chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vascular pain, Vasodilatation
Clinical narrative: I am having issues of bulging veins in my leg.  They surfaced about 3 weeks after the vaccination was received. They did not go away, have continued to get worse, and become painful during every day life.
Age: 2.25
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Lpn, Mix covid vial with 1.3ml of saline instead of 2.2ml, Patient received 2nd covid vaccine & 3rd. As per CDC patient doesn't need a 3rd vaccine since pt received a Higher concentrated dose.  no symptoms as per mom
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Lpn Mix and Drew covid vaccine with a less amount of Saline. Vial was mixed with 1.3ml instead of 2.2 ml, Patient received a Higher concentrated dose of the vaccine itself.  As per CDC pt doesn't need a 3rd dose.  2nd dose covers 2nd & 3rd. as per mom pt doesn't have any symptoms Pt is cover with all series until CD changes any guidelines .
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Itchy, red, and hot area on arm, several inches by several inches.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: NOT AN ADVERSE EVENT. THE PATIENT RECEIVED THE WRONG VACCINE. NOT YET 65. SHOULD HAVE BEEN INFLUENZA QADRIVALENT; NOT HIGH DOSE.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Vitiligo
Clinical narrative: I WAS DIAGNOSED WITH VITILIAGO. I DO NOT HAVE A FAMILY HISTORY. MY EXHUSBAND WHO WENT WITH ME TO HAVE THE VACCINE DONE...ALSO STARTED HAVING SYMPTOMS OF VITLIAGO. NO FAMILY HISTORY.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Myalgia, Nausea, Oral herpes, Pyrexia
Clinical narrative: Low grade fever, achy muscles, fever blisters in mouth/lips/nose, headache, nausea
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: as per mom patients has no symptom
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Headache, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Headeache, fever, chills, whole body muscle aches for duration of approx 8 hrs, starting at 12 hrs after vaccination.  Vaccination site slight redness and soreness at 3 days after vaccination currently.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: Headeache, fever, chills, whole body muscle aches for duration of approx 8 hrs, starting at 12 hrs after vaccination.  Vaccination site slight redness and soreness at 3 days after vaccination currently.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: about a week after the booster was administered, I began experiencing pain in the area between my shoulder and the point of the shot.  I can still barely move my arm above 90 degrees.  I was examined by my doctor, and he prescribed physical therapy.  I can still feel the exact point of the shot.  I have never, ever had this happen before in my life with any shot of any type.  so I would like to know if you are receiving other reports like this. my activities are somewhat limited;  things like putting on my seatbelt, dressing, reaching.
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: LPN diluted Covid vial with 1.3ml of saline instead of 2.3ml. Patient received 2nd dose as per CDC pt doesn't need a 3rd dose. Patient received a higher concentrated dose of covid vaccine, Patients is cover for all series until CDC updates any guidelines.    As pe rmom patient is stable no symptoms .
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness bilateral, Tinnitus
Clinical narrative: Tinnitus- leading to  hearing loss - bilateral
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site turned, hot, red and swollen. The redness spread over 2 days to like a 2 x 4 Inch patch with itching and muscle soreness. Was sensitive to touch, could feel shirt rubbing it. Had a slight headache on Saturday and on Sunday noticed leg muscle (thigh) weakness going up and down the stairs doing laundry. An ice pack did help some with the swelling
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Injection site turned, hot, red and swollen. The redness spread over 2 days to like a 2 x 4 Inch patch with itching and muscle soreness. Was sensitive to touch, could feel shirt rubbing it. Had a slight headache on Saturday and on Sunday noticed leg muscle (thigh) weakness going up and down the stairs doing laundry. An ice pack did help some with the swelling
Age: 30.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Breast tenderness, Fatigue, Pain
Clinical narrative: Want to note I do not know what type of flu shot I had, I got it from the pharmacy.  For a few days after I received my COVID booster and flu shot, as expected, I was sore and tired for a few days/. However, over a week later while all of my other symptoms are gone, I have notice I still have a lot of breast tenderness that can be mildly painful when moving around.  I wanted to report this in case this is something other women are experiencing, and to better understand hoiw long I should expect this to last.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Papule, Rash, Rash papular, Rash pruritic
Clinical narrative: 10/16/22 Employee called Employee Health hotline to report she had a silver dollar size rash to the side of her 10/14 flu  injection site and another one a few hows later below her injection site.  The next day she had a rash on her next. Rashes were raised small papiales that were itchy and warm to touch.  Employee states she took Benadryl.  She declines any SOB.  She has had many flu vaccine but never reacted this way before.  She did have a bad hive reaction to Varivax some years ago. The neck rash has resolved as of 10/16/22 but the arm rask is still present. She is followin up with Occupational Health provider on 10/17/22.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: 10/16/22 Employee called Employee Health hotline to report she had a silver dollar size rash to the side of her 10/14 flu  injection site and another one a few hows later below her injection site.  The next day she had a rash on her next. Rashes were raised small papiales that were itchy and warm to touch.  Employee states she took Benadryl.  She declines any SOB.  She has had many flu vaccine but never reacted this way before.  She did have a bad hive reaction to Varivax some years ago. The neck rash has resolved as of 10/16/22 but the arm rask is still present. She is followin up with Occupational Health provider on 10/17/22.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Condition aggravated, Fatigue, Myalgia
Clinical narrative: Fever, chill, extreme fatigue even with plenty of rest (18-20h), muscle ache, neck and shoulder pain greater than usual,
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: Fever, chill, extreme fatigue even with plenty of rest (18-20h), muscle ache, neck and shoulder pain greater than usual,
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring normal, Chest X-ray normal, Chest pain, Computerised tomogram thorax normal, Cough
Clinical narrative: ~3 weeks after 2nd vaccine and gradual onset slowly in the following months:  Shortness of breath, chest pain, cough, muscular weakness/atrophy, body aches, flushing, dizziness, vertigo, hypertension, tachycardia, muscle spasms, post exertional malaise.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: ~3 weeks after 2nd vaccine and gradual onset slowly in the following months:  Shortness of breath, chest pain, cough, muscular weakness/atrophy, body aches, flushing, dizziness, vertigo, hypertension, tachycardia, muscle spasms, post exertional malaise.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hypertension, Inflammatory marker test, Laboratory test normal, Malaise
Clinical narrative: ~3 weeks after 2nd vaccine and gradual onset slowly in the following months:  Shortness of breath, chest pain, cough, muscular weakness/atrophy, body aches, flushing, dizziness, vertigo, hypertension, tachycardia, muscle spasms, post exertional malaise.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle atrophy, Muscle spasms, Muscular weakness, Pain, Pulmonary function test normal
Clinical narrative: ~3 weeks after 2nd vaccine and gradual onset slowly in the following months:  Shortness of breath, chest pain, cough, muscular weakness/atrophy, body aches, flushing, dizziness, vertigo, hypertension, tachycardia, muscle spasms, post exertional malaise.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Tachycardia, Vertigo
Clinical narrative: ~3 weeks after 2nd vaccine and gradual onset slowly in the following months:  Shortness of breath, chest pain, cough, muscular weakness/atrophy, body aches, flushing, dizziness, vertigo, hypertension, tachycardia, muscle spasms, post exertional malaise.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Bone pain, Fatigue, Malaise, Myalgia, Pain
Clinical narrative: Extremely painful thigh muscles/bones; achy all over; low grade fever (99.8); general malaise. Lasted until Sunday (10/16/22) morning.Still felt very tired and achy  much of the day.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Pyrexia
Clinical narrative: Extremely painful thigh muscles/bones; achy all over; low grade fever (99.8); general malaise. Lasted until Sunday (10/16/22) morning.Still felt very tired and achy  much of the day.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen and painful area around injection site.  Warm, red, tender and itchy,  with a 5 inch circumference, raised about 3 cm. .  Periodically applied  an ice pack with some relief.  Swelling and redness subsided after 3 days,   Tenderness and itch subsided on the 5th day.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium normal, Electrocardiogram normal, Fatigue, Full blood count normal, Headache
Clinical narrative: Had a few/rare heart palpitations earlier in 2021 after first and second does of Moderna vaccine.   Had no other side effects besides a sore arm after these doses.  After the booster dose on 10/29/21 I had several side effects two days after the booster which lasted about 24 hours.  Side effects included fatigue, low grade fever, body aches, and headache.  About 7-10 days after the booster I started to have heart palpitations a few times/day that increased in frequency to several times/day.  The palpitations maintained this frequency until about mid-May and they have decreased to a few times/week.  Received a booster of the Moderna vaccine on 6/21/22 and no side effects except a sore arm was noted.  Palpitations did not increase in frequency after the booster but they do remain.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Metabolic function test normal, Pain, Palpitations, Pyrexia
Clinical narrative: Had a few/rare heart palpitations earlier in 2021 after first and second does of Moderna vaccine.   Had no other side effects besides a sore arm after these doses.  After the booster dose on 10/29/21 I had several side effects two days after the booster which lasted about 24 hours.  Side effects included fatigue, low grade fever, body aches, and headache.  About 7-10 days after the booster I started to have heart palpitations a few times/day that increased in frequency to several times/day.  The palpitations maintained this frequency until about mid-May and they have decreased to a few times/week.  Received a booster of the Moderna vaccine on 6/21/22 and no side effects except a sore arm was noted.  Palpitations did not increase in frequency after the booster but they do remain.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test normal
Clinical narrative: Had a few/rare heart palpitations earlier in 2021 after first and second does of Moderna vaccine.   Had no other side effects besides a sore arm after these doses.  After the booster dose on 10/29/21 I had several side effects two days after the booster which lasted about 24 hours.  Side effects included fatigue, low grade fever, body aches, and headache.  About 7-10 days after the booster I started to have heart palpitations a few times/day that increased in frequency to several times/day.  The palpitations maintained this frequency until about mid-May and they have decreased to a few times/week.  Received a booster of the Moderna vaccine on 6/21/22 and no side effects except a sore arm was noted.  Palpitations did not increase in frequency after the booster but they do remain.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chest pain, Dizziness, Feeling abnormal, Hypertension
Clinical narrative: Day after shot for 1 month I had rashes on my torso . Dizzy and light headed . Blood pressure was very high causing chest pain . Blood pressure would drop and I would pass out . Had brain fog for 2 months . Right arm would go numb off and on for 3 months . Night sweats and terrors lasted about 8 months . Vision in left eye still off after first vaccine . Overall symptoms did not stop until February 2022 . Started within minutes of first shot and got worse after second . After first shot went to clinic with sever chest pain . Doctor stated it was probably an adverse reaction to the ingredients .  Both shots made me far sicker than Covid 19 .
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of consciousness, Malaise, Night sweats, Rash
Clinical narrative: Day after shot for 1 month I had rashes on my torso . Dizzy and light headed . Blood pressure was very high causing chest pain . Blood pressure would drop and I would pass out . Had brain fog for 2 months . Right arm would go numb off and on for 3 months . Night sweats and terrors lasted about 8 months . Vision in left eye still off after first vaccine . Overall symptoms did not stop until February 2022 . Started within minutes of first shot and got worse after second . After first shot went to clinic with sever chest pain . Doctor stated it was probably an adverse reaction to the ingredients .  Both shots made me far sicker than Covid 19 .
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep terror, Visual impairment
Clinical narrative: Day after shot for 1 month I had rashes on my torso . Dizzy and light headed . Blood pressure was very high causing chest pain . Blood pressure would drop and I would pass out . Had brain fog for 2 months . Right arm would go numb off and on for 3 months . Night sweats and terrors lasted about 8 months . Vision in left eye still off after first vaccine . Overall symptoms did not stop until February 2022 . Started within minutes of first shot and got worse after second . After first shot went to clinic with sever chest pain . Doctor stated it was probably an adverse reaction to the ingredients .  Both shots made me far sicker than Covid 19 .
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: The patient called the pharmacy reporting a small rash on her inner left leg. The patient reported the rash was not itching nor painful. The patient called the pharmacy back about 45 minutes later reporting the rash was clearing up and less noticeable. I, the pharmacist, called the patient's primary doctor. I left a message with the answering service. Service reported they will have Dr. call Pharmacy today 10/16/2022. The patient reported she had no swollen tongue nor lip, no difficulty breathing nor chest pain and no respiratory conditions nor cardiovascular conditions
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: L mid arm redness, swelling, increased warmth, pain within 24 hrs of Td given (it does not appear that vaccine was given in deltoid muscle, but rather in the mid arm)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin lesion
Clinical narrative: 2 DAYS AFTER SECOND SHOT DEVELOPED SEVER ITCHING AND SORES ON SCALP IT STILL CONTINUES AND HAS INCRESED SENCE I GOT COVID 3 WEEKS AGO
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Chest discomfort, Dizziness, Hypoaesthesia oral
Clinical narrative: Patient reported that her chest was feeling tight and she was feeling dizzy. The tightness in her chest persisted and got worse. Patient then reported that her tongue went numb. Vital signs were taken and all WNL. EMS were called and paramedics assessed her, including heart monitoring. Patient was sent to the ER for further treatment and observation. She remained alert and conscious the entire time.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: pain in left shoulder at injection site, chills, clammy, constipated, trouble sleeping
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cold sweat, Constipation, Injection site pain, Insomnia
Clinical narrative: pain in left shoulder at injection site, chills, clammy, constipated, trouble sleeping
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Underdose, Vaccination site irritation, Wrong technique in product usage process
Clinical narrative: Covic 19 Vaccine was improperly administrated in the left arm by Pharmacy Technician. NOT SURE what amount of the Covic 19 Vaccine went into the feeder; a LARGE PERCENTAGE did not enter the arm and ran down the outside of the arm from the injection sight.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syringe issue, Wrong technique in product usage process
Clinical narrative: Covic 19 Vaccine was improperly administrated in the left arm by Pharmacy Technician. NOT SURE what amount of the Covic 19 Vaccine went into the feeder; a LARGE PERCENTAGE did not enter the arm and ran down the outside of the arm from the injection sight.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis, Troponin
Clinical narrative: Adverse Event: Myocarditis  Treatment: Hospitalization for 2 days- no medications or interventions required.  Outcome: Released from hospital. Stable at 6 weeks post-discharge
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Adverse Event: Myocarditis  Treatment: Hospitalization for 2 days- no medications or interventions required.  Outcome: Released from hospital. Stable at 6 weeks post-discharge
Age: 13.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Erythema, Injection site rash, Pruritus, Urticaria
Clinical narrative: Per pt / mother child  Started having itching rash( hives) in thigh 3 hrs after office visit Rash was spreading : mother gave benadryl with no improvement . Mother call EMS  The rash spread to most parts of body leading to ER visit No other symptoms : no itchy/ tingly throat/ no chest pain or SOB no palpitations , no  dizziness no other symptoms per pt In ER per mother child was observed : found to have rash  Around  The injection site for flu. She was given an injection  ( probably epinephrine) with good resolution  Of rash . She was observed for another > 1 hr and then discharged. Discharge diagnosis : allergic reaction  etio ?  Per mother possibly to flu vaccine ( no discharge notes/ papers available in
Age: 13.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Hypersensitivity, Injection site rash, Rash pruritic, Urticaria
Clinical narrative: Per pt / mother child  Started having itching rash( hives) in thigh 3 hrs after office visit Rash was spreading : mother gave benadryl with no improvement . Mother call EMS  The rash spread to most parts of body leading to ER visit No other symptoms : no itchy/ tingly throat/ no chest pain or SOB no palpitations , no  dizziness no other symptoms per pt In ER per mother child was observed : found to have rash  Around  The injection site for flu. She was given an injection  ( probably epinephrine) with good resolution  Of rash . She was observed for another > 1 hr and then discharged. Discharge diagnosis : allergic reaction  etio ?  Per mother possibly to flu vaccine ( no discharge notes/ papers available in
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Insomnia, Muscle discomfort, Pain in extremity, Walking aid user
Clinical narrative: pain in both legs but was able to walk; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in both legs but was able to walk) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Reaction to food coloring (Allergy to artificial colors) and Reaction to flavoring (Allergy to flavors). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in both legs but was able to walk). The patient was treated with TRAMADOL for Pain in leg, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain in leg, at an unspecified dose and frequency. In February 2021, PAIN IN EXTREMITY (pain in both legs but was able to walk) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient had pain in both legs during 3 weeks but was able to walk. Patient never experienced similar event in past. It was also reported that patient visited a pain medicine doctor. Treatment included 3 or 4 medications (did not remember names) for pain in the legs.   This case was linked to MOD-2022-658252, MOD-2022-658249 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in both legs but was able to walk; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in both legs but was able to walk) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Reaction to food coloring (Allergy to artificial colors) and Reaction to flavoring (Allergy to flavors). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in both legs but was able to walk). The patient was treated with TRAMADOL for Pain in leg, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain in leg, at an unspecified dose and frequency. In February 2021, PAIN IN EXTREMITY (pain in both legs but was able to walk) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient had pain in both legs during 3 weeks but was able to walk. Patient never experienced similar event in past. It was also reported that patient visited a pain medicine doctor. Treatment included 3 or 4 medications (did not remember names) for pain in the legs.   This case was linked to MOD-2022-658252, MOD-2022-658249 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2
Symptoms: Pain, Rotator cuff syndrome
Clinical narrative: Within 2 days stiffness developed in left shoulder, increasing on 10/13/22 to pain levels similar to rotator cuff surgery.  Spoke with medical doctor who indicated that if this continued to Monday, it would be appropriate to seek further medical care. Unable to sleep laying down or find a comfortable arm position.  Had to sleep semi sitting and even then difficult to find position of comfort. Applied ice and Tylenol, 3 days of intense pain, limited ROM, strength very reduced.  By Sunday 10/16/22 able to use arm in a limited fashion but ROM still limited and strength very limited.  Began moving arm gently and passively through painful movements and will be requesting PT to ensure proper recovery of function.  Feeling lower arm aching in various places (concerning), and continuing to ice, take Tylenol, and gently move arm both passively and very carefully actively.  Did try heat, does not feel helpful.  Also used hydrotherapy in the shower with hot/cold/hot/cold repeated starting on Sunday 10/16/22.  This is impairing my daily activities, interfering with my martial arts, fitness, and yoga workouts, and still causing me trouble when working, also interfering with my other artistic endeavors.  Cannot rotate my arm medially and dorsally without  marked discomfort, must assist arm movements overhead and overall movement still quite stiff + weak.  NOTE 1: I had BOTH the COVID19 Pfizer Updated Booster 12+ 0.3ml AND the FLUCELVAX PFS 2022-23 INJ 0.5ml intramuscularly in the left shoulder.  NOTE 2: I previously had Rotator Cuff surgery in the RIGHT shoulder (6/2017), so am familiar with the pain levels of the injury + surgery. This vaccine injury is to the LEFT shoulder.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2
Symptoms: Arthralgia, Asthenia, Discomfort, Exercise tolerance decreased, Impaired work ability
Clinical narrative: Within 2 days stiffness developed in left shoulder, increasing on 10/13/22 to pain levels similar to rotator cuff surgery.  Spoke with medical doctor who indicated that if this continued to Monday, it would be appropriate to seek further medical care. Unable to sleep laying down or find a comfortable arm position.  Had to sleep semi sitting and even then difficult to find position of comfort. Applied ice and Tylenol, 3 days of intense pain, limited ROM, strength very reduced.  By Sunday 10/16/22 able to use arm in a limited fashion but ROM still limited and strength very limited.  Began moving arm gently and passively through painful movements and will be requesting PT to ensure proper recovery of function.  Feeling lower arm aching in various places (concerning), and continuing to ice, take Tylenol, and gently move arm both passively and very carefully actively.  Did try heat, does not feel helpful.  Also used hydrotherapy in the shower with hot/cold/hot/cold repeated starting on Sunday 10/16/22.  This is impairing my daily activities, interfering with my martial arts, fitness, and yoga workouts, and still causing me trouble when working, also interfering with my other artistic endeavors.  Cannot rotate my arm medially and dorsally without  marked discomfort, must assist arm movements overhead and overall movement still quite stiff + weak.  NOTE 1: I had BOTH the COVID19 Pfizer Updated Booster 12+ 0.3ml AND the FLUCELVAX PFS 2022-23 INJ 0.5ml intramuscularly in the left shoulder.  NOTE 2: I previously had Rotator Cuff surgery in the RIGHT shoulder (6/2017), so am familiar with the pain levels of the injury + surgery. This vaccine injury is to the LEFT shoulder.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2
Symptoms: Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Within 2 days stiffness developed in left shoulder, increasing on 10/13/22 to pain levels similar to rotator cuff surgery.  Spoke with medical doctor who indicated that if this continued to Monday, it would be appropriate to seek further medical care. Unable to sleep laying down or find a comfortable arm position.  Had to sleep semi sitting and even then difficult to find position of comfort. Applied ice and Tylenol, 3 days of intense pain, limited ROM, strength very reduced.  By Sunday 10/16/22 able to use arm in a limited fashion but ROM still limited and strength very limited.  Began moving arm gently and passively through painful movements and will be requesting PT to ensure proper recovery of function.  Feeling lower arm aching in various places (concerning), and continuing to ice, take Tylenol, and gently move arm both passively and very carefully actively.  Did try heat, does not feel helpful.  Also used hydrotherapy in the shower with hot/cold/hot/cold repeated starting on Sunday 10/16/22.  This is impairing my daily activities, interfering with my martial arts, fitness, and yoga workouts, and still causing me trouble when working, also interfering with my other artistic endeavors.  Cannot rotate my arm medially and dorsally without  marked discomfort, must assist arm movements overhead and overall movement still quite stiff + weak.  NOTE 1: I had BOTH the COVID19 Pfizer Updated Booster 12+ 0.3ml AND the FLUCELVAX PFS 2022-23 INJ 0.5ml intramuscularly in the left shoulder.  NOTE 2: I previously had Rotator Cuff surgery in the RIGHT shoulder (6/2017), so am familiar with the pain levels of the injury + surgery. This vaccine injury is to the LEFT shoulder.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller explained VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from a medical assistant, referring to patient of unknown age or gender.   The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided.  On 12-JUL-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, lot number U025204 has been verified to be a valid lot number with expiration date on 13-AUG-2023, administered as prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).  The varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature of 26.6 degree Fahrenheit (F) for 1 hour and 7.9 degrees F for 30 minutes. There was no previous temperature excursion.  No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a woman that was in her 70s that managed to get GARDASIL 9; No additional AE information reported.; This spontaneous report was received from a consumer and refers to a female patient of 70s (also reported as 70-80 years old).  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) in her 70s (product administered to patient of inappropriate age) and she was doing well. No additional adverse event information reported. No product quality complaint reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; Consumer received the VARIVAX vaccine intramuscularly; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, historical drug, drug reactions/allergies and concomitant therapies were not provided.  On 28-SEP-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U019904, expiration date: 24-JUN-2023, administered intramuscularly (Incorrect route of product administration) for prophylaxis (strength was not provided).  No adverse symptoms were reported.
Sex: M
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: a recent titer test showed that it was low; This spontaneous report has been received from a pharmacist and refers to a 56-year-old male patient. The patient's medical history, current conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On an unknown date (reported as: "when the patient was a baby"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection or measles, mumps, and rubella (MANUFACTURER UNKNOWN), administered for prophylaxis (strength, dose, vaccination scheme, lot #, expiry date, and route of administration were not provided).  On an unknown date, recent titer test showed that it was low (viral titre decreased).   The outcome of the event, and the causality assessment between the viral titre decreased  and the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection or measles, mumps, and rubella (MANUFACTURER UNKNOWN) were not provided
Age: 1.25
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Inbound call from HCP reporting that a PROQUAD was administered after a supported temp excursion.; This spontaneous report has been received from a physician, concerning to a 15-months-old patient of unknow gender. The patient's concomitant medications included sterile diluent. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not provided.  On 30-SEP-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) subcutaneous injection (strength, dose, vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot number W019624 that was verified to be valid with an expiration date reported and established as 19-DEC-2023) for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion of 15.1 degrees Fahrenheit (F) during a time frame of 3 hours and 49 minutes with 0 seconds. There was not a previously temperature excursion reported; and it was mentioned that varicella (oka-merck) virus vaccine live (PROQUAD) was administered after a supported temperature excursion.  There was no additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.    On 12-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular Injection (lot number W002889 has been verified to be a valid lot number, expiration date 06-MAR-2023) (strength, dose, frequency, and anatomical location were not provided) indicated as prophylaxis (product storage error).  The  hepatitis a vaccine, inactivated (VAQTA) vaccine was stored at a temperature of 46.5 Fahrenheit (F) for the ime frame of 1 hour 0 minutes 0 seconds. There was no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report as received from a registered nurse refers to a 14 month old patient of unknown gender. On 06-SEP-2022, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W002601 exp date 24-JAN-2024). The temperature of excursion was 1 hour and 45 minutes and there was no previous temperature excursion. No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose, Wrong product administered
Clinical narrative: no adverse event; PROQUAD in combination with VARIVAX; Wrong vaccine administered; This spontaneous report was received from a nurse referring to an unknown gender 12-month-old patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  The patient was intended to be administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in combination with varicella virus vaccine live (oka/merck) (VARIVAX) but on 26-SEP-2022, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection rHA (recombinant Human albumin), lot #W020548, expiration date: 26-DEC-2023, administered for prophylaxis (strength, dose and route of administration were not provided) with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W016746, expiration date: 23-MAY-2024, administered for prophylaxis (strength, dose and route of administration were not provided) (overdose, wrong product administered). The patient had never been administered corresponding measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) prior to or at current call time. The reporter was unable to further clarify these statements at current call time. No adverse event was reported.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from registered nurse and refers to a 7-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, quantity: 1, lot #W002601, expiration date: 24-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided)(product storage error). The vaccine was exposed to the temperature excursions for 1 hour and 45 minutes. There was no previous temperature excursion. No additional adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-SEP-2022, the patient was vaccinated with improper stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W017567, expiration date reported as 29-DEC-2021, but upon internal validation established as 29-NOV-2023, administered for prophylaxis (dose, strength, and route of administration were not provided) (product storage error). The vaccine was exposed to the temperature excursions: -11.8 Degrees Celsius for 1 hour and 45 minutes. There was no previous temperature excursion. No additional adverse event. No product quality complaint.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; an improperly stored dose of PROQUAD was administered to the patient on 29SEP2022; This spontaneous report was received from a medical assistant referring to a patient of unknow gender and age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 29-SEP-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) 0.5 milliliter, lot #U028183, expiration date: 08-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). The temperature was 11.1 Fahrenheit (F), and time frame was 3 hours and 25 minutes. There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Age: 1.83
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Caller reported that PROQUAD that had undergone temperature excursion was administered to a patient.; This spontaneous report was received from a nurse referring to a 22-month-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 28-SEP-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot #W012743, expiration date: 16-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was undergone temperature excursion, with temperature was -11.8 Celsius (C) and time frame was 1 hour and 45 minutes. There was previous temperature excursion. No additional adverse event was reported (no adverse event).
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; A 12 month old pediatric patient was administered an adult dose of VAQTA; This spontaneous report has been received from a nurse practitioner, referring to a 12-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-SEP-2022 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1 dose (strength, route, and anatomical site of administration were not reported, lot number U036184, and expiration date 02-MAR-2023) as prophylaxis. The pediatric patient was administered with an adult dose (product administered to patient of inappropriate age). No additional AE reported (no adverse event). No PQC reported.  The reporter gave consent for follow-up.
Age: 54.0
Sex: F
Vaccine: PNC15, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report was received from a physician and lawyer referring to a adult female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.     Yearly from 2005 to 2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) or pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) (reported as pneumococcal vaccine) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). In September 2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.    The case was split from a legal case referring the same patient. ; Sender's Comments:  US-009507513-2207USA007086:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's and no PQC's were reported.; A nurse reported that an expired dose of PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a registered nurse concerning a patient of unknown gender and age. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 06-OCT-2022, an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U002528, expiration date 13-SEP-2022; strength, dose, route of administration were not reported) was administered to the patient (expired product administered). No additional adverse events (AEs) were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported, no further information provided; The physician reported that a patient received improperly stored vaccine; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.  07-OCT-2022, the patient was vaccinated with 1 improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # w017571 has been verified to be valid, expiration date reported and established as 29-NOV-2023; formulation, strength, dose and route were not provided) for prophylaxis (product storage error).   The storage temperature of the vaccine was 10.1 degrees Fahrenheit (F) for a time frame of 51 hours. There was no previous temperature excursion. No additional adverse event (AE) was reported, no further information provided.
Sex: M
Vaccine: PPV
Symptoms: Injection site bruising, Injection site urticaria
Clinical narrative: Received the PNEUMOVAX 23 vaccine and the next day experience hives and bruise at the injection site.; Received the PNEUMOVAX 23 vaccine and the next day experience hives and bruise at the injection site.; This spontaneous report has been received from a company representative referring a male patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided).  On an unknown date, husband and wife both received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the next day experience hives (vaccination site urticaria) and bruise (vaccination site bruising) at the injection site. At time of reporting, the events where improving (recovering).   The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA002883:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Product use in unapproved indication
Clinical narrative: Pain under her arm; HCP was administered PNEUMOVAX 23 and experienced puffiness/swelling at the injection site; HCP was administered PNEUMOVAX 23 and experienced redness; the HCP received the PNEUMOVAX23 because she is asthmatic; This spontaneous report has been received from other health professional regarding to herself as female patient of unknown age.The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On an unknown date in 2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, as treatment for asthma (product use in unapproved indication) (strength, dosage, route of administration, anatomical site of injection, vaccination scheme frequency, lot number and expiration date were not reported). On an unspecified date, the patient experienced puffiness, swelling (injection site swelling), and redness (injection site erythema), at the injection site as well as pain under her arm (pain in extremity). At the time of reporting, the outcome of injection site swelling, injection site erythema, and pain in extremity was not provided   The causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not reported.