chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: tia; This spontaneous case was reported by a patient and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (tia) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     Patient had a lot of chronic problems.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Dose 2) and COVID-19 VACCINE JANSSEN (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and COVID-19 VACCINE JANSSEN.    In 2022, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In August 2023, the patient experienced TRANSIENT ISCHAEMIC ATTACK (tia) (seriousness criterion medically significant). The patient was treated with SIMVASTATIN (STATIN [SIMVASTATIN]) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (tia) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that She did not had any problem with the Moderna vaccine but now she had been hearing that the new Moderna vaccine was made differently. She said that the RNA right now was different. She was concerned about the safety of the new vaccine. She also had Transient ischaemic attack (TIA) on unspecified date of Aug-2023 and was on statin and aspirin.   She also stated that she heard that a lot of people are dying and having a stroke from the vaccine. She also heard about a 38 year old person who dies after getting the vaccine although she was not sure whether it was Moderna or another brand.  Company Comment This spontaneous case concerns a female patient of an unknown age with medical history of Previously administered products COVID-19 VACCINE JANSSEN (2 doses) and with a lot of chronic problems who experienced the seriousness criterion medically significant unexpected AESI of transient ischaemic attack (TIA)  the following year after 3rd. dose of SPIKEVAX NOS vaccine. As the patient received doses of Vaxzevria vaccine; "interchange of vaccine products" and "revaccination with different Covid-19 vaccine" were noted in this case. At the time of the report, the event´s outcome is unknown. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: right supraclavicular lymph node enlargement; right arm pain/right leg pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (right supraclavicular lymph node enlargement), PAIN IN EXTREMITY (right arm pain/right leg pain) and FATIGUE (fatigue) in a 29-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 18-Nov-2023, the patient experienced LYMPHADENOPATHY (right supraclavicular lymph node enlargement), PAIN IN EXTREMITY (right arm pain/right leg pain) and FATIGUE (fatigue). At the time of the report, LYMPHADENOPATHY (right supraclavicular lymph node enlargement), PAIN IN EXTREMITY (right arm pain/right leg pain) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: sore throat; achy for a couple of days; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and PAIN (achy for a couple of days) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced PAIN (achy for a couple of days). On 16-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PAIN (achy for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea, Pyrexia
Clinical narrative: muscle pain; joint pain; fever; nausea symptom; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever) and NAUSEA (nausea symptom) in a 53-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included GERD. Concurrent medical conditions included Hypothyroidism, Hypoglycemia and Asthma.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 18-Nov-2023, the patient experienced MYALGIA (muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever) and NAUSEA (nausea symptom). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever) and NAUSEA (nausea symptom) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  Patient was asking Why do She get side effects every time patient get booster.  Muscle pain, joint pain, fever, nausea. Symptom get worse each she have booster. She have 3 Moderna boaster. It was unknown if the patient experienced any additional symptoms/events. Patient was taking Tylenol for pain.  There were no lab data/results available.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Diarrhoea, Fatigue
Clinical narrative: cold; tachycardia; cramping; flu; body aches; low back pain; diarrhea; chills; fever; joint pain; fatigue; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu) and PAIN (body aches) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Pfizer (all prior doses were Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Hypometabolism (sensitive person to medication, meaning slow metabolizer of medication.).    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Nov-2023, the patient experienced NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu), PAIN (body aches), BACK PAIN (low back pain), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Nov-2023, NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu), PAIN (body aches), BACK PAIN (low back pain), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient had received Spikevax around 2 PM on Friday, 17-Nov-2023  4 hours after vaccination she experienced extreme chills, never felt this cold before, tachycardia which she attributes to her fever, achy, body aches, low back pain, which caused her to worry as she was a Registered NP. Joint pain, pronounced fatigue, didn't want to move at all, terrible headache, diarrhea and cramping, a 103 which went down to 102 after taking Tylenol. Reported that back ache, terrible headache, lasted until Sunday evening. HCP stated that it felt like I had a bad Flu.  Concomitant medications were not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Muscle spasms, Nasopharyngitis, Pain
Clinical narrative: cold; tachycardia; cramping; flu; body aches; low back pain; diarrhea; chills; fever; joint pain; fatigue; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu) and PAIN (body aches) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Pfizer (all prior doses were Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Hypometabolism (sensitive person to medication, meaning slow metabolizer of medication.).    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Nov-2023, the patient experienced NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu), PAIN (body aches), BACK PAIN (low back pain), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Nov-2023, NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu), PAIN (body aches), BACK PAIN (low back pain), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient had received Spikevax around 2 PM on Friday, 17-Nov-2023  4 hours after vaccination she experienced extreme chills, never felt this cold before, tachycardia which she attributes to her fever, achy, body aches, low back pain, which caused her to worry as she was a Registered NP. Joint pain, pronounced fatigue, didn't want to move at all, terrible headache, diarrhea and cramping, a 103 which went down to 102 after taking Tylenol. Reported that back ache, terrible headache, lasted until Sunday evening. HCP stated that it felt like I had a bad Flu.  Concomitant medications were not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: cold; tachycardia; cramping; flu; body aches; low back pain; diarrhea; chills; fever; joint pain; fatigue; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu) and PAIN (body aches) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Pfizer (all prior doses were Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Hypometabolism (sensitive person to medication, meaning slow metabolizer of medication.).    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Nov-2023, the patient experienced NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu), PAIN (body aches), BACK PAIN (low back pain), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Nov-2023, NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu), PAIN (body aches), BACK PAIN (low back pain), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient had received Spikevax around 2 PM on Friday, 17-Nov-2023  4 hours after vaccination she experienced extreme chills, never felt this cold before, tachycardia which she attributes to her fever, achy, body aches, low back pain, which caused her to worry as she was a Registered NP. Joint pain, pronounced fatigue, didn't want to move at all, terrible headache, diarrhea and cramping, a 103 which went down to 102 after taking Tylenol. Reported that back ache, terrible headache, lasted until Sunday evening. HCP stated that it felt like I had a bad Flu.  Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19
Clinical narrative: Patient had long COVID, symptoms were more severe. Lost sense of smell and taste, fatigue, coughing, body ache, sore throat, congestion, felt like fever, chills.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient had long COVID, symptoms were more severe. Lost sense of smell and taste, fatigue, coughing, body ache, sore throat, congestion, felt like fever, chills.) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 15-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (Patient had long COVID, symptoms were more severe. Lost sense of smell and taste, fatigue, coughing, body ache, sore throat, congestion, felt like fever, chills.). At the time of the report, COVID-19 (Patient had long COVID, symptoms were more severe. Lost sense of smell and taste, fatigue, coughing, body ache, sore throat, congestion, felt like fever, chills.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Body temperature: 98.5 F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.       No concomitant medication was reported.  Patient believed she received the pediatrics vaccine instead of the adult vaccine. The reason was because she entered the lot number in a system it stated pediatrics and they also got COVID-19. Patient believed the strength of the pediatrics was lower so that might have cause her to have COVID-19. Patient had an O2 sensor at home and it came back normal for her and her husband. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750412 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750412:Husband case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation
Clinical narrative: they also got COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (they also got COVID-19) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (they also got COVID-19). At the time of the report, COVID-19 (they also got COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: Normal.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The patient did not have information for previous vaccination doses.  Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750308 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750308:Wife case
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.            No concomitant medication was reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient had COVID-19, 2 times since receiving the most recent booster. Once in AUG2022 and currently. The patient had not taken any medications or treatments. The patient went to an urgent care who diagnosed him with COVID-19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dyspnoea, Headache, Malaise
Clinical narrative: She is out of breath when she goes for her regular walk; I just don't feel good; She has no energy; She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),; She has constant headache; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (She is out of breath when she goes for her regular walk), MALAISE (I just don't feel good), ASTHENIA (She has no energy), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) 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 06-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 06-Nov-2023, the patient experienced DYSPNOEA (She is out of breath when she goes for her regular walk), MALAISE (I just don't feel good), ASTHENIA (She has no energy), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (She is out of breath when she goes for her regular walk), MALAISE (I just don't feel good), ASTHENIA (She has no energy), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2023, Body temperature: Low grade fever 98.9 F to 99.9 F, normal temperature is 97.8 F.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. She stated that after all the other Moderna shots, she had similar side effects but with previous shots the side effects lasted only 4 days. After the shot on 06-NOV-2023, the side effects did not go away. It has been 15 days now. When she takes 2 Tylenol the fever goes away, but it comes back the next day. She stated that she drunk hot tea and coffee but not water. She stated that may be the adult dose she got was too much for her small body. She weighs as much as a teenager.   This case was linked to MOD-2023-750595, MOD-2023-750581 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She is out of breath when she goes for her regular walk; I just don't feel good; She has no energy; She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),; She has constant headache; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (She is out of breath when she goes for her regular walk), MALAISE (I just don't feel good), ASTHENIA (She has no energy), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) 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 06-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 06-Nov-2023, the patient experienced DYSPNOEA (She is out of breath when she goes for her regular walk), MALAISE (I just don't feel good), ASTHENIA (She has no energy), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (She is out of breath when she goes for her regular walk), MALAISE (I just don't feel good), ASTHENIA (She has no energy), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2023, Body temperature: Low grade fever 98.9 F to 99.9 F, normal temperature is 97.8 F.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. She stated that after all the other Moderna shots, she had similar side effects but with previous shots the side effects lasted only 4 days. After the shot on 06-NOV-2023, the side effects did not go away. It has been 15 days now. When she takes 2 Tylenol the fever goes away, but it comes back the next day. She stated that she drunk hot tea and coffee but not water. She stated that may be the adult dose she got was too much for her small body. She weighs as much as a teenager.   This case was linked to MOD-2023-750595, MOD-2023-750581 (Patient Link).
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Company comment: This spontaneous case concerns a 17-year-old patient of an unknown gender, with no medical history reported, who died an unknown time after a dose of mRNA-1273 (Moderna COVID-19 Vaccine) (seriousness assessment reported as fatal and medically significant). Cause of death was not reported. Information regarding clinical evaluation, diagnostic tests, autopsy report, and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750558, US-MODERNATX, INC.-MOD-2023-750508 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750558:Same Reporter Patient US-MODERNATX, INC.-MOD-2023-750508:Same Reporter Patient; Reported Cause(s) of Death: Unknown cause of death
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death and medically significant). The reported cause of death was complication of stroke. An autopsy was not performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Company comment: This spontaneous case concerns a 26-year-old male patient, with no medical history reported, who experienced the unexpected and serious (death and medically significant) AESI of CEREBROVASCULAR ACCIDENT and died. The vaccination date with an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine was not reported; hence, latency could not be properly assessed. The reported cause of death was complication of a stroke. It is unknown if an autopsy was performed. Information regarding clinical evaluation, diagnostic tests, autopsy report, and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750562, US-MODERNATX, INC.-MOD-2023-750508 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750562:Same Reporter Different Patient US-MODERNATX, INC.-MOD-2023-750508:Same Reporter Different Patient; Reported Cause(s) of Death: complication of stroke
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid cancer
Clinical narrative: Swollen lymphnodes arm and neck for a year. Thyroid turned hypervascular, and now have 2 different thyroid cancers; This spontaneous case was reported by an other health care professional and describes the occurrence of THYROID CANCER (Swollen lymphnodes arm and neck for a year. Thyroid turned hypervascular, and now have 2 different thyroid cancers) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A and 027H21B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism (Thyroid was not enlarged or hypervascular. No cancer.), Wheat allergy and Peanut allergy.   On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 18-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THYROID CANCER (Swollen lymphnodes arm and neck for a year. Thyroid turned hypervascular, and now have 2 different thyroid cancers) (seriousness criterion medically significant). At the time of the report, THYROID CANCER (Swollen lymphnodes arm and neck for a year. Thyroid turned hypervascular, and now have 2 different thyroid cancers) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  A third precancer removed from left thyroid sample.  This vaccine ruined patient life. It was unknown if the patient experienced any additional symptoms/events. Lab data: Pathology reports and records every step of the way since receiving the mandatory vaccines. Thyroid, right, hemithyroidectomy: Multifocal, papillary carcinomas, infiltrative follicular subtype, three with: sizes 2 mm. No evidence of extrathyroidal extension, Inked margins of resection, free. Chronic thyroiditis with dystrophic calcification. mildly hypercellular parathyroid. Two lymph node, no evidence of malignancy. Tumors were present on frozen section. tumors were immunoreactive to HBME1,Galectin 2, and Ck19.  No treatment information was reported. Company comment-This is a spontaneous case concerning a 36-year-old female patient with no relevant medical history reported who experienced the unexpected and serious (medically significant) event thyroid cancer 16 days after a second dose of mRNA-1273 vaccine was administered. A first dose of mRNA-1273 vaccine was given in an appropriate schedule of vaccination (31 days interval). It was reported patient had swollen lymph nodes in arm and neck for a year. Thyroid turned hyper vascular, and now has 2 different thyroid cancers. Right hemithyroidectomy was performed. Patient´s gender remains as a contributory risk factor for the event. The event was assessed as not related to mRNA-1273 vaccine due to lack of biological plausibility. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: tachycardia; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (tachycardia) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 010M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced TACHYCARDIA (tachycardia). At the time of the report, TACHYCARDIA (tachycardia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 125 breaths per minute and 190 breaths per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  After having the first round of vaccines, within 3-4 weeks of the second shot, patient started having weird heartrate spikes. These started one month after his first round of COVID-19 vaccines. He was a runner and regularly monitors his heart rate. He spoke to his doctor who referred him to a cardiologist. The cardiologist was also able to observe tachycardia. He was not being bothered by this condition anymore. He had seen spikevax labelling information and realized there is a listed risk to discuss an elevated heart rate with his HCP. He had received COVID-19 vaccines as follows: 18MAR2021 (lot number 010M20A) 15APR2021 (lot number 021B21A) 11NOV2021 (lot number 065F21A) 19APR2022 (lot number 005M21A) 23SEP2022 (Pfizer bivalent, lot number GJ8739) His heart rate while running would be 125 BPM then would shoot up to around 190 BPM immediately. Would stop and put down head and that would bring his heart rate down quickly. No pain or dizziness. Just a weird feeling and concerning to him. Last incident was sometime early this past spring. No medications or treatments. Has also received flu shots and shingles vaccine over this time. Shingles was last spring.   treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Hypersensitivity, Interchange of vaccine products, Malaise, Pruritus
Clinical narrative: she is not feeling well; She is itchy. She is itching on her arm, chest, back; She received Spikevax about 2 weeks ago and she has been experiencing allergies all over her body since then; This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn´t experience anything like this; This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn´t experience anything like this; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she is not feeling well), PRURITUS (She is itchy. She is itching on her arm, chest, back), HYPERSENSITIVITY (She received Spikevax about 2 weeks ago and she has been experiencing allergies all over her body since then), INTERCHANGE OF VACCINE PRODUCTS (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn´t experience anything like this) and COVID-19 IMMUNISATION (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn´t experience anything like this) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (she is not feeling well), PRURITUS (She is itchy. She is itching on her arm, chest, back), HYPERSENSITIVITY (She received Spikevax about 2 weeks ago and she has been experiencing allergies all over her body since then), INTERCHANGE OF VACCINE PRODUCTS (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn´t experience anything like this) and COVID-19 IMMUNISATION (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn´t experience anything like this). At the time of the report, MALAISE (she is not feeling well) and PRURITUS (She is itchy. She is itching on her arm, chest, back) had not resolved and HYPERSENSITIVITY (She received Spikevax about 2 weeks ago and she has been experiencing allergies all over her body since then), INTERCHANGE OF VACCINE PRODUCTS (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn´t experience anything like this) and COVID-19 IMMUNISATION (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn´t experience anything like this) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm
Clinical narrative: aneurysm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANEURYSM (aneurysm) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) 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 ANEURYSM (aneurysm). At the time of the report, ANEURYSM (aneurysm) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  The caller mentioned that her mother developed an Aneurysm, after having the Moderna vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: appears to be my vastus lateralls muscle. I couldn't feel anything in that part of my leg, only pressure when I pressed the area; After the numbness went away my leg tingles periodically in the same area; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (appears to be my vastus lateralls muscle. I couldn't feel anything in that part of my leg, only pressure when I pressed the area) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 11-Nov-2023, the patient experienced HYPOAESTHESIA (appears to be my vastus lateralls muscle. I couldn't feel anything in that part of my leg, only pressure when I pressed the area) (seriousness criterion hospitalization) and PARAESTHESIA (After the numbness went away my leg tingles periodically in the same area). In November 2023, HYPOAESTHESIA (appears to be my vastus lateralls muscle. I couldn't feel anything in that part of my leg, only pressure when I pressed the area) had resolved. At the time of the report, PARAESTHESIA (After the numbness went away my leg tingles periodically in the same area) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  within 24 hours of getting the shot her leg became numb, appeared to be her vastus lateralls muscle. She couldn't feel anything in that part of her leg, only pressure when she pressed the area. It was numb for approximately 2-3 days.  After the numbness went away her leg tingles periodically in the same area, sort of like when foot falls asleep, same feeling. The tingling continues as of today, but the numbness was gone so this was partially resolved. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported. Company comment: This spontaneous case concerns a 58-year-old female patient, with no medical history reported, who experienced the unexpected and serious (hospitalization) event of HYPOAESTHESIA, and the unexpected and non-serious event of PARAESTHESIA, 2 days after an unspecified dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. She experienced numbness for approximately 2-3 days. After the numbness recovered tingling continues periodically in the same area. No details of previous doses were provided. No treatment information was reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: I have body itching; she still has mild itching and a fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I have body itching) and PYREXIA (she still has mild itching and a fever) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031895) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 20-Nov-2023, the patient experienced PRURITUS (I have body itching) and PYREXIA (she still has mild itching and a fever). At the time of the report, PRURITUS (I have body itching) and PYREXIA (she still has mild itching and a fever) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The patent had body itching, also had it before but took antihistamine.   No concomitant and treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: he has been having a low grade headache; little pain on his injection site and it went away; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (he has been having a low grade headache) and INJECTION SITE PAIN (little pain on his injection site and it went away) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (He said the injection site pain was worst than when he had Pfizer. He had 5 or 6 Pfizer shots previously.). Past adverse reactions to the above products included Injection site pain with Pfizer vaccine.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Nov-2023, the patient experienced HEADACHE (he has been having a low grade headache) and INJECTION SITE PAIN (little pain on his injection site and it went away). In November 2023, INJECTION SITE PAIN (little pain on his injection site and it went away) had resolved. At the time of the report, HEADACHE (he has been having a low grade headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 16-Nov-2023, the patient went to his local pharmacy and they did not have Pfizer COVID-19 shots, so they administered Spikevax to the patient. He stated that since 16-Nov-2023, he had been having a low-grade headache. He had a little pain on his injection site and it went away. He said that the injection site pain was worst than when he had Pfizer vaccine.  No treatment medications were reported.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Tremor
Clinical narrative: shaking; Extreme chill; severe headache for two days after, then came back on me once a week for 7 weeks.; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking), CHILLS (Extreme chill) and HEADACHE (severe headache for two days after, then came back on me once a week for 7 weeks.) in a 63-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking), CHILLS (Extreme chill) and HEADACHE (severe headache for two days after, then came back on me once a week for 7 weeks.). At the time of the report, TREMOR (shaking), CHILLS (Extreme chill) and HEADACHE (severe headache for two days after, then came back on me once a week for 7 weeks.) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient experienced extreme chill and shaking, severe headache for two days after, then came back once a week for 7 weeks. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-750546 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750546:Same patient different dose
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Severe headache still going on; Chills for at least 29 hours; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Severe headache still going on) and CHILLS (Chills for at least 29 hours) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis and Obesity.    On 20-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Nov-2023, the patient experienced HEADACHE (Severe headache still going on) and CHILLS (Chills for at least 29 hours). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) at a dose of 500 milligram and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at a dose of 500 milligram. In November 2023, CHILLS (Chills for at least 29 hours) had resolved. At the time of the report, HEADACHE (Severe headache still going on) had not resolved.            No concomitant medications were reported.  Reported that patient had chills for at least 29 hours. Severe headache still going on. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.   This case was linked to MOD-2023-750533 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Gingival pain, Injection site pain, Oral pain, Oropharyngeal pain
Clinical narrative: Mouth soreness and tender gums; Mouth soreness and tender gums; sore throat; fever up to 102.1 F; injection site soreness; This spontaneous case was reported by a non-health professional and describes the occurrence of ORAL PAIN (Mouth soreness and tender gums), GINGIVAL PAIN (Mouth soreness and tender gums), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever up to 102.1 F) and INJECTION SITE PAIN (injection site soreness) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Nov-2023, the patient experienced ORAL PAIN (Mouth soreness and tender gums), GINGIVAL PAIN (Mouth soreness and tender gums), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever up to 102.1 F) and INJECTION SITE PAIN (injection site soreness). At the time of the report, ORAL PAIN (Mouth soreness and tender gums), GINGIVAL PAIN (Mouth soreness and tender gums), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever up to 102.1 F) and INJECTION SITE PAIN (injection site soreness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: upto 102.1 F.         No concomitant medications were reported. It was reported that fever lifted after 48 hrs. Still have sore mouth, gums, throat. It was unknown if the patient experienced any additional symptoms/event. No treatment medications were reported.