chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; Severe vomiting; Chills; Headache; Arm was sore; Fatigue; A spontaneous report was received from a medical assistant, concerning herself, a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sore arm, fever, severe vomiting, headache, chills and fatigue.  The patient's medical history included COVID-19 at the end of Oct-2020. Concomitant product use was not provided by the reporter.  On 25-Jan-2021 at 07:50 AM, the patient received their first of two planned doses of mRNA-1273 (Lot # 012L20A) in the left arm for prophylaxis of COVID-19 infection.       On 25-Jan-2021, late in the afternoon, after the first dose of vaccine, the patient got headache and her arm was sore. The same evening, she experienced chills, fever of 100.7 Fahrenheit (was high in the hospital) and severe vomiting. Hence, she was hospitalized for two days from 25-Jan-2021 to 27 Jan 2021 and was treated with acetaminophen, fluids, ondansetron and potassium. On 28-Jan -2021, patient still had a little bit of headache and fatigued.   Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, headache and fatigue were considered not resolved at the of this report. The outcome of the events, sore arm, fever, severe vomiting and chills were resolved on 27-Jan-2021.  The reporter did not provide an assessment of the events, headache, sore arm, chills, fever, severe vomiting and fatigue.; 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 will be requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; Severe vomiting; Chills; Headache; Arm was sore; Fatigue; A spontaneous report was received from a medical assistant, concerning herself, a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sore arm, fever, severe vomiting, headache, chills and fatigue.  The patient's medical history included COVID-19 at the end of Oct-2020. Concomitant product use was not provided by the reporter.  On 25-Jan-2021 at 07:50 AM, the patient received their first of two planned doses of mRNA-1273 (Lot # 012L20A) in the left arm for prophylaxis of COVID-19 infection.       On 25-Jan-2021, late in the afternoon, after the first dose of vaccine, the patient got headache and her arm was sore. The same evening, she experienced chills, fever of 100.7 Fahrenheit (was high in the hospital) and severe vomiting. Hence, she was hospitalized for two days from 25-Jan-2021 to 27 Jan 2021 and was treated with acetaminophen, fluids, ondansetron and potassium. On 28-Jan -2021, patient still had a little bit of headache and fatigued.   Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, headache and fatigue were considered not resolved at the of this report. The outcome of the events, sore arm, fever, severe vomiting and chills were resolved on 27-Jan-2021.  The reporter did not provide an assessment of the events, headache, sore arm, chills, fever, severe vomiting and fatigue.; 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 will be requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Eyelid disorder, Facial paralysis, Headache, Hemiparesis
Clinical narrative: Facial paralysis; Bradycardia; Weakness on his right arm and right leg; Difficulty talking; Can´t close eyes; Right leg is numb; Severe headache; Some eye issues, sees blurry; A spontaneous report was received from a paramedic, who was also a 59-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia.   The patient's medical history was not provided. Concomitant product use reported included, insulin, statin, losartan, and metformin.  On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Jan 2021, after receiving the vaccine, the patient experienced eye issues and would see blurry and had a severe headache.  On 23 Jan 2021, the patient was hospitalized for 36 hours because he thought he was having a stroke. Test results showed the patient did not have a stroke. The patient did, however, experience facial paralysis, couldn't close his eyes, bradycardia, weakness in the right arm and right leg, difficulty talking, and his right leg felt numb. Treatment for the events included prednisone, valaciclovir, and unspecified calming medication while at the hospital.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right am and right leg, right leg is numb, can't close eyes, and bradycardia, was considered not resolved.; Reporter's Comments: This case concerns a 59 year old male was hospitalized with a serious events of some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia after first dose to mRNA-1273 in the left arm. Comcomitant medications include insulin, metformin, atorvastatin, losartan.  Hospital work-up showed ne did not have a stroke, and he was treated with prednisone, valaciclovir and a "calming medicine". b) 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.   +  b) 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Speech disorder, Vision blurred
Clinical narrative: Facial paralysis; Bradycardia; Weakness on his right arm and right leg; Difficulty talking; Can´t close eyes; Right leg is numb; Severe headache; Some eye issues, sees blurry; A spontaneous report was received from a paramedic, who was also a 59-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia.   The patient's medical history was not provided. Concomitant product use reported included, insulin, statin, losartan, and metformin.  On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Jan 2021, after receiving the vaccine, the patient experienced eye issues and would see blurry and had a severe headache.  On 23 Jan 2021, the patient was hospitalized for 36 hours because he thought he was having a stroke. Test results showed the patient did not have a stroke. The patient did, however, experience facial paralysis, couldn't close his eyes, bradycardia, weakness in the right arm and right leg, difficulty talking, and his right leg felt numb. Treatment for the events included prednisone, valaciclovir, and unspecified calming medication while at the hospital.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right am and right leg, right leg is numb, can't close eyes, and bradycardia, was considered not resolved.; Reporter's Comments: This case concerns a 59 year old male was hospitalized with a serious events of some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia after first dose to mRNA-1273 in the left arm. Comcomitant medications include insulin, metformin, atorvastatin, losartan.  Hospital work-up showed ne did not have a stroke, and he was treated with prednisone, valaciclovir and a "calming medicine". b) 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.   +  b) 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis; A spontaneous report was received from a consumer concerning a 68-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced cellulitis from the vaccine. No further details were provided.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event cellulitis was unknown.; Reporter's Comments: This case concerns a 68 year-old, male patient, who experienced event of cellulitis. The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Based on the current available limited information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Had a syncopal event; A spontaneous report was received from a health care provider who is also the patient, a male of unreported age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a syncopal episode.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 17 Jan 2021, after receiving the vaccine, the patient had a syncopal episode.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event, syncopal episode, was considered unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history is not provided. The patient experienced a medically significant and unexpected event of Syncope occurred one day (same day) after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Sensitive skin
Clinical narrative: New sensitives to face cleansers; Anaphylactic shock; A spontaneous report was received from a consumer, concerning herself, a 47-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic shock and "newsensitives to face cleansers".  The patient's medical history was not provided. Concomitant product use included face cleansers.  On 08-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08-Jan-2021, approximately five minutes after receiving the vaccine, the patient experienced anaphylactic shock as evidenced by throat warm and tingling, arms was bright red and warm to touch, trouble breathing, felt like choking, and nausea. Hence, she was treated with "epinephrine quite a few times along with steroids and ranitidine". On 09-Jan-2021, the patient went to the hospital two more times for "breathing issues", however she was not admitted. On 10-Jan-2021, in the morning, the patient had "passed out" and was given another epinephrine injection as she went into anaphylaxis shock again. On-29 Jan-2021, the patient also reported her arm, legs and chest are "bright red" and "burns".  The patient also experienced new sensitivities to the face cleansers she has used for over 12 years.  Action taken with mRNA-1273 in response to the events were unknown.  The events, anaphylactic shock, was considered newsensitives to face cleanser" were considered not resolved.; Reporter's Comments: This case concerns a 47-year-old female patient, who experienced serious event of anaphylactic shock and non-serious event of sensitive skin. The event of anaphylactic shock occurred on the same day and re-occurred again approximately 2 days after first dose of mRNA-1273, lot # unknown. 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Epistaxis, Oropharyngeal pain
Clinical narrative: nosebleeds got worse where she was filling up towels with blood; sore throat; cough; A solicited report was received from a 61-year-old female patient, who who received Moderna's COVID-19 vaccine (mRNA-1273) developed significant nosebleeds where she was filling up towels full of blood, sore throat and coughing during and after her Tyvaso session.   The patient's medical history included Secondary Pulmonary Arterial Hypertension. Products known to have been used by the patient within two weeks prior to the event was Sildenafil Citrate. Additional suspected products included Treprostinil Sodium, Plavix, and Aspirin.  On an unknown date, the patient received one of two planned doses of mRNA-1273 (Lot: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, after receiving the vaccine, the patient experienced worsening of nosebleeds filling up towels full of blood, sore throat and coughing. Treatment for the events, nosebleed, sore throat and cough was not reported.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The event, worsening of nosebleeds filling up towels full of blood was considered not resolved and outcome of the events, sore throat and cough was not reported.; Reporter's Comments: This case concerns a 61 year old female patient with medical history of Secondary Pulmonary Arterial Hypertension, who experienced a serious unexpected event of Epistaxis and NS events of oropharyngeal pain and cough. The events occurred on an unknown date after first dose of the study medication administration.  A causal relationship cannot be excluded. Noting the subject's underlying medical condition and concomitant medication could remain a confounder.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic, Dizziness, Electrocardiogram, Gastrointestinal haemorrhage, Heart rate
Clinical narrative: Bled Out 40% of blood from lower GI; Bloody diarrhea; Lightheaded; Sweating; Malaise; Fever; tachycardia; A spontaneous report was received from a pharmacist who is a 60-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal tract, tachycardia, sweating, lightheaded, malaise and fever.  The patient's medical history was not provided. No concomitant product use was reported.  On 31 Dec2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient reported 14 days after receiving the vaccine, he developed tachycardia with a heart rate of 120 and did not feel right. The patient stated was sweating and thought he was having a heart attack.   On an unknown date, the patient saw his doctor who performed an electrocardiogram (EKG)  results not provided. The patient also stated he had blood pressure issues but did not provide any further information.  On an unknown date, the patient reported he was hospitalized with bloody diarrhea. He stated he bled out 40 percent of blood from his lower gastrointestinal track. He reported he had malaise and fever as well. The patient reported he had to have surgery to stop the bleeding.   Treatment for the event included surgery.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal track, tachycardia, sweating, lightheaded, malaise and fever, were considered unknown.; Reporter's Comments: This case concerns a 60 year old male patient, who experienced a serious event of gastrointestinal haemorrhage, associated with other non-serious events after receiving first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Pyrexia, Tachycardia
Clinical narrative: Bled Out 40% of blood from lower GI; Bloody diarrhea; Lightheaded; Sweating; Malaise; Fever; tachycardia; A spontaneous report was received from a pharmacist who is a 60-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal tract, tachycardia, sweating, lightheaded, malaise and fever.  The patient's medical history was not provided. No concomitant product use was reported.  On 31 Dec2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient reported 14 days after receiving the vaccine, he developed tachycardia with a heart rate of 120 and did not feel right. The patient stated was sweating and thought he was having a heart attack.   On an unknown date, the patient saw his doctor who performed an electrocardiogram (EKG)  results not provided. The patient also stated he had blood pressure issues but did not provide any further information.  On an unknown date, the patient reported he was hospitalized with bloody diarrhea. He stated he bled out 40 percent of blood from his lower gastrointestinal track. He reported he had malaise and fever as well. The patient reported he had to have surgery to stop the bleeding.   Treatment for the event included surgery.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal track, tachycardia, sweating, lightheaded, malaise and fever, were considered unknown.; Reporter's Comments: This case concerns a 60 year old male patient, who experienced a serious event of gastrointestinal haemorrhage, associated with other non-serious events after receiving first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted; A spontaneous report was received from a 21-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainted (syncope).    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received her first of two planned doses of mRNA-1273 (lot/batch number unknown) in the left arm in approximately January 2021 for prophylaxis of COVID-19 infection.  In approximately January 2021 (a few days later after vaccination), the patient experienced fainted.  Treatment information was not provided.  The action taken with mRNA-in response to the event was unknown.  The outcome of the event fainted was unknown.; Reporter's Comments: This case concerns a 21-year-old, female, patient, who experienced a serious unexpected event of syncope. The event occurred at unknown date, reported as few days later, after first dose of mRNA-1273, lot # unknown. Treatment information is not provided. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Underdose, Vaccination site discharge
Clinical narrative: If it was administered wrong; injection site leaking clear, watery liquid; A spontaneous report (United States) was received from a consumer concerning a female patient, of unknown age, who was administered Moderna's COVID-19 vaccine and it was leaked out and administered wrong.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration in the arm for prophylaxis of COVID-19 infection.  On 28-Jan-2021 at 3:30 pm the patient had her first dose of the Moderna vaccine. She felt the needle go into her arm; however, when the person removed the needle, she said the patient was bleeding. The patient immediately put her hand over the area on her shoulder and then looked at it. Per the patient, her hand was wet, not a few drops, but her whole palm was wet with clear watery looking liquid, there was no blood. The patient tried to call the pharmacist same day at 6:30pm but the pharmacy was closed. On 30-Jan -2021 patient got a Covid nasal swab done for work and came negative. Patient asked doctor at the clinic if she should have had that much of leakage that filled her hand and doctor replied no. The patient spoke with the pharmacist on 31-Jan-2021 regarding this issue. Patient was concerned if she should get another vaccine or if okay to get 2nd dose on 25-Feb-2021. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, vaccine leaked out and administered wrong, was considered resolved on 28-Jan-2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number: unknown)  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Flushing, Hypertensive crisis, Swelling face
Clinical narrative: Hypertensive crisis; Flushing in face, it became red, and swollen; Flushing in face, it became red, and swollen; Flushing in face, it became red, and swollen; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a hypertensive crisis, flushing in face, it became red and swollen.   The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   On the unknown date, approximately half an hour after receiving the Moderna COVID-19 vaccine, the patient had facial flushing, it was red and swollen. The patient was taken to the emergency room for hypertensive crisis. Her blood pressure was 250/150 mmHg. She was in the emergency room for four hours until her blood pressure came down. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, hypertensive crisis, flushing in face, it became red and swollen, was unknown.; Reporter's Comments: This spontaneous report (which concerns a female patient who experienced hypertensive crisis and flushing in face and it became red and swollen. The events occurred half hour after the administration of mRNA-1273 vaccine (Lot number: 041L20A, expiration date: unknown).   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.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Diarrhoea, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: Had headache that was similar to migraine; Feeling foggy; Diarrhea; Episode of nausea; Extreme fatigue; Muscle ache; Rash inside armpit; Anaphylactic reaction; Tingling in arm; Itching; Rapid heartbeat; Started feeling hot; Petechia eye; Tiny broken vessel on both ankles; A spontaneous report  was received from a consumer who was also a female patient over the age of 55 but under 60 years of age who received Moderna's Covid-19 vaccine (mRNA-1273) and who experienced anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye,  tiny broken vessel on both ankles, headache similar to migraine, nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea. The patient's medical history was significant for anaphylactic reaction to cephalosporin antibiotics. No other medical history was provided by the patient. Concomitant product use was not provided by the patient. On 24 Jan 2021, prior to the onset of symptoms, at the County Health Department, the patient received the first of two planned doses of mRNA-1273 intramuscularly into her upper left arm. Because of her past medical history, the patient was observed for 30 minutes at the facility for any adverse reaction. When the observation period ended the patient went to her car and sometime later began having a delayed reaction. She reported experiencing the following symptoms: "tingling in arm", "itching", "rapid heartbeat", "started feeling hot", "rash inside of armpit", "petechia eye", and "tiny broken vessel on both ankles". The patient went to an Urgent Care Clinic, where she was treated with an injection of diphenhydramine and an oral prednisone.  She was given a prescription for diphenhydramine, and prednisone. The patient was informed that she had an anaphylactic reaction to the vaccine. On 25 Jan 2021, the patient stated she had a "headache similar to a migraine", "episode of nausea", "extreme fatigue", "feeling foggy", "muscle ache", and "diarrhea". She was being followed up by an allergist. Action taken with mRBA-1273 in response to the events was not provided. The outcome of the events, anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye,  and tiny broken vessel on both ankles, and  headache similar to a migraine, episode of nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea, was considered unknown.; Reporter's Comments: This case concerns a 55-60 year old female who had a serious unexpected anaphylactic reaction, with NS unexpected paranesthesia, pruritus, HR increased, feeling hot, rash, petechia, telangiectasia, migraine, feeling abnormal, diarrhea, and NS expected nausea, fatigue, myalgia. Event onset 1 day after first dose mRNA-1273. 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: F
Vaccine: COVID19
Symptoms: Heart rate increased, Migraine, Myalgia, Nausea, Paraesthesia
Clinical narrative: Had headache that was similar to migraine; Feeling foggy; Diarrhea; Episode of nausea; Extreme fatigue; Muscle ache; Rash inside armpit; Anaphylactic reaction; Tingling in arm; Itching; Rapid heartbeat; Started feeling hot; Petechia eye; Tiny broken vessel on both ankles; A spontaneous report  was received from a consumer who was also a female patient over the age of 55 but under 60 years of age who received Moderna's Covid-19 vaccine (mRNA-1273) and who experienced anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye,  tiny broken vessel on both ankles, headache similar to migraine, nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea. The patient's medical history was significant for anaphylactic reaction to cephalosporin antibiotics. No other medical history was provided by the patient. Concomitant product use was not provided by the patient. On 24 Jan 2021, prior to the onset of symptoms, at the County Health Department, the patient received the first of two planned doses of mRNA-1273 intramuscularly into her upper left arm. Because of her past medical history, the patient was observed for 30 minutes at the facility for any adverse reaction. When the observation period ended the patient went to her car and sometime later began having a delayed reaction. She reported experiencing the following symptoms: "tingling in arm", "itching", "rapid heartbeat", "started feeling hot", "rash inside of armpit", "petechia eye", and "tiny broken vessel on both ankles". The patient went to an Urgent Care Clinic, where she was treated with an injection of diphenhydramine and an oral prednisone.  She was given a prescription for diphenhydramine, and prednisone. The patient was informed that she had an anaphylactic reaction to the vaccine. On 25 Jan 2021, the patient stated she had a "headache similar to a migraine", "episode of nausea", "extreme fatigue", "feeling foggy", "muscle ache", and "diarrhea". She was being followed up by an allergist. Action taken with mRBA-1273 in response to the events was not provided. The outcome of the events, anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye,  and tiny broken vessel on both ankles, and  headache similar to a migraine, episode of nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea, was considered unknown.; Reporter's Comments: This case concerns a 55-60 year old female who had a serious unexpected anaphylactic reaction, with NS unexpected paranesthesia, pruritus, HR increased, feeling hot, rash, petechia, telangiectasia, migraine, feeling abnormal, diarrhea, and NS expected nausea, fatigue, myalgia. Event onset 1 day after first dose mRNA-1273. 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: F
Vaccine: COVID19
Symptoms: Petechiae, Pruritus, Rash, Telangiectasia
Clinical narrative: Had headache that was similar to migraine; Feeling foggy; Diarrhea; Episode of nausea; Extreme fatigue; Muscle ache; Rash inside armpit; Anaphylactic reaction; Tingling in arm; Itching; Rapid heartbeat; Started feeling hot; Petechia eye; Tiny broken vessel on both ankles; A spontaneous report  was received from a consumer who was also a female patient over the age of 55 but under 60 years of age who received Moderna's Covid-19 vaccine (mRNA-1273) and who experienced anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye,  tiny broken vessel on both ankles, headache similar to migraine, nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea. The patient's medical history was significant for anaphylactic reaction to cephalosporin antibiotics. No other medical history was provided by the patient. Concomitant product use was not provided by the patient. On 24 Jan 2021, prior to the onset of symptoms, at the County Health Department, the patient received the first of two planned doses of mRNA-1273 intramuscularly into her upper left arm. Because of her past medical history, the patient was observed for 30 minutes at the facility for any adverse reaction. When the observation period ended the patient went to her car and sometime later began having a delayed reaction. She reported experiencing the following symptoms: "tingling in arm", "itching", "rapid heartbeat", "started feeling hot", "rash inside of armpit", "petechia eye", and "tiny broken vessel on both ankles". The patient went to an Urgent Care Clinic, where she was treated with an injection of diphenhydramine and an oral prednisone.  She was given a prescription for diphenhydramine, and prednisone. The patient was informed that she had an anaphylactic reaction to the vaccine. On 25 Jan 2021, the patient stated she had a "headache similar to a migraine", "episode of nausea", "extreme fatigue", "feeling foggy", "muscle ache", and "diarrhea". She was being followed up by an allergist. Action taken with mRBA-1273 in response to the events was not provided. The outcome of the events, anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye,  and tiny broken vessel on both ankles, and  headache similar to a migraine, episode of nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea, was considered unknown.; Reporter's Comments: This case concerns a 55-60 year old female who had a serious unexpected anaphylactic reaction, with NS unexpected paranesthesia, pruritus, HR increased, feeling hot, rash, petechia, telangiectasia, migraine, feeling abnormal, diarrhea, and NS expected nausea, fatigue, myalgia. Event onset 1 day after first dose mRNA-1273. 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Muscular weakness
Clinical narrative: Lightheadedness within 5 minutes; weakness of muscles; rapid heart rate; This is a spontaneous report from a contactable  other HCP reporting for herself.  A 28-years-old female patient received the first dose of  bnt162b2 (BNT162B2) vaccine , intramuscular on 25Jan2021 09:00 at single dose  for Covid-19 immunisation .  The patient medical history and concomitant medicatons were not reported.  The patient previously took amoxicillin and experienced drug hypersensitivity.  The patient experienced lightheadedness, weakness of muscles and rapid heart rate  on 25Jan2021 09:15 with outcome of recovering. The patient was treated in Emergency Room with steroids and anxiety medications.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test, Liver function test increased, Pancreatitis
Clinical narrative: looked like pancreatitis; developed increased LFTs; This is a spontaneous report from a contactable physician (patient). A 53-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, saoluion ), via an unspecified route of administration on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia and benign prostatic hyperplasia (BPH). The patient has no known drug allergy (NKDA) and no known food allergy (NKFA). Concomitant medications included duloxetine hydrochloride (CYMBALTA), acetylsalicylic acid (ASPIRIN 81), diphenhydramine hydrochloride (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]), multivitamins [vitamins NOS] (MULTIVITAMINS [VITAMINS NOS]). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: eh9899, expiration date: unknown), at the age of 53 years old, on the left arm on 17Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed increased liver function tests (LFTs) that looked like pancreatitis on 08Jan2021 at 12:00. Treatment received for the adverse event include addition of PPI. The events resolved with sequel.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, PPV
Symptoms: Death, Inappropriate schedule of product administration
Clinical narrative: a male patient received the pneumonia shot 12 days after the first dose of the vaccine; he had died; This is a spontaneous report from a contactable consumer or other non hcp.   A 76 years old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID 19 immunisation and received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date 12 days after bnt162b2 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  Information on lot and batch number has been requested.  Follow-up: (08Feb2021): Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: a male patient received the pneumonia shot 12 days after the first dose of the vaccine; he had died
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: she felt so tired; her breathing was heavy and felt tight; This is a spontaneous report from a contactable nurse. A 67-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9262), at age 67 years, injection into the left upper arm/deltoid, first dose on 27Jan2021 14:00 at single dose, for COVID-19 vaccination. Ongoing medical history included diabetes diagnosed more than 10 years ago and high cholesterol diagnosed around 10 years ago, maybe longer. The patient's concomitant medications were unspecified maintenance medications because she is diabetic and has high cholesterol. She said that she has been taking these medications for a long time though already. Patient was a retired registered nurse that was calling about the COVID-19 vaccine and reported that she had the first dose injection on 27Jan2021 at 14:00 and 2 hours after she got home, she felt so tired that she did not feel like moving and her breathing was heavy and felt tight. Patient said that her breathing feeling heavy and tight did not last too long, maybe an hour then went away. Her tiredness, felt so tired lasted through the day and whole night and she was fine and completely recovered after waking up in the morning. For breathing feeling heavy and tight: She clarified that it lasted from like 14:00-17:00 yesterday 27Jan2021. Patient wanted to know with the symptoms she had is it contraindicated to get the second dose? She was reading the information about the injection and seemed like the symptoms are part of it. The outcome of the events was recovered, for felt so tired was on 28Jan2021 and for breathing was heavy and felt tight was on 27Jan2021. Case was reported as serious with other medically important condition as seriousness criteria. The reporter assessed the events she felt so tired and her breathing was heavy and felt tight as related to the suspect drug COVID-19 Vaccine.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cardiac disorder, Cardiac stress test, Chest discomfort, Chills
Clinical narrative: Was in the hospital for his heart condition; he had something around his chest area, some kind of pressure on his chest area; Chills; He ran a temperature of 100.4/running a temperature of 100.8; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration on the left arm on 27Jan2021, at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter (patient's wife) stated that both (patient and patient's wife) had the Vaccine shot on Wednesday, 27Jan2021. After that she was okay but he was not, he had something around his chest area, some kind of pressure on his chest area on Thursday (28Jan2021), he was in the hospital for his heart condition. Patient was done with stress test was good, had another test (unspecified) and he was okay. He had some temperature on Thursday while he was in hospital, next day on Friday (29Jan2021) he was relieved, then he was doing fine. He came home on 29Jan2021, and he started getting aspirin (given in hospital) and took cardiac medicine (unspecified). Everything was okay until few hours later, around 7 o'clock he started getting chills with running a temperature of 100.8 and then by 8 o'clock he ran a temperature of 100.4 (on 29Jan2021). Then call to nurse and the doctor, nurse said to give him the Extra Tylenol which was given at 9 o'clock and then patient's wife took his temperature again last at 11 o'clock, it was 99.55. Then this morning (30Jan2021) at 8 am it was 99.5 and patient had Tylenol and then also at 11 o'clock this morning it was 98.2, this afternoon at 2:45 it was back up to 99. At then at 3:53 it went up to 100.2, so at that point at 4 o'clock, given him Tylenol. He had some chills with it (Clarification unknown), chills were going back and forth. Seriousness of the events heart condition and chest pressure was reported as hospitalization. Outcome of the events was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pyrexia
Clinical narrative: Was in the hospital for his heart condition; he had something around his chest area, some kind of pressure on his chest area; Chills; He ran a temperature of 100.4/running a temperature of 100.8; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration on the left arm on 27Jan2021, at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter (patient's wife) stated that both (patient and patient's wife) had the Vaccine shot on Wednesday, 27Jan2021. After that she was okay but he was not, he had something around his chest area, some kind of pressure on his chest area on Thursday (28Jan2021), he was in the hospital for his heart condition. Patient was done with stress test was good, had another test (unspecified) and he was okay. He had some temperature on Thursday while he was in hospital, next day on Friday (29Jan2021) he was relieved, then he was doing fine. He came home on 29Jan2021, and he started getting aspirin (given in hospital) and took cardiac medicine (unspecified). Everything was okay until few hours later, around 7 o'clock he started getting chills with running a temperature of 100.8 and then by 8 o'clock he ran a temperature of 100.4 (on 29Jan2021). Then call to nurse and the doctor, nurse said to give him the Extra Tylenol which was given at 9 o'clock and then patient's wife took his temperature again last at 11 o'clock, it was 99.55. Then this morning (30Jan2021) at 8 am it was 99.5 and patient had Tylenol and then also at 11 o'clock this morning it was 98.2, this afternoon at 2:45 it was back up to 99. At then at 3:53 it went up to 100.2, so at that point at 4 o'clock, given him Tylenol. He had some chills with it (Clarification unknown), chills were going back and forth. Seriousness of the events heart condition and chest pressure was reported as hospitalization. Outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Loss of consciousness, Salivary hypersecretion
Clinical narrative: passed out and almost broke her arm; started salivating really bad/it's lot of drool; Heart rate started pounding; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261, expiration date May2021), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunisation.  Medical history included: Allergy.  Concomitant medication included drospirenone, ethinylestradiol (YASMIN) for Birth control, chlorphenamine maleate (PIRITON) for Allergy.  The patient was perfectly fine up until about the 3 hours after the vaccine, she started salivating really bad, she was not throwing up or nauseas or anything, it's just that it's lot of drool, like she even had just go over sink as just salivating so much it was weird, and her heart rate started pounding and she passed out and almost broke her arm, so and then she kind of like blacked out and don't remember anything for rest of the evening. The events onset date was on 26Jan2021 08:30. No treatment was received. The outcome of events was recovered in Jan2021.