chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC20, RV5
Symptoms: Extra dose administered
Clinical narrative: Pt was given the HIB in error today in addition to the combination Pentacel which includes the HIB. Poison Control was called and no treatments needed.  Mother was notified of the error and informed that the 2nd HIB does not count towards patient's scheduled immunizations.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/No PQC; an expired dose of MMR II was administered to a 4-year-old female patient on 6/16/2025.; This spontaneous report was received from an Other health professional and referres to a 4-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 16-Jun-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X008385, expiration date: 21-Mar-2025) 0.5 mL, for prophylaxis (Expired vaccine used). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). No additional AE.
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: one of our patients they were not sure which of the four others had only the diluent; one of our patients they were not sure which of the four others had only the diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: one of our patients they were not sure which of the four others had only the diluent) and inappropriate dose of vaccine administered (Verbatim: one of our patients they were not sure which of the four others had only the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 10-JUN-2025 and 11-JUN-2025 The reporter was Clinic Administrator and was looking for some guidance.  They had a box of Menveo vaccine and when, he/she had a clinical staff nurse that went to administered the last dose and noticed there were 2 vials of the concentrate, if they would and only one bottle of the diluent in there. So, it appeared that one of our patients they were not sure which of the four others had only the diluent and not the full dosing of the Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. So, he/she was just wondering what recommendations for those four patients and asked if they had to re-vaccinate or what. The reporter did not know the patients information nor when did the patients received the vaccine. 4 Suspected patients. He only provided the lot number of the vaccine. The reporter consented to follow up.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received first dose of vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2025 Patient had done it and still got it.  He/she had received two vaccines and got it right afterward.
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unapproved age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age). The outcome of the inappropriate age at vaccine administration was 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: 13-JUN-2025 One of the medical assistants had administered a DTaP vaccine to a 49 year old patient, which led to Inappropriate age at vaccine administration
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurry visions; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry visions) in a female patient of an unknown age 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 VISION BLURRED (Blurry visions). At the time of the report, VISION BLURRED (Blurry visions) outcome was unknown.            Concomitant medication was not provided.  Patient reported same symptoms as reporter. The patient had eye examination one month prior to vaccination and had no issues with eyes. She experienced symptoms approximately two weeks post-vaccination. Her doctor attributed the condition to the moderna vaccine. She felt like Moderna was responsible for her issue as they were not given any warning, and it was Moderna responsibility to report those side effects to the public.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787613 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787613:Master case (Patient 1)
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes on left side, neck and axillary Pt referred to Allergy and Immunology Tender lymph node area and swelling
Age: 79.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Muscle spasms, Pain, Pain in extremity
Clinical narrative: Pt reported being awakened in the middle of the night the evening after receiving the vaccines by a shooting pain that traveled down the left side of the body down to the foot, with the big toe of that side spasming in a painful upright position. This lasted about 5 minutes, then resolved on its own. This occurred on the same side of the body that the RSV shot had been administered. She was initially concerned about a potential cardiac event until it passed.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Allergy to arthropod bite, Arthralgia, Borrelia test negative, Joint swelling, Rash
Clinical narrative: Left ankle swelling 6/3/25 and then on 6/14/25 seemed to get some insect bites and then developed hive like break out and seemed to worsen - ankle swollen and painful - seen in ER steroids given - lyme titer done - negative. Improved fast. Currently no issues. Dx with urticaria due to insect bites or post viral infection or post hpv reaction.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Streptococcus test negative, Urticaria
Clinical narrative: Left ankle swelling 6/3/25 and then on 6/14/25 seemed to get some insect bites and then developed hive like break out and seemed to worsen - ankle swollen and painful - seen in ER steroids given - lyme titer done - negative. Improved fast. Currently no issues. Dx with urticaria due to insect bites or post viral infection or post hpv reaction.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Coronary arterial stent insertion, Deep vein thrombosis, Depression
Clinical narrative: pt states that when he shows up for work that Monday morning, he had electrical shocking pain down his right leg that was causing terrible pain. He continued to work while hurting but ended up in an ambulance to the ER (redacted) Hospital in (redacted state). He was admitted and spent 3 days in there because his BP was so high but was not treated for the pain in his leg. After being discharged he was told to see his PCP. He went to Medical. Dr. ran some test and given an EMG. The nerve was dead in his right leg from a blood clot. The hematoma hit his sciatic nerve and killed his leg and his leg is dead today.  He is on blood thinner now for the clots. and has DVT.  Had to go to the hospital in (redacted) for a heart attack. Dr. placed 4 stints in his heart. No further treatment. On Jan 19th, 2025, He had to take an ambulance to Hospital in (redacted) for pneumonia.  He had a z-pack and sedative. After being released, he couldn't fill meds because pharmacy was closed so he went back to the ER. They wanted to give him another sedative and send him home. He told them he was not going home. They sent him security vehicle to (redacted) Hospital and is now on mood stabilizers for his mental state from anxiety and depression. He is currently being treated with physicians through (redacted) Health. Currents medications. buspirone 10mg 3x daily, Hydroxyz 25 mg prn x 3 daily, lisinopril 10mg x 1 daily, propranolol 20 mg x 2 daily, mirtazapine 15mg x1 tab daily, abilify 5 mg x1 daily, Lipitor 20mg x 1 daily, Plavix 75mg, Lexapro 20mg x1 daily, depico 500 mg x 2 daily, gabapentin 300 mg x 3 daily, Flomax .4 mg 1 daily.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Electromyogram abnormal, Haematoma, Hypertension, Laboratory test
Clinical narrative: pt states that when he shows up for work that Monday morning, he had electrical shocking pain down his right leg that was causing terrible pain. He continued to work while hurting but ended up in an ambulance to the ER (redacted) Hospital in (redacted state). He was admitted and spent 3 days in there because his BP was so high but was not treated for the pain in his leg. After being discharged he was told to see his PCP. He went to Medical. Dr. ran some test and given an EMG. The nerve was dead in his right leg from a blood clot. The hematoma hit his sciatic nerve and killed his leg and his leg is dead today.  He is on blood thinner now for the clots. and has DVT.  Had to go to the hospital in (redacted) for a heart attack. Dr. placed 4 stints in his heart. No further treatment. On Jan 19th, 2025, He had to take an ambulance to Hospital in (redacted) for pneumonia.  He had a z-pack and sedative. After being released, he couldn't fill meds because pharmacy was closed so he went back to the ER. They wanted to give him another sedative and send him home. He told them he was not going home. They sent him security vehicle to (redacted) Hospital and is now on mood stabilizers for his mental state from anxiety and depression. He is currently being treated with physicians through (redacted) Health. Currents medications. buspirone 10mg 3x daily, Hydroxyz 25 mg prn x 3 daily, lisinopril 10mg x 1 daily, propranolol 20 mg x 2 daily, mirtazapine 15mg x1 tab daily, abilify 5 mg x1 daily, Lipitor 20mg x 1 daily, Plavix 75mg, Lexapro 20mg x1 daily, depico 500 mg x 2 daily, gabapentin 300 mg x 3 daily, Flomax .4 mg 1 daily.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Nerve injury, Pain in extremity, Pneumonia
Clinical narrative: pt states that when he shows up for work that Monday morning, he had electrical shocking pain down his right leg that was causing terrible pain. He continued to work while hurting but ended up in an ambulance to the ER (redacted) Hospital in (redacted state). He was admitted and spent 3 days in there because his BP was so high but was not treated for the pain in his leg. After being discharged he was told to see his PCP. He went to Medical. Dr. ran some test and given an EMG. The nerve was dead in his right leg from a blood clot. The hematoma hit his sciatic nerve and killed his leg and his leg is dead today.  He is on blood thinner now for the clots. and has DVT.  Had to go to the hospital in (redacted) for a heart attack. Dr. placed 4 stints in his heart. No further treatment. On Jan 19th, 2025, He had to take an ambulance to Hospital in (redacted) for pneumonia.  He had a z-pack and sedative. After being released, he couldn't fill meds because pharmacy was closed so he went back to the ER. They wanted to give him another sedative and send him home. He told them he was not going home. They sent him security vehicle to (redacted) Hospital and is now on mood stabilizers for his mental state from anxiety and depression. He is currently being treated with physicians through (redacted) Health. Currents medications. buspirone 10mg 3x daily, Hydroxyz 25 mg prn x 3 daily, lisinopril 10mg x 1 daily, propranolol 20 mg x 2 daily, mirtazapine 15mg x1 tab daily, abilify 5 mg x1 daily, Lipitor 20mg x 1 daily, Plavix 75mg, Lexapro 20mg x1 daily, depico 500 mg x 2 daily, gabapentin 300 mg x 3 daily, Flomax .4 mg 1 daily.
Age: 67.0
Sex: F
Vaccine: MENB
Symptoms: Tremor
Clinical narrative: Patient experienced shaking 3hrs after vaccine was administered
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Gastritis, Imaging procedure abnormal, Large intestinal obstruction
Clinical narrative: 1/6/22 extreme diarrhea, nausea, abdominal pain. Reported to ER. Imaging revealed hundreds of splenic lesions. Admitted and placed on liquid diet. Diarrhea subsided, nausea and abdominal pain remained. Ultimate diagnosis for cause of abdominal pain and nausea was gastritis. No history of gastritis prior. Treated with PPIs, symptoms continue today when stopping medication. GI issues continue including blocked colon during 20204.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Splenic lesion
Clinical narrative: 1/6/22 extreme diarrhea, nausea, abdominal pain. Reported to ER. Imaging revealed hundreds of splenic lesions. Admitted and placed on liquid diet. Diarrhea subsided, nausea and abdominal pain remained. Ultimate diagnosis for cause of abdominal pain and nausea was gastritis. No history of gastritis prior. Treated with PPIs, symptoms continue today when stopping medication. GI issues continue including blocked colon during 20204.
Age: 79.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, pain, redness of injection site.  Told pt they could use IBU for pain and ice for swelling but if it got worse or did not get better they need to go be seen by HCP.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Eye movement disorder, Muscle rigidity
Clinical narrative: During observation period, patient family member called out for help. Patient was found leaning rigidly next to exam bed while being supported by family member. Patient's eyes were rolled back and body was tense and legs were unable to be straightened. After approximately 5 seconds patient opened eyes wide and was heavily breathing. Symptoms resolved but 10 minutes later, patient's left arm was flexed with wrist also flexed in, right arm was semi-flexed, patients head was bent forward, and patient was very stiff and not responding to commands. This lasted approximately 10 seconds. Symptoms completed resolved after 10 minutes and patient was discharged later in stable condition.
Age: 1.5
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was due to receive dose #4 of DTaP series, but instead received a dose of TDaP. Provider, management and pt's mother were all informed. Per CDC guidelines, this TDaP dose DOES count for #4 in DTaP series.  No adverse reactions have occurred/been reported
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the expiration date which was 04/25/2025. Vaccine was given on 04/28/2025
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after it was expired on 04/25/2025. Vaccine given on 04/30/2025
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had already received the RSV vaccine on 2/22/2024 and no other doses were required. An additional dose was administered on 6/18/2025
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Erythema, Irritability, Papule, Pyrexia, Rash
Clinical narrative: Rash of face and trunk. Disseminated 1 mm erythematous papules. Increased fussiness, subjective fever per mother. Otherwise well.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: On May 11, he got an allergic reaction all over his body around 6PM. He complained of being itchy. His skin was red with rash and hives covering his face, neck, torso, arms and legs. Took an antihistamine, which brought the itch down a bit, but had no effect on the rash/hives. On May 12, he saw Dr. who recommended Zyrtec. He took the Zyrtec and symptoms were 90% decreased by that evening. May 13, he was fatigued and continued the Zyrtec. May 14, was fully recovered and continued the Zyrtec. May 15 discontinued Zyrtec. Symptoms did not return.
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: Autologous blood patching, Borrelia test negative, Brain fog, CSF lymphocyte count increased, CSF protein normal
Clinical narrative: Initially had local injection site reaction (common reaction) with regional lymphadenopathy but hen developed what patient described as brain fog and non-vertiginous, one episode of pre-syncopal dizziness followed by non-specific, non-presyncopal, dizziness.  His symptoms persisted although he tried to work, it was interfering with his desk job and was very tired. There were no definite fevers or focal neurological symptoms or headache at time. His arm inflammation responded very nicely to moderate doses of ibuprofen.  He got significantly worse with activity. I followed him closely by phone then saw him in office 5/21 and the arm and regional nodes were essentially resolved back to normal. His exam was reassuring and seemed like a viral syndrome with encephalopathy from YF vaccination. He called 2 days later that he now had headache and I referred to ED for MRI and LP. He looked too well to the ED staff with a normal physical exam and only non-contrast MRI was done which was normal. He was sent home. He felt worse and family encouraged ED visit and this time to another hospital 5/28/25. His exam was reassuring but had LP and revealed CSF pleocytosis. He was seen by Neurology and Inf Dis consultation services and monitored for 24 hrs. CDC was consulted regarding YEL-AND and CSF was sent to CDC. Other tests were done and negative including syphilis.  He had worse  headache that was due to lumbar puncture and was sent home on analgesics. After DC to home he called complaining of ongoing symptoms and HA was not improved and had new back stiffness. I arranged for blood patch and this resolved those symptoms. His dizziness and brain fog persisted and had new peripheral sensory and motor  symptoms and I worried about ADEM and GBS vs anxiety. He went back to our ED and was  admitted for ruled out. He had another neurology consult and contrast brain MRI which was reassuringly normal. There was no meningismus or hallucinations and there were no seizure-like symptoms. Drug screen was negative and EEG was not done. He was discharged home and since has improved
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: CSF white blood cell count increased, Dizziness, Drug screen negative, Fatigue, HIV test negative
Clinical narrative: Initially had local injection site reaction (common reaction) with regional lymphadenopathy but hen developed what patient described as brain fog and non-vertiginous, one episode of pre-syncopal dizziness followed by non-specific, non-presyncopal, dizziness.  His symptoms persisted although he tried to work, it was interfering with his desk job and was very tired. There were no definite fevers or focal neurological symptoms or headache at time. His arm inflammation responded very nicely to moderate doses of ibuprofen.  He got significantly worse with activity. I followed him closely by phone then saw him in office 5/21 and the arm and regional nodes were essentially resolved back to normal. His exam was reassuring and seemed like a viral syndrome with encephalopathy from YF vaccination. He called 2 days later that he now had headache and I referred to ED for MRI and LP. He looked too well to the ED staff with a normal physical exam and only non-contrast MRI was done which was normal. He was sent home. He felt worse and family encouraged ED visit and this time to another hospital 5/28/25. His exam was reassuring but had LP and revealed CSF pleocytosis. He was seen by Neurology and Inf Dis consultation services and monitored for 24 hrs. CDC was consulted regarding YEL-AND and CSF was sent to CDC. Other tests were done and negative including syphilis.  He had worse  headache that was due to lumbar puncture and was sent home on analgesics. After DC to home he called complaining of ongoing symptoms and HA was not improved and had new back stiffness. I arranged for blood patch and this resolved those symptoms. His dizziness and brain fog persisted and had new peripheral sensory and motor  symptoms and I worried about ADEM and GBS vs anxiety. He went back to our ED and was  admitted for ruled out. He had another neurology consult and contrast brain MRI which was reassuringly normal. There was no meningismus or hallucinations and there were no seizure-like symptoms. Drug screen was negative and EEG was not done. He was discharged home and since has improved
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: Headache, Impaired work ability, Inflammation, Injection site reaction, Laboratory test normal
Clinical narrative: Initially had local injection site reaction (common reaction) with regional lymphadenopathy but hen developed what patient described as brain fog and non-vertiginous, one episode of pre-syncopal dizziness followed by non-specific, non-presyncopal, dizziness.  His symptoms persisted although he tried to work, it was interfering with his desk job and was very tired. There were no definite fevers or focal neurological symptoms or headache at time. His arm inflammation responded very nicely to moderate doses of ibuprofen.  He got significantly worse with activity. I followed him closely by phone then saw him in office 5/21 and the arm and regional nodes were essentially resolved back to normal. His exam was reassuring and seemed like a viral syndrome with encephalopathy from YF vaccination. He called 2 days later that he now had headache and I referred to ED for MRI and LP. He looked too well to the ED staff with a normal physical exam and only non-contrast MRI was done which was normal. He was sent home. He felt worse and family encouraged ED visit and this time to another hospital 5/28/25. His exam was reassuring but had LP and revealed CSF pleocytosis. He was seen by Neurology and Inf Dis consultation services and monitored for 24 hrs. CDC was consulted regarding YEL-AND and CSF was sent to CDC. Other tests were done and negative including syphilis.  He had worse  headache that was due to lumbar puncture and was sent home on analgesics. After DC to home he called complaining of ongoing symptoms and HA was not improved and had new back stiffness. I arranged for blood patch and this resolved those symptoms. His dizziness and brain fog persisted and had new peripheral sensory and motor  symptoms and I worried about ADEM and GBS vs anxiety. He went back to our ED and was  admitted for ruled out. He had another neurology consult and contrast brain MRI which was reassuringly normal. There was no meningismus or hallucinations and there were no seizure-like symptoms. Drug screen was negative and EEG was not done. He was discharged home and since has improved
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: Lymphadenopathy, Magnetic resonance imaging head normal, Musculoskeletal stiffness, Neurological symptom, Pleocytosis
Clinical narrative: Initially had local injection site reaction (common reaction) with regional lymphadenopathy but hen developed what patient described as brain fog and non-vertiginous, one episode of pre-syncopal dizziness followed by non-specific, non-presyncopal, dizziness.  His symptoms persisted although he tried to work, it was interfering with his desk job and was very tired. There were no definite fevers or focal neurological symptoms or headache at time. His arm inflammation responded very nicely to moderate doses of ibuprofen.  He got significantly worse with activity. I followed him closely by phone then saw him in office 5/21 and the arm and regional nodes were essentially resolved back to normal. His exam was reassuring and seemed like a viral syndrome with encephalopathy from YF vaccination. He called 2 days later that he now had headache and I referred to ED for MRI and LP. He looked too well to the ED staff with a normal physical exam and only non-contrast MRI was done which was normal. He was sent home. He felt worse and family encouraged ED visit and this time to another hospital 5/28/25. His exam was reassuring but had LP and revealed CSF pleocytosis. He was seen by Neurology and Inf Dis consultation services and monitored for 24 hrs. CDC was consulted regarding YEL-AND and CSF was sent to CDC. Other tests were done and negative including syphilis.  He had worse  headache that was due to lumbar puncture and was sent home on analgesics. After DC to home he called complaining of ongoing symptoms and HA was not improved and had new back stiffness. I arranged for blood patch and this resolved those symptoms. His dizziness and brain fog persisted and had new peripheral sensory and motor  symptoms and I worried about ADEM and GBS vs anxiety. He went back to our ED and was  admitted for ruled out. He had another neurology consult and contrast brain MRI which was reassuringly normal. There was no meningismus or hallucinations and there were no seizure-like symptoms. Drug screen was negative and EEG was not done. He was discharged home and since has improved
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: Presyncope, Scan with contrast normal, Syphilis test negative
Clinical narrative: Initially had local injection site reaction (common reaction) with regional lymphadenopathy but hen developed what patient described as brain fog and non-vertiginous, one episode of pre-syncopal dizziness followed by non-specific, non-presyncopal, dizziness.  His symptoms persisted although he tried to work, it was interfering with his desk job and was very tired. There were no definite fevers or focal neurological symptoms or headache at time. His arm inflammation responded very nicely to moderate doses of ibuprofen.  He got significantly worse with activity. I followed him closely by phone then saw him in office 5/21 and the arm and regional nodes were essentially resolved back to normal. His exam was reassuring and seemed like a viral syndrome with encephalopathy from YF vaccination. He called 2 days later that he now had headache and I referred to ED for MRI and LP. He looked too well to the ED staff with a normal physical exam and only non-contrast MRI was done which was normal. He was sent home. He felt worse and family encouraged ED visit and this time to another hospital 5/28/25. His exam was reassuring but had LP and revealed CSF pleocytosis. He was seen by Neurology and Inf Dis consultation services and monitored for 24 hrs. CDC was consulted regarding YEL-AND and CSF was sent to CDC. Other tests were done and negative including syphilis.  He had worse  headache that was due to lumbar puncture and was sent home on analgesics. After DC to home he called complaining of ongoing symptoms and HA was not improved and had new back stiffness. I arranged for blood patch and this resolved those symptoms. His dizziness and brain fog persisted and had new peripheral sensory and motor  symptoms and I worried about ADEM and GBS vs anxiety. He went back to our ED and was  admitted for ruled out. He had another neurology consult and contrast brain MRI which was reassuringly normal. There was no meningismus or hallucinations and there were no seizure-like symptoms. Drug screen was negative and EEG was not done. He was discharged home and since has improved
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Erythema, Flushing, Pruritus, Rash
Clinical narrative: Patient reported back to the clinic after 45 minutes of being vaccinated. Facial flushing, itching, localized rash, hives and redness, slight dizziness. Patient A/O x10;NKA; stable, and no breathing difficulties. Cold compress implemented on the face to reduce inflammation and pain; cetirizine 10mg  administered, and blood pressure monitored. Patient monitored for 45 minutes, was  stable, swelling, itching, hives, and redness reduced, pt. voiced "I feel better, thank you" Patient educated and encourage to monitor flushing and itching and report to urgent care if needed.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Patient reported back to the clinic after 45 minutes of being vaccinated. Facial flushing, itching, localized rash, hives and redness, slight dizziness. Patient A/O x10;NKA; stable, and no breathing difficulties. Cold compress implemented on the face to reduce inflammation and pain; cetirizine 10mg  administered, and blood pressure monitored. Patient monitored for 45 minutes, was  stable, swelling, itching, hives, and redness reduced, pt. voiced "I feel better, thank you" Patient educated and encourage to monitor flushing and itching and report to urgent care if needed.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Blood iron, Fatigue, Full blood count, Lipase, Metabolic function test
Clinical narrative: She had nausea, vomiting and extreme fatigue starting a few days after the vaccine was given
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Vomiting
Clinical narrative: She had nausea, vomiting and extreme fatigue starting a few days after the vaccine was given
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Dizziness, Fatigue, Nausea
Clinical narrative: After vaccination patient experienced dizziness, fatigue, and intermittent nausea and anxiety related to these symptoms. She denied trouble breathing, trouble swallowing, rash, or itchiness. She says this started about 15 minutes following vaccination but was not reported to anyone until about an hour following vaccination.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Affect lability, Anxiety, Crying, Personality change
Clinical narrative: Per Mom eight hours after the vaccines were administered the patient started crying, which continued for another 3 weeks. The parents also noticed abrupt changes in her personality, there was a significant emotional liability and severe anxiety that was not present prior to the vaccines. This required multiple therapy appointments and has recently  been prescribed medication to help with the mental changes.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was supposed to get Dtap and was given Tdap. Parents notified right after event and told to watch for fever or other concerns. Nurse spoke with patient about 30 minutes after immunization and no adverse side effects noted.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: EE contacted this nurse to report she experienced post Hep B vaccine arm swelling to injection site and had red and itchiness to site. States she got the itching to her whole body for a couple of days. Reports she took benadryl and that helped clear it up on 6/14/25.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: A patient came by this am on 6/20/2025 to show me her arm from a shingles shot she got on 6/12/25.  There was a 6 inch pinkish patch from the mid-deltoid halfway to her elbow that started the evening of 6/12/2025 and next morning.  She said it was itching but otherwise not bothersome.  Patient was advised that the second shot was not advisable and that she might try Benadryl and a itch cream like Benadryl cream or hydrocortisone.  She said she's been putting Cerave on it and that helped the itching.
Age: 20.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Confusional state, Disorientation, Dizziness, Gaze palsy, Laboratory test
Clinical narrative: Patient stood up from the vaccine administration area, walked to the counter to obtain the paperwork and then looked at me and said, ?am I pale? I think I?m going to pass out.? She then crumpled into my arms. I took her to the ground ? her eyes were rolled back in her head. I tried to wake her. She then had a small convulsion/seizure.  When she awoke she was confused and disoriented.
Age: 20.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Seizure
Clinical narrative: Patient stood up from the vaccine administration area, walked to the counter to obtain the paperwork and then looked at me and said, ?am I pale? I think I?m going to pass out.? She then crumpled into my arms. I took her to the ground ? her eyes were rolled back in her head. I tried to wake her. She then had a small convulsion/seizure.  When she awoke she was confused and disoriented.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The medical assistant administered Dtap instead of Tdap. Corrective action has been taken. Education provided.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Headache, Immediate post-injection reaction
Clinical narrative: Patient stated immediately after the vaccine he developed a headache and later felt a little weak. He denied dizziness, feeling faint, shortness of breath, difficulty breathing. Patient's BP was 135/77 and HR 77 taken by pharmacist. Patient refused to lie down and refused ambulance. He was planning to go back to urgent care who directed him to receive vaccine, stated as soon as he got to his car was already feeling better.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 3rd Tdap was given too early. No known adverse effects.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient administered Bexsero at well child check in February. Mother informed office in June she noticed on patients medical records that the patient was administered Bexsero instead of Menveo.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes decreased, Blood glucose increased, Fatigue, Gastrooesophageal reflux disease, Glycosylated haemoglobin increased
Clinical narrative: Blurred vision, increased thirst. Followed two months later by weight loss, exhaustion and acid reflux. Followed three months later by increased weight loss, unquenchable thirst, constant exhaustion and severe acid reflux. Urgent care visit showed BG level of 600+. immediate hospitalization determined depleted electrolytes and A1C of 14. Test results determined diagnosis of type 1 diabetes.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thirst, Type 1 diabetes mellitus, Vision blurred, Weight decreased
Clinical narrative: Blurred vision, increased thirst. Followed two months later by weight loss, exhaustion and acid reflux. Followed three months later by increased weight loss, unquenchable thirst, constant exhaustion and severe acid reflux. Urgent care visit showed BG level of 600+. immediate hospitalization determined depleted electrolytes and A1C of 14. Test results determined diagnosis of type 1 diabetes.
Age: 45.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: She reported on 06/18/2025 that a few hours after she received the Typhoid vaccine during her travel medicine appt. she developed a headache, 101 fever, body aches and shoulder/neck pain that was bilateral but worse on her left side. Pt states she took Tylenol and the symptoms resolved within a few hours. Pt reports she has had Typhoid vaccine several times in the past and has never had a reaction before this. She reports all symptoms resolved and have not returned.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Gait inability, Joint swelling
Clinical narrative: Soreness in arm for several days after shot.  Approximately 6 or 7 months after the shot l was feeling very fatique and simply had no energy.  I noticed l had swelling in my left calf and ankle but it wasn't really causing much pain until one night l woke up with pain and swelling and couldn't walk.  Contacted Dr. at that point.  Dr. sent me to get an Ultrasound and a 23 inch blood clot was confirmed.  Been on 20 MG Xarelto ever since.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Soreness in arm for several days after shot.  Approximately 6 or 7 months after the shot l was feeling very fatique and simply had no energy.  I noticed l had swelling in my left calf and ankle but it wasn't really causing much pain until one night l woke up with pain and swelling and couldn't walk.  Contacted Dr. at that point.  Dr. sent me to get an Ultrasound and a 23 inch blood clot was confirmed.  Been on 20 MG Xarelto ever since.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: AFTER RECEIVING THE VACCINES, SHE WAS DIZZY AND LIGHT-HEADED. SHE FAINTED IN THE WAITING ROOM. THE EPISODE LASTED ABOUT 60 SECONDS.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Laboratory test normal
Clinical narrative: I became very dizzy and I'm never dizzy.    I waited from Sunday to Wednesday and then went to urgent care--MD who did a full neurological work up. They said that they couldn't be sure it was from the vaccine though I read several studies indicating that it was a lesser known side-effect. It would have been helpful to be aware of that as it is not on the main sheets of information
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: PATIENT RECIVED THE VACCINE SO HIGH IN THE SHOULDE THAT SHE COULDNT MOVE HER ARM FOR 2 DAYS AND SHE STILL HAVE SHOULDER PAIN
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives that started 2 hours after the vaccine was given and are expaning to the rest of the body, pruritic, she was prescribed cetirizine, Hydrocortisone 1% topical as needed and benadryl as needed
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: The vaccination administration itself went well but then the patient reported he had a lot of arm pain and loss of arm strength. He reported this to us at the pharmacy on 6/18/2025. At this time we found out the patient had already gone to his doctor and received prednisone  for his reaction but he did not report much relief on 6/202/2025 when he finally called me back to discuss.
Age: 75.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event noted, patient is doing well reports no soreness. Injection was given IM vs approved SQ route
Age: 69.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Acute kidney injury, Blood creatinine increased, Chromaturia, Haematuria, Headache
Clinical narrative: Fever (high as 102.3F), body aches, headache, injection site soreness and gross hematuria with pyuria and AKI.
Age: 69.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Injection site pain, Pain, Protein urine present, Pyrexia, Pyuria
Clinical narrative: Fever (high as 102.3F), body aches, headache, injection site soreness and gross hematuria with pyuria and AKI.
Age: 69.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Urine abnormality, White blood cells urine positive
Clinical narrative: Fever (high as 102.3F), body aches, headache, injection site soreness and gross hematuria with pyuria and AKI.
Age: 69.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Acute kidney injury, Back pain, Bacterial test positive, Blood creatinine normal, Blood urine present
Clinical narrative: Fever (high as 102.3F), body aches, headache, injection site soreness and gross hematuria with pyuria and AKI.
Age: 69.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Chromaturia, Condition aggravated, Haematuria, Headache, Injection site pain
Clinical narrative: Fever (high as 102.3F), body aches, headache, injection site soreness and gross hematuria with pyuria and AKI.
Age: 69.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Pain, Protein urine present, Pyrexia, Pyuria, Urinary squamous epithelial cells increased
Clinical narrative: Fever (high as 102.3F), body aches, headache, injection site soreness and gross hematuria with pyuria and AKI.
Age: 5.0
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: TDAP vaccine was inadvertently administered instead of DTAP.No adverse reactions noted.DTAP vaccine administered as indicated in clinic same day no adverse reactions to either vaccine
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling
Clinical narrative: Arm swelling on the site of injection left deltoid; treatment: apply cold compress, maintain hygiene, Tylenol PRN q4h for pain, advised to return if no improvement.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: Patient received his first Trumenba at his well visit today. Shortly after receiving is vaccine he said he felt dizzy and like he was going to faint. He became pale, diaphoretic, complained of changes to his vision and then lost consciousness and became very stiff. He was laid on exam table by parent, and two nurses. MD notified and came to bedside to assess. BP/HR obtained. Patient came to without intervention after a couple of minutes. After he regained consciousness, he was given a popsicle, granola bar, and water.  He was repositioned to recheck blood pressure when sitting and again became nauseated and feeling faint. He was laid back down on exam table with legs elevated. After several minutes he was able to sit on the edge of the table and BP was reassessed and was normal with normal HR.  He denied any feelings of nausea or visual changes/feelings of being faint. He was then able to leave the exam room and office in the care of his mother.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Visual impairment
Clinical narrative: Patient received his first Trumenba at his well visit today. Shortly after receiving is vaccine he said he felt dizzy and like he was going to faint. He became pale, diaphoretic, complained of changes to his vision and then lost consciousness and became very stiff. He was laid on exam table by parent, and two nurses. MD notified and came to bedside to assess. BP/HR obtained. Patient came to without intervention after a couple of minutes. After he regained consciousness, he was given a popsicle, granola bar, and water.  He was repositioned to recheck blood pressure when sitting and again became nauseated and feeling faint. He was laid back down on exam table with legs elevated. After several minutes he was able to sit on the edge of the table and BP was reassessed and was normal with normal HR.  He denied any feelings of nausea or visual changes/feelings of being faint. He was then able to leave the exam room and office in the care of his mother.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Pt is 37w pregnant. She was accidentally scheduled on the RN schedule for fetal monitoring and labeled as a 28 week pregnant patient. A tdap was given to the pt this day, as routinely done with 28 week appts. After further discussion, the patient and I were confused on dates while scheduling follow-up pregnancy appts, at which time she realized she was not 28 weeks and we together realized she is 37 weeks. She said she was confused as well and when double checking the immunization record, it was then discovered that she had already had her 28 week appt and tdap vaccine on April 11, 2025.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: pt had injection in office. Two days after injection mother called in stating the pt had a read area around injection site. Mother brought pt in for nurse visit. Injection site was red, warm to the touch, raised. Symptoms contained to R upper arm.  PCP assessed area and informed pt to take OTC allergy medication, can use OTC anti-itch cream and continue to monitor area.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Induration, Injection site vesicles, Skin warm
Clinical narrative: The patient states that her arm became red as soon as she received the vaccine and was hot.  It has been 2 weeks since her vaccination and her arm is still red, hard, and starting to blister at the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Crying, Hypotonia, Pallor, Unresponsive to stimuli
Clinical narrative: The client, sitting on her mom s lap talking approximately five minutes after receiving vaccinations, suddenly became limp, unresponsive to verbal stimuli and color to face was ashen. Client was gently lowered to the floor lying on her back. Sternal rubs were done, and the client responded by opening her eyes and crying for her mother. Client was transferred on to a mat, feet elevated above her heart and a cool compress was applied to her forehead and neck. Once the client was able to answer questions appropriately and sit upright without any assistance, she was given orange juice which she took several sips without any problems. Client monitored for 30 minutes after adverse. No further adverse issues were noted and no complaints were voiced. Color with pink. Mother instructed to 1. notify client s primary care physician of adverse reaction to vaccines and follow up with primary care physician or go to the ER for any adverse changes in condition 2. Make sure client eats something soon as she leaves the clinic 3. with future vaccinations make sure healthcare provider is aware of possible adverse reaction. Mom verbalized understanding to instructions and felt comfortable with taking child home. Client is alert, oriented x3 and able to walk on her own without any issues.
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: red, hot painful arm; red, hot painful arm; red, hot painful arm; Information has been received from the Food and Drug Administration (FDA) (agency number 2836907-1). This spontaneous report refers to a 65-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-Apr-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), lot #Y019158, expiration date: 20-May-2026, administered by intramuscular route in the left arm for prophylaxis; and with Shingrix (Varicella zoster vaccine rgE (CHO)), lot #EK225, administered by intramuscular route (indication and expiration date were not reported).  On 17-Apr-2025, the patient experienced red, hot painful arm (Skin warm, Pain in extremity, Erythema). On an unspecified date the patient recovered from the event of red, hot painful arm.   The causal relationship between the events and the suspect therapies was not provided.