chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Reported Symptoms: 10029829:NUMBNESS; 10043876:TINGLING; 10047862:WEAKNESS; Narrative: Patient reports immediately w/ administration of the covid-19 vaccine on 3/17/23 that he experienced severe burning pain while vaccine was being injected. He is right handed and states that the vaccine administrator chose to administer it towards the back of his upper right arm, which he though was unusual. Since then he has experienced persistent numbness and tingling in his right fourth and fifth fingers along with weakness of the right 5th finger. He states that he was unable to make a fist initially due to the pinky finger not closing, but slowly over the past two years has regained ability to make a fist however still remains difficult for him to open a jar. Paresthesias persist. Objectively with symmetric hand grip strength, however with diminished sensation to vibration, cold temperature, and light touch to the right fourth and fifth fingers compared to the left. Strength is also modestly diminished with adduction of the right 5th finger, but otherwise strength in the fingers and wrists are symmetrical. Other Relevant HX: Other: pain followed by persistent numbness and tingling of the right 5th and 4th fingers and weakness of the 5th finger
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal disorder, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Reported Symptoms: 10029829:NUMBNESS; 10043876:TINGLING; 10047862:WEAKNESS; Narrative: Patient reports immediately w/ administration of the covid-19 vaccine on 3/17/23 that he experienced severe burning pain while vaccine was being injected. He is right handed and states that the vaccine administrator chose to administer it towards the back of his upper right arm, which he though was unusual. Since then he has experienced persistent numbness and tingling in his right fourth and fifth fingers along with weakness of the right 5th finger. He states that he was unable to make a fist initially due to the pinky finger not closing, but slowly over the past two years has regained ability to make a fist however still remains difficult for him to open a jar. Paresthesias persist. Objectively with symmetric hand grip strength, however with diminished sensation to vibration, cold temperature, and light touch to the right fourth and fifth fingers compared to the left. Strength is also modestly diminished with adduction of the right 5th finger, but otherwise strength in the fingers and wrists are symmetrical. Other Relevant HX: Other: pain followed by persistent numbness and tingling of the right 5th and 4th fingers and weakness of the 5th finger
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Reported Symptoms: 10029829:NUMBNESS; 10043876:TINGLING; 10047862:WEAKNESS; Narrative: Patient reports immediately w/ administration of the covid-19 vaccine on 3/17/23 that he experienced severe burning pain while vaccine was being injected. He is right handed and states that the vaccine administrator chose to administer it towards the back of his upper right arm, which he though was unusual. Since then he has experienced persistent numbness and tingling in his right fourth and fifth fingers along with weakness of the right 5th finger. He states that he was unable to make a fist initially due to the pinky finger not closing, but slowly over the past two years has regained ability to make a fist however still remains difficult for him to open a jar. Paresthesias persist. Objectively with symmetric hand grip strength, however with diminished sensation to vibration, cold temperature, and light touch to the right fourth and fifth fingers compared to the left. Strength is also modestly diminished with adduction of the right 5th finger, but otherwise strength in the fingers and wrists are symmetrical. Other Relevant HX: Other: pain followed by persistent numbness and tingling of the right 5th and 4th fingers and weakness of the 5th finger
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Acute kidney injury, Asthenia, COVID-19, COVID-19 pneumonia, Cardiac failure acute
Clinical narrative: Reported Symptoms: 10012727:DIARRHEA; 10013573:DIZZINESS; 10038436:RENAL FAILURE ACUTE; 10038678:RESPIRATORY DEPRESSION; 10043088:TACHYPNEA; 10084380:COVID-19 PNEUMONIA; Narrative: Patient received five doses of Pfizer COVID 19 vaccine (Mar/Apr/Oct 21/Mar/Oct 22). The patient presented to the ED on 21 August 2023 with shortness of breath, falling, diarrhea, and weakness. The patient tested positive for COVID 19 on 21 August 2023. The patient was admitted with acute covid 19 infection and acute heart failure. The patient was treated with supportive care and furosemide. The patient was discharged on 23 August 23, but the patient was readmitted on 25 August 2023 with increased lethargy and COVID pneumonia, acute renal injury, and respiratory failure. The patient was treated appropriately and discharged on 6 Sep 23 in stable condition. Reported per EUA. Other Relevant HX: Other: covid pneumonia
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Fall, Lethargy
Clinical narrative: Reported Symptoms: 10012727:DIARRHEA; 10013573:DIZZINESS; 10038436:RENAL FAILURE ACUTE; 10038678:RESPIRATORY DEPRESSION; 10043088:TACHYPNEA; 10084380:COVID-19 PNEUMONIA; Narrative: Patient received five doses of Pfizer COVID 19 vaccine (Mar/Apr/Oct 21/Mar/Oct 22). The patient presented to the ED on 21 August 2023 with shortness of breath, falling, diarrhea, and weakness. The patient tested positive for COVID 19 on 21 August 2023. The patient was admitted with acute covid 19 infection and acute heart failure. The patient was treated with supportive care and furosemide. The patient was discharged on 23 August 23, but the patient was readmitted on 25 August 2023 with increased lethargy and COVID pneumonia, acute renal injury, and respiratory failure. The patient was treated appropriately and discharged on 6 Sep 23 in stable condition. Reported per EUA. Other Relevant HX: Other: covid pneumonia
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Respiratory depression, Respiratory failure, SARS-CoV-2 test positive, Tachypnoea
Clinical narrative: Reported Symptoms: 10012727:DIARRHEA; 10013573:DIZZINESS; 10038436:RENAL FAILURE ACUTE; 10038678:RESPIRATORY DEPRESSION; 10043088:TACHYPNEA; 10084380:COVID-19 PNEUMONIA; Narrative: Patient received five doses of Pfizer COVID 19 vaccine (Mar/Apr/Oct 21/Mar/Oct 22). The patient presented to the ED on 21 August 2023 with shortness of breath, falling, diarrhea, and weakness. The patient tested positive for COVID 19 on 21 August 2023. The patient was admitted with acute covid 19 infection and acute heart failure. The patient was treated with supportive care and furosemide. The patient was discharged on 23 August 23, but the patient was readmitted on 25 August 2023 with increased lethargy and COVID pneumonia, acute renal injury, and respiratory failure. The patient was treated appropriately and discharged on 6 Sep 23 in stable condition. Reported per EUA. Other Relevant HX: Other: covid pneumonia
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Dyspnoea, Nausea, Pyrexia
Clinical narrative: Reported Symptoms:  10012727:DIARRHEA;  10016558:FEVER;  10043071:TACHYCARDIA;  10043088:TACHYPNEA;  10047700:VOMITING;  10084268:COVID-19;  Narrative:  Patient received one dose Moderna COVID 19 vaccine Aug 2021.   The patient presented to the ED on 19 August 2023 with shortness of breath, nausea/vomiting, and fever.  The patient tested positive for COVID 19 on 19 August 2023.  The patient was admitted to the hospital with sinus tachycardia and COVID 19 and was treated with symptomatic care.  The patient was discharged on 21 August 2023 in stable condition.  Reported per EUA.  Other Relevant HX:  Other: covid 19
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sinus tachycardia, Tachycardia, Tachypnoea, Vomiting
Clinical narrative: Reported Symptoms:  10012727:DIARRHEA;  10016558:FEVER;  10043071:TACHYCARDIA;  10043088:TACHYPNEA;  10047700:VOMITING;  10084268:COVID-19;  Narrative:  Patient received one dose Moderna COVID 19 vaccine Aug 2021.   The patient presented to the ED on 19 August 2023 with shortness of breath, nausea/vomiting, and fever.  The patient tested positive for COVID 19 on 19 August 2023.  The patient was admitted to the hospital with sinus tachycardia and COVID 19 and was treated with symptomatic care.  The patient was discharged on 21 August 2023 in stable condition.  Reported per EUA.  Other Relevant HX:  Other: covid 19
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms:  10067923:VACCINE BREATHROUGH INFECTION; 10084401:COVID-29 RESPIRATORY INFECTION;   Narrative:  Other Relevant  HX:  Other:  COVID Breakthrough
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms:  10067923; VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION;  Narrative:  Other Relevant HX:  Other: COVID Breakthrough
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Facial paralysis, Hemiparesis
Clinical narrative: Reported Symptoms: 10042244:STROKE; Narrative: Patient presented to the ER after waking up with right sided weakness and facial droop. Diagnosis: S/p CVA She received TPA and was discharged from hospital with home health. Other Relevant HX: Other:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Respiratory tract congestion, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: Reported Symptoms:  10011232:COUGHING;  10040742:SINUS CONGESTION;   Narrative:  # Covid 19 positive with upper airway congestion.  Pt admitted for observation, provided sx support, and subsequently discharged the following day.  Other Relevant HX:   Other:  CONGESTION
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms:  10084355: COVID-19 VIRUS TEST POSITIVE;  Narrative: 76 y/o male presented to Emergency Department on 8/27/23 with c/o dizziness, nasal drainage, and + COVID test. Admitted for overnight observation and then discharged home on 8/28/23. Other Relevant Hx: Other: COVID +
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arrhythmia, COVID-19, Cardiac failure, Chills, Hypogeusia
Clinical narrative: Reported Symptoms:  10033556:PALPITATION;   Narrative:  Patient was transferred to the Hospital from an outside facility for arrhythmias.  Patient was tested at outside facility for COVID-19 and test was negative, but when transferred to Hospital, Hospital's COVID screen was positive.  Patient reported mild symptoms (decreased taste, cough with phlegm, and chills).  Remdesivir was contraindicated due to renal function.  Per shared decision with patient and his family, treatment was deferred and symptoms were monitored. Patient was admitted for acute decompensated heart systolic/diastolic failure requiring milrinone and sustained Vtach.  Other Relevant HX:   Other:
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Productive cough, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms:  10033556:PALPITATION;   Narrative:  Patient was transferred to the Hospital from an outside facility for arrhythmias.  Patient was tested at outside facility for COVID-19 and test was negative, but when transferred to Hospital, Hospital's COVID screen was positive.  Patient reported mild symptoms (decreased taste, cough with phlegm, and chills).  Remdesivir was contraindicated due to renal function.  Per shared decision with patient and his family, treatment was deferred and symptoms were monitored. Patient was admitted for acute decompensated heart systolic/diastolic failure requiring milrinone and sustained Vtach.  Other Relevant HX:   Other:
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: PULMONARY  EMBOLISMS; BLOOD CLOTS IN NECK, ARMS, LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraines, anxiety, and PTSD (Post-traumatic stress disorder) issues. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, subcutaneous, batch number was not reported) dose was not reported, administered on 23-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 15-APR-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient went to the hospital with blood clots in neck, arms, legs and pulmonary embolisms (Dose number in series 1).  Patient was later discharged. It was reported that VAERS (Vaccine Adverse Event Reporting System) was filed and monitoring was ongoing through facility for tracking. It was also reported that in CDC system (Centers for Disease Control and Prevention), the patient was showing as 'patient 10', with blood clots tracking (VITT (vaccine-induced immune thrombotic thrombocytopenia), TTS (Thrombosis with thrombocytopenia syndrome)). Patient was unable to carry children. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in neck, arms, legs and pulmonary embolisms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-Pulmonary embolism. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration. -Thrombosis. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Blood test normal, Chest X-ray normal, Cough, Dyspnoea, Fatigue
Clinical narrative: Upper respiratory infection; Weakness; mucous; difficulty breathing; coughing; This non-serious case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma.   On 25-OCT-2023, the patient received Arexvy (intramuscular). In NOV-2023, 1 week after receiving Arexvy, the patient experienced difficulty breathing (Verbatim: difficulty breathing), cough (Verbatim: coughing) and nasal mucus increased (Verbatim: mucous). On an unknown date, the patient experienced upper respiratory tract infection (Verbatim: Upper respiratory infection) and weakness (Verbatim: Weakness). The patient was treated with salbutamol (Albuterol). The outcome of the difficulty breathing, cough, upper respiratory tract infection, nasal mucus increased and weakness were not resolved.   It was unknown if the reporter considered the difficulty breathing, cough, upper respiratory tract infection, nasal mucus increased and weakness to be related to Arexvy.     It was unknown if the company considered the difficulty breathing, cough, upper respiratory tract infection, nasal mucus increased and weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-DEC-2023 The patient reported that she received the arexvy vaccine and about a week later she had difficulty breathing, cough and mucous. The patient went to the emergency room.  The patient was diagnosed with an upper respiratory tract infection.  The patient was put on steroids, cough medicine and albuterol. The patient stated that symptoms have not gone away and she was still taking cough drops.  The patient still felt very weak.  Emergency room visit was required. The reporter did not consent to follow-up.
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Productive cough, Respiratory tract congestion, SARS-CoV-2 test negative, Upper respiratory tract infection, Wheezing
Clinical narrative: Upper respiratory infection; Weakness; mucous; difficulty breathing; coughing; This non-serious case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma.   On 25-OCT-2023, the patient received Arexvy (intramuscular). In NOV-2023, 1 week after receiving Arexvy, the patient experienced difficulty breathing (Verbatim: difficulty breathing), cough (Verbatim: coughing) and nasal mucus increased (Verbatim: mucous). On an unknown date, the patient experienced upper respiratory tract infection (Verbatim: Upper respiratory infection) and weakness (Verbatim: Weakness). The patient was treated with salbutamol (Albuterol). The outcome of the difficulty breathing, cough, upper respiratory tract infection, nasal mucus increased and weakness were not resolved.   It was unknown if the reporter considered the difficulty breathing, cough, upper respiratory tract infection, nasal mucus increased and weakness to be related to Arexvy.     It was unknown if the company considered the difficulty breathing, cough, upper respiratory tract infection, nasal mucus increased and weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-DEC-2023 The patient reported that she received the arexvy vaccine and about a week later she had difficulty breathing, cough and mucous. The patient went to the emergency room.  The patient was diagnosed with an upper respiratory tract infection.  The patient was put on steroids, cough medicine and albuterol. The patient stated that symptoms have not gone away and she was still taking cough drops.  The patient still felt very weak.  Emergency room visit was required. The reporter did not consent to follow-up.
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, Cough, Dyspnoea, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: Upper respiratory infection; Weakness; mucous; difficulty breathing; coughing; This non-serious case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma.   On 25-OCT-2023, the patient received Arexvy (intramuscular). In NOV-2023, 1 week after receiving Arexvy, the patient experienced difficulty breathing (Verbatim: difficulty breathing), cough (Verbatim: coughing) and nasal mucus increased (Verbatim: mucous). On an unknown date, the patient experienced upper respiratory tract infection (Verbatim: Upper respiratory infection) and weakness (Verbatim: Weakness). The patient was treated with salbutamol (Albuterol). The outcome of the difficulty breathing, cough, upper respiratory tract infection, nasal mucus increased and weakness were not resolved.   It was unknown if the reporter considered the difficulty breathing, cough, upper respiratory tract infection, nasal mucus increased and weakness to be related to Arexvy.     It was unknown if the company considered the difficulty breathing, cough, upper respiratory tract infection, nasal mucus increased and weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-DEC-2023 The patient reported that she received the arexvy vaccine and about a week later she had difficulty breathing, cough and mucous. The patient went to the emergency room.  The patient was diagnosed with an upper respiratory tract infection.  The patient was put on steroids, cough medicine and albuterol. The patient stated that symptoms have not gone away and she was still taking cough drops.  The patient still felt very weak.  Emergency room visit was required. The reporter did not consent to follow-up.
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Product packaging confusion, Wrong product administered
Clinical narrative: Nurse grabbed the wrong box which was similar in color; Received a 3rd dose of Shingrix/ was supposed to get the RSV vaccine instead; received a 3rd dose of Shingrix/ was supposed to get the RSV vaccine instead; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received full series on 2019).   On 06-DEC-2023, the patient received the 3rd dose of Shingrix. On 06-DEC-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Received a 3rd dose of Shingrix/ was supposed to get the RSV vaccine instead) and extra dose administered (Verbatim: received a 3rd dose of Shingrix/ was supposed to get the RSV vaccine instead). On an unknown date, the patient experienced product packaging confusion (Verbatim: Nurse grabbed the wrong box which was similar in color). The outcome of the wrong vaccine administered, extra dose administered and product packaging confusion were unknown.   Additional Information: GSK Receipt Date: 12-Dec-2023 The patient received third dose of Shingrix vaccine which she was supposed to receive the RSV vaccine instead, the nurse grabbed the wrong box which was similar in color, which led to wrong vaccine administered, extra dose administered and product packaging confusion. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product packaging confusion, Wrong product administered
Clinical narrative: Nurse grabbed the wrong box which was similar in color; Received a 3rd dose of Shingrix/ was supposed to get the RSV vaccine instead; received a 3rd dose of Shingrix/ was supposed to get the RSV vaccine instead; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received full series on 2019).   On 06-DEC-2023, the patient received the 3rd dose of Shingrix. On 06-DEC-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Received a 3rd dose of Shingrix/ was supposed to get the RSV vaccine instead) and extra dose administered (Verbatim: received a 3rd dose of Shingrix/ was supposed to get the RSV vaccine instead). On an unknown date, the patient experienced product packaging confusion (Verbatim: Nurse grabbed the wrong box which was similar in color). The outcome of the wrong vaccine administered, extra dose administered and product packaging confusion were unknown.   Additional Information: GSK Receipt Date: 12-Dec-2023 The patient received third dose of Shingrix vaccine which she was supposed to receive the RSV vaccine instead, the nurse grabbed the wrong box which was similar in color, which led to wrong vaccine administered, extra dose administered and product packaging confusion. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drooling, Extremity contracture, Eye movement disorder, Gaze palsy, Seizure like phenomena
Clinical narrative: Patient had a possible seizure; This spontaneous case was reported by a physician and describes the occurrence of SEIZURE (Patient had a possible seizure) in an 80-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032708) for COVID-19 prophylaxis.     Concurrent medical conditions included Seizure (placed on Keppra at that time) since 2022.    On 12-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 14-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced SEIZURE (Patient had a possible seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Patient had a possible seizure) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, patient had a possible seizure 14-Dec-1023. Patient was vocally calling out (non-verbal was baseline), body was shaking and rigid, fists clenched, eyes rolled up and darting, and drooling. Lasted a couple minutes but happened again the following morning on 15-Dec-2023.  This patient had a history of seizure like activity that started in 2022 but was placed on Keppra at that time and not had a seizure in quite some time, until now.  Patient had no previous reactions to COVID vaccines. No acute illnesses. No other vaccine administered at the same time. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided. Company Comment: This is a spontaneous case concerning an 80-year-old female patient with a history of Seizure (placed on Keppra at that time) since 2022, who experienced the serious (due to medically significant) unexpected, AESI event of Seizure, which occurred approximately 2 days after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine, received as the fifth dose of COVID-19 vaccination schedule. It was reported that patient was vocally calling out, body was shaking and rigid, fists clenched, eyes rolled up and darting, and drooling. Lasted a couple minutes but happened again on the following morning. The outcome of the event was reported as recovering. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Patient had a possible seizure; This spontaneous case was reported by a physician and describes the occurrence of SEIZURE (Patient had a possible seizure) in an 80-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032708) for COVID-19 prophylaxis.     Concurrent medical conditions included Seizure (placed on Keppra at that time) since 2022.    On 12-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 14-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced SEIZURE (Patient had a possible seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Patient had a possible seizure) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, patient had a possible seizure 14-Dec-1023. Patient was vocally calling out (non-verbal was baseline), body was shaking and rigid, fists clenched, eyes rolled up and darting, and drooling. Lasted a couple minutes but happened again the following morning on 15-Dec-2023.  This patient had a history of seizure like activity that started in 2022 but was placed on Keppra at that time and not had a seizure in quite some time, until now.  Patient had no previous reactions to COVID vaccines. No acute illnesses. No other vaccine administered at the same time. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided. Company Comment: This is a spontaneous case concerning an 80-year-old female patient with a history of Seizure (placed on Keppra at that time) since 2022, who experienced the serious (due to medically significant) unexpected, AESI event of Seizure, which occurred approximately 2 days after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine, received as the fifth dose of COVID-19 vaccination schedule. It was reported that patient was vocally calling out, body was shaking and rigid, fists clenched, eyes rolled up and darting, and drooling. Lasted a couple minutes but happened again on the following morning. The outcome of the event was reported as recovering. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Patient had a possible seizure; This spontaneous case was reported by a physician and describes the occurrence of SEIZURE (Patient had a possible seizure) in an 80-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032708) for COVID-19 prophylaxis.     Concurrent medical conditions included Seizure (placed on Keppra at that time) since 2022.    On 12-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 14-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced SEIZURE (Patient had a possible seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Patient had a possible seizure) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, patient had a possible seizure 14-Dec-1023. Patient was vocally calling out (non-verbal was baseline), body was shaking and rigid, fists clenched, eyes rolled up and darting, and drooling. Lasted a couple minutes but happened again the following morning on 15-Dec-2023.  This patient had a history of seizure like activity that started in 2022 but was placed on Keppra at that time and not had a seizure in quite some time, until now.  Patient had no previous reactions to COVID vaccines. No acute illnesses. No other vaccine administered at the same time. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided. Company Comment: This is a spontaneous case concerning an 80-year-old female patient with a history of Seizure (placed on Keppra at that time) since 2022, who experienced the serious (due to medically significant) unexpected, AESI event of Seizure, which occurred approximately 2 days after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine, received as the fifth dose of COVID-19 vaccination schedule. It was reported that patient was vocally calling out, body was shaking and rigid, fists clenched, eyes rolled up and darting, and drooling. Lasted a couple minutes but happened again on the following morning. The outcome of the event was reported as recovering. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: weakness in the strength of my right arm; arm/neck pain; arm/neck pain; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (weakness in the strength of my right arm), PAIN IN EXTREMITY (arm/neck pain) and NECK PAIN (arm/neck pain) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness in the strength of my right arm), PAIN IN EXTREMITY (arm/neck pain) and NECK PAIN (arm/neck pain). At the time of the report, MUSCULAR WEAKNESS (weakness in the strength of my right arm), PAIN IN EXTREMITY (arm/neck pain) and NECK PAIN (arm/neck pain) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that over 3 weeks later experienced arm/neck pain and weakness in the strength of my right arm. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-753325 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-Dec-2023: Significant follow up received: Reporter contact details and events were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753325:same repoter
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: weakness in the strength of my right arm; arm/neck pain; arm/neck pain; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (weakness in the strength of my right arm), PAIN IN EXTREMITY (arm/neck pain) and NECK PAIN (arm/neck pain) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness in the strength of my right arm), PAIN IN EXTREMITY (arm/neck pain) and NECK PAIN (arm/neck pain). At the time of the report, MUSCULAR WEAKNESS (weakness in the strength of my right arm), PAIN IN EXTREMITY (arm/neck pain) and NECK PAIN (arm/neck pain) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that over 3 weeks later experienced arm/neck pain and weakness in the strength of my right arm. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-753325 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-Dec-2023: Significant follow up received: Reporter contact details and events were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753325:same repoter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Systemic lupus; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus) in a 52-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination.     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 SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus) (seriousness criterion medically significant). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that the patient was always a healthy person who never went to the physician for anything. After the individual was forced to get vaccinated, the patient was deeply sick for 4 to 6 months, with vomiting, lethargy, loss of hair and all sorts of stuff. Unspecified tests were run, and the patient was diagnosed with systemic lupus. It was reported that the patient lost work. On 05-Dec-2023, the patient got really sick and deathly ill after receiving the vaccine.  No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 52-year-old healthy female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Systemic Lupus erythematosus, which occurred on an unknown date after an unspecified dose of SPIKEVAX NOS vaccine. Since no vaccination non event dates were provided, temporal association and latency cannot be properly assessed. As reported, the patient was deeply sick for 4 to 6 months, with vomiting, lethargy, loss of hair, "all sorts of stuff." Unspecified tests were ran, and the individual was diagnosed with systemic lupus. It was reported the individual lost work. No information disclosed about clinical course or treatments received. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Vaccination site pain
Clinical narrative: Intermittently I get a pain in my left arm, the injection site is in my left arm. The upper left arm; There's a feeling of warmth underneath the skin; pain radiates Up to my left shoulder.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Intermittently I get a pain in my left arm, the injection site is in my left arm. The upper left arm), FEELING HOT (There's a feeling of warmth underneath the skin) and PAIN (pain radiates Up to my left shoulder.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050c21a, 022b21a and 084j21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Intermittently I get a pain in my left arm, the injection site is in my left arm. The upper left arm), FEELING HOT (There's a feeling of warmth underneath the skin) and PAIN (pain radiates Up to my left shoulder.). At the time of the report, VACCINATION SITE PAIN (Intermittently I get a pain in my left arm, the injection site is in my left arm. The upper left arm) and FEELING HOT (There's a feeling of warmth underneath the skin) had not resolved and PAIN (pain radiates Up to my left shoulder.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Patient received the vaccine, had a lingering problem. It's intermittent. But only occurred after received the vaccine. She did not have this issue prior to that. Intermittently get a pain in her left arm, the injection site was in left arm. The upper left arm. That was the site the arm where she had received the boosters and vaccines. She had pain. On occasion. There's a feeling of warmth underneath the skin. Sometimes it feels like this. It's hot, like there's a somebody's holding a match under the skin. Sometimes that heat and the pain radiates Up to left shoulder. This pain, and that's that hot seat feeling.  Patient took 1st booster Moderna 20 Oct 2022 with lot no. AS7140C and 2nd booster Moderna 11 Oct 2023 with lot no. Unknown.   Most recent FOLLOW-UP information incorporated above includes: On 18-Dec-2023: Live follow-up received-reference no added.
Age: 42.0
Sex: F
Vaccine: COVID19, FLUC4, PNC20
Symptoms: Abdominal discomfort, Pyrexia, Vomiting
Clinical narrative: Vomiting, upset stomach @11pm same night  fever@ 1:30am 12/21/2023
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered
Clinical narrative: partial dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number xl3d4, expiry date 25-MAR-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: partial dose administered). The outcome of the incomplete dose administered was unknown.   Additional Information: RA Receipt Date: 11-DEC-2023 The reporter stated that that while administering Arexvy to a patient some of the dose seeped out of the needle and syringe and patient did not receive full dose, which led to incomplete dose administered. No issues with vials for Arexvy (No product quality complaint was reported). No mention of exposure of vaccine to skin but did not proactively ask. The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received a dose of the one vial presentation of Menveo instead of the 2 vial presentation; received a dose of the one vial presentation of Menveo instead of the 2 vial presentation; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 5-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 9C2KP, expiry date 02-MAR-2024) for prophylaxis.   On 08-DEC-2023, the patient received Menveo. On 08-DEC-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received a dose of the one vial presentation of Menveo instead of the 2 vial presentation) and inappropriate dose of vaccine administered (Verbatim: received a dose of the one vial presentation of Menveo instead of the 2 vial presentation). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-DEC-2023 A nurse called to inform that the patient received a dose of the on vial presentation of Menveo instead of the 2 vial presentation which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Never had a reaction except maybe sore arm and tiredness; Never had a reaction except maybe sore arm and tiredness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Never had a reaction except maybe sore arm and tiredness) and FATIGUE (Never had a reaction except maybe sore arm and tiredness) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hay fever (used to have hay fever but not anymore).    On 05-Jul-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Never had a reaction except maybe sore arm and tiredness) and FATIGUE (Never had a reaction except maybe sore arm and tiredness). At the time of the report, PAIN IN EXTREMITY (Never had a reaction except maybe sore arm and tiredness) and FATIGUE (Never had a reaction except maybe sore arm and tiredness) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient stated she had received all Moderna COVID-19 vaccines in the past, except for her 5th dose (Pfizer) as followed, On 09-Mar-2021, the patient received first dose of Moderna COVID-19 vaccine with batch number 029A21A. On 06-Apr-2021, the patient received second dose of Moderna COVID-19 vaccine with batch number 045A21A. On 15-Nov-2021, the patient received third dose of Moderna COVID-19 vaccine with batch number 039F21A. On 28-Apr-2022, the patient received fourth dose of Moderna COVID-19 vaccine with batch number 002M21A. On 18-Oct-2022, the patient received her fifth dose with Pfizer.  Patient never had COVID, no colds, or even the flu.  No treatment information was provided.   This case was linked to MOD-2023-753900, MOD-2023-754017 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: He had pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (He had pericarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 025B21A and 026A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (He had pericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 6 days due to PERICARDITIS. At the time of the report, PERICARDITIS (He had pericarditis) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.  Reporter stated he took all the vaccines and got sick.  The patient had inflammation around the lining of the heart. He spends 6 days in the hospital. The patient underwent multiple-echo and MRI. Result was not provided.  Company comment: This spontaneous case concerns an adult male patient (unknown age), with no medical history reported, who received three doses of Moderna COVID-19 Vaccine (mRNA  1273) and experienced the expected serious (hospitalization and medically significant) event of pericarditis. Latency cannot be properly assessed since exact onset date was not provided. The report stated that the patient got sick, he had experienced inflammation around the lining of the heart and was hospitalized for 6 days. The outcome of the event was not recovered. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Moderna COVID-19 Vaccine (mRNA  1273) is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pain in jaw
Clinical narrative: Increasing jaw pain on the right side. No noticeable swelling. Pain on opening jaws and biting down.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Child had a rash all over hands, arms and legs
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: Nurse 12/19/2023 11:57:41 AM > A phone call was received by this nurse from Dr. The vaccine given to Mom for transport to the allergist's office by this nurse was NOT an MMR vaccine, but rather was a Varivax vaccine (Merck Manufacturer Lot # X020149, with an expiration date of 08.01.25)  The Varivax vaccine was administered to Niels in the allergist's office. The health care professional who injected the vaccine noted - after giving the vaccine - that it was a Varivax vaccine and NOT an MMR vaccine. This nurse has spoken with Dr. and Pt's mother to apologize. This nurse has also spoken with the medical team at Merck to gather data and research regarding the administration of a Varivax vaccine app. 2 months after a previous Varivax immunization.  Merck will e-mail this nurse their data and that will be e-mailed to Mom along with her request for a list of allergists. Dr. has spoken at length by phone this morning with Mom and Dr. regarding this issue. An inservice will be held at Pediatrics to re-educate and reinforce the importance of double-checking and triple-checking all vaccines and medicines to be admnstered to all patients.