chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination abnormal, Paraesthesia, Skin tightness
Clinical narrative: Won't let me type everything. Long story short. Face tingled for a few days after shot, forehead skin got tight and dry, now I've lost vision in my right eye! Today is exactly 2 weeks after 1st vaccine and sight in my right eye is worse and painful
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 9 days after shot left arm vacc site appeared red, warm in strip about 3" wide and sore to touch.  (Initial soreness had disappeared 2-3 days after shot). Had virtual visit w primary's NP,  site viewed. Determined to be "Covid arm" since no other symptoms present. Ice pack used. Redness slightly increased but lighter in color on 2/15.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: Nasty headache which remained after acetaminohen/ibuprofen,  congestion,  fever,  felt like my hesd was on someone else's body, aloofness, etc.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first GARDASIL 9 dose in 2014 on an unknown month; Information has been received from a pharmacist concerning a 21-year-old female patient. The patient's concurrent conditions, pertinent medical history, drug allergies/drug reactions and concomitant medications were not provided.  It was reported that on unspecified day in 2014, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, Lot # and expiration date not reported) and on 20-JUL-2020 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, Lot # and expiration date not reported) by another health care professional for prophylaxis.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine was administered on 25-JAN-2021; Information has been received from a Registered Nurse (R.N.) concerning a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/drug reactions and concomitant medications were not reported.      It was reported that on 25-JAN-2021, the patient was vaccinated with a dose (1 injection) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequecny and route were not provided) (Lot # 1688504, expiration date 19-NOV-2021 (also reported as 18-NOV-2021)) for prophylaxis.         It was reported that the vaccine was improperly stored above 9 Celcius degrees (13.4 °C) for 2 hours and 9 minutes. There was no previous temperature excursion and it was stated that the call was made because of a Digital data logger (Yes).  This is one of several cases from the same source (US-009507513-2101USA013389).; Sender's Comments:  US-009507513-2101USA013389:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a HCP reporting an AE for VARlVAX. Caller states the vaccine was administered after a temperature excursion; Information has been received from a other health professional, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T012551, expiration date on 10-APR-2022, 0.5 milliliter (anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported.  The vaccine had a temperature excursion of -13.8 Celsius degrees (C), during 41 minutes. It was confirmed that no previous temperature excursions occurred and a digital data logger was involved.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: No further AE details; PROQUAD was stored in the refrigerator instead of thee freezer; PROQUAD administered concomitantly with VARIVAX; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.       It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator instead of the freezer since 01-DEC-2020.   On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Product storage error) (dose number, strength, anatomical location and route of administration were not reported, lot # T025221, expiration date 19-JAN-2022, therapy type: recombinant Human albumin (rHA)) at a dose of 0.5 milliliter for prophylaxis, administered concomitantly with a properly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose number strength, anatomical location, route of administration, lot # and expiration date were not reported) at a dose of 0.5 milliliter for prophylaxis (Inappropriate schedule of product administration).  It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine was exposed to a temperature of 44 Fahrenheit (F) for a time frame of 1506 hours. There was no previous temperature excursion and the call was not due to a data logger. No further adverse event (AE) details were provided.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2102USA001266: US-009507513-2102USA001044: US-009507513-2102USA000941: US-009507513-2102USA001248: US-009507513-2102USA001301:
Sex: F
Vaccine: PPV
Symptoms: Blood test, Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: her arm getting sore and stiff along with a painful sensation; her arm getting sore and stiff along with a painful sensation; This spontaneous report was received from a currently 80 year old female consumer concerning herself. Current conditions include: Allergy to pills, dust, mold and mildew; leukemia, congestion (unspecified). There was no information about the patient's concomitant medication.  On an unknown date, the patient was vaccinated with  a dose of vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her right arm for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unknown date, the patient experienced a reaction to it. It was reported that her reaction consisted of her arm getting sore and stiff along with a painful sensation (PT: pain in extremity, injected limb mobility decreased). No treatment was given for the events. A blood work was performed, on an unspecified date (data not showed).The outcome of pain in extremity and injected limb mobility decreased was reported as recovered, on an unknown date, reported as "4 or 5 days after she  received the injection" . It was mentioned that the patient seek unspecified medical attention.  The reporter considered pain in extremity and injected limb mobility decreased to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Age: 50.0
Sex: U
Vaccine: PNC, PPV
Symptoms: Pneumonia, Therapy partial responder
Clinical narrative: They are only 30% effective; I have been "overdosed" with the PREVNAR and PNUEMOVAX shots. I am 68 and have been getting then since I was 50; I have been "overdosed" with the PREVNAR and PNUEMOVAX shots. I am 68 and have been getting then since I was 50; Pneumonia; This spontaneous report was received from a 68-year-old patient of an unknown gender concerning to themself via Pfizer. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not provided.  On an unknown date, since the patient was 50-year-old, the patient had been getting vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported) and with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) (indication, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported) (inappropriate schedule of product administration). The patient was certain the she had been "overdosed" with the vaccines shots(overdose).  In January 2021 (reported as last January), she got pneumonia and went to the urgent care, where, the patient explained to the physician she was diligent with the vaccines and the physician stated that vaccines were only 30 percent effective (therapy partial responder).  The outcome of pneumonia and therapy partial responder was unknown. The causal assessment between the events and the suspect vaccines were not reported.  Upon internal review, pneumonia had been considered a medically significant event.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: patient passed out; patient became stiff; This spontaneous report was received from a nurse via company representative regardin a 11-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 09-FEB-2021, the patient was vaccinate with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and other dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) in the opposite arm (dose, route, anatomical location, lot number and expiration date were not reported for both vaccines); all for prophylaxis.  On the same day immediately after received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient became stiff and passed out (stiffness and loss of consciousness). The patient was monitored in the office for about 30 minutes and then released home. The did not seek medical attention and no treatment was given for the events.  At the time of the report, the patient had recovered from the events on 09-FEB-2021.  The relatedness between the events of stiffness and loss of consciousness and therapy with received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  Upon internal review, loss of consciousness was determined to be medically significant event.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product formulation administered
Clinical narrative: vaccines were administered to patients prior to having them evaluated/does not have complete temperature excursion; Information has been received from an office manager concerning a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/drug allergies and concomitant medications were not reported.  It was reported that on 18-JAN-2021, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot # T003707 and expiration date 30-JAN-2022), subcutaneous for prophylaxis.  Other suspect vaccine given on the same day included a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, frequency, route, Lot # and expiration date not provided).      It was reported that the vaccines were administered to patients prior to having them evaluated and the reporter still did not have cumulative and complete temperature excursion information to have them evaluated.  This is one of several cases from the same source (US-009507513-2102USA004608).; Sender's Comments:  US-009507513-2102USA004608:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: taking Eliquis who died after receiving the Pfizer-BioNtech Covid-l9; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-014171), license party for apixaban (ELIQUIS).  This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (taking Eliquis who died after receiving the Pfizer-BioNtech Covid-l9) in patient of an unknown age and gender who received apixaban (Eliquis) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine. On an unknown date, the patient started Eliquis (unknown route) and Covid-19 Vaccine (unknown route). DEATH occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The doctor died after taking Eliquis with Covid-19 Vaccine. For Eliquis(Unknown), the reporter did not provide any causality assessments. This case was linked to US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-012621 (Linked Report).; Sender's Comments: BMS Medical Evaluation Comment: This patient died after receiving apixaban therapy. Patient also received COVID-19 vaccine.  Based on the limited information available regarding the cause of death and autopsy details, it cannot be ascertained with the reasonable possibility that the apixaban could have caused the event.; Reported Cause(s) of Death: Unknown cause of death
Age: 0.33
Sex: U
Vaccine: MENB, MENB
Symptoms: Erythema, Induration, Product administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: skin become red; skin became / hard; 4 months baby received her second dose of Bexsero; nurse did not administer the injection at 90 degree angle in my baby's leg.; 4 months baby received her second dose of Bexsero; This case was reported by a consumer via media and described the occurrence of skin red in a 4-month-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 9 hrs after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced skin red, skin induration, inappropriate age at vaccine administration, wrong injection technique and inappropriate age at vaccine administration. On an unknown date, the outcome of the skin red, skin induration, inappropriate age at vaccine administration, wrong injection technique and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the skin red and skin induration to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The patient received 2nd dose of Bexsero and the reporter noticed the nurse did not administer the injection at 90 degree angle in baby's leg. About 9 hrs. post vaccination, baby's skin became red and hard not at the injection site but close to it.   Upon internal reveiw the following corrections were made on 10th February 2021: The device problem for suspect Bexsero Pre-Filled Syringe Device was updated to Adverse Event Without Identified Device or Use Problem.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Fatigue, Feeling abnormal, Tinnitus
Clinical narrative: Upper frequency hearing loss; Ringing in my ears; Really tired; Little bit spaced out; A spontaneous report was received from a consumer concerning a 75-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced "ringing in my ears", upper frequency hearing loss, really tired and little bit spaced out.  The patient's medical history was not provided. Concomitant medication included Clopidogrel bisulfate, Bromelain, Pantoprazole sodium, Atorvastatin, low dose aspirin and Vitamin C.   On 28 Jan 2021, approximately 2-3 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 28 Jan 2021, the patient reported that after the injection he noticed ringing in his ears with upper frequency hearing loss. He felt tired and a little bit spaced out. Treatment information was not provided.   On 29 Jan 2021, the patient reported ringing was a little better, but the upper frequency hearing loss was still there along with feeling spaced out.  Action taken with mRNA-1273 in response to the events was not provided.   On 29 Jan 2021, the patient was recovered from really tired. The outcome of the events "ringing in my ears", upper frequency hearing loss, and little bit spaced out was unknown.; Reporter's Comments: This case concerns a 75-year-old, male, who experienced serious unexpected event of deafness, non-serious unexpected event of tinnitus, feeling abnormal and, non-serious expected event of fatigue. The events occurred 1 days (2-3 hrs) after mRNA-1273 (Lot# Unknown). Concomitant medications included Clopidogrel bisulfate, Bromelain, Pantoprazole sodium, Atorvastatin, low dose aspirin and Vitamin C.  Treatment details were not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis; A spontaneous report (United States) was received from a consumer regarding a 31 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced cellulitis.   The patient's medical history was not provided. Concomitant medication use was not provided.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.  On 19 Jan 2021 the patient experienced cellulitis.   Treatment for the event included intravenous antibiotics.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the event , cellulitis,  was considered unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time.  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.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Syncope
Clinical narrative: Faint; Shortness of breath; Dizzy; Headache; A spontaneous report  was received from a consumer who is a 34-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainting, dizziness, shortness of breath and headache.  The patient's medical history was not provided. Concomitant medications were not reported.   On 30 Jan 2021, the patient received their second dose of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly in his right arm for the prophylaxis of COVID-19 infection.  On 31 Jan 2021, 14 hours after the second dose, the patient experienced fainting, dizziness, shortness of breath and headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, fainting, dizziness, shortness of breath and headache, were unknown.; Reporter's Comments: This case concerns a 34-year-old male patient, who experienced medically significant unlisted event of Syncope,  non-serious listed event of Headache, and non-serious unlisted events of Dyspnea and Dizziness. The events occurred approximately 14 hours after receiving their second of two planned doses of mRNA-1273 (Lot #029L20A). Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Pneumonia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Pneumonia; COVID-19; Fever of 100.4; A spontaneous report was received from a health care professional concerning a 73-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fever, pneumonia, and COVID-19.  The patient's medical history, as provided by the reporter, included a previous COVID-19 infection diagnosis. Concomitant medications were not reported.  On 29 Dec 2020, the patient received their first dose of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient experienced fever of 100.4 and was given paracetamol.   On 31 Dec 2020, the patient had a chest x-ray and was admitted to the hospital for pneumonia.   On 03 Jan 2021 the patient tested positive for COVID-19. The patient had previously tested positive for COVID-19 in November. No additional treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, fever, pneumonia, and COVID-19, was unknown.; Reporter's Comments: This case concerns a 73-year-old, male patient, with a previous COVID-19 infection prior to vaccination, who experienced a serious event of Pneumonia and non-serious events of Covid-19, and Pyrexia after receiving first dose of mRNA-1273 (Lot# 039K20A). Based on the mechanism of action of mRNA-1273, the event of Covid-19 is assessed as unlikely related to mRNA-1273. Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, Pain in extremity
Clinical narrative: Myocarditis; Acute onset of chest pain; Soreness of the arm; A spontaneous report was received from a physician concerning a 20-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of the arm, acute onset of chest pain, and myocarditis.   The patient's medical history, as provided by the reporter, included asthma, and allergy to egg, peanut and tree nuts. Concomitant medications reported included dupilumab, montelukast, budesonide / formoterol, cetirizine, albuterol and epinephrine.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 26 Jan 2021, after receiving the second dose of the vaccine, the patient reported soreness of the arm for 3 to 4 days.  On 30 Jan 2021, the patient presented to the hospital with acute onset of left sided chest pain. The physician reported that the patient developed myocarditis. Consent for Safety to follow up was received.  Treatment for the events, as reported, included patient's concomitant medications of dupilumab, montelukast, budesonide / formoterol, cetirizine and albuterol. No additional treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, soreness of the arm, was resolved on unknown date. The event acute onset of chest pain and myocarditis was not resolved at the time of this report.; Reporter's Comments: This case concerns a 20 year old male with medical history of multiple allergies, who was hospitalized with serious unexpected events of chest pain and myocarditis and a non-serious unexpected event of pain in extremity.  The chest pain and myocarditis occurred 33 days after first dose and 4 days after last dose of mRNA-1273.  Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Bedridden, Body temperature increased, Decreased appetite, Feeling abnormal
Clinical narrative: feeling much worse; Bloodwork with elevated parameters (troponins); Couldn't take food; Couldn't get up from bed; Fever (101°F); Atrial fibrillation; Pericarditis; A spontaneous report was received from a non-healthcare professional concerning a 67-year-old, female patient who developed a fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation.    The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Pentasa, metformin, insulin, Zoloft and atorvastatin.  The patient received their first of two planned doses of mRNA-1273 (lot number 028L20A) on 20 Jan 2021 in the right arm for prophylaxis of COVID-19 infection.  The patient developed a fever on 25 Jan 2021, and it got up to 101 degrees Fahrenheit on 26 Jan 2021.  On 26 Jan 2021 she felt must worse, couldn't take food, and couldn't get up from bed. On 27 Jan 2021, she was taken to the emergency room where her oxygen saturation was low, but the fever was gone.  She was placed on oxygen, and blood work had elevated troponin. The patient was diagnosed with pericarditis and she was kept overnight. On 28 Jan 2021 she had atrial fibrillation and the medical team couldn't convert her chemically.  She was stabilized on 30 Jan 2021 and she was feeling much better.   Treatments of these events included oxygen and ibuprofen.    The events, fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation were considered Recovering.; Reporter's Comments: This case concerns a 67 year old female who experienced serious unexpected events of feeling abnormal, decreased appetite, bedridden, elevated troponin, pericarditis, and atrial fibrillation, and a serious expected event of fever. The events began 6 days after first dose of mRNA-1273. Treatment with ibuprofen. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pericarditis, Pyrexia, Troponin
Clinical narrative: feeling much worse; Bloodwork with elevated parameters (troponins); Couldn't take food; Couldn't get up from bed; Fever (101°F); Atrial fibrillation; Pericarditis; A spontaneous report was received from a non-healthcare professional concerning a 67-year-old, female patient who developed a fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation.    The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Pentasa, metformin, insulin, Zoloft and atorvastatin.  The patient received their first of two planned doses of mRNA-1273 (lot number 028L20A) on 20 Jan 2021 in the right arm for prophylaxis of COVID-19 infection.  The patient developed a fever on 25 Jan 2021, and it got up to 101 degrees Fahrenheit on 26 Jan 2021.  On 26 Jan 2021 she felt must worse, couldn't take food, and couldn't get up from bed. On 27 Jan 2021, she was taken to the emergency room where her oxygen saturation was low, but the fever was gone.  She was placed on oxygen, and blood work had elevated troponin. The patient was diagnosed with pericarditis and she was kept overnight. On 28 Jan 2021 she had atrial fibrillation and the medical team couldn't convert her chemically.  She was stabilized on 30 Jan 2021 and she was feeling much better.   Treatments of these events included oxygen and ibuprofen.    The events, fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation were considered Recovering.; Reporter's Comments: This case concerns a 67 year old female who experienced serious unexpected events of feeling abnormal, decreased appetite, bedridden, elevated troponin, pericarditis, and atrial fibrillation, and a serious expected event of fever. The events began 6 days after first dose of mRNA-1273. Treatment with ibuprofen. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Ophthalmoplegia
Clinical narrative: sixth nerve palsy of the right eye; A spontaneous report was received from a healthcare professional concerning a 73-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed sixth nerve palsy of the right eye.    The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, approximately two weeks prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 01 FEB 2021, she was seen at an ophthalmologist office and diagnosed with sixth nerve palsy of the right eye. An MRI was performed on an unknown date for the patient's condition which revealed there was mild generalized cerebral atrophy, prominent enlargement of the lateral and 3rd ventricles out of proportion to degree of cerebral atrophy. 4th ventricle is non dilated. There is patchy bilateral cerebral white matter flares. Hyperintensity is noted likely representing findings of chronic microvascular ischemic change. No obstructive lesion identified. No contiguous band of flare/T2 hyperintensity along the surface of the ventricles to suggest the presence of transependymal CSF flow. Impression was that in the setting of potential 6th nerve palsy, this constellation of findings may potentially represent underlying increased intracranial pressure. Normal pressure hydrocephalus was an alternative consideration in the appropriate clinical context. No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, developed sixth nerve palsy of the right eye, was not reported.; Reporter's Comments: This case concerns a 73 year old, female patient who experienced a serious event of Ophthalmoplegia after receiving second dose of mRNA-1273 (Lot# unknown). Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diabetic ketoacidosis, Heart rate increased, Migraine, Nausea
Clinical narrative: Diabetic Ketoacidosis (nausea, heavy breath, could not form words, PH dropping); Increase of resting heart rate 114 to 120 to 130 and max 150; Terrible Migraine; Extreme nausea; A spontaneous report  was received from a consumer, concerning her son, who is 27-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced diabetic ketoacidosis (DKA), terrible migraine, nausea, heavy breathing and increased heart rate.  The patient's medical history, as provided by the reporter, included Asperger syndrome and Diabetes. No concomitant products were reported.  On 14 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 15 Jan 2021, at 10:30 AM, the patient had terrible migraine and extreme nausea. He experienced DKA as he could hardly breath and breathing was heavy. At 6 PM, as stated by the reporter, the patient went to the emergency room and tests were done which confirmed DKA. The patient stayed there for 2 hours but his PH level was decreasing, couldn't form words and heart rate was 150 beats per minute(bpm) and was transferred to bigger hospital where he stayed in ICU. He was discharged in the afternoon on 17 Jan 2021.  On 20 Jan 2021, the reporter stated that the patient again went back into DKA and was sent to hospital.  On 23 Jan 2021, all symptoms were resolved, and the patient was discharged.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, diabetic ketoacidosis (DKA), terrible migraine, nausea, heavy breathing and increased heart rate, were considered resolved on 23 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, COVID-19, Hallucination, Malaise, Oxygen saturation decreased
Clinical narrative: Hallucination; Feeling sick; High blood pressure; Oxygen was low; Covid-19; Fever; A spontaneous report  was received from a consumer regarding a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced malaise, having fever, high blood pressure, abnormal, hallucination, oxygen being low/ oxygen saturation decreased, and COVID-19.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 05 Jan 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 after the mRNA-1273 vaccine was given, the patient experienced being sick, having fever, high blood pressure, hallucination, and oxygen being low.  On 13 Jan 2021, the patient tested positive for COVID-19.  Treatment included azithromycin.   Action taken with mRNA-1273 was not reported.  The outcome of the events, being sick, having fever, high blood pressure, hallucination, and oxygen being low, was not reported.; Reporter's Comments: Fever is consistent with the known safety profile of the product and temporarily associated with the administration. Hence, a causal association cannot be excluded.  Based on the known etiology for COVID-19 the other events are including COVID-19 are considered unlikely associated with product use and can be attributed to COVID-19 infection.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-1 test
Clinical narrative: Hallucination; Feeling sick; High blood pressure; Oxygen was low; Covid-19; Fever; A spontaneous report  was received from a consumer regarding a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced malaise, having fever, high blood pressure, abnormal, hallucination, oxygen being low/ oxygen saturation decreased, and COVID-19.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 05 Jan 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 after the mRNA-1273 vaccine was given, the patient experienced being sick, having fever, high blood pressure, hallucination, and oxygen being low.  On 13 Jan 2021, the patient tested positive for COVID-19.  Treatment included azithromycin.   Action taken with mRNA-1273 was not reported.  The outcome of the events, being sick, having fever, high blood pressure, hallucination, and oxygen being low, was not reported.; Reporter's Comments: Fever is consistent with the known safety profile of the product and temporarily associated with the administration. Hence, a causal association cannot be excluded.  Based on the known etiology for COVID-19 the other events are including COVID-19 are considered unlikely associated with product use and can be attributed to COVID-19 infection.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial paralysis, Insomnia, Pain, Tremor
Clinical narrative: Facial paralysis; Shaking all over her body/shaking for 8 days; Can not sleep; Whole body hurts and it does not go away; Terrible chills and shivers; A spontaneous report was received from a consumer who is a 61-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain).  The patient's medical history was not provided. Concomitant medications were not reported.  On 13 Jan 2021, the patient received their first two planned doses of mRNA-1273 intramuscularly in her left arm for the prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced terrible chills, shaking for 8 days, shivers and cold all the time, cannot sleep and whole-body hurts. On 28 Jan 2021, the patient experienced facial paralysis which was getting worse more on right side then moved to the middle of her face. The patient was given steroids.  Treatment for the events included steroids.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain), were considered unknown.; Reporter's Comments: This case concerns a 61-year-old female who experienced a serious unexpected event of facial paralysis, the non-serious unexpected events of tremors, insomnia and pain, and a non-serious expected event of chills. Events began on 21-Jan-21 after the first dose of mRNA-1273 on 13-Jan-21. Treatment with steroids. Outcomes unknown. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient was died.  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, the patient received his first dose of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient was died.  Treatment of this event was not provided.  The patient was died. The cause of death was not provided. Autopsy details were not provided.; Reporter's Comments: This case concerns a male patient (unknown age), who experienced event of death (cause unknown). The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Autopsy and cause of death were not reported.  Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.; Reported Cause(s) of Death: Death
Sex: M
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Hallucinations/ Have seen ghosts; A spontaneous report was received from a consumer who is a male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hallucinations and seeing ghosts.  The patient's medical history, as reported, included problem in eye that caused patient to see weird things some years ago. Concomitant medications were not reported.  On an unspecified date, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced hallucinations and seeing ghosts.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, hallucinations and seeing ghosts, was unknown.; Reporter's Comments: This case concerns a 72-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of hallucinations.  Based on the current available information and temporal association between the use of the product and the onset of the event after vaccination, a causal relationship cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Splenic haemorrhage, Splenic rupture
Clinical narrative: Spontaneous splenic hemorrhage and rupture; Spontaneous splenic hemorrhage and rupture; A spontaneous report was received from a consumer who is  a 40-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a spontaneous splenic hemorrhage and rupture.   The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 16 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:013L20A) for prophylaxis of COVID-19 infection.    On 19 Jan 2021, at approximately 8 am, the patient suffered a spontaneous splenic hemorrhage and rupture. He went to the hospital and was admitted.   On 21 Jan 2021, a splenectomy was performed.    On 22 Jan 2021, he was discharged from the hospital after four days. Pathology was performed on the ruptured spleen and nothing pathological was found. All blood tests and virus tests came back negative. Cause of spleen hemorrhage and rupture was unknown.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events spontaneous splenic hemorrhage and rupture was unknown.; Reporter's Comments: This case concerns a 40-year-old male subject, who experienced serious unexpected event of Splenic hemorrhage and splenic rupture. The events occurred 3 days after the first dose of the mRNA-1273 (Lot number:013L20A) administration. Cause of events were unknown. Very limited information regarding these events have been provided at this time. 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.
Sex: M
Vaccine: COVID19
Symptoms: Keratitis
Clinical narrative: Both eyes with Keratoconjunctivitis virus; A spontaneous report was received from a pharmacist concerning a 75 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced both eyes with keratoconjunctivitis virus.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On an 07 Feb 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 026L20A and expiery date 28 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient experienced irritated eyes, problems with vision, sensitivity to light, didn't sleep  the night, and felt like someone put acid in his eyes. On 09 Jan 2021, the patient was seen by his eye doctor and diagnosed with immune response to vaccine with keratoconjunctivitis virus with no infection. Treatment included an unspecified drug.   Action taken with the mRNA-1273 in response to the event was not reported.  On 15 Jan 2021, the outcome of the event keratoconjunctivitis virus was resolved.; Reporter's Comments: This case concerns a 75-year-old, male, who experienced a serious unexpected event of Keratoconjunctivitis (bilateral). The events occurred 2 day after mRNA-1273 (Lot# 026L20A). Treatment information was not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: One case of anaphylaxis, after an individual received Moderna's vaccine; A spontaneous report was received from other manufacturer Pfizer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced one case of anaphylaxis, after an individual received Moderna's vaccine.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an undisclosed date, the patient received their dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Other manufacturer forwarded article posted via social media regarding COVID-19 vaccines. The article contained a brief statement from the Center for Disease Control (CDC) that stated, they also noted one case of anaphylaxis, which can cause throat swelling and breathing difficulty, after individual received Moderna's vaccine'. No further information was provided regarding Moderna's COVID-19 Vaccine (mRNA-1273).  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Dysgeusia, Headache, Nausea
Clinical narrative: the swelling and extreme tenderness of the site of injection; the swelling and extreme tenderness of the site of injection; headache; I couldn't sleep last night because I have headache, thrombing headache and back pain; Nausea; I had like metallic taste; Dizziness; The initial case was missing the following minimum criteria: suspect drug. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable physician. A 61-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685, expiration date Mar2021) on his left arm, intramuscular on 18Dec2020 at 0.3 mL, single for COVID-19 immunization.  Medical history included hypertensive, 2 stents in heart in 2016, Hyperlipidemia, hypothyroidism, coronary artery disease in 2016 and Allergic (Allergic rhinitis + Chronic sinusitis). Concomitant medication included acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX). It was reported that the patient had swelling and severe tenderness left his arm. He couldn't sleep last night because he had throbbing headache and back pain on 18Dec2020. Initially, he had nausea. Patient stated further stated that Headache and swelling and extreme tenderness of the site of injection, that is the swelling, no redness but the swelling and tender and painful. Initially, he had till now the mild back pain. He patient said she took Tylenol. She also mentioned that initially she had like metallic taste and then disappear. The patient also had dizziness a little bit. The outcome of the event vaccination site swelling, dysgeusia and tenderness was recovered on unspecified dates, headache and back pain was not recovered, recovering for nausea while unknown for the remaining events.