chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received Flu vaccine 1 day prior to receiving 1st dose of Moderna Covid Vaccine; A spontaneous report was received from a consumer concerning a 53-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) in one day of receiving flu vaccine / Inappropriate schedule of vaccine administered.  The patient medical history was not provided. No relevant concomitant medications were provided.  On 10 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient received flu vaccine 1 day prior to receiving first dose of Moderna's COVID-19 vaccine (mRNA-1273) vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, received flu vaccine 1 day prior to receiving first dose of Moderna's COVID-19 vaccine (mRNA-1273) vaccine, were considered resolved on 10 Feb 2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273 vaccine, batch number not provided, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye infection bacterial, Herpes zoster, Pain in extremity, Pyrexia
Clinical narrative: bacterial eye infection; shingles; pain in injection arm; fever; chills; redness at injection site; A spontaneous report  was received from a consumer concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, pain in injection arm, redness at injection site, shingles and bacterial eye infection.  The patient's medical history was not provided by the reporter. Concomitant medications included duloxetine hydrochloride and heart medications.  On 3 Feb 2021, approximately a few hours after prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 3 Feb 2021, prior to receiving mRNA-1273, the patient felt fever, chills, pain in injection arm, redness at injection site. on 23 Feb 2021, shingles, bacterial eye infection. Treatment for the events included eye medications and antibiotics.  The event of bacterial eye infection was considered to be serious with criteria of important medical event.  Action taken with mRNA-1273 in response to the events was not reported.   The events, fever, chills, pain in injection arm, redness at injection site were considered resolved on 10 Feb 2021.  The outcome of events shingles and bacterial eye infection were unknown.; Reporter's Comments: This case concerns a 51-year-old female who had serious unexpected events of eye infection bacterial along with nonserious unexpected herpes zoster, pain in extremity and expected pyrexia, chills, vaccination site erythema.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with antibiotics. 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: bacterial eye infection; shingles; pain in injection arm; fever; chills; redness at injection site; A spontaneous report  was received from a consumer concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, pain in injection arm, redness at injection site, shingles and bacterial eye infection.  The patient's medical history was not provided by the reporter. Concomitant medications included duloxetine hydrochloride and heart medications.  On 3 Feb 2021, approximately a few hours after prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 3 Feb 2021, prior to receiving mRNA-1273, the patient felt fever, chills, pain in injection arm, redness at injection site. on 23 Feb 2021, shingles, bacterial eye infection. Treatment for the events included eye medications and antibiotics.  The event of bacterial eye infection was considered to be serious with criteria of important medical event.  Action taken with mRNA-1273 in response to the events was not reported.   The events, fever, chills, pain in injection arm, redness at injection site were considered resolved on 10 Feb 2021.  The outcome of events shingles and bacterial eye infection were unknown.; Reporter's Comments: This case concerns a 51-year-old female who had serious unexpected events of eye infection bacterial along with nonserious unexpected herpes zoster, pain in extremity and expected pyrexia, chills, vaccination site erythema.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with antibiotics. 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Cellulitis, Heart rate
Clinical narrative: Cellulitis; blood pressure increased; red spot just a little to the right of where the injection went in/came back bigger and redder/darker; hard lump underneath it; it was sore; also mildly itchy, at times; A spontaneous report was received from Consumer and healthcare professional concerning a 67-yeay-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced spot just a little to the right of where the injection went in/it came back bigger and redder/darker, hard lump underneath it, it was sore, also mildly itchy, at times, cellulitis and blood pressure increased.  The patient's medical history was not provided. Concomitant products were not provided.  On 28 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number 025A21A) by intramuscular route on left arm for prophylaxis of COVID-19 infection.   Patient reported noticing a red spot just a little to the right of where the injection site. There was a hard lump underneath it, and it was sore. The area was about 3 inch across. It was also mildly itchy, at times. On follow up, she stated she developed cellulitis around the injection site and was on antibiotics to treat the infection. Patient stated, to the right of where she was injected she had a red spot the size of a quarter, sore, it was a lump, and warm. She stated that it began to fade between 2 Mar 2021 and 5 Mar 2021. Then this past weekend, 6 Mar 2021 it came back bigger and redder/darker. She went to a walk in clinic because it was bothering her. She was diagnosed with cellulitis and was told it was either an allergic reaction to the needle or something in vaccine. She stated that when she went to the clinic it wasn't quite 3 inches in diameter.  Lab tests were included Vitals taken at clinic: Temperature - 99.5 degrees Fahrenheit, Blood Pressure: 203/81 - She stated that her BP is never that high, Pulse Rate: 104, Respiratory Rate: 16 and O2 sat: 98%.  The event of cellulitis was considered as serious with criteria of important medical event.  Treatment was antibiotics, tylenol, ice pack on injection site for her symptoms.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events spot just a little to the right of where the injection went in/it came back bigger and redder/darker, hard lump underneath it, it was sore, also mildly itchy, at times, cellulitis, and blood pressure increased 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 events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Respiratory rate, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Cellulitis; blood pressure increased; red spot just a little to the right of where the injection went in/came back bigger and redder/darker; hard lump underneath it; it was sore; also mildly itchy, at times; A spontaneous report was received from Consumer and healthcare professional concerning a 67-yeay-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced spot just a little to the right of where the injection went in/it came back bigger and redder/darker, hard lump underneath it, it was sore, also mildly itchy, at times, cellulitis and blood pressure increased.  The patient's medical history was not provided. Concomitant products were not provided.  On 28 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number 025A21A) by intramuscular route on left arm for prophylaxis of COVID-19 infection.   Patient reported noticing a red spot just a little to the right of where the injection site. There was a hard lump underneath it, and it was sore. The area was about 3 inch across. It was also mildly itchy, at times. On follow up, she stated she developed cellulitis around the injection site and was on antibiotics to treat the infection. Patient stated, to the right of where she was injected she had a red spot the size of a quarter, sore, it was a lump, and warm. She stated that it began to fade between 2 Mar 2021 and 5 Mar 2021. Then this past weekend, 6 Mar 2021 it came back bigger and redder/darker. She went to a walk in clinic because it was bothering her. She was diagnosed with cellulitis and was told it was either an allergic reaction to the needle or something in vaccine. She stated that when she went to the clinic it wasn't quite 3 inches in diameter.  Lab tests were included Vitals taken at clinic: Temperature - 99.5 degrees Fahrenheit, Blood Pressure: 203/81 - She stated that her BP is never that high, Pulse Rate: 104, Respiratory Rate: 16 and O2 sat: 98%.  The event of cellulitis was considered as serious with criteria of important medical event.  Treatment was antibiotics, tylenol, ice pack on injection site for her symptoms.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events spot just a little to the right of where the injection went in/it came back bigger and redder/darker, hard lump underneath it, it was sore, also mildly itchy, at times, cellulitis, and blood pressure increased 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 events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Cellulitis; blood pressure increased; red spot just a little to the right of where the injection went in/came back bigger and redder/darker; hard lump underneath it; it was sore; also mildly itchy, at times; A spontaneous report was received from Consumer and healthcare professional concerning a 67-yeay-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced spot just a little to the right of where the injection went in/it came back bigger and redder/darker, hard lump underneath it, it was sore, also mildly itchy, at times, cellulitis and blood pressure increased.  The patient's medical history was not provided. Concomitant products were not provided.  On 28 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number 025A21A) by intramuscular route on left arm for prophylaxis of COVID-19 infection.   Patient reported noticing a red spot just a little to the right of where the injection site. There was a hard lump underneath it, and it was sore. The area was about 3 inch across. It was also mildly itchy, at times. On follow up, she stated she developed cellulitis around the injection site and was on antibiotics to treat the infection. Patient stated, to the right of where she was injected she had a red spot the size of a quarter, sore, it was a lump, and warm. She stated that it began to fade between 2 Mar 2021 and 5 Mar 2021. Then this past weekend, 6 Mar 2021 it came back bigger and redder/darker. She went to a walk in clinic because it was bothering her. She was diagnosed with cellulitis and was told it was either an allergic reaction to the needle or something in vaccine. She stated that when she went to the clinic it wasn't quite 3 inches in diameter.  Lab tests were included Vitals taken at clinic: Temperature - 99.5 degrees Fahrenheit, Blood Pressure: 203/81 - She stated that her BP is never that high, Pulse Rate: 104, Respiratory Rate: 16 and O2 sat: 98%.  The event of cellulitis was considered as serious with criteria of important medical event.  Treatment was antibiotics, tylenol, ice pack on injection site for her symptoms.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events spot just a little to the right of where the injection went in/it came back bigger and redder/darker, hard lump underneath it, it was sore, also mildly itchy, at times, cellulitis, and blood pressure increased 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperaesthesia, Paraesthesia, Somnolence
Clinical narrative: Tingling in her hands and feet; Skin is extremely sensitive to any type of clothing-sensory issue; Persistently asleep, takes naps ever day; Reaction was extremely painful initially; Extreme fatigue; chills; A spontaneous report was received from a consumer, concerning a female patient of age 37, who received Moderna's COVID-19 vaccine and experienced chills, paresthesia/tingling in her hands and feet, skin is extremely sensitive to any type of clothing/hyperesthesia, extreme fatigue, persistently asleep and  pain in the injection site.   The patient's medical history included Hashimoto's. Products known to have been used by the patient included progesterone, testosterone, liothyronine, and levothyroxine.   On 06 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 012L20A) via unknown route for COVID-19 infection prophylaxis. On 05 Feb 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 05 Feb 2021, after second dose of vaccine, the patient experienced chills, paresthesia/tingling in her hands and feet, skin is extremely sensitive to any type of clothing/hyperesthesia, extreme fatigue, persistently asleep and pain in the injection site. Treatment medication with Tylenol, Ibuprofen, fexofenadine hydrochloride and cetirizine was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events was considered to be 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tingling in her hands and feet; Skin is extremely sensitive to any type of clothing-sensory issue; Persistently asleep, takes naps ever day; Reaction was extremely painful initially; Extreme fatigue; chills; A spontaneous report was received from a consumer, concerning a female patient of age 37, who received Moderna's COVID-19 vaccine and experienced chills, paresthesia/tingling in her hands and feet, skin is extremely sensitive to any type of clothing/hyperesthesia, extreme fatigue, persistently asleep and  pain in the injection site.   The patient's medical history included Hashimoto's. Products known to have been used by the patient included progesterone, testosterone, liothyronine, and levothyroxine.   On 06 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 012L20A) via unknown route for COVID-19 infection prophylaxis. On 05 Feb 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 05 Feb 2021, after second dose of vaccine, the patient experienced chills, paresthesia/tingling in her hands and feet, skin is extremely sensitive to any type of clothing/hyperesthesia, extreme fatigue, persistently asleep and pain in the injection site. Treatment medication with Tylenol, Ibuprofen, fexofenadine hydrochloride and cetirizine was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events was considered to be 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Fatigue, Headache
Clinical narrative: Congestion in lungs - coughed up blood , brown, green and yellow mucus; stopped up; Loss sense of taste and smell; Loss sense of taste and smell; Headache; Fever; Very tired; Chills; A spontaneous report was received from a consumer, who is a 63-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestion in lungs- coughed up blood , brown, green and yellow mucus/ pulmonary congestion, stopped up/ nasal cavity packing, headache, fever/ pyrexia, very tired/ fatigue, chills, loss sense of taste/ ageusia and smell/ anosmia.  The patient's medical history included injuries in right arm. Concomitant medications included clonazepam, potassium, magnesium, fluticasone propionate, salmeterol xinafoate, dexamethasone, metformin, sumatriptan, bupropion and cyclobenzaprine.  On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 07 Mar 2021, approximately 4 days after receiving vaccine, the patient experienced congestion in lungs- coughed up blood , brown, green and yellow mucus (medically significant), stopped up, headache, fever, very tired, chills, loss sense of taste and smell. Treatment medication was reported as paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, congestion in lungs- coughed up blood , brown, green and yellow mucus stopped up, headache, fever, very tired, chills, loss sense of taste and smell was considered as resolved on 10 Mar 2021.; 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pulmonary congestion, Pyrexia
Clinical narrative: Congestion in lungs - coughed up blood , brown, green and yellow mucus; stopped up; Loss sense of taste and smell; Loss sense of taste and smell; Headache; Fever; Very tired; Chills; A spontaneous report was received from a consumer, who is a 63-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestion in lungs- coughed up blood , brown, green and yellow mucus/ pulmonary congestion, stopped up/ nasal cavity packing, headache, fever/ pyrexia, very tired/ fatigue, chills, loss sense of taste/ ageusia and smell/ anosmia.  The patient's medical history included injuries in right arm. Concomitant medications included clonazepam, potassium, magnesium, fluticasone propionate, salmeterol xinafoate, dexamethasone, metformin, sumatriptan, bupropion and cyclobenzaprine.  On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 07 Mar 2021, approximately 4 days after receiving vaccine, the patient experienced congestion in lungs- coughed up blood , brown, green and yellow mucus (medically significant), stopped up, headache, fever, very tired, chills, loss sense of taste and smell. Treatment medication was reported as paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, congestion in lungs- coughed up blood , brown, green and yellow mucus stopped up, headache, fever, very tired, chills, loss sense of taste and smell was considered as resolved on 10 Mar 2021.; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Unresponsive to stimuli
Clinical narrative: Looks like a stroke; She became unresponsive; A spontaneous report was received from a consumer concerning a 80-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and she became unresponsive and it  looked like a stroke.  The patient's medical history was not provided. Concomitant medications reported included carvedilol, acetyl salicylic acid and an occasional injection for hives. The last injection for hives was administered a week and a half ago.  On 10 Mar 2021 at 4pm, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 11 Mar 2021, it was reported that the patient became unresponsive and she appeared to be having a stroke. The patient was taken to the emergency room where she underwent treatment.  No other details were provided.  Treatment information were not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken in response to the events was not applicable.   The outcome of events, became unresponsive and it looked like a stroke, was considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Loss of consciousness, Thrombosis
Clinical narrative: Blacked out; Multiple blood clots; inflammation in spine; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced multiple blood clots/ thrombosis, inflammation in spine/inflammation, blacked out/loss of consciousness.  The patient's medical history included blood clots. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 via unknown route for COVID-19 infection prophylaxis.  On 11 Mar 2021, the reporter stated that her sister received the Moderna vaccine and she had multiple blood clots, inflammation in spine and blacked out. The events multiple blood clots and blacked out were assessed as serious based on IME list. Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events multiple blood clots, inflammation in spine and blacked out was reported to be 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 events, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Dysarthria, Insomnia, Intentional dose omission
Clinical narrative: he could sleep little but not properly at night; patient will not be getting second dose; suicidal thought came in his mind when he was going through all these but he is not a depressed person at all it was just a thought in his brain; he couldn't speak, he couldn't get the words to make any sense at all; right arm wasn't performing properly,he felt like it was more neurological problem; he was dizzy; Patient started losing his balance after receiving 1st dose; A spontaneous report was received from a consumer concerning a male patient of 74 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events suicidal thought came in his mind,started losing his balance, he couldn't speak,dizziness and right arm not working properly related to neurological problem and Insomnia.  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 04 Mar 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 001A21A) vaccine intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 05 Mar 2021, he experienced balance disorder(Started losing his balance).  On an unknown date patient experienced insomnia. and on 11 Mar 2021 patient decided not getting second dose (Intentional dose omission ).  On 07 Mar 2021, he experienced slurry speech,dizziness, Monoparesis, suicidal ideation.On 11Mar2021, he is about 90% better.  The event suicidal thought was considered to be medically significant based on IME list.Seriousness of other events are not reported.  Treatment medications include Aleve, Aspirin.  Action taken with the mRNA-1273 in response to the event was unknown.  The outcome of events slurry speech, dizziness,Monoparesis, suicidal ideation,balance disorder was considered to be recovering/resolving.  The outcome of events insomnia, intentional dose omission 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 these events, a causal relationship cannot be excluded. This report also refers to a case of Intentional drug omission for mRNA-1273, lot number 001A21A.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Monoparesis, Suicidal ideation
Clinical narrative: he could sleep little but not properly at night; patient will not be getting second dose; suicidal thought came in his mind when he was going through all these but he is not a depressed person at all it was just a thought in his brain; he couldn't speak, he couldn't get the words to make any sense at all; right arm wasn't performing properly,he felt like it was more neurological problem; he was dizzy; Patient started losing his balance after receiving 1st dose; A spontaneous report was received from a consumer concerning a male patient of 74 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events suicidal thought came in his mind,started losing his balance, he couldn't speak,dizziness and right arm not working properly related to neurological problem and Insomnia.  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 04 Mar 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 001A21A) vaccine intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 05 Mar 2021, he experienced balance disorder(Started losing his balance).  On an unknown date patient experienced insomnia. and on 11 Mar 2021 patient decided not getting second dose (Intentional dose omission ).  On 07 Mar 2021, he experienced slurry speech,dizziness, Monoparesis, suicidal ideation.On 11Mar2021, he is about 90% better.  The event suicidal thought was considered to be medically significant based on IME list.Seriousness of other events are not reported.  Treatment medications include Aleve, Aspirin.  Action taken with the mRNA-1273 in response to the event was unknown.  The outcome of events slurry speech, dizziness,Monoparesis, suicidal ideation,balance disorder was considered to be recovering/resolving.  The outcome of events insomnia, intentional dose omission 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 these events, a causal relationship cannot be excluded. This report also refers to a case of Intentional drug omission for mRNA-1273, lot number 001A21A.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypotension
Clinical narrative: COVID-19; low blood pressure; A spontaneous report  was received from a consumer concerning a 68-year-old, female patient who experienced COVID-19 and low blood pressure/hypotension.   The patient's medical history included lupus. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date. On an unknown date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient contracted COVID-19 since an unknown date. They also experienced low blood pressure.  The laboratory investigations included blood pressure performed on an unknown date with result 91/50. The patient was hospitalized on an unknown date and was discharged after two days, date unknown.  Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, COVID-19 and hypotension were 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 except for the event of COVID-19. The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Haematoma
Clinical narrative: Hematoma Cellulitis; Hematoma Cellulitis; A spontaneous report was received from a nurse professional (patient) concerning a 66-years-old female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and had hematoma cellulitis (cellulitis) and hematoma cellulitis (haematoma).  No medical history was reported. The concomitant medications included metoprolol, colecalciferol, atorvastatin, ibuprofen.  On 28 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly in left deltoid for the prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient developed hematoma cellulitis (medically significant).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events of hematoma cellulitis (cellulitis) and hematoma cellulitis (haematoma) was unknown.   The reporter did not provide assessment for the event of hematoma cellulitis (cellulitis) and hematoma cellulitis (haematoma).; 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. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Body temperature, Gait inability, Pyrexia, Speech disorder
Clinical narrative: Stunned; Very high fever; Not able to walk; Not able to speak; A spontaneous report was received from a consumer concerning a 74 year old, female patient who experienced very high fever-104.2°F (pyrexia), was stunned (altered state of consciousness), not able to walk (gait inability), and not able to speak (speech disorder). The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Mar 2021 at 19:00, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 11-Mar-2021, the patient woke up with a very high fever of 104.2°F, stunned, not able to speak or move. The patient took Ibuprofen 600 mg to treat the fever and felt better, but was told that might have been counterproductive.  Treatment details included Ibuprofen 600 mg.  Action taken with mRNA-1273 in response to the events was not reported.   The events of very high fever-104.2°F (pyrexia), was stunned (altered state of consciousness), not able to walk (gait inability), and not able to speak (speech disorder) were considered recovering.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Inappropriate schedule of product administration
Clinical narrative: Stroke; Missed or late 2nd dose; A spontaneous report was received from a consumer concerning, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke and missed or late 2nd dose.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 03 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  The patient missed the second dose which was scheduled on 05 Mar 2021 as she was hospitalized for a stroke.  No Laboratory investigations were provided. No Treatment information provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, missed or late second dose was considered resolved on 05 Mar 2021. The outcome of the event stroke 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 events, a causal relationship cannot be excluded
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Inflammation, Myalgia
Clinical narrative: deep joint pain; inflammation; deep muscle pain; Headache; A spontaneous report was received from a consumer concerning a 69 Years-old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced events headache, deep muscle pain/ myalgia, deep joint pain/ arthalgia, and inflammation.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the for prophylaxis of COVID-19 infection.  06 Feb 2021, the patient experienced headache, deep muscle pain, joint pain and could hardly walk. On 25 Feb 2021, she was hospitalized and left hospital on 28 Feb 2021. Her HCP said it was severe joint pain.   Laboratory details were provided as Ultrasound and X-ray came back normal, however the patient stated it showed inflammation..  Treatment details were provided as Tramadol, muscle relaxer, Tylenol, Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events were 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 events, a causal relationship cannot be excluded
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Loss of consciousness, Malaise, Nausea, Retching
Clinical narrative: passed out; Golf ball sized knot from hitting head somehow, believes he passed out; Nauseous and sick; Dry heaves for 10-15 minutes; Nauseous and sick; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of loss of consciousness, haed injury,malaise, nauseous and retching, believes he passed out, dry heaves for 10-15 minutes, golf ball sized knot from hitting head.  The patient's medical history was not provided. Concomitant medications reported were blood pressure meds for drug use for an unknown indication.  On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot number: 031L20A) via unknown route for prophylaxis of COVID-19 infection. On 10 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot number: 011A21A) via unknown route for prophylaxis of COVID-19 infection.  On 11 Mar 2021, the patient experienced the event(s)loss of consciousness, head injury, malaise, nauseous and retching, believes he passed out, dry heaves for 10-15 minutes, golf ball sized knot from hitting head.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not applicable.  On 12 Mar 2021 the outcome of event(s), nauseous and sick, believes he passed out, dry heaves for 10-15 minutes, golf ball sized knot from hitting head was considered as recovered/resolved..; 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.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pulmonary embolism
Clinical narrative: Blood clot in lungs; Pneumonia; A spontaneous report was received from a consumer concerning her husband, male patient who developed blood clot in lungs/pulmonary embolism, pneumonia/pneumonia.   The patient's medical history included Parkinson's. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273  for prophylaxis of COVID-19 infection.   On 4 Mar 2021 the patient was admitted due to blood clot in lungs and pneumonia. The medically significant event caused hospitalization. Treatment of the event included blood thinners.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events blood clot in lungs and pneumonia was not reported.; 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Herpes zoster, Pain
Clinical narrative: Shingles; Abdomen started to bloat and becamne incredibly swollen; Sore arm; A spontaneous report was received from a consumer concerning a 61-year-old male who received Moderna's COVID-19 vaccine (mRNA-1273) and developed shingles/ Herpes zoster, abdominal started to bloat and became incredibly swollen/abdominal distension and sore arm/injection site pain.  The patient's medical history included hepatic cancer and unspecified liver procedure. Concomitant products known to have been used within two weeks prior to the vaccination included pembrolizumab.  On 19 Feb 2021, the patient received her first dose of mRNA-1273 (batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 19FEB2021 the patient had a sore arm.  On 24 Feb 2021, the patient developed shingles which broke out all over his face affecting his lips, ears, gums and inside of his mouth. His abdomen started to bloat and became incredibly swollen. It was unknown if he received any treatment in response to the events.   Action taken with mRNA-1273 and pembrolizumab in the response to the events shingles, abdomen started to bloat and became incredibly swollen and sore arm was not known.  The outcome of the events, herpes zoster, abdominal distention and injection site pain were 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 events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Loss of consciousness
Clinical narrative: Got the vaccine, became unconscious just after the shot, waked up in a Hospital 2 days later; a severe allergic reaction to the vaccine.; A spontaneous report was received from consumer concerning a 65 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and woke up in a hospital 2 days later unable to remember anything.  The physician stated he suffered a severe allergic reaction to the vaccine/hypersensitivity.   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   The patient received first dose of two planned doses of mRNA-1273 (Batch number: unknown) on 9 Mar 2021 at unknown injection site for prophylaxis of COVID-19 infection.   On 9 Mar 2021, the patient did not remember anything after receiving the vaccine and woke up two days later in a hospital. The physician stated he suffered a severe allergic reaction to the vaccine. The event, unconscious just after the shot, waking up in a hospital 2 days later, is considered medically significant.    Treatment for the events are not known.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event, waking up in a hospital 2 days after receiving the vaccine, was considered resolved. The outcome of the event, severe allergic reaction to the vaccine, was not reported.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Chills, Cough, Rash pruritic
Clinical narrative: A week and a half ago he started bronchitis; A week and a half ago he started having cough; Chills once in a while; He had some itchy bumps on his body; A spontaneous report was received from consumer, who was also a male patient of unknown age, who received the Moderna COVID-19 (mRNA-1273) vaccine and developed a week and a half ago he started bronchitis/bronchitis, he had some itchy bumps on his body/rash pruritic, a week and a half ago he started having cough/cough, chills once in a while/chills.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received first dose of two planned doses of mRNA-1273 (Batch number: unknown) on 17 Feb 2021 intramuscularly at unknown injection site for prophylaxis of COVID-19 infection.   The patient initially had some itchy bumps on his body and a week and a half ago he started having cough, bronchitis. Chills occasionally. The medically significant event is a week and a half ago he started bronchitis/bronchitis. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events a week and a half ago he started bronchitis, he had some itchy bumps on his body, a week, and a half ago he started having cough, chills occasionally was not reported.; Reporter's Comments: This case concerns a male patient who developed a medically significant and serious unexpected event of bronchitis along with nonserious unexpected cough, pruritic rash and expected chills.  Event onset occurred on Day 5 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Oedema peripheral, Paraesthesia, Thrombosis
Clinical narrative: blood clots in upper thigh down to foot; swelling of the foot; tingling; clot was burning and hot; A spontaneous report was received from a consumer concerning a 62-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blood clots in upper thigh down to foot, swelling of the foot, tingling, and clot was burning and hot.  The patient's medical history included insertion of a blood clot filter. Concomitant medications reported were Xarelto for drug use for unknown indication. She is also taking 17 other medications (not provided) and has other medical issues (not provided). She also has a blood clot filter inside her body (location not provided). She also wears compression and diabetic socks.  On 25 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: L014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) blood clots in upper thigh down to foot, swelling of the foot, tingling, clot was burning and hot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s), blood clots in upper thigh down to foot, swelling of the foot, tingling, clot was burning and hot 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nephrolithiasis, Pain
Clinical narrative: Kidney Stone; Pain; Terrible Headaches; A spontaneous report was received from consumer concerning 66 year old, female  patient who developed kidney stone/nephrolithiasis, terrible headaches/headache, pain.   The patient's medical history included a procedure for colonoscopy. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 9 Mar 2021 intramuscularly at right arm for prophylaxis of COVID-19 infection.   On 9 Mar 2021 the patient experienced terrible headaches and pain; therefore visited emergency department. Upon arrival to ED, the patient was diagnosed with kidney stone and discharged the same day with Ondansetron and Ibuprofen. The headaches and pain did not subside, so the patient visited ED again on 10 Mar 2021 and was once again discharged after few hours. The patient visited the ED 3rd time on 12 Mar 2021 and was given IV fluids and Ibuprofen. She was discharged on 13 Mar 2021. The medically significant event is kidney stone. Treatment for the event included IV fluids, Ondansetron, and Ibuprofen.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events kidney stone, terrible headaches, and pain were considered Resolved.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and the administration of mRNA-1273 vaccine and based on the known safety profile, a causal association cannot be excluded for the event of fever.  Kidney stone and pain are assessed as unlikely based on the known etiology of the disease.