chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood pressure measurement, Chest discomfort, Dizziness, Dysgeusia
Clinical narrative: went into seizure; felt a metallic taste; felt dizzy; nearly fainted; not able to walk; had chest tightness; did not feel like she could breathe; did not feel well; her face was flushed like she was on fire; A Spontaneous report was received from a physcian concerning a 63  Year old Female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dysgeusia/Felt like metallic taste, Dizziness/Dizzy, Presyncope/ Near fainting, Gait Disturbance /Walking difficulty, Chest discomfort/ Chest tightness, Dyspnoea/ Breathing difficult, Malaise/ Feeling unwell, Seizure, Blood pressure abnormal, Blood sugar abnormal and Flushing.  The patient's medical history included Asthma.   No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 9 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown)  via intramuscular route and unknown location for prophylaxis of COVID-19 infection.   had chest tightness and she is an asthma patient. She did not feel like she could breathe and did not feel well. She went back to the pharmacy and they did not want to give her EpiPen. She went into seizure because she already had seizure disorder. Her blood pressure went to 162/80 and her blood sugar went to 152 when she was on her way to the hospital and her face was flushed like she was on fire. She took Zofran during her 5 hours of hospitalization and got a CT scan. They diagnosed her with a post vaccination reaction but she still wants to get the second dose. Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the event Dysgeusia, Dizziness, Presyncope, Walking difficulty, Chest discomforts, Dyspnoea, Malaise, Seizure, Blood pressure abnormal, Blood sugar abnormal and Flushing was considered unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, and excluding other etiologies but for history of asthma, causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Gait disturbance, Malaise, Presyncope
Clinical narrative: went into seizure; felt a metallic taste; felt dizzy; nearly fainted; not able to walk; had chest tightness; did not feel like she could breathe; did not feel well; her face was flushed like she was on fire; A Spontaneous report was received from a physcian concerning a 63  Year old Female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dysgeusia/Felt like metallic taste, Dizziness/Dizzy, Presyncope/ Near fainting, Gait Disturbance /Walking difficulty, Chest discomfort/ Chest tightness, Dyspnoea/ Breathing difficult, Malaise/ Feeling unwell, Seizure, Blood pressure abnormal, Blood sugar abnormal and Flushing.  The patient's medical history included Asthma.   No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 9 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown)  via intramuscular route and unknown location for prophylaxis of COVID-19 infection.   had chest tightness and she is an asthma patient. She did not feel like she could breathe and did not feel well. She went back to the pharmacy and they did not want to give her EpiPen. She went into seizure because she already had seizure disorder. Her blood pressure went to 162/80 and her blood sugar went to 152 when she was on her way to the hospital and her face was flushed like she was on fire. She took Zofran during her 5 hours of hospitalization and got a CT scan. They diagnosed her with a post vaccination reaction but she still wants to get the second dose. Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the event Dysgeusia, Dizziness, Presyncope, Walking difficulty, Chest discomforts, Dyspnoea, Malaise, Seizure, Blood pressure abnormal, Blood sugar abnormal and Flushing was considered unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, and excluding other etiologies but for history of asthma, causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: went into seizure; felt a metallic taste; felt dizzy; nearly fainted; not able to walk; had chest tightness; did not feel like she could breathe; did not feel well; her face was flushed like she was on fire; A Spontaneous report was received from a physcian concerning a 63  Year old Female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dysgeusia/Felt like metallic taste, Dizziness/Dizzy, Presyncope/ Near fainting, Gait Disturbance /Walking difficulty, Chest discomfort/ Chest tightness, Dyspnoea/ Breathing difficult, Malaise/ Feeling unwell, Seizure, Blood pressure abnormal, Blood sugar abnormal and Flushing.  The patient's medical history included Asthma.   No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 9 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown)  via intramuscular route and unknown location for prophylaxis of COVID-19 infection.   had chest tightness and she is an asthma patient. She did not feel like she could breathe and did not feel well. She went back to the pharmacy and they did not want to give her EpiPen. She went into seizure because she already had seizure disorder. Her blood pressure went to 162/80 and her blood sugar went to 152 when she was on her way to the hospital and her face was flushed like she was on fire. She took Zofran during her 5 hours of hospitalization and got a CT scan. They diagnosed her with a post vaccination reaction but she still wants to get the second dose. Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the event Dysgeusia, Dizziness, Presyncope, Walking difficulty, Chest discomforts, Dyspnoea, Malaise, Seizure, Blood pressure abnormal, Blood sugar abnormal and Flushing was considered unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, and excluding other etiologies but for history of asthma, causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Localised infection, Product dose omission issue
Clinical narrative: foot infection; Almost 8 weeks since first dose (missed second dose); This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (foot infection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Almost 8 weeks since first dose (missed second dose)). On an unknown date, the patient experienced LOCALISED INFECTION (foot infection) (seriousness criterion hospitalization). The patient was hospitalized on 11-Feb-2021 due to LOCALISED INFECTION. The patient was treated with Wound care (Hyperbaric Oxygen Chamber Therapy) for Localised infection. On 23-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Almost 8 weeks since first dose (missed second dose)) had resolved. At the time of the report, LOCALISED INFECTION (foot infection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event, localized infection included antibiotics.   Reporter did not allow further contact; Sender's Comments: This case concerns a 70-year-old male hospitalized with a serious unexpected event of localised infection in his foot, also with a nonserious unexpected event of product dose omission issue.  Event onset 2 months and 2 days after first dose mRNA-1273. Treated with antibiotics. Event resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypokalaemia, Hyponatraemia, Nausea, Vomiting
Clinical narrative: low potassium; low sodium; chills; started throwing up; felt very nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKALAEMIA (low potassium) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (patient had covi1-19  on last march and was hospitalized.).  On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (chills), VOMITING (started throwing up) and NAUSEA (felt very nauseous). On an unknown date, the patient experienced HYPOKALAEMIA (low potassium) (seriousness criterion medically significant) and HYPONATRAEMIA (low sodium). At the time of the report, HYPOKALAEMIA (low potassium), HYPONATRAEMIA (low sodium), CHILLS (chills), VOMITING (started throwing up) and NAUSEA (felt very nauseous) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Haematochezia, Muscle spasms, Pain
Clinical narrative: Bloody stools; Pain; Cramps; Diarrhea; Abdominal pain; A spontaneous report was received from a female patient who received mRNA-1273 vaccine and experienced loose bloody stools/haematochezia, pain, cramps/muscle spasms, diarrhoea, and abdominal pain.  No medical history and concomitant medications were provided by the reporter.  On 23 Mar 2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: unknown) via intramuscular route for prophylaxis of COVID-19 infection.   On 24 Mar 2021, the patient experienced loose bloody stools, pain, cramps, diarrhoea, and abdominal pain. No treatment medication was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcomes of the events pain, cramps, diarrhoea, abdominal pain were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dystonia, Hot flush, Premature menopause, Pyrexia
Clinical narrative: premature menopause; ovary got shut down; lot of jerking; Involuntary muscle movements.; Almost 100 hot flashes a day all thru the night for every few minutes.; fever; chills; A spontaneous report was received from a consumer concerning a 37-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events almost 100 hot flashes a day all thru the night for every few minutes/ Hot flush,  involuntary muscle movements/ Dystonia,  a lot of jerking/ Tonic clonic movements,  fever/ Pyrexia,  chills/ Chills, premature menopause/ Premature menopause,  ovary got shut down/ Premature menopause.  The patient's medical history was not provided. Concomitant medications was also unknown.  On 10 Feb2021., prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, After 8 hours the patient experienced the event involuntary muscle movements, a lot of jerking, fever, and chills. She went to premature menopause at young age. Her ovary got shut down Estrogen is extremely low and FSH is extremely high. Almost 100 hot flashes a day all thru the night for every few minutes.   Treatment information was provided As offered birth control pills/therapy and hormonal therapy by the doctor. But she wants to take sometime before she start the treatment.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s). s Almost 100 hot flashes a day all thru the night for every few minutes/ Hot flush,  involuntary muscle movements/ Dystonia,  a lot of jerking/ Tonic clonic movements,  fever/ Pyrexia,  chills/ Chills, premature menopause/ Premature menopause,  ovary got shut down/ Premature menopause was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tonic clonic movements
Clinical narrative: premature menopause; ovary got shut down; lot of jerking; Involuntary muscle movements.; Almost 100 hot flashes a day all thru the night for every few minutes.; fever; chills; A spontaneous report was received from a consumer concerning a 37-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events almost 100 hot flashes a day all thru the night for every few minutes/ Hot flush,  involuntary muscle movements/ Dystonia,  a lot of jerking/ Tonic clonic movements,  fever/ Pyrexia,  chills/ Chills, premature menopause/ Premature menopause,  ovary got shut down/ Premature menopause.  The patient's medical history was not provided. Concomitant medications was also unknown.  On 10 Feb2021., prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, After 8 hours the patient experienced the event involuntary muscle movements, a lot of jerking, fever, and chills. She went to premature menopause at young age. Her ovary got shut down Estrogen is extremely low and FSH is extremely high. Almost 100 hot flashes a day all thru the night for every few minutes.   Treatment information was provided As offered birth control pills/therapy and hormonal therapy by the doctor. But she wants to take sometime before she start the treatment.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s). s Almost 100 hot flashes a day all thru the night for every few minutes/ Hot flush,  involuntary muscle movements/ Dystonia,  a lot of jerking/ Tonic clonic movements,  fever/ Pyrexia,  chills/ Chills, premature menopause/ Premature menopause,  ovary got shut down/ Premature menopause was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling cold, Gait inability
Clinical narrative: Went black, did not loose consciousnes, but hit the head on the tiles; Hit head on the tiles; Woke up and could not even walk; Heart was in a fast heartbeat; Weakness; Slept whole day; Dizziness; Tired; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immune disorder (NOS) and Knee surgery NOS in 2019. Concurrent medical conditions included Macular degeneration. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D3, MAGNESIUM and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced FEELING COLD (Freezing) and FATIGUE (Tired). On 22-Mar-2021, the patient experienced SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles) (seriousness criterion medically significant), HEAD INJURY (Hit head on the tiles), GAIT INABILITY (Woke up and could not even walk), HEART RATE INCREASED (Heart was in a fast heartbeat), ASTHENIA (Weakness), SOMNOLENCE (Slept whole day) and DIZZINESS (Dizziness). At the time of the report, SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles), HEAD INJURY (Hit head on the tiles), GAIT INABILITY (Woke up and could not even walk), HEART RATE INCREASED (Heart was in a fast heartbeat), FEELING COLD (Freezing), ASTHENIA (Weakness), SOMNOLENCE (Slept whole day), DIZZINESS (Dizziness) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-056437 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-056437:Crosslinked case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Heart rate increased, Somnolence, Syncope
Clinical narrative: Went black, did not loose consciousnes, but hit the head on the tiles; Hit head on the tiles; Woke up and could not even walk; Heart was in a fast heartbeat; Weakness; Slept whole day; Dizziness; Tired; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immune disorder (NOS) and Knee surgery NOS in 2019. Concurrent medical conditions included Macular degeneration. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D3, MAGNESIUM and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced FEELING COLD (Freezing) and FATIGUE (Tired). On 22-Mar-2021, the patient experienced SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles) (seriousness criterion medically significant), HEAD INJURY (Hit head on the tiles), GAIT INABILITY (Woke up and could not even walk), HEART RATE INCREASED (Heart was in a fast heartbeat), ASTHENIA (Weakness), SOMNOLENCE (Slept whole day) and DIZZINESS (Dizziness). At the time of the report, SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles), HEAD INJURY (Hit head on the tiles), GAIT INABILITY (Woke up and could not even walk), HEART RATE INCREASED (Heart was in a fast heartbeat), FEELING COLD (Freezing), ASTHENIA (Weakness), SOMNOLENCE (Slept whole day), DIZZINESS (Dizziness) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-056437 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-056437:Crosslinked case
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: one friend got COVID after the shot and has passed away; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine and got COVID after the shot and has died/COVID-19.  The patient's medical history was not provided. Concomitant product use was not provided by reporter.    On an unknown date the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    Reporter mentioned that her friend got COVID after the shot and has died. No treatment information was provided.   Action taken with the second dose of mRNA-1273 in response to the event death is not applicable.   The patient died on an unknown date. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: A case of death of female patient of an unknown age who developed COVI on an unknown date post mRNA-1273 (vaccination (lot   unknown) and died.  Very limited information regarding this event/s has been provided at this time.  However, based on the known etiology of COVID and the established profile of mRNA-1273, the event is assessed as unlikely related to mRNA-1273 administration. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: A broken blood vessel on my left eye.; A spontaneous report was received from a consumer concerning a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a broken blood vessel on her left eye.    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included valproate semisodium, amlodipine, clopidogrel bisulfate, bupropion hydrochloride, iron polysaccharide complex, multivitamins, potassium, acetylsalicylic acid, sodium bicarbonate and humira.   On 26-MAR-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 046A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26-MAR- 2021, she noticed a broken blood vessel on her left eye which doesn't really bother her.   Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Wrong injection site/got the 1st shot in the triceps and not in the deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Wrong injection site/got the 1st shot in the triceps and not in the deltoid muscle) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ADMINISTERED AT INAPPROPRIATE SITE (Wrong injection site/got the 1st shot in the triceps and not in the deltoid muscle). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Wrong injection site/got the 1st shot in the triceps and not in the deltoid muscle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.; Sender's Comments: This report refers to a case of vaccine administered at inappropriate site for mRNA-1273, lot # unknown  with no associated AEs
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Irregular breathing, Lip swelling, Paraesthesia oral
Clinical narrative: breathing altered; throat tightened; intermittently could not breath and swallow, could not speak; intermittently could not breath and swallow, could not speak; intermittently could not breath and swallow, could not speak; tongue proceeded to swell; tongue started to tingle; lips started to swell; This spontaneous case was reported by a consumer and describes the occurrence of IRREGULAR BREATHING (breathing altered), THROAT TIGHTNESS (throat tightened), DYSPNOEA (intermittently could not breath and swallow, could not speak), SPEECH DISORDER (intermittently could not breath and swallow, could not speak), DYSPHAGIA (intermittently could not breath and swallow, could not speak) and SWOLLEN TONGUE (tongue proceeded to swell) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced IRREGULAR BREATHING (breathing altered) (seriousness criterion life threatening), THROAT TIGHTNESS (throat tightened) (seriousness criterion life threatening), SWOLLEN TONGUE (tongue proceeded to swell) (seriousness criterion life threatening), PARAESTHESIA ORAL (tongue started to tingle) and LIP SWELLING (lips started to swell). On an unknown date, the patient experienced DYSPNOEA (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening), SPEECH DISORDER (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening) and DYSPHAGIA (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening). At the time of the report, IRREGULAR BREATHING (breathing altered), THROAT TIGHTNESS (throat tightened), DYSPNOEA (intermittently could not breath and swallow, could not speak), SPEECH DISORDER (intermittently could not breath and swallow, could not speak), DYSPHAGIA (intermittently could not breath and swallow, could not speak), SWOLLEN TONGUE (tongue proceeded to swell), PARAESTHESIA ORAL (tongue started to tingle) and LIP SWELLING (lips started to swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Swollen tongue, Throat tightness
Clinical narrative: breathing altered; throat tightened; intermittently could not breath and swallow, could not speak; intermittently could not breath and swallow, could not speak; intermittently could not breath and swallow, could not speak; tongue proceeded to swell; tongue started to tingle; lips started to swell; This spontaneous case was reported by a consumer and describes the occurrence of IRREGULAR BREATHING (breathing altered), THROAT TIGHTNESS (throat tightened), DYSPNOEA (intermittently could not breath and swallow, could not speak), SPEECH DISORDER (intermittently could not breath and swallow, could not speak), DYSPHAGIA (intermittently could not breath and swallow, could not speak) and SWOLLEN TONGUE (tongue proceeded to swell) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced IRREGULAR BREATHING (breathing altered) (seriousness criterion life threatening), THROAT TIGHTNESS (throat tightened) (seriousness criterion life threatening), SWOLLEN TONGUE (tongue proceeded to swell) (seriousness criterion life threatening), PARAESTHESIA ORAL (tongue started to tingle) and LIP SWELLING (lips started to swell). On an unknown date, the patient experienced DYSPNOEA (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening), SPEECH DISORDER (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening) and DYSPHAGIA (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening). At the time of the report, IRREGULAR BREATHING (breathing altered), THROAT TIGHTNESS (throat tightened), DYSPNOEA (intermittently could not breath and swallow, could not speak), SPEECH DISORDER (intermittently could not breath and swallow, could not speak), DYSPHAGIA (intermittently could not breath and swallow, could not speak), SWOLLEN TONGUE (tongue proceeded to swell), PARAESTHESIA ORAL (tongue started to tingle) and LIP SWELLING (lips started to swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Bacteraemia, Cardiac valve vegetation, Endocarditis, Myositis, Osteomyelitis
Clinical narrative: Osteomyelitis; Bacteremia; Endocarditis; Mitral valve vegetation; Myositis; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the right arm on 18Dec2020 22:00 (at the age of 47 years) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included thyroid cancer from 1996 to an unspecified date; anxiety; and asthma. Concomitant medications included thyroid (ARMOUR THYROID), escitalopram oxalate (LEXAPRO), drospirenone, ethinylestradiol betadex clathrate (YAZ), cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE). On 20Dec2020, the patient had osteomyelitis, bacteremia, endocarditis, mitral valve vegetation and myositis. The reported events resulted into an emergency room visit. The patient was hospitalized for ten days due to the reported events. The events were also reported to have caused disability, and were life-threatening. The patient was treated with intravenous antibiotics, steroids and pain regimen for all the events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination; and had been tested for COVID-19 (Nasal swab) on 11Jan2021, with a negative result.  Information about lot/batch number has been requested.  Follow-up (31Mar2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events cannot be completely excluded. Concomitant medical conditions represent confounding factors. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Osteomyelitis; Bacteremia; Endocarditis; Mitral valve vegetation; Myositis; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the right arm on 18Dec2020 22:00 (at the age of 47 years) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included thyroid cancer from 1996 to an unspecified date; anxiety; and asthma. Concomitant medications included thyroid (ARMOUR THYROID), escitalopram oxalate (LEXAPRO), drospirenone, ethinylestradiol betadex clathrate (YAZ), cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE). On 20Dec2020, the patient had osteomyelitis, bacteremia, endocarditis, mitral valve vegetation and myositis. The reported events resulted into an emergency room visit. The patient was hospitalized for ten days due to the reported events. The events were also reported to have caused disability, and were life-threatening. The patient was treated with intravenous antibiotics, steroids and pain regimen for all the events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination; and had been tested for COVID-19 (Nasal swab) on 11Jan2021, with a negative result.  Information about lot/batch number has been requested.  Follow-up (31Mar2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events cannot be completely excluded. Concomitant medical conditions represent confounding factors. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest, SARS-CoV-2 test
Clinical narrative: Cardiopulmonary arrest; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscular on 14Mar2021 (12:00) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hepatitis B. The patient's concomitant medications were not reported. The patient previously took tenofovir. On 14Mar2021 (21:00), the patient had cardiopulmonary arrest. The reported event had resulted into emergency room/department or urgent care visit. The patient was hospitalized from Mar2021 to an unspecified date due to the reported event, and was reported to be life-threatening. The patient was intubated in response to the event. The patient had a negative SARS CoV-2 test both on 14Mar2021 and 15Mar2021. The outcome of the event, cardiopulmonary arrest, was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information provided and a temporal association, a causal relationship between the event cardiopulmonary arrest and BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: FLUX
Symptoms: Herpes virus infection
Clinical narrative: patient got herpes once from taking the flu shot; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social medias.  This case involves a patient of unknown age and gender who got Herpes (Herpes virus infection), after he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant therapy, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got Herpes (Herpes virus infection) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: M
Vaccine: FLU4
Symptoms: Impaired work ability, Paralysis
Clinical narrative: patient had an AE and may be paralyzed for the rest of life; patient had an AE and has not been able to work; Initial information received on 22-Mar-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional (patient's step-daughter).  This case involves adult male patient (unspecified age) who had an adverse event and has not been able to work (impaired work ability), may be paralyzed for the rest of life (paralysis) while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient had no medical history, concomitant disease or risk factor.   Past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious an adverse event and has not been able to work (impaired work ability), may be paralyzed for the rest of life (paralysis) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This events were was leading to disability and event paralysis was assessed as medically significant.  The reporter wanted to know if there is any compensation from the company since they were losing income and just wanting for some one in safety/quality to contact her.   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown  Information on lot number was requested for this case.; Sender's Comments: This case concerns male patient (unspecified age) who had paralysis and impaired work ability after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: RAB
Symptoms: Illness
Clinical narrative: sick all the day; Initial information received on 18-Feb-2021 regarding an unsolicited valid serious case received from a consumer.  This case involves male patient who developed sick all day (Illness), while she received vaccine RABIES VACCINE.  The patient's past medical history included cat scratch and bite, Past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect RABIES VACCINE produced by unknown manufacturer lot number not reported for prophylactic vaccination.  On an unknown date (latency: unknown), after taken suspect RABIES VACCINE, reported developed sick all day (Illness). It was reported having the first three shots with not getting sick and that as the 6 to 7 shot series went along getting a reaction of being sick all day long with having to lay in bed.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for this event.
Age: 0.83
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via agency (Reference number- 00517090) and transmitted to Sanofi on 12-Mar-2021.  This case involves a 10-month-old male patient who received an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ182AAA and expiry date: 08-Mar-2021) via an unknown route in left thigh for prophylactic vaccination on 12-Mar-2021.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE on 12-Mar-2021 for prophylactic vaccination.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of IPOL was inadvertently administered today with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via physician via Global Medical Information (Reference number- 00530069) and transmitted to Sanofi on 22-Mar-2021.  This case involves a 1 years old male patient who inadvertently received 0.5 mL dose of suspect IPV (VERO) lot R1B252M, expiry date- 13-Mar-2021 via intramuscular route in right thigh for prophylactic vaccination on 22-Mar-2021.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  It was a case of an actual medication error due to expired vaccine used (latency same day).  Caller with question on whether dose needs repeating and in what time frame. Additional Description of event Adverse events: Clinic administrator reporting an expired dose of IPOL was inadvertently administered today.  At the time of report there was no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under left arm
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Swelling, rash, itching, pain at infection site
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Flushing, Hyperhidrosis, Lethargy, Peripheral swelling
Clinical narrative: My left arm puffed up on Saturday, late afternoon, evening. It was painful to touch around the vaccination spot and hurt to put pressure on. Sunday I ran a low fever; it reached 99.1 near the end of the Ibuprofen time limit (~ every 4 hours). I stayed wet with sweat and my back itched throughout the day. Food tasted bad--my stomach was sour. I was lethargic and slept most of Sunday and straight through Sunday night/Monday morning. My nose and cheeks pealed this (Monday) morning and I look as if I have a mild suntan. I haven't been in the sun or wind for more than a few minutes, for over a week and I haven't been outside at all since I received my vaccine.   The soreness in my arm is now only at the vaccination spot and it is tender only if I press it; touching it no longer causes wincing.  I feel flushed but no llonger have a fever. I'm no longer taking Ibuprofen. Food is tasting better today but it's not back to normal--my stomach is still a little sour.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Skin exfoliation, Taste disorder, Vaccination site pain
Clinical narrative: My left arm puffed up on Saturday, late afternoon, evening. It was painful to touch around the vaccination spot and hurt to put pressure on. Sunday I ran a low fever; it reached 99.1 near the end of the Ibuprofen time limit (~ every 4 hours). I stayed wet with sweat and my back itched throughout the day. Food tasted bad--my stomach was sour. I was lethargic and slept most of Sunday and straight through Sunday night/Monday morning. My nose and cheeks pealed this (Monday) morning and I look as if I have a mild suntan. I haven't been in the sun or wind for more than a few minutes, for over a week and I haven't been outside at all since I received my vaccine.   The soreness in my arm is now only at the vaccination spot and it is tender only if I press it; touching it no longer causes wincing.  I feel flushed but no llonger have a fever. I'm no longer taking Ibuprofen. Food is tasting better today but it's not back to normal--my stomach is still a little sour.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Tremor, Vision blurred
Clinical narrative: shaking, blurred vion, flushed.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: PATIENT HAS BEEN EXPERIENCING SEVERE DIARRHEA SINCE VACCINATION
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Covid vaccine left arm Swollen from time of Vaccine 3/22/2021 through current date 4/5/2021
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Full blood count, Gait inability, Metabolic function test, Myalgia
Clinical narrative: Moderna COVID-19 Vaccine EUA  Hospitalized for weakness and muscle aches, unable to walk, rhabomyolysis
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, Rhabdomyolysis, Urine analysis
Clinical narrative: Moderna COVID-19 Vaccine EUA  Hospitalized for weakness and muscle aches, unable to walk, rhabomyolysis
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Laboratory confirmed COVID-19