chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Palpitations
Clinical narrative: Severe heart palpitations; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Severe heart palpitations) and DYSPNOEA (Shortness of breath) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Severe heart palpitations) and DYSPNOEA (Shortness of breath). At the time of the report, PALPITATIONS (Severe heart palpitations) and DYSPNOEA (Shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 84 (abnormal) sitting down her heart rate was 84 and 136 (High) standing up it was like 136.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  The patient experienced the events 4 days after receiving the vaccine. The symptoms lasted for 2.5 days where they were consistent but have not gone away completely. Patient went to Doctor on 14-Sep-2021, said it was probably stress and anxiety but the patient thought it was from the vaccine. The patient was scared to get the second shot.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Second shot hurt afterwards a little bit more; nagging pain/ hurt a little bit more; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Second shot hurt afterwards a little bit more) and PAIN (nagging pain/ hurt a little bit more) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 029L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), METOPROLOL and VITAMINS NOS for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Second shot hurt afterwards a little bit more) and PAIN (nagging pain/ hurt a little bit more). At the time of the report, PAIN IN EXTREMITY (Second shot hurt afterwards a little bit more) and PAIN (nagging pain/ hurt a little bit more) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown Concomitant products included Ellipta   This case was linked to MOD-2021-320166, MOD-2021-320262.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased activity, Inappropriate schedule of product administration, Limb discomfort, Pain in extremity
Clinical narrative: Every time I pick something up with my left arm it hurts; I can not lift my arm up, over my head/ I am basically disable on my left side; I am so hindered; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Every time I pick something up with my left arm it hurts), LIMB DISCOMFORT (I can not lift my arm up, over my head/ I am basically disable on my left side), DECREASED ACTIVITY (I am so hindered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088021A, 029L20A and 042L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), METOPROLOL and VITAMINS NOS for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAIN IN EXTREMITY (Every time I pick something up with my left arm it hurts), LIMB DISCOMFORT (I can not lift my arm up, over my head/ I am basically disable on my left side) and DECREASED ACTIVITY (I am so hindered). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) on 04-Sep-2021 for Relaxation, at an unspecified dose and frequency. On 14-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Every time I pick something up with my left arm it hurts), LIMB DISCOMFORT (I can not lift my arm up, over my head/ I am basically disable on my left side) and DECREASED ACTIVITY (I am so hindered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Concomitant product included Ellipta.  The patient was not able to lift arm up over head and every time, after trying to pick something up, it hurts.  On 04-Sep-2021, the patient visited urgent care. There was nothing wrong, except for the shot.  On the same date, the patient took treatment medication, anti inflammatory injection (Flexeril to relax it, and pain medication).   This case was linked to MOD-2021-320261, MOD-2021-320166 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site my left shoulder hurt slightly/ Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site my left shoulder hurt slightly/ Sore left injection site arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site my left shoulder hurt slightly/ Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Injection site my left shoulder hurt slightly/ Sore left injection site arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported. No treatment medication was reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling drained and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling drained and fatigued) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced FATIGUE (Feeling drained and fatigued). At the time of the report, FATIGUE (Feeling drained and fatigued) outcome was unknown.            No concomitant medications were taken by the patient.  No treatment medications were taken by the patient.  Patient reported that everything was fine on 14 Sep 2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. List of concomitant medication were not given.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dyspnoea
Clinical narrative: Trouble breathing; Dehydrated; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (Trouble breathing) and DEHYDRATION (Dehydrated) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced DYSPNOEA (Trouble breathing) (seriousness criterion hospitalization) and DEHYDRATION (Dehydrated) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Trouble breathing) and DEHYDRATION (Dehydrated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Patient reported that On 14-sep-2021, the patient went for walk and experienced trouble breathing.  Treatment information was not provided.  Company Comment: This case concerns a 35-year-old, male patient with no previous relevant medical history, who experienced the unexpected events of dyspnoea and dehydration. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 35-year-old, male patient with no previous relevant medical history, who experienced the unexpected events of dyspnoea and dehydration. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Inappropriate schedule of product administration, Oral herpes, Paranasal sinus discomfort
Clinical narrative: Doses too far apart/ first Moderna vaccine on 4May2021/ second vaccine was on 31Aug2021; Pressure behind nose; Head being squeezed; Fever blisters around lips; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses too far apart/ first Moderna vaccine on 4May2021/ second vaccine was on 31Aug2021), PARANASAL SINUS DISCOMFORT (Pressure behind nose), HEAD DISCOMFORT (Head being squeezed), ORAL HERPES (Fever blisters around lips) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 002C21A) for COVID-19 vaccination.     The patient's past medical history included Shingles (the exact pain in the exact spot on her right side.). Previously administered products included for an unreported indication: SHINGRIX.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses too far apart/ first Moderna vaccine on 4May2021/ second vaccine was on 31Aug2021), PARANASAL SINUS DISCOMFORT (Pressure behind nose), HEAD DISCOMFORT (Head being squeezed), ORAL HERPES (Fever blisters around lips) and HEADACHE (Headache). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses too far apart/ first Moderna vaccine on 4May2021/ second vaccine was on 31Aug2021) had resolved and PARANASAL SINUS DISCOMFORT (Pressure behind nose), HEAD DISCOMFORT (Head being squeezed), ORAL HERPES (Fever blisters around lips) and HEADACHE (Headache) outcome was unknown.            Patient started having a headache not really like a throbbing headache but a pressure in head and nose area like her head was being squeezed. It hurt mostly when she would lean down.  Concomitant medications were not reported. Treatment details were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Potencially not received the second dose on the recommended time frame; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Potencially not received the second dose on the recommended time frame) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Potencially not received the second dose on the recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Potencially not received the second dose on the recommended time frame) had resolved.            No concomitant medications are provided . No treatment medications are provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose >36 days later (after 41 days of 1st dose, 2nd dose taken); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose >36 days later (after 41 days of 1st dose, 2nd dose taken)) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-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 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose >36 days later (after 41 days of 1st dose, 2nd dose taken)). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose >36 days later (after 41 days of 1st dose, 2nd dose taken)) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-320320 (Patient Link).   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: Shortness of breath/Trouble breathing; Rash; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath/Trouble breathing) and RASH (Rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath/Trouble breathing) and RASH (Rash). The patient was treated with EPINEPHRINE for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath/Trouble breathing) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was asking if she should take the second shot with the reaction as bad as it was.   No concomitant medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Thrombosis, Vaccination complication
Clinical narrative: Had blood clotting; Had some issues; Scared to take second shot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Had blood clotting), VACCINATION COMPLICATION (Had some issues) and ANXIETY (Scared to take second shot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Had blood clotting), VACCINATION COMPLICATION (Had some issues) and ANXIETY (Scared to take second shot). At the time of the report, THROMBOSIS (Had blood clotting), VACCINATION COMPLICATION (Had some issues) and ANXIETY (Scared to take second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. It is stated that patient had some issues and blood clotting, because of that she was scared to take second shot. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up information received on 15 Sep 2021, Updated year in date of birth of patient.; Sender's Comments: This case concerns a 61-year-old female patient with no details on previous relevant medical history, who experienced the unexpected event of Thrombosis (reported as Had blood clotting) after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred after the first dose of Spikevax, temporal relationship is unknown. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Thrombosis was automatically upgraded as serious as per list. However, based on information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD ((i.e. past 30 days at fridge temperature); previously received 1 dose of AstraZeneca; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD ((i.e. past 30 days at fridge temperature)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (previously received 1 dose of AstraZeneca) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination.    No Medical History information was reported.   On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD ((i.e. past 30 days at fridge temperature)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (previously received 1 dose of AstraZeneca). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD ((i.e. past 30 days at fridge temperature)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (previously received 1 dose of AstraZeneca) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not given Treatment information was not provided by the reporter.  The reporter had confirmed that the individuals did not report any adverse events after receiving their vaccine dose.   This case was linked to MOD-2021-321072, MOD-2021-320812, MOD-2021-320876 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Patient demograhics (age, gender) updated. Cosuspect (AstraZeneca) was added. Dose number, route of administration and expiry date was updated for suspect. On 22-Sep-2021: Follow up document received on 22-sep-2021 contains no significant information.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery disease
Clinical narrative: cause of death of unknown aetiology (her spelling) coronary artery disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CORONARY ARTERY DISEASE (cause of death of unknown aetiology (her spelling) coronary artery disease) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced CORONARY ARTERY DISEASE (cause of death of unknown aetiology (her spelling) coronary artery disease) (seriousness criterion death). The patient died on 30-Jan-2021. The reported cause of death was unknown aetiology (her spelling) coronary artery disease. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant and treatment medications were reported.  Company comment- This case concerns a 77-year-old, male patient with no known medical history, who experienced the unexpected event of CORONARY ARTERY DISEASE. The event occurred approximately 11 days after the first dose of Spikevax and had a fatal outcome, with death occurring in this day. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 77-year-old, male patient with no known medical history, who experienced the unexpected event of CORONARY ARTERY DISEASE. The event occurred approximately 11 days after the first dose of Spikevax and had a fatal outcome, with death occurring in this day. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: unknown aetiology (her spelling) coronary artery disease
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood pressure measurement, Headache, Hypertension, Immune system disorder
Clinical narrative: High blood pressure; Vertigo; Headache; flu like symptoms (just as she did with the second dose); Immune system has been overstimulated; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), VERTIGO (Vertigo), INFLUENZA LIKE ILLNESS (flu like symptoms (just as she did with the second dose)), IMMUNE SYSTEM DISORDER (Immune system has been overstimulated) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included PEGINTERFERON ALFA-2A (PEGASYS) from an unknown date to 08-Sep-2021 for Immunocompromised, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM and PROGESTERONE for an unknown indication.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms (just as she did with the second dose)) and IMMUNE SYSTEM DISORDER (Immune system has been overstimulated). On 04-Sep-2021, the patient experienced HYPERTENSION (High blood pressure), VERTIGO (Vertigo) and HEADACHE (Headache). At the time of the report, HYPERTENSION (High blood pressure) and VERTIGO (Vertigo) had not resolved and INFLUENZA LIKE ILLNESS (flu like symptoms (just as she did with the second dose)), IMMUNE SYSTEM DISORDER (Immune system has been overstimulated) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: high (High) titers were high. On an unknown date, Blood pressure measurement: low (Low) used to be low before the third dose.         The patient was a classic example of someone who was small. Before receiving third dose, the patient asked her doctor to do her antibody test again, but doctor told they didn't believe in Ab testing. The patient still had high BP and vertigo. The doctors told the patient to stay hydrated.   On 13-Sep-2021, the patient went to a specialist the vertigo and she was given some exercises but that got her worse, so she had stopped them.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-320592 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vertigo
Clinical narrative: High blood pressure; Vertigo; Headache; flu like symptoms (just as she did with the second dose); Immune system has been overstimulated; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), VERTIGO (Vertigo), INFLUENZA LIKE ILLNESS (flu like symptoms (just as she did with the second dose)), IMMUNE SYSTEM DISORDER (Immune system has been overstimulated) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included PEGINTERFERON ALFA-2A (PEGASYS) from an unknown date to 08-Sep-2021 for Immunocompromised, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM and PROGESTERONE for an unknown indication.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms (just as she did with the second dose)) and IMMUNE SYSTEM DISORDER (Immune system has been overstimulated). On 04-Sep-2021, the patient experienced HYPERTENSION (High blood pressure), VERTIGO (Vertigo) and HEADACHE (Headache). At the time of the report, HYPERTENSION (High blood pressure) and VERTIGO (Vertigo) had not resolved and INFLUENZA LIKE ILLNESS (flu like symptoms (just as she did with the second dose)), IMMUNE SYSTEM DISORDER (Immune system has been overstimulated) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: high (High) titers were high. On an unknown date, Blood pressure measurement: low (Low) used to be low before the third dose.         The patient was a classic example of someone who was small. Before receiving third dose, the patient asked her doctor to do her antibody test again, but doctor told they didn't believe in Ab testing. The patient still had high BP and vertigo. The doctors told the patient to stay hydrated.   On 13-Sep-2021, the patient went to a specialist the vertigo and she was given some exercises but that got her worse, so she had stopped them.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-320592 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Middle ear effusion, Nausea
Clinical narrative: Fluid build up in ears; More than 35 days for 2nd dose; Felt like throwing up; Almost passed out; Sweaty; Hot; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost passed out) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 06-Mar-2021, the patient experienced PRESYNCOPE (Almost passed out) (seriousness criterion medically significant), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), DIZZINESS (Dizzy) and NAUSEA (Felt like throwing up). On an unknown date, the patient experienced MIDDLE EAR EFFUSION (Fluid build up in ears) and PRODUCT DOSE OMISSION ISSUE (More than 35 days for 2nd dose). At the time of the report, PRESYNCOPE (Almost passed out), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), DIZZINESS (Dizzy), MIDDLE EAR EFFUSION (Fluid build up in ears) and NAUSEA (Felt like throwing up) was resolving and PRODUCT DOSE OMISSION ISSUE (More than 35 days for 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported. Patient had a reaction after getting the 1st dose of the vaccine and stated that after 24 hours almost passed out due to being sweaty and hot, also reported felt like throwing up and feeling dizzy, had fluid build-up in ears and this may have occurred a week or two later and did not provide exact dates for onset and duration. Patient still gets dizzy but not so pronounced and all of the other adverse events have subsided. Patint may have been given antibiotics for fluid buildup, but not sure and was sure that was prescribed steroids.  Treatment included Steroids and possibly antibiotics. Company comment: This case concerns a 48-year-old, male patient with no relevant medical history, who experienced the unexpected event of almost passed out (presyncope). The event occurred approximately 2 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 48-year-old, male patient with no relevant medical history, who experienced the unexpected event of almost passed out (presyncope). The event occurred approximately 2 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Product dose omission issue
Clinical narrative: Fluid build up in ears; More than 35 days for 2nd dose; Felt like throwing up; Almost passed out; Sweaty; Hot; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost passed out) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 06-Mar-2021, the patient experienced PRESYNCOPE (Almost passed out) (seriousness criterion medically significant), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), DIZZINESS (Dizzy) and NAUSEA (Felt like throwing up). On an unknown date, the patient experienced MIDDLE EAR EFFUSION (Fluid build up in ears) and PRODUCT DOSE OMISSION ISSUE (More than 35 days for 2nd dose). At the time of the report, PRESYNCOPE (Almost passed out), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), DIZZINESS (Dizzy), MIDDLE EAR EFFUSION (Fluid build up in ears) and NAUSEA (Felt like throwing up) was resolving and PRODUCT DOSE OMISSION ISSUE (More than 35 days for 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported. Patient had a reaction after getting the 1st dose of the vaccine and stated that after 24 hours almost passed out due to being sweaty and hot, also reported felt like throwing up and feeling dizzy, had fluid build-up in ears and this may have occurred a week or two later and did not provide exact dates for onset and duration. Patient still gets dizzy but not so pronounced and all of the other adverse events have subsided. Patint may have been given antibiotics for fluid buildup, but not sure and was sure that was prescribed steroids.  Treatment included Steroids and possibly antibiotics. Company comment: This case concerns a 48-year-old, male patient with no relevant medical history, who experienced the unexpected event of almost passed out (presyncope). The event occurred approximately 2 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 48-year-old, male patient with no relevant medical history, who experienced the unexpected event of almost passed out (presyncope). The event occurred approximately 2 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Second dose is non Moderna Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Second dose is non Moderna Vaccine) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 13-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Second dose is non Moderna Vaccine). On 13-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Second dose is non Moderna Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not had any adverse reaction or symptoms.  No concomitant medications were reported.  No treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspepsia, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: sore arm a little bit; tired; EKG indicated cluster on her heart; burning sensation in chest; Couldn't catch her breath/shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (EKG indicated cluster on her heart), DYSPEPSIA (burning sensation in chest), DYSPNOEA (Couldn't catch her breath/shortness of breath), MYALGIA (sore arm a little bit) and FATIGUE (tired) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced CARDIAC DISORDER (EKG indicated cluster on her heart), DYSPEPSIA (burning sensation in chest) and DYSPNOEA (Couldn't catch her breath/shortness of breath). On an unknown date, the patient experienced MYALGIA (sore arm a little bit) and FATIGUE (tired). At the time of the report, CARDIAC DISORDER (EKG indicated cluster on her heart), DYSPEPSIA (burning sensation in chest), DYSPNOEA (Couldn't catch her breath/shortness of breath), MYALGIA (sore arm a little bit) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Electrocardiogram: cluster on her heart (abnormal) cluster on her heart.         No concomitant medication were reported. The patient never experienced these symptoms before receiving the Moderna COVID-19 vaccine. No treatment information was reported. The patient needed further monitoring. The patient experienced burning sensation in chest and shortness of breath. The patient had an EKG and indicated had a cluster on her heart and that further monitoring was needed. Day of shots was tired and had a sore arm a little bit.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm a little bit; tired; EKG indicated cluster on her heart; burning sensation in chest; Couldn't catch her breath/shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (EKG indicated cluster on her heart), DYSPEPSIA (burning sensation in chest), DYSPNOEA (Couldn't catch her breath/shortness of breath), MYALGIA (sore arm a little bit) and FATIGUE (tired) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced CARDIAC DISORDER (EKG indicated cluster on her heart), DYSPEPSIA (burning sensation in chest) and DYSPNOEA (Couldn't catch her breath/shortness of breath). On an unknown date, the patient experienced MYALGIA (sore arm a little bit) and FATIGUE (tired). At the time of the report, CARDIAC DISORDER (EKG indicated cluster on her heart), DYSPEPSIA (burning sensation in chest), DYSPNOEA (Couldn't catch her breath/shortness of breath), MYALGIA (sore arm a little bit) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Electrocardiogram: cluster on her heart (abnormal) cluster on her heart.         No concomitant medication were reported. The patient never experienced these symptoms before receiving the Moderna COVID-19 vaccine. No treatment information was reported. The patient needed further monitoring. The patient experienced burning sensation in chest and shortness of breath. The patient had an EKG and indicated had a cluster on her heart and that further monitoring was needed. Day of shots was tired and had a sore arm a little bit.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Product dose omission issue
Clinical narrative: Blood pressure spiked up above 200/117 for several weeks; More than 35 days from 1st vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure spiked up above 200/117 for several weeks) and PRODUCT DOSE OMISSION ISSUE (More than 35 days from 1st vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure spiked up above 200/117 for several weeks) and PRODUCT DOSE OMISSION ISSUE (More than 35 days from 1st vaccination). The patient was treated with LISINOPRIL for Blood pressure, at an unspecified dose and frequency and METOPROLOL for Blood pressure, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure spiked up above 200/117 for several weeks) was resolving and PRODUCT DOSE OMISSION ISSUE (More than 35 days from 1st vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200/117 (High) 200/117 High Blood Pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug information was provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine was administered to seven patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered to seven patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered to seven patients). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered to seven patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The pharmacist reported that the expired vaccine was administered to seven patients. One vial was moved from the freezer to the refrigerator on 01-SEP-2021,   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow-up received on 16 SEP 2021 contains NNI.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered\170 doses of lot number 007B21A that expired on 08SEP2021 and some patients have received it after the expiration.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered\170 doses of lot number 007B21A that expired on 08SEP2021 and some patients have received it after the expiration.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Medical history was not provided.     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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered\170 doses of lot number 007B21A that expired on 08SEP2021 and some patients have received it after the expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered\170 doses of lot number 007B21A that expired on 08SEP2021 and some patients have received it after the expiration.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The caller stated that 170 doses of lot number 007B21A that expired on 08SEP2021 and some patients had received it after the expiration. Caller was not sure how many patients received it but approximately 30 to 40 patients, and he doesn't  had any information on the patients.Caller stated that to his knowledge, the lot number has not undergone any previous excursion, but also some partial box opened that were sitting in the refrigerator. The vaccine in the refrigerator was moved from the freezer to the refrigerator on 13SEP2021.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects following vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 VACCINATION COMPLICATION (side effects following vaccination). At the time of the report, VACCINATION COMPLICATION (side effects following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided.  No treatment medications were provided.