chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: sepsis regarding to a cancer; A spontaneous report was received from a consumer concerning an unknown aged female patient.  Medical history included unspecified cancer  No relevant concomitant medication was reported.  On 11Jan2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  On 10 Feb2021, the patient was hospitalized due to sepsis regarding a cancer.  No treatment was reported.  Action taken with the mRNA-1273 was not reported.  The outcome of the event, sepsis, was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. However, patient's medical history of unspecified cancer is a confounding factor that may play a possible contributory role.  Further information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old patient received the first dose of Moderna Covid-19 vaccine; A spontaneous report received from a pharmacist concerning, 17-year-old female patient who has received the first dose of Moderna COVID-19 vaccine    The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown.    On 01-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Reporter stated that a 17 year-old patient received the vaccine. No further information was provided. Treatment information was not provided/ unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.    The outcome of the event was considered resolved on 01 Feb 2021.; Reporter's Comments: This is a case of 17-year-old female patient who was administered mRNA-1273 (product administered to patient of inappropriate age) (Batch #: unknown). There was no associated adverse event reported  for the event of product administered to patient of inappropriate age.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Received dose in tricep; A spontaneous report received from other Health Professional concerning, unkown age and unknown gender patient who received dose of Moderna COVID-19 vaccine in tricep.   The patient's medical history was not included. Patient's concomitant was not included.    On unknown date, the patient received their unknown of two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Consumer called in stated that patient received dose of the Moderna COVID-19 vaccine in their tricep.   Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: scheduled his 2nd dose on 17March2021 and he knows that's way passed 42 days; A spontaneous report was received from a consumer of unknown age on 11 FEB 2021 stating that he received his 1st Moderna vaccine on 21Jan2021 through the department of health at Goldsboro, North Carolina. They didn't schedule his 2nd dose until 10 FEB 2021. They called him on 10 FEB 2021 and scheduled his 2nd dose on 17 March2021. He knows that's way past 42 days, so he wants to know if that'd still be effective and if he needs to start over the vaccine series.   Patient's medical history was not provided. Action taken with mRNA-1273 was not reported. The outcome of the event was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 with no associated AEs.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Dizziness, Hallucination, Headache
Clinical narrative: axillary lymph node was the size of a golf ball; fever of 101.6 then 102.2; hallucinations; dizziness; confusion; severe headache; body aches; nausea; vomiting; A spontaneous report was received from a healthcare professional concerning a 47 years-old, female patient who experienced hallucinations/MedDRA PT: hallucination, confusion/MedDRA PT: confusion, dizziness/MedDRA PT: dizziness, severe headache/MedDRA PT: headache, body aches/MedDRA PT: myalgia, fever of 101.6 then 102.2/MedDRA PT: pyrexia, nausea/MedDRA PT: nausea, vomiting/MedDRA PT: vomiting, and axillary lymph node was the size of a golf ball/MedDRA PT: vaccination site lymphadenopathy.  The patient's medical history was not provided. Concomitant product use included levothyroxine, lisinopril, metformin, liraglutide, atorvastatin, furosemide, famotidine, cetirizine hydrochloride and vitamins NOS.  The patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) on 07 Jan 2021. On 03 Feb 2021 at 4:00pm, approximately 4 and a half hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot # not provided) intramuscularly, in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 03 Feb 2021 at approximately 8:30pm, the patient began to experience severe headache and body aches. By midnight, the patient had a fever of 101.6 then 102.2 which was the highest reading.  The patient experienced nausea and vomiting for 36 hours and couldn't keep food down.  On Thursday (04 Feb 2021), patient had dizziness, confusion and hallucinations - patient had a conversation with spouse who was not at home. Patient's axillary lymph node was the size of a golf ball. Patient took Tylenol at the 25 hour mark once symptoms began which was about 5:00pm on Thursday. By Friday night (05 Feb 2021) patient was able to keep food down. By Sunday (07 Feb 2021) the patient felt 85% better. The patient still had axillary lymph node swelling but reported 90% improvement. Patient had ongoing headaches at the time of this report for which Tylenol is taken daily.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The event severe headache was not resolved. The events hallucinations, confusion, dizziness, body aches, fever of 101.6 then 102.2, nausea, vomiting, and and axillary lymph node was the size of a golf ball were resolving.; Reporter's Comments: This case concerns a 47-year-old female with serious expected Hallucinations, NS unexpected confusion, dizziness and NS expected fever, headache, myalgia, nausea, vomiting, vaccination site lymphadenopathy.  Event onset 29 days after first dose and 4 hours after second dose mRNA-1273. Treatment with Tylenol. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site lymphadenopathy, Vomiting
Clinical narrative: axillary lymph node was the size of a golf ball; fever of 101.6 then 102.2; hallucinations; dizziness; confusion; severe headache; body aches; nausea; vomiting; A spontaneous report was received from a healthcare professional concerning a 47 years-old, female patient who experienced hallucinations/MedDRA PT: hallucination, confusion/MedDRA PT: confusion, dizziness/MedDRA PT: dizziness, severe headache/MedDRA PT: headache, body aches/MedDRA PT: myalgia, fever of 101.6 then 102.2/MedDRA PT: pyrexia, nausea/MedDRA PT: nausea, vomiting/MedDRA PT: vomiting, and axillary lymph node was the size of a golf ball/MedDRA PT: vaccination site lymphadenopathy.  The patient's medical history was not provided. Concomitant product use included levothyroxine, lisinopril, metformin, liraglutide, atorvastatin, furosemide, famotidine, cetirizine hydrochloride and vitamins NOS.  The patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) on 07 Jan 2021. On 03 Feb 2021 at 4:00pm, approximately 4 and a half hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot # not provided) intramuscularly, in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 03 Feb 2021 at approximately 8:30pm, the patient began to experience severe headache and body aches. By midnight, the patient had a fever of 101.6 then 102.2 which was the highest reading.  The patient experienced nausea and vomiting for 36 hours and couldn't keep food down.  On Thursday (04 Feb 2021), patient had dizziness, confusion and hallucinations - patient had a conversation with spouse who was not at home. Patient's axillary lymph node was the size of a golf ball. Patient took Tylenol at the 25 hour mark once symptoms began which was about 5:00pm on Thursday. By Friday night (05 Feb 2021) patient was able to keep food down. By Sunday (07 Feb 2021) the patient felt 85% better. The patient still had axillary lymph node swelling but reported 90% improvement. Patient had ongoing headaches at the time of this report for which Tylenol is taken daily.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The event severe headache was not resolved. The events hallucinations, confusion, dizziness, body aches, fever of 101.6 then 102.2, nausea, vomiting, and and axillary lymph node was the size of a golf ball were resolving.; Reporter's Comments: This case concerns a 47-year-old female with serious expected Hallucinations, NS unexpected confusion, dizziness and NS expected fever, headache, myalgia, nausea, vomiting, vaccination site lymphadenopathy.  Event onset 29 days after first dose and 4 hours after second dose mRNA-1273. Treatment with Tylenol. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 90% of the vaccine leaked onto arm/ Did not get a full second dose; A spontaneous report was received from a  Consumer concerning a 28-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 90% of the vaccine leaked onto arm/ Did not get a full second dose (incomplete dose administered).    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14Jan2021 the patient received first dose of the Moderna Covid-19 vaccine (2:30PM). It was administered on her left arm prophylaxis of COVID-19 infection with unknown dose and route of administration. Lot number 011L20A, unknown expiration date.  On 11Feb2021, the patient had her 2nd dose of the Moderna Covid-19 vaccine (3:00PM) at a local hospital. She had it on her left arm with unknown route of administration. Lot number 0B2L20A, expiration date was unknown.  During the administration of the 2nd dose, the 90% of the vaccine leaked on to her arm.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was resolved on 11 Feb 2021.; Reporter's Comments: This is a case of 28-year-old female patient who was administered second dose of mRNA-1273 vaccine and experienced 90% of the vaccine leaked on to arm (incomplete dose administered) Lot #: 11L20A. There was no associated adverse event reported for the event of incomplete dose administered.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Resident received the 1st dose of the Moderna vaccine on 05 Feb 2021. She got the second dose today.; A spontaneous report was received from a nurse concerning an 83-years-old, female patient who experienced inappropriate schedule of product administration (resident received the 1st dose of the Moderna vaccine on 05 Feb 2021. She got the second dose today.)    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 [Lot number 010M20A] on 05 Feb 2021.  On 11 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 [Lot number 030M230A] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Feb2021, the patient received her 2nd dose only six days after her first dose was administered. She reports no side effects from the 1st dose. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event resident received the 1st dose of the Moderna vaccine on 05 Feb 2021. She got the second dose today was considered recovered/resolved on 11 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #030M230A for second dose) with no associated AEs reported. Patient received second dose six days after the first dose.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: patient was given 1ml dose in one setting instead of .5ML; A spontaneous report was received from a physician concerning a patient who experienced accidental overdose (patient was given 1ml dose in one setting instead of .5ML).    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 10 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 030M30A) intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, the patient was given 1 mL dose in one setting instead of .5 mL. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event patient was given 1ml dose in one setting instead of .5ML was unknown.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Administered dose of vial that wasn't thawed as recommended; A spontaneous report was received from a consumer concerning a male patient who experienced product preparation issue (administered dose of vial that wasn't thawed as recommended).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient reported that the pharmacist took the vial out and injected him immediately instead of waiting 15 minutes to administer. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event administered dose of vial that wasn't thawed as recommended was unknown.; Reporter's Comments: This report refers to a case of  product preparation issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Nausea
Clinical narrative: headache; nausea; left the vaccine out for longer than 6 hours after the vial was punctured; A spontaneous report  was received from a consumer who was a 53-year-old, female patient, who was administered Moderna's COVID-19 vaccine and the patient received first dose more than six hours after vial was punctured/expired product administered, and had headache and nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 FEB 2021, the patient received her second dose of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.   The patient's doctor told her that she received a non-effective first dose of the vaccine because the doctor left the vaccine out for longer than the six hours after the vial was punctured which was on 14 JAN 2021. The patient returned to the healthcare professional for second dose and she was informed her first dose might had been invalid/ineffective. On 11 FEB 2021, the patient experienced headache and nausea. The treatment included ondansetron as an indication for nausea on 12 FEB 2021 in the morning (am).  The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable.  The outcome of event, received first dose more than six hours after vial was punctured was considered as resolved on 14 JAN 2021. The outcome of the events, headache and nausea were considered as unknown.; Reporter's Comments: This case concerns a 53-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Expired product administered. Additionally, the patient experienced headache and nausea after receiving their second of two planned doses of mRNA-1273 (Lot number: 029L20A). Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Electrocardiogram, Feeling cold, Feeling hot, Full blood count
Clinical narrative: felt like crap; became hot; left hand suddenly started jerking and left hand was having spasms; Vasovagal Syncope, Post Immunization Reaction; became cold; sweaty; sore arm; achy; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasovagal syncope, post immunization reaction (syncope vasovagal).  The patient's medical history, as provided by the reporter, included chronic cough, acid reflux, minor allergies, hypercholesterolemia and a penicillin allergy.  Concomitant product use included esomeprazole, atorvastatin, famotidine, cetirizine, Montelukast, Vitamin D, zinc, fiber pills and antacids.   On 10 Feb 2021, several hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #:030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  After the injection in the evening on 10 Feb 2021, the patient reported experiencing a sore arm. During the night, he became cold, sweaty and achy.  On 11 Feb 2021, the patient stated he "felt like crud" and was still achy and his left arm hurt more.  The patient sat down at the table and again became "hot" and "sweaty." His left hand suddenly started jerking and having spasms, and the patient's head went back and then forward and he became unresponsive for approximately 2 to 3 minutes. After the episode, he went to a sofa chair and fell asleep for 1 to 1.5 hours.  The patient's wife called a nurse at the Hospital to report the events, and the nurse suggested to take him to the emergency room (ER) immediately.  At the ER, a series of tests/labs were performed including complete blood count (CBC) differential with platelets, COVID-19 test, cardiac panel-acute, comprehensive metabolic panel, electrocardiogram (EKG), and chest x-ray.  All test results were normal.  The patient's COVID-19 test was negative.  Treatment for the event included IV fluids (sodium chloride IV). The patient was discharged from the ER 2 to 3 hours after treatment with a discharge diagnosis of "vasovagal syncope, post immunization reaction."  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event, vasovagal syncope, post immunization reaction, was considered recovered/resolved.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Metabolic function test, Muscle spasms, Myalgia
Clinical narrative: felt like crap; became hot; left hand suddenly started jerking and left hand was having spasms; Vasovagal Syncope, Post Immunization Reaction; became cold; sweaty; sore arm; achy; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasovagal syncope, post immunization reaction (syncope vasovagal).  The patient's medical history, as provided by the reporter, included chronic cough, acid reflux, minor allergies, hypercholesterolemia and a penicillin allergy.  Concomitant product use included esomeprazole, atorvastatin, famotidine, cetirizine, Montelukast, Vitamin D, zinc, fiber pills and antacids.   On 10 Feb 2021, several hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #:030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  After the injection in the evening on 10 Feb 2021, the patient reported experiencing a sore arm. During the night, he became cold, sweaty and achy.  On 11 Feb 2021, the patient stated he "felt like crud" and was still achy and his left arm hurt more.  The patient sat down at the table and again became "hot" and "sweaty." His left hand suddenly started jerking and having spasms, and the patient's head went back and then forward and he became unresponsive for approximately 2 to 3 minutes. After the episode, he went to a sofa chair and fell asleep for 1 to 1.5 hours.  The patient's wife called a nurse at the Hospital to report the events, and the nurse suggested to take him to the emergency room (ER) immediately.  At the ER, a series of tests/labs were performed including complete blood count (CBC) differential with platelets, COVID-19 test, cardiac panel-acute, comprehensive metabolic panel, electrocardiogram (EKG), and chest x-ray.  All test results were normal.  The patient's COVID-19 test was negative.  Treatment for the event included IV fluids (sodium chloride IV). The patient was discharged from the ER 2 to 3 hours after treatment with a discharge diagnosis of "vasovagal syncope, post immunization reaction."  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event, vasovagal syncope, post immunization reaction, was considered recovered/resolved.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, SARS-CoV-2 test, Syncope, Vaccination site pain
Clinical narrative: felt like crap; became hot; left hand suddenly started jerking and left hand was having spasms; Vasovagal Syncope, Post Immunization Reaction; became cold; sweaty; sore arm; achy; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasovagal syncope, post immunization reaction (syncope vasovagal).  The patient's medical history, as provided by the reporter, included chronic cough, acid reflux, minor allergies, hypercholesterolemia and a penicillin allergy.  Concomitant product use included esomeprazole, atorvastatin, famotidine, cetirizine, Montelukast, Vitamin D, zinc, fiber pills and antacids.   On 10 Feb 2021, several hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #:030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  After the injection in the evening on 10 Feb 2021, the patient reported experiencing a sore arm. During the night, he became cold, sweaty and achy.  On 11 Feb 2021, the patient stated he "felt like crud" and was still achy and his left arm hurt more.  The patient sat down at the table and again became "hot" and "sweaty." His left hand suddenly started jerking and having spasms, and the patient's head went back and then forward and he became unresponsive for approximately 2 to 3 minutes. After the episode, he went to a sofa chair and fell asleep for 1 to 1.5 hours.  The patient's wife called a nurse at the Hospital to report the events, and the nurse suggested to take him to the emergency room (ER) immediately.  At the ER, a series of tests/labs were performed including complete blood count (CBC) differential with platelets, COVID-19 test, cardiac panel-acute, comprehensive metabolic panel, electrocardiogram (EKG), and chest x-ray.  All test results were normal.  The patient's COVID-19 test was negative.  Treatment for the event included IV fluids (sodium chloride IV). The patient was discharged from the ER 2 to 3 hours after treatment with a discharge diagnosis of "vasovagal syncope, post immunization reaction."  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event, vasovagal syncope, post immunization reaction, was considered recovered/resolved.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: pulled the syringe to early that the complete dose could not be injected in the patient body; it spilled off from the needle and on the patient's arm; A spontaneous report was received from a Healthcare Professional, concerning a patient of unknown age, who was administered Moderna's COVID-19 vaccine and the reporter noticed that one of their nurse pulled the syringe to early that the complete dose could not be injected in the patient body and it spilled off from the needle and on the patient's arm/ underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their second dose of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.   The reporter noticed that one of their nurse while administering the vaccine to a patient that she pulled the syringe to early that the complete dose could not be injected in the patient body and it spilled off from the needle and on the patient's arm on an unknown date.  The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable.  The outcome of event, pulled the syringe to early that the complete dose could not be injected in the patient body and it spilled off from the needle and on the patient's arm was considered as resolved.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273, lot # 041L20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Second dose was Pfizer's; A spontaneous report was received from a consumer concerning a female patient, of 85-year-old, who was administered Moderna's COVID-19 vaccine and second dose was Pfizer's/wrong product administered.  The patient's medical history not reported. Products known to have been used by the patient, within two weeks prior to the event, included were acetylsalicylic acid, lisinopril, centrum vitamins, linagliptin and furosemide sodium from an unknown date for an unknown indication.  On 06 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in the right arm for prophylaxis of COVID-19 infection.   On 22 JAN 2021, the patient was given second dose of Pfizer's vaccine. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was unknown.  The outcome of event, second dose was Pfizer's was considered as resolved on 22 JAN 2021.; Reporter's Comments: This is a case of 85-year-old female patient who was administered mRNA-1273 vaccine and second dose was Pfizer's (wrong product administered) Lot number: unknown. There was no associated adverse event reported for the event of wrong product administered.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Erythema
Clinical narrative: Anaphylactic reaction; Redness; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed redness and anaphylactic reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed redness and anaphylactic reaction. She took ibuprofen post vaccination and diphenhydramine for the anaphylactic reaction. Her physician assistant also ordered epinephrine.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, redness and anaphylactic reaction, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Dizziness, Dysacusis, Tinnitus
Clinical narrative: lost 70-80% of sight; dizzy; ringing in ear; all sounds were coming down a tunnel; A spontaneous report was received from a consumer concerning a 34-year-old old, male patient who experienced 70-80% blindness, dizziness, and ringing in his ear.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.    On 10FEB2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Patient got first dose of Moderna vaccine on 10FEB2021 in left non dominant arm. Patient notes he has always had a reaction to anything external going in his body. After receiving vaccine, he felt fine for about 5 seconds then felt dizzy, lost 70-80% of sight and had ringing in his ear. Patient said all sounds were coming down a tunnel. Patient asked for a place to lie down and symptoms resolved about 2 minutes later. Patient wants to know if it is safe to get second dose. Also wants to know if he can change vaccination facility for second dose. Treatment information was not provided/unknown.     The events resolved on same day.; Reporter's Comments: This case concerns a 34 year old, male patient, who experienced a serious unexpected event of blindness transient, among other non-serious events, after receiving first dose mRNA-1273 (Lot# unknown).  Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: Received the COVID vaccine at age 16; Injecstion site pain; A spontaneous report was received from a physician regarding his daughter who is a 17-year-old female, unknown race and ethnicity, who was administered Moderna Covid-19 vaccine and experienced pain at injection site.  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On 22-Jan-2021, prior to the onset of events, patient received her first of two planned doses of Moderna Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. (Lot#011J20A). The physician who is patient's father would like to give her the second dose. Also, he wanted to consider her for pediatric trials.  Action taken with vaccine is physician showed willingness to give his daughter a second dose.  The outcome of the events, inappropriate age at vaccination and pain at injection site is unknown at the time of report.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (Lot # 011J20A) with pain at injection site reported. 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: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Appetite disorder, Asthenia, Balance disorder, Dizziness, Fatigue
Clinical narrative: Rapid heart beat; spinning intermittent; off balance leaning left; slow to breath; Appetite; Weakness; Fatigue; Blackout; Nausea; Dizzy/ room spinning; A spontaneous report was received from a consumer ( concerning an 88-year-old, patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced blackout, dizziness, nausea, fatigue, room spinning counter clockwise, loss of appetite, weakness, rapid heartbeat, spinning intermittent, off balance leaning left and slow breath.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 3FEB2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:013ML0A) intramuscularly for prophylaxis of COVID-19 infection.     On 5 Feb2021,the patient became dizzy. On 6 Feb 2021, the patient experienced blackout and nausea.. On 7 Feb 2021, the patient experienced fatigue. The next day, on 8 Feb 2021,the patient had loss of appetite and weakness .On 10 Feb 2021, the patient had rapid heartbeat, spinning intermittent, off balance leaning left and slow to breath. Treatment information was not provided.     The outcome of the events was unknown/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 reported events, a causal relationship cannot be excluded. Nausea and fatigue are consistent with the known safety profile of mRNA-1273.
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Loss of consciousness, Nausea, Respiratory rate decreased, Vertigo
Clinical narrative: Rapid heart beat; spinning intermittent; off balance leaning left; slow to breath; Appetite; Weakness; Fatigue; Blackout; Nausea; Dizzy/ room spinning; A spontaneous report was received from a consumer ( concerning an 88-year-old, patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced blackout, dizziness, nausea, fatigue, room spinning counter clockwise, loss of appetite, weakness, rapid heartbeat, spinning intermittent, off balance leaning left and slow breath.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 3FEB2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:013ML0A) intramuscularly for prophylaxis of COVID-19 infection.     On 5 Feb2021,the patient became dizzy. On 6 Feb 2021, the patient experienced blackout and nausea.. On 7 Feb 2021, the patient experienced fatigue. The next day, on 8 Feb 2021,the patient had loss of appetite and weakness .On 10 Feb 2021, the patient had rapid heartbeat, spinning intermittent, off balance leaning left and slow to breath. Treatment information was not provided.     The outcome of the events was unknown/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 reported events, a causal relationship cannot be excluded. Nausea and fatigue are consistent with the known safety profile of mRNA-1273.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure inadequately controlled, Blood pressure increased, Constipation, Intestinal obstruction, Pain
Clinical narrative: Blood Pressure did not decrease significantly post medication; Blood Pressure increased to 224; Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades; Intestine blockage; Constipation Continued (Initiated 3 days prior to Vaccination); A spontaneous report was received from a consumer concerning a 91-year-old, female patient who developed Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades, Constipation Continued (Initiated 3 days prior to Vaccination), Blood Pressure increased to 224, Blood Pressure Did not decrease significantly post medication, Intestine blockage, and Reduced Pain (Grade 4 out of 10 now) post Bowel Movement.    The patient's medical history included constipation. Concomitant product use was not provided by the reporter.     On 28JAN2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the upper arm for prophylaxis of COVID-19 infection.    On 28JAN2021 patient received the first dose of Moderna COVID-19 vaccine. For three days prior to vaccination patient was constipated and did not have a Bowel Movement at all. After the vaccination patient had pain (Grade 8 out of 10) under breast line, chest and across the back-shoulder blades. The evening of 28JAN2021 she visited the Emergency Room because of the pain. ER nurse reported patient Blood Pressure went up to 224 and was very high. Patient was treated with BP medication, but BP did not change significantly. This led to patient being admitted to the hospital at for overnight for observations. All tests were negative. She was diagnosed as "Intestines were blocked". She was released on 29JAN2021. She had a BM 6 days later on 03FEB2021. The pain is better (Grade 4 out of 10 now).   The outcome of the events was unknown; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: she did go to anaphylactic shock; A spontaneous report was received from a consumer concerning a 38-year-old female patient who experienced immediate anaphylactic shock (she did go to anaphylactic shock).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 13-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.    The reporter stated that her daughter had an immediate anaphylactic shock after receiving the vaccine on 13-JAN-2021 in another state.  The reporter's daughter was treated with EpiPen (epinephrine) x 2 and then was transferred to an emergency room (ER) by ambulance where she was observed all day. She reports that her daughter is not allowed to get the second shot.  The second dose of mRNA-1273 was discontinued in response to the event.  The outcome of the event 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 event, a causal relationship cannot be excluded.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received 1th shot of Moderna vaccine; A spontaneous report was received from a healthcare provider concerning a 16-year-old patient of unknown gender who received the vaccine.  The patient's medical history included Sickle Cell Disease. Concomitant product use was not provided by the reporter.     On 10FEB2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    HCP reporting 16-year-old patient with Sickle Cell Disease has received 1st shot of Moderna vaccine on 10Feb2021. HCP is asking if the patient should receive 2nd Moderna shot.   The event, vaccine at inappropriate age (16 years old), was recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Heart rate increased, Heart rate irregular, Hypertension
Clinical narrative: AFib; Jaw and tooth pain; Jaw and tooth pain; Rapid heartbeat/Rapid pulse; Extreme weakness; Irregular heartbeat; blood pressure was 142/80; A spontaneous report was received from a consumer concerning a 92-years-old, male patient who experienced AFib (atrial fibrillation), rapid heartbeat/rapid pulse, extreme weakness, irregular heartbeat, blood pressure was 142/80, jaw and tooth pain.   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 levothyroxine sodium, metoprolol tartrate, pravastatin, fexofenadine, vitamin D, acetylsalicylic acid, fluticasone propionate and latanoprost.   On 04 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 004M20A] intramuscularly in the for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the patient woke up that night with jaw and tooth pain. He later experienced rapid heartbeat, extreme weakness, irregular heartbeat, rapid pulse and AFib (atrial fibrillation) which was confirmed by his primary care physician (PCP) on 06 Feb 2021. On 08 Feb 2021, patient repoted his blood pressure was 142/80. Treatment for the event included metoprolol IV.   Action taken with mRNA-1273 in response to the events was not provided.  The events rapid heartbeat/rapid pulse and extreme weakness were considered recovered/resolved or on 08 Feb 2021 and the outcome of the events AFib (atrial fibrillation), irregular heartbeat, blood pressure was 142/80, jaw and tooth pain were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, Pain in jaw, Toothache
Clinical narrative: AFib; Jaw and tooth pain; Jaw and tooth pain; Rapid heartbeat/Rapid pulse; Extreme weakness; Irregular heartbeat; blood pressure was 142/80; A spontaneous report was received from a consumer concerning a 92-years-old, male patient who experienced AFib (atrial fibrillation), rapid heartbeat/rapid pulse, extreme weakness, irregular heartbeat, blood pressure was 142/80, jaw and tooth pain.   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 levothyroxine sodium, metoprolol tartrate, pravastatin, fexofenadine, vitamin D, acetylsalicylic acid, fluticasone propionate and latanoprost.   On 04 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 004M20A] intramuscularly in the for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the patient woke up that night with jaw and tooth pain. He later experienced rapid heartbeat, extreme weakness, irregular heartbeat, rapid pulse and AFib (atrial fibrillation) which was confirmed by his primary care physician (PCP) on 06 Feb 2021. On 08 Feb 2021, patient repoted his blood pressure was 142/80. Treatment for the event included metoprolol IV.   Action taken with mRNA-1273 in response to the events was not provided.  The events rapid heartbeat/rapid pulse and extreme weakness were considered recovered/resolved or on 08 Feb 2021 and the outcome of the events AFib (atrial fibrillation), irregular heartbeat, blood pressure was 142/80, jaw and tooth pain were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site extravasation
Clinical narrative: Blood and fluid that leaked out on to arm; Did not get the full dose; A spontaneous report was received from a consumer concerning a 59--year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced when the needle was pulled out she felt that there was blood and fluid that leaked out on to her arm and she thinks she did not get the full dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (BATCH # 029L20A) on 15 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 (BATCH # 006M20A) on 12 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Reporter stated that she had her second dose of the Modera COVID-19 vaccine 12 Feb 2021, at a drive in vaccination clinic. She had it on her left arm. When the needle was pulled out, she felt that there was blood and fluid that leaked out on to her arm and she thinks that she did not get the full dose. Lot number 006M20A, expiration date unknown. The first dose was administered through the same site on 15 Jan 2021 on her left arm with unknown dose and route of administration. Lot number 029L20A, unknown expiration date. Reporter wanted to know what the protocol was for vaccine leakages, if she should get another dose and if she got the full protection from the vaccine. No further information was reported.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events was unknown.; Reporter's Comments: This is a case of 59--year-old, female patient who was administered mRNA-1273 and experienced when the needle was pulled out she felt that there was blood and fluid that leaked  (Injection site leaking ) out on to her arm and she thinks she did not get the full dose ( incomplete dose administered) batch # 006M20A. There was no associated adverse event reported for the events of injection site leaking and incomplete dose administered.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Lung neoplasm malignant
Clinical narrative: Lung cancer; A spontaneous report  was received from a consumer concerning a 79-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lung cancer.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Feb 2021, approximately 0 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient tested positive for lung cancer. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event lung cancer was unknown.; Reporter's Comments: Based on the current available information and the very short duration of onset between the use of the product and the start date of lung cancer, a causal relationship is unlikely. Further information has been requested.