chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain injury, Death, Myocardial infarction
Clinical narrative: According to registry, patient received Moderna dose 1 at "pharmacy" on 3/3/2021.  Patient arrived in ED on 3/4/21 at approx 9AM via ambulance.  ED physician note:  "56-year-old male brought in by EMS intubated with CPR in progress.  It was reported that he arrived to work and then passed out.  CPR was initiated almost immediately.  BLS determined that he was  pulseless and AED was applied.  He was defibrillated twice.  He was then intubated by ALS and administered epinephrine twice with return of spontaneous circulation.  He maintained a pulse for approximately 20 minutes when he again developed cardiac arrest.  ACLS guidelines were again initiated and there was no return of pulse for approximately 20-25 minutes until he arrived in the emergency department.  Emergency department CPR was continued and he was administered an additional epinephrine with return of a pulse.  Is reported that he had no complaints prior to the event."  Patient was intubated and ventilated, started on norepinephrine drip in ED.  Twelve-lead EKG demonstrated right bundle branch block with left posterior fascicular block and diffuse QRS widening and diffuse repolarization abnormalities.  Family consented to Cath Lab.    Per Interventional Cardiologist note:  "1.  Angiography demonstrated proximal to mid LAD hazy 90-95% lesion likely culprit for cardiac arrest.  1 stent placed.  2.  Diffuse distal right coronary disease that is likely nonculprit for cardiac arrest.  3.  Left ventriculography demonstrated severe anterior wall hypokinesis with overall left ventricular ejection fraction of 40%.  4.  Patient electrically and hemodynamically stable.  Levophed has been stopped.  Amiodarone bolus given in the Cath Lab for frequent ventricular ectopy.  No drip was continued due to resolution of ectopy.  5.  Dyslipidemia he will be on high-dose statin therapy.  6.  Diabetic management as per primary team.  7.  Quad-Lumen placed by me.  Hypothermia protocol to be initiated in the ICU given GCS score less than 8 with no purposeful movements.  Head CT scan completed before cardiac catheterization that demonstrated diffuse cerebral edema.  8.  Prognosis guarded and likely poor.  The next 24 to 40 hours will be critical.  Family was updated in detail."  Patient transferred to ICU post Cath Lab.  Remains intubated, ventilated in ICU.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: 2-26-2021 woke up with swollen face and eye lids. member states unable to open eyes.  Took OTC Benadryl and swelling resolved over 24 hours
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Patient reported flushing, sweating, and dizziness about 5 minutes after vaccine administration.  Symptoms subsided within 10 minutes of onset.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Pt fainted and looked to have seizing. pt revived and said he was fine, and asked for alcohol to smell. EMS was called and pt was examined. Pt later disclosed that he always faints when he gets shots and he has anxiety.  Pt refused to go with EMS and pt mom said she would take him to doctor
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Full blood count abnormal, Liver function test abnormal, Serum ferritin abnormal
Clinical narrative: Patient received dose 1 and dose 2 of the COVID 19 vaccine, 2/2/21 (Lot EL9265, Pfizer)  and 2/24/21 (Lot EN6202, Pfizer), on 2/28/21 patient presented to the Emergency Department at our facility. CBC lab test was abnormal, possible Leukemia, patient transferred to Medical Center for further evaluation and treatment. Patient expired on March 2, 2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Muscular weakness, Pyrexia
Clinical narrative: Dizziness,  high fever, chills, headache, muscle weakness,   Started and I?m no better
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Oropharyngeal discomfort, Tachycardia
Clinical narrative: Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chills, throat discomfort.  Patient had improvement with water, O2 and juice. Patient left in wheelchair after 90 minutes of observation with resolution of tachycardia and throat discomfort.. States she had similar reactions to influenza vaccine in past, but did not last that long. We discussed ER evaluation at which patient elected to go home as she had driver and wanted to go home. Patient instructed Benadryl, rest and fluids day of event. 911/ER if worsening symptoms. Patient in agreement to plan.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood pressure decreased, Chills, Dizziness, Laboratory test
Clinical narrative: I had Covid-19 in December 2020. On the following day of my first vaccine, in the middle of the night, I experienced chills, body aches. At 7am the next day I woke up feeling light headed and passed out. When I woke up I had thrown up on myself and started to hear a whooshing sound in my ears and I went back to bed. At 9am my symptoms started all over again. I live with my house maid and since I did not look well, she took me to urgent care. My BP had dropped and I was super dizzy. I got an IV drip for an hour, anti-nausea medication. My blood was also drawn and found to have underlying anemia. My urine test was negative. The pulse oximetry was fine and by the next day I slowly started to feel better.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain, Tinnitus, Urine analysis normal, Vomiting
Clinical narrative: I had Covid-19 in December 2020. On the following day of my first vaccine, in the middle of the night, I experienced chills, body aches. At 7am the next day I woke up feeling light headed and passed out. When I woke up I had thrown up on myself and started to hear a whooshing sound in my ears and I went back to bed. At 9am my symptoms started all over again. I live with my house maid and since I did not look well, she took me to urgent care. My BP had dropped and I was super dizzy. I got an IV drip for an hour, anti-nausea medication. My blood was also drawn and found to have underlying anemia. My urine test was negative. The pulse oximetry was fine and by the next day I slowly started to feel better.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Left arm developed a rash: Rash was from her left deltoid to her left wrist. Onset provider evaluated the patient and 50 mg of Diphenhydramine was given orally
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose normal, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Within the 15 minutes following vaccination client complained of feeling light headed, weak, and nauseated. He appeared very pale and diaphoretic. Reportedly may have  loss consciousness for few seconds per monitoring staff. While in his car his seat was inclined. His B.P. was 124/76 Heart Rate 63, O2 level was 93 % initially and increased to 97%. He reported improvement after being in inclined position for few minutes. However after 10 minutes he complained again of feeling light headed and nauseated, appearing pale. Blood Sugar level was 134.  MDs assessing client decided that it was best to have him further evaluated in the ER and therefore 911 was activated. With EMT clients Vital Signs were 130/80 HR in the 60's and O2 sats continued to go between 93%  and 97%. Client continued to be diaphoretic, pale, also shaky
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Tremor
Clinical narrative: Within the 15 minutes following vaccination client complained of feeling light headed, weak, and nauseated. He appeared very pale and diaphoretic. Reportedly may have  loss consciousness for few seconds per monitoring staff. While in his car his seat was inclined. His B.P. was 124/76 Heart Rate 63, O2 level was 93 % initially and increased to 97%. He reported improvement after being in inclined position for few minutes. However after 10 minutes he complained again of feeling light headed and nauseated, appearing pale. Blood Sugar level was 134.  MDs assessing client decided that it was best to have him further evaluated in the ER and therefore 911 was activated. With EMT clients Vital Signs were 130/80 HR in the 60's and O2 sats continued to go between 93%  and 97%. Client continued to be diaphoretic, pale, also shaky
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Patient has a previous history of seizure disorder. She received the vaccination and proceeded to the waiting area. While there she reported to staff embers that she could feel a seizure coming on. She was moved to the floor in a safe location and monitored. She was able to contact her spouse to bring her medication. She began to seize and at one point she did lose consciousness. She regained consciousness and improved rapidly afterwards. EMS was called, but she declined the service. She said that these seizures aren't uncommon and she wanted to go home to recover.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Communication disorder, Condition aggravated, Feeling abnormal, Seizure
Clinical narrative: Patient has a previous history of seizure disorder. She received the vaccination and proceeded to the waiting area. While there she reported to staff embers that she could feel a seizure coming on. She was moved to the floor in a safe location and monitored. She was able to contact her spouse to bring her medication. She began to seize and at one point she did lose consciousness. She regained consciousness and improved rapidly afterwards. EMS was called, but she declined the service. She said that these seizures aren't uncommon and she wanted to go home to recover.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: Red rash on face, neck, and chest. Prednisone 20mg 1xday. Triamcinolone Acetonide Cream, applied on skin 2xday. Ache in left arm. All symptoms are still present after one week.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Nausea
Clinical narrative: Severe nausea, 102.8 temp, severe chills, odd headache,  arm very sore, fatigue
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe nausea, 102.8 temp, severe chills, odd headache,  arm very sore, fatigue
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chapped lips, Glossodynia, Headache, Lip pain
Clinical narrative: Sore arm (not as bad as 1st dose) Bad headache (not as bad as 1st dose) Extremely red and sore tongue,sore/chapped lips and mouth around inside of lips with a few small blisters.  It started first on the tip of my tongue and got worse as the week progressed.  Everything felt like it was on fire.  I called my Dr, who called in a prescription mouthwash to swish in mouth and spit out.  When I realized it might be related to the vaccine, I also took a Benedryl which seemed to help.  I?m on day two of the meds.  It?s not burning quite as badly, but still isn?t gone.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Pain in extremity
Clinical narrative: Sore arm (not as bad as 1st dose) Bad headache (not as bad as 1st dose) Extremely red and sore tongue,sore/chapped lips and mouth around inside of lips with a few small blisters.  It started first on the tip of my tongue and got worse as the week progressed.  Everything felt like it was on fire.  I called my Dr, who called in a prescription mouthwash to swish in mouth and spit out.  When I realized it might be related to the vaccine, I also took a Benedryl which seemed to help.  I?m on day two of the meds.  It?s not burning quite as badly, but still isn?t gone.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Throat irritation
Clinical narrative: Itching of throat, swelling. History of anxiety. BP's - 182/123 (pulse 118), 164/102. Water given.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 60-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In November 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In November 2020, less than a day after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra 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 case was reported by patient's wife. The age at vaccination was not reported. The reporter stated patient experienced diarrhea after receiving Fluarix, in the first week of November 2020. The patient began experiencing diarrhea within 12 hours of receiving the vaccine. The reported stated diarrhea lasted at least 4 days, possibly longer. Consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Tremor, Vertigo, Vomiting
Clinical narrative: vertigo; dizziness; trembling; throwup; terrible right hip pain; A spontaneous report was received from a consumer who was also a 70-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vertigo, dizziness, trembling/tremor, throw up/vomiting, terrible right hip pain/arthralgia.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 12 February 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 031mz0) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 14 February 2021, approximately two days after the mRNA-1273 vaccine was given, the patient experienced vertigo, dizziness, trembling, and throw up. He reported being hospitalized for these symptoms.  On 16 February 2021, he reports that he is feeling much better, but is experiencing terrible hip pain.  Consent to contact was provided.  Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, vertigo, dizziness, trembling, throw up, and terrible hip pain, were considered unknown.; Reporter's Comments: This case concerns a 70 year old male patient, who experienced a serious unexpected event of vertigo, dizziness, and tremor among others, 3 day after receiving first dose mRNA- 1273 (Lot# 031mz0). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Was found deceased a little less than 12 hours following COVID vaccination; A spontaneous report was received from a reporter concerning a 96-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was found deceased a little less than 12 hours following COVID vaccination.  The patient's medical history included hospice care. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient was found deceased a little less than 12 hours following COVID vaccination, and he had had some changes over the last two days. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  On an unknown date the patient died. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 96 year old male patient, who was on hospice care experienced a fatal event of death, after receiving mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Pneumonia
Clinical narrative: Mild case of pneumonia; Tested positive for COVID; Shortness of breath; A spontaneous was received from a healthcare facility staff member concerning 55 years of old, male patient who developed shortness of breath, mild case of pneumonia and tested positive for COVID. The patient's medical history included back issue. The patient had an epidural for bulging disk in back in an unknown date in December. Concomitant product use was not provided by the reporter.   On 29-JAN-2021, eight days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on left arm for prophylaxis of COVID-19 infection.  On 20-JAN-2021, the patient had COVID symptoms including congestion and cough but tested negative on rapid testing. Since tested negative, the patient received first dose of Moderna COVID-19 vaccine as scheduled on 29-JAN-2021 at Hospital.  On 06-FEB-2021 after experiencing shortness of breath, the patient was retested by rapid test, which was also negative. However, the patient tested positive for COVID on Polymerase Chain reaction test at Urgent Care. The patient had a mild case of pneumonia  The reporter believes that the patient probably was positive before, as patient had been home since 19-DEC-2020 due to a back issue. Thinks that the patient's son may have been asymptomatic and all eight members in the household tested positive except the reporter. Treatment for the events included antibiotic azithromycin 5 days z-pack.  The events shortness of breath, mild case of pneumonia and tested positive for COVID were considered recovered/resolved on an unknown date.; Reporter's Comments: Based on reporter's causality and high probability of corona infection from the close contacts where all eight members in the household were tested positive except the patient immediately before the vaccination, the event is assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Bells Palsy; Numbness in left side of face; A spontaneous report was received from a consumer who was also a 43 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced Bell's Palsy / facial paralysis and numbness in left side of face / hypoaesthesia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021 at 3:15 pm, approximately 25 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.   On 17 Feb 2021, about 25 minutes after receiving the vaccination administration, the patient reported numbness on the left side of his face. His doctor informed him that he had Bell's Palsy and to take diphenhydramine. Consent to follow up from safety was provided by the patient.  Action taken with the first dose of mRNA-1273 vaccine was not reported.  The events, Bell's Palsy and numbness in left side of face, were ongoing at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Neuropathy peripheral, Paraesthesia
Clinical narrative: Neuropathy that is affecting his balance; Neuropathy that is affecting his balance; Tingling; A spontaneous report was received from a consumer concerning a 74-year-old, male patient, who experienced neuropathy that is affecting his balance (neuropathy peripheral and balance difficulty), and tingling (paraesthesia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received his first of two planned doses of mRNA-1273 (Lot unknown) on unknown date. On 29-Jan-2021, prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot number: 029K20A) for prophylaxis of Covid-19 infection.   The patient stated that at some point after receiving the second vaccine, he began experiencing neuropathy that affected his balance and caused tingling.    Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, neuropathy that is affecting his balance and tingling, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Malaise, Nausea
Clinical narrative: Not feeling great; Very nauseous/Extreme nausea; hallucinations; A spontaneous report was received from a consumer who was also  a 51-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nauseous, minor hallucinations, kind of a rough night, and not feeling great.   The patient's medical history included diabetes and multiple sclerosis. Products known to have been used by the patient, within two weeks prior to the event, included insulin glulisine, insulin degludec, fingolimod hydrochloride, and levothyroxine.  On 14th Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient reported she was very nauseous 11-12 hours after receiving the vaccination. She was not sure if she was having minor hallucinations or not due to the extreme nausea. On 15 Feb 2021, the patient was not feeling great. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event nausea was recovered on 17 Feb 2021. The outcome of the events, hallucinations and not feeling great, were unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 vaccine cannot be excluded. The event of nausea is consistent with the known safety profile of the vaccine and a causal association cannot be excluded
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 YEAR OLD WAS ACCIDENTLY VACCINATED; A spontaneous report was received from other healthcare professional (Pharmacist) concerning a 16-years-old patient, received who Moderna's COVID-19 vaccine (mRNA-1273) accidentally.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, the patient received their dose of mRNA-1273 (Batch Number: Unknown), intramuscularly in the shoulder for prophylaxis of COVID-19 infection.  On 18 Feb 2021, 16 -years-old patient was accidentally vaccinated with the Moderna Covid-19 vaccine  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event 16 -years-old patient was accidentally vaccinated with the Moderna Covid-19 vaccine was considered recovered.; Reporter's Comments: This report refers to a case of a 16-year-old patient with Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated adverse events.   Event considered resolved.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Injection that was given 7 days early; A spontaneous report  was received from a consumer concerning a female patient, of unknown age, who reported that injection was given 7 days early/ MedDRA PT: inappropriate schedule of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (Lot number not provided) on an unknown date. On an unspecified date, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection.  The patient stated that injection was given 7 days early. No further information was provided. Treatment information was unknown.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The event, injection was given 7 days early, was considered resolved.; Reporter's Comments: This report refers to a case of a female of unknown age with Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated adverse events. The event, injection was given 7 days early, was considered resolved.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 years old was accidentally given Moderna Covid-19 Vaccine; A spontaneous report was received from a health care professional concerning a 16-year-old patient who received Moderna's Covid 19 vaccine(mRNA1273) at an inappropriate age (dosing error-pediatric use)  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    On an unknown date, the patient received first of two planned doses of mRNA-1273 (batch number-Unknown) intramuscularly on a n unknown day for prophylaxis of Covid-19 infection.  A 16 year old patient was accidentally given the Moderna Covid-19 vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event, inappropriate age at vaccine administration were considered as recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose administered 16 days after the first dose; A spontaneous report was received from a consumer for a 78-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient received second dose after sixteen days after receiving the first dose of vaccine.  The patient's medical history was not provided. The patient is allergic rogaine hair products, sulfur eyedrops, latex gloves and tape, ciprofloxacin hydrochloride (500mg), advil and cefalexin. Concurrent conditions included acid reflux, cholesterol, depression, glaucoma (both eyes), headache, hypertension, nausea,  sinus disorder and sleep disorder. The concomitant medications included  timolol maleate, latanoprost, atorvastatin, pantoprazole, trazodone, montelukast sodium, amlodipine, vitamin d3, acetylsalicylic acid and magnesium .  On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Feb 2021, sixteen days after receiving the first dose of vaccine, the patient's vaccination card was checked by the facility and mRNA-1273 (Lot number: 022M20A) was administered intramuscularly. Additionally, it was reported that the patient was registered to receive vaccine under County Group of Vaccination and County Public Health (CPH).   Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event second dose administered 16 days after the first dose was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administration for mRNA-1273, lot # 012M20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Atrial fibrillation, Cardiac failure chronic
Clinical narrative: AFIB; Chronic Heart failure; Asthma got out of control out of no where.; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine and was admitted to hospital for atrial fibrillation and chronic heart failure, a feeling of wasn't feeling well, Asthma got out of control out of nowhere.  Patient's medical history was not provided, and concomitant medicines taken by the patient, within two weeks prior to the event was not provided.  On 16 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly  for prophylaxis of COVID-19 infection.  On 11 FEB 2021, the patient was admitted in hospital for atrial fibrillation and chronic heart failure, a feeling of wasn't feeling well and asthma got out of control out of nowhere and was discharged on 19 FEB 2021. Treatment was not provided.  Action taken with mRNA-1273 was not reported.  The outcome of the events, to hospital admission for atrial fibrillation and chronic heart failure, a feeling of wasn't feeling well, Asthma got out of control out of nowhere was unknown.; Reporter's Comments: Very limited information regarding this event of heart attack has been provided at this time. Patient's medical history, list of concomitant medications, onset date and clinical details of the event is lacking. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Fatigue, Malaise, Pneumonia
Clinical narrative: Did not feel well; pneumonia; Covid-19; trouble breathing well; a little tired for a couple of days; A spontaneous report received from a Consumer concerning, a 67-year-old age female patient who received first dose of the Moderna COVID-19 vaccine and developed a serious, medically important event of pneumonia, in addition to non-serious events of COVID positive test, dyspnoe (reported as trouble breathing) and malaise (reported as do not feel well).  The patient's medical history included cancer, cough and fatigue. Patient's concomitant included Ibrance, Levofloxacin and Dexamethasone.   On 01 FEB 2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 043L20A or 043620A) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated that she had a cough before receiving the vaccine which can be caused by cancer medication that she takes. She reported that she was also a little tired for a couple of days. Patient stated a week later on 10 FEB 2021, she saw her oncologist and let them know that she had trouble breathing well and did not feel well since the day before. Patient stated she was informed by the nurse that it's probably just a reaction to the vaccine. She stated she received her regular cancer treatment that day. Patient stated the following week on Tuesday 16 FEB 2021 she had trouble breathing and saw her primary doctor who diagnosed her with pneumonia and prescribed levofloxacin for 10 days and dexamethasone twice daily 7 days. She was also tested for COVID which came back positive. Patient provided consent to follow up with her.  Treatment medication was prescribed by primary doctor (Levofloxacin and Dexamethasone).  Action taken with mRNA-1273 in response to the event was not provided.  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 start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Did not feel well; pneumonia; Covid-19; trouble breathing well; a little tired for a couple of days; A spontaneous report received from a Consumer concerning, a 67-year-old age female patient who received first dose of the Moderna COVID-19 vaccine and developed a serious, medically important event of pneumonia, in addition to non-serious events of COVID positive test, dyspnoe (reported as trouble breathing) and malaise (reported as do not feel well).  The patient's medical history included cancer, cough and fatigue. Patient's concomitant included Ibrance, Levofloxacin and Dexamethasone.   On 01 FEB 2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 043L20A or 043620A) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated that she had a cough before receiving the vaccine which can be caused by cancer medication that she takes. She reported that she was also a little tired for a couple of days. Patient stated a week later on 10 FEB 2021, she saw her oncologist and let them know that she had trouble breathing well and did not feel well since the day before. Patient stated she was informed by the nurse that it's probably just a reaction to the vaccine. She stated she received her regular cancer treatment that day. Patient stated the following week on Tuesday 16 FEB 2021 she had trouble breathing and saw her primary doctor who diagnosed her with pneumonia and prescribed levofloxacin for 10 days and dexamethasone twice daily 7 days. She was also tested for COVID which came back positive. Patient provided consent to follow up with her.  Treatment medication was prescribed by primary doctor (Levofloxacin and Dexamethasone).  Action taken with mRNA-1273 in response to the event was not provided.  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 start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Contusion, Joint lock, Loss of control of legs
Clinical narrative: Has some seriously bruises; knees locked up, lost his balance, lost control of his legs; knees locked up; lost his balance; A spontaneous report was received from consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, knees locked up, lost his balance, lost control of legs and some serious bruises.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 18-Feb-2021, six days later, patient reported that his knees locked up, he lost his balance and lost control of his legs.  He stated that as of 22-Feb-2021, he has some serious bruises.  Laboratory details were not provided.  No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events,  knees locked up, lost his balance, lost control of legs and some serious bruises, was unknown.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Loss of control of legs among others,7 days after receiving 2nd dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Arrhythmia; A spontaneous report was received from a consumer who was an 81-year-old, male patient who was administered Moderna Covid-19 vaccine.  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On 21-Jan-2021, approximately four hours prior to the onset of events, patient received first of two planned doses of Moderna Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot number unknown).   On the same day, four hours after administration, patient experienced Arrhythmia and continued on and off for 4 days and stopped. It is not known that patient seek the treatment for the condition and details were not provided.  Action taken with 2nd dose of vaccine is not reported.  The outcome of the event Arrhythmia is resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Bilateral pulmonary emboli; A Spontaneous report was received from a consumer concerning a 90-Years-old male patient who received both doses of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bilateral pulmonary emboli.   The patient's medical history was not provided. NO Concomitant medication was reported  On  15 Jan 2021, the patient received their first planned doses of mRNA-12 (lot no: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021 prior to the onset of the events, the patient received their second planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 16 Feb 2021, the patient was hospitalized due to Bilateral pulmonary emboli.  Treatment for the event included apixaban for blood thinning and Atorvastatin which was stopped a month before was restarted.  The action taken with the drug in response to the event is unknown.  At the time of this report, the outcome of the event Bilateral pulmonary emboli was considered resolved.; Reporter's Comments: This case concerns a 90-Years-old, male patient who experienced serious event of Bilateral pulmonary emboli. Treatment for the event included apixaban and Atorvastatin (which was stopped a month before) was restarted. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Chromaturia, Fatigue, Gastrointestinal pain
Clinical narrative: Nausea; Chills; Cramps in intestines; Vomiting; Temperature of 99.4; muscle spasms; Headache; Felt lethargic; Felt tired; Dark urine like motor oil gold; like having a bad flu.; A spontaneous report  was received from a Consumer concerning a 70-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball  The patient's medical history was not provided.  Relevant concomitant medications were not reported.   On 17-FEB-2021, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18-FEB-2021, the patient experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball.  His wife took him to the ER at Hospital on the 18-FEB-2021 in the afternoon but patient decided that he would rather go home.  The patients temperature was 99.4.  Treatment information was provided as Tylenol for headache and Something for nausea and to relax muscles at the hospital.  Action taken with mRNA-1273 in response to the events was not reported.   On 18-FEB-2021, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.  At the time of this report, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Lethargy, Muscle spasms, Nausea
Clinical narrative: Nausea; Chills; Cramps in intestines; Vomiting; Temperature of 99.4; muscle spasms; Headache; Felt lethargic; Felt tired; Dark urine like motor oil gold; like having a bad flu.; A spontaneous report  was received from a Consumer concerning a 70-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball  The patient's medical history was not provided.  Relevant concomitant medications were not reported.   On 17-FEB-2021, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18-FEB-2021, the patient experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball.  His wife took him to the ER at Hospital on the 18-FEB-2021 in the afternoon but patient decided that he would rather go home.  The patients temperature was 99.4.  Treatment information was provided as Tylenol for headache and Something for nausea and to relax muscles at the hospital.  Action taken with mRNA-1273 in response to the events was not reported.   On 18-FEB-2021, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.  At the time of this report, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea; Chills; Cramps in intestines; Vomiting; Temperature of 99.4; muscle spasms; Headache; Felt lethargic; Felt tired; Dark urine like motor oil gold; like having a bad flu.; A spontaneous report  was received from a Consumer concerning a 70-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball  The patient's medical history was not provided.  Relevant concomitant medications were not reported.   On 17-FEB-2021, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18-FEB-2021, the patient experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball.  His wife took him to the ER at Hospital on the 18-FEB-2021 in the afternoon but patient decided that he would rather go home.  The patients temperature was 99.4.  Treatment information was provided as Tylenol for headache and Something for nausea and to relax muscles at the hospital.  Action taken with mRNA-1273 in response to the events was not reported.   On 18-FEB-2021, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.  At the time of this report, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dyspnoea, Fatigue, SARS-CoV-2 test positive
Clinical narrative: Tested positive fo COVID; Shortness of breath; Tired; No eating; Diarrhea; A spontaneous report was received from the wife of a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID (SARS-CoV-2 test positive) and experienced shortness of breath (dyspnoea), diarrhea, tired (fatigue), and no eating (decreased appetite)  The patient's medical history was not provided. Concomitant product use was not provided.  On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot/batch:030L20A) intramuscularly for the prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced shortness of breath, diarrhea, tired, and no eating.  He was hospitalized and tested positive for COVID.  The patient was discharged on 21 Feb 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events of tested positive for COVID, shortness of breath, diarrhea, tired, and no eating was unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported events and the administration of mRNA-1273 vaccine is assessed as unlikely related The vaccine is not known to cause COVD infection.  The other events are consistent with symptom of the disease.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had a stroke; A spontaneous report was received from a caregiver concerning an 81-years-old female patient who received Moderna's Covid-19 vaccine and had a stroke.  Patient's medical history included a mini stroke (5-6 years ago). Concomitant medication included blood thinners.  On 02 Feb 2021 at 4:30 pm, ten days prior to onset of the event stroke, the patient received the first of two planned doses of mRNA-1273 vaccine (Lot/batch: unknown) for prophylaxis of Covid-19 infection.  On 11 Feb 2021, the patient had an event of stroke for which was hospitalized. The patient was on a lot of medications (not specified).   Action taken with second dose of mRNA-1273 in response to the event was not recorded.  The outcome of the event stroke was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stroke, a causal relationship cannot be excluded. However, patient's elderly age and prior history of TIA are considered as risk factors.