chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: congestion on her chest; having allergic reaction for a week.allergic reactions keep coming back; little bumps all over her face and body which are like measles after the vaccine; swollen eyes; watery eyes; runny nose; sneezing; ear feels full; dry eye socket with crust on eyelashes; Crust on eyelashes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Food allergy since an unknown date. Concomitant products included LIRAGLUTIDE, INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PULMONARY CONGESTION (congestion on her chest) (seriousness criterion medically significant), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (congestion on her chest), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache) had not resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  Treatment medications Provided were 25 mg Benadryl. 16 mg hydrocortisone cream. metoprolol steroid, and Doxycycline for 7 days given by her HCP.  Company Comment: 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.   This case was linked to MOD-2021-095089 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Death, Hepatic failure, Nausea, Renal failure
Clinical narrative: Renal failure; Liver failure; Unresponsive; Died; Stomach pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (Unresponsive), DEATH (Died), RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary biliary cirrhosis.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive) (seriousness criterion hospitalization). On 23-Apr-2021, the patient experienced DEATH (Died) (seriousness criterion death), RENAL FAILURE (Renal failure) (seriousness criterion hospitalization) and HEPATIC FAILURE (Liver failure) (seriousness criterion hospitalization). On 23-Apr-2021, RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) had resolved and NAUSEA (Nausea) outcome was unknown. The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, UNRESPONSIVE TO STIMULI (Unresponsive) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.            The concomitant medication included liver medications, as reported by the reporter. On 07Apr2021 around 1230pm, the patient experienced stomach pain and nausea which the family attributed to her liver medications. The patient went to sleep later that evening. The next day, 08Apr2021, the patient was found to be sleeping around 8am but was unresponsive around 1:30pm. She was taken by ambulance to the local hospital. The patient was eventually placed on life support and passed on 23Apr2021.  No other treatment medication were reported.  Company comment: Very limited information regarding this events has been provided at this time.  However, 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.; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, 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.; Reported Cause(s) of Death: unkown cause of death
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Renal failure; Liver failure; Unresponsive; Died; Stomach pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (Unresponsive), DEATH (Died), RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary biliary cirrhosis.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive) (seriousness criterion hospitalization). On 23-Apr-2021, the patient experienced DEATH (Died) (seriousness criterion death), RENAL FAILURE (Renal failure) (seriousness criterion hospitalization) and HEPATIC FAILURE (Liver failure) (seriousness criterion hospitalization). On 23-Apr-2021, RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) had resolved and NAUSEA (Nausea) outcome was unknown. The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, UNRESPONSIVE TO STIMULI (Unresponsive) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.            The concomitant medication included liver medications, as reported by the reporter. On 07Apr2021 around 1230pm, the patient experienced stomach pain and nausea which the family attributed to her liver medications. The patient went to sleep later that evening. The next day, 08Apr2021, the patient was found to be sleeping around 8am but was unresponsive around 1:30pm. She was taken by ambulance to the local hospital. The patient was eventually placed on life support and passed on 23Apr2021.  No other treatment medication were reported.  Company comment: Very limited information regarding this events has been provided at this time.  However, 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.; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, 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.; Reported Cause(s) of Death: unkown cause of death
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash developed on injection site arm below actual injection area, 7 days post injection. Started as quarter sized area with raised burning/itchy bumps, red and warm to the touch. Coverage area slowly grew throughout the day and became swollen. Day 2 area of rash was a good portion of outer bicep area, accompanied with fever, chills and aches. Fever, chills and aches subsided in 24 hours. Red, itchy, swollen rash continued to spread so that on day 3 it covered most of upper arm, wrapping all the way around. Today is day 4 and swelling is subsiding but redness & itch are still present and it still slowly spreading a little. May contact my pcp today
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Rash developed on injection site arm below actual injection area, 7 days post injection. Started as quarter sized area with raised burning/itchy bumps, red and warm to the touch. Coverage area slowly grew throughout the day and became swollen. Day 2 area of rash was a good portion of outer bicep area, accompanied with fever, chills and aches. Fever, chills and aches subsided in 24 hours. Red, itchy, swollen rash continued to spread so that on day 3 it covered most of upper arm, wrapping all the way around. Today is day 4 and swelling is subsiding but redness & itch are still present and it still slowly spreading a little. May contact my pcp today
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Percutaneous coronary intervention
Clinical narrative: STEMI that occurred 24 hours after vaccination. Suspect coincidental but temporally related.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Vascular stent thrombosis
Clinical narrative: STEMI that occurred 24 hours after vaccination. Suspect coincidental but temporally related.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Percutaneous coronary intervention
Clinical narrative: Patient presented to the hospital with STEMI and in-stent thrombosis
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Vascular stent thrombosis
Clinical narrative: Patient presented to the hospital with STEMI and in-stent thrombosis
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Blood test normal, Menstrual disorder, Vaginal haemorrhage
Clinical narrative: Almost instantaneous ovary pains, blood clots passing vaginally, abnormal vaginal bleeding for two weeks
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough
Clinical narrative: Chronic cough lasting over 12 weeks
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Fatigue, Pain
Clinical narrative: Starting from midnight, i experienced fever and body aches. In am i had extreme dizziness and vomited.  I also experienced extreme weakness. Fever continued past following midnight. Stomach upset was noted. Following day i still experienced extreme fatigue and weakness.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Starting from midnight, i experienced fever and body aches. In am i had extreme dizziness and vomited.  I also experienced extreme weakness. Fever continued past following midnight. Stomach upset was noted. Following day i still experienced extreme fatigue and weakness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Soreness at injection site, swollen lymph node under armpit near injection site, fever of 100.2, headache, fatigue, loss of appetite, muscle soreness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Soreness at injection site, swollen lymph node under armpit near injection site, fever of 100.2, headache, fatigue, loss of appetite, muscle soreness.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: immediately after dose arm was sore as expected. This subsided within several days. No additional issues were noted until day 13 post dose when I suddenly felt an onset of a raised, warm, reddened area that was very sore and achy. Being a nurse I recognized this as cellulitis. I managed on my own as it was the weekend and I could only go to an ER which seemed unnecessary or the urgent care, which I knew would be busy. It subsided within two or three days
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: After two days, my arm began to swell, itch, turned red and felt hot to the touch.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Sudden rash and red welts all over body and worsening on arms, spreading across face and legs.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Tachycardia
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Systemic: Tachycardia-Mild
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Blood magnesium, Blood phosphorus, Blood thyroid stimulating hormone
Clinical narrative: 3/12/21 fatigue, brain fog, chills for about 12 hours as expected  3/16-3/21 extreme fatigue 3/21-3/22 stomach upset, dizziness, severe anxiety and panic 3/27/21 ER visit due to anxiety and panic; prescribed Ativan with no tests run  3/23- present  Severe anxiety and panic, depression, heart burn, diahhrea, dizziness, headaches, weight loss of 20 lbs (unintentional), lack of appetite, insomnia, fatigue On 4/16/21 I had my thyroid levels checked. TSH in a October 2020 was 1.42. On 4/16/21 it was 0.21. Ultrasound of thyroid on 4/30/21 showed normal thyroid but 3 measurable calcium deposits on the side of the thyroid that are now being monitored.  I have been unable to work on-site in school due to the anxiety and panic. I?ve tried 2 different anxiety meds but unable to take due to side effects.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Calcinosis, Decreased appetite, Depression, Diarrhoea, Dizziness
Clinical narrative: 3/12/21 fatigue, brain fog, chills for about 12 hours as expected  3/16-3/21 extreme fatigue 3/21-3/22 stomach upset, dizziness, severe anxiety and panic 3/27/21 ER visit due to anxiety and panic; prescribed Ativan with no tests run  3/23- present  Severe anxiety and panic, depression, heart burn, diahhrea, dizziness, headaches, weight loss of 20 lbs (unintentional), lack of appetite, insomnia, fatigue On 4/16/21 I had my thyroid levels checked. TSH in a October 2020 was 1.42. On 4/16/21 it was 0.21. Ultrasound of thyroid on 4/30/21 showed normal thyroid but 3 measurable calcium deposits on the side of the thyroid that are now being monitored.  I have been unable to work on-site in school due to the anxiety and panic. I?ve tried 2 different anxiety meds but unable to take due to side effects.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Fatigue, Feeling abnormal, Headache, Insomnia
Clinical narrative: 3/12/21 fatigue, brain fog, chills for about 12 hours as expected  3/16-3/21 extreme fatigue 3/21-3/22 stomach upset, dizziness, severe anxiety and panic 3/27/21 ER visit due to anxiety and panic; prescribed Ativan with no tests run  3/23- present  Severe anxiety and panic, depression, heart burn, diahhrea, dizziness, headaches, weight loss of 20 lbs (unintentional), lack of appetite, insomnia, fatigue On 4/16/21 I had my thyroid levels checked. TSH in a October 2020 was 1.42. On 4/16/21 it was 0.21. Ultrasound of thyroid on 4/30/21 showed normal thyroid but 3 measurable calcium deposits on the side of the thyroid that are now being monitored.  I have been unable to work on-site in school due to the anxiety and panic. I?ve tried 2 different anxiety meds but unable to take due to side effects.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, Panic attack, Ultrasound thyroid normal, Weight decreased
Clinical narrative: 3/12/21 fatigue, brain fog, chills for about 12 hours as expected  3/16-3/21 extreme fatigue 3/21-3/22 stomach upset, dizziness, severe anxiety and panic 3/27/21 ER visit due to anxiety and panic; prescribed Ativan with no tests run  3/23- present  Severe anxiety and panic, depression, heart burn, diahhrea, dizziness, headaches, weight loss of 20 lbs (unintentional), lack of appetite, insomnia, fatigue On 4/16/21 I had my thyroid levels checked. TSH in a October 2020 was 1.42. On 4/16/21 it was 0.21. Ultrasound of thyroid on 4/30/21 showed normal thyroid but 3 measurable calcium deposits on the side of the thyroid that are now being monitored.  I have been unable to work on-site in school due to the anxiety and panic. I?ve tried 2 different anxiety meds but unable to take due to side effects.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: BP 112/70 HR 65 bpm
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: BP 112/70 HR 65 bpm
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Flushing, Hyperhidrosis, Pain
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Arthralgia, Electrocardiogram normal, Myalgia, Nasopharyngitis
Clinical narrative: Extreme pain left shoulder, burning and radiant feeling. It lasted for 2 days. I went to urgent care facility, got X-rays and ekg, results were normal.  Pain was onset by a common cold, sore throat and aphonia.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, X-ray normal
Clinical narrative: Extreme pain left shoulder, burning and radiant feeling. It lasted for 2 days. I went to urgent care facility, got X-rays and ekg, results were normal.  Pain was onset by a common cold, sore throat and aphonia.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Brain injury, Hemiplegia, Vaccination site pain
Clinical narrative: Could be a minor brain injury; Left side of the body got paralyzed on his leg and whole arm; Some pain in the right arm; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HEMIPLEGIA (Left side of the body got paralyzed on his leg and whole arm) and BRAIN INJURY (Could be a minor brain injury) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HEMIPLEGIA (Left side of the body got paralyzed on his leg and whole arm) (seriousness criterion hospitalization), BRAIN INJURY (Could be a minor brain injury) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (Some pain in the right arm). The patient was hospitalized on 02-Apr-2021 due to HEMIPLEGIA, and then on 02-Apr-2021 due to BRAIN INJURY. At the time of the report, HEMIPLEGIA (Left side of the body got paralyzed on his leg and whole arm) and BRAIN INJURY (Could be a minor brain injury) outcome was unknown and VACCINATION SITE PAIN (Some pain in the right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.  Treatment information mentioned post hospitalization rehab and physical therapy. Due to the paralysis, patient mentioned walking using a cane. Treatment medications included Aspirin 81mg one per day, Atorvastatin 80mg one per day, Lisinopril 10mg, Amlodipine 10mg, Hydralazine 25mg.  He mentioned was thinking of cancelling the second dose.  Company Comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events hemiplegia and vaccination site pain, a causal relationship cannot be excluded. Vaccination site pain is consistent with the product known safety profile.  There is not enough information to assess the event of brain injury as it was not specified.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events hemiplegia and vaccination site pain, a causal relationship cannot be excluded. Vaccination site pain is consistent with the product known safety profile.  There is not enough information to assess the event of brain injury as it was not specified.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Fatigue, Headache, Hyperpyrexia
Clinical narrative: Has a little cold; Bones started to hurt; Very weak; Injection arm soreness; Very tired/Feels a little tired; Fever of 108F/105F; Headache; Body aching; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (Fever of 108F/105F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included DOXEPIN for Sleep disorder NOS, OLOPATADINE, ONDANSETRON, LOSARTAN POTASSIUM, TRAMADOL, MONTELUKAST SODIUM, MOMETASONE FUROATE, HYDROCHLOROTHIAZIDE, CHOLESTEROL, PANTOPRAZOLE, METFORMIN, ALENDRONATE SODIUM, METOPROLOL, OXYBUTYNIN, LORAZEPAM, CYANOCOBALAMIN and CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE VITAMIN D3) for an unknown indication.    On 30-Apr-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced HYPERPYREXIA (Fever of 108F/105F) (seriousness criterion medically significant). 30-Apr-2021, the patient experienced PAIN (Body aching) and HEADACHE (Headache). On 01-May-2021, the patient experienced BONE PAIN (Bones started to hurt), ASTHENIA (Very weak), PAIN IN EXTREMITY (Injection arm soreness) and FATIGUE (Very tired/Feels a little tired). On 02-May-2021, the patient experienced NASOPHARYNGITIS (Has a little cold). At the time of the report, HYPERPYREXIA (Fever of 108F/105F), NASOPHARYNGITIS (Has a little cold), BONE PAIN (Bones started to hurt), ASTHENIA (Very weak), PAIN (Body aching), PAIN IN EXTREMITY (Injection arm soreness), HEADACHE (Headache) and FATIGUE (Very tired/Feels a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included benzonate.  The patient applied cold compress and took diphenhydramine medication as treatment. Company comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Based on the additional information received, additional events (including a serious event), concomitant medications and treatment information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: Has a little cold; Bones started to hurt; Very weak; Injection arm soreness; Very tired/Feels a little tired; Fever of 108F/105F; Headache; Body aching; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (Fever of 108F/105F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included DOXEPIN for Sleep disorder NOS, OLOPATADINE, ONDANSETRON, LOSARTAN POTASSIUM, TRAMADOL, MONTELUKAST SODIUM, MOMETASONE FUROATE, HYDROCHLOROTHIAZIDE, CHOLESTEROL, PANTOPRAZOLE, METFORMIN, ALENDRONATE SODIUM, METOPROLOL, OXYBUTYNIN, LORAZEPAM, CYANOCOBALAMIN and CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE VITAMIN D3) for an unknown indication.    On 30-Apr-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced HYPERPYREXIA (Fever of 108F/105F) (seriousness criterion medically significant). 30-Apr-2021, the patient experienced PAIN (Body aching) and HEADACHE (Headache). On 01-May-2021, the patient experienced BONE PAIN (Bones started to hurt), ASTHENIA (Very weak), PAIN IN EXTREMITY (Injection arm soreness) and FATIGUE (Very tired/Feels a little tired). On 02-May-2021, the patient experienced NASOPHARYNGITIS (Has a little cold). At the time of the report, HYPERPYREXIA (Fever of 108F/105F), NASOPHARYNGITIS (Has a little cold), BONE PAIN (Bones started to hurt), ASTHENIA (Very weak), PAIN (Body aching), PAIN IN EXTREMITY (Injection arm soreness), HEADACHE (Headache) and FATIGUE (Very tired/Feels a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included benzonate.  The patient applied cold compress and took diphenhydramine medication as treatment. Company comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Based on the additional information received, additional events (including a serious event), concomitant medications and treatment information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: 20% hearing loss; Ringing in the ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (20% hearing loss) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A. and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced DEAFNESS (20% hearing loss) (seriousness criterion medically significant) and TINNITUS (Ringing in the ear). At the time of the report, DEAFNESS (20% hearing loss) and TINNITUS (Ringing in the ear) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Prednisone.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Company Comment: 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Chills, Oesophageal achalasia, Pyrexia, Vomiting
Clinical narrative: Diagnosed with Achalasia; He also lost about 40 pound; Chills; Fever; Throwing up Has trouble keeping food and water down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OESOPHAGEAL ACHALASIA (Diagnosed with Achalasia) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A 2(Z)1A and 041L(C)20D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastroesophageal reflux disease in 2020.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OESOPHAGEAL ACHALASIA (Diagnosed with Achalasia) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (He also lost about 40 pound), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up Has trouble keeping food and water down). At the time of the report, OESOPHAGEAL ACHALASIA (Diagnosed with Achalasia), ABNORMAL LOSS OF WEIGHT (He also lost about 40 pound), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up Has trouble keeping food and water down) outcome was unknown.            Concomitant product use was not reported. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The causality assessment was not provided.  Patient called on 03MAY2021 to report that on 20JAN2021 he received his 1st dose of the Moderna vaccine and 23FEB2021 he received his 2nd dose. After the 2nd dose he experienced chills, fever and had been throwing up. He said he had been having trouble keeping food and water down and it has gotten worse. He also lost 40 pounds. Patient saw a gastroenterologist and had tests done April, 2021. The specialist said patient's esophagus is not functioning well and diagnosed him with Achalasia. Patient is scheduled for further consultation and potential surgery in August 2021 with a Specialist. Patient also stated he had GERDS Reflux about a year ago (2020).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Encephalitis
Clinical narrative: Stroke; Encephalitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and ENCEPHALITIS (Encephalitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood disorder NOS (blood clotting disorder from 20 years). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant) and ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and ENCEPHALITIS (Encephalitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that magnetic resonance imaging (MRI scan) performed months back detected encephalitis, stroke and stated as totally asymptomatic.   The patient reported to be taking Clopidogrel (Plavix) to treat the event.  Company Comment: 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.   This case was linked to MOD-2021-101992 (Patient Link).; Sender'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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Skin discolouration, Swelling face
Clinical narrative: Swollen face that is black and blue; Swollen face that is black and blue; Nosebleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swollen face that is black and blue) and SKIN DISCOLOURATION (Swollen face that is black and blue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced EPISTAXIS (Nosebleed). On 01-May-2021, the patient experienced SWELLING FACE (Swollen face that is black and blue) (seriousness criterion hospitalization) and SKIN DISCOLOURATION (Swollen face that is black and blue) (seriousness criterion hospitalization). At the time of the report, SWELLING FACE (Swollen face that is black and blue), SKIN DISCOLOURATION (Swollen face that is black and blue) and EPISTAXIS (Nosebleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Prednisone 20mg, Affrin, and Bacitracin, as advised by their HCP to try to alleviate the symptoms.  Company comment: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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Dysphonia, Dyspnoea
Clinical narrative: shortness of breath; coughing problems; chest started tightening; hoarseness; chest hurts; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (coughing problems), CHEST DISCOMFORT (chest started tightening), DYSPHONIA (hoarseness) and DYSPNOEA (shortness of breath) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced COUGH (coughing problems) (seriousness criterion hospitalization), CHEST DISCOMFORT (chest started tightening) (seriousness criterion hospitalization) and DYSPHONIA (hoarseness) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization) and CHEST PAIN (chest hurts). At the time of the report, COUGH (coughing problems), CHEST DISCOMFORT (chest started tightening) and DYSPNOEA (shortness of breath) had not resolved and DYSPHONIA (hoarseness) and CHEST PAIN (chest hurts) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of these events included an epi-pen, Benadryl, Pepcid, water pill and an unspecified steroid.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: the patient only received the IPV and DTAP and not the HIB portion, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (nurse) via medical information (MI) (Reference number- 00577376) and transmitted to Sanofi on 26-Apr-2021.  This case involves a 7 month old male patient who only received the IPV and DTAP and not the HIB portion, while patient received a third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number: UJ336AA, expiry date and other dosing details were not reported] on 24-Mar-2021 for prophylactic vaccination (product preparation issue).  Medical history, medical treatment, vaccination and family history were not reported.  Concomitant vaccinations included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) (PNEUMOC 13,).  It was a case of actual medication error due to inappropriate reconstitution technique. (Latency: same day)  It was reported that, while doing inventory, reporter discovered an extra vial of Act HIB in a Pentacel box.   It was also reported that, recently the have had vaccinated 2 children in last 2-3 weeks with Pentacel but they could not tell which child only got the IPV/DTaP vial and not the powder Act HIB vial.   At the time of reporting, reporter was not sure that, the patient details reported for child that one if only IPV/DTAP portion and not the HIB portion of Pentacel or not.   About lot number it was reported that, the way they document the lot for Pentacel, it was reported to her.   At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Daughter received an unknown flu vaccine and experienced arm pain; This spontaneous case was received on 26-Apr-2021 from other non-health professional via Communications (reference number: SEQW21-01228) and concerned a female patient of an unspecified age.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced arm pain.   The outcome of the event 'pain in arm' was not reported.   The patient did not provide a causality assessment.   This case is linked to case 202102297 and 202102299 (the same reporter).  Company comment: A female patient of an unspecified age developed pain in extremity after vaccination with the suspect product, influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Anatomical location of vaccination and event location was not clearly reported. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to lack of information, causality for the reported event is unassessable.; Sender's Comments: A female patient of an unspecified age developed pain in extremity after vaccination with the suspect product, influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Anatomical location of vaccination and event location was not clearly reported. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to lack of information, causality for the reported event is unassessable.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: A friend received an unknown flu vaccine and experienced arm pain; This spontaneous case was received on 26-Apr-2021 from other non-health professional via Communications (reference number: SEQW21-01228) and concerned a patient of an unspecified age and gender.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced arm pain.   The outcome of the event 'pain in arm' was not reported.   The patient did not provide a causality assessment.   This case is linked to case 202102297 and 202102298 (the same reporter).  Company comment: A patient of an unspecified age and gender developed pain in extremity after vaccination with the suspect product, influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Anatomical location of vaccination and event location was not clearly reported. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to lack of information, causality for the reported event is unassessable.; Sender's Comments: A patient of an unspecified age and gender developed pain in extremity after vaccination with the suspect product, influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Anatomical location of vaccination and event location was not clearly reported. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to lack of information, causality for the reported event is unassessable.
Age: 1.67
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; a dose of VAQTA had been inadvertently administered after its labeled expiry date; This spontaneous report was received from a certified medical assistant and refers to a 20-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-APR-2021, the patient was inadvertently vaccinated with expired hepatitis A vaccine, inactivated (VAQTA) prefilled syringe (PFS) 25U/0.5 milliliter, lot # S037576, expiration date 10-APR-2021 (route of administration and anatomical location were not provided) for prophylaxis. There were no prior temperature excursions on the involved vaccine. There was no additional adverse event (AE) reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S037576; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: No signs or symptoms reported; temperature excursion on PROQUAD that was administered; This spontaneous report was received from the medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-APR-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (1 time dose), lot number T027115 and expiration date of 07-FEB-2022 for prophylaxis (dose, route of administration and anatomical location were not reported).  Administered dose of vaccine experienced temperature excursion of 6°F to 14°F (13.8°F) for 1 hour 45 minutes 0 seconds; 15°F to 46°F( 14.5°F) for 2 hours 30 minutes 0 Seconds, with a time frame of Time frame: 4 hours 15 minutes 0 seconds. No signs or symptoms were reported. Data logger was not involved. There were no previous excursions reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007568: US-009507513-2104USA007341: US-009507513-2104USA007516: US-009507513-2104USA007569:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; dose of PROQUAD had expired on 4/7/2021 was inadvertently administered on 4/29/2021; This spontaneous report was received from a pharmacist and nurse via a vaccine representative and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-APR-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # S031884, expiration date: 07-APR-2021 (exact dose, route of administration and injection site were not provided) for prophylaxis. No additional adverse events were reported.