chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Pruritus, Respiratory tract congestion
Clinical narrative: Pt. reported back to clinic at 1540 with c/o tingling, itchiness and "feeling hot'.  Pt. also had cough and stated he felt "short of breath".   Temperature was 100.4F.  Pt. given 50mg of Benadryl PO and was continued to be monitored by Dr.  Dr. noted chest congestion on auscultation and therefore administered Epi Pen 0.3mg in pt. thigh at 1550.  Pt. remained alert and oriented.  Shortly after pt. reported feeling better and was advised to go to ER for further evaluation.  Pt. taken by friend in personal vehicle to ER.  Pt. reported he was being monitored at the ER.
Age: 1.67
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Child inadvertently given HPV Gardasil-9 instead of intended prevnar vaccine. 2 days after administration child had fever 100.2 with no other symptoms.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The technician accidentally gave 2 doses of the covid-19 vaccine rather than one. The patient's partner was also in the room with him and was supposed to receive the dose that was accidentally given.  So far, the patient has not reported any adverse reactions.
Age: 1.0
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13, UNK
Symptoms: Abnormal behaviour, Aphasia, Crying, Diet refusal, Injection site rash
Clinical narrative: The day after his vaccines, patient developed big, raised rashes on both thighs (injection sites). He also had intermittent fevers. We were told this was normal for up to 3 days following his vaccines. His symptoms seemed to be improving but on the 5th day following his vaccines he was inconsolable. He was screaming - at times so hard I thought he'd stop breathing. He is a very talkative baby but he completely stopped talking. He would not eat or sleep. He would stop screaming and calm down every hour or so for a few minutes and then would start up again. The behavior was completely abnormal for him and was extremely worrisome. We took him to Urgent Care around 9pm and was told it was 'teething'. Patient has MANY of his teeth already (started teething at 4mo old) - as his parent I know that this was not teething. Thankfully the next day he slowly started to come back to himself but the event was terrifying as I have heard stories of children becoming non verbal after vaccinations. I really thought that was what we were facing. During the 12+ hours that he was screaming it truly seemed like he had been poisoned. He no longer had a fever but it seemed like something was eating at him from inside. I'm sorry for not having better words to describe this but it was like nothing I've ever experienced and I know it was from the shots that he received.
Age: 1.0
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13, UNK
Symptoms: Injection site swelling, Pyrexia, Screaming, Sleep disorder
Clinical narrative: The day after his vaccines, patient developed big, raised rashes on both thighs (injection sites). He also had intermittent fevers. We were told this was normal for up to 3 days following his vaccines. His symptoms seemed to be improving but on the 5th day following his vaccines he was inconsolable. He was screaming - at times so hard I thought he'd stop breathing. He is a very talkative baby but he completely stopped talking. He would not eat or sleep. He would stop screaming and calm down every hour or so for a few minutes and then would start up again. The behavior was completely abnormal for him and was extremely worrisome. We took him to Urgent Care around 9pm and was told it was 'teething'. Patient has MANY of his teeth already (started teething at 4mo old) - as his parent I know that this was not teething. Thankfully the next day he slowly started to come back to himself but the event was terrifying as I have heard stories of children becoming non verbal after vaccinations. I really thought that was what we were facing. During the 12+ hours that he was screaming it truly seemed like he had been poisoned. He no longer had a fever but it seemed like something was eating at him from inside. I'm sorry for not having better words to describe this but it was like nothing I've ever experienced and I know it was from the shots that he received.
Sex: U
Vaccine: RSV
Symptoms: Product prescribing error
Clinical narrative: recommended to his Pts to get Arexvy every year like the flu shot; This non-serious case was reported by a physician via sales rep and described the occurrence of drug prescribing error in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced drug prescribing error (Verbatim: recommended to his Pts to get Arexvy every year like the flu shot). The outcome of the drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2024 The physician reported that Arexvy vaccine early on in the life recommended to his patients to get the Arexvy every year like the flu shot which led to Drug prescribing error. What was the risk to patients if they have received the two doses of Arexvy vaccine. Did need to called all of these patients to inform them that recommended otherwise.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Needle issue
Clinical narrative: Faulty needle, had to reinject patient
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Back pain, CSF protein increased, Gait inability, Immunoglobulin therapy, Intervertebral disc protrusion
Clinical narrative: Patient received RSV vaccine on 6/6/24  Unknown brand but system had HM9849 as Lot number.  On 6/11 /24 Patient presented to ED via EMS with chief complaint of lower extremity tingling, weakness, cannot bear weight. Symptoms began approx 10 hours prior to presentation.  Tingling in legs bilaterally is related to back pain but nothing worse or new.  He can move legs but can not walk. No injuries, no fevers or chills. Physical exam unremarkable except that he can move lower extremities normally with exception of not being able to move toes. 6/11/24: Patient had MRI of cervical, thoracic and lumbar spine. No significant findings to explain symptoms.  Lumbar puncture on 6/12/24  obtained only abnormal finding was CSF Total Protein 72.2 (High) .  Patient was started on IVIG 6/12/24 - 6/16/24 (50 grams daily) & Steroids (solumedrol 500mg IV BID) 6/14-6/17/24  for potential Guillian-Barre Syndrome.  Repeat MRI lumbar spine w/wo con IMPRESSION:  1. Current MRI is mild to moderately degraded by motion on all sequences and worse than the prior MRI. 2. Stable abnormal increased T2 signal within the lower thoracic cord from the lower T11 vertebra down to the conus without associated abnormal enhancement or mass effect and without significant change from the prior MRI 6/11/2024. 3. Question new small focus of increased T2 signal within the lower thoracic cord at the T10-11 disc though only seen on the sagittal T2 images and not corroborated on the STIR or axial images and therefore may be artifactual and not seen on the prior MRI thoracic spine. 4. Stable multilevel degenerative changes lumbar spine worse at L3-4 where there is associated small to moderate left lateral recess disc protrusion produces moderate left lateral recess narrowing and mild to moderate bilateral foraminal narrowing without significant change though better seen previously. 5. Stable degenerative retrolisthesis at L2-3 produces mild-to-moderate central canal narrowing and mild bilateral foraminal narrowing left worse than right better seen previously. 6. No other definite abnormality or change and no abnormal mass or enhancement unchanged.   Final diagnosis per Neurology was idiopathic transverse myelitis. Patient was discharged to Rehab  6/25/24- 7/18/24. At time of discharge from Rehab his strength and sensation have improved but are not back to normal. Ambulating with a walker.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Lumbar spinal stenosis, Magnetic resonance imaging spinal abnormal, Mobility decreased, Muscular weakness, Myelitis transverse
Clinical narrative: Patient received RSV vaccine on 6/6/24  Unknown brand but system had HM9849 as Lot number.  On 6/11 /24 Patient presented to ED via EMS with chief complaint of lower extremity tingling, weakness, cannot bear weight. Symptoms began approx 10 hours prior to presentation.  Tingling in legs bilaterally is related to back pain but nothing worse or new.  He can move legs but can not walk. No injuries, no fevers or chills. Physical exam unremarkable except that he can move lower extremities normally with exception of not being able to move toes. 6/11/24: Patient had MRI of cervical, thoracic and lumbar spine. No significant findings to explain symptoms.  Lumbar puncture on 6/12/24  obtained only abnormal finding was CSF Total Protein 72.2 (High) .  Patient was started on IVIG 6/12/24 - 6/16/24 (50 grams daily) & Steroids (solumedrol 500mg IV BID) 6/14-6/17/24  for potential Guillian-Barre Syndrome.  Repeat MRI lumbar spine w/wo con IMPRESSION:  1. Current MRI is mild to moderately degraded by motion on all sequences and worse than the prior MRI. 2. Stable abnormal increased T2 signal within the lower thoracic cord from the lower T11 vertebra down to the conus without associated abnormal enhancement or mass effect and without significant change from the prior MRI 6/11/2024. 3. Question new small focus of increased T2 signal within the lower thoracic cord at the T10-11 disc though only seen on the sagittal T2 images and not corroborated on the STIR or axial images and therefore may be artifactual and not seen on the prior MRI thoracic spine. 4. Stable multilevel degenerative changes lumbar spine worse at L3-4 where there is associated small to moderate left lateral recess disc protrusion produces moderate left lateral recess narrowing and mild to moderate bilateral foraminal narrowing without significant change though better seen previously. 5. Stable degenerative retrolisthesis at L2-3 produces mild-to-moderate central canal narrowing and mild bilateral foraminal narrowing left worse than right better seen previously. 6. No other definite abnormality or change and no abnormal mass or enhancement unchanged.   Final diagnosis per Neurology was idiopathic transverse myelitis. Patient was discharged to Rehab  6/25/24- 7/18/24. At time of discharge from Rehab his strength and sensation have improved but are not back to normal. Ambulating with a walker.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Paraesthesia, Scan with contrast abnormal, Spinal osteoarthritis, Spinal retrolisthesis, Vertebral foraminal stenosis
Clinical narrative: Patient received RSV vaccine on 6/6/24  Unknown brand but system had HM9849 as Lot number.  On 6/11 /24 Patient presented to ED via EMS with chief complaint of lower extremity tingling, weakness, cannot bear weight. Symptoms began approx 10 hours prior to presentation.  Tingling in legs bilaterally is related to back pain but nothing worse or new.  He can move legs but can not walk. No injuries, no fevers or chills. Physical exam unremarkable except that he can move lower extremities normally with exception of not being able to move toes. 6/11/24: Patient had MRI of cervical, thoracic and lumbar spine. No significant findings to explain symptoms.  Lumbar puncture on 6/12/24  obtained only abnormal finding was CSF Total Protein 72.2 (High) .  Patient was started on IVIG 6/12/24 - 6/16/24 (50 grams daily) & Steroids (solumedrol 500mg IV BID) 6/14-6/17/24  for potential Guillian-Barre Syndrome.  Repeat MRI lumbar spine w/wo con IMPRESSION:  1. Current MRI is mild to moderately degraded by motion on all sequences and worse than the prior MRI. 2. Stable abnormal increased T2 signal within the lower thoracic cord from the lower T11 vertebra down to the conus without associated abnormal enhancement or mass effect and without significant change from the prior MRI 6/11/2024. 3. Question new small focus of increased T2 signal within the lower thoracic cord at the T10-11 disc though only seen on the sagittal T2 images and not corroborated on the STIR or axial images and therefore may be artifactual and not seen on the prior MRI thoracic spine. 4. Stable multilevel degenerative changes lumbar spine worse at L3-4 where there is associated small to moderate left lateral recess disc protrusion produces moderate left lateral recess narrowing and mild to moderate bilateral foraminal narrowing without significant change though better seen previously. 5. Stable degenerative retrolisthesis at L2-3 produces mild-to-moderate central canal narrowing and mild bilateral foraminal narrowing left worse than right better seen previously. 6. No other definite abnormality or change and no abnormal mass or enhancement unchanged.   Final diagnosis per Neurology was idiopathic transverse myelitis. Patient was discharged to Rehab  6/25/24- 7/18/24. At time of discharge from Rehab his strength and sensation have improved but are not back to normal. Ambulating with a walker.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Walking aid user, Weight bearing difficulty
Clinical narrative: Patient received RSV vaccine on 6/6/24  Unknown brand but system had HM9849 as Lot number.  On 6/11 /24 Patient presented to ED via EMS with chief complaint of lower extremity tingling, weakness, cannot bear weight. Symptoms began approx 10 hours prior to presentation.  Tingling in legs bilaterally is related to back pain but nothing worse or new.  He can move legs but can not walk. No injuries, no fevers or chills. Physical exam unremarkable except that he can move lower extremities normally with exception of not being able to move toes. 6/11/24: Patient had MRI of cervical, thoracic and lumbar spine. No significant findings to explain symptoms.  Lumbar puncture on 6/12/24  obtained only abnormal finding was CSF Total Protein 72.2 (High) .  Patient was started on IVIG 6/12/24 - 6/16/24 (50 grams daily) & Steroids (solumedrol 500mg IV BID) 6/14-6/17/24  for potential Guillian-Barre Syndrome.  Repeat MRI lumbar spine w/wo con IMPRESSION:  1. Current MRI is mild to moderately degraded by motion on all sequences and worse than the prior MRI. 2. Stable abnormal increased T2 signal within the lower thoracic cord from the lower T11 vertebra down to the conus without associated abnormal enhancement or mass effect and without significant change from the prior MRI 6/11/2024. 3. Question new small focus of increased T2 signal within the lower thoracic cord at the T10-11 disc though only seen on the sagittal T2 images and not corroborated on the STIR or axial images and therefore may be artifactual and not seen on the prior MRI thoracic spine. 4. Stable multilevel degenerative changes lumbar spine worse at L3-4 where there is associated small to moderate left lateral recess disc protrusion produces moderate left lateral recess narrowing and mild to moderate bilateral foraminal narrowing without significant change though better seen previously. 5. Stable degenerative retrolisthesis at L2-3 produces mild-to-moderate central canal narrowing and mild bilateral foraminal narrowing left worse than right better seen previously. 6. No other definite abnormality or change and no abnormal mass or enhancement unchanged.   Final diagnosis per Neurology was idiopathic transverse myelitis. Patient was discharged to Rehab  6/25/24- 7/18/24. At time of discharge from Rehab his strength and sensation have improved but are not back to normal. Ambulating with a walker.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Asthenia, Muscle tightness, Myalgia
Clinical narrative: Adverse reaction: muscles in legs are tight and very painful, difficult to get up from a squat, decreased strength.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Heart rate increased, Hyperhidrosis
Clinical narrative: About 20 hours after receiving the vaccine, I started sweating profusely, and had a swollen, red arm at the injection site. My resting heart rate jumped from 83 to 90,  and my chest has been tight and in pain. I feel like I can?t breathe.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: About 20 hours after receiving the vaccine, I started sweating profusely, and had a swollen, red arm at the injection site. My resting heart rate jumped from 83 to 90,  and my chest has been tight and in pain. I feel like I can?t breathe.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: They have tested positive for COVID-19 twice; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (They have tested positive for COVID-19 twice) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (They have tested positive for COVID-19 twice). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in 2023 for COVID-19, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) in 2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (They have tested positive for COVID-19 twice) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive. In 2023, SARS-CoV-2 test: Positive.         No concomitant medication was reported.  In 2022, she got Covid and also in 2023. Patient was fully vaccinated with Moderna COVID-19 vaccine. Patient was tested positive for COVID-19 twice, and patient took Paxlovid each time for treatment. Patient wanted to know if she could take Paxlovid for the third time. The last time when she took, it was last summer.   This case was linked to US-MODERNATX, INC.-MOD-2024-773382 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773382:Husband case
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Lethargy, Urticaria
Clinical narrative: Feeling lethargic; urticaria and hives; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (Feeling lethargic) and URTICARIA (urticaria and hives) in a 67-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080433) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1) on 25-Feb-2021, Moderna covid-19 vaccine (Dose 2) on 24-Mar-2021, Moderna covid-19 vaccine (Dose 3) on 29-Oct-2021, Moderna covid-19 vaccine (Dose 4) on 02-Apr-2022, Moderna covid-19 vaccine (Dose 5) on 09-Sep-2022 and Moderna covid-19 vaccine (Dose 6) on 27-Sep-2022. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine. Concurrent medical conditions included Acute myeloid leukemia (resolved and monitoring. No further diagnoses) since 2000.    On 03-Sep-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On 03-Sep-2024, the patient experienced LETHARGY (Feeling lethargic) and URTICARIA (urticaria and hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 03-Sep-2024 at a dose of 25 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 03-Sep-2024 at a dose of 25 milligram. On 04-Sep-2024, LETHARGY (Feeling lethargic) and URTICARIA (urticaria and hives) had resolved.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. Patient felt asleep on the couch, remembered, dragging himself to bed in the middle of the night and felt lethargic in the morning with no further symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fall, Tremor, Vaccination site pain
Clinical narrative: falls; dizziness/vertigo; Injection site soreness/swelling; Injection site soreness/swelling; chills; shaking; dizziness/vertigo; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), VERTIGO (dizziness/vertigo), FALL (falls), DIZZINESS (dizziness/vertigo) and VACCINATION SITE PAIN (Injection site soreness/swelling) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic migraine and Factor V Leiden mutation. Previously administered products included for Product used for unknown indication: Flu shot on 26-Aug-2024. Past adverse reactions to the above products included No adverse effect with Flu shot.    On 03-Sep-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 03-Sep-2024, the patient experienced TREMOR (shaking), VERTIGO (dizziness/vertigo), DIZZINESS (dizziness/vertigo), VACCINATION SITE PAIN (Injection site soreness/swelling), VACCINATION SITE SWELLING (Injection site soreness/swelling) and CHILLS (chills). On an unknown date, the patient experienced FALL (falls). At the time of the report, TREMOR (shaking), VERTIGO (dizziness/vertigo), DIZZINESS (dizziness/vertigo), VACCINATION SITE PAIN (Injection site soreness/swelling), VACCINATION SITE SWELLING (Injection site soreness/swelling) and CHILLS (chills) was resolving and FALL (falls) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter causality was not reported.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if the patient had any additional medical history, concomitant disease or risk factor. Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vertigo
Clinical narrative: falls; dizziness/vertigo; Injection site soreness/swelling; Injection site soreness/swelling; chills; shaking; dizziness/vertigo; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), VERTIGO (dizziness/vertigo), FALL (falls), DIZZINESS (dizziness/vertigo) and VACCINATION SITE PAIN (Injection site soreness/swelling) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic migraine and Factor V Leiden mutation. Previously administered products included for Product used for unknown indication: Flu shot on 26-Aug-2024. Past adverse reactions to the above products included No adverse effect with Flu shot.    On 03-Sep-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 03-Sep-2024, the patient experienced TREMOR (shaking), VERTIGO (dizziness/vertigo), DIZZINESS (dizziness/vertigo), VACCINATION SITE PAIN (Injection site soreness/swelling), VACCINATION SITE SWELLING (Injection site soreness/swelling) and CHILLS (chills). On an unknown date, the patient experienced FALL (falls). At the time of the report, TREMOR (shaking), VERTIGO (dizziness/vertigo), DIZZINESS (dizziness/vertigo), VACCINATION SITE PAIN (Injection site soreness/swelling), VACCINATION SITE SWELLING (Injection site soreness/swelling) and CHILLS (chills) was resolving and FALL (falls) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter causality was not reported.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if the patient had any additional medical history, concomitant disease or risk factor. Treatment medications were not provided.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pyrexia, Vertigo
Clinical narrative: nausea; head spinning; fever; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (nausea), VERTIGO (head spinning) and PYREXIA (fever) in an 80-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Sep-2024, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 04-Sep-2024, the patient experienced NAUSEA (nausea), VERTIGO (head spinning) and PYREXIA (fever). At the time of the report, NAUSEA (nausea), VERTIGO (head spinning) and PYREXIA (fever) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient stated she was real upset. She heard Moderna was better for older people, lasted longer. She received her first and only dose of Moderna vaccine and had nausea, head spinning, and a fever. She added that she never had that with the Pfizer vaccine. Her reflexes at age 80 are not as good as they should be. Reporter causality was not reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Headache, Vomiting
Clinical narrative: she currently has not eaten anything; headache; vomited; diarrhea; dizziness; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (dizziness), DECREASED APPETITE (she currently has not eaten anything), HEADACHE (headache) and VOMITING (vomited) in a 62-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042879) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1), MODERNA COVID-19 VACCINE (Dose 2), MODERNA COVID-19 VACCINE (Dose 6), MODERNA COVID-19 VACCINE (Dose 4), MODERNA COVID-19 VACCINE (Dose 5) and MODERNA COVID-19 VACCINE (Dose 3). Past adverse reactions to the above products included No adverse effect with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.    On 31-Aug-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 02-Sep-2024, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (dizziness), HEADACHE (headache) and VOMITING (vomited). On 04-Sep-2024, the patient experienced DECREASED APPETITE (she currently has not eaten anything). At the time of the report, DIARRHOEA (diarrhea), DIZZINESS (dizziness), DECREASED APPETITE (she currently has not eaten anything), HEADACHE (headache) and VOMITING (vomited) was resolving.            It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine or not.  It was unknown if patient had any relevant medical history/conditions, allergy, concomitant diseases and risk factor.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Patient did not to experience symptoms until 02-Sep-2024. She had diarrhea, headache, dizziness and vomited a lot. He states that her symptoms lasted all of 03-Sep-2024 and she currently had not eaten anything on 04-Sep-2024 but she was doing better.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773383 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773383:Patient husband case
Sex: F
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: She is shaking like a son of a gun; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TREMOR (She is shaking like a son of a gun) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (She is shaking like a son of a gun). At the time of the report, TREMOR (She is shaking like a son of a gun) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.     No concomitant medication was reported.  Suspect product dosage text was reported as Unknown. The reporter stated that on 03SEP24, around 24 or 36 hours ago, he and his wife had a COVID-19 vaccination but his wife was shaking and she claims she's read that this can happen. The reporter stated that his wife was shaking uncontrollably. She had to try and hold her hands. Reporter causality was not reported. No treatment medication was reported
Sex: U
Vaccine: HPVX, MEN, MENB
Symptoms: Limb mass
Clinical narrative: Hard lump under skin on her arm which she does not describe as swelling/ that it's been 5 days since she received the vaccines and she had 2 lumps; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024SA234242 (Sanofi).  Initial information received on 03-Aug-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer/ Non-Healthcare Professional. This case involves a 12 years old female patient who had "hard lump under her skin" on her arm which she does not describe as swelling/that it's been 5 days since she received the vaccines and she had 2 lumps received both MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) and MENINGOCOCCAL A-C-Y- W 135 (T CONJ) VACCINE (MENQUADFI) in the same arm and received both meningitis vaccines in the same day and also received HPV VACCINE. It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatments, vaccination(s) and family history were not provided. On 01-Aug-2024, the patient received MENINGOCOCCAL A-C-Y- W 135 (T CONJ) VACCINE Solution for injection, TRUMENBA and HPV VACCINE not produced by Sanofi Pasteur via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, dose, batch number and expiry date unknown) both meningitis vaccines in the same arm (vaccination error) and received both meningitis vaccines in the same day (extra dose administered) (latency same day). Information on batch number corresponding to the one at time of event occurrence could not be requested. On 06-AUG-2024 the patient had "hard lump under her skin" on her arm which she does not describe as swelling/that it's been 5 days since she received the vaccines and she had 2 lumps (nodule). It is unknown if there were lab data/ results available. Action taken: not applicable. It was not reported if the patient received a corrective treatment for nodule.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Ophthalmic migraine, Vestibular disorder
Clinical narrative: ocular migraines; vestibular issues; Initial information received on 21-Aug-2024 regarding an unsolicited valid non-serious case received from a patient.  This case involves a 57 years old female patient who had ocular migraines and vestibular issues after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Sodium.  On an unknown date in May 2021, the patient received 0.5 mL 1X, Suspension for injection of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6855AA via unknown route in unknown administration site for  Immunization (strength, batch number unknown).  On an unknown date in 2021 the patient had ocular migraines (ophthalmic migraine) and vestibular issues (vestibular disorder) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Not Recovered / Not Resolved for the events.
Sex: U
Vaccine: DTAP, DTAPIPVHIB, MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: PENTACEL, DAPTACEL, MENQUADFI/temperature become a little bit colder Max/low temperature it got to a lowest of 31.6 Fahrenheit 45 minutes/Human error with no AE; the vaccines were given after the excursion happened with no AE; Initial information received on 28-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to (2024SA253381, 2024SA253310) cases.  This case involves an unknown age and unknown gender patient where meningococcal a-c-y-w135 (t conj) vaccine [menquadfi], diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] and diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] /temperature become a little bit colder max/low temperature it got to a lowest of 31.6 fahrenheit 45 minutes/human error with no adverse event and the vaccines were given after the excursion happened with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot- U8113BA and expiration date- 31-JUL-2026) via unknown route in unknown administration site and received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot- UK017AA and expiration date- 30-JUN-2025) via unknown route in unknown administration site and received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot- 3CA03C3 and expiration date- 30-SEP-2025) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (product storage error) and (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 2-month old patient has received ipol and vaxelis on the same day with no reported adverse event; Initial information received on 29-Aug-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 months old male patient who has received both vaccine IPV (VERO) [IPOL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [VAXELIS] on the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) for Immunisation.   On 23-Aug-2024, the patient received total 0.5 ml of suspect IPV (VERO), Suspension for injection (lot W1A191M and expiry 16-Feb-2025) (strength: unknown) via subcutaneous route in the thigh nos (not specified) and VAXELIS not produced by Sanofi Pasteur (extra dose administered, latency same day) (lot U7801BA and expiry 30-Jun-2026) (dose, formulation, route and strength: unknown) both for prophylactic vaccination.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA252504:
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: because of your medication your mRNA DNA altering technology killed my mother no I don't want to report a side effect you guys have had these side effects reported; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (because of your medication your mRNA DNA altering technology killed my mother no I don't want to report a side effect you guys have had these side effects reported) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant and treatment medication were reported. Company comment-This spontaneous fatal case concerns a female patient of unknown age with no medical history reported who experienced the serious (death and medically significant) unexpected event death on an unknown day after a dose of SPIKEVAX NOS vaccine was given. Cause of death was reported as unknown. Exact date of death is unknown. It is unknown if an autopsy was done. Very limited information was provided for medical review. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-773347 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773347:Same reporter (Multiple patient's case); Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: They have tested positive for COVID-19 twice; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (They have tested positive for COVID-19 twice) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (They have tested positive for COVID-19 twice). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (They have tested positive for COVID-19 twice) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive and Positive.         No relevant concomitant medications were reported.  Reporter mentioned that they (she and her husband) were fully vaccinated with Moderna COVID-19 vaccine. They had tested positive for COVID-19 twice, and they took Paxlovid each time. Reporter got covid in 2022 and 2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-773381 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773381:Husband case
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Incorrect route of product administration
Clinical narrative: patient received dose subcutaneously; blood pressure was 180/105; lightheaded; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HYPERTENSION (medically significant) with onset 2021, 8 days after the suspect product(s) administration, outcome "recovered", described as "blood pressure was 180/105"; DIZZINESS (non-serious) with onset 2021, 8 days after the suspect product(s) administration, outcome "recovered", described as "lightheaded"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Jul2021, outcome "unknown", described as "patient received dose subcutaneously". The clinical course was reported as follows: The patient reported that 8 days after vaccination, the patient woke up lightheaded. The patient went to urgent care and blood pressure was 180/105. The patient went to the emergency room (ER), and fluids were administered (as reported). The blood pressure decreased in a couple of hours and was released to go back home. The patient underwent the following laboratory tests and procedures mentioned before.   The reporter assessed the causality between the event and BNT162b2 as associated.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: Patient presented to medical clinic in town with injection site reaction at clinic.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blister, Pruritus, Rash, Skin weeping, Urticaria
Clinical narrative: Patient got the vaccine at around 11:30 on August 14th. In the evening, his right arm started itching. In the span of three or four days, and subsequently, little bumps like hives appear, and then they would turn into blisters, which would would. This occurred for three weeks and is ongoing. Liquid definitely was oozing out. (We believe this is from his reaction to the HPV vaccine, though I do not know what type it is. There is an article of one child having the same effect as our son.) We called the doctor, but they did not know what to do as none of them have seen such a reaction to the vaccine before. The doctor and nurse said to give him Zyrtec for the itch and continue to apply fresh aloe as we have been doing for the antibacterial and healing quality. We have been doing it. Three weeks into the reaction, I started stressing out because it keeps on spreading out the outer edges. I can see the bumps forming and from there, I can see where it is spreading next. Buy now, the inner lower right arm is entirely impacted, and the both lower and upper left inner arm have been impacted, and it seems it is spreading to the underside of the upper arm. The doctors are stumped and are not diagnosing it correctly in my opinion.  I think this is what my son has. And he needs treatment because it is still spreading, though it looks a lot better than it once did.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm is swollen, red and hot in a circle of approx 2.5 inches diameter around the site of the injection.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted after receiving her vaccine.  She regained consciousness quickly and remained in the pharmacy area for approximately 40  minutes with her husband. She ate ice cream and was feeling better.  She stated she has fainting episodes in the past, particularly with having blood drawn.  She said she felt fine when she left and states she did not need further medical attention.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: Patient received the pediatric (6mo-11yr) vaccine instead of the adult dose. Did not report any adverse effects.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received the pediatric  (6mo to 11yr) dose instead of the regular 12+ dose. Patient did not report any side effects.
Age: 70.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Burning sensation, Hypoaesthesia, Pain in extremity, Ultrasound Doppler normal, X-ray normal
Clinical narrative: LEFT LEG SKIN BURNING SENSATION, PAIN FROM HIP TO ANKLE, LEG NUMBNESS, X-RAY AND ULTRASOUND NEGATIVE FOR DVT
Age: 70.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Discomfort, Fall, Gait disturbance, Insomnia
Clinical narrative: LEFT LEG SKIN BURNING SENSATION, PAIN FROM HIP TO ANKLE, LEG NUMBNESS, X-RAY AND ULTRASOUND NEGATIVE FOR DVT
Age: 70.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Monoplegia, Muscular weakness, Pain, Ultrasound Doppler normal, X-ray normal
Clinical narrative: LEFT LEG SKIN BURNING SENSATION, PAIN FROM HIP TO ANKLE, LEG NUMBNESS, X-RAY AND ULTRASOUND NEGATIVE FOR DVT
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received the pediatric (6mo to 11yr) dose instead of the regular 12+ dose. Patient did not report any side effects.
Age: 56.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Pharyngeal swelling
Clinical narrative: Patient was given Flublok (top) and comirnaty(bottom) of left deltoid muscle at 9:15am within 10 minutes  complaining of swelling in her throat. Patient was given 10ml of benadryl and 911 was called. She was evaluated by firefighters and EMT, still having complaint of the swelling, she was then taken to hospital ER.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received the pediatric (6mo to 11yr) dose instead of the regular 12+ dose. Patient did not report any adverse effects.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Immediate post-injection reaction, Loss of consciousness, Skin warm, Syncope
Clinical narrative: Patient was given vaccination and within one to two seconds fainted. After 10-15 seconds patient regained consciousness. She was clammy and felt hot. Patient was given water, a soda (to help with low sugar as she stated she had not eaten since the previous day), and an ice pack for the back of her neck. Patient rested for approximately 15 minutes and then felt well enough to leave with her sister going to her sister's home.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted after leaving the pharmacy in the shopping center.
Age: 17.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Disorientation, Immediate post-injection reaction, Syncope
Clinical narrative: Patient suddenly fainted about 30 seconds following the second injection. She was lowered to the floor in a controlled manner when I realized what was happening. She awoke spontaneously several seconds later. While she was briefly disoriented, she reported feeling fine and was able to carry out conversation normally with a few seconds. She remained laying down for approximately 5 minutes, then stood up and was able to walk unassisted. She remained in the pharmacy waiting area for a brief time afterwards for monitoring, then left with her family.