chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: On 1/16/21, Patient received the first dose of the Pfizer vaccine (lot#EL8982) and was seated in the chair when he immediately became unresponsive. The facility manager, obtained the facility's AED and called 911 (5:34PM), while staff began CPR. Medical care was continued until EMS and Fire Rescue personnel arrived on site. Patient was pronounced deceased on-site at 5:33PM.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Immediate post-injection reaction, Resuscitation, Unresponsive to stimuli
Clinical narrative: On 1/16/21, Patient received the first dose of the Pfizer vaccine (lot#EL8982) and was seated in the chair when he immediately became unresponsive. The facility manager, obtained the facility's AED and called 911 (5:34PM), while staff began CPR. Medical care was continued until EMS and Fire Rescue personnel arrived on site. Patient was pronounced deceased on-site at 5:33PM.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Bursitis, Product administered at inappropriate site, X-ray
Clinical narrative: Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am.  The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications.  She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa.  The employee informed employee health director on 1/20/2021 and evaluated on same day.  On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bursitis, Imaging procedure, Immediate post-injection reaction, Injected limb mobility decreased, Injection site extravasation
Clinical narrative: Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am.  The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications.  She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa.  The employee informed employee health director on 1/20/2021 and evaluated on same day.  On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Injection site reaction, Pain in extremity, SARS-CoV-2 antibody test negative, Tendonitis
Clinical narrative: Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am.  The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications.  She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa.  The employee informed employee health director on 1/20/2021 and evaluated on same day.  On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am.  The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications.  She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa.  The employee informed employee health director on 1/20/2021 and evaluated on same day.  On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Intensive care, Plasmapheresis
Clinical narrative: perioral numbness, numbness of toes and fingers within 24 hrs, proximal muscle weakness 4 days later, inability to stand admitted to the hospital with diagnosis of Guillain Barre syndrome, course ongoing, received plasmapheresis
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram spine, Dysstasia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: perioral numbness, numbness of toes and fingers within 24 hrs, proximal muscle weakness 4 days later, inability to stand admitted to the hospital with diagnosis of Guillain Barre syndrome, course ongoing, received plasmapheresis
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Lumbar puncture, Magnetic resonance imaging brain, Muscular weakness, Plasmapheresis
Clinical narrative: perioral numbness, numbness of toes and fingers within 24 hrs, proximal muscle weakness 4 days later, inability to stand admitted to the hospital with diagnosis of Guillain Barre syndrome, course ongoing, received plasmapheresis
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia oral, Lumbar puncture
Clinical narrative: perioral numbness, numbness of toes and fingers within 24 hrs, proximal muscle weakness 4 days later, inability to stand admitted to the hospital with diagnosis of Guillain Barre syndrome, course ongoing, received plasmapheresis
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: perioral numbness, numbness of toes and fingers within 24 hrs, proximal muscle weakness 4 days later, inability to stand admitted to the hospital with diagnosis of Guillain Barre syndrome, course ongoing, received plasmapheresis
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Patient was vaccinated on 01/19/21 using hte Pfizer COVID-19 vaccine.  He completed a 30 minute observation team.  Later in the day after the vaccination team had already departed the facility, patient had a seizure and passed away.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Death, Seizure
Clinical narrative: Patient was vaccinated on 01/19/21 using hte Pfizer COVID-19 vaccine.  He completed a 30 minute observation team.  Later in the day after the vaccination team had already departed the facility, patient had a seizure and passed away.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: THE PATIENT DESCRIBED SYMPTOMS OF FEVER ( UPTO 102, FOR WHICH SHE TOOK TYLENOL, AND IT RESOLVED. SHE DESCRIBED,VOMITTING
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Vomiting
Clinical narrative: THE PATIENT DESCRIBED SYMPTOMS OF FEVER ( UPTO 102, FOR WHICH SHE TOOK TYLENOL, AND IT RESOLVED. SHE DESCRIBED,VOMITTING
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: erythema, edema, HD, fatigue , left upper arm discomfort, tx for cellulitis as a precaution - doxy
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Erythema, Fatigue, Hodgkin's disease, Limb discomfort
Clinical narrative: erythema, edema, HD, fatigue , left upper arm discomfort, tx for cellulitis as a precaution - doxy
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oedema
Clinical narrative: erythema, edema, HD, fatigue , left upper arm discomfort, tx for cellulitis as a precaution - doxy
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Dizziness and Nausea starting 01/17/2021 thru today 1/22. Some days stronger than others, with today being very minor and hopefully over.  I am prone to motion sickness and these symptoms are very similiar, even to the point of looking up to see the horizon and getting some relief. Took some Meclizine with mixed results.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness and Nausea starting 01/17/2021 thru today 1/22. Some days stronger than others, with today being very minor and hopefully over.  I am prone to motion sickness and these symptoms are very similiar, even to the point of looking up to see the horizon and getting some relief. Took some Meclizine with mixed results.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Crepitations, Death, Dyspnoea, Pallor
Clinical narrative: Patient began with a wet productive cough with crackles heard at 4 pm,  at 5pm he went to dinner and still had cough,  at 630 was administered his medications and he had cough,  no shortness of breath and was in a good mood.  By 7:45pm  CNA found him in the  lounge with labored breathing, 02 was at 85%.  They gave him 4 liters o2, then a facemask at 5 liters which brought his o2 into the 90's.   At that time called ambulance,  patient arrived to ER around 9:20pm and passed away shortly after.   Cardiac Arrest
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Productive cough
Clinical narrative: Patient began with a wet productive cough with crackles heard at 4 pm,  at 5pm he went to dinner and still had cough,  at 630 was administered his medications and he had cough,  no shortness of breath and was in a good mood.  By 7:45pm  CNA found him in the  lounge with labored breathing, 02 was at 85%.  They gave him 4 liters o2, then a facemask at 5 liters which brought his o2 into the 90's.   At that time called ambulance,  patient arrived to ER around 9:20pm and passed away shortly after.   Cardiac Arrest
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Crepitations, Death, Dyspnoea, Productive cough
Clinical narrative: Patient began with a wet productive cough with crackles heard at 4 pm,  at 5pm he went to dinner and still had cough,  at 630 was administered his medications and he had cough,  no shortness of breath and was in a good mood.  By 7:45pm  CNA found him in the  lounge with labored breathing, 02 was at 85%.  They gave him 4 liters o2, then a facemask at 5 liters which brought his o2 into the 90's.   At that time called ambulance,  patient arrived to ER around 9:20pm and passed away shortly after.   Cardiac Arrest
Age: 88.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Death, Dyspnoea, Lethargy, Oxygen saturation decreased
Clinical narrative: Systemic: Vaccine administered 1/15/21, patient passed away on 1/18/21
Age: 88.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Death
Clinical narrative: Systemic: Vaccine administered 1/15/21, patient passed away on 1/18/21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Electrocardiogram, Flushing, Paraesthesia, Urticaria
Clinical narrative: Within 2 minutes after vaccine administration,pt felt warmness to upper chest and throat. no constriction of throat. PT also developed blotchy redness to upper chest. Pt HR palpated and found to be 112 bpm. PT given 2 ml of Benadryl  per phn protocol and was laid supine prior and b/p was monitored prior and bp stable. pt also reported cool feeling to upper and lower hands and feet. EMS was activated also immediately and pt's hr found to be 112 bpm. pt declined ER visit. pt contact and followed up with after event around 2 hours after and said warm feeling,rash, and etc had subsided and hr was within limits. pt also contacted on day after and found to be stable and no further complaints.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Electrocardiogram, Feeling cold, Rash macular
Clinical narrative: Within 2 minutes after vaccine administration,pt felt warmness to upper chest and throat. no constriction of throat. PT also developed blotchy redness to upper chest. Pt HR palpated and found to be 112 bpm. PT given 2 ml of Benadryl  per phn protocol and was laid supine prior and b/p was monitored prior and bp stable. pt also reported cool feeling to upper and lower hands and feet. EMS was activated also immediately and pt's hr found to be 112 bpm. pt declined ER visit. pt contact and followed up with after event around 2 hours after and said warm feeling,rash, and etc had subsided and hr was within limits. pt also contacted on day after and found to be stable and no further complaints.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Administration of improperly stored PROQUAD (20.5F); No adverse event; Information has been received from a certified medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.  On 22-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Lot # T015598, recombinant Human albumin (rHA), expiration date on 02-NOV-2021, dosage, route and anatomical location were not provided) for prophylaxis.   The dose was stored at 20.5 Fahrenheit degrees for 1 hour and 54 minutes. Previously the dose experienced a temperature excursion from 6 to 14 Fahrenheit degrees (12.3 Fahrenheit degrees) for 23 hours. The report was because of data logger. No adverse event was reported.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; a dose of ROTATEQ was administered during a temperature excursion; This spontaneous report was received from a medical assistant referring to a 7 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 18-DEC-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength was not reported, lot # 1684149, expiration date was reported as 21-JUN-2021, but upon internal validation established as 25-JUN-2021) 2 ml orally for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 8.5 degree Celsius for a time frame of 3 minutes. Data logger was not involved. There were no previous temperature excursions. No further adverse event (AE) information was provided.
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity
Clinical narrative: Caller called to inquiere about components in the PNEUMOVAX23 vaccine and wether or not the COVID 19 vaccine has the same components due to an allergic reaction she experienced when the caller received PNEUMOVAX23 in 2013; This spontaneous report had been received from a female consumer of unknown age regarding herself. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On unspecified date in 2013, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (dose, anatomical location, vaccine scheme, lot number, and expiration date were not provided), as prophylaxis.  On an unspecified date, the reporter called to inquired about components in the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) vaccine and whether or not the COVID 19 vaccine had the same components due to an allergic reaction she experienced when she received Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) in an unspecified date in 2013 (Drug hypersensitivity). Therefore, she sought medical attention due the event.   The outcome of the event Drug hypersensitivity was not provided.   The causal relationship between the event Drug hypersensitivity and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was related.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; A spontaneous report was received from a 23-year-old, female consumer who was also a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction.   The patient's medical history included allergy to amoxicillin. Concomitant medications reported included gabapentin, escitalopram oxalate, and montelukast sodium.  On 04 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, within 24 hours of vaccination, the patient experienced anaphylactic reaction. Treatment for the event included Diphenhydramine.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, anaphylactic reaction, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 23 year old female patient, who experienced a serious unexpected event of Anaphylactic reaction. Event occurred apparently within 24 hrs. after first dose of mRNA-1273 (Lot# 011L20A) vaccine administration. 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Haematochezia
Clinical narrative: Blooded stools; Eyes are a little bit itchy; Right eye swollen; A spontaneous report was received from a consumer who was an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blooded stools, eyes are a little bit itchy, and right eye swollen.  The patient's medical history was not provided. Concomitant medications reported included magnesium.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J00/NA) intramuscularly for prophylaxis of COVID-19 infection.   On the evening of 04 Jan 2021, the patient experienced blooded stools, eyes are a little bit itchy, and right eye swollen. The patient reported having blooded stools that were not diarrhea, but had occurred three or four times. Treatment for the events included non specified allergy medicine for the eyes.  On 06 Jan 2021, the patient reported feeling better in regard to the blooded stools and was unsure if it was actually blood or not in her stools and she had ate spicy and red food.  Action taken with mRNA-1273 in response to the events was not provided.  The event, blooded stools, was considered resolved. The outcome for the events, eyes are a little bit itchy and right eye swollen was unknown.; Reporter's Comments: This case concerns an 83-year-old female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot 025J00/NA), and who experienced the unlisted serious event of Haematochezia and the unlisted non-serious events of Eye pruritus and Eye swelling.  Based on the current available information and temporal association between the use of the product and the start date of the event on the day of vaccination, a causal relationship cannot be excluded making the events possibly related to the vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Malaise, Pain in extremity, Syncope
Clinical narrative: Fainted; Did not feel well; Hit head; A little pain in arm; A spontaneous report was received from a 68-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the events, fainted, hit head, did not feel well, and a little pain in arm.    The patient's medical history was not provided. Relevant concomitant medications reported included ezetimibe, atorvastatin, and atenolol.   On 04 Jan 2021 at 9:00 am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient reported that she took the vaccine on 04 Jan 2021 and she did not feel anything after but a little pain in her arm.   On 05 Jan 2021 around 7:00 pm, the patient went to her fridge for a drink and told her husband she did not feel very well, and then fainted. The patient reported that she hit her head and has never fainted before. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, fainted, hit head, did not feel well, and a little pain in arm, were unknown.; Reporter's Comments: This case concerns a 68-year-old female patient  with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of Syncope, the non-serious listed event of Pain in extremity, and the non-serious unlisted events of Head injury and Malaise.  Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Intentional product use issue
Clinical narrative: Intentionally received two doses of vaccine back to back; Intentionally received two doses of vaccine back to back; A spontaneous report  was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and intentionally received two doses of vaccine back to back.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 4 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 7 Jan 2021, the patient received a second dose of mRNA-1273. The patient intentionally received the two doses of the Moderna COVID-19 vaccine back to back. No treatment information was provided. No other adverse event was reported.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, intentionally received two doses of vaccine back to back, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration and intentional product use issue for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered by device, Syringe issue
Clinical narrative: Plunger broke loose and vaccine leaked while administering; Given less or more of the dose; A spontaneous report was received from a physician concerning a patient who received Moderna's Vaccine (mRNA-1273) and experienced syringe issue and incorrect dose administered by device.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection, and during the administration of the vaccine, the plunger broke loose, and the vaccine leaked out. The patient was likely given less than a full dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The events, syringe issue and incorrect dose administered by device, were considered resolved on unknown date.; Reporter's Comments: This report refers to a case of syringe issue and incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 0.1ml instead of 0.5ml dose given; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had 0.1ml instead of 0.5ml dose given.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) for prophylaxis of COVID-19 infection.  On an unknown date, during vaccine administration, the patient was given a 0.1 milliliters (ml) dose of vaccine instead of 0.5 ml. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, 0.1ml instead of 0.5ml dose given, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # 039K20A). There were no reported AEs associated with this case of incorrect dose administered.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered, Needle issue
Clinical narrative: Only a third of the vaccine was given; Patient felt liquid dripping on her right arm; The needle messed up; A spontaneous report was received from a consumer who was a 82-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the needle messed up, the patient felt liquid dripping on her right arm, and only a third of the vaccine was given.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, during vaccine administration, the needle messed up and the patient felt liquid dripping on her right arm. The patient was given only one third of the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The events, needle messed up, the patient felt liquid dripping on her right arm, and only a third of the vaccine was given, were considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered, exposure via skin contact and needle issue for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect route of product administration, Paraesthesia
Clinical narrative: tingling in figures of both arms on and off; injection given to her is little lower and not properly in muscle; Headache; A spontaneous report was received from a dentist concerning a 64-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, tingling in fingers of both arms, and injection given to her is little lower and not properly in muscle.  The patient's medical history was not provided. Concomitant medication included rosuvastatin calcium.  On 01 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced headache, tingling in fingers of both arms, and injection given to her is little lower and not properly in muscle. The treatment information included paracetamol and ibuprofen.  Action taken with mRNA-1273 in response to the events was not provided.  The event, injection given to her is little lower and not properly in muscle, was considered resolved on 01 Jan 2021. The outcome for the events, headache and tingling in figured of both arms, was unknown.; Reporter's Comments: This case concerns 64-year-old, female, who experienced the non-serious unexpected events of paraesthesia, a non-serious expected event of headache and incorrect route of product administration for mRNA-1273 (Lot# 011L20A). The events of paraesthesia and headache occurred 1 day after the first dose of mRNA-1273 (Lot# 011L20A). There were no reported AEs associated with this case of incorrect route of product administration. The treatment details were not provided. Based on temporal association between the use of the product and the start date of the events (paraesthesia and headache), a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: received dose 1 of the Moderna vaccine past the 6 hr used-by time; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received dose 1 of the Moderna vaccine past the 6 hour used-by time.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient stated that he received 1 dose of the vaccine past the 6 hour used-by time. He stated that his dose of the vaccine was administered 48 hours after the bottle was opened on 29 Dec 2020.  No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, received dose 1 of the Moderna vaccine past the 6 hour used-by time, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot 025L20A), reporting Out of specification product use without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine injected into shoulder joint; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine was injected into shoulder joint.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 30 Dec 2020, during vaccine administration, the vaccine was injected into the patient's shoulder joint instead of the muscle. Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, vaccine injected into shoulder joint, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission in error
Clinical narrative: We think an empty syringe was administered to a patient; A spontaneous report was received from a pharmacist concerning a 51-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) who experienced empty syringe administered to patient.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The pharmacist reported that they thought an empty syringe was administered to the patient. They wanted to administer a confirmed dose to the patient, so a second dose was administered.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, empty syringe administered to patient, was resolved on 08 Jan 2021.; Reporter's Comments: This report refers to a case of 51- year-old female patient who experienced non-serious unexpected event of empty syringe was administered to the patient (Product dose omission in error). There were no reported AEs associated with this case of product dose omission in error.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Received first dose of moderna vaccine but it was administered 1 cm below the deltoid muscle; A spontaneous report was received from a physician concerning a female patient who was received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced received first dose of Moderna vaccine but it was administered 1 cm below the deltoid muscle.   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 on an undisclosed date intramuscularly for prophylaxis of COVID-19 infection and experienced product administered at inappropriate site when the vaccine was administered one centimeter below the deltoid by a medical student.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event, received first dose of Moderna vaccine but it was administered 1 cm below the deltoid muscle, was not provided.   The event, received first dose of Moderna vaccine but it was administered 1 cm below the deltoid muscle, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site papule, Cellulitis, Injection site pruritus, Vaccination site inflammation
Clinical narrative: Left arm cellulitis; Multiple other bumps going down her arm; Itchiness on her left arm close to the vaccination site; One big welt approximately the size of a nickel; A spontaneous report was received from a 44 year-old, female health care professional, who was also the patient, who received Moderna's COVID-19 vaccine and experienced left arm cellulitis, multiple other bumps going down her arm, itchiness on her left arm close to the vaccination site, and one big welt approximately the size of a nickel.   The patient's medical history was not provided. Concomitant product use was not provided.    On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) in their left arm for prophylaxis of COVID-19 infection.   On the morning of 06 Jan 2021, the patient felt itchiness on her left arm close to the vaccination site. The patient had one big welt approximately the size of a nickel, with multiple other bumps going down her arm. The patient took a diphenhydramine hydrochloride, and her symptoms were improving. The bumps going down her arm were resolving, but not fully resolved. Later, the patient noted that she had experienced cellulitis on her left arm starting eight days after vaccination (06 Jan 2021). She received an injection of triamcinolone acetonide on 11 Jan 2021 that helped with the cellulitis's noticeability.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event cellulitis was unknown. The events multiple other bumps going down her arm, itchiness on her left arm close to the vaccination site, and one big welt approximately the size of a nickel, were considered recovering/resolving.; Reporter's Comments: This case concerns a 44- year old, female, healthcare professional.  The patient's medical history was not provided. The patient experienced a serious  event of cellulitis, injection site pruritis, vaccination site inflammation and papules. The event occurred 9 days after first dose of mRNA-1273 (Lot number: 025J20A).  Vaccination site inflammation is listed on the factsheet and is related to mRNA. 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: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine given to a 16 year old; A spontaneous report was received from a nurse concerning a female 16 year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given to a 16 year old.    The patient's reported medical history included severe intellectual disabilities. No relevant concomitant medications were reported.   On 7 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 7 Jan 2021, the nurse reported the Moderna COVID vaccine was given to a 16 year old female patient. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine given to 16 year old, was considered resolved on 7 Jan 2021.; Reporter's Comments: This case concerns a 16-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 037K20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood pressure increased, Erythema, Feeling abnormal, Swelling face
Clinical narrative: Felt a sudden rush of weird sensation that went from her feet to her head; Face went beat red; Face started to swell; Couldn't speak; Blood pressure went from 120/70 to 210/107; A spontaneous report was received from a nurse, who was also a 56-years-old, female patient, who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced a sudden rush of a weird sensation that went from her feet to her head, face went beat red, face started to swell, couldn't speak, and blood pressure went from 120/70 to 210/107.  The patient's medical history was not provided. Concomitant product use was not provided.  On 05 Jan 2021, fifteen minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) for prophylaxis of COVID-19 infection.  The patient reported she felt a sudden rush of a weird sensation that went from her feet to her head, and her face went beat red and started to swell. She could not speak. Her blood pressure went from 120/70 to 210/107. Treatment included diphenhydramine, intravenous fluids, and famotidine. Within 15 to 20 minutes after treatment was given, the patient reported that all the symptoms went down (blood pressure, swelling, and the rushed feeling she experienced).   Action taken with mRNA-1273 in response to the events was not provided.   The events, a sudden rush of a weird sensation that went from her feet to her head, face went beat red, face started to swell, couldn't speak, blood pressure went from 120/70 to 210/107, were considered resolved on 05 Jan 2021.; Reporter's Comments: This case concerns a nurse who is 56- year old, female patient, who experienced a serious, unexpected event of feeling abnormal, erythema, swelling of face, aphasia and increased blood pressure.The event occurred on 05 Jan 2021, fifteen minutes after receiving the first dose of mRNA-1273 (Lot number: 025J20A). Treatment for the event included diphenhydramine, intravenous fluids, and famotidine. The patient's medical history was not provided. Based on the current available information and temporal association between the use of mRNA-1273 (Lot number: 025J20A) and the start of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Syncope
Clinical narrative: fainted; a little pain in arm; A spontaneous report was received from a consumer concerning a 68-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting and pain in her arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 04 Jan 2021, at approximately 09:00am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid prophylaxis of COVID-19 infection.    On 04 Jan 2021, after receiving the vaccine, the patient felt a little pain in her arm. On 05 Jan 2021, at approximately 19:00 the patient fainted after standing up. She hit her head on the floor and had a small bump on her head. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the events, fainting and pain in her arm, were considered unknown.; Reporter's Comments: This case concerns a 68-year-old female subject with who experienced a serious,  unexpected event of fainting and pain her arm. Her medical history and con meds were not provided. The fainting event occurred 1 day after the first dose of the mRNA-1273 study medication administration, after patient stood up, fainted, and hit her head on the floor and sustained a small bump on her head. Treatment for this event was not provided. Very limited information regarding the fainting event has been provided at this time.  Based on 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: Facial paralysis
Clinical narrative: Facial weakness - palsy; A spontaneous report report was received from a physician concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273)"  and developed facial weakness - palsy.  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 on 24 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient received the vaccine and a week later on an unknown date had developed chronical complication, facial weakness  palsy. Treatment information included prednisone.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, facial weakness - palsy, was resolved.; Reporter's Comments: This case concerns a female patient with medical history not provided, who developed a serious unexpected event of facial paralysis. The event occurred approximately 2 weeks after first dose of the mRNA-1273 (Lot# unknown). The patient was treated with prednisone and the event was resolved. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report (United States) was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report  was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021. Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.