chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Bronchitis; Arm pain; A spontaneous report  was received from a consumer for a 57 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, cough and arm pain and diagnosed with bronchitis.  The patient's medical history was not provided. Concomitant product use included alprazolam.  On 29 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 029C20A) and on 26 Feb 2021, she received the second of two planned doses of mRNA-1273 (Lot number: 001A21A) intramuscularly in left non dominant arm for prophylaxis of COVID-19 infection. On 26 Feb 2021 in evening around 8 PM, after receiving the vaccine, patient got fever, chills, cough and arm pain. On 01-Mar-2021, her doctor did Covid test and it resulted negative. She was then diagnosed with bronchitis and was prescribed Zithromax as treatment. She wanted to know if she could take Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was not reported.; Reporter's Comments: 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Blood test, Dyspnoea, Hypertension
Clinical narrative: Got heart attack; High blood pressure; Shortness of breath; Hip is paining; A spontaneous report was received from a consumer (Patient's husband) concerning a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart attack, high blood pressure, pain in hip and shortness of breath.  The patient's medical history included three by-pass (open) heart surgery in 2020. No relevant concomitant medications were reported.  On 25 Feb 2021 Thursday, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, Thursday night, the patient experienced high blood pressure of 189/101 and got a heart attack followed by shortness of breath and the patient hospitalized on 25 Feb 2021 Thursday night. On 26 Feb 2021, Friday at 04:00 PM, the patient was discharged from hospital. The patient experienced hip pain and little high blood pressure than normal.  Laboratory details included blood work normal and high blood pressure, 189/101.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, heart attack pain in hip and shortness of breath was not reported. The outcome for event high blood pressure was considered resolving.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments:  MOD21-043135:Same reporter
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Got heart attack; High blood pressure; Shortness of breath; Hip is paining; A spontaneous report was received from a consumer (Patient's husband) concerning a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart attack, high blood pressure, pain in hip and shortness of breath.  The patient's medical history included three by-pass (open) heart surgery in 2020. No relevant concomitant medications were reported.  On 25 Feb 2021 Thursday, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, Thursday night, the patient experienced high blood pressure of 189/101 and got a heart attack followed by shortness of breath and the patient hospitalized on 25 Feb 2021 Thursday night. On 26 Feb 2021, Friday at 04:00 PM, the patient was discharged from hospital. The patient experienced hip pain and little high blood pressure than normal.  Laboratory details included blood work normal and high blood pressure, 189/101.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, heart attack pain in hip and shortness of breath was not reported. The outcome for event high blood pressure was considered resolving.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments:  MOD21-043135:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: no fetal heartbeat; pregnant and received vaccine; A spontaneous report was received from a 37-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) while pregnant, and there was not fetal heartbeat.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins.  The consumer received the second of the two planned doses of mRNA-1273 on 26-JAN-2021 (Batch# 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02-MAR-2021, the patient stated her fetus had no heartbeat. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter's Comments: This is a case of product exposure during pregnancy for this 37 year old woman with associated event of absent fetal heartbeat. The patient will continue to be contacted for follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: She saw blood in stool; A spontaneous report was received from a consumer concerning a female patient (age unspecified) who received Moderna's COVID-19 vaccine (mRNA-1273) and saw blood in her stool.   The patient's medical history included urinary tract infection (UTI) and was prescribed antibiotics. No relevant concomitant medications were reported.  On 11/Feb/2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 14/Feb/2021, the patient experienced the event after dinner, she saw blood in stool. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, saw blood in stool was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Dizziness, Dyspnoea, Injection site pain
Clinical narrative: He was paralyzed,couldn't use his legs, hand, got collapsed; Lack of strength; Injection site was annoying, rubbing, scratchy; down deep in his muscle a slight feel pain at injection site; extreme dizziness lasted for a day and a half.; shortness of breath; A spontaneous report was received from a consumer concerning himself, 70 years old, male patient who experienced he was paralyzed, couldn't use his legs, hand, got collapsed/paralysis, injection site was annoying, rubbing, scratchy/injection site pruritus, down deep in his muscle a slight feel pain at injection site/injection site pain, shortness of breath/dyspnoea, lack of strength/weakness, extreme dizziness lasted for a day and a half/dizziness.  The patient's medical history was not provided. 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 24 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection.    The patient was paralyzed, he couldn't use his legs, hand, got collapsed. Injection site was annoying, rubbing, scratchy, down deep in his muscle a slight feel pain. He also had shortness of breath, lack of strength and extreme dizziness lasted for a day and a half. Treatment of the events was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event he was paralyzed, couldn't use his legs, hand, got collapsed, injection site was annoying, rubbing, scratchy and down deep in his muscle a slight feel pain at injection site was unknown and of events shortness of breath, lack of strength, extreme dizziness lasted for a day and a half was recovered.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Injection site pain and injection site pruritus are consistent with the known safety profile of the vaccine
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Paralysis
Clinical narrative: He was paralyzed,couldn't use his legs, hand, got collapsed; Lack of strength; Injection site was annoying, rubbing, scratchy; down deep in his muscle a slight feel pain at injection site; extreme dizziness lasted for a day and a half.; shortness of breath; A spontaneous report was received from a consumer concerning himself, 70 years old, male patient who experienced he was paralyzed, couldn't use his legs, hand, got collapsed/paralysis, injection site was annoying, rubbing, scratchy/injection site pruritus, down deep in his muscle a slight feel pain at injection site/injection site pain, shortness of breath/dyspnoea, lack of strength/weakness, extreme dizziness lasted for a day and a half/dizziness.  The patient's medical history was not provided. 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 24 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection.    The patient was paralyzed, he couldn't use his legs, hand, got collapsed. Injection site was annoying, rubbing, scratchy, down deep in his muscle a slight feel pain. He also had shortness of breath, lack of strength and extreme dizziness lasted for a day and a half. Treatment of the events was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event he was paralyzed, couldn't use his legs, hand, got collapsed, injection site was annoying, rubbing, scratchy and down deep in his muscle a slight feel pain at injection site was unknown and of events shortness of breath, lack of strength, extreme dizziness lasted for a day and a half was recovered.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Injection site pain and injection site pruritus are consistent with the known safety profile of the vaccine
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia, Vaccination site pain
Clinical narrative: pneumonia; tested positive for COVID-19; sore arm; A spontaneous report was received from a consumer concerning a 74-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pneumonia, sore arm and tested positive for COVID19.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included baby aspirin, morphine sulfate, vitamins, and unspecified antihyperlipidemic medication.  On 27 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Jan 2021, post vaccination, the patient developed sore arm. On 08 Feb 2021, the patient tested positive for COVID19. On 12 Feb 2021, the patient went to the Emergency Room for symptoms and was diagnosed with pneumonia. The patient was not hospitalized. Treatment for the event was not reported.    There was no change planned to the dosing schedule of mRNA-1273 in response to the events.   The outcome of the events, was unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported event- vaccination site pain and the administration of the mRNA-1273 cannot be excluded. However, the event of Covid-19 is Unlikely related to mRNA-1273. and a very limited information regarding the event (pneumonia) has been provided. However, the subject's concurrent history of COVID-19 may remain as a risk factor for pneumonia.
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: a friend died from the vaccine; A spontaneous report  was received from a non health care professional, concerning her friend, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and  died from the vaccine.  The patient's medical history,concomitant history, and lab data was not provided by the  reporter.   On an unknown date,  the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  The patient experienced death after receiving the moderna mRNA1273 vaccine.  No further details were provided.  The action taken with the second dose of mRNA-1273 in response to the event was not applicable.   The  outcome of the events, died from the vaccine, were considered as fatal.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Dizziness, Heart rate increased
Clinical narrative: Lost her vision; Dizzy, lightheaded, lightheadedness; Increased heart rate; A spontaneous report was received from a consumer concerning a 70-years-old female patient who was received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of vision, dizziness and increased heart rate.  The patients medical history was not provided. No relevant concomitant medications were reported.  On 28 feb 2021, approximately three days prior to the onset of events loss of vision, dizziness and increased heart rate, the patient received the first of two planned dose of mRNA-1273(Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 02 mar 2021, The patient had lost her vision, became dizzy lightheaded, which led to an increased heart rate. The patient still had intermittent lightheadedness. The event loss of vision was medically significant. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events loss of vision, dizziness and increased heart rate was not provided.; 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysentery, Fatigue, Headache
Clinical narrative: DYSENTERY; NAUSEOUS; CHILLS; SORE ARM; HEADACHE; fever; MUSCLES CRAMPING; SWEATS; Got dizzy; slept a bunch; A spontaneous report was received from a consumer concerning a 58 year old, male patient who experienced dizziness, fever, sweats/hyperhidrosis, nausea, chills, dysentery, slept a bunch/fatigue, sore arm/injection site pain, headache, and muscles cramping/muscle spasm.  The patient's medical history included having COVID-19 in December 2020.  Concomitant product use not provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number 016M20A) on 10-Feb-2021 intramuscularly for prophylaxis of COVID-19 infection.  On 11-Feb-2021, around 2 o'clock in the morning the patient got dizzy, got a fever, sweats, nauseous, had chills, he got dysentery and got sick to his stomach. He was sick about one day or so after that. He slept a bunch. He  looked bad and started sweating. He had a sore arm for a few days. He also had headaches and his muscles were cramping.  Treatment for the event none provided.  The outcome of the events were unknown.; Reporter's Comments: Based on the information provided, the event of dysentery is assessed as unlikely as it is infective etiology, the other events are temporarily association with mRNA-1273 administration, a causal association between the reported events and the product use cannot be excluded. Nausea, chills, injection site pain, headache, pyrexia, fatigue are consistent with the safety profile of the vaccine.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site pain, Muscle spasms, Nausea, Pyrexia
Clinical narrative: DYSENTERY; NAUSEOUS; CHILLS; SORE ARM; HEADACHE; fever; MUSCLES CRAMPING; SWEATS; Got dizzy; slept a bunch; A spontaneous report was received from a consumer concerning a 58 year old, male patient who experienced dizziness, fever, sweats/hyperhidrosis, nausea, chills, dysentery, slept a bunch/fatigue, sore arm/injection site pain, headache, and muscles cramping/muscle spasm.  The patient's medical history included having COVID-19 in December 2020.  Concomitant product use not provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number 016M20A) on 10-Feb-2021 intramuscularly for prophylaxis of COVID-19 infection.  On 11-Feb-2021, around 2 o'clock in the morning the patient got dizzy, got a fever, sweats, nauseous, had chills, he got dysentery and got sick to his stomach. He was sick about one day or so after that. He slept a bunch. He  looked bad and started sweating. He had a sore arm for a few days. He also had headaches and his muscles were cramping.  Treatment for the event none provided.  The outcome of the events were unknown.; Reporter's Comments: Based on the information provided, the event of dysentery is assessed as unlikely as it is infective etiology, the other events are temporarily association with mRNA-1273 administration, a causal association between the reported events and the product use cannot be excluded. Nausea, chills, injection site pain, headache, pyrexia, fatigue are consistent with the safety profile of the vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Eye swelling, Fear, Malaise
Clinical narrative: She felt sick; afraid may have this eye issue for rest of life and concern since a school bus driver she may lose her job; right eye is puffy and hurt(painful; right eye is puffy and hurt(painful; Both eyes started to swell.; had chills; fever; A spontaneous report was received from a consumer concerning a 58 years old, female patient who experienced, both eyes swollen(eye swelling), chills, fever(pyrexia), felt sick(malaise), right eye is puffy and hurt(periorbital swelling), right eye is hurt (eye pain), afraid may have this eye issue for rest of life and concern since a school bus driver she may lose her job (fear).  The patient's medical history not included.Concomitant medicine was not reported.No Lab data was reported.   On 24 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number:  011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Feb 2021, her both eyes started to swell, felt sick and had chills and fever. Her right eye was puffy and painful. She also afraid that she may lose job.Treatment for the event include cold compress, Benadryl, neomyc-polym-dexamet ointment.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events were reported as unknown.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Chills and fever are consistent with the known safety profile of the vaccine; Sender's Comments:  MOD-2021-034769:Case for 1st dose of vaccine
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Pyrexia
Clinical narrative: She felt sick; afraid may have this eye issue for rest of life and concern since a school bus driver she may lose her job; right eye is puffy and hurt(painful; right eye is puffy and hurt(painful; Both eyes started to swell.; had chills; fever; A spontaneous report was received from a consumer concerning a 58 years old, female patient who experienced, both eyes swollen(eye swelling), chills, fever(pyrexia), felt sick(malaise), right eye is puffy and hurt(periorbital swelling), right eye is hurt (eye pain), afraid may have this eye issue for rest of life and concern since a school bus driver she may lose her job (fear).  The patient's medical history not included.Concomitant medicine was not reported.No Lab data was reported.   On 24 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number:  011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Feb 2021, her both eyes started to swell, felt sick and had chills and fever. Her right eye was puffy and painful. She also afraid that she may lose job.Treatment for the event include cold compress, Benadryl, neomyc-polym-dexamet ointment.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events were reported as unknown.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Chills and fever are consistent with the known safety profile of the vaccine; Sender's Comments:  MOD-2021-034769:Case for 1st dose of vaccine
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Presyncope, Syncope, Vision blurred
Clinical narrative: Syncope; Flushing; Blurred vision; Felt like is going to pass out; A spontaneous report was received from a pharmacist concerning a 67-year-old, female patient, and experienced syncope, flushing, blurred vision (vision blurred) and felt like she is going to pass out (presyncope).  The patient's medical history, was diabetes type 2, high blood pressure and anxiety. Concomitant medications reported included non specified medications to diabetes type 2, high blood pressure and to anxiety.  On 04 Mar 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced syncope, she was flushing and had blurred vision. She felt like she is going to pass out.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, syncope, flushing, blurred vision (vision blurred) and felt like she is going to pass out (presyncope) were considered as 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: Angina pectoris, Arthralgia, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: angina; difficulty breathing; throat closing; funny taste in mouth; shooting pain in jaw; hotness; joint pain; redness and raised area at injection site; redness and raised area at injection site; pain in arm; A spontaneous report was received from a consumer, a 74 years old female patient who experienced  difficulty breathing/ dyspnea, throat closing / throat tightness, funny taste in mouth / taste disorder, pain in arm / pain in extremity, shooting pain in jaw/ pain in jaw, angina / angina pectoris, joint pain / arthralgia, injection site redness / injection site erythema and raised area at injection site / injection site swelling, and injection site hotness / injection site warmth.  The patient's medical history not included. Products known to have been used by the patient, within two weeks prior to the event, included nitroglycerine.     On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient experienced difficulty breathing, throat closing, funny taste in mouth, pain in arm, shooting pain in jaw, angina, joint pain, redness and raised area at injection site and hotness. Treatment for the events included Benadryl, liquid nitro, aspirin, and inhaler.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events, difficulty breathing, throat closing, pain in arm, angina, joint pain, redness, raised area at injection site, and hotness, were considered recovered. The outcomes of the events, funny taste in mouth and shooting pain in jaw, were considered not recovered.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Arthralgia, Injection site redness and injection site swelling are consistent with the known safety profile of the vaccine
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain in extremity, Pain in jaw, Taste disorder, Throat tightness
Clinical narrative: angina; difficulty breathing; throat closing; funny taste in mouth; shooting pain in jaw; hotness; joint pain; redness and raised area at injection site; redness and raised area at injection site; pain in arm; A spontaneous report was received from a consumer, a 74 years old female patient who experienced  difficulty breathing/ dyspnea, throat closing / throat tightness, funny taste in mouth / taste disorder, pain in arm / pain in extremity, shooting pain in jaw/ pain in jaw, angina / angina pectoris, joint pain / arthralgia, injection site redness / injection site erythema and raised area at injection site / injection site swelling, and injection site hotness / injection site warmth.  The patient's medical history not included. Products known to have been used by the patient, within two weeks prior to the event, included nitroglycerine.     On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient experienced difficulty breathing, throat closing, funny taste in mouth, pain in arm, shooting pain in jaw, angina, joint pain, redness and raised area at injection site and hotness. Treatment for the events included Benadryl, liquid nitro, aspirin, and inhaler.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events, difficulty breathing, throat closing, pain in arm, angina, joint pain, redness, raised area at injection site, and hotness, were considered recovered. The outcomes of the events, funny taste in mouth and shooting pain in jaw, were considered not recovered.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Arthralgia, Injection site redness and injection site swelling are consistent with the known safety profile of the vaccine
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pneumonia
Clinical narrative: pneumonia-like symptoms; lot of pain; A regulatory authority report was received from a consumer concerning a  female patient ( age unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia-like symptoms and was in a lot of pain.  Patient's medical history  was not provided by the reporter. Concomitant medications were not reported. Laboratory details was not given.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient felt pneumonia-like symptoms and a lot of pain. pneumonia like symptoms with medically significant. Treatment for the events were not reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, pneumonia-like symptoms, a lot of pain were considered unknown.; Reporter's Comments: Although a temporal association exist, there is not enough information to assess the causal association as very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Mouth swelling, Palatal swelling, Respiratory tract oedema
Clinical narrative: Roof of mouth swelling; Mouth Swelling; Swelling of Airway; difficulty in Breathing; A spontaneous report was received from a Consumer concerning a herself, 58 years- old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, swelling of airway (respiratory tract oedema), difficulty in breathing (dyspnoea), and  roof of mouth swelling (palatal swelling), and mouth swelling.  The patient's medical history was not provided.   The concomitant medications included verapamil, triamterene, and hydrochlorothiazide  On 27 Jan 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 27 Jan 2021 ,10 minutes after vaccination, the patient developed airway swelling and difficulty breathing. The patient was rushed to the ER, diphenhydramine and epinephrine were given which eventually resolved her symptoms. However, the next day, on 28 Jan 2021, patient noticed that the roof of her mouth was swelling up but resolved after consuming prednisolone as prescribed. Now, patient develops swelling of airways and mouth about 3 hours after any meal. Food allergy source unknown after multiple food allergy test. The events, swelling of airway, difficulty in breathing were also considered medically significant.  No Laboratory investigations were provided.   The Treatment information included Epinephrine, Benadryl and prednisolone.  Action taken with mRNA-1273 in response to the events was unknown.   The events, Swelling of Airway, and Difficulty in Breathing were considered resolved on 27 Jan 2021. The event Roof of mouth swelling was considered resolved on 28 Jan 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: An episode of angioedema; Hives; A spontaneous report was on 05 Mar 2021 received from a consumer concerning, a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives and a second episode of angioedema.   The patient's medical history, as provided by the reporter, included an episode of angioedema after receiving first dose of mRNA-1273. Concomitant products included sertraline hydrochloride 100 milligrams once daily, and zolpidem tartrate 10 milligrams in the evening, diphenhydramine hydrochloride, and cetirizine hydrochloride.   The patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in left arm for prophylaxis of COVID-19 infection on 10 Jan 2021.  On 07 Feb 2021, approximately 13 days prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 20 Feb 2021, approximately 13 days after receiving the second dose of vaccine, the patient experienced hives and a second episode of angioedema. Treatment for the reported events was self-administration of an EpiPen as a treatment.   The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, hives and a second episode of angioedema, 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: Vertigo
Clinical narrative: Vertigo; A spontaneous report was received from a consumer concerning himself, a 70-year-old, male patient who developed vertigo.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 12 Feb 2021, approximately 2 days prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (lot#: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient presented to the emergency room with an extreme case of dizziness, nausea, and the inability to turn head his head left or right. The patient was diagnosed with vertigo and was hospitalized for 2 days. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, vertigo was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Hypoaesthesia
Clinical narrative: Wanted to die; Extreme exhaustion; Slept for 22 hours straight; Fever; Chills; Headache; Tingling in hand, fingers and arm; Numbness in hands and wrist; 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 extreme exhaustion, slept for 22 hours straight, fever, chills, headache, wanted to die, numbness in hands and wrist, tingling in arm fingers and hand.  The patient's medical history was not provided. Concomitant medications as provided by the reporter included vitamins, turmeric and metformin.  On 11 Feb 2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20A) in the left arm for prophylaxis of COVID-19 infection.   On 11 Feb  2021, at 9:00 pm ,the patient experienced extreme exhaustion, slept for 22 hours straight, no appetite but was able to have some cereal, and slept for another 13 hours. She also experienced fever, chills, headache, wanted to die, numbness in hands and wrist, tingling in arm fingers and hand.   Treatment medication included low dose aspirin.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of events fever and chills were  considered as resolved. The outcome of events, numbness in hands and wrist, tingling in arm fingers and hand ,were not resolved. The events extreme exhaustion, slept for 22 hours straight, headache, wanted to die, were considered as 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. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Suicidal ideation
Clinical narrative: Wanted to die; Extreme exhaustion; Slept for 22 hours straight; Fever; Chills; Headache; Tingling in hand, fingers and arm; Numbness in hands and wrist; 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 extreme exhaustion, slept for 22 hours straight, fever, chills, headache, wanted to die, numbness in hands and wrist, tingling in arm fingers and hand.  The patient's medical history was not provided. Concomitant medications as provided by the reporter included vitamins, turmeric and metformin.  On 11 Feb 2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20A) in the left arm for prophylaxis of COVID-19 infection.   On 11 Feb  2021, at 9:00 pm ,the patient experienced extreme exhaustion, slept for 22 hours straight, no appetite but was able to have some cereal, and slept for another 13 hours. She also experienced fever, chills, headache, wanted to die, numbness in hands and wrist, tingling in arm fingers and hand.   Treatment medication included low dose aspirin.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of events fever and chills were  considered as resolved. The outcome of events, numbness in hands and wrist, tingling in arm fingers and hand ,were not resolved. The events extreme exhaustion, slept for 22 hours straight, headache, wanted to die, were considered as 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. Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed Shingles (herpes zoster) approximately 10-12 days after receiving the first  covid-19 vaccine; This is a spontaneous report from a contactable Nurse (Patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL1284), via an unspecified route of administration, in right arm, on 31Dec2020 at 11:00 as SINGLE DOSE for covid-19 immunisation at Hospital. Age at vaccination was 67 years. The patient's medical history included asthma, osteoporosis. Allergies to medications, food, or other products included NSAIDS allergy. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included fluticasone propionate, salmeterol xinafoate (ADVAIR); montelukast sodium (SINGULAIR); omeprazole (PRILOSEC [OMEPRAZOLE]); ergocalciferol (VIT D); Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated "I am a healthy active senior citizen. On 12Jan2021 at 04:00 after the first dose of vaccination the patient developed shingles (herpes zoster) approximately 10-12 days after receiving the first covid-19 vaccine. I did not have a weakened or compromised immune system prior to the first covid-19 vaccination." The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration, in left arm, on 21Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The patient received treatment included Valacyclovir 1 gm PO three times daily for 7 days. Since the vaccination, the patient hasn't been tested for COVID-19. Outcome of the events was not recovered. The events were considered non-serious by the reporter.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Impetigo
Clinical narrative: Shingles to the left side of my face and left eye; Impetigo to my jaw line on both sides of my back and back of my neck/hairline area; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-years-old male patient received bnt162b2 (BNT162B2),(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL1284) dose 2 via an unspecified route of administration, administered in Arm Left on 10Jan2021 as SINGLE DOSE for covid-19 immunisation .Medical history included hypertension from an unknown date and unknown if ongoing , nephrolithiasis from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included potassium citrate (POTASSIUM CITRATE) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; chlorthalidone (CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced shingles to the left side of my face and left eye  on 19Jan2021 15:30 and  impetigo to my jaw line on both sides of my back and back of my neck/hairline area on 19Jan2021 15:30 and The events were considered as non-serious by the other healthcare professional. The outcome of the events was recovered
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: He got the first vaccine dose before Christmas and was checked for antibodies which came back negative; This is a spontaneous report from a contactable physician (patient himself) via a medical information team. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller reports that he thought he would test positive for antibodies after being vaccinated, calling to ask for more information about this as it was not an expected outcome. Question: Caller was a physician, who asks if he should expect to test positive for antibodies after receipt of the first vaccine dose or not. Caller reports that he got the first vaccine dose before Christmas and was checked for antibodies which came back negative on an unspecified date. Caller asks if this was normal and was it because he checked it too soon and asks for any information on antibody testing following vaccination. Used a qualitative total antibody test. Realized after calls end. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had a COVID test done which came back positive for COVID/She had mild symptoms of COVID including runny nose and congestion; had a COVID test done which came back positive for COVID/She had mild symptoms of COVID including runny nose and congestion; This is a spontaneous report from a contactable Other healthcare professional, Dentist (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration on 06Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, this Dentist is the patient. She got her first dose of Pfizer COVID-19 Vaccine on 06Jan2021. On 22Jan2021, more than 2 weeks after that first dose, she contracted COVID. She had a COVID test done which came back positive for COVID. She had mild symptoms of COVID including runny nose and congestion. The second dose of Pfizer COVID-19 Vaccine was scheduled for 27Jan2021 but she heard when you have COVID symptoms you cannot take that second dose so she cancelled that appointment. She has not gotten the second dose of Pfizer COVID-19 vaccine. She called to ask if she can get the second dose of Pfizer COVID-19 Vaccine, and if so how long does she need to wait to get it or schedule it. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: The efficacy of a vaccine varies from patient to patient and can be affected by different factors; however, a contributory role to the reported drug ineffective cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm the day after; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unknown date in Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. The patient experienced soreness in arm the day after vaccination on an unknow date in Jan2021. The seriousness of the event was reported as no. The treatment received for the adverse event was reported as unknown. The outcome of the event was unknown. Prior to vaccination, the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, the patient been tested for COVID-19 was reported as unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 positive RT PCR assay test; I had my first shot of the Pfizer covid vaccine on 15Jan2021, I was diagnosed with covid on 26Jan; This is a spontaneous report from a contactable other hcp. A 58-year-old male patient started to receive bnt162b2 (BNT162B2, Solution for injection, Lot #: EL0142), via an unspecified route of administration from 15Jan2021 to 15Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing Caller says this was diagnosed 20 years ago, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing Caller says this was diagnosed 20 years ago. There were no concomitant medications. On 26Jan2021, the patient experienced i had my first shot of the pfizer covid vaccine on 15jan2021, i was diagnosed with covid on 26jan, On 28Jan2021, covid-19 positive rt pcr assay test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test positive
Clinical narrative: COVID-19 positive RT PCR assay test; I had my first shot of the Pfizer covid vaccine on 15Jan2021, I was diagnosed with covid on 26Jan; This is a spontaneous report from a contactable other hcp. A 58-year-old male patient started to receive bnt162b2 (BNT162B2, Solution for injection, Lot #: EL0142), via an unspecified route of administration from 15Jan2021 to 15Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing Caller says this was diagnosed 20 years ago, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing Caller says this was diagnosed 20 years ago. There were no concomitant medications. On 26Jan2021, the patient experienced i had my first shot of the pfizer covid vaccine on 15jan2021, i was diagnosed with covid on 26jan, On 28Jan2021, covid-19 positive rt pcr assay test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.