chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 3rd dose on 13-MAY-2014; Early 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On 13-MAY-2014, the patient received the 3rd dose of Twinrix. On 22-NOV-2013, the patient received the 2nd dose of Twinrix. On 22-NOV-2013, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose). On 13-MAY-2014, the patient experienced drug dose administration interval too long (Verbatim: received 3rd dose on 13-MAY-2014). The outcome of the drug dose administration interval too long and drug dose administration interval too short were not applicable.   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: 27-JUN-2025 The pharmacist called to request information about the possibility of getting Hepatitis B titers to make sure she was covered.  The patient received 1st dose of Twinrix on 10-NOV-2013, 2nd dose on 22-NOV-2013 and 3rd dose on 13-MAY-2014 The reporter did not know if those dates were accurate and would get in contact with physician to confirm the dates. The patient was the health care professional and has 65 year of age at the moment. The patient received 2nd dose of Twinrix vaccine earlier than recommended interval, which led to shortening of vaccination schedule. The patient received 3rd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Maladministration of the diluent only; Maladministration of the diluent only; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 28-year-old female patient who received MMR (Priorix) (batch number 3ZE3E, expiry date 22-NOV-2028) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the diluent only) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the diluent only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   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-JUN-2025 The reporter reported that there was maladministration of a Priorix diluent before reconstituting, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They request information about what to do.  The Vaccine Administration Facility is the same as Primary Reporter
Sex: M
Vaccine: CHIK
Symptoms: Arthralgia, Diarrhoea, Dyspepsia, Fatigue, Headache
Clinical narrative: Fatigue; Joint pain; Muscle pain; Fever; Nausea; Headache; Diarrhea; Indigestion; Pruritis; Blurry vision; The following information was received from a consumer on 24 Jun 2025.  A 29-year-old male vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV)), batch number 24I005) on an unknown date.  Four days after vaccination he developed fatigue, joint and muscle pain, fever, nausea, headache, diarrhea, indigestion, pruritis and blurry vision, which lasted greater than two weeks.; Sender's Comments: Company's medical assessment: The causality was assessed as possibly related for all reported events, as time to onset is plausible (4 days past vaccination) indicative of a systemic vaccination reaction, and as Fatigue, joint and muscle pain, fever, nausea and headache are listed for IXCHIQ according to RSI. No further details were provided and no confounding factors were reported.
Sex: M
Vaccine: CHIK
Symptoms: Myalgia, Nausea, Pruritus, Pyrexia, Vision blurred
Clinical narrative: Fatigue; Joint pain; Muscle pain; Fever; Nausea; Headache; Diarrhea; Indigestion; Pruritis; Blurry vision; The following information was received from a consumer on 24 Jun 2025.  A 29-year-old male vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV)), batch number 24I005) on an unknown date.  Four days after vaccination he developed fatigue, joint and muscle pain, fever, nausea, headache, diarrhea, indigestion, pruritis and blurry vision, which lasted greater than two weeks.; Sender's Comments: Company's medical assessment: The causality was assessed as possibly related for all reported events, as time to onset is plausible (4 days past vaccination) indicative of a systemic vaccination reaction, and as Fatigue, joint and muscle pain, fever, nausea and headache are listed for IXCHIQ according to RSI. No further details were provided and no confounding factors were reported.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain
Clinical narrative: common mild side effects (e.g., aches); common mild side effects (e.g., aches); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (common mild side effects (e.g., aches)) and PAIN (common mild side effects (e.g., aches)) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Cardiac stent placement in 2002 and Interventional procedure (additional intervention a few years ago where more stents were placed). Concurrent medical conditions included Heart disorder (Heart condition).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (common mild side effects (e.g., aches)) and PAIN (common mild side effects (e.g., aches)). At the time of the report, IMMUNISATION REACTION (common mild side effects (e.g., aches)) outcome was unknown and PAIN (common mild side effects (e.g., aches)) had resolved.            No concomitant medication was reported.  He was still active and healthy, despite his condition. He had received all recommended Moderna COVID-19 vaccines and boosters for his age group, with no adverse reactions beyond common mild side effects (e.g., aches).  The patient did not experience any additional symptoms/events.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787946 (Patient Link).
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient now critically ill with COVID-19 after facing the same difficulty accessing the updated vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient now critically ill with COVID-19 after facing the same difficulty accessing the updated vaccine) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient now critically ill with COVID-19 after facing the same difficulty accessing the updated vaccine) (seriousness criterion life threatening). At the time of the report, COVID-19 (Patient now critically ill with COVID-19 after facing the same difficulty accessing the updated vaccine) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2025-787946 (E2B Linked Report).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787946:Friend case
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain
Clinical narrative: common mild side effects (e.g., aches); common mild side effects (e.g., aches); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (common mild side effects (e.g., aches)) and PAIN (common mild side effects (e.g., aches)) in a 74-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Cardiac stent placement in 2002 and Interventional procedure (additional intervention a few years ago where more stents were placed). Concurrent medical conditions included Heart disorder.    In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (common mild side effects (e.g., aches)) and PAIN (common mild side effects (e.g., aches)). At the time of the report, IMMUNISATION REACTION (common mild side effects (e.g., aches)) outcome was unknown and PAIN (common mild side effects (e.g., aches)) had resolved.            No concomitant medication was reported.  He was still active and healthy, despite his condition. He had received all recommended Moderna COVID-19 vaccines and boosters for his age group, with no adverse reactions beyond common mild side effects (e.g., aches).  Patient had ongoing difficulties accessing the Spikevax 2024-2025 COVID-19 vaccine. Patient had concern that this issue was happening nationwide, not just to him.  The patient did not experience any additional symptoms/events.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787949, US-MODERNATX, INC.-MOD-2025-787973 (E2B Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2025-787948 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787949:Patient 3 (Wife case) US-MODERNATX, INC.-MOD-2025-787973:Friend case
Sex: M
Vaccine: RSV
Symptoms: Device issue, Underdose
Clinical narrative: the plunger stopped and kept pushing, pulled the needle out and malfunctioned/Administered; the plunger stopped and kept pushing, pulled the needle out and malfunctioned/Administered; that there was half of the vaccine left in the syringe.; This is a spontaneous report received from a Pharmacist from medical information team, Program ID: 004756.  An 85-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: LL8394, Expiration Date: Feb2026) for immunisation, Device Lot Number: LH6570, Device Expiration Date: Apr2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MECHANICAL ISSUE (non-serious), POOR QUALITY DEVICE USED (non-serious), outcome "unknown" and all described as "the plunger stopped and kept pushing, pulled the needle out and malfunctioned/Administered"; UNDERDOSE (non-serious), outcome "unknown", described as "that there was half of the vaccine left in the syringe.".  Additional information: The pharmacist called in with regard to a dosage and administration question on Abrysvo. So, what she said, happened was when she was giving the vaccine to the patient the plunger stop as if it was done like it is normally does. So, when she went to throw it, she felt like there was more vaccine. So, she looked into the sharps container to confirm it and she saw that there was still vaccine left. She estimated that the patient got half of the vaccine. Then she was not able to fully confirm the presentation of the Abrysvo but she said, it is the one with the vial, adaptor."  When paraphrased the concern, reporter stated, "I was giving the vaccine the plunger stop as if the vaccine had all been given. The times seemed like it was correct as well. I guess per usual and then as I was throwing it away, you know how like those like, instinctive thing, just kick in. I thought, as it was going in the sharp, saw liquid in there. I confirmed that later, I could see it in the sharp's container that there seemed to be a half a vial or half dose, still there."  Causality for "the plunger stopped and kept pushing, pulled the needle out and malfunctioned/administered" and "that there was half of the vaccine left in the syringe." was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Dizziness, Electrocardiogram, Feeling hot, Head injury
Clinical narrative: After receiving he vaccines patient passed out/blacked out and hit her head. Before we went down she said she felt hot, dizzy, and some chest pain. After the nurses woke her up she said her side of face and arm felt numb and still do
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Loss of consciousness, Urine analysis
Clinical narrative: After receiving he vaccines patient passed out/blacked out and hit her head. Before we went down she said she felt hot, dizzy, and some chest pain. After the nurses woke her up she said her side of face and arm felt numb and still do
Age: 11.0
Sex: M
Vaccine: DTAP, MENB
Symptoms: Abdominal pain upper, Abnormal behaviour, Disturbance in attention, Feeling hot, Headache
Clinical narrative: Hello Team - I read the note from the vaccine follow up with doctor on Friday.  I think more detailed information should be in that note.  Here is a timeline of events.     Patient?s Vaccine Response Timeline  Wednesday, June 5, 2025 Vaccines administered: Tdap and meningitis Initial response: Slept a lot afterward (same day)   Friday, June 7, 2025 Severe headache You had to leave work to care for him No fever, but he said he ?felt hot? This was the first major neurological-type symptom noted   Monday, June 9, 2025 Behavioral incident at school Swore in class - 3x's - uncharacteristic. That afternoon at baseball, he and a teammate took a kid?s hat and dragged it in the dirt and poured contents of a hand warmer package into it. Result: Suspended from baseball   Tuesday, June 11, 2025 (approximate) Emotional flag noted Your friend (a para at the school) noticed patient seemed sad and asked if he was okay.  Could have been about suspension - but it was notable.   Wednesday, June 12, 2025 Extreme stomach pain Patient had to be sent home from school   Friday, June 13, 2025 Incident involving another student Patients impulse control was so bad he injured another student at school.  When usually he would have restraint - his put his fingers into a students collar bone and caused a red mark. This appears to have escalated school concern.   Each day after the vaccine - patient has appeared not to be able to focus, process information or follow simple instructions - looking off into the distance, shaking his head and having no impulse control.    As of today - patient?s sleep cycles still remain disrupted and processing,impulse control and hyperactivity remain increased as opposed to where is was on his drs visit where we reported it was much more controlled.  Patient was beginning to cook before these vaccines and with his lack of impulse control and ability to focus it?s unsafe for him to do so at this time.  Hoping it stabilizes soon.  He was doing so well.   Thank you for reviewing this progression.
Age: 11.0
Sex: M
Vaccine: DTAP, MENB
Symptoms: Hypersomnia, Physical assault, Psychomotor hyperactivity, Sleep disorder, Staring
Clinical narrative: Hello Team - I read the note from the vaccine follow up with doctor on Friday.  I think more detailed information should be in that note.  Here is a timeline of events.     Patient?s Vaccine Response Timeline  Wednesday, June 5, 2025 Vaccines administered: Tdap and meningitis Initial response: Slept a lot afterward (same day)   Friday, June 7, 2025 Severe headache You had to leave work to care for him No fever, but he said he ?felt hot? This was the first major neurological-type symptom noted   Monday, June 9, 2025 Behavioral incident at school Swore in class - 3x's - uncharacteristic. That afternoon at baseball, he and a teammate took a kid?s hat and dragged it in the dirt and poured contents of a hand warmer package into it. Result: Suspended from baseball   Tuesday, June 11, 2025 (approximate) Emotional flag noted Your friend (a para at the school) noticed patient seemed sad and asked if he was okay.  Could have been about suspension - but it was notable.   Wednesday, June 12, 2025 Extreme stomach pain Patient had to be sent home from school   Friday, June 13, 2025 Incident involving another student Patients impulse control was so bad he injured another student at school.  When usually he would have restraint - his put his fingers into a students collar bone and caused a red mark. This appears to have escalated school concern.   Each day after the vaccine - patient has appeared not to be able to focus, process information or follow simple instructions - looking off into the distance, shaking his head and having no impulse control.    As of today - patient?s sleep cycles still remain disrupted and processing,impulse control and hyperactivity remain increased as opposed to where is was on his drs visit where we reported it was much more controlled.  Patient was beginning to cook before these vaccines and with his lack of impulse control and ability to focus it?s unsafe for him to do so at this time.  Hoping it stabilizes soon.  He was doing so well.   Thank you for reviewing this progression.
Age: 11.0
Sex: M
Vaccine: DTAP, MENB
Symptoms: Tremor
Clinical narrative: Hello Team - I read the note from the vaccine follow up with doctor on Friday.  I think more detailed information should be in that note.  Here is a timeline of events.     Patient?s Vaccine Response Timeline  Wednesday, June 5, 2025 Vaccines administered: Tdap and meningitis Initial response: Slept a lot afterward (same day)   Friday, June 7, 2025 Severe headache You had to leave work to care for him No fever, but he said he ?felt hot? This was the first major neurological-type symptom noted   Monday, June 9, 2025 Behavioral incident at school Swore in class - 3x's - uncharacteristic. That afternoon at baseball, he and a teammate took a kid?s hat and dragged it in the dirt and poured contents of a hand warmer package into it. Result: Suspended from baseball   Tuesday, June 11, 2025 (approximate) Emotional flag noted Your friend (a para at the school) noticed patient seemed sad and asked if he was okay.  Could have been about suspension - but it was notable.   Wednesday, June 12, 2025 Extreme stomach pain Patient had to be sent home from school   Friday, June 13, 2025 Incident involving another student Patients impulse control was so bad he injured another student at school.  When usually he would have restraint - his put his fingers into a students collar bone and caused a red mark. This appears to have escalated school concern.   Each day after the vaccine - patient has appeared not to be able to focus, process information or follow simple instructions - looking off into the distance, shaking his head and having no impulse control.    As of today - patient?s sleep cycles still remain disrupted and processing,impulse control and hyperactivity remain increased as opposed to where is was on his drs visit where we reported it was much more controlled.  Patient was beginning to cook before these vaccines and with his lack of impulse control and ability to focus it?s unsafe for him to do so at this time.  Hoping it stabilizes soon.  He was doing so well.   Thank you for reviewing this progression.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Unevaluable event
Clinical narrative: No adverse event noted.
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site pain, Injection site rash, Malaise, Mobility decreased
Clinical narrative: PATIENT FELT VERY ILL A COUPLE DAYS LATER. PATIENT COULD HARDLY MOVE AND GET OUT OF BED. PATIENT ALSO HAD A BAD RASH (REDNESS) ON UPPER LEFT ARM AND IT WAS ALSO VERY SORE.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Brain fog, Brain operation, Cognitive disorder, Impaired work ability
Clinical narrative: Within days of the second shot, I started to have issues with cognition, speech, and memory - similar to 'brain fog'. This continued until I could hardly speak, couldn't remember my name, and was admitted to the hospital with stroke-like symptoms. I was eventually diagnosed with MoyaMoya. I had brain surgery, but was left in extreme pain. 4 years later, I am not able to work and still have bad symptoms.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Memory impairment, Moyamoya disease, Neurological symptom, Pain, Speech disorder
Clinical narrative: Within days of the second shot, I started to have issues with cognition, speech, and memory - similar to 'brain fog'. This continued until I could hardly speak, couldn't remember my name, and was admitted to the hospital with stroke-like symptoms. I was eventually diagnosed with MoyaMoya. I had brain surgery, but was left in extreme pain. 4 years later, I am not able to work and still have bad symptoms.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Fall
Clinical narrative: Patient given vaccine and when they were checking out of the office seemed to become very lightheaded and fell to the floor. Assisted patient to room 1 and placed in lying position with feet elevated. Offered juice, crackers. Mother stated client had not eaten breakfast. After juice given and waiting about 15-20 minutes client was well enough to leave after being evaluated by MD.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Heart rate decreased, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Vasovagal response after vaccine. Patient had slow pulse, loss of color and temporary loss of consciousness.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Hot flush, Neck pain, Pain in extremity
Clinical narrative: Pain (felt like nerve pain) from left arm across shoulders and also neck. Also feel hot flushes
Age: 45.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site rash, Rash
Clinical narrative: Patient called in to report a rash that developed on both arms after being vaccinated on 7/2. Per patient, the rashes developed on 7/3 around the injection site and continued to grow towards the elbow until patient went to the ER on 7/8 for treatment.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Brain fog, Dizziness, Headache, Influenza like illness
Clinical narrative: It was about 2 hours after, I left the pharmacy and I got a real high fever and I started shaking really bad, I began to throw up. It felt almost like flu symptoms. And that lasted for about 2 days. I got an extreme headache and that lasted the whole time. I felt faint, I was very depleted. And that was about it at first, and then it just kept getting worse as the days and months went past. I was unable to do anything like any activities, i had brain fog really bad. I was just not my self. And i have seen over 30 doctors and only one has put that the COVID vaccine could be related to my symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pyrexia, Tremor, Vomiting
Clinical narrative: It was about 2 hours after, I left the pharmacy and I got a real high fever and I started shaking really bad, I began to throw up. It felt almost like flu symptoms. And that lasted for about 2 days. I got an extreme headache and that lasted the whole time. I felt faint, I was very depleted. And that was about it at first, and then it just kept getting worse as the days and months went past. I was unable to do anything like any activities, i had brain fog really bad. I was just not my self. And i have seen over 30 doctors and only one has put that the COVID vaccine could be related to my symptoms.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: covid infection after vaccination
Age: 30.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthma late onset, Dyspnoea, Electrocardiogram normal, Impaired quality of life, Pulmonary function test
Clinical narrative: 2 days after injection, had severe trouble breathing. Went to urgent care, ran oxygen saturation tests and EKG, normal levels. Was prescribed a steroid to get passed it. Still had issues post steroids, spoke to primary care physician which referred me to Allergist/Asthma specialists. Have done extensive testing now for my breathing issues, now have severe adult onset asthma, have use daily inhaler (Trelegy Ellipta) and still have trouble breathing some days but it is controlled and on maintenance. Disruptive quality of life, and never had been diagnosed with asthma or asthma-related issues prior to this time period.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Seizure
Clinical narrative: CONVULSUION AFTER 10 MINUTES OF VACCINE ADMINISTRATION. PER MOM EPISODE LASTED ABOUT 30 SECONDS. PT RESPONSIVE AND ALERT AFTER.
Sex: M
Vaccine: HEP
Symptoms: Basal ganglia infarction, Cyanosis, Dyspnoea, Listless, Magnetic resonance imaging head abnormal
Clinical narrative: After hospital discharge following patient's birth, we were home for about an hour when he started turning blue and was struggling to breathe. He was ?dusty? and listless.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Hyposmia, Influenza like illness, Pain
Clinical narrative: After being forced to have the two different COVID vaccinations administered in 2021, I noticed fatigue, headaches, body aches, and severe flu like symptoms over the course of three weeks. Within one week, I noticed limited sense of smell comparatively to before my vaccinations. It is now 2025, and my sense of smell is still limited to pungent or strong odors.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac normal, Echocardiogram, Electrocardiogram normal, Magnetic resonance imaging heart abnormal, Myopericarditis
Clinical narrative: Admitted to the hospital and diagnosed with myopericarditis without CAD.  Treatment started with Colchicine daily and ibuprofen three times daily x 3 month course.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased, Ventricular hypokinesia
Clinical narrative: Admitted to the hospital and diagnosed with myopericarditis without CAD.  Treatment started with Colchicine daily and ibuprofen three times daily x 3 month course.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose normal, Fatigue, Gait disturbance, Heart rate decreased, Loss of consciousness
Clinical narrative: Syncope episode directly following vaccines administration. Patient stood up to walk out of room and her gait starting getting un even. Placed on the ground. She did have a small tonic episode and heart rate dropped to the 40s. By fanning patient and scratching head we were able to bring back to consciousness. However directly following event patient kept going in and out of it and was very tired. Heart rate would drop to the mid 40s.  Sent by EMS to ER for further eval
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Syncope, Tonic convulsion
Clinical narrative: Syncope episode directly following vaccines administration. Patient stood up to walk out of room and her gait starting getting un even. Placed on the ground. She did have a small tonic episode and heart rate dropped to the 40s. By fanning patient and scratching head we were able to bring back to consciousness. However directly following event patient kept going in and out of it and was very tired. Heart rate would drop to the mid 40s.  Sent by EMS to ER for further eval
Age: 38.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Day of vaccine 7/3: Fatigue, headache, exhaustion, injection site pain. 7/4: Fatigue, headache, exhaustion, injection site pain (intense). 7/5: Fatigue, headache, injection site pain, injection site redness w/raised red rash that is warm to the touch. 7/6: Fatigue, headache, injection site pain (greatly reduced) with rash disappearing. 7/7-7/8: Fatigue, headache, injection site redness w/large red blotchy rash, very intense itching, warm to the touch. 7/9: Fatigue, headache, injection site redness has gone down, but the intense itching persists.  It's still warm to the touch.
Age: 38.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Rash erythematous, Rash macular, Rash papular, Rash pruritic
Clinical narrative: Day of vaccine 7/3: Fatigue, headache, exhaustion, injection site pain. 7/4: Fatigue, headache, exhaustion, injection site pain (intense). 7/5: Fatigue, headache, injection site pain, injection site redness w/raised red rash that is warm to the touch. 7/6: Fatigue, headache, injection site pain (greatly reduced) with rash disappearing. 7/7-7/8: Fatigue, headache, injection site redness w/large red blotchy rash, very intense itching, warm to the touch. 7/9: Fatigue, headache, injection site redness has gone down, but the intense itching persists.  It's still warm to the touch.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient in clinic for Well Child Check. Was administered Men B vaccination too early by accident. No symptoms or adverse effects at this time. Parent and patient were informed of this incident in clinic by provider.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Mental status changes, Metabolic function test
Clinical narrative: Resident is having altered mental status - labs are being drawn at this time
Age: 61.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Diplopia, Muscle spasms, Neck pain, Paraesthesia oral
Clinical narrative: Patient developed, tingling in her mouth, double vision, pain in back of her neck and muscle spasms on her back a few hours after vaccine administration.  She took Bendaryl OTC, methocarbamol 500 mg and tramadol before she could sleep that night
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Myalgia, Painful respiration
Clinical narrative: Severe muscle aches, including legs, arms, head and neck, shoulders, and chest muscles (which made breathing difficult and painful).  The pain lasted for three days, then gradually disappeared during the next three days, six days total.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Musculoskeletal stiffness
Clinical narrative: bad large area of lower back stiffness and pain.  My back was great before.  It started within a day.  it's been 22 days and still it's somewhat stiff and painful.    I associate it with normal use of EMS based HIIT exercise I did the day before.  It drains me for a few days. I won't be getting vaccines again right after I do EMS.  Could just be a coincidence.
Age: 15.0
Sex: F
Vaccine: HPV9, IPV, TD
Symptoms: Hypotonia, Pallor, Unresponsive to stimuli
Clinical narrative: The client was sitting in the lobby with a translator and was given a drink and candy per her request. Suddenly, she became limp, pale, and nonverbally responsive. She was moved into a recliner and her feet were elevated, airway checked, and vitals were WNL. oxygen was available, sternal rub completed with no reaction, applied cool compress and fan.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Child here with mother to receive immunizations for 7th grade entry. Mom elected for child to receive TDaP and HPV dose #1 in series. Immunizations were given without difficulty and child tolerated. Parent and child were escorted to waiting area to check out and get a copy of immunization record for school. While waiting, public health office assistant yelled the need for a nurse up front and stated child had passed out. Child was standing with mother when nurses arrived on scene. Child and mother were escorted to clinic room and child was laid down and vital signs obtained: BP 104/72, HR 69, Temp 97.9, O2 Sat 98% on RA. Child stated she had not eaten anything today and was given peanut butter and crackers and water. Nurses monitored child for 15 minutes. Child had no visible injuries and color returned to normal when she was escorted back to the front to continue checking out.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Back pain, Death, Endotracheal intubation, Fall, Gait inability
Clinical narrative: Patient had right hand numbness onset 6/13/25 that progressed pain in lower back and bilateral thighs on 6/14/25. Sunday 6/15/25 bilateral feet numbness, lower extremity numbness to the point she could not ambulate and fell. Monday 6/16/25 symptoms progressed to tingling on tongue and Headache to bilateral temporal area. On 6/16/25 she was admitted to hospital. She was started on IVVG 400mg mg/kg/day  x 5 days for Guillain Barre syndrome.  On 6/17/25 she was transferred to ICU due concern for deteriorating respiratory status. On 6/19/25 she was intubated due to worsening respiratory status. On 6/20/25 she was transferred to a higher level of care for Plasmapheresis. Patient died on 7/4/2025 due to severe Guillain Barre Syndrome caused from Pneumonia Vaccine.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy, Intensive care
Clinical narrative: Patient had right hand numbness onset 6/13/25 that progressed pain in lower back and bilateral thighs on 6/14/25. Sunday 6/15/25 bilateral feet numbness, lower extremity numbness to the point she could not ambulate and fell. Monday 6/16/25 symptoms progressed to tingling on tongue and Headache to bilateral temporal area. On 6/16/25 she was admitted to hospital. She was started on IVVG 400mg mg/kg/day  x 5 days for Guillain Barre syndrome.  On 6/17/25 she was transferred to ICU due concern for deteriorating respiratory status. On 6/19/25 she was intubated due to worsening respiratory status. On 6/20/25 she was transferred to a higher level of care for Plasmapheresis. Patient died on 7/4/2025 due to severe Guillain Barre Syndrome caused from Pneumonia Vaccine.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Pain in extremity, Paraesthesia oral, Plasmapheresis, Respiratory distress
Clinical narrative: Patient had right hand numbness onset 6/13/25 that progressed pain in lower back and bilateral thighs on 6/14/25. Sunday 6/15/25 bilateral feet numbness, lower extremity numbness to the point she could not ambulate and fell. Monday 6/16/25 symptoms progressed to tingling on tongue and Headache to bilateral temporal area. On 6/16/25 she was admitted to hospital. She was started on IVVG 400mg mg/kg/day  x 5 days for Guillain Barre syndrome.  On 6/17/25 she was transferred to ICU due concern for deteriorating respiratory status. On 6/19/25 she was intubated due to worsening respiratory status. On 6/20/25 she was transferred to a higher level of care for Plasmapheresis. Patient died on 7/4/2025 due to severe Guillain Barre Syndrome caused from Pneumonia Vaccine.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Administered vaccine to patient. While counseling patient, patient stated she started feeling "lightheaded" and "clammy" , patient then fainted.  We Called 911. We tried to get patient to response.  Patient started to response.. Patient was assessed  and cleared by paramedics.. Pt did not leave by Ambulance
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: customer had swollen arm and redness
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Grip strength decreased, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Peripheral coldness
Clinical narrative: Approx 15 mins after Covid vax administered, pt reported his left arm felt cold and numb, and was harder to move than usual. Was able to perform full ROM of fingers, wrist, elbow and shoulder. 3-4/5 grip strength L hand. No lesion or erythema at injection site. Parents report these symptoms resolved slowly over the next 36 hrs. Today his arm is back to normal except for mild soreness of deltoid muscle with full flexion of arm. Sensation, motor abilities and circulation normal by dad's report today.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash with diffuse border approximately 4" in diameter.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Amnesia, Dyskinesia, Gait disturbance, Immunoglobulin therapy, Mental status changes
Clinical narrative: First time seizure on 6/6/25, the following days patient developed altered mental status, abnormal gait, and right extremity movements. At that time patient was started on Keppra 500 mg BID. Then on 6/18/25 patient had worsening memory loss and abnormal movements. Currently being worked-up for uncontrolled epilepsy vs autoimmune encephalitis. Pt had a Rituxan infusion 7/1 and plan for interval Rituxan out patient as well as monthly IVIG infusions for at least 6mo to prevent relapse. Pt was D/C from hospital on Oxcarbazepine 300mg BID, omeprazole-sodium bicarbonate 10mg BID, Clonazepam 0.5mg and Clonidine 0.1mg at bedtime x 30d days. He has multiple follow ups with specialists set up including Neuro, speech therapy, physical therapy, and occupational therapy.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Seizure
Clinical narrative: First time seizure on 6/6/25, the following days patient developed altered mental status, abnormal gait, and right extremity movements. At that time patient was started on Keppra 500 mg BID. Then on 6/18/25 patient had worsening memory loss and abnormal movements. Currently being worked-up for uncontrolled epilepsy vs autoimmune encephalitis. Pt had a Rituxan infusion 7/1 and plan for interval Rituxan out patient as well as monthly IVIG infusions for at least 6mo to prevent relapse. Pt was D/C from hospital on Oxcarbazepine 300mg BID, omeprazole-sodium bicarbonate 10mg BID, Clonazepam 0.5mg and Clonidine 0.1mg at bedtime x 30d days. He has multiple follow ups with specialists set up including Neuro, speech therapy, physical therapy, and occupational therapy.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt caregiver called stating he got diagnosed with shingles 1 week after having the second vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Bursitis, Gait disturbance, Hypoaesthesia
Clinical narrative: Severe knee pain, swelling both knees.  bursitis and arthritis in both knees. Knees will randomly swell to the pointy of twice the size should be. Hard time walking or bending knees.  Severe pain swelling in shoulders and fingers, wrists. Numbness in legs feet and hands at times.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Severe knee pain, swelling both knees.  bursitis and arthritis in both knees. Knees will randomly swell to the pointy of twice the size should be. Hard time walking or bending knees.  Severe pain swelling in shoulders and fingers, wrists. Numbness in legs feet and hands at times.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Mobility decreased, Muscle spasms, X-ray limb
Clinical narrative: Pt/parent report that pt was given 2 meningitis vaccines into upper left arm on 7/3/2025.  Pt reports left shoulder started to be painful two hours later, then progressed to decreased ROM and arm spasms when gripping items and continues today.          Please note:  I cannot confirm the brand name of the vaccines that were given.  I was unable to complete form with "unknown vaccine".
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Electromyogram abnormal, Hypoaesthesia, Magnetic resonance imaging neck, Muscular weakness, Neuralgic amyotrophy
Clinical narrative: Injection (L) Deltoid - within 24 hrs numbness, sensory loss, weakness (L) arm & hand. Findings consistent with brachial plexitis. Shot in July 2024 with persistent weakness and sensory loss Abnormal EMG
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Sensory loss
Clinical narrative: Injection (L) Deltoid - within 24 hrs numbness, sensory loss, weakness (L) arm & hand. Findings consistent with brachial plexitis. Shot in July 2024 with persistent weakness and sensory loss Abnormal EMG
Sex: M
Vaccine: FLU3, HEPAB, HPV9, MMR, PNC21, FLU3, HEPAB, HPV9, MMR, PNC21
Symptoms: Erythema, Nausea, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: ERYTHEMA; SKIN WARM; PERIPHERAL SWELLING; VOMITING; NAUSEA; TENDERNESS; Information has been received from the Food Drug Administration (FDA) (agency # 2834378-1) on 16-JUN-2025. This spontaneous report refers to a 43-years-old male patient. The patient's medical history and concomitant therapies were not reported. As concurrent conditions were reported diabetes, seizures and hyperlipidemia. On 27-Mar-2025, the patient was vaccinated with the first dose of Pneumococcal 21-valent Conjugate Vaccine(CAPVAXIVE)) (lot #Y019158, expiration date: 20-May-2026), dose number 1, (Dose 1), administered by Intramuscular route in Left Arm; the patient was also vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y007322, expiration date: 18-Aug-2026), dose number 1, (Dose 1), administered by Intramuscular route in Left Arm; with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y013172, expiration date: 31-Jul-2026), dose number 1, (Dose 1), administered by Intramuscular route in Left Arm; with a dose of Hepatitis a vaccine inact;Hepatitis b vaccine rHBsAg (yeast)(TWINRIX) (lot #M4B34) administered by Intramuscular route (expiration date was not reported) and also with a dose of Influenza vaccine inact sAg 3v(45 µg FLUCELVAX) (lot #946620) administered by Intramuscular route (expiration date was not reported). All the five vaccines were administered as prophylaxis. On 28-Mar-2025, the patient experienced redness, swelling, warmth and tenderness in the left arm (for the first few days but this has subsided). He also has had nausea and vomiting for 9 day which was still going on.  At the reporting time, the patient had not recovered from skin warm, peripheral swelling, erythema, vomiting, nausea and tenderness.  The causal relationship between the events of skin warm, peripheral swelling, erythema, vomiting, nausea and tenderness with Pneumococcal 21-valent Conjugate Vaccine(CAPVAXIVE), Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Hepatitis a vaccine inact;Hepatitis b vaccine rHBsAg (yeast)(TWINRIX) and Influenza vaccine inact sAg 3v(45 µg FLUCELVAX) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-06-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2834378-1 , Central date : 2025-06-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: M
Vaccine: FLU3, HEPAB, HPV9, MMR, PNC21, FLU3, HEPAB, HPV9, MMR, PNC21
Symptoms: Vomiting
Clinical narrative: ERYTHEMA; SKIN WARM; PERIPHERAL SWELLING; VOMITING; NAUSEA; TENDERNESS; Information has been received from the Food Drug Administration (FDA) (agency # 2834378-1) on 16-JUN-2025. This spontaneous report refers to a 43-years-old male patient. The patient's medical history and concomitant therapies were not reported. As concurrent conditions were reported diabetes, seizures and hyperlipidemia. On 27-Mar-2025, the patient was vaccinated with the first dose of Pneumococcal 21-valent Conjugate Vaccine(CAPVAXIVE)) (lot #Y019158, expiration date: 20-May-2026), dose number 1, (Dose 1), administered by Intramuscular route in Left Arm; the patient was also vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y007322, expiration date: 18-Aug-2026), dose number 1, (Dose 1), administered by Intramuscular route in Left Arm; with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y013172, expiration date: 31-Jul-2026), dose number 1, (Dose 1), administered by Intramuscular route in Left Arm; with a dose of Hepatitis a vaccine inact;Hepatitis b vaccine rHBsAg (yeast)(TWINRIX) (lot #M4B34) administered by Intramuscular route (expiration date was not reported) and also with a dose of Influenza vaccine inact sAg 3v(45 µg FLUCELVAX) (lot #946620) administered by Intramuscular route (expiration date was not reported). All the five vaccines were administered as prophylaxis. On 28-Mar-2025, the patient experienced redness, swelling, warmth and tenderness in the left arm (for the first few days but this has subsided). He also has had nausea and vomiting for 9 day which was still going on.  At the reporting time, the patient had not recovered from skin warm, peripheral swelling, erythema, vomiting, nausea and tenderness.  The causal relationship between the events of skin warm, peripheral swelling, erythema, vomiting, nausea and tenderness with Pneumococcal 21-valent Conjugate Vaccine(CAPVAXIVE), Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Hepatitis a vaccine inact;Hepatitis b vaccine rHBsAg (yeast)(TWINRIX) and Influenza vaccine inact sAg 3v(45 µg FLUCELVAX) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-06-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2834378-1 , Central date : 2025-06-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Liquid product physical issue, No adverse event
Clinical narrative: No additional AE; An Email/Case was received in the Email to case Queue via interaction 02830005 on 06/30/2025 at 0457ET  containing a question from a consumer sent by a Merck group. GARDASIL 9 was administered  on 06/28/2025 so this case i; The solution appeared clear, whereas the package insert states that the vaccine should be shaken well before use and that it should appear cloudy after shaking; This spontaneous report was received from a patient of unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 28-JUN-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as prophylaxis. However, the patient, noticed that the nurse administered the vaccine without shaking the vial beforehand. It was reported that the solution appeared clear, whereas the package insert states that the vaccine should be shaken well before use and that it should appear cloudy after shaking.   The patient was concerned whether the vaccine was administered correctly and whether it would still be effective under these circumstances and asked on whether the dose needed to be repeated or if any further action was necessary. No additional adverse event reported.  Lot # is being requested and will be submitted if received.