the B shoulders.  Then B arms with neuropathy 72 hours (tip of the shoulders into the hands buzzing, burning, tingling pain) which progressed and lasted x 2 weeks.  Cognition was decreased with brain fog x 2 weeks.  The facial swelling went through to  20 d later Still is experiencing facial flushing.  9 days after with some possible skin reaction with back swelling to the point of shininess that lasted 4 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Facial paralysis, Flushing, Headache, Hypoacusis, Immediate post-injection reaction
Clinical narrative: Immediate Reaction Post-Vaccination: The patient experienced brain flush, unilateral facial and eye burning with blurred vision (caused her to have to get a new prescription) with muscular incoordination of the eyes (8 days post vaccine) with facial drooping, R facial and eye swelling,  within 10 minutes of receiving the pneumococcal vaccine.  Jaw dropping started 2-3 hours after the vaccine (unable to close her mouth), the tongue was swollen, throat was swollen and all the lymph nodes in the neck were enlarged, and later the angioedema worsened to the point the eyes were swollen to halfway and the nose was swollen to shift.   Was having chest pressure and palpitations, headaches by 3:40 PM and lost the hearing as well around that time.  Buzzing muffled sound (like someone vacuuming behind her.) The L side of her body was also swollen and inflamed after the vaccine.  With severe burning searing pain in the R arm started 8:15 PM last x 2 weeks, then waxed and waned x 2 weeks, then started being able to be use the arm in the next month.   Aching pain in the B shoulders.  Then B arms with neuropathy 72 hours (tip of the shoulders into the hands buzzing, burning, tingling pain) which progressed and lasted x 2 weeks.  Cognition was decreased with brain fog x 2 weeks.  The facial swelling went through to  20 d later Still is experiencing facial flushing.  9 days after with some possible skin reaction with back swelling to the point of shininess that lasted 4 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injected limb mobility decreased, Lymphadenopathy, Neuromyopathy, Neuropathy peripheral
Clinical narrative: Immediate Reaction Post-Vaccination: The patient experienced brain flush, unilateral facial and eye burning with blurred vision (caused her to have to get a new prescription) with muscular incoordination of the eyes (8 days post vaccine) with facial drooping, R facial and eye swelling,  within 10 minutes of receiving the pneumococcal vaccine.  Jaw dropping started 2-3 hours after the vaccine (unable to close her mouth), the tongue was swollen, throat was swollen and all the lymph nodes in the neck were enlarged, and later the angioedema worsened to the point the eyes were swollen to halfway and the nose was swollen to shift.   Was having chest pressure and palpitations, headaches by 3:40 PM and lost the hearing as well around that time.  Buzzing muffled sound (like someone vacuuming behind her.) The L side of her body was also swollen and inflamed after the vaccine.  With severe burning searing pain in the R arm started 8:15 PM last x 2 weeks, then waxed and waned x 2 weeks, then started being able to be use the arm in the next month.   Aching pain in the B shoulders.  Then B arms with neuropathy 72 hours (tip of the shoulders into the hands buzzing, burning, tingling pain) which progressed and lasted x 2 weeks.  Cognition was decreased with brain fog x 2 weeks.  The facial swelling went through to  20 d later Still is experiencing facial flushing.  9 days after with some possible skin reaction with back swelling to the point of shininess that lasted 4 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Palpitations, Paraesthesia, Pharyngeal swelling, Skin burning sensation
Clinical narrative: Immediate Reaction Post-Vaccination: The patient experienced brain flush, unilateral facial and eye burning with blurred vision (caused her to have to get a new prescription) with muscular incoordination of the eyes (8 days post vaccine) with facial drooping, R facial and eye swelling,  within 10 minutes of receiving the pneumococcal vaccine.  Jaw dropping started 2-3 hours after the vaccine (unable to close her mouth), the tongue was swollen, throat was swollen and all the lymph nodes in the neck were enlarged, and later the angioedema worsened to the point the eyes were swollen to halfway and the nose was swollen to shift.   Was having chest pressure and palpitations, headaches by 3:40 PM and lost the hearing as well around that time.  Buzzing muffled sound (like someone vacuuming behind her.) The L side of her body was also swollen and inflamed after the vaccine.  With severe burning searing pain in the R arm started 8:15 PM last x 2 weeks, then waxed and waned x 2 weeks, then started being able to be use the arm in the next month.   Aching pain in the B shoulders.  Then B arms with neuropathy 72 hours (tip of the shoulders into the hands buzzing, burning, tingling pain) which progressed and lasted x 2 weeks.  Cognition was decreased with brain fog x 2 weeks.  The facial swelling went through to  20 d later Still is experiencing facial flushing.  9 days after with some possible skin reaction with back swelling to the point of shininess that lasted 4 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Skin disorder, Swelling, Swelling face, Swelling of eyelid, Swollen tongue
Clinical narrative: Immediate Reaction Post-Vaccination: The patient experienced brain flush, unilateral facial and eye burning with blurred vision (caused her to have to get a new prescription) with muscular incoordination of the eyes (8 days post vaccine) with facial drooping, R facial and eye swelling,  within 10 minutes of receiving the pneumococcal vaccine.  Jaw dropping started 2-3 hours after the vaccine (unable to close her mouth), the tongue was swollen, throat was swollen and all the lymph nodes in the neck were enlarged, and later the angioedema worsened to the point the eyes were swollen to halfway and the nose was swollen to shift.   Was having chest pressure and palpitations, headaches by 3:40 PM and lost the hearing as well around that time.  Buzzing muffled sound (like someone vacuuming behind her.) The L side of her body was also swollen and inflamed after the vaccine.  With severe burning searing pain in the R arm started 8:15 PM last x 2 weeks, then waxed and waned x 2 weeks, then started being able to be use the arm in the next month.   Aching pain in the B shoulders.  Then B arms with neuropathy 72 hours (tip of the shoulders into the hands buzzing, burning, tingling pain) which progressed and lasted x 2 weeks.  Cognition was decreased with brain fog x 2 weeks.  The facial swelling went through to  20 d later Still is experiencing facial flushing.  9 days after with some possible skin reaction with back swelling to the point of shininess that lasted 4 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Tinnitus, Trismus, Vision blurred
Clinical narrative: Immediate Reaction Post-Vaccination: The patient experienced brain flush, unilateral facial and eye burning with blurred vision (caused her to have to get a new prescription) with muscular incoordination of the eyes (8 days post vaccine) with facial drooping, R facial and eye swelling,  within 10 minutes of receiving the pneumococcal vaccine.  Jaw dropping started 2-3 hours after the vaccine (unable to close her mouth), the tongue was swollen, throat was swollen and all the lymph nodes in the neck were enlarged, and later the angioedema worsened to the point the eyes were swollen to halfway and the nose was swollen to shift.   Was having chest pressure and palpitations, headaches by 3:40 PM and lost the hearing as well around that time.  Buzzing muffled sound (like someone vacuuming behind her.) The L side of her body was also swollen and inflamed after the vaccine.  With severe burning searing pain in the R arm started 8:15 PM last x 2 weeks, then waxed and waned x 2 weeks, then started being able to be use the arm in the next month.   Aching pain in the B shoulders.  Then B arms with neuropathy 72 hours (tip of the shoulders into the hands buzzing, burning, tingling pain) which progressed and lasted x 2 weeks.  Cognition was decreased with brain fog x 2 weeks.  The facial swelling went through to  20 d later Still is experiencing facial flushing.  9 days after with some possible skin reaction with back swelling to the point of shininess that lasted 4 days.
Age: 41.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Amnesia, Depressed level of consciousness, Discomfort, Dizziness, Headache
Clinical narrative: On 03/04/2025 requested to be vaccinated for an immigration process (Hepatitis B, TDAP, MMR, Varicella, Flu). Pre-screen assessment of immunization completed. Client denied any allergy or significant medical history.  At 9:02am RN administered Hepatitis B dose#1 and TDAP dose #2 both to the left deltoid, MMR dose #2 Left Arm. Immediately following the MMR vaccine client complained of discomfort and light headedness. At 9:03 am client became pale and complained of dizziness. RN paused the vaccination. At 9:04am client experienced decreased consciousness and began to slide out of the chair.  She was immediately assisted to semi-fowler's position in a reclining chair. RN requested additional assistance from another staff RN and PHN, who helped with client transfer and the recording of vital signs and referred to policy for syncope event.  At 9:05 am blood pressure:70/40, pulse 46, SpO2 sat 99%, temperature -97.2. Client was unresponsive for about 30 seconds with opened eyes. At 9:07 am client complains of slight headache and asked what happened. Vital signs were taken as follows: 9:14am- blood pressure 78/48, pulse 49, SpO2 sat 99%, temperature 97.7.  At 9:18am client stated she felt a little dizzy, blood pressure 65/39, pulse 49, SpO2 sat 99%, temperature 97.6; At 9:20am client's skin color back to normal, speech normal, blood pressure 82/48, P52, spO2 sat 99%, temperature 7.8; 9:27 blood pressure 100/67, p58, SpO2 sat 99%, client denied dizziness. Client was offered to stop vaccination and postpone till next visit, client responded that she feels much better and insist to continue vaccination. Client was offered cup of coffee with sugar per her request. Client is alert and oriented to person, place and time. At 9:36 am RN administered Flu vaccine to the right deltoid, client tolerated well; 9:38am Varicella vaccine was administered right arm by RN, client tolerated well, blood pressure 105/72, P54. At 9:41am client independently transitioned to standing position, no evidence of rebound symptoms, vital signs: blood pressure 106/73, P59, spO2 sat 99%, temperature 97.8. RN provided instruction to follow up with medical provider or seeking urgent/emergency services if symptoms return. Client confirmed and agreed. Client was strongly encouraged to call a family member for a ride, client refused to call.  At 9:55 am client, denied further symptoms, was alert and oriented to person place and time and in no apparent distress and ambulated without assistance out of the clinic.  The phone number of the clinic was given to the client, and she was encouraged to call back on arrival to home. At 10:25am RN received a phone call from the client that she arrived safely and denied recurrent symptoms or any distress. As a response to this event, the team will conduct a review and drill of response to syncope event in the clinic per policy.
Age: 41.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Immediate post-injection reaction, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: On 03/04/2025 requested to be vaccinated for an immigration process (Hepatitis B, TDAP, MMR, Varicella, Flu). Pre-screen assessment of immunization completed. Client denied any allergy or significant medical history.  At 9:02am RN administered Hepatitis B dose#1 and TDAP dose #2 both to the left deltoid, MMR dose #2 Left Arm. Immediately following the MMR vaccine client complained of discomfort and light headedness. At 9:03 am client became pale and complained of dizziness. RN paused the vaccination. At 9:04am client experienced decreased consciousness and began to slide out of the chair.  She was immediately assisted to semi-fowler's position in a reclining chair. RN requested additional assistance from another staff RN and PHN, who helped with client transfer and the recording of vital signs and referred to policy for syncope event.  At 9:05 am blood pressure:70/40, pulse 46, SpO2 sat 99%, temperature -97.2. Client was unresponsive for about 30 seconds with opened eyes. At 9:07 am client complains of slight headache and asked what happened. Vital signs were taken as follows: 9:14am- blood pressure 78/48, pulse 49, SpO2 sat 99%, temperature 97.7.  At 9:18am client stated she felt a little dizzy, blood pressure 65/39, pulse 49, SpO2 sat 99%, temperature 97.6; At 9:20am client's skin color back to normal, speech normal, blood pressure 82/48, P52, spO2 sat 99%, temperature 7.8; 9:27 blood pressure 100/67, p58, SpO2 sat 99%, client denied dizziness. Client was offered to stop vaccination and postpone till next visit, client responded that she feels much better and insist to continue vaccination. Client was offered cup of coffee with sugar per her request. Client is alert and oriented to person, place and time. At 9:36 am RN administered Flu vaccine to the right deltoid, client tolerated well; 9:38am Varicella vaccine was administered right arm by RN, client tolerated well, blood pressure 105/72, P54. At 9:41am client independently transitioned to standing position, no evidence of rebound symptoms, vital signs: blood pressure 106/73, P59, spO2 sat 99%, temperature 97.8. RN provided instruction to follow up with medical provider or seeking urgent/emergency services if symptoms return. Client confirmed and agreed. Client was strongly encouraged to call a family member for a ride, client refused to call.  At 9:55 am client, denied further symptoms, was alert and oriented to person place and time and in no apparent distress and ambulated without assistance out of the clinic.  The phone number of the clinic was given to the client, and she was encouraged to call back on arrival to home. At 10:25am RN received a phone call from the client that she arrived safely and denied recurrent symptoms or any distress. As a response to this event, the team will conduct a review and drill of response to syncope event in the clinic per policy.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: TDAP was given in 06/08/2023 Patient was 11 yrs old, another dose of TDAP was given today patient is 13 yrs old. No adverse reactions observed, patient is stable.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: No adverse event
Clinical narrative: Patient no have a reaction, symptom, sing.
Age: 30.0
Sex: M
Vaccine: PNC20
Symptoms: Unevaluable event
Clinical narrative: none
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was set to receive a shingles vaccine alongside her Tdap but inadvertently was administered two Tdap vaccines. Patient did not report any adverse events at time of error or for 15 minutes after error. I aim to follow up with the patient and she assured me she would contact me with any adverse events.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Unevaluable event
Clinical narrative: I did a clinic for this facility Country Club. Patient came in asking for RSV. I explained to him that this only a one dose vaccine and if he had this before. He said no, his first time.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Amenorrhoea, Breast enlargement, Euphoric mood, Fatigue
Clinical narrative: Within 24 hours of receiving an mRNA shot, i an altered state of consciousness for about 24 hours, fever of 104, euphoria, could not get out of bed. Then I did not menstruate for 4 months and gained 40 pounds. Rapid breast growth. Physicians could not find a hormonal imbalance. Very not been able to lose weight on a GLP-1, has ongoing fatigue.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia, Weight increased
Clinical narrative: Within 24 hours of receiving an mRNA shot, i an altered state of consciousness for about 24 hours, fever of 104, euphoria, could not get out of bed. Then I did not menstruate for 4 months and gained 40 pounds. Rapid breast growth. Physicians could not find a hormonal imbalance. Very not been able to lose weight on a GLP-1, has ongoing fatigue.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Colectomy, Enema administration, Intussusception, Laparotomy
Clinical narrative: Patient had long segment ileocolonic intussusception and pneumatic reduction was unsuccessful so patient required  laparoscopy that was converted to exploratory laparotomy with R hemicolectomy
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue
Clinical narrative: fatigue
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Patient diagnosed with right deep vein thrombosis on 2/20/25
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Electroencephalogram normal, Laboratory test normal, Laryngoscopy normal, Mechanical ventilation, Respiratory pathogen panel
Clinical narrative: My son had a prolonged seizure that put him on a ventilator 10 days after vaccinations. Most likely due to the MMR vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Seizure
Clinical narrative: My son had a prolonged seizure that put him on a ventilator 10 days after vaccinations. Most likely due to the MMR vaccine.
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No adverse event; Inbound call received from a customer who said doses of GARDASIL 9 were administered to two patients after experiencing a temperature excursion in December 2024. The caller said one of the doses was administered on 07JAN2025 and the other dose was ad; This spontaneous report was received from other health professional and a nurse regarding to a 10-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On an unspecified date in January 2025 (also reported as "one of the doses was administered on 07-JAN-2025 and the other dose was administered on 21-JAN-2025. The caller did not specify or clarify the date each specific patient received their dose, so this information is unknown"), the patient was vaccinated human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) injection, lot number 1957407 (lot number 1957407 had been verified to be valid lot number for human papillomavirus 9-valent vaccine, recombinant suspension for injection), expiration date 23-JAN-2026 (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis; after experiencing a temperature excursion in December 2024 (temperature: 31.6F, time frame: 240 hours, no previous temperature excursion).   The caller confirmed no additional adverse effects or events were noted after administration. No additional information was provided to further clarify the details. No additional adverse event (AE) reported. No product quality complaint (PQC).   This is one case from 2 cases of the same reporter.
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Inbound call received from a customer who said doses of GARDASIL 9 were administered to two patients after experiencing a temperature excursion in December 2024. The caller said one of the doses was administered on 07JAN2025 and the other dose was ad; This spontaneous report was received from other health professional and a nurse regarding to a 10-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On an unspecified date in January 2025 (also reported as "one of the doses was administered on 07-JAN-2025 and the other dose was administered on 21-JAN-2025. The caller did not specify or clarify the date each specific patient received their dose, so this information is unknown"), the patient was vaccinated human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) injection, lot number 1957407 (lot number 1957407 had been verified to be valid lot number for human papillomavirus 9-valent vaccine, recombinant suspension for injection), expiration date 23-JAN-2026 (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis; after experiencing a temperature excursion in December 2024 (temperature: 31.6F, time frame: 240 hours, no previous temperature excursion).   The caller confirmed no additional adverse effects or events were noted after administration. No additional information was provided to further clarify the details. No additional adverse event (AE) reported. No product quality complaint (PQC).   This is one case from 2 cases of the same reporter.
Sex: F
Vaccine: MEA, MEA
Symptoms: Eye pain
Clinical narrative: Eye Pain; Eye pain; This spontaneous report was received from a Consumer regarding to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (Manufacturer unknown), (lot #, expiration date, dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis.   On an unknown date, the patient experienced eye pain, she felt like being stabbed in the eye. On an unknown date, a month later, she received the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), Solution for injection, lot #, expiration date, dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis; on an unknown date, the patient experienced eye pain like being stabbed in the eye so bad that she had to go to the emergency room (ER). On an unknown date, the patient was admitted into the hospital due to the event. At the reporting time, the patient recovered from the events of Eye Pain on an unspecified date.   The causal relationship between both events of Eye Pain and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) were unknown.   Lot # is being requested and will be submitted if is reported.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: he HCP stated that no patients reported any adverse issues or side effects from any of the administered doses.; Temperature of fridge went up to 48 F excursion; This spontaneous report has been received from a medical assistant regarding a 17-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included meningococcal vaccine B rfHbp/NadA/NHBA OMV (BEXSERO).  On 03-JAN-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered intramuscularly in the left arm as the second dose (lot number reported as Y010656, which has been verified as valid, expiration date reported and validated as 29-NOV-2026) (dose was not reported).  The administered dose was exposed to a temperature that went up to 48 Fahrenheit degrees (F) (Product storage error). The vaccine was determined good for further use. The reporter stated that no patients reported any adverse issues or side effects from any of the administered doses.
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received One Dose on HEPLISAV B on 12/11/2024, and Then a Dose Engerix on 1/15/2025; Initial report received on 20-Feb-2025.    A pharmacist reported that a patient (age, gender, race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given ENGERIX-B as the second dose.   No medical history or concomitant medications were reported.     On 11-Dec-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)].   On 15-Jan-2025, 35 days after having been vaccinated with HEPLISAV-B, the patient was given ENGERIX-B (lot #, expiration date, NDC #, route, and site not available).  No adverse events were reported.   No additional information is available.      Company Comment: ?The company assessed the event as non-serious.; Sender's Comments: ? The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: The 2nd Dose of HEPLISAV-B was Confirmed to be Missed; Initial report received on 20-Feb-2025.    A pharmacist reported that a 43-year-old male (race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet.   No medical history or concomitant vaccines were reported.    On 24-Sep-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 43528-003-05, expiration date 16-Nov-2026, NDC # 43528-003-05)] intramuscularly in the left arm.    At the time of the report, the patient has not received the second dose.  It was confirmed to be missed.   Additional information was not provided.      Company Comment: ? The company assessed the event as non-serious.; Sender's Comments: ? The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 Year Received Heplisav-B; Initial report received on 25-Feb-2025.  A nurse reported that a 15-year-old male patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while at an inappropriate age.  No medical history or concomitant medications were reported.    On 25-Feb-2025, the patient received a dose of a hepatitis B vaccine [HEPLISAV-B (NDC # 43528-002-01, lot #, expiration date, route, and site not available).  The patient was 15 years old when he received HEPLISAV-B. There were no adverse events reported.  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: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious case was reported by a consumer and described the occurrence of fever in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis. Concomitant products included methotrexate.   On 25-FEB-2025, the patient received Shingrix. On 26-FEB-2025, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2025 The patient self-reported this case for himself. The patient received Shingrix vaccine and experienced fever. The symptoms were treated.
Sex: F
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: syncope after the administration/Fainting; This serious case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 34-year-old female patient who received HBV (Engerix B) (expiry date 11-JUL-2026) for prophylaxis.   On 25-FEB-2025, the patient received Engerix B. In FEB-2025, less than a week after receiving Engerix B, the patient experienced syncope (Verbatim: syncope after the administration/Fainting) (serious criteria GSK medically significant). The outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     The company considered the syncope to be unrelated to Engerix B and Engerix B 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: 26-FEB-2025 Other HCP wanted to know the percentage of patients fainting after receiving Engerix-B. Information found in the prescribing information about syncope after the administration was given and also offered to be escalated to a second line specialist, but declined it. Reporter mentioned that the vaccine was administered in a facility different than the one registered in the system and provided only the zip code of this administration site. Reporter did not knew the batch number because she was not in that facility and had nothing from the product to find out the lot number.; Sender's Comments: Syncope is a listed event which, due to the following criteria ((insufficient information provided about the clinical description, medical history, concurrent conditions, concomitant medications, lab results) is considered unrelated to GSK vaccine Engerix B and Engerix B PRE-FILLED SYRINGE DEVICE.