chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Fatigue, Loss of consciousness, Nausea
Clinical narrative: Passed out and was unconscious for approximately 5 minutes; Nausea; Tightening or squeezing sensation of my chest; Tired; Vasovagal event; A spontaneous report was received from a healthcare professional who is the patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tightening or squeezing sensation in my chest, passed out, unconscious for approximately 5 minutes, nausea, vasovagal event and tired.   The patient's medical history was not provided. No concomitant product use was reported.  On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On 29 Jan 2021, at 01:30, the patient reported they started to feel a tightening or squeezing sensation in their chest.   On 29 Jan 2021 at 02:30, the patient's symptoms worsened, they reported increased chest tightening and were nauseated. The patient went into their bathroom and "I passed out and ended up on the floor". The patient reported they were unconscious for approximately 5 minutes. The patient's wife called 911 due to chest pains and to rule out a mild heart attack. The patient stated, "all tests came back negative". The patient stated they had a vasovagal event while in the hospital with a blood pressure reading of 77/40. Patient feeling better now, but still tired".  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, tightening or squeezing sensation in my chest, passed out, unconscious for approximately 5 minutes, nausea, vasovagal event and tired, were considered unknown.; Reporter's Comments: This spontaneous report from a healthcare professional of unknown gender who experienced the serious events of unconscious, passed out and tightening or squeezing sensation in my chest and non-serious events of nausea, vasovagal event and tired. The events occurred 1 day after the administration of mRNA-1273 vaccine (Lot number: unknown, expiration date: unknown). Treatment given was not provided and outcome is resolved. Based on the information provided which shows a temporal association a causal association, between the reported events and the administration of mRNA-1273 vaccine cannot be excluded. The events of nausea and fatigue are consistent with the known safety profile of mRNA -1273 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Passed out and was unconscious for approximately 5 minutes; Nausea; Tightening or squeezing sensation of my chest; Tired; Vasovagal event; A spontaneous report was received from a healthcare professional who is the patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tightening or squeezing sensation in my chest, passed out, unconscious for approximately 5 minutes, nausea, vasovagal event and tired.   The patient's medical history was not provided. No concomitant product use was reported.  On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On 29 Jan 2021, at 01:30, the patient reported they started to feel a tightening or squeezing sensation in their chest.   On 29 Jan 2021 at 02:30, the patient's symptoms worsened, they reported increased chest tightening and were nauseated. The patient went into their bathroom and "I passed out and ended up on the floor". The patient reported they were unconscious for approximately 5 minutes. The patient's wife called 911 due to chest pains and to rule out a mild heart attack. The patient stated, "all tests came back negative". The patient stated they had a vasovagal event while in the hospital with a blood pressure reading of 77/40. Patient feeling better now, but still tired".  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, tightening or squeezing sensation in my chest, passed out, unconscious for approximately 5 minutes, nausea, vasovagal event and tired, were considered unknown.; Reporter's Comments: This spontaneous report from a healthcare professional of unknown gender who experienced the serious events of unconscious, passed out and tightening or squeezing sensation in my chest and non-serious events of nausea, vasovagal event and tired. The events occurred 1 day after the administration of mRNA-1273 vaccine (Lot number: unknown, expiration date: unknown). Treatment given was not provided and outcome is resolved. Based on the information provided which shows a temporal association a causal association, between the reported events and the administration of mRNA-1273 vaccine cannot be excluded. The events of nausea and fatigue are consistent with the known safety profile of mRNA -1273 vaccine.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hypotension, Influenza like illness, Syncope
Clinical narrative: Syncope; Diarrhea; Low pressure; Flu-like symptoms; A regulatory report  was received from a consumer concerning a 72-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced flu-like symptoms, head went back, eyes went white, jaw move left to right, made a last breath, thought he died, diarrhea and low pressure.  The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included Metoprolol succinate.  On 24 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 25 Jan 2021, the patient reported flu-like symptoms. Treatment information was not provided.   On 26 Jan 2021, the patient reported head went back, eyes went white, jaw move left to right, made a last breath, thought he died, diarrhea and low pressure. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The event, flu-like symptoms was considered recovered/resolved on 25 Jan 2021.  The events, head went back, eyes went white, jaw move left to right, made a last breath, thought he died, and diarrhea was considered recovered/resolved on 26 Jan 2021.  The outcome of the event low pressure was unknown.; Reporter's Comments: This case concerns a 72 year old male with medical history of hypertension on metoprolol, who experienced a serious unexpected event of syncope and non-serious unexpected events of flu-like symptoms, diarrhea, and low blood pressure. Event onset was 1 day after first dose of mRNA-1273. Flu-like symptoms resolved. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Mastocytosis
Clinical narrative: Mastocytosis symptoms; flare up of Mastocytosis; A spontaneous report was received from a nurse who was also a 90 years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced a flare up of mastocytosis symptoms (mastocytosis and condition aggravated).  The patient's medical history included mastocytosis. Products known to have been used by the patient, within two weeks prior to the event, included cimetidine and diphenhydramine hydrochloride.  The patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A), intramuscularly, in the left arm on 30 Dec 2020 for prophylaxis of COVID-19 infection.  On 02 Jan 2021, 48 hours after vaccination, the patient went to the emergency room (ER) with mastocytosis symptoms including low grade hives, increased heart rate, burning sensation and heat on the skin. The patient had a long history of mastocytosis and carried an ephedrine and diphenhydramine hydrochloride. The ER physician thought the vaccine caused flare up of mastocytosis. The patient was given diphenhydramine hydrochloride and methylprednisolone and sent home.   A few days later, the patient had another episode of the same symptoms and went to the ER again on 15 Jan 2021. The physician recommended the patient wait and not get the second shot which was due on 28 Jan 2021.   Treatment for the event included diphenhydramine hydrochloride and methylprednisolone.  The second dose of mRNA-1273 was temporarily withheld in response to the event.   The outcome of the event, flare up of mastocytosis symptoms, was not reported.; Reporter's Comments: This is a 90 year male patient with relevant medical history of mastocytosis which is a confounding factor that may a play contributory role providing an alternative explanation. Further information is requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Haemorrhagic stroke, Headache, Limb discomfort, Malaise
Clinical narrative: Stroke (blood in the brain); heavy legs; not feeling himself; difficulty walking secondary to stroke; Bad Headache; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who experienced bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, and not feeling himself.    The patient's medical history included atrial fibrillation (A-Fib) four years ago. 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 blood thinners.   On 10 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient experienced a headache.   On 28 Jan 2021, he reported having a bad headache, heavy legs and was not feeling himself. On 29 Jan 2021, the patient was admitted to the hospital and was told he had a stroke (blood in the brain). Patient was discharged on 02 Feb 2021. He now has difficulty walking and is trying to walk with a walker and has to go to rehab. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The events bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, not feeling himself and headache were resolved on 02 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's medical history of atrial fibrillation and concomitant use of blood thinners may have been contributory for hemorrhagic stroke.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Injection site swelling
Clinical narrative: slight anaphylaxis reaction; difficulty swallowing; swelling at the injection; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced slight anaphylaxis, difficulty swallowing and swelling at the injection.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Patient called to inquire about the second dose. She stated she had a slight anaphylaxis reaction. When quired for more details regarding her event she mentioned that it was sort of difficulty swallowing, which didn't last long and some swelling at the injection.   No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The event difficulty in swallowing was considered as resolved. The outcome of the event slight anaphylaxis and swelling at the injection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose is overdue; A spontaneous report was received from a patient of an unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and 2nd dose of Moderna vaccine was overdue.   The patient's medical history was not provided.     The patient reported recently moved to an area where they just started giving 1st dose of Moderna whereas mine 2nd dose was overdue.  The date for when the patient received their first of two planned doses of mRNA-1273 (Batch number: not given) intramuscularly for prophylaxis of COVID-19 infection was not provided.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The event was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Cellulitis, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Significant cellulitis on his left shin and foot; Anorexia/lack of appetite; Abdominal pain; Diarrhea; Fever; Chills; Fatigue/frequently had to lay in bed; A spontaneous report was received from a physician concerning a 50-year-old, White, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, and cellulitis on his left shin and foot.  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, and cellulitis on his left shin and foot. The patient took paracetamol and naproxen for the events, which somewhat helped.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, were considered resolved on an unknown date. The outcome for the event, cellulitis on his left shin and foot, was reported as not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. Cellulitis of shin and foot is unlikely related to mRNA-1273.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Significant cellulitis on his left shin and foot; Anorexia/lack of appetite; Abdominal pain; Diarrhea; Fever; Chills; Fatigue/frequently had to lay in bed; A spontaneous report was received from a physician concerning a 50-year-old, White, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, and cellulitis on his left shin and foot.  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, and cellulitis on his left shin and foot. The patient took paracetamol and naproxen for the events, which somewhat helped.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, were considered resolved on an unknown date. The outcome for the event, cellulitis on his left shin and foot, was reported as not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. Cellulitis of shin and foot is unlikely related to mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Facial paralysis, Magnetic resonance imaging, Paraesthesia oral
Clinical narrative: Bell's Palsy; Tongue started tingling; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy and tongue started tingling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, within two days after injection, the patient's tongue started tingling.  On 23 Jan 2021, the patient spent 18 hours in the emergency room. Two MRIs (magnetic resonance imaging) and bloodwork were conducted, they confirmed the patient had Bell's Palsy on the left side of the face.  On 27 Jan 2021, the patient's tongue began tingling again and had not resolved at the time of reporting. Treatment for the events was not provided.  Action taken the second dose of mRNA-1273 in response to the events was not reported.  The event, tongue started tingling, was reported as not resolved. The outcome for the event, Bell's Palsy, was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: Major dementia type symptoms; A spontaneous report was received from a consumer concerning an elderly, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed some major dementia type symptoms/dementia.  The patient's medical history was not provided. Concomitant medication history was not provided.  On 03 Feb 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  The reporter stated that the patient have been having some real major dementia type symptoms that were new for her (Onset date not provided).  Treatment for this event was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, major dementia type symptoms/dementia was unknown.; Reporter's Comments: Based on the 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. However, the patient's age is a risk factor and confounds causality assessment.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiplegia
Clinical narrative: Debilitating Stroke; Affecting the left side of her body; A spontaneous report was received from a consumer concerning an 85-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced debilitating stroke (cerebrovascular accident), affecting the left side of her body (hemiplegia).  The patient's medical history was not provided. No concomitant medications were reported.   On 23 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Jan 2021, the patient experienced debilitating stroke, affecting the left side of her body. Treatment information was not provided. The reporter stated that the patient was now in hospice care.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, debilitating stroke, affecting the left side of her body, was unknown.; Reporter's Comments: This case concerns a 85-year-old, female patient who experienced debilitating cerebrovascular accident and hemiplegia 3 days after the first dose of mRNA-1273 (Lot number: 029L20A). Very limited information regarding this event has been provided at this time.  Further information regarding patient's medical history and comorbidities has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Eye pain, Myalgia, Psychotic disorder
Clinical narrative: Psychosis; Pain in the back of eyes; Weakness; Chills; Muscle pains/ Myalgia; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed psychosis, pain in the back of his eyes, chills, myalgia, and weakness.   The patient's medical history included schizoaffective bipolar disorder. Products known to have been used by the patient, within two weeks prior to the event, included paliperidone.   The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on 24 Dec 2020. On 21 Jan 2021, an unknown amount of time prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 27 Jan 2021, the patient received paliperidone.  On an undisclosed date, the patient experienced pain in the back of his eyes, felt a chill, muscle pains, and weakness. The patient had been diagnosed with schizoaffective bipolar disorder and was missing at the time of the report. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable because the patient had received both doses.   The outcome of the events psychosis, pain in the back of his eyes, chills, myalgia, and weakness, was not reported.; Reporter's Comments: This case concerns a male patient of an unknown age who experienced a medically important event of psychosis, and in addition non-serious events of pain in the back of his eyes, chills, myalgia, and weakness. Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded, however the patient's history of schizoaffective bipolar disorder is a strong confounder for the event of psychosis. The case is lost to follow-up as Consumer did not give consent to follow-up.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine to a 16 year old patient; A spontaneous report was received from a pharmacist  concerning a 16 year old patient who was administered a COVID vaccine at an inappropriate age.  The pharmacist wants to know how to manage this situation.   The patient's medical history was not provided.  Concomitant medication details were not reported.  On an unreported date, The patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) on 05/Feb/2021 intramuscularly for prophylaxis of COVID-19 infection.   On an unreported date, 16 year old patient who was administered a COVID vaccine at an inappropriate age.  The pharmacist wants to know how to manage this situation. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not applicable.  The event was considered resolved on an unreported date.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age  for mRNA-1273, lot # 030L20A with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: Patients arm on the injection site was red; Patients arm on the injection site was swollen; vaccinated subcutaneous and not intramuscular; A spontaneous report was received from a consumer concerning a 38-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and was vaccinated subcutaneous route, and experienced injection site red and swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) subcutaneously in the arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient reported that they were vaccinated subcutaneous and not intramuscular. On 27 Jan 2021, the patient's arm on the injection site was red and swollen. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, vaccinated subcutaneous and not intramuscular, was considered resolved on 25 Jan 2021. The outcome of events injection site red and swollen were unknown.; Reporter's Comments: This case concerns a 38-year-old female patient (gender to be clarified) who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect route of product administration and associated non-serious adverse events of Injection site erythema and Injection site swelling. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy (tingling and burning in the feet and legs); A spontaneous report was received from a consumer, regarding herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neuropathy (tingling and burning in the feet and legs).  The patient's medical history was not provided. Concomitant product use was not provided.  On 13 Jan 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection.    On 13 Jan 2021, after the first dose of mRNA-1273 vaccine, the patient noted neuropathy (tingling and burning in the feet and legs). Was inquiring whether this will recur after the second injection. Treatment information was not provided.   Action taken with mRNA-1273 in response to event was not reported.  The outcome of the event, neuropathy (tingling and burning in the feet and legs) was unknown 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 event, a causal relationship cannot be excluded.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: bell's palsy; A spontaneous report was received from a healthcare professional (HCP) concerning a 56-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's Palsy/facial paralysis.  The patient's medical history was not provided.  Concomitant products known to have been used by the patient, within two weeks prior to the event, included valsartan, insulin, insulin degludec, rosuvastatin, and acetylsalicylic acid.  On 12 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot number: 06L20A) intramuscularly in his left arm for prophylaxis of COVID-19 infection.  The patient experienced Bell's Palsy on 25 Jan 2021.    Treatments of these events were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, Bell's Palsy/facial paralysis was unknown.; Reporter's Comments: Based on the 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Seizure
Clinical narrative: Mini seizures; Body chills; A spontaneous report was received from a consumer, concerning herself, a 21-year-old female patient, who received Moderna's COVID-19 vaccine and experienced mini seizures and some chills.  The patient's medical history reported includes seizures. Concomitant product use was not provided by the reporter.  On 06-FEB-2021, prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for the prophylaxis of covid-19 infection.   On an unspecified date in Jan-2021, the patient received her first dose of vaccine and on 07-FEB-2021, a day after the second dose of vaccine, patient experienced some chills and mini seizures. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events, mini seizures and some chills were considered unknown at the time of this report.; Reporter's Comments: Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, however, patient's history of seizure is a confounding factor that may a possible contributory role. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage
Clinical narrative: Bleeding in his gut; A spontaneous report was received from a consumer, male patient of unknow age, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced bleeding in his gut (gastrointestinal haemorrhage).  The patient's medical history was not reported. No concomitant medications were reported.  On an unknown date, prior to the onset of event, the patient received their second planned dose of mRNA-1273 (batch number: unknown), for the prophylaxis of COVID-19 infection.  On an unknown date, the patient stated that he was bleeding in his gut, but he had the symptoms before receiving the vaccine. The patient got disconnected during call and was unavailable during call back. No treatment medication information was provided  Action taken with second dose of mRNA-1273 in response to the event was not applicable.   The outcome of the event, bleeding in his gut, was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; fever 102.6/ 101.6; body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 on an unspecified date. The patient experienced sore arm, fever 102.6/ 101.6, body aches on an unspecified date after 2nd dose of COVID 19 vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea
Clinical narrative: nauseous; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; This is a spontaneous report from a contactable consumers (patient's wife and patient). An 81 year old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included bleeding ulcer and stent put in my heart valve. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) and acetylsalicylic acid, clopidogrel bisulfate (CLOPID-AS [ACETYLSALICYLIC ACID;CLOPIDOGREL BISULFATE]). On an unspecifed date, the patient's wife reported that her husband: He's having some episodes of going on in his head almost like a headache, hard to explain what's going on. Also nauseous, with the heart specialist told him to take probiotics with his medicine. He was hospitalized on January 7-11. He is on 81mg low dose aspirin, Clopidogrel 75mg daily medication. Prior to that week before Nov2007 he had a reaction to the aspirin and was hospitalized because it gave him a bleeding ulcer. The patient was hospitalized for the events on an unspecified date. Outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Haemorrhage, Thrombosis
Clinical narrative: experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; This is a spontaneous report from a contactable healthcare professional (patient). A 32-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 05Jan2021 10:15 at a single dose for COVID-19 immunization at a hospital. Medical history included idiopathic hypersomnia and allergies to eggplant. The patient has no covid prior to vaccination. Concomitant medications included methylphenidate hydrochloride (CONCERTA), methenamine, levonorgestrel (MIRENA), propranolol hydrochloride (PROPRANOL) and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). The patient had no other vaccine in four weeks. The patient previously took cefazolin and levaquin and experienced allergies to both. The patient has a Mirena IUD and never get her period at all. Within 6 hours of her first Pfizer injection (02Feb2021 16:00), the patient experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting. Resolved within 48 hours as quickly as it came and didn't occur with second dose 1 week out. The patient was not tested for Covid post vaccination. The events were not treated. The outcome of the events was recovered on 04Feb2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and known drug profile it  is unlikely that the reported events were causally  related to   BNT162B2.  These are intercurrent  conditions.   A contributory role of the patient's Mirena IUD  should be  evaluated.  Case will be reassessed if additional information is received.   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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Dysphagia, Erythema
Clinical narrative: Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chondritis, Ear swelling, Ear, nose and throat examination, Inappropriate schedule of product administration, Nasal oedema
Clinical narrative: chondritis or polychondritis; chondritis or polychondritis; my nose and right ear swelled up; my nose and right ear swelled up; dose number=1: administration date=28Dec2020/dose number=2: vaccine date=08Jan2021; dose number=1: administration date=28Dec2020/dose number=2: vaccine date=08Jan2021; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received the second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number EJ1686) via intramuscular on 08Jan2021 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient got allergies to bentyl, codein, flagyl and got Hx diverticulitis, ileitis, hypothyroid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included levothyroxine, metoprolol and diazepam. The patient previously took the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number EK5730) via intramuscular on 28Dec2020 12:00 into left arm at a single dose for covid-19 immunisation. On 11Jan2021 04:00, the patient nose and right ear swelled up. On 05Feb2021, per ENT, it was chondritis or polychondritis. Refer to rheumatologist pending, for further diagnostics. The adverse event resulted in doctor or other healthcare professional office/clinic visit and received treatment included amoxicillin, labs drawn, then prednisone tx, more labs drawn, more prednisone prescribed on 05Feb2021. Since the vaccination, the patient has tested for COVID 19 named saliva test on 03Feb2021 and got negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided, it is unlikely that chondritis or polychondritis is unlikely related to suspect product. Case will be reassessed as and when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Polychondritis, SARS-CoV-2 test
Clinical narrative: chondritis or polychondritis; chondritis or polychondritis; my nose and right ear swelled up; my nose and right ear swelled up; dose number=1: administration date=28Dec2020/dose number=2: vaccine date=08Jan2021; dose number=1: administration date=28Dec2020/dose number=2: vaccine date=08Jan2021; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received the second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number EJ1686) via intramuscular on 08Jan2021 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient got allergies to bentyl, codein, flagyl and got Hx diverticulitis, ileitis, hypothyroid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included levothyroxine, metoprolol and diazepam. The patient previously took the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number EK5730) via intramuscular on 28Dec2020 12:00 into left arm at a single dose for covid-19 immunisation. On 11Jan2021 04:00, the patient nose and right ear swelled up. On 05Feb2021, per ENT, it was chondritis or polychondritis. Refer to rheumatologist pending, for further diagnostics. The adverse event resulted in doctor or other healthcare professional office/clinic visit and received treatment included amoxicillin, labs drawn, then prednisone tx, more labs drawn, more prednisone prescribed on 05Feb2021. Since the vaccination, the patient has tested for COVID 19 named saliva test on 03Feb2021 and got negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided, it is unlikely that chondritis or polychondritis is unlikely related to suspect product. Case will be reassessed as and when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Disorientation, Dizziness
Clinical narrative: Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Flushing, Heart rate, Hypotension
Clinical narrative: Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be 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.