chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Neck pain
Clinical narrative: Bell's palsy; Left side facial paralysis; Severe headache; Pain on left side of neck; She couldn't test; Couldn't blink her left eye; This spontaneous case, initially received on 29-Oct-2024 including additional information received on 29-OCT-2024, was reported by a non health professional and concerns an adult female patient.  At the time of the event the patient had High blood pressure, Asthma.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 21-Oct-2024, the patient received Flucelvax (TIV) for Flu vaccination, Influenza immunisation, Dose regimen: 0.5 ml, route of administration: not reported; Lot number: 946616. batch number reported as 946616. CSL Seqirus Batch number unable to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Oct-2024, the patient experienced Pain on left side of neck (outcome: Not recovered / Not resolved). On 22-Oct-2024, the patient experienced Bell's palsy (Medically Significant, Hospitalized, outcome: Not recovered / Not resolved). Associated symptoms included: Left side facial paralysis, Severe headache, She couldn't test, Couldn't blink her left eye.  Consumer reported she came down with Bell's Palsy. The day after the vaccination she experienced severe headache and pain on left side of neck. Symptoms progressively got worse and she could not taste or blink her left eye. Her left side of her face was. She initially thought she was having a stroke. She went to ER on Saturday 26-ct-2024 and stroke was ruled out. They stated symptoms were related to flu vaccine.  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Prednisone 50 mg  Reporter's assessment: The reporter considered the event(s) Bell's palsy and Pain on left side of neck related to the administration of Flucelvax (TIV) and considered events as non-serious.  Case correction (29-Oct-2024) upon internal review some changes were required so the event stroke was deleted , as it is mentioned that stroke is- ruled out. And the event facial paralysis, headache, couldn't taste and couldn't blink were assessed as symptoms of bell's palsy.; Reporter's Comments: Causality: Related for Bell's palsy and neck pain considering plausible temporal relationship (1 day after vaccination). Brighton collaboration criteria is assessed as level 4 due to insufficient information provided.
Sex: F
Vaccine: FLUX
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Babinski reflex test, Central nervous system lesion, Decreased nasolabial fold
Clinical narrative: Acute disseminated encephalomyelitis; Lethargy; Fever; Weakness; Headache; Multiple episodes of vomiting; Difficulty speaking; Drooling; Irritable; Difficulty walking; This literature report (Initial receipt: 29-Oct-2024) concerns an child female presented with lethargy, fever, and weakness 2 weeks after receiving the influenza vaccine (trade name, manufacturer and lot number not reported - to be requested upon follow up).  Five days after receiving the vaccine, she developed fever, headache, and multiple episodes of vomiting. Over the course of the next week, the patient had some episodes of difficulty speaking, became more lethargic, and refused oral intake. On the day before admission, the patient began drooling and became more irritable. Upon admission, she was afebrile; however, she developed right facial and arm weakness and also had difficulty walking. On physical examination, the patient was still drooling and irritable. She had a decreased right nasolabial fold but was able to wrinkle her forehead. She had a slow and narrow based gait. Her arms were flexed but were able to extend when prompted. Extraocular muscles were intact, tongue was midline, strength and sensation were intact, and deep tendon reflexes were 2+ with a negative Babinski reflex. Initial MRI (Magnetic Resonance Imaging) of the brain revealed numerous amorphous and rounded, slightly expansive, non enhancing lesions in the cerebral hemispheres and brainstem. She was treated with high-dose steroids with resolution of her symptoms. During admission, the patient had several episodes of seizure that persisted even after her other symptoms resolved. Follow-up MRI without contrast performed 1month after initial presentation showed near resolution of the abnormal signal besides some residual abnormalities in the left occipital lobe.  Author comments: Acute Disseminated Encephalomyelitis (ADEM) was analyzed. Interestingly, patients in cases 2, 3, and 5 to 7 consistently presented in an immunocompromised state; either having overcome a recent viral-like illness, currently experiencing an episode of a febrile illness or, less commonly, postvaccination.; Reporter's Comments: Causality: Related for event considering plausible temporal relationship (symptoms started 5 days after vaccination). Brighton collaboration criteria is assessed as level 3 as symptoms provided.
Sex: F
Vaccine: FLUX
Symptoms: Drooling, Dysarthria, Facial paresis, Food refusal, Gait disturbance
Clinical narrative: Acute disseminated encephalomyelitis; Lethargy; Fever; Weakness; Headache; Multiple episodes of vomiting; Difficulty speaking; Drooling; Irritable; Difficulty walking; This literature report (Initial receipt: 29-Oct-2024) concerns an child female presented with lethargy, fever, and weakness 2 weeks after receiving the influenza vaccine (trade name, manufacturer and lot number not reported - to be requested upon follow up).  Five days after receiving the vaccine, she developed fever, headache, and multiple episodes of vomiting. Over the course of the next week, the patient had some episodes of difficulty speaking, became more lethargic, and refused oral intake. On the day before admission, the patient began drooling and became more irritable. Upon admission, she was afebrile; however, she developed right facial and arm weakness and also had difficulty walking. On physical examination, the patient was still drooling and irritable. She had a decreased right nasolabial fold but was able to wrinkle her forehead. She had a slow and narrow based gait. Her arms were flexed but were able to extend when prompted. Extraocular muscles were intact, tongue was midline, strength and sensation were intact, and deep tendon reflexes were 2+ with a negative Babinski reflex. Initial MRI (Magnetic Resonance Imaging) of the brain revealed numerous amorphous and rounded, slightly expansive, non enhancing lesions in the cerebral hemispheres and brainstem. She was treated with high-dose steroids with resolution of her symptoms. During admission, the patient had several episodes of seizure that persisted even after her other symptoms resolved. Follow-up MRI without contrast performed 1month after initial presentation showed near resolution of the abnormal signal besides some residual abnormalities in the left occipital lobe.  Author comments: Acute Disseminated Encephalomyelitis (ADEM) was analyzed. Interestingly, patients in cases 2, 3, and 5 to 7 consistently presented in an immunocompromised state; either having overcome a recent viral-like illness, currently experiencing an episode of a febrile illness or, less commonly, postvaccination.; Reporter's Comments: Causality: Related for event considering plausible temporal relationship (symptoms started 5 days after vaccination). Brighton collaboration criteria is assessed as level 3 as symptoms provided.
Sex: F
Vaccine: FLUX
Symptoms: Headache, Irritability, Lethargy, Magnetic resonance imaging head abnormal, Muscular weakness
Clinical narrative: Acute disseminated encephalomyelitis; Lethargy; Fever; Weakness; Headache; Multiple episodes of vomiting; Difficulty speaking; Drooling; Irritable; Difficulty walking; This literature report (Initial receipt: 29-Oct-2024) concerns an child female presented with lethargy, fever, and weakness 2 weeks after receiving the influenza vaccine (trade name, manufacturer and lot number not reported - to be requested upon follow up).  Five days after receiving the vaccine, she developed fever, headache, and multiple episodes of vomiting. Over the course of the next week, the patient had some episodes of difficulty speaking, became more lethargic, and refused oral intake. On the day before admission, the patient began drooling and became more irritable. Upon admission, she was afebrile; however, she developed right facial and arm weakness and also had difficulty walking. On physical examination, the patient was still drooling and irritable. She had a decreased right nasolabial fold but was able to wrinkle her forehead. She had a slow and narrow based gait. Her arms were flexed but were able to extend when prompted. Extraocular muscles were intact, tongue was midline, strength and sensation were intact, and deep tendon reflexes were 2+ with a negative Babinski reflex. Initial MRI (Magnetic Resonance Imaging) of the brain revealed numerous amorphous and rounded, slightly expansive, non enhancing lesions in the cerebral hemispheres and brainstem. She was treated with high-dose steroids with resolution of her symptoms. During admission, the patient had several episodes of seizure that persisted even after her other symptoms resolved. Follow-up MRI without contrast performed 1month after initial presentation showed near resolution of the abnormal signal besides some residual abnormalities in the left occipital lobe.  Author comments: Acute Disseminated Encephalomyelitis (ADEM) was analyzed. Interestingly, patients in cases 2, 3, and 5 to 7 consistently presented in an immunocompromised state; either having overcome a recent viral-like illness, currently experiencing an episode of a febrile illness or, less commonly, postvaccination.; Reporter's Comments: Causality: Related for event considering plausible temporal relationship (symptoms started 5 days after vaccination). Brighton collaboration criteria is assessed as level 3 as symptoms provided.
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Reflex test normal, Seizure, Vomiting
Clinical narrative: Acute disseminated encephalomyelitis; Lethargy; Fever; Weakness; Headache; Multiple episodes of vomiting; Difficulty speaking; Drooling; Irritable; Difficulty walking; This literature report (Initial receipt: 29-Oct-2024) concerns an child female presented with lethargy, fever, and weakness 2 weeks after receiving the influenza vaccine (trade name, manufacturer and lot number not reported - to be requested upon follow up).  Five days after receiving the vaccine, she developed fever, headache, and multiple episodes of vomiting. Over the course of the next week, the patient had some episodes of difficulty speaking, became more lethargic, and refused oral intake. On the day before admission, the patient began drooling and became more irritable. Upon admission, she was afebrile; however, she developed right facial and arm weakness and also had difficulty walking. On physical examination, the patient was still drooling and irritable. She had a decreased right nasolabial fold but was able to wrinkle her forehead. She had a slow and narrow based gait. Her arms were flexed but were able to extend when prompted. Extraocular muscles were intact, tongue was midline, strength and sensation were intact, and deep tendon reflexes were 2+ with a negative Babinski reflex. Initial MRI (Magnetic Resonance Imaging) of the brain revealed numerous amorphous and rounded, slightly expansive, non enhancing lesions in the cerebral hemispheres and brainstem. She was treated with high-dose steroids with resolution of her symptoms. During admission, the patient had several episodes of seizure that persisted even after her other symptoms resolved. Follow-up MRI without contrast performed 1month after initial presentation showed near resolution of the abnormal signal besides some residual abnormalities in the left occipital lobe.  Author comments: Acute Disseminated Encephalomyelitis (ADEM) was analyzed. Interestingly, patients in cases 2, 3, and 5 to 7 consistently presented in an immunocompromised state; either having overcome a recent viral-like illness, currently experiencing an episode of a febrile illness or, less commonly, postvaccination.; Reporter's Comments: Causality: Related for event considering plausible temporal relationship (symptoms started 5 days after vaccination). Brighton collaboration criteria is assessed as level 3 as symptoms provided.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Asthenia, Erythema, Fatigue, Gait inability, Myalgia
Clinical narrative: Muscle pain in entire body, Hives in entire body, weakness, could/t walk, fatigue, red swollen upper arm. Patient took tylenol, naproxen, allegra, claritin, and pepcid. the severe symptoms lasted 4 days, she still has muscle pain and weakness 2 weeks later when this report is being sent.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Muscle pain in entire body, Hives in entire body, weakness, could/t walk, fatigue, red swollen upper arm. Patient took tylenol, naproxen, allegra, claritin, and pepcid. the severe symptoms lasted 4 days, she still has muscle pain and weakness 2 weeks later when this report is being sent.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Hyperhidrosis, Syncope
Clinical narrative: Patient had syncope, sweat and disorientation after the vaccines . It happened after 1 minutes of administration and the patient experienced for 5-10 minutes after the administration
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Herpes zoster, Pain, Pruritus
Clinical narrative: I developed a case of shingles on the morning of 11/08/2024. (I am familiar with the disease, because I have previously experienced cases of shingles. No treatment, just wait it out. Chills, aching itch on left side above waist line, fever (99.8), fatigue.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I developed a case of shingles on the morning of 11/08/2024. (I am familiar with the disease, because I have previously experienced cases of shingles. No treatment, just wait it out. Chills, aching itch on left side above waist line, fever (99.8), fatigue.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Hypersomnia, Loss of consciousness, Pallor
Clinical narrative: Patient was given Meningococcal B. After administration, patient noted that he was feeling faint, and he passed out after applying bandaid to the arm. He appeared palor in color and was not responsive to my questions. After about 10-15 seconds, he came back to and was responsive. He was able to verify where he was, and what happened. Father, present in the clinic, and I brought him back to the room and notified him of syncope episode. Vitals were gathered and WNL for Patient. Patient waited in exam room for 20 minutes after episode for observation. VIS provided to patient. Pt felt very tired and slightly dizzy as well. He did not drive home. Father later called back on 11/7/24 night saying he had an episode of dry heaving on the way home and was sleeping a lot more than normal and had one episode of clear emesis.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Retching, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient was given Meningococcal B. After administration, patient noted that he was feeling faint, and he passed out after applying bandaid to the arm. He appeared palor in color and was not responsive to my questions. After about 10-15 seconds, he came back to and was responsive. He was able to verify where he was, and what happened. Father, present in the clinic, and I brought him back to the room and notified him of syncope episode. Vitals were gathered and WNL for Patient. Patient waited in exam room for 20 minutes after episode for observation. VIS provided to patient. Pt felt very tired and slightly dizzy as well. He did not drive home. Father later called back on 11/7/24 night saying he had an episode of dry heaving on the way home and was sleeping a lot more than normal and had one episode of clear emesis.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Pneumonia, Productive cough, Wheezing
Clinical narrative: My dad received the vaccination the morning of 10/30, after lunch he had developed a wet cough and was wheezing. The day before on 10/29 the hospice nurse had visited him, and he was doing fine. We got the x-ray report back the night of 10/30 and he was developing pneumonia.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Today, Pt noticed some redness, itching and swelling on his right upper arm where he received his vaccine.  He came back to the clinic and received an ice pack after hydrocortisone cream was applied to the area.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neck pain, Pain
Clinical narrative: Crick in  left/right sides of neck with pain upon turning head.  I took Tylenol to ease pain.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse events noted
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Potentially a third dose given. Processed vaccine and gave on 11/8/24, and due to a miscommunication, vaccination was declined by insurance as exceeding lifetime dose. Company stated that patient needed a second covid vaccination, and was also told by her doctor to come in. After calling agency, they stated that a paid claim happened at a pharmacy, but no records were found of such an event and the RX number given by agency did not pull up anything. There may have been a reversal which was never captured by agency, as they are convinced only one was given in august of this year. There has not been any adverse reaction, and this may not even be the third dose. I just wanted to submit this in the event that anything does occur regarding the one given on 11/8/24.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None noted
Age: 1.08
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: The medical assistant giving the vaccines confused MCV4 with MMR.  MCV4 was given to this 13-month-old instead of MMR.  We consulted with one of our physician assistants and he advised us to call mother of child and tell her that if the child develops a fever or any other reaction over the weekend to take him to the ER.  We contacted the mother of the child and informed her.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Patient received 4 vaccines on 10/12/24, Fluzone high dose, Abrysvo, Prevnar 20, and Novovax (2 in each arm).  She states that she has been having right shoulder pain since receiving the vaccines. She received both the Fluzone high dose and Abrysvo in this arm. The Fluzone was given above the Abrysvo.   She spoke to her roommate who she describes as  a "doctor" who told her it could be bursitis given recent vaccines, but has not been to her regular physician for diagnosis.  Patient states she has been using Meloxicam that she had received prior to the vaccines to control her pain.  She states the pain bothers her mostly at night.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Lymphadenopathy, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Had the vaccine at the same time in same arm as prevnar20  (pneumonia) - So not sure which caused what -- but they should NOT be taken together!! Lots of pain and swelling in arm for 4 days, pain in all joints, swelling of all lymph nodes,  racking pain throughoutt my body like I would imagine very bad arthritis to be, then my chest and throat started swelling and feeling scratchy as if I had some bad bronchial infection - but different. I could tell it was something to do with the vaccines. On the 5th day, as I was planning to go to the emergency room, it tarted getting better.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal swelling, Swelling, Throat irritation
Clinical narrative: Had the vaccine at the same time in same arm as prevnar20  (pneumonia) - So not sure which caused what -- but they should NOT be taken together!! Lots of pain and swelling in arm for 4 days, pain in all joints, swelling of all lymph nodes,  racking pain throughoutt my body like I would imagine very bad arthritis to be, then my chest and throat started swelling and feeling scratchy as if I had some bad bronchial infection - but different. I could tell it was something to do with the vaccines. On the 5th day, as I was planning to go to the emergency room, it tarted getting better.
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient got dose 1 of Gardasil 9. The patient DID NOT have an adverse reaction. Patient was 46 years old at the time and there was no indication patient needed the vaccine after the age of 45. Vaccine given in error. Patient had no side effects from receiving the vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: patient's arm is red and swollen, painful and itchy
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: joint pain in wrists, shoulders, knees. No joint swelling. Sister has similar symptoms.  Mother was recently diagnosed with arthritis.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Muscular weakness, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: joint pains in wrists, elbows, shoulders, hips, knees, ankles. Sometimes feels weak, can't hold a pencil. No swelling, nontender to palpation.  Sister has similar joint complaints. Mother was recently diagnosed with arthritis.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had no adverse effects.   Patient was administered a second dose of the same flu vaccine in the same season.  First dose of Fluad was administered 8/24/24.  Second Fluad dose was given 11/6/2024.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu symptoms
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Cough, Peripheral swelling, Rash pruritic, Urticaria
Clinical narrative: itchy rash that has mostly subsided.  Raised itchy welts the size of a larger dot from a marker She has some swelling in her hands as well She had a cough which stopped after the benadryl
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Severe abdominal cramping, abdominal pain, and vomiting starting the evening of vaccine, resolved within 24-48 hours.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Atrioventricular block, Atrioventricular block second degree, Borrelia test negative, Computerised tomogram head abnormal
Clinical narrative: On 10/3/24 at 12:45pm (approximately 17.5 hours after vaccination), Patient collapsed and hit her head. She was feeling fine prior and only lost consciousness (we think) for a few seconds. She was face down and crying after the fall but hit the back left side of her head. She had amnesia so we took her to the hospital for evaluation.  The hospital staff ran lots of tests to see how severe patietnt's head trauma was and also to try to find the cause of the collapse. The ct scan of the brain showed a severe concussion from the fall but no bleeding or fracture. The ekg showed a prolonged qr interval and was in the 400?s. The amnesia lasted more than 8 hours. They admitted patient for further evaluation. On 10/4/24 in the morning before no medication, the ekg was still abnormal but better than 10/3/24. The cardiology team suspected Lyme disease since they saw a heart block on the ekg. Patient had no other Lyme symptoms. The cardiology team started ceftriaxone in the hospital in the afternoon on 10/4 for the suspected Lyme. The ekg was almost normal on 10/5 so the team discharged Patient with doxycycline for at home treatment of the Lyme disease until the bloodwork came back. The Lyme test came back negative and a repeat Lyme test a few days later also came back negative.  Over the past 4 weeks, the pcp and cardiologist have run multiple tests to rule out causes of the collapse. Everything has come back negative. Patient wore a Holter monitor for 7 days during the middle of October to monitor her heart function. The results came back and showed 12 wenckebach episodes during deep sleep over the 7 days.  On 10/30/24, Patient had a normal ekg and the cardiologists cleared Patient saying that the Holter monitor results are normal for deep sleep for certain people and are not related to the incident on 10/3/24. As long as there are no other issues, the cardiology team will do a 3 day Holter monitor in 6 months before fully discharging Patient from their care. She is still being followed and is on restriction from the neurosurgery team for the concussion because of its severity.  The medical team does not have an answer for what caused the collapse after thorough evaluation and all signs are pointing to the Covid vaccine received on 10/2/24 as the cause.  Patient has received Covid vaccines in the past with no issues.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Concussion, Crying, Electrocardiogram QT prolonged, Electrocardiogram ambulatory abnormal, Head injury
Clinical narrative: On 10/3/24 at 12:45pm (approximately 17.5 hours after vaccination), Patient collapsed and hit her head. She was feeling fine prior and only lost consciousness (we think) for a few seconds. She was face down and crying after the fall but hit the back left side of her head. She had amnesia so we took her to the hospital for evaluation.  The hospital staff ran lots of tests to see how severe patietnt's head trauma was and also to try to find the cause of the collapse. The ct scan of the brain showed a severe concussion from the fall but no bleeding or fracture. The ekg showed a prolonged qr interval and was in the 400?s. The amnesia lasted more than 8 hours. They admitted patient for further evaluation. On 10/4/24 in the morning before no medication, the ekg was still abnormal but better than 10/3/24. The cardiology team suspected Lyme disease since they saw a heart block on the ekg. Patient had no other Lyme symptoms. The cardiology team started ceftriaxone in the hospital in the afternoon on 10/4 for the suspected Lyme. The ekg was almost normal on 10/5 so the team discharged Patient with doxycycline for at home treatment of the Lyme disease until the bloodwork came back. The Lyme test came back negative and a repeat Lyme test a few days later also came back negative.  Over the past 4 weeks, the pcp and cardiologist have run multiple tests to rule out causes of the collapse. Everything has come back negative. Patient wore a Holter monitor for 7 days during the middle of October to monitor her heart function. The results came back and showed 12 wenckebach episodes during deep sleep over the 7 days.  On 10/30/24, Patient had a normal ekg and the cardiologists cleared Patient saying that the Holter monitor results are normal for deep sleep for certain people and are not related to the incident on 10/3/24. As long as there are no other issues, the cardiology team will do a 3 day Holter monitor in 6 months before fully discharging Patient from their care. She is still being followed and is on restriction from the neurosurgery team for the concussion because of its severity.  The medical team does not have an answer for what caused the collapse after thorough evaluation and all signs are pointing to the Covid vaccine received on 10/2/24 as the cause.  Patient has received Covid vaccines in the past with no issues.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: On 10/3/24 at 12:45pm (approximately 17.5 hours after vaccination), Patient collapsed and hit her head. She was feeling fine prior and only lost consciousness (we think) for a few seconds. She was face down and crying after the fall but hit the back left side of her head. She had amnesia so we took her to the hospital for evaluation.  The hospital staff ran lots of tests to see how severe patietnt's head trauma was and also to try to find the cause of the collapse. The ct scan of the brain showed a severe concussion from the fall but no bleeding or fracture. The ekg showed a prolonged qr interval and was in the 400?s. The amnesia lasted more than 8 hours. They admitted patient for further evaluation. On 10/4/24 in the morning before no medication, the ekg was still abnormal but better than 10/3/24. The cardiology team suspected Lyme disease since they saw a heart block on the ekg. Patient had no other Lyme symptoms. The cardiology team started ceftriaxone in the hospital in the afternoon on 10/4 for the suspected Lyme. The ekg was almost normal on 10/5 so the team discharged Patient with doxycycline for at home treatment of the Lyme disease until the bloodwork came back. The Lyme test came back negative and a repeat Lyme test a few days later also came back negative.  Over the past 4 weeks, the pcp and cardiologist have run multiple tests to rule out causes of the collapse. Everything has come back negative. Patient wore a Holter monitor for 7 days during the middle of October to monitor her heart function. The results came back and showed 12 wenckebach episodes during deep sleep over the 7 days.  On 10/30/24, Patient had a normal ekg and the cardiologists cleared Patient saying that the Holter monitor results are normal for deep sleep for certain people and are not related to the incident on 10/3/24. As long as there are no other issues, the cardiology team will do a 3 day Holter monitor in 6 months before fully discharging Patient from their care. She is still being followed and is on restriction from the neurosurgery team for the concussion because of its severity.  The medical team does not have an answer for what caused the collapse after thorough evaluation and all signs are pointing to the Covid vaccine received on 10/2/24 as the cause.  Patient has received Covid vaccines in the past with no issues.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Atrioventricular block second degree, Computerised tomogram head, Concussion, Electrocardiogram
Clinical narrative: On 10/3/24 at 12:45pm (approximately 17.5 hours after vaccination), Patient collapsed and hit her head. She was feeling fine prior and only lost consciousness (we think) for a few seconds. She was face down and crying after the fall but hit the back left side of her head. She had amnesia so we took her to the hospital for evaluation.  The hospital staff ran lots of tests to see how severe patietnt's head trauma was and also to try to find the cause of the collapse. The ct scan of the brain showed a severe concussion from the fall but no bleeding or fracture. The ekg showed a prolonged qr interval and was in the 400?s. The amnesia lasted more than 8 hours. They admitted patient for further evaluation. On 10/4/24 in the morning before no medication, the ekg was still abnormal but better than 10/3/24. The cardiology team suspected Lyme disease since they saw a heart block on the ekg. Patient had no other Lyme symptoms. The cardiology team started ceftriaxone in the hospital in the afternoon on 10/4 for the suspected Lyme. The ekg was almost normal on 10/5 so the team discharged Patient with doxycycline for at home treatment of the Lyme disease until the bloodwork came back. The Lyme test came back negative and a repeat Lyme test a few days later also came back negative.  Over the past 4 weeks, the pcp and cardiologist have run multiple tests to rule out causes of the collapse. Everything has come back negative. Patient wore a Holter monitor for 7 days during the middle of October to monitor her heart function. The results came back and showed 12 wenckebach episodes during deep sleep over the 7 days.  On 10/30/24, Patient had a normal ekg and the cardiologists cleared Patient saying that the Holter monitor results are normal for deep sleep for certain people and are not related to the incident on 10/3/24. As long as there are no other issues, the cardiology team will do a 3 day Holter monitor in 6 months before fully discharging Patient from their care. She is still being followed and is on restriction from the neurosurgery team for the concussion because of its severity.  The medical team does not have an answer for what caused the collapse after thorough evaluation and all signs are pointing to the Covid vaccine received on 10/2/24 as the cause.  Patient has received Covid vaccines in the past with no issues.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Head injury, Laboratory test, Loss of consciousness
Clinical narrative: On 10/3/24 at 12:45pm (approximately 17.5 hours after vaccination), Patient collapsed and hit her head. She was feeling fine prior and only lost consciousness (we think) for a few seconds. She was face down and crying after the fall but hit the back left side of her head. She had amnesia so we took her to the hospital for evaluation.  The hospital staff ran lots of tests to see how severe patietnt's head trauma was and also to try to find the cause of the collapse. The ct scan of the brain showed a severe concussion from the fall but no bleeding or fracture. The ekg showed a prolonged qr interval and was in the 400?s. The amnesia lasted more than 8 hours. They admitted patient for further evaluation. On 10/4/24 in the morning before no medication, the ekg was still abnormal but better than 10/3/24. The cardiology team suspected Lyme disease since they saw a heart block on the ekg. Patient had no other Lyme symptoms. The cardiology team started ceftriaxone in the hospital in the afternoon on 10/4 for the suspected Lyme. The ekg was almost normal on 10/5 so the team discharged Patient with doxycycline for at home treatment of the Lyme disease until the bloodwork came back. The Lyme test came back negative and a repeat Lyme test a few days later also came back negative.  Over the past 4 weeks, the pcp and cardiologist have run multiple tests to rule out causes of the collapse. Everything has come back negative. Patient wore a Holter monitor for 7 days during the middle of October to monitor her heart function. The results came back and showed 12 wenckebach episodes during deep sleep over the 7 days.  On 10/30/24, Patient had a normal ekg and the cardiologists cleared Patient saying that the Holter monitor results are normal for deep sleep for certain people and are not related to the incident on 10/3/24. As long as there are no other issues, the cardiology team will do a 3 day Holter monitor in 6 months before fully discharging Patient from their care. She is still being followed and is on restriction from the neurosurgery team for the concussion because of its severity.  The medical team does not have an answer for what caused the collapse after thorough evaluation and all signs are pointing to the Covid vaccine received on 10/2/24 as the cause.  Patient has received Covid vaccines in the past with no issues.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Headache, Hypoaesthesia, Laboratory test normal, Nausea
Clinical narrative: Patient described they were experiencing some numbness in their hands and fingers. They had headache, were nauseated, and their blood pressure was elevated.
Age: 52.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Aphasia, Feeling hot, Hyperhidrosis, Malaise, Pallor
Clinical narrative: I gave flu vaccine first, then gave the covid vaccine. After the covid vaccine the patient started leaning forward with a blank stare in his eyes and turning pale.  He started sweating on his forehead and turned hot to the touch.  He was unable to speak for about 5 minutes.  His companion said he'd done that in the past; like a seizure response.  I offered to call an ambulance.  She said no and wanted me to hurry and give her 2 vaccines so she could get him outside.   He sat not speaking for about 3 or 4 minutes before they got up.  I attempted to call several times through out the day to check on him.  Companion answered around 4 pm and said he was napping  and was still feeling under the weather.  The patients companion did mention that he had not eaten breakfast that morning.
Age: 52.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Seizure like phenomena
Clinical narrative: I gave flu vaccine first, then gave the covid vaccine. After the covid vaccine the patient started leaning forward with a blank stare in his eyes and turning pale.  He started sweating on his forehead and turned hot to the touch.  He was unable to speak for about 5 minutes.  His companion said he'd done that in the past; like a seizure response.  I offered to call an ambulance.  She said no and wanted me to hurry and give her 2 vaccines so she could get him outside.   He sat not speaking for about 3 or 4 minutes before they got up.  I attempted to call several times through out the day to check on him.  Companion answered around 4 pm and said he was napping  and was still feeling under the weather.  The patients companion did mention that he had not eaten breakfast that morning.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sharp pain in lower limbs, best described as a needle poke, lasting 2-3 seconds about 4-5 times daily for 2 weeks. Unknown long term effects.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: After receiving both a Flu shot and COVID shot in my left arm. I woke up on 11/624 with arm and shoulder pain, each day. it has gotten progressively worse. Like a big deep ache running from left arm up my left shoulder, and down around left shoulder blade. Going to Dr. X Rays treatment ongoing
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Injection site discharge, Rash, Rash pruritic
Clinical narrative: 5 min after injection became flushed, lightheaded, scratchy throat, itchy rash over face & chest. Some shortness of breath. Took po Benadryl & symptoms continued to progress. Seen in ED & given IV Pepcid, IV Benadryl & IV Solu-Medrol. Discharged with prescription for oral prednisone.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: 5 min after injection became flushed, lightheaded, scratchy throat, itchy rash over face & chest. Some shortness of breath. Took po Benadryl & symptoms continued to progress. Seen in ED & given IV Pepcid, IV Benadryl & IV Solu-Medrol. Discharged with prescription for oral prednisone.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site erythema, Pyrexia
Clinical narrative: 1 day after receiving PCV20 vaccine, patient developed erythematous patch ~5cm x 3cm around injection site. In the following 2 days, she developed 3 other erythematous, pruritic patches ranging in size from 1cm x 1cm to 7cm x 5cm on the distal L arm from the injection site. Patient also reports 3 days of subjective fevers that started 1 day after injection.
Age: 6.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidentally administered wrong vaccine, Covid 12+. Vaccine had been verified by Provider and didn't catch it.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt received Fluad 9/3/2024 & again 11/6/2024 Duplication of flu vaccine No AE
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient experiencing pain in upper right shoulder near injection site.  No sign of infection, swelling, redness, bruising.  Patient reports doctor could find nothing wrong, no signs of infection.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Patient experiencing pain in upper right shoulder near injection site.  No sign of infection, swelling, redness, bruising.  Patient reports doctor could find nothing wrong, no signs of infection.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Point in the process the medication error occurred: preparation for administration and administration; Vaccine count was done on 14-SEP-2024 and 11-SEP-2024 and expiration date was missed; Vaccine expired on 08-SEP-2024 was administered to a patient on 09-SEP-2024; This spontaneous report has been received from Other Health Professional (Nurse practitioner) referring to a patient of an unknown age and gender.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 09-SEP-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, rHA, administered as prophylaxis (strength, dose administered, route and anatomical location of administration were not provided; lot # reported as W028734, which has been determined to be a valid lot # for this vaccine, expiration date provided and validated to be on  08-SEP-2024) (expired product administered). No additional adverse event (AE) (no adverse event).   This is a non-valid case due to the lack of patient's identifiers.  Follow up information has been received from the Nurse practitioner on 05-NOV-2024.  This spontaneous report refers a 13-years-old female patient. Concomitant vaccines included Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).   On 09-SEP-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, rHA, administered subcutaneously (SC) at right deltoid as prophylaxis (strength, and dose administered were not provided; lot # reported as W028734, which has been determined to be a valid lot # for this vaccine, expiration date provided and validated to be on  08-SEP-2024). It was emphasized that the vaccine was 1 day expired; the company was notified and recommended no re-vaccination and stated that vaccine should still be intact if stored properly; the physician was notified about this and was in agreement to not re-vaccinate. Vaccine count was done on 14-SEP-2024 and 11-SEP-2024 and expiration date was missed (product expiration date issue). It was stated that the point in the process the medication error occurred was at the preparation for administration (product preparation error) and also at the administration.
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: First Dose Heplisav-B, and Second Dose Engerix-B; Initial report received on 30-Oct-2024.  A pharmacist in the reported that a 23-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and was given ENGERIX-B as the second dose.  No medical history or concomitant medications were reported.  On 17-Sep-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot# 944942, 03-Jan-2024, NDC #43528-003-05)] intramuscularly in the left deltoid.   On 17-Oct-2024, 30 days after having been vaccinated with HEPLISAV-B, the reporter stated that the patient was accidentally given ENGERIX-B as the second dose of hepatitis B vaccine instead of being given HEPLISAV-B.  The vaccine was administered by a pharmacist who floated to other pharmacies and had either given it accidentally or there was no HEPLISAV-B supply on hand and the pharmacist had no other choice but to give ENGERIX-B.  No issues or adverse events were noted.  No additional information was reported.    Company Comment: The  company assessed the event as non-serious.; Sender's Comments: The  company assessed the event as non-serious.
Sex: U
Vaccine: ANTH
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: Headache; Pain; Muscle soreness; Fatigue; This spontaneous case report received on 30-Oct-2024 from other health care professional regarding adult patient (patient two, age 20s- 70s) of unknown gender who had "pain" (PT: Pain), "muscle soreness" (PT: Myalgia), "fatigue" (PT: Fatigue), and "headache" (PT: Headache).   The patient's medical history, concurrent conditions and allergies were not reported.   On an unknown date, the patient was administered two doses of Cyfendus (AVA + CPG 7909, lot number: unknown) and doxycycline for postexposure prophylaxis   The patient experienced pain, muscle soreness, fatigue, and headache. All events were considered as mild. The vaccine was tolerated well.   There was no labs/imaging reported.   The outcome of the reported events was unknown.  Company comment: A consumer received two doses of Cyfendus for postexposure prophylaxis and experienced pain, muscle soreness (myalgia), fatigue, and headache. All events were considered mild. The patient also received doxycycline along with Cyfendus. Further information regarding the events was limited. Considering the case information and potential of Cyfendus to cause these events, the causality of pain, myalgia, fatigue, and headache is assessed as possible. The case is considered non serious as per the medical assessment.; Sender's Comments: A consumer received two doses of Cyfendus for postexposure prophylaxis and experienced pain, muscle soreness (myalgia), fatigue, and headache. All events were considered mild. The patient also received doxycycline along with Cyfendus. Further information regarding the events was limited. Considering the case information and potential of Cyfendus to cause these events, the causality of pain, myalgia, fatigue, and headache is assessed as possible. The case is considered non serious as per the medical assessment. US-EMERGENT BIOSOLUTIONS-24000179:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000182:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000183:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000184:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000183:Cyfendus PMR Study- same reporter
Sex: U
Vaccine: ANTH
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: Headaches; Pain; Muscle soreness; Fatigue; This spontaneous case report received on 30-Oct-2024 from other health care professional regarding adult patient (patient three, age 20s-70s) of unknown gender who had "pain" (PT: Pain), "muscle soreness" (PT: Myalgia), "fatigue" (PT: Fatigue), and "headache" (PT: Headache).   The patient's medical history, concurrent conditions and allergies were not reported.   On an unknown date, the patient was administered two doses of Cyfendus (AVA + CPG 7909, lot number: unknown) and doxycycline for postexposure prophylaxis   The patient experienced pain, muscle soreness, fatigue, and headache. All events were considered as mild. The vaccine was tolerated well.   There was no labs/imaging reported.   The outcome of the reported events was unknown.  Company comment: A consumer received two doses of Cyfendus for postexposure prophylaxis and experienced pain, muscle soreness (myalgia), fatigue, and headache. All events were considered mild. The patient also received doxycycline along with Cyfendus. Further information regarding the events was limited. Considering the case information and potential of Cyfendus to cause these events, the causality of pain, myalgia, fatigue, and headache is assessed as possible. The case is considered non serious as per the medical assessment.; Sender's Comments: A consumer received two doses of Cyfendus for postexposure prophylaxis and experienced pain, muscle soreness (myalgia), fatigue, and headache. All events were considered mild. The patient also received doxycycline along with Cyfendus. Further information regarding the events was limited. Considering the case information and potential of Cyfendus to cause these events, the causality of pain, myalgia, fatigue, and headache is assessed as possible. The case is considered non serious as per the medical assessment. US-EMERGENT BIOSOLUTIONS-24000179:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000180:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000182:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000183:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000184:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000183:Cyfendus PMR Study- same reporter