chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: U
Vaccine: HEP
Symptoms: Bell's palsy, Ear pain, Facial paralysis
Clinical narrative: Bell's Palsy; Initial Report Received on 02-Dec-2020  A patient who is registered nurse reported that she, a 60 year-old female (race and ethnicity not provided), had received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed Bell's Palsy.  The patient declined to share her medical history and shared that she was not sick.  No concomitant medications were reported.  At the end of Sep-2020, the patient received her first and only dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) from a medical office.  About 30 days later, the patient began having ear pain and facial paralysis to the left side of her face. She previously had the ENGERIX-B series but did not show immunity when tested. The patient was working and taking care of her parents prior to developing Bell's palsy. The patient received medication but did not share what medications that she had since completed. At the time of report, she was receiving acupuncture treatments to tone her facial muscle.  No additional information was reported. An attempt was made by Medical Information to obtain the lot number, expiration and serial number from the medical office clinic but was referred to medical records instead. No information was received regarding the company's request to follow-up with the medical records department.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); Swollen / in the arm (site of injection); Redness in the arm (site of injection); General discomfort; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 12 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160: US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210166: US-GLAXOSMITHKLINE-US2020208660:same reporter
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Computerised tomogram abdomen abnormal, Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: hemorrhoid pain; bloody diarrhea; severe diarrhea; Nausea; abdominal pain; shaking chills; Severe leg cramps; A spontaneous report was received from a 62 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe leg cramps, severe diarrhea, nausea, abdominal pain, shaking chills, hemorrhoid pain and the serious event of bloody diarrhea.  The patient's medical history included diverticulitis.  No relevant concomitant medications were reported.  On 22 Dec 2020, about 4pm, the patient received their first of two planned doses of mRNA-1273 (Lot #011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22 Dec 2020, around 7pm, the patient experienced severe leg cramps.    On 23 Dec 2020, she experienced severe diarrhea, nausea, abdominal pain, shaking chills and bloody diarrhea. Treatment for nausea was ondansetron.    On 24 Dec 2020, the patient experienced terrible hemorrhoid pain and abdominal pain. On 25 Dec 2020, the patient went to the emergency room where she received a computed tomography scan. The computed tomography scan of  the lower abdomen showed that earlier diagnosis of diverticulitis 27 Nov 2020 "inflammation" had gotten better.    Action taken with mRNA-1273 in response to the events were not reported.  The outcome for events, severe leg cramps, severe diarrhea, nausea, abdominal pain, shaking chills, bloody diarrhea and hemorrhoid pain, were unknown.; Reporter's Comments: This case concerns a 62-year-old female patient with medical history of diverticulitis, who received their first of two planned doses of mRNA-1273 (Lot 011J20A), and who experienced the serious unlisted event of bloody diarrhea, the non-serious listed events of nausea and chills, and the non-serious unlisted events of severe leg cramps, severe diarrhea, abdominal pain, and hemorrhoid pain.  Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  The patient's history of diverticulitis is noted.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhoids, Muscle spasms, Nausea, Pain, Tremor
Clinical narrative: hemorrhoid pain; bloody diarrhea; severe diarrhea; Nausea; abdominal pain; shaking chills; Severe leg cramps; A spontaneous report was received from a 62 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe leg cramps, severe diarrhea, nausea, abdominal pain, shaking chills, hemorrhoid pain and the serious event of bloody diarrhea.  The patient's medical history included diverticulitis.  No relevant concomitant medications were reported.  On 22 Dec 2020, about 4pm, the patient received their first of two planned doses of mRNA-1273 (Lot #011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22 Dec 2020, around 7pm, the patient experienced severe leg cramps.    On 23 Dec 2020, she experienced severe diarrhea, nausea, abdominal pain, shaking chills and bloody diarrhea. Treatment for nausea was ondansetron.    On 24 Dec 2020, the patient experienced terrible hemorrhoid pain and abdominal pain. On 25 Dec 2020, the patient went to the emergency room where she received a computed tomography scan. The computed tomography scan of  the lower abdomen showed that earlier diagnosis of diverticulitis 27 Nov 2020 "inflammation" had gotten better.    Action taken with mRNA-1273 in response to the events were not reported.  The outcome for events, severe leg cramps, severe diarrhea, nausea, abdominal pain, shaking chills, bloody diarrhea and hemorrhoid pain, were unknown.; Reporter's Comments: This case concerns a 62-year-old female patient with medical history of diverticulitis, who received their first of two planned doses of mRNA-1273 (Lot 011J20A), and who experienced the serious unlisted event of bloody diarrhea, the non-serious listed events of nausea and chills, and the non-serious unlisted events of severe leg cramps, severe diarrhea, abdominal pain, and hemorrhoid pain.  Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  The patient's history of diverticulitis is noted.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; A spontaneous report was received from a 28 year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a urinary tract infection (UTI).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 21 Jan 2021, a day prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number 02AL20A) intramuscularly in the left arm for COVID-19 infection prophylaxis.   On 22 Jan 2021, the patient reported that she had experienced a UTI. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, UTI was unknown.; Reporter's Comments: This case concerns a 28 year-old female patient, who experienced a serious unexpected event of urinary tract infection. The event of urinary tract infection occurred 2 days after first dose of mRNA-1273, lot # 02AL20A.  Treatment was not reported. 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness, Malaise, Pyrexia
Clinical narrative: Experienced symptoms of Benign Paroxysimal Postural Vertigo or BPPD; Malaise; Felt like mild flu; Swelling; Joint Pain; Fatigue; Feeling feverish; A spontaneous report was received from a consumer concerning a 74-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysmal, postural vertigo or BPPD.   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 Acetaminophen, Losartan, Hydrochlorothiazide, and Trazadone.  On 11 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 026I20A) intramuscularly in the right arm deltoid for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysimal, postural vertigo or BPPD.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish, and experienced symptoms of benign paroxysmal, postural vertigo or BPPD was not reported; Reporter's Comments: This spontaneous report concerns a 74-years-old, female patient who experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysmal, postural vertigo or BPPD. The events occurred 3 days after the administration of the first dose of mRNA 1273 (lot number 026l20A, expiration date unknown).  No treatment information was provided, and outcome is Unknown.  Fever, fatigue and joint pain are consistent with the known safety profile of the mRNA-1273 vaccine and based on the current available information and temporal association between the use of the mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vertigo positional
Clinical narrative: Experienced symptoms of Benign Paroxysimal Postural Vertigo or BPPD; Malaise; Felt like mild flu; Swelling; Joint Pain; Fatigue; Feeling feverish; A spontaneous report was received from a consumer concerning a 74-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysmal, postural vertigo or BPPD.   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 Acetaminophen, Losartan, Hydrochlorothiazide, and Trazadone.  On 11 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 026I20A) intramuscularly in the right arm deltoid for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysimal, postural vertigo or BPPD.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish, and experienced symptoms of benign paroxysmal, postural vertigo or BPPD was not reported; Reporter's Comments: This spontaneous report concerns a 74-years-old, female patient who experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysmal, postural vertigo or BPPD. The events occurred 3 days after the administration of the first dose of mRNA 1273 (lot number 026l20A, expiration date unknown).  No treatment information was provided, and outcome is Unknown.  Fever, fatigue and joint pain are consistent with the known safety profile of the mRNA-1273 vaccine and based on the current available information and temporal association between the use of the mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin abnormal, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: Presumed miscarriage; human chorionic gonadotropin decreased; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced vaccine exposure during pregnancy, human chorionic gonadotropin decreased and presumed miscarriage.  The patient's medical history was not provided. The patient's prior history of pregnancies were two miscarriages (2013 and 2015) and two full term births (2017 and 2019) were reported. The patient's last menstrual period was 25 Nov 2021. The estimated due date was 1 Sep 2021. Concomitant medications included sertraline hydrochloride and vitamins.  On 27 Dec 2020, the patient found out she was pregnant, but she already had some bleeding.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On undisclosed date, after receiving the vaccine her human chorionic gonadotropin (hCG) levels went down to 0. Her health care professional presumed it was a miscarriage. Treatment for the event was not reported.  On 19th Jan 2021, her hCG levels started to climb back up again.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, presumed miscarriage, and human chorionic gonadotropin decreased was unknown. The outcome of the event, vaccine exposure during pregnancy, was resolved on 28 Dec 2020.; Reporter's Comments: This spontaneous report concerns a 31-years-old, G5P2 female patient who experienced vaccine exposure during pregnancy and presumed miscarriage. The patient's last menstrual period was 25-Nov-2020 with estimated date of delivery as 01-Sep-2021. One day after the patient discovered she was pregnant; she received the first dose of mRNA-1273 vaccine (lot # 026L20A expiration date unknown). The event of presumed miscarriage (human chorionic gonadotropin (hCG) levels went down to 0) was diagnosed on an unknown date after vaccine administration.  The HCG level began to climb up again 22 days after the vaccine administration. Based on the information provided which includes, the patient's obstetric history, vaginal bleeding the day prior to mRNA-1273 vaccination and without definitive confirmation of pregnancy loss, there is not enough evidence to assess that that there was a miscarriage and is also unlikely to be associated with mRNA-1273 administration. The event of vaccine exposure during pregnancy is considered not applicable
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFIB; A spontaneous report was received from a nurse concerning a 71-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced AFIB (Atrial fibrillation).  The patient's medical history including COVID-19. Concomitant product use was not provided.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient was hospitalized for two days with atrial fibrillation. The patient received Cardizem IV, converted back to sinus rhythm and discharged home two days later on Lopressor PO.   Treatment for the event included Cardizem IV and Lopressor PO.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event AFIB was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of atrial fibrillation. This event occurred 1 days after first dose of mRNA-1273, lot # 013L20A.  Treatment included Cardizem iv and Lopressor po. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram ambulatory, Loss of consciousness, Pain in extremity, Presyncope
Clinical narrative: Passed out-was totally out for a couple of second; UTI; PVCs; very very dizzy; Vasovagal reaction; Arm was sore-not hurting much; A spontaneous report was received from a 74-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain.   The patient's medical history included back problems with osteoarthritis in the spinal column neck and lower back. Products known to have been used by the patient, within two weeks prior to the event, included celecoxib and nortriptyline.   On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient reported she got very dizzy and passed out. Her husband relays that she was totally out for a couple of seconds. She went to the emergency room and was diagnosed with a vasovagal reaction and urinary tract infection. Premature ventricular contractions were also discovered and was not known prior to this event. Patient reports a normal blood pressure of 114-120/75. Patient also stated her arm was sore the day after vaccine but not hurting much during her usual four mile walk.   Treatment for the event included intravenous medications in the emergency room, cephalexin, and a heart monitor.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events passed out, dizziness, vasovagal reaction and arm pain were resolved. The outcome of the events, urinary tract infection and premature ventricular contractions were unknown.; Reporter's Comments: This case concerns a 74 year-old, female patient, who experienced events of dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain.  The events occurred the next day after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.  Further information have been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Ventricular extrasystoles
Clinical narrative: Passed out-was totally out for a couple of second; UTI; PVCs; very very dizzy; Vasovagal reaction; Arm was sore-not hurting much; A spontaneous report was received from a 74-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain.   The patient's medical history included back problems with osteoarthritis in the spinal column neck and lower back. Products known to have been used by the patient, within two weeks prior to the event, included celecoxib and nortriptyline.   On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient reported she got very dizzy and passed out. Her husband relays that she was totally out for a couple of seconds. She went to the emergency room and was diagnosed with a vasovagal reaction and urinary tract infection. Premature ventricular contractions were also discovered and was not known prior to this event. Patient reports a normal blood pressure of 114-120/75. Patient also stated her arm was sore the day after vaccine but not hurting much during her usual four mile walk.   Treatment for the event included intravenous medications in the emergency room, cephalexin, and a heart monitor.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events passed out, dizziness, vasovagal reaction and arm pain were resolved. The outcome of the events, urinary tract infection and premature ventricular contractions were unknown.; Reporter's Comments: This case concerns a 74 year-old, female patient, who experienced events of dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain.  The events occurred the next day after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.  Further information have been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; A spontaneous report was received from a nurse concerning a 91-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died two days later.  The patient's medical history included dementia.  Concomitant medications reported included paracetamol.  On 21 Jan 2021, approximately two days prior to her death, the patient received the first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient died.  The nurse reporting the event stated that the patient's death was considered as due to "natural causes" and that she was not aware of any new-onset symptoms of illness prior to the patient's death.  The patient was described as "fragile" and was under hospice care at the time of her death.  An autopsy was not performed.  Action taken with the drug in response to the event is not applicable.  The patient died on 23 Jan 2021. The cause of death was natural cause of death related to dementia. Autopsy was not performed.; Reporter's Comments: This case concerns a 91-years-old female patient, with medical history of dementia, who experienced a serious unexpected event of death. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. At the time of death, the subject was very fragile and was in hospice care. Concomitant medication included Tylenol. Treatment details were not provided. The doctor considered that the death was due to natural causes. However, autopsy was not performed. Very limited information regarding this event has been provided at this time.  Based on the limited information available, it is difficult to assess a cause and effect relationship. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Natural cause of death related to dementia
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Neuropathy peripheral
Clinical narrative: Neuropathy in the finger / Neuropathy in the right arm; chills; Nausea; Headache; A spontaneous report  received from a consumer concerning a 73-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced chills, nausea, headache, neuropathy in the finger and right arm.  The patient's medical history was not provided. Concomitant medications reported included rosuvastatin and eye drop.  On 16 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced chills, nausea and headache, all of which resolved within 36 hours on 18 Jan 2021. She took 3 Tylenol, and a Zomig to help with the symptoms.  On 24 Jan 2021, the patient began to experience neuropathy in her finger and right arm, which she reported as it was getting worse.    Action taken with mRNA-1273 in response to the events was not reported.  The events, chills, nausea and headache, were considered resolved on 18 Jan 2021. The outcomes of the events, neuropathy in the finger / neuropathy in the right arm  were unknown.; Reporter's Comments: This spontaneous report concerns a 73-year-old female patient who experienced a serious event of neuropathy in the right finger and non-serious events of chills, nausea and headache. The events of chills, nausea and headache occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). Neuropathy occurred 8 days after the administration of mRNA-1273 vaccine. Treatment administered included Tylenol and Zomig for chills, nausea and headache with resolution.  The events of chills, nausea and headache are consistent with the safety profile for mRNA-1273 vaccine.  Based on the information provided, including temporal association and in the absence of any other etiology, a causal association cannot be excluded for all reported events. Causality for the event of neuropathy is also confounded by the patient's advanced age.  Main field defaults to possibly related'
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Chest pain, Cough, Dyspnoea
Clinical narrative: Anaphylactic reaction; A spontaneous report was received from a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction.  The patient's medical history, as reported, included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome.  On 24 Jan 2021, about 15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 24 Jan 2021, 30 minutes prior to receiving the vaccine, the patient took prednisone (dose unknown), per instructions from her doctor due to her history of anaphylactic reactions. She did notify the vaccinators of her history and there was an ambulance present. About 15 minutes after receiving the vaccine, the patient started coughing, had heavy chest pain, trouble breathing, and felt like her throat was constricting more than usual. No rash developed. She approached the ambulance and asked if she could take diphenhydramine. She took one dose, followed by 3 other doses, and felt a bit better. Consent given for Safety to follow up with patient.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, anaphylactic reaction was resolving at the time of this report.; Reporter's Comments: This case concerns a 62 year old female patient with medical history of included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. She experienced a serious unexpected event of Anaphylactic reaction that needed treatment diphenhydramine. The event occurred approximately 15 minutes after first dose of the study medication administration even thought the patient took prednisone prior to receiving the vaccine. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Anaphylactic reaction; A spontaneous report was received from a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction.  The patient's medical history, as reported, included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome.  On 24 Jan 2021, about 15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 24 Jan 2021, 30 minutes prior to receiving the vaccine, the patient took prednisone (dose unknown), per instructions from her doctor due to her history of anaphylactic reactions. She did notify the vaccinators of her history and there was an ambulance present. About 15 minutes after receiving the vaccine, the patient started coughing, had heavy chest pain, trouble breathing, and felt like her throat was constricting more than usual. No rash developed. She approached the ambulance and asked if she could take diphenhydramine. She took one dose, followed by 3 other doses, and felt a bit better. Consent given for Safety to follow up with patient.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, anaphylactic reaction was resolving at the time of this report.; Reporter's Comments: This case concerns a 62 year old female patient with medical history of included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. She experienced a serious unexpected event of Anaphylactic reaction that needed treatment diphenhydramine. The event occurred approximately 15 minutes after first dose of the study medication administration even thought the patient took prednisone prior to receiving the vaccine. 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood glucose increased, Condition aggravated, Feeling abnormal, Heart rate increased
Clinical narrative: Afib; Feeling uncomfortable; Blood sugar was around 150, which is higher than her normal levels; A spontaneous report was received from a consumer who is 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced atrial fibrillation, feeling uncomfortable, and increased blood sugar.  The patient's medical history included diabetes and atrial fibrillation. Concomitant medications were not reported.  On 02 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 025LZ0A) intramuscularly in her right arm for the prophylaxis of COVID-19 infection.  On 02 Jan 2021, the patient experienced heart beating very fast and feeling uncomfortable; it lasted for a few hours. She stated it was atrial fibrillation, she had a diagnosis of this, and it only lasted a few hours. The patient also stated that her blood glucose was 150, which was higher than normal.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, increased blood sugar, was considered not resolved. The outcome of the events, atrial fibrillation and feeling uncomfortable, was considered resolved.; Reporter's Comments: This case concerns a 76 year-old female patient with a significant medical history of atrial fibrillation and diabetes, who experienced a serious unexpected event of Atrial fibrillation and non-serious unexpected events of Discomfort and Blood glucose increased. The events occurred one day (same day) after first dose of mRNA-1273, lot # 025LZ0A. Treatment was not reported. 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. However, patient's medical history of atrial fibrillation and diabetes were considered strong confounders.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Dizziness postural, Hyperhidrosis
Clinical narrative: felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse.  A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Pallor, Palpitations, Presyncope
Clinical narrative: felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse.  A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse.  A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: had been running a temperature of 99.5 to 101; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female non-pregnant patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 3249 and expiry date unknown) via unspecified route of administration at the left arm on 11Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. The patient has no covid prior vaccination. Concomitant medication included losartan and vitamin; both from unspecified date for unspecified indication. The patient previously took vancomycin and Keftab; both experienced allergies. The patient had no other vaccine in four weeks. The patient had been running a temperature of 99.5 to 101 since Monday 11Jan2021 during the night (also reported as 11Jan2021 12:00 AM). The patient was not covid tested post vaccination. The patient did not receive treatment due to the event. The outcome of the event had been running a temperature of 99.5 to 101 was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Off label use, Pain of skin, Product use issue
Clinical narrative: skin on her face feels burnt and sore to touch; skin on her face feels burnt and sore to touch; Bad headache; medical history:  lupus anticoagulant positive; medical history:  lupus anticoagulant positive; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via intramuscular route of administration on 19Jan2021 at 12:00 at a single dose in the arm left for COVID-19 immunization. The patient's medical history included high blood pressure, hypothyroidism, depression, lupus anticoagulant positive, and anemia. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), verapamil, apixaban (ELIQUIS), montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID) , ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC), hydrocodone bitartrate, paracetamol (NORCO). The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and acetylsalicylic acid (ASPIRIN) and experienced allergies. The patient also previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 ) on 29Dec2020 at 08:00 pm, via intramuscular route in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Jan2021 at 19:00, the patient stated that her skin on her face feels burnt and sore to touch without any redness or signs of injury and had a bad headache. The patient did not receive any treatment for the reported events skin on her face feels burnt and sore to touch and bad headache. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient has not recovered from the events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This is a spontaneous report from a contactable consumer, the patient. This 72-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EH9899, Expiration date: 31Mar2021), first dose, via an unspecified route of administration in the left arm on 28Dec2020 at 09:30 (at 72-years-old) as a single dose for COVID-19 vaccination. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included famotidine (FAMOTIDINE), tiotropium bromide (SPIRIVA), latanoprost (LATANOPROST), timolol (TIMOLOL) and loratadine (LORATADINE). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the patient experienced arm hurt. The event did not require a visit to physician or ER. The outcome of the event arm hurt was resolved on 29Dec2020.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Lymphadenopathy, Myalgia
Clinical narrative: Chills; Muscle pain remote from injection site; Headache; Painful lymphadenopathy (left axilla); Administration date=19Jan2021, dose number=2/ Administration date=21Dec2020, dose number=1; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular on 19Jan2021 at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. Patient has no known allergies. Concomitant medication included atorvastatin and lisinopril. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 21Dec2020 at a single dose on left arm for COVID-19 immunization. The patient experienced chills, muscle pain remote from injection site, headache, and painful lymphadenopathy (left axilla) on 20Jan2021. No treatment received for events. The outcome of the events was recovering. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Myalgia, Vaccination site discolouration
Clinical narrative: Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); This is a spontaneous report from a contactable physician (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3283), via an unspecified route of administration on 20Jan2021 at a single dose on Right deltoid for COVID-19 immunization. Medical history included Chronic lymphocytic leukemia with 65% of cells lymph's, low WBC count (13500) otherwise; DM2, A1C usually close to 6.1; HTN. Unspecified concomitant medication taken. The patient previously took nickel and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9331), intramuscular on 31Dec2020 12:15 PM at a single dose on left arm for COVID-19 immunization. The patient experienced chills, rigors, wheezing, shortness of breath, local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop), cough, myalgias on 20Jan2021 23:30. Therapeutic measures were taken as a result of the events which included Benadryl, Aleve, Nebulizer treatment, change in local temperature to help stop rigors. The outcome of the events was recovering. No other vaccine in four weeks. The patient was not pregnant. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.