chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Amnesia, Bladder hypertrophy, Bladder obstruction, Brain contusion
Clinical narrative: Clinical Summary PATIENT is a 91 y.o. male with a history of HTN, recent diagnosis COVID-19 at urgent care visit who presented to RMH 9/5/2023 as a trauma s/p mechanical fall. Found to have acute SDH, SAH, and hemorrhagic contusion requiring further care. Additionally developed acute hypoxia respiratory failure. Agency was consulted for geriatric evaluation, assumed care as primary on 9/7/23.   1. Acute SDH/SAH/Hemorrhagic Contusion with Cerebral Edema: Traumatic due to fall. Admit 9/5/23 with acute left subdural and subarachnoid hemorrhages with 8 mm left-to-right midline shift; acute cerebral hemorrhagic contusion in the right inferior temporal lobe. Repeat CTHs stable except for slightly increased rightward subfalcine herniation. NSG recommended NOM, OP follow up in 3-4 weeks for repeat CTH.  2. Fall: Pt went down to the basement for COVID-19 isolation, fell down the stairs, amnestic to event. Hit head with LOC. Injuries as discussed. TTE 9/7/23 with EF 69%, no WMA. Evaluated with EEG for 48hrs which did not reveal any seizures. 3. COVID-19 Infection: Patient with cough and congestion, tested positive for COVID-19 at urgent care 9/5/23. S/p 4 doses of Moderna. Admit CT chest 9/5/23 with nonspecific mild mosaic ground-glass attenuation of the lung parenchyma bilaterally. Initially had no need for O2 but later required so Decadron and Remdesivir initiated.  4. Acute Hypoxic Respiratory Failure: In setting of COVID-19. VBG niot obtained. CXR as discussed. Required up to 4L NC on admit, stable on 2L NC 9/7/23. Weaned off o2 by time of discharge. 5. Thrombocytopenia: Baseline Plt unknown. Admit Plt 168, down-trended to 119 on 9/6/23. In setting of illness/trauma.  6. Incidental Findings: Per admit imaging 9/5/23: Diverticulosis, prostatic enlargement, diffuse urinary bladder wall thickening consistent with chronic urinary bladder outlet obstruction, small bilateral fat-containing inguinal hernias, bilateral renal cysts. Asymptomatic. Recommend OP follow up.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Brain herniation, Brain oedema, COVID-19, Cerebral haemorrhage, Cerebral mass effect
Clinical narrative: Clinical Summary PATIENT is a 91 y.o. male with a history of HTN, recent diagnosis COVID-19 at urgent care visit who presented to RMH 9/5/2023 as a trauma s/p mechanical fall. Found to have acute SDH, SAH, and hemorrhagic contusion requiring further care. Additionally developed acute hypoxia respiratory failure. Agency was consulted for geriatric evaluation, assumed care as primary on 9/7/23.   1. Acute SDH/SAH/Hemorrhagic Contusion with Cerebral Edema: Traumatic due to fall. Admit 9/5/23 with acute left subdural and subarachnoid hemorrhages with 8 mm left-to-right midline shift; acute cerebral hemorrhagic contusion in the right inferior temporal lobe. Repeat CTHs stable except for slightly increased rightward subfalcine herniation. NSG recommended NOM, OP follow up in 3-4 weeks for repeat CTH.  2. Fall: Pt went down to the basement for COVID-19 isolation, fell down the stairs, amnestic to event. Hit head with LOC. Injuries as discussed. TTE 9/7/23 with EF 69%, no WMA. Evaluated with EEG for 48hrs which did not reveal any seizures. 3. COVID-19 Infection: Patient with cough and congestion, tested positive for COVID-19 at urgent care 9/5/23. S/p 4 doses of Moderna. Admit CT chest 9/5/23 with nonspecific mild mosaic ground-glass attenuation of the lung parenchyma bilaterally. Initially had no need for O2 but later required so Decadron and Remdesivir initiated.  4. Acute Hypoxic Respiratory Failure: In setting of COVID-19. VBG niot obtained. CXR as discussed. Required up to 4L NC on admit, stable on 2L NC 9/7/23. Weaned off o2 by time of discharge. 5. Thrombocytopenia: Baseline Plt unknown. Admit Plt 168, down-trended to 119 on 9/6/23. In setting of illness/trauma.  6. Incidental Findings: Per admit imaging 9/5/23: Diverticulosis, prostatic enlargement, diffuse urinary bladder wall thickening consistent with chronic urinary bladder outlet obstruction, small bilateral fat-containing inguinal hernias, bilateral renal cysts. Asymptomatic. Recommend OP follow up.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest X-ray, Computerised tomogram head abnormal, Computerised tomogram thorax abnormal, Cough, Diverticulum
Clinical narrative: Clinical Summary PATIENT is a 91 y.o. male with a history of HTN, recent diagnosis COVID-19 at urgent care visit who presented to RMH 9/5/2023 as a trauma s/p mechanical fall. Found to have acute SDH, SAH, and hemorrhagic contusion requiring further care. Additionally developed acute hypoxia respiratory failure. Agency was consulted for geriatric evaluation, assumed care as primary on 9/7/23.   1. Acute SDH/SAH/Hemorrhagic Contusion with Cerebral Edema: Traumatic due to fall. Admit 9/5/23 with acute left subdural and subarachnoid hemorrhages with 8 mm left-to-right midline shift; acute cerebral hemorrhagic contusion in the right inferior temporal lobe. Repeat CTHs stable except for slightly increased rightward subfalcine herniation. NSG recommended NOM, OP follow up in 3-4 weeks for repeat CTH.  2. Fall: Pt went down to the basement for COVID-19 isolation, fell down the stairs, amnestic to event. Hit head with LOC. Injuries as discussed. TTE 9/7/23 with EF 69%, no WMA. Evaluated with EEG for 48hrs which did not reveal any seizures. 3. COVID-19 Infection: Patient with cough and congestion, tested positive for COVID-19 at urgent care 9/5/23. S/p 4 doses of Moderna. Admit CT chest 9/5/23 with nonspecific mild mosaic ground-glass attenuation of the lung parenchyma bilaterally. Initially had no need for O2 but later required so Decadron and Remdesivir initiated.  4. Acute Hypoxic Respiratory Failure: In setting of COVID-19. VBG niot obtained. CXR as discussed. Required up to 4L NC on admit, stable on 2L NC 9/7/23. Weaned off o2 by time of discharge. 5. Thrombocytopenia: Baseline Plt unknown. Admit Plt 168, down-trended to 119 on 9/6/23. In setting of illness/trauma.  6. Incidental Findings: Per admit imaging 9/5/23: Diverticulosis, prostatic enlargement, diffuse urinary bladder wall thickening consistent with chronic urinary bladder outlet obstruction, small bilateral fat-containing inguinal hernias, bilateral renal cysts. Asymptomatic. Recommend OP follow up.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Echocardiogram, Electroencephalogram normal, Fall, Head injury, Illness
Clinical narrative: Clinical Summary PATIENT is a 91 y.o. male with a history of HTN, recent diagnosis COVID-19 at urgent care visit who presented to RMH 9/5/2023 as a trauma s/p mechanical fall. Found to have acute SDH, SAH, and hemorrhagic contusion requiring further care. Additionally developed acute hypoxia respiratory failure. Agency was consulted for geriatric evaluation, assumed care as primary on 9/7/23.   1. Acute SDH/SAH/Hemorrhagic Contusion with Cerebral Edema: Traumatic due to fall. Admit 9/5/23 with acute left subdural and subarachnoid hemorrhages with 8 mm left-to-right midline shift; acute cerebral hemorrhagic contusion in the right inferior temporal lobe. Repeat CTHs stable except for slightly increased rightward subfalcine herniation. NSG recommended NOM, OP follow up in 3-4 weeks for repeat CTH.  2. Fall: Pt went down to the basement for COVID-19 isolation, fell down the stairs, amnestic to event. Hit head with LOC. Injuries as discussed. TTE 9/7/23 with EF 69%, no WMA. Evaluated with EEG for 48hrs which did not reveal any seizures. 3. COVID-19 Infection: Patient with cough and congestion, tested positive for COVID-19 at urgent care 9/5/23. S/p 4 doses of Moderna. Admit CT chest 9/5/23 with nonspecific mild mosaic ground-glass attenuation of the lung parenchyma bilaterally. Initially had no need for O2 but later required so Decadron and Remdesivir initiated.  4. Acute Hypoxic Respiratory Failure: In setting of COVID-19. VBG niot obtained. CXR as discussed. Required up to 4L NC on admit, stable on 2L NC 9/7/23. Weaned off o2 by time of discharge. 5. Thrombocytopenia: Baseline Plt unknown. Admit Plt 168, down-trended to 119 on 9/6/23. In setting of illness/trauma.  6. Incidental Findings: Per admit imaging 9/5/23: Diverticulosis, prostatic enlargement, diffuse urinary bladder wall thickening consistent with chronic urinary bladder outlet obstruction, small bilateral fat-containing inguinal hernias, bilateral renal cysts. Asymptomatic. Recommend OP follow up.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Imaging procedure abnormal, Inguinal hernia, Injury, Loss of consciousness, Lung opacity
Clinical narrative: Clinical Summary PATIENT is a 91 y.o. male with a history of HTN, recent diagnosis COVID-19 at urgent care visit who presented to RMH 9/5/2023 as a trauma s/p mechanical fall. Found to have acute SDH, SAH, and hemorrhagic contusion requiring further care. Additionally developed acute hypoxia respiratory failure. Agency was consulted for geriatric evaluation, assumed care as primary on 9/7/23.   1. Acute SDH/SAH/Hemorrhagic Contusion with Cerebral Edema: Traumatic due to fall. Admit 9/5/23 with acute left subdural and subarachnoid hemorrhages with 8 mm left-to-right midline shift; acute cerebral hemorrhagic contusion in the right inferior temporal lobe. Repeat CTHs stable except for slightly increased rightward subfalcine herniation. NSG recommended NOM, OP follow up in 3-4 weeks for repeat CTH.  2. Fall: Pt went down to the basement for COVID-19 isolation, fell down the stairs, amnestic to event. Hit head with LOC. Injuries as discussed. TTE 9/7/23 with EF 69%, no WMA. Evaluated with EEG for 48hrs which did not reveal any seizures. 3. COVID-19 Infection: Patient with cough and congestion, tested positive for COVID-19 at urgent care 9/5/23. S/p 4 doses of Moderna. Admit CT chest 9/5/23 with nonspecific mild mosaic ground-glass attenuation of the lung parenchyma bilaterally. Initially had no need for O2 but later required so Decadron and Remdesivir initiated.  4. Acute Hypoxic Respiratory Failure: In setting of COVID-19. VBG niot obtained. CXR as discussed. Required up to 4L NC on admit, stable on 2L NC 9/7/23. Weaned off o2 by time of discharge. 5. Thrombocytopenia: Baseline Plt unknown. Admit Plt 168, down-trended to 119 on 9/6/23. In setting of illness/trauma.  6. Incidental Findings: Per admit imaging 9/5/23: Diverticulosis, prostatic enlargement, diffuse urinary bladder wall thickening consistent with chronic urinary bladder outlet obstruction, small bilateral fat-containing inguinal hernias, bilateral renal cysts. Asymptomatic. Recommend OP follow up.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Platelet count decreased, Prostatomegaly, Renal cyst, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Clinical Summary PATIENT is a 91 y.o. male with a history of HTN, recent diagnosis COVID-19 at urgent care visit who presented to RMH 9/5/2023 as a trauma s/p mechanical fall. Found to have acute SDH, SAH, and hemorrhagic contusion requiring further care. Additionally developed acute hypoxia respiratory failure. Agency was consulted for geriatric evaluation, assumed care as primary on 9/7/23.   1. Acute SDH/SAH/Hemorrhagic Contusion with Cerebral Edema: Traumatic due to fall. Admit 9/5/23 with acute left subdural and subarachnoid hemorrhages with 8 mm left-to-right midline shift; acute cerebral hemorrhagic contusion in the right inferior temporal lobe. Repeat CTHs stable except for slightly increased rightward subfalcine herniation. NSG recommended NOM, OP follow up in 3-4 weeks for repeat CTH.  2. Fall: Pt went down to the basement for COVID-19 isolation, fell down the stairs, amnestic to event. Hit head with LOC. Injuries as discussed. TTE 9/7/23 with EF 69%, no WMA. Evaluated with EEG for 48hrs which did not reveal any seizures. 3. COVID-19 Infection: Patient with cough and congestion, tested positive for COVID-19 at urgent care 9/5/23. S/p 4 doses of Moderna. Admit CT chest 9/5/23 with nonspecific mild mosaic ground-glass attenuation of the lung parenchyma bilaterally. Initially had no need for O2 but later required so Decadron and Remdesivir initiated.  4. Acute Hypoxic Respiratory Failure: In setting of COVID-19. VBG niot obtained. CXR as discussed. Required up to 4L NC on admit, stable on 2L NC 9/7/23. Weaned off o2 by time of discharge. 5. Thrombocytopenia: Baseline Plt unknown. Admit Plt 168, down-trended to 119 on 9/6/23. In setting of illness/trauma.  6. Incidental Findings: Per admit imaging 9/5/23: Diverticulosis, prostatic enlargement, diffuse urinary bladder wall thickening consistent with chronic urinary bladder outlet obstruction, small bilateral fat-containing inguinal hernias, bilateral renal cysts. Asymptomatic. Recommend OP follow up.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Subarachnoid haemorrhage, Subdural haemorrhage, Thrombocytopenia
Clinical narrative: Clinical Summary PATIENT is a 91 y.o. male with a history of HTN, recent diagnosis COVID-19 at urgent care visit who presented to RMH 9/5/2023 as a trauma s/p mechanical fall. Found to have acute SDH, SAH, and hemorrhagic contusion requiring further care. Additionally developed acute hypoxia respiratory failure. Agency was consulted for geriatric evaluation, assumed care as primary on 9/7/23.   1. Acute SDH/SAH/Hemorrhagic Contusion with Cerebral Edema: Traumatic due to fall. Admit 9/5/23 with acute left subdural and subarachnoid hemorrhages with 8 mm left-to-right midline shift; acute cerebral hemorrhagic contusion in the right inferior temporal lobe. Repeat CTHs stable except for slightly increased rightward subfalcine herniation. NSG recommended NOM, OP follow up in 3-4 weeks for repeat CTH.  2. Fall: Pt went down to the basement for COVID-19 isolation, fell down the stairs, amnestic to event. Hit head with LOC. Injuries as discussed. TTE 9/7/23 with EF 69%, no WMA. Evaluated with EEG for 48hrs which did not reveal any seizures. 3. COVID-19 Infection: Patient with cough and congestion, tested positive for COVID-19 at urgent care 9/5/23. S/p 4 doses of Moderna. Admit CT chest 9/5/23 with nonspecific mild mosaic ground-glass attenuation of the lung parenchyma bilaterally. Initially had no need for O2 but later required so Decadron and Remdesivir initiated.  4. Acute Hypoxic Respiratory Failure: In setting of COVID-19. VBG niot obtained. CXR as discussed. Required up to 4L NC on admit, stable on 2L NC 9/7/23. Weaned off o2 by time of discharge. 5. Thrombocytopenia: Baseline Plt unknown. Admit Plt 168, down-trended to 119 on 9/6/23. In setting of illness/trauma.  6. Incidental Findings: Per admit imaging 9/5/23: Diverticulosis, prostatic enlargement, diffuse urinary bladder wall thickening consistent with chronic urinary bladder outlet obstruction, small bilateral fat-containing inguinal hernias, bilateral renal cysts. Asymptomatic. Recommend OP follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Wrong product administered
Clinical narrative: Previously received Pentacel but what about Pediarix?  We have a little one who received Pediarix at 2 & 4 months but when he came in for his 6 month well child check, he was given Vaxelis.No additional information available from this first contact; This spontaneous non -serious safety report, with reference number 2023SA244561 (Inquiry number), was received by the partner on 08-AUG-2023 and forwarded to agency on 10-AUG-2023, from a health professional.  The causal relationship between Vaxelis and the reported event " Previously received Pentacel but what about Pediarix? We have a little one who received Pediarix at 2 & 4 months but when he came in for his 6 months well child check, he was given Vaxelis. No additional information available from this first contact" was assessed as not applicable due to the nature of the event.  Further information is expected.   Significant follow-up information was received by agency on 06-SEP-2023, from a HCP. The case is maintained as non-serious.  The causal relationship between Vaxelis and the reported event " Previously received Pentacel but what about Pediarix? We have a little one who received Pediarix at 2 & 4 months but when he came in for his 6 months well child check, he was given Vaxelis. No additional information available from this first contact" was assessed as not applicable due to the nature of the event.  No further information is expected.  NI is not working, added State under vaccine facility information and Reporter State.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a 2nd Fluzone HD dose for the year, 1st on Septmeber 18th 2023 . no reaction at this time will follow up with patient during the week
Age: 62.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was under 65 years old and received Fluad for 65 and older. Patient requested the vaccine because of a medical condition lowering her immunity. This was discovered about 1 year after the event because the patient was looking for "the same shot I got last year". After stating she wants the high dose shot because of her disease. Patient did not report any issues or adverse events associated with getting the vaccine.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Fatigue, Muscle spasms, Myalgia
Clinical narrative: Generalized muscle pain and tiredness with intermittent cramps in both thigh, started 3 days after injection.  The symptoms has been gradually subsiding, but not completely gone as of 10/02/2023.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 80.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Flank pain, Musculoskeletal chest pain, Pain in extremity, Pain in jaw, Skin warm
Clinical narrative: Around 7pm left arm was sore and warm. At 3 AM woke up in excruciating pain on left side that was under ribs. Lowered the bed flat. Tried to get comfortable, couldn't. Had a hydrocodone tablet left over from a prescription given in March. Took one. No relief. Got up at 5:20 tried to eat my cereal and jaw hurt too much to chew and room started spinning. My husband had too almost carry me back to bed because I was in so much pain on left side. Took an Excedrin migraine, no relief, got up at 10AM in pain. Husband gave me one of his tramadol. Pain eased somewhat. Took a Tylenol at 2pm. Pain on left side only, lower ribs, inside body cavity to around the side to back.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Sleep disorder, Trismus, Vertigo
Clinical narrative: Around 7pm left arm was sore and warm. At 3 AM woke up in excruciating pain on left side that was under ribs. Lowered the bed flat. Tried to get comfortable, couldn't. Had a hydrocodone tablet left over from a prescription given in March. Took one. No relief. Got up at 5:20 tried to eat my cereal and jaw hurt too much to chew and room started spinning. My husband had too almost carry me back to bed because I was in so much pain on left side. Took an Excedrin migraine, no relief, got up at 10AM in pain. Husband gave me one of his tramadol. Pain eased somewhat. Took a Tylenol at 2pm. Pain on left side only, lower ribs, inside body cavity to around the side to back.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary pain, Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: Itching occurred less than an hour after the vaccine had been administered. I took one diphenhydramine 25mg tablet when I got home about 1500 on 9/30. I took another diphenhydramine tablet about 2100 on 9/30. Woke up on 10/1 it was very red, itchy, raised, and hurt to touch. Took my normal antihistamines I take for allergies (allegra in the morning, xyzal at night) still was itching bought diphenydramine cream at the store applied it. I took diphenydramine 50mg that night. Monday morning, the blotchiness and redness had not decreased, my arm was hurting all the way into my armpit around my lymph node. I am a clinical pharmacist in a hospital, had a physician look at it and he suggested having my PCP look at it. She looked at it and prescribed 20mg prednisone x5 days. After taking the first dose of prednisone the redness, itching, and size has decreased.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tenderness
Clinical narrative: Itching occurred less than an hour after the vaccine had been administered. I took one diphenhydramine 25mg tablet when I got home about 1500 on 9/30. I took another diphenhydramine tablet about 2100 on 9/30. Woke up on 10/1 it was very red, itchy, raised, and hurt to touch. Took my normal antihistamines I take for allergies (allegra in the morning, xyzal at night) still was itching bought diphenydramine cream at the store applied it. I took diphenydramine 50mg that night. Monday morning, the blotchiness and redness had not decreased, my arm was hurting all the way into my armpit around my lymph node. I am a clinical pharmacist in a hospital, had a physician look at it and he suggested having my PCP look at it. She looked at it and prescribed 20mg prednisone x5 days. After taking the first dose of prednisone the redness, itching, and size has decreased.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: The patient went to Pharmacy on 9/20/2023 and was given a Flu shot and we received a fax on that day. On 9/22/2023 it was added to the patient immunization record in her chart. She came in for a annual wellness visit on 9/26/2023 and was given a 2nd flu shot. When the log was printed and doing the dose accountability logs. It was found on 9/29/2023 when going through the decrementing for the week. administration was notified and provider notified
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Mast cell activation syndrome
Clinical narrative: Mast Cell Activation Syndrome (MCAS); Life has been miserable since then; I don't leave the house; This serious, initial spontaneous safety report from the country was received by Novavax on 29-SEP-2023 from a consumer, via the contact center and customer experience center.  A female of an unspecified age and race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine unspecified dose (booster) on an unreported day in OCT-2022.  Medical history included Polymers allergy (polyethylene glycol), so the individual had Allergy to other unspecified COVID-19 vaccines, and Drug hypersensitivity to Paxlovid (nirmatrelvir, ritonavir).  No concomitant medications were reported.  On an unspecified date, reported as by JAN-2023, the individual developed mast cell activation syndrome (MCAS) (PT: Mast cell activation syndrome) (Serious: Medically Significant). Since an unspecified day in JAN-2023, her life had been miserable, and she didn't leave the house (PT: Feeling abnormal).  At the time of reporting, the event outcomes of Mast cell activation syndrome and Feeling abnormal were not recovered/not resolved.  Lot number was not provided in the report.; Sender's Comments: This female of an unspecified age experienced: Mast cell activation syndrome and Feeling abnormal after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Mast cell activation syndrome was reported as serious. The event Feeling abnormal was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety, Dizziness, Feeling hot, Loss of consciousness, Syncope
Clinical narrative: A few minutes after providing vaccination, client reported feeling warm and appeared anxious. Client was offered water and fruit snacks to help with potential nausea. Client then fainted for a short period of time. Client regained consciousness and was alert and oriented x3. Client drank more water until dizziness subsided, and Mom and client remained under observation until client stated he was feeling better and able to stand up without any dizziness.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Musculoskeletal stiffness, Rash
Clinical narrative: Rash covering injection site and spread throughout arm; site stiffness, erythema throughout
Age: 28.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Injection site pain, redness, burning (8am 10/2-ongoing)  other symptoms:  Muscular arm pain (11am 9/30-ongoing) Fatigue (5pm 9/30-10am 10/1) Full body skin sensitivity (8pm 9/30-10am 10/1) Headache (8pm 9/30-10am 10/1)
Age: 28.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Sensitive skin
Clinical narrative: Injection site pain, redness, burning (8am 10/2-ongoing)  other symptoms:  Muscular arm pain (11am 9/30-ongoing) Fatigue (5pm 9/30-10am 10/1) Full body skin sensitivity (8pm 9/30-10am 10/1) Headache (8pm 9/30-10am 10/1)
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pustule, Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Reports a pruritic rash with pustules and pain as she previously had with chicken pox presenting unclear time after vaccine but reported 4th day after vaccination, presenting 10/2 to clinic with a maculopapular rash chest and abdomen, little residual back or legs.  Not unlike a case of a severe grover's disease flare.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness without rash
Age: 71.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Erythema, Insomnia, Pain in extremity, Pyrexia, Skin swelling
Clinical narrative: Patient reports arm being sore, red and puffy. Difficult to sleep on and reports a low grade fever.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Myalgia, Pain, Pyrexia, Syncope
Clinical narrative: High fever x 2 days, body wide muscle pain and soreness (more severe at injection site), syncope 09/28
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Dyspnoea, Fatigue, General physical condition abnormal, Hypertension
Clinical narrative: Achy arm. In the same arm I developed a big red rash that itched intensely for 5-6 days. I am very tired and lethargic. My stomach hurts/aches. The doctor said I don't look good. My blood pressure is high. I also get short of breath and I know its the shot because I didn't feel this way before the shot.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Lethargy, Pain in extremity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Achy arm. In the same arm I developed a big red rash that itched intensely for 5-6 days. I am very tired and lethargic. My stomach hurts/aches. The doctor said I don't look good. My blood pressure is high. I also get short of breath and I know its the shot because I didn't feel this way before the shot.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Laboratory test, Oral mucosal eruption, Rash, Rash maculo-papular, Stevens-Johnson syndrome
Clinical narrative: Mild SJS: Maculopapular rash involving arms, trunk, and mouth
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pain
Clinical narrative: Continued Muscle Aches. Described as deep and dull as of today's date. Patient reports the aches/pains have not gotten better or worse since onset.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Unbeknownst to the Pharmacist, patient had already received a Fluarix shot on August 27, 2023. Patient and caregivers did not inform Pharmacist until after the Fluarix was already given. As such, patient received two Fluarix shots in the same season. One on 8.27.2023 and another on 10.02.2023
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Cellulitis, Chills, Fatigue, Headache, Malaise
Clinical narrative: Headache, fever, chills, malaise, and fatigue x 3 days then on day 5 had skin reaction on feet.  Treated in medical Center ER for cellulitis with Cephalexin.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Pyrexia, Skin reaction
Clinical narrative: Headache, fever, chills, malaise, and fatigue x 3 days then on day 5 had skin reaction on feet.  Treated in medical Center ER for cellulitis with Cephalexin.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Back pain, Condition aggravated, Feeling abnormal
Clinical narrative: Significant inflammation at injection site on left arm.  Bruising occurred in same area.  Large area of left arm around injection site became hot to the touch.  I began running a low grade fever around 5 PM.  At 9 PM, I started seeing black spots in my vision.  I went to sleep.  Next morning I began to experience body aches and felt generally miserable.  Areas where I have some arthritis such as my right knee, my left hip, and my back became inflamed and more painful than usual.  I ran another low grade fever that night.  By Monday morning, the symptoms had subsided but I still do not feel 100%.  Two of my family members who received the shot on the same day as me at approximately the same time also had similar reactions, but mine was the most significant.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Injection site bruising, Injection site inflammation, Injection site warmth, Pain
Clinical narrative: Significant inflammation at injection site on left arm.  Bruising occurred in same area.  Large area of left arm around injection site became hot to the touch.  I began running a low grade fever around 5 PM.  At 9 PM, I started seeing black spots in my vision.  I went to sleep.  Next morning I began to experience body aches and felt generally miserable.  Areas where I have some arthritis such as my right knee, my left hip, and my back became inflamed and more painful than usual.  I ran another low grade fever that night.  By Monday morning, the symptoms had subsided but I still do not feel 100%.  Two of my family members who received the shot on the same day as me at approximately the same time also had similar reactions, but mine was the most significant.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Visual impairment
Clinical narrative: Significant inflammation at injection site on left arm.  Bruising occurred in same area.  Large area of left arm around injection site became hot to the touch.  I began running a low grade fever around 5 PM.  At 9 PM, I started seeing black spots in my vision.  I went to sleep.  Next morning I began to experience body aches and felt generally miserable.  Areas where I have some arthritis such as my right knee, my left hip, and my back became inflamed and more painful than usual.  I ran another low grade fever that night.  By Monday morning, the symptoms had subsided but I still do not feel 100%.  Two of my family members who received the shot on the same day as me at approximately the same time also had similar reactions, but mine was the most significant.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was given a dose of vaccine that was expired.  No complaints or reactions have been notified of.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: None noted.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Back pain, Bedridden
Clinical narrative: (Previous 4 vaccinations were: 1+2 primary strain monovalent series, 1 strain booster, 1 bivalent booster. The 2nd vaccine had comparably bad side effects, but overall the 5th round may have been worse.)  Starting 12 hours post vaccination, and continuing for 24 hours (about 36 hours post-vaccination), the following side effects were observed. The overall effect was "severe", in that I was bedridden for 20 of those 24 hours, and several the times pain/discomfort level reached 6-7 out of 10, _despite_ dosing at the maximum OTC rate of acetominophen (500mg every 5-6 hours). In the prior 2 boosters, taking acetaminophen managed symptoms somewhat adequately.  - fever / chills / shivering -- fever topped out around 38C, but did not fully respond to acetaminophen   - stomach pain -- could not hold down any food after 11am on 9/30  - nausea  - repeated diarrhea   - muscle pain, especially head/neck/back pain that did not respond to acetaminophen -- but also aches in the extremities  The "severe" phase started to subside around 18:00 on 9/3, but the fever/muscle aches/upper & lower digestive issues continued until the morning of 9/4, when I was able to take some simple food for the first time.  At 36-72 hours post-vaccination, I was able to gradually resume normal activities, with these notable sequelae:  - significant fatigue requiring 6+ extra hours of sleep on 9/4  - residual neuromuscular pain (esp left wrist pain & tingling, left shoulder-blade pain)  - residual GI discomfort (looser / more frequent stools)
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Discomfort, Fatigue, Gastrointestinal disorder
Clinical narrative: (Previous 4 vaccinations were: 1+2 primary strain monovalent series, 1 strain booster, 1 bivalent booster. The 2nd vaccine had comparably bad side effects, but overall the 5th round may have been worse.)  Starting 12 hours post vaccination, and continuing for 24 hours (about 36 hours post-vaccination), the following side effects were observed. The overall effect was "severe", in that I was bedridden for 20 of those 24 hours, and several the times pain/discomfort level reached 6-7 out of 10, _despite_ dosing at the maximum OTC rate of acetominophen (500mg every 5-6 hours). In the prior 2 boosters, taking acetaminophen managed symptoms somewhat adequately.  - fever / chills / shivering -- fever topped out around 38C, but did not fully respond to acetaminophen   - stomach pain -- could not hold down any food after 11am on 9/30  - nausea  - repeated diarrhea   - muscle pain, especially head/neck/back pain that did not respond to acetaminophen -- but also aches in the extremities  The "severe" phase started to subside around 18:00 on 9/3, but the fever/muscle aches/upper & lower digestive issues continued until the morning of 9/4, when I was able to take some simple food for the first time.  At 36-72 hours post-vaccination, I was able to gradually resume normal activities, with these notable sequelae:  - significant fatigue requiring 6+ extra hours of sleep on 9/4  - residual neuromuscular pain (esp left wrist pain & tingling, left shoulder-blade pain)  - residual GI discomfort (looser / more frequent stools)
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal pain, Myalgia, Nausea, Neck pain
Clinical narrative: (Previous 4 vaccinations were: 1+2 primary strain monovalent series, 1 strain booster, 1 bivalent booster. The 2nd vaccine had comparably bad side effects, but overall the 5th round may have been worse.)  Starting 12 hours post vaccination, and continuing for 24 hours (about 36 hours post-vaccination), the following side effects were observed. The overall effect was "severe", in that I was bedridden for 20 of those 24 hours, and several the times pain/discomfort level reached 6-7 out of 10, _despite_ dosing at the maximum OTC rate of acetominophen (500mg every 5-6 hours). In the prior 2 boosters, taking acetaminophen managed symptoms somewhat adequately.  - fever / chills / shivering -- fever topped out around 38C, but did not fully respond to acetaminophen   - stomach pain -- could not hold down any food after 11am on 9/30  - nausea  - repeated diarrhea   - muscle pain, especially head/neck/back pain that did not respond to acetaminophen -- but also aches in the extremities  The "severe" phase started to subside around 18:00 on 9/3, but the fever/muscle aches/upper & lower digestive issues continued until the morning of 9/4, when I was able to take some simple food for the first time.  At 36-72 hours post-vaccination, I was able to gradually resume normal activities, with these notable sequelae:  - significant fatigue requiring 6+ extra hours of sleep on 9/4  - residual neuromuscular pain (esp left wrist pain & tingling, left shoulder-blade pain)  - residual GI discomfort (looser / more frequent stools)
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Neuromuscular pain, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: (Previous 4 vaccinations were: 1+2 primary strain monovalent series, 1 strain booster, 1 bivalent booster. The 2nd vaccine had comparably bad side effects, but overall the 5th round may have been worse.)  Starting 12 hours post vaccination, and continuing for 24 hours (about 36 hours post-vaccination), the following side effects were observed. The overall effect was "severe", in that I was bedridden for 20 of those 24 hours, and several the times pain/discomfort level reached 6-7 out of 10, _despite_ dosing at the maximum OTC rate of acetominophen (500mg every 5-6 hours). In the prior 2 boosters, taking acetaminophen managed symptoms somewhat adequately.  - fever / chills / shivering -- fever topped out around 38C, but did not fully respond to acetaminophen   - stomach pain -- could not hold down any food after 11am on 9/30  - nausea  - repeated diarrhea   - muscle pain, especially head/neck/back pain that did not respond to acetaminophen -- but also aches in the extremities  The "severe" phase started to subside around 18:00 on 9/3, but the fever/muscle aches/upper & lower digestive issues continued until the morning of 9/4, when I was able to take some simple food for the first time.  At 36-72 hours post-vaccination, I was able to gradually resume normal activities, with these notable sequelae:  - significant fatigue requiring 6+ extra hours of sleep on 9/4  - residual neuromuscular pain (esp left wrist pain & tingling, left shoulder-blade pain)  - residual GI discomfort (looser / more frequent stools)
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: (Previous 4 vaccinations were: 1+2 primary strain monovalent series, 1 strain booster, 1 bivalent booster. The 2nd vaccine had comparably bad side effects, but overall the 5th round may have been worse.)  Starting 12 hours post vaccination, and continuing for 24 hours (about 36 hours post-vaccination), the following side effects were observed. The overall effect was "severe", in that I was bedridden for 20 of those 24 hours, and several the times pain/discomfort level reached 6-7 out of 10, _despite_ dosing at the maximum OTC rate of acetominophen (500mg every 5-6 hours). In the prior 2 boosters, taking acetaminophen managed symptoms somewhat adequately.  - fever / chills / shivering -- fever topped out around 38C, but did not fully respond to acetaminophen   - stomach pain -- could not hold down any food after 11am on 9/30  - nausea  - repeated diarrhea   - muscle pain, especially head/neck/back pain that did not respond to acetaminophen -- but also aches in the extremities  The "severe" phase started to subside around 18:00 on 9/3, but the fever/muscle aches/upper & lower digestive issues continued until the morning of 9/4, when I was able to take some simple food for the first time.  At 36-72 hours post-vaccination, I was able to gradually resume normal activities, with these notable sequelae:  - significant fatigue requiring 6+ extra hours of sleep on 9/4  - residual neuromuscular pain (esp left wrist pain & tingling, left shoulder-blade pain)  - residual GI discomfort (looser / more frequent stools)
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Body temperature increased, Cellulitis, Hyperaesthesia, Injection site pain, Vaccination site bruising
Clinical narrative: She got her vaccine, it turned out real red the following day, was the size of a silver dollar and then it spread and growing, just barely visible now and is bruised that she noticed today.  I was running a low grade temp of 100.4.  She had already taken her regular medicines that she takes and 2 Tylenol that morning.  She went to the doctor on 9/27/23 and was told that she had cellulitis.  They put her on antibiotics, Keflex.  She was told to put hot and cold compresses on it.  It was tender the touch to the point that she could barely touch it.    It is much better now and does not hurt right now, redness is gone now and just barely bruised.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site erythema
Clinical narrative: She got her vaccine, it turned out real red the following day, was the size of a silver dollar and then it spread and growing, just barely visible now and is bruised that she noticed today.  I was running a low grade temp of 100.4.  She had already taken her regular medicines that she takes and 2 Tylenol that morning.  She went to the doctor on 9/27/23 and was told that she had cellulitis.  They put her on antibiotics, Keflex.  She was told to put hot and cold compresses on it.  It was tender the touch to the point that she could barely touch it.    It is much better now and does not hurt right now, redness is gone now and just barely bruised.
Age: 36.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Aphonia, Brain fog, Energy increased, Fatigue, Pericoronitis
Clinical narrative: At around 6pm, 4 hours after receiving the vaccines, I experienced about 30 minutes of significantly increased energy.  At around 6:30pm, extreme fatigue set in that has continued through today, Monday, October 2.  On Friday, September 29, the fatigue increased substantially and I had trouble staying awake.  I began to lose my voice, and experienced pericoronitis, or swelling or the tissue around my right molars.  Throughout this entire time, I have had significant brain fog and an inability to think clearly.  These symptoms are beginning to resolve after several days of rest.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Foetal monitoring normal, Uterine spasm, Vaginal haemorrhage
Clinical narrative: A couple hours after getting the vaccine, I started experiencing tightness all throughout my uterus. Like a Braxton hicks contraction that wouldn?t stop, although I laid down and drank water. It eventually went away. It came back the next morning, off and on, despite being hydrated. Then I started spotting vaginally. My obstetrician sent me to Labor and Delivery, where I was eventually cleared and sent home. No signs of premature labor. Cervix length was good. Was 20wks1d at time of vaccination, 20wks2d at time of L&D visits. Never had these symptoms before during two prior successful pregnancies, also received a covid vaccine without incident my second successful pregnancy, it was Pfizer.
Age: 56.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Brain fog, Erythema, Injection site erythema, Injection site reaction, Lethargy
Clinical narrative: Most of left arm is swollen, red, warm to touch. Injection site is red and blotchy. Patient feels lethargic and mind feels foggy.
Age: 56.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Peripheral swelling, Rash macular, Skin warm
Clinical narrative: Most of left arm is swollen, red, warm to touch. Injection site is red and blotchy. Patient feels lethargic and mind feels foggy.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Severe Chills for several hours
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 73.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Chills, Hypoaesthesia oral, Lip swelling, Pain in extremity, Pyrexia
Clinical narrative: Initial within the first few hours, had a sore right arm and then began to chills.  Lager on that evening had a fever.  Fever and chills persisted through the night.  Took Advil multiple times to combat the symptoms.  In the morning, by around 8 am felt my upper lip becoming a bit numb and growing in size.  Began taking benadryl. within the hour.  and took every 4 hours the rest of Sunday.  My lip size did grow a bit larger ad was somewhat numb, like the dentist after an anesthetic,  By the afternoon, my lip size began to recede and continued until was about normal by 9 pm. Fever and chills were gone by that time. And all normal on Monday 10/02/23.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 17.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Seizure like phenomena
Clinical narrative: Other nurse  was alerted to patient experiencing "seizure like" activity in the waiting area at approximately 1430. Per nurse patient appeared lucid and conscious upon her immediate response. Writer arrived for unrelated reason and saw other nurse was already tending to patient. Patient noted to have legs elevated, and a cool towel on head. nurse asked student nurse to get a snack and gatorade while writer was looking for cold compress on arrival. Writer provided nurse with a cold compress and she placed it on patient's chest approximately one minute after arrival. After 2 minutes of lying down with feet elevated patient stated he wanted to sit up in a chair. Writer and nurse assisted to chair. Writer observed patient for approximately 10 minutes. Patient stated he was feeling better. Patient's representative was instructed to have patient wait another 10 minutes in observation area. Both patient and patient's representative verbalized understanding.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Unresponsive to stimuli
Clinical narrative: Patient quickly became lightheaded following flublock, but wanted to go ahead and get shingrix.  I moved him to another chair in the same room and brought his wife into the room.  We started talking to the patient, but he did not respond even though his eyes were open.  We both went to his side and started giving him our full attention.  He appeared to struggle for a breath for a short time, then came to and started sweating profusely.  I had a technician call EMS and had the other pharmacist come for assistance.  After quite a bit of more profuse sweating, the paramedics arrived.  The patient said that he was feeling okay by then.  They checked his vitals and his heart rate and blood pressure were in a normal range for him.  He refused to go to the hospital , but the paramedics walked him out to his car.  He told us that he had sometimes had this type of reaction before, but never brought on by the flu vaccine or the shingles vaccine.  His wife texted me later that he was doing fine and sleeping quite a bit.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeling hot, Headache, Myalgia
Clinical narrative: muscle pain, weakness, hot, headache
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT