chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report was received from a physician concerning a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was inadvertently given the vaccine from a vial that was punctured a day before (expired product administered).  The patients' medical history was not provided. Concomitant product use was not provided.  On 13 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  The reporter stated that the patient was inadvertently given the vaccine from a vial that was punctured a day before.  A single dose was taken out of that vial and put back outside the six-hour window.    Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.  The event, was inadvertently given the vaccine from a vial that was punctured a day before, was considered resolved on 13 Feb 2021.; Reporter's Comments: This case concerns a 41-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 016M20A), reporting Expired product administered without any associated adverse events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-013964:same reporter, different patient US-MODERNATX, INC.-MOD-2021-013965:same reporter, different patient
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report was received from a physician regarding a 22-year-old male patient who inadvertently received Moderna's mRNA-1273 vaccine from a vial that was punctured the day before/expired product administered.  The patient's medical history was not provided. Concomitant medications were not provided.   On 13 February 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 February 2021, it was noticed that the vial being used had been punctured the day before, beyond the 6-hour expiration.  Treatment information was not provided.  Action taken with mRNA-1273 was not provided.  The outcome of the event, inadvertently given a vaccine from a vial that was punctured the day before, was considered resolved.; Reporter's Comments: This case concerns a 22-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 016M20A), reporting Expired product administered without any associated adverse events.; Sender's Comments:  MOD-2021-013965:same reporter, different patient MOD-2021-013964:same reporter, different patient
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after sitting in room temperature for 6 hours and 25 minutes; A spontaneous report was received from a 57 year-old, male patient, age who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given after sitting in room temperature for 6 hours and 25 minutes.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007m20A) for prophylaxis of COVID-19 infection.  On 14 Feb 2021, a dose of Moderna's vaccine was administered to the patient after sitting in room temperature for 6 hours and 25 minutes. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, expired vaccine used,  was considered resolved on 14 Feb 2021.; Reporter's Comments: This report refers to a case of Expired product used for mRNA-1273(Batch number: 007m20A), with no associated AEs.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: When needle came out there was a squirt so maybe didn't get the full dose; A spontaneous report was received from a consumer concerning a 74 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced when needle came out there was a squirt so maybe didn't get the full dose (Product administration error, Incomplete dose administered).     The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.       On 14-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A) on 14-JAN-2021.    On 11-FEB-2021, approximately prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the for prophylaxis of COVID-19 infection.    On 11-FEB-2021, during administration of the second dose, when the needle came out there was a squirt so he thought maybe he didn't get the full dose.   Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event was recovered on 11 Feb 2021.; Reporter's Comments: This is a case of 74-year-old male patient who was administered second dose of mRNA-1273 vaccine and experienced  needle came out there was a squirt so maybe didn't get the full dose (Product administration error, Incomplete dose administered) Lot #: 030L20A. There was no associated adverse event reported for the events of Product administration error, Incomplete dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 15 patients received doses from vials that were more than 6 hours post initial puncture; A spontaneous report was received from a health care professional concerning a 14 patients who received doses from vials that were more than 6 hours post initial puncture.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    The health care  professional reported that they had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture. The health care professional wanted to know if they needed  to revaccinate those patients? During follow-up call: HCP stated that there were actually 14 patients that received doses from vials that more than 6 hours post initial puncture. The HCP was unable to provide any additional information at the time of the call and stated that a colleague would call back with further details. Consent for Safety to follow up with HCP was not provided as she does not have any additional information to   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event,14 patients received doses from vials that were more than 6 hours post initial puncture, was recovered/resolved.; Reporter's Comments: This report refers to a case of Product administration error where total of 15 patients had experienced expired product administration for mRNA-1273(unknown batch). This case had no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received first dose on 30Dec2020 and has not received second dose yet; A spontaneous report was received from a consumer concerning male patient of unknown age, who received Moderna's COVID-19 vaccine first dose and has not received second dose yet.   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 (Lot number:025L20A) unknown route of administration on 30 Dec 2020 for prophylaxis of COVID-19 infection.    Patient stated he had missed his email for being able to return for his second dose. His first dose was on 30-Dec-2020. He returned to the same clinic on 28-Jan-2021 but they turned him away and told he will receive an email and he is still waiting on that. During a follow up call patient stated he was able to get in touch with an alternative vaccination site who advised him to come on 12-Feb-2021 and see if they will vaccinate him. Patient was unsure if they will vaccinate him since last time he showed up without an appointment and he was turned away.  No treatment information was provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The event, Patient received first dose on 30-Dec-2020 and has not received second dose yet was considered resolved.; Reporter's Comments: This case concerns a male of unknown age who experienced a nonserious unexpected event of Inappropriate schedule of product administration for mRNA-1273 (lot # 025L20A) without associated adverse events.  Patient received first dose mRNA-2173 on 30-Dec-2020 and has not yet received the second dose.  The missed second dose of mRNA-1273 occurred 1 month and 13 days after the first dose of mRNA-1273. Further information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Headache, Underdose
Clinical narrative: Headache around her temples and nose; Did not get full shot since syringe messed up; Did not get full shot since syringe messed up; A spontaneous report was received from a consumer concerning an 80-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced that she did not get the full shot since the syringe messed up/device connection issue, vaccine underdose and headache.  The patient's medical history was not provided.  Concomitant medications were not provided.  On 15 FEB 2021, the patient received her second dose of mRNA-1273 (lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient stated that she received her vaccine on 15 FEB 2021, but the syringe messed up and she didn't get the full dose.  The healthcare professional (HCP) told her to come back on 18 FEB 2021 for the full dose.  On 16 FEB 2021 the patient woke up with a headache around her temples and nose.  Treatment for these events were not reported.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, device connection issue and vaccine underdose were recovered.  The outcome of the event, headache was unknown.; Reporter's Comments: This case concerns a 80-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 025L20A), reporting device connection issue, vaccine underdose and associated headache. 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.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Facial paralysis
Clinical narrative: Bells Palsy; A spontaneous report was received from a consumer concerning a 65 year old male patient who experienced Bells Palsy/Facial Paralysis, Slurred speech/.Dysarthria, Facial droop/Facial droop,  Numbness on Facial right side/ Facial Paresthesia, Thumb numbness/ Thumb Paresthesia, Right paralysis/Right Paralysis, Right eye lid will not close/Right Eyelid Paralysis  The patient's medical history was not provided. Products known to have been used by the patient,  within in two weeks prior to the events, included Insulin Zinc Suspension, Insulin Aspart, Clopidogrel bisulfate, Gabapentin, Mesalamine, and Atorvastatin.  On 18-Jan-2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 ( Batch number: 09L20A) intramuscularly into the right arm for prophylaxis of Covid-19 infection.  On 15-Feb-2021 the patient received the second of two planned doses of mRNA-1273 ( Batch number: 024M20A)  intramuscularly (site not provided) for prophylaxis of Covid-19 infection.  On 15 Feb-2021,  the patient left a voicemail message to safety and stated "got right paralysis, thought I had stroke, spent 4 days in the hospital and  diagnosed me with Bells Palsy".  Hospital admission, treatment information, and discharge dates were not provided.  On 16-Feb-2021 Safety agent reached the patient to clarify the information provided in his first report (15-Feb-2021).   The patient reported his symptoms began on 08-Feb-2021, 21 days following the first dose of mRNA-1273,  the patient experienced slurred speech, facial droop , numbness on facial right side, thumb numbness, right paralysis, right eye lid will not close and blurred vision of the right eye. He was hospitalized (date not provided).  Treatment information included a CT scan which was reported as normal . He reported seeing a speech therapist to help with his speech and improve swallowing. He reported no treatment was given to him. A physician diagnosed him with Bells Palsy on 10-Feb-2021.  Hospital discharge date was not provided.   The second dose of mRNA-1273 was temporarily withheld in response to the events rechallenge  date 15-Feb-2021 was reported as negative.  The outcome of the events,  Bells Palsy,slurred speech, facial droop , numbness on facial right side, thumb numbness, right paralysis, right eye lid will not close and blurred vision of the right eye were considered Not recovered/Not resolved.  Company Comment: the reported event Bells Palsy was considered possibly related to mRNA-1273.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; A report was received from a healthcare facility staff member concerning a  50 year old, female patient (a nurse) who was participating in the mRNA-1273 Emergency Use Program and experienced an anaphylactic reaction.  No relevant concomitant medications and medical history were reported.    The patient received their first of two planned doses of mRNA-1273 on 19-DEC-2020.   On 26-JAN-2021, the patient received their second of two planned doses of mRNA-1273 (Batch 030L20A) in her Left deltoid arm (IM injection) and on the same day, experienced the serious adverse event of anaphylactic reaction.  She was transported by ambulance to the ER. She stayed there for one day and now is fine.  Treatment included Benadryl, epinephrine, steroid, advance, peptide, Motrin.   Laboratory details was not provided.  The event, anaphylactic reaction, was considered recovered on 26-JAN-2021.  Action taken with mRNA-1273 in response to 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.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Cardiac failure
Clinical narrative: heart failure; blood sugar was really high; This is a spontaneous case report sent by a Non-Health Professional which refers to an 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cardiac failure and blood sugar was really high.  The following drugs are known to have been taken by the patient prior to the event: Amlodipine ,atorvastatin, Breo, Diovan, furosemide, metoprolol, Xarelto, Trulicity  On  30-Jan-2021 the patient took the first dose of the Moderna COVID-19 Vaccine for COVID-19 infection. On the next day ('Sunday") her blood sugar was high and on Monday the patient developed heart failure and she is not attributing the heart failure to the vaccine but is wondering if her blood sugar is high due to the vaccine or CHF.  Gliperide and metformin are the treatment for symptoms.  Relevant laboratory results included. The hospital discharge summary was not available. The eventual diagnosis made on was cardiac failure . Patient wants to know that she should take second dose of vaccine.  The Non-Health Professional did not declare any relatedness between heart failure and Moderna COVID-19 Vaccine    Terse Narrative (for narratives and signal review) Brief 3 line summary of above for agency listing: Report Source- Non-Health Professional,  Age- 81 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- heart failure - Unknown,blood sugar was really high - Unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported events and the administration of mRNA-1273 is assessed as unlikely. Causality is confounded by the patient's underlying medical history suggestive in concomitant therapy.  Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: was accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot; A spontaneous report was received from a other healthcare professional concerning an unknown patient who was accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot.  Lot number and expiration date for mRNA-1273 were not reported   Medical history and concomitant medications were not reported. No additional information relevant to the event was reported.  Action taken with the second dose of mRNA-1273 in response to the event was unknown.; Reporter's Comments: This report refers to a case of accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot for mRNA-1273, lot# (unknown) with no associated adverse events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: lost hearing in right ear; ringing in the ear; A spontaneous report was received from a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ringing in the ear and loss of hearing in the right.  The patient's medical history was not provided. Products known to have been used by the patient were not included.  On 03 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On an unspecified date, the patient experienced ringing in the ear and lost hearing in the right ear.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, ringing in the ear and  lost hearing in the right ear was not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Headache, Myalgia, Neck pain, Pain in jaw
Clinical narrative: Bell's Palsy; body aches; Pain in the head; Neck pain; Jaw pain; A spontaneous reportwas received from a 56-years-old, female patient who experienced jaw pain, neck pain, pain in the head, body aches and bells palsy.    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, fluticasone propionate, loratadine, vitamin E, vitamin B, vitamin C, ibuprofen and tizanidine.   On 26 Jan 2021, approximately fifteen days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 2039K20A] intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, the patient experienced jaw pain, neck pain, head pain and body aches.   On 14 Feb 2021, she was diagnosed with Bells palsy after going to urgent care . Treatment for the event included valaciclovir hydrochloride, salve for eye, steroid ear drop.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events jaw pain, neck pain, pain in the head, body aches and bell's palsy were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Loss of consciousness, Malaise, Myalgia
Clinical narrative: Passed out; Shakes so bad; So sick; Headache; Muscle pain; Temperature for five days (102.7F); A spontaneous report was received from a consumer, female patient of unknown age, with unknown race and ethnicity, who was administered Moderna's COVID-19 Vaccine (mRNA-1273) and experienced passed out (loss of consciousness), shakes so bad (tremor), so sick (malaise), headache, muscle pain (myalgia), and temperature for five days (102.7F) (pyrexia).  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date in JAN 2021, the patient received their first of planned doses of mRNA-1273 (batch number: unknown), intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that the difficulties which she experienced after the first Moderna vaccine were terrible and so bad. The patient had all the side effects, which includes headache, muscle pain, passed out, fever, and was so sick. The patient wanted to report the side effects and unsure if she should take the second vaccine or not. The patient doesn't think that she can handle the second vaccine. She had a temperature of 102.7 F and was shaking so bad. The patient second vaccine was due in 28 days in February. Upon callback, the patient had a hard of hearing and stated that the vaccine hit her hard and had a temperature for five days. She was concerned about getting the second dose. No treatment medication information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, passed out, shakes so bad, so sick, headache, muscle pain, and temperature for five days (102.7F), were 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.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Passed out; Shakes so bad; So sick; Headache; Muscle pain; Temperature for five days (102.7F); A spontaneous report was received from a consumer, female patient of unknown age, with unknown race and ethnicity, who was administered Moderna's COVID-19 Vaccine (mRNA-1273) and experienced passed out (loss of consciousness), shakes so bad (tremor), so sick (malaise), headache, muscle pain (myalgia), and temperature for five days (102.7F) (pyrexia).  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date in JAN 2021, the patient received their first of planned doses of mRNA-1273 (batch number: unknown), intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that the difficulties which she experienced after the first Moderna vaccine were terrible and so bad. The patient had all the side effects, which includes headache, muscle pain, passed out, fever, and was so sick. The patient wanted to report the side effects and unsure if she should take the second vaccine or not. The patient doesn't think that she can handle the second vaccine. She had a temperature of 102.7 F and was shaking so bad. The patient second vaccine was due in 28 days in February. Upon callback, the patient had a hard of hearing and stated that the vaccine hit her hard and had a temperature for five days. She was concerned about getting the second dose. No treatment medication information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, passed out, shakes so bad, so sick, headache, muscle pain, and temperature for five days (102.7F), were 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.  Further information has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year-old received the Moderna COVID-19 vaccine; A spontaneous report was received from a nurse concerning a 17-year-old, male who received Moderna's COVID-19 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12-Feb-2021, prior to the onset of the event, the patient received their first of two planned does of mRNA-1273 (Lot number: 012M20A) for prophylaxis of COVID-19 infection.  On 12-Feb-2021, the patient was administered mRNA-1273 vaccine.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, 17-year-old received the Moderna COVID-19 vaccine, was considered resolved on 12 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hemiparaesthesia, Hypoaesthesia, Lip swelling, Swollen tongue
Clinical narrative: left side of face began to tingle and be numb; left side of face began to tingle and be numb; 2 episodes of rapid heartbeat; burning in arm; lips and tongue started swelling; tongue started swelling; severe headache; A spontaneous report was received from a consumer reporting on herself, a 67-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left side of face began to tingle and be numb/MedDRA PT: Hemiparesthesia, rapid heartbeat/MedDRA PT: tachycardia, burning in arm/MedDRA PT: vaccination site burning, lips started swelling/MedDRA PT: swelling of  lips, tongue started swelling/MedDRA PT: swelling of tongue, severe and headache/MedDRA PT: headache.  The patient's medical history included allergy to latex and reaction to oseltamivir phosphate (Tamiflu).Products known to have been used by the patient, within two weeks prior to the event, included losartan, potassium citrate, diltiazem, allopurinol, atorvastatin, famotidine and levocetirizine.   On 12 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT# 015M20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Four minutes after the vaccination, the patient felt burning in her arm and the left side of her face began to tingle and feel numb. In addition, the patient's lips and tongue began to swell and she had 2 episodes of rapid heart rate. Within 20 minutes it started to resolved and then she developed a severe headache.  On 13 Feb 2021, the patient reported that all of the symptoms were back except the fast heartbeat. The patient called Urgent Care and was prescribed treatment with diphyendramine and famotidine.   On 14 Feb 2021, the patient went to the emergency room and received a steroid injection, "liquid to drink", and steroid medication for 5 days. She reported a history of a similar reaction to oseltamivir phosphate (Tamiflu).  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events of left side of face began to tingle and be numb, 2 episodes of rapid heartbeat, burning in arm, lips and tongue started swelling and severe headache (12 Feb 2021) were considered recovered/resolved. The outcome of events of left side of face began to tingle and be numb, burning in arm, lips and tongue started swelling and severe headache (13 Feb 2021) were considered unknown; Reporter's Comments: This case concerns a 67-year-old female, with latex and drug allergies, who had serious unexpected hemiparesthesia and hypoaesthesia, NS unexpected lip swelling, swollen tongue, tachycardia, and NS expected vaccination site pain, headache. Event onset 4 minutes after first dose of mRNA-1273. Treated with Benadryl and steroids. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site pain
Clinical narrative: left side of face began to tingle and be numb; left side of face began to tingle and be numb; 2 episodes of rapid heartbeat; burning in arm; lips and tongue started swelling; tongue started swelling; severe headache; A spontaneous report was received from a consumer reporting on herself, a 67-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left side of face began to tingle and be numb/MedDRA PT: Hemiparesthesia, rapid heartbeat/MedDRA PT: tachycardia, burning in arm/MedDRA PT: vaccination site burning, lips started swelling/MedDRA PT: swelling of  lips, tongue started swelling/MedDRA PT: swelling of tongue, severe and headache/MedDRA PT: headache.  The patient's medical history included allergy to latex and reaction to oseltamivir phosphate (Tamiflu).Products known to have been used by the patient, within two weeks prior to the event, included losartan, potassium citrate, diltiazem, allopurinol, atorvastatin, famotidine and levocetirizine.   On 12 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT# 015M20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Four minutes after the vaccination, the patient felt burning in her arm and the left side of her face began to tingle and feel numb. In addition, the patient's lips and tongue began to swell and she had 2 episodes of rapid heart rate. Within 20 minutes it started to resolved and then she developed a severe headache.  On 13 Feb 2021, the patient reported that all of the symptoms were back except the fast heartbeat. The patient called Urgent Care and was prescribed treatment with diphyendramine and famotidine.   On 14 Feb 2021, the patient went to the emergency room and received a steroid injection, "liquid to drink", and steroid medication for 5 days. She reported a history of a similar reaction to oseltamivir phosphate (Tamiflu).  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events of left side of face began to tingle and be numb, 2 episodes of rapid heartbeat, burning in arm, lips and tongue started swelling and severe headache (12 Feb 2021) were considered recovered/resolved. The outcome of events of left side of face began to tingle and be numb, burning in arm, lips and tongue started swelling and severe headache (13 Feb 2021) were considered unknown; Reporter's Comments: This case concerns a 67-year-old female, with latex and drug allergies, who had serious unexpected hemiparesthesia and hypoaesthesia, NS unexpected lip swelling, swollen tongue, tachycardia, and NS expected vaccination site pain, headache. Event onset 4 minutes after first dose of mRNA-1273. Treated with Benadryl and steroids. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong technique in product usage process
Clinical narrative: Sore arm; Pulled the dose from multiple vials (2-3 vials) to complete the 0.5ML; A spontaneous report was received from a pharmacist, concerning her mother, a 57-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) where in pulled the dose from multiple vials (2-3 vials) to complete the 0.5 ML and developed sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 16 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot: 00UM20A) for prophylaxis of COVID-19 infection.   On 16 Feb 2021, the patient's vaccine dose was pulled the from multiple vials (2-3 vials) to complete the 0.5 ML. Patient also experienced sore arm. Laboratory details not provided. No treatment information was provided.    Action taken with mRNA-1273 in response to the events were not reported.     The outcome of the event Pulled the dose from multiple vials (2-3Vials) to complete the 0.5ML was considered resolved on 16 Feb 2021. The outcome of event sore arm was considered unknown at the time of this report.; Reporter's Comments: This report refers to a case of Inappropriate drug extraction with syringe for mRNA-1273, lot # 00UM20A with sore arm. developed
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got their second vaccine earlier than they should have; A spontaneous report was received from a nurse regarding a 78-year-old female patient who received Moderna's mRNA-1273 vaccine earlier then she should have/inappropriate schedule of vaccine administered.  The patient's medical history was not provided. Concomitant medications were not provided.   On 04 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection.   On 16 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Batch: 024M20A) for prophylaxis of COVID-19 infection.  On 16 Feb 2021, accidently patient got through and got their second vaccine earlier than they should have. Patient got their first dose of the Moderna vaccine at a different place, that's how this ended up happening. Treatment information was not provided.   Action taken with mRNA-1273 was not applicable.   The outcome of the event, receiving the vaccine earlier than she should have, was considered resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, with no associated AEs.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: The coroner said it was some type of heart attack; A spontaneous Report Received from a Health care professional concerning a 84 year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced a heart attack / myocardial infarction.  The patient's had undergone triple bypass surgery years ago. Concomitant medications were vitamins.  On 18-Jan-2021 prior to onset of events the patient received his first of first two planned doses of (mRNA-1273) COVID-19 vaccine of unknown batch no, unknown route and unknown site of administration for prophylaxis of COVID-19 infection.  On 13-Feb-2021 the patient experienced death 27 days after the first dose of the vaccine. The coroner said it was some type of heart attack and think he expired sometime Saturday 13-Feb-2021.  On 16-Feb-2021 the patient was supposed to have his second dose of (mRNA-1273) COVID-19 vaccine.  The event, heart attack, was fatal.; Reporter's Comments: This is a case of death to heart attack in a 84-year-old female subject with a hx of triple bypass surgery, who died 27 days after receiving first dose of vaccine. Very limited information has been provided at this time. No death certificate provided. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of Death
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID 19 infection but asymptomatic; A spontaneous report was received from a (Reporter like HCP and Consumer) concerning a 38 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events COVID 19 infection but asymptomatic.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 19-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 19-JAN-2021, The patient experienced the events COVID 19 infection but asymptomatic was given.   Laboratory details COVID 19 test positive was provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event, which events are being referenced here was unknown.  The reporter assessed the events COVID 19 infection but asymptomatic as related to study drug.; Reporter's Comments: This case concerns a 38-year-old male who experienced a nonserious unexpected event of COVID-19 (COVID 19 infection but asymptomatic).  The event of COVID-19 test positive occurred the same day as the first dose of mRNA-1273. No additional information available. Further information has been requested. 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: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product administered to patient of inappropriate age
Clinical narrative: Headache; 16 years old received vaccine; A spontaneous report was received from a patient concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and 16 years old received vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 21-Jan-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 23-Jan-2021, the patient experienced headache for a couple of days. Treatment for the event included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, headache and 16 years old received vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of product administration error  Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with event of headache.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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Behcet's syndrome, Paraesthesia, Vaccination site pain
Clinical narrative: Her Behcet's disease was in remission for three years but after 18 hs of the shot it reappeared; tingling; sore arm; A spontaneous case was received from the consumer concerning a 65-years-old female patient who received Moderna's  COVID-19 vaccine and experienced sore arm, tingling and Behcet's disease.  The patient's medical history was not provided. No relevant concomitant medications was reported.  On 29 Jan 2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 (Lot Number:026L20A) for the prophylaxis of COVID-19 infection.  On 29 Jan 2021 the patient experienced sore arm and tingling. Her Behcet's disease / systemic vasculitis (lupus like element) which was in remission for three years reappeared 18 hours after the shot. Treatment of the event was not reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm, tingling was not provided. But the outcome of the event for her Behcet's disease was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance
Clinical narrative: Fatigue; could not walk; A spontaneous report was received from consumer concerning a 39-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue and could not walk.  Medical history was not reported. Concomitant medication was not reported.  On 19-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in unknown anatomical location for prophylaxis of COVID-19 infection and developed fatigue.  On 21-Jan-2021, the patient could not walk and was hospitalized.  Laboratory details was not provided.  Treatment medication was not provided.  Action taken with mRNA-1273 in response to the events fatigue and could not walk was not provided.  The outcome of the events fatigue and could not walk was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site erythema, Vaccination site warmth
Clinical narrative: drug administered at inappropriate site; injection site hot to touch; Two-inch red circle at injection site; A spontaneous report was received from a Consumer concerning a 58 -Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site erythema and injection site warmth.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On 13 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 02TJ20A) in the deltoid for prophylaxis of COVID-19 infection.    On 13 Feb 2021, The patient was concerned now whether they gave her the shot in the deltoid muscle and concerned if it was still effective? Also about eight days later she developed a 2 inch red circle that was hot to the touch.   Laboratory details not provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.    In Feb-2021, the outcome of the injection site erythema and injection site warmth resolved. On 13 Feb 2021, the event was product administered at inappropriate site was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site erythema and vaccination site warmth, a causal relationship cannot be excluded.  The causality for vaccine administered at inappropriate site is not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a 33-year old, male patient who received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a 35-year old, male patient who received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Feeling abnormal, Herpes zoster, Pain in extremity, Post-traumatic neuralgia
Clinical narrative: still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated "she got shingles on her face, 7 years ago, and had recent dental work done," specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her "arm was a little sore". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her "upper back started hurting" and thought "maybe [she] sat on the couch for too long". On 31Jan2021 (Sunday evening), she added her "back was very tender and sensitive around the spine area" therefore, she "took some tylenol and used a heating pad thinking [she] pulled a muscle". On 01Feb2021 (By Monday) she said her "the back and front were very sensitive" to the point where: when she "touched [her] skin it felt like [she] was touching some live nerves". She explained seeing a physician assistant who "couldn't figure out what was going on" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then "went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her "brother, who is a doctor, thinks [she] has post traumatic neuralgia" related to her shingles on an unspecified date in Jan2021. She then added there is "still a part of her forehead that feels like a live nerve" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown.  The information on the Batch/Lot number has been requested.