chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Crying, Developmental regression
Clinical narrative: Began crying inconsolably around 1pm same day as shot and it continued for almost three hours.  After a short nap the crying began again for another 3 hours. Days later a noticeable regression  in level of engagement with parents and loved ones. Stopped babbling and smiling. A week later a significant head lag was present during routine ?pull to sit? milestone test after not being present at 4 month ped appointment.  Resulted in recommendation from pediatrician and muscular therapist to get an early intervention evaluation done.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Migraine, Pain in extremity, Paraesthesia
Clinical narrative: Extreme soreness in upper left arm, some tingling going down into left hand, extreme headache (bordering on a migraine), extreme fatigue
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Hot flush, Nausea
Clinical narrative: Patient reported around 1220 pounding "headache" with hot flashes and feeling nauseous. Patient was instructed to return to his room by Instructor.  At 1232 Instructor called patient to follow up to see if there is any history of headaches or migraines patient stated he does experience "migraines" every now and then. He also stated he felt a minor one earlier in the morning but did not mention it as he thought it would pass on it's own. Instructor asked patient if he thinks this could be a migraine episode and patient stated "possibly". Patient was instructed to remain in his room to rest and to call Medical immediately if his symptoms worsen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Ear pain, Fatigue, Headache, Hyperhidrosis
Clinical narrative: On 12/8/2020 I experienced severe fatigue. By 8:00pm I had a severe headache, the worst I've ever had and a 100 degree fever. In the middle of the night I had severe body aches, even my ear hurt while laying on the pillow. My muscle felt very tight and achy.  My arm was sore and swollen at the injection site. This continued throughout the whole next day (12/9/20). I was so fatigued I could do nothing but lay on the couch. My thinking was muddled. I was sweating from the fever. I had no appetite.  I slept 11 hours that night and could have slept more but I had to get up for work (I work from home). When I woke up at 6:30am all of my symptoms were milder and by noon my fever and headache were gone. By the end of the end, the body aches ended but the fatigue continued (milder that the day before).  As of right now, my arm is still sore and slightly swollen and I am still tired.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Injection site pain, Injection site swelling, Muscle tightness, Myalgia
Clinical narrative: On 12/8/2020 I experienced severe fatigue. By 8:00pm I had a severe headache, the worst I've ever had and a 100 degree fever. In the middle of the night I had severe body aches, even my ear hurt while laying on the pillow. My muscle felt very tight and achy.  My arm was sore and swollen at the injection site. This continued throughout the whole next day (12/9/20). I was so fatigued I could do nothing but lay on the couch. My thinking was muddled. I was sweating from the fever. I had no appetite.  I slept 11 hours that night and could have slept more but I had to get up for work (I work from home). When I woke up at 6:30am all of my symptoms were milder and by noon my fever and headache were gone. By the end of the end, the body aches ended but the fatigue continued (milder that the day before).  As of right now, my arm is still sore and slightly swollen and I am still tired.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Thinking abnormal
Clinical narrative: On 12/8/2020 I experienced severe fatigue. By 8:00pm I had a severe headache, the worst I've ever had and a 100 degree fever. In the middle of the night I had severe body aches, even my ear hurt while laying on the pillow. My muscle felt very tight and achy.  My arm was sore and swollen at the injection site. This continued throughout the whole next day (12/9/20). I was so fatigued I could do nothing but lay on the couch. My thinking was muddled. I was sweating from the fever. I had no appetite.  I slept 11 hours that night and could have slept more but I had to get up for work (I work from home). When I woke up at 6:30am all of my symptoms were milder and by noon my fever and headache were gone. By the end of the end, the body aches ended but the fatigue continued (milder that the day before).  As of right now, my arm is still sore and slightly swollen and I am still tired.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: patient told physician she could not lift her arm and it was very sore.  being treated with diclofenac 75mg which is helping with symptoms
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Mobility decreased
Clinical narrative: Patients reports pain on the interior of her right brachial muscle near the axilla. She says she has trouble lifting her arm and has trouble putting on clothes.
Age: 50.0
Sex: M
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Bedridden
Clinical narrative: I was bed ridden as a result of the following vax on Monday,  07 Dec 2020: Influenza, 6 month and older (4-valet) (single dose) .5 ml 12/7/2020 Administered Shingrix 12/7/2020 Administered Tdap
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Vomiting and stomach pain
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Patient was given two doses of the Shingrix vaccine. One in each arm. She experienced flu like symptoms for a few days.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Depression, Dermatitis, Panic attack, Skin infection
Clinical narrative: Within 2 months, patient began to experience severe panic attacks, and noted substantial depression, without any active or acute cause.  Was back in with doctor by 5/29/12 and did note this to the attending physician.  The primary purpose of this follow-up visit was for a skin inflammation/infection.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Neck pain, Rash
Clinical narrative: ON WEDNESDAY 12/09/2020 PATIENT REPORTED THE PHARMACY OF HAVING SEVERE HEADACHES AND ELECTRIC SHOCK GOING DOWN HIS NECK. PATIENT REPORTED THAT HE HAS BEEN HAVING THESE SYMPTOMS SINCE A COUPLE DAYS AFTER GETTING THE VACCINE. PATIENT ALSO REPORTED OF HAVING A RASH/BLISTER BEHIND HIS EAR. PATIENT WENT TO HIS PRIMARY CARE PROVIDER AND WAS PRESCRIBED GABAPENTIN TO HELP WITH THE PAIN. ON WEDNESDAY 12/09/2020 WHEN PATIENT REPORTED THE PHARMACY OF HIS SYMPTOMS, PATIENT WAS RECOMMENDED TO GO TO THE ER OR URGENT CARE IF HIS  SYMPTOMS WERE NOT IMPROVING. ON FRIDAY 12/11/2020 PATIENT REPORTED THE PHARMACY THAT HE WAS DIAGNOSED WITH SHINGLES AND WAS BEING TREATED FOR SHINGLES.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site pain, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Within 90 minutes of vaccine administration patient experienced extreme at the injection site which continued to worsen over the next 15 hours.  On a pain scale 1-10 patient reported being a 10.  Patient lost conscientiousness for about 45 seconds.  Wife believes that her husband when into A-Fib.  Patient had nausea  and when to toilet to vomit and passed out for another 45 seconds.  Patient was sweating profusely.  Patient's wife assisted him up and after he lost consciousness after the third time.  Then wife tested his oxygen and blood pressure which were normal.   Spouse gave him a dose of Flecainide
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, chills and headache
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Fatigue starting at 6 pm Extreme and increasing pain, swelling, heat and redness at injection site - so severe I could not move my arm without intense pain. By about 9 pm had fever of 99.8 At 10 pm fever incresed to 101 Fever and pain continued throughout the night 5:00 am fever was 100.6. Awoke with slightly less pain in arm, but experienced severe joint pain and dizziness. Fever remained at 100.5 until about noon Took a shower whereupon the fever dropped to 99.5 Pain in arm diminished for a bit. At 3 pm pain in arm returned along with sever back pain and low fever of 99.8 As of this report 6 pm CST 12/12 - pain in right arm is significant.  Right upper arm is swollen, firm and hot
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Fatigue starting at 6 pm Extreme and increasing pain, swelling, heat and redness at injection site - so severe I could not move my arm without intense pain. By about 9 pm had fever of 99.8 At 10 pm fever incresed to 101 Fever and pain continued throughout the night 5:00 am fever was 100.6. Awoke with slightly less pain in arm, but experienced severe joint pain and dizziness. Fever remained at 100.5 until about noon Took a shower whereupon the fever dropped to 99.5 Pain in arm diminished for a bit. At 3 pm pain in arm returned along with sever back pain and low fever of 99.8 As of this report 6 pm CST 12/12 - pain in right arm is significant.  Right upper arm is swollen, firm and hot
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue starting at 6 pm Extreme and increasing pain, swelling, heat and redness at injection site - so severe I could not move my arm without intense pain. By about 9 pm had fever of 99.8 At 10 pm fever incresed to 101 Fever and pain continued throughout the night 5:00 am fever was 100.6. Awoke with slightly less pain in arm, but experienced severe joint pain and dizziness. Fever remained at 100.5 until about noon Took a shower whereupon the fever dropped to 99.5 Pain in arm diminished for a bit. At 3 pm pain in arm returned along with sever back pain and low fever of 99.8 As of this report 6 pm CST 12/12 - pain in right arm is significant.  Right upper arm is swollen, firm and hot
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: FEVER >100F, CHILLS, ACHES LASTING 2-3 DAYS
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pain
Clinical narrative: Muscle ache,  Throbbing pain and 10/10  on pain scale. Took Ibuprofen,  Tylenol,   Aspirin , Votaren,  Lidacaine and they are all ineffective.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Back pain, Chills, Cold sweat, Decreased appetite, Headache
Clinical narrative: Patient reports 104 fever, cold sweats, achy back, headache, chills, insomnia, and loss of appetite. Left arm was hot to the touch and painful to move. Symptoms started 12/8/2020 8pm and continued until 12/11/2020 9am.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Insomnia, Pain, Pyrexia, Skin warm
Clinical narrative: Patient reports 104 fever, cold sweats, achy back, headache, chills, insomnia, and loss of appetite. Left arm was hot to the touch and painful to move. Symptoms started 12/8/2020 8pm and continued until 12/11/2020 9am.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Erythema, Lymphadenopathy, Malaise, Musculoskeletal stiffness
Clinical narrative: after receiving the MMR vaccine not to long after I had a rash on my chest, my ears where super hot and red and it appeared my lymph nodes in neck where slightly swollen.  I also felt like my joints in my finger and neck hurt and where stiff the next day and I was sick. it lasted a few days only. I have a lot of sensitive's  to medications and food. so I am not sure if that was what happened.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Rash, Skin warm
Clinical narrative: after receiving the MMR vaccine not to long after I had a rash on my chest, my ears where super hot and red and it appeared my lymph nodes in neck where slightly swollen.  I also felt like my joints in my finger and neck hurt and where stiff the next day and I was sick. it lasted a few days only. I have a lot of sensitive's  to medications and food. so I am not sure if that was what happened.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Anxiety, Blood prolactin decreased, Cardiac stress test normal, Chest pain
Clinical narrative: Six months after injection #2, I had middle of the day severe heart palpitations with chest pain that continued for 30 minutes.  There was no stressful incident that had occurred prior to the onset of chest pain/palpitations.  Had to be taken to an empty office at work and laid down to try to calm/get them to stop.   Previous to that moment patient had never experienced chest pain.  Patient had also stopped receiving a menstrual bleed from the time of injection #1 to that point.   Booked an urgent care appointment but then cancelled due to anxiety/exhaustion following cessation of heart palpitations, tho chest pain lingered into next day.  Doctors office called and said I needed to be seen by PCP next day.  Next day appointment (1/25/10), heart-related tests and pelvic ultrasound ordered.  Based on ultrasound results PCP did not think patient had PCOS, based on healthy weight within BMI, but referred to a GYN who did diagnose patient with PCOS and after physical examination reported patient would have issues conceiving naturally.  Patient was healthy up until this point and there is no family history on either side of family for PCOS nor infertility.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram abnormal, Fatigue, Infertility, Palpitations, Polycystic ovaries
Clinical narrative: Six months after injection #2, I had middle of the day severe heart palpitations with chest pain that continued for 30 minutes.  There was no stressful incident that had occurred prior to the onset of chest pain/palpitations.  Had to be taken to an empty office at work and laid down to try to calm/get them to stop.   Previous to that moment patient had never experienced chest pain.  Patient had also stopped receiving a menstrual bleed from the time of injection #1 to that point.   Booked an urgent care appointment but then cancelled due to anxiety/exhaustion following cessation of heart palpitations, tho chest pain lingered into next day.  Doctors office called and said I needed to be seen by PCP next day.  Next day appointment (1/25/10), heart-related tests and pelvic ultrasound ordered.  Based on ultrasound results PCP did not think patient had PCOS, based on healthy weight within BMI, but referred to a GYN who did diagnose patient with PCOS and after physical examination reported patient would have issues conceiving naturally.  Patient was healthy up until this point and there is no family history on either side of family for PCOS nor infertility.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Ultrasound pelvis abnormal
Clinical narrative: Six months after injection #2, I had middle of the day severe heart palpitations with chest pain that continued for 30 minutes.  There was no stressful incident that had occurred prior to the onset of chest pain/palpitations.  Had to be taken to an empty office at work and laid down to try to calm/get them to stop.   Previous to that moment patient had never experienced chest pain.  Patient had also stopped receiving a menstrual bleed from the time of injection #1 to that point.   Booked an urgent care appointment but then cancelled due to anxiety/exhaustion following cessation of heart palpitations, tho chest pain lingered into next day.  Doctors office called and said I needed to be seen by PCP next day.  Next day appointment (1/25/10), heart-related tests and pelvic ultrasound ordered.  Based on ultrasound results PCP did not think patient had PCOS, based on healthy weight within BMI, but referred to a GYN who did diagnose patient with PCOS and after physical examination reported patient would have issues conceiving naturally.  Patient was healthy up until this point and there is no family history on either side of family for PCOS nor infertility.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cough, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever 102 Body aches Fatigue Nausea Headache Cough Congestion  Went to clinic, 10/8/2020. Was tested for covid.  Test was negative. Was ill with above symptoms for 5 days. Had lingering cough for 10 days. Treated at home with tylenol and delsym.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Fever 102 Body aches Fatigue Nausea Headache Cough Congestion  Went to clinic, 10/8/2020. Was tested for covid.  Test was negative. Was ill with above symptoms for 5 days. Had lingering cough for 10 days. Treated at home with tylenol and delsym.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient's arm hurts when trying to lift above shoulder height
Age: 56.0
Sex: U
Vaccine: TDAP
Symptoms: Lymphadenopathy, Sluggishness
Clinical narrative: Patient states lymph nodes were swollen and patient felt sluggish starting 2 days after the vaccination for about a whole month.
Age: 35.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Dyspnoea, Loss of consciousness
Clinical narrative: Patient became unconscious momentarily after the shot and had difficulty breathing. Immediately called 911. The EMT checked him and found all vitals normal. Patient OK & did not want to go to ER.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Deafness unilateral, Vertigo
Clinical narrative: WOKE UP WITH VERTIGO AND LOSS OF HEARING IN LEFT EAR
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Nausea, Pain in extremity
Clinical narrative: Nausea; pain in my arm; tired; weakness in body
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Shivers, headache, body aches and low grade fever ( 100.5 ).  Also soreness at injection site.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Condition aggravated, Convulsions local, Headache, Magnetic resonance imaging brain normal
Clinical narrative: I had a headache starting 15 minutes after the injection then a couple hours later I had what has since been diagnosed by a neurologist as a thunderclap headache around my left temple. My right leg convulsed when this happened. This was debilitating and I lost motor functions in my right arm and leg. I am still recovering and still have migraines everyday. I had a brain MRI which was normal.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Motor dysfunction, Scan with contrast normal, Thunderclap headache
Clinical narrative: I had a headache starting 15 minutes after the injection then a couple hours later I had what has since been diagnosed by a neurologist as a thunderclap headache around my left temple. My right leg convulsed when this happened. This was debilitating and I lost motor functions in my right arm and leg. I am still recovering and still have migraines everyday. I had a brain MRI which was normal.
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Circadian rhythm sleep disorder, Headache, Limb discomfort, Malaise, Nerve injury
Clinical narrative: I took 2 vaccine (simultaneously) Basic arm tightness and malaise, tolerable for 2 to 3 days.... Headache for one week affecting nerve damaged by Shringle on L side of top of head.  It bacame Hypnic Headache by 4th and 5th days, and now became Circul Rhy Sleep Disorder (CRSD) waking up at 2pm every night. I am a person that have no headache usually. Concern will be if I should take any COVID vaccine in the future causing more headache problems???
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Chills (shivering) and muscle ache throughout the body for approximately 3 to 4 hours
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Sore arm for over 6 weeks. Soreness going away now around 12/10/2020
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever, fatigue, dizziness, slight, cough, slight nausea
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient came to pharmacy on 12/13/2020 to report that approximately 48 hours after the flu shot on 9/26/2020, he began to have mild arm pain. Over the next few months, the pain did not go away and has worsened over time to the point where his pain is bad and lifting his arm is difficult. He is going to his physician to have it evaluated on 12/14/2020 as per patient.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Headache, Hemiplegia, Musculoskeletal stiffness
Clinical narrative: After receiving flu vaccine at my local health department, the following day I was subject to severe headache, which has lasted 4 days on a continuous basis. On Sunday, December 13, 2020 (11:00 am EST), I woke up and left arm was partially paralyzed, no useful function for a period of 10-15 minutes, extreme redness, and stiffness. No other issues on right hand side of body.  No prior issues with arm or hands in the past. Also had severe headache on this day as well.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: WIDESPREAD REDNESS ON UPPER ARM, NO FEVER
Age: 77.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient stated that she is having severe upper right arm pain since receiving the pneumovax 23 vaccine. She has limited arm movement and can not lift her arm past her shoulders. Other  immediate reaction she had after the injection  was swelling and itching which has then gone away. The upper arm pain however, still persist 3 months after the vaccine was administered. Her quality of life has been affected by her inability to sleep comfortably or lay down on her right side due to the pain.
Age: 77.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Quality of life decreased, Sleep disorder
Clinical narrative: Patient stated that she is having severe upper right arm pain since receiving the pneumovax 23 vaccine. She has limited arm movement and can not lift her arm past her shoulders. Other  immediate reaction she had after the injection  was swelling and itching which has then gone away. The upper arm pain however, still persist 3 months after the vaccine was administered. Her quality of life has been affected by her inability to sleep comfortably or lay down on her right side due to the pain.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: brief episode of syncope; resolved within 1-2 min
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash, Urticaria
Clinical narrative: Arm began swelling after injection with same amount of pain as previous injection later that evening.  Rash noted 45 hours after injection with urticaria on upper trunk and neck.  No rash noted after first injection in August.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Von Willebrand's disease
Clinical narrative: Patient came to the pharmacy to notify us of her experience with the shot she got & showed me a picture (taken with her phone) of the bruised spot on her left arm, at the site of Shingrix vaccine administration. She however stated that she has a history of Von Wilhelms disease (a blood clotting disorder). She said that she would monitor the bruising for any worsening & consult with her doctor.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Area around injection was still itchy, red, swollen, and painful a week after injection was given. It had improved over time.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Headache, Impaired driving ability, Insomnia, Myalgia
Clinical narrative: head ache (left side of neck; ); can't sleep; blurry vision; aches and pains; muscle aches; very shaky; memory problems; scared to drive; very nervous and shaky; very drained; went to the doctor, who advised her to let the pharmacy know that she was probably having a reaction to the shingles shot; This was her 2nd shot in the series, AND she had Zostavax back in 2009 (with no problems) - no problems with the 1st dose of shingrix
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Nervousness, Pain, Tremor, Vision blurred
Clinical narrative: head ache (left side of neck; ); can't sleep; blurry vision; aches and pains; muscle aches; very shaky; memory problems; scared to drive; very nervous and shaky; very drained; went to the doctor, who advised her to let the pharmacy know that she was probably having a reaction to the shingles shot; This was her 2nd shot in the series, AND she had Zostavax back in 2009 (with no problems) - no problems with the 1st dose of shingrix
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is only 46 years old and was administered Shingrix by a visiting pharmacist on duty. The indication for Shingrix is only 50 years or older.  This was his second dose and he had gotten his first done at the doctor's office back in March 2020.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vision blurred
Clinical narrative: Blurred vision within 5 hours Fainted when getting up in the night to address eye concern
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: Pain in my left shoulder started the following day. That night the pain was bad enough that I slept in a recliner with my left arm above my head as that was the only way I could get comfortable. The pain would ebb and flow over the next few days, but it spread to my right shoulder as well. Now I have that pain in both shoulders. The pain usually is worse in the morning but gets better with shoulder stretching throughout the day. I still have the pain when I wake up. Sometimes it gets much better throughout the day but sometimes it remains painful, even a month later.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient noticed a rash on her torso on Friday evening that seemed to be resolving on its own by Saturday.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Loss of consciousness, Wheezing
Clinical narrative: ~3-5 minutes after receiving the vaccination, the patient started to appear to lose consciousness, displayed weakness, and wheezing and shortness of breath. The pharmacist carefully lowered the patient to the ground and had his staff contact 9-1-1 while he administered an Epi-pen injection to the patient's right outer thigh. The patient immediately responded to the injection, was alert and talkative. EMS arrived and took over. Patient left on his own thereafter (~15 mins). Patient was advised to reach out/follow-up with his physician for medical evaluation.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Nausea, Pain
Clinical narrative: Patient contacted the pharmacy on next day around 10:12 am and stated about one hour after vaccine administered she started experiencing  shills, ache all over the body, fever 102 F lasted only one night, she was not febrile next day on 12/9/2020. on 12/9/2020 she reported that body pain not as bad as before, she had stomach upset on 12/8/2020, no appetite, sick stomach, nausea and vomiting on 12/8/2020, which she feels fine on 12/9/2020, no nausea and vomiting, and she was able to take some Tylenol on 12/9/2020
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient contacted the pharmacy on next day around 10:12 am and stated about one hour after vaccine administered she started experiencing  shills, ache all over the body, fever 102 F lasted only one night, she was not febrile next day on 12/9/2020. on 12/9/2020 she reported that body pain not as bad as before, she had stomach upset on 12/8/2020, no appetite, sick stomach, nausea and vomiting on 12/8/2020, which she feels fine on 12/9/2020, no nausea and vomiting, and she was able to take some Tylenol on 12/9/2020
Age: 14.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Aphasia, Biopsy brain abnormal, Blood test abnormal, Central nervous system vasculitis, Cerebrovascular accident
Clinical narrative: July 4 , 2020- right-handed weakness with numbness, slurred speak, and had trouble finding words. July 6, 2020 - couldn't move her entire right side of her body and could not speak at all. Hospitalized on July 6, 2020 and determined she had a stroke based on an MRI. Numerous blood tests were taken along with a 2nd MRI with her braces removed.
Age: 14.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Dysarthria, Hypoaesthesia, Magnetic resonance imaging abnormal, Movement disorder, Muscular weakness
Clinical narrative: July 4 , 2020- right-handed weakness with numbness, slurred speak, and had trouble finding words. July 6, 2020 - couldn't move her entire right side of her body and could not speak at all. Hospitalized on July 6, 2020 and determined she had a stroke based on an MRI. Numerous blood tests were taken along with a 2nd MRI with her braces removed.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, shivering, headache, tired.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pain
Clinical narrative: I had extreme pain in my left upper arm and shoulder. I could not move my left arm up and down without experiencing severe pain that lasted for about 10 days. My doctor prescribed Prednisone, and urgent care prescribed Naproxen. I felt extreme pain in most positions that I sat in or when I lay down. I could barely lift my left arm to a resting position on a table or sofa arm without extreme pain that caused me to wince and even brought tears to my eyes at times. I have never had a reaction even remotely similar to this with another vaccine and never expected it to be this painful. I was very concerned that my arm and shoulder might be permanently damaged. I still feel a twinge at times in my left shoulder when I lift something heavy or reach for something up high.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Needle issue, Nervousness, Underdose
Clinical narrative: We had a Influenza Shotex event and had a 7 year old patient receive only half the 0.5ml flu vaccine due to the child flinching/pulling away that the needle came out and the person providing the vaccine accidently locked the needle with the safety mechanism.
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, Fever, Body aches  Shingles vaccine.....not on the list
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Lightheaded.  Queasy.  Arm pain.  Fever: 100.4. Fatigue.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis from shot - went to urgent care & they gave her antibiotic
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Intense pain in my injection sight and shoulder pain. Becomes worse lying down. Loss of range of motion could hardly lift arm.   First doctor visit was presribed Tizanidine 4mg tabs every 6 hours and Aleve for pain. I was on those for a week and the pain became more intense. I had a second doctor visit; was taken off the Tizanidine and put on Hydrocodone 5/325MG tabs at bedtime with the Aleve. ( Aleve twice a day). The pain stayed the same, went back for a third visit where my doctor did a shoulder X-Ray. It was negative. Given physical therapy exercises. I am going on two months now. Off Hydrocodone but on Tizanidine and Aleve at bedtime. Still have pain.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Joint range of motion decreased, X-ray limb normal
Clinical narrative: Intense pain in my injection sight and shoulder pain. Becomes worse lying down. Loss of range of motion could hardly lift arm.   First doctor visit was presribed Tizanidine 4mg tabs every 6 hours and Aleve for pain. I was on those for a week and the pain became more intense. I had a second doctor visit; was taken off the Tizanidine and put on Hydrocodone 5/325MG tabs at bedtime with the Aleve. ( Aleve twice a day). The pain stayed the same, went back for a third visit where my doctor did a shoulder X-Ray. It was negative. Given physical therapy exercises. I am going on two months now. Off Hydrocodone but on Tizanidine and Aleve at bedtime. Still have pain.
Age: 76.0
Sex: F
Vaccine: FLUA3, FLUA4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: I started having pain where the injection was given.  I continued to have pain which worsened, and started doing down my arm, into my shoulder up to my neck.  Each week after, it hurt more, limiting my activity.  I could not raise my arm over my head.  I couldn't use my arm for lifting or reaching.  Difficult because I need that arm to  help my right arm which had rotator cuff surgery, and needs some help when lifting thing in daily activity (putting dishes away, etc.).  Almost two months later, and it is still not back to normal.  My arm still hurts when I lift it, and if I happen to bend it while it is up, or turn it, it really hurts.  I am having to over-use my right arm to do things.
Age: 76.0
Sex: F
Vaccine: FLUA3, FLUA4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Neck pain
Clinical narrative: I started having pain where the injection was given.  I continued to have pain which worsened, and started doing down my arm, into my shoulder up to my neck.  Each week after, it hurt more, limiting my activity.  I could not raise my arm over my head.  I couldn't use my arm for lifting or reaching.  Difficult because I need that arm to  help my right arm which had rotator cuff surgery, and needs some help when lifting thing in daily activity (putting dishes away, etc.).  Almost two months later, and it is still not back to normal.  My arm still hurts when I lift it, and if I happen to bend it while it is up, or turn it, it really hurts.  I am having to over-use my right arm to do things.
Age: 76.0
Sex: F
Vaccine: FLUA3, FLUA4
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: I started having pain where the injection was given.  I continued to have pain which worsened, and started doing down my arm, into my shoulder up to my neck.  Each week after, it hurt more, limiting my activity.  I could not raise my arm over my head.  I couldn't use my arm for lifting or reaching.  Difficult because I need that arm to  help my right arm which had rotator cuff surgery, and needs some help when lifting thing in daily activity (putting dishes away, etc.).  Almost two months later, and it is still not back to normal.  My arm still hurts when I lift it, and if I happen to bend it while it is up, or turn it, it really hurts.  I am having to over-use my right arm to do things.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Poor quality sleep, Tachycardia
Clinical narrative: Poor sleep progressing to severe chills, shivers, and tachycardia > 100 BPM.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site pain, Injection site swelling, Pain
Clinical narrative: CONTINUOUS RIGHT  ARM PAIN AT SITE OF INJECTION, STILL PRESENT, RADIATING DOWN ARM, CANNOT LIFT ARM UP OVER 90 DEGREES NOR SLEEP ON LEFT SIDE DUE TO PAIN. NEVER HAD THIS CONDITION BEFORE; NO HISTORY OF ARM OR NERVE INJURY IN PAST. FULL USE OF ARM TILL AFTER INJECTION. DISCOLORATION AND SWELLING AT SITE OF INJECTION FOR AT LEAST TWO WEEKS.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: CONTINUOUS RIGHT  ARM PAIN AT SITE OF INJECTION, STILL PRESENT, RADIATING DOWN ARM, CANNOT LIFT ARM UP OVER 90 DEGREES NOR SLEEP ON LEFT SIDE DUE TO PAIN. NEVER HAD THIS CONDITION BEFORE; NO HISTORY OF ARM OR NERVE INJURY IN PAST. FULL USE OF ARM TILL AFTER INJECTION. DISCOLORATION AND SWELLING AT SITE OF INJECTION FOR AT LEAST TWO WEEKS.
Age: 53.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Injection site pain, Limb discomfort, Nausea, Pain, Screaming
Clinical narrative: I received healthcare from Pharmacy in the early evening on October 9, 2020 in the form of the following two vaccines:  DRUG: FLUBLOK QUAD 2020-2021 PFS NDC: 49281-0720-10; QTY: 0.5  DRUG: SHINGRIX VIAL KIT NDC: 58160-0823-11; QTY: 1  Firstly, the flu shot was administered in the left shoulder. I've had many a flu shot, and none were this painful. I think the young man pharmacist didn't use the proper length needle, because I had the sensation that the needle went right through the muscle and into the bone. It hurt a lot, so much so that I let out an un-ladylike expletive.  Second was the Shingles shot in the right shoulder. I once again had the sensation that the needle went all the way through my muscle and into the bone. It hurt a lot. Later that same evening, I felt nauseous like I wanted to throw up, and I had such excruciating pain in my right shoulder that I was screaming & writhing in pain and the neighbor's dog could hear me [by barking in acknowledgement]. I applied ice and I was finally able to fall asleep. It was better the next morning. However, to this day (today is 12/14/2020 as I write this), my shoulder is not the same. I am not able to reach for things or use my shoulder in certain ways without experiencing pain and discomfort. I don't think the young man pharmacist followed proper technique in administering the vaccine(s) to me. And I feel sorry for all his prior and subsequent patients, both young and old.  Upon reading articles on the internet about the proper technique for administering shots (in order to help explain the extraordinary pain I've been having in my right shoulder weeks after my shot at Pharmacy on 10/9/2020), I've come to the conclusion that the needle was too long. Also, I don't remember the pharmacist bunching up my muscle first before giving me the shot. I'm not saying that it didn't happen; it's just that I don't remember whether he did or not. In my mind, I'm thinking that he didn't.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Chills, muscle ache, headache, nausea
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: Only a partial dose of an unknown quantity was administered to the patient; The patient's parent did not fully secure the patient's leg and the needle came out of the patient's leg upon movement during administration of the vaccine; This spontaneous report as received from a medical assistant and refers to a 18 month old patient of unknown gender. The patient's concurrent and historical conditions, as well as the concomitant medications, were not reported.  On 27-NOV-2020, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) lot # T008698, expiration date 04-JUN-2021, for prophylaxis on the leg (dose, strength, and route were not reported).  During the vaccination, the patient's parent did not fully secure the patient's leg and the needle came out of the patient's leg upon movement (product usage process). Only a partial dose of an unknown quantity was administered to this patient (incorrect dose administered). The medical assistant disposed the hepatitis a vaccine, inactivated(VAQTA) syringe after administration. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0; operatorofdevice: Medical Assistant; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: High and low temperature excursion; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. Information regarding patient's medical history, concomitant medication, drug allergies or reactions was not provided.  On 03-DEC-2020, the patient was vaccinated with a improperly stored  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T032003 expiration date 08-MAY-2022, 0.5 milliliter for prophylaxis (administration route and dose number were not provided). The vaccine suffer a high and low temperature excursion one day previous administration , to a temperature above 47 Fahrenheit degree for a time frame of 85 hours, no digital data logger was involved, and none previous temperature excursion was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T032003; expirationdate: 08-MAY-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2012USA002405:
Sex: M
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Deafness, Muscular weakness, Myopathy, Syncope
Clinical narrative: Chronic inflammatory demyelinating polyneuropathy; thrombocytopenia; hearing loss; syncope; myopathy; muscle weakness; Information has been received regarding a case in litigation from a lawyer, a male patient (pt) of unknown age, and his spouse. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication.  On or about 03-SEP-2013, the pt was administered the zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported).   On unknown dates (reported as "shortly after"), the pt was diagnosed with chronic Inflammatory demyelinating polyneuropathy(CIDP), myopathy, thrombocytopenia, hearing loss (deafness), syncope, and muscle weakness, that resulted in extensive medical treatment (unspecified). It was stated that the symptoms have resulted in serious, progressive, severe, permanent personal and incurable injuries/physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and that these injuries have resulted in extensive medical treatment and have severely and negatively affected the pt's quality of life, as well as, well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt also claimed loss of consortium., loss of services and economic losses (medical expenses; the loss of accumulations). The outcome of the events was not recovered.  The reporter considered all aforementioned events disabling and to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events chronic inflammatory demyelinating polyradiculoneuropathy, syncope, deafness and thrombocytopenia to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Thrombocytopenia
Clinical narrative: Chronic inflammatory demyelinating polyneuropathy; thrombocytopenia; hearing loss; syncope; myopathy; muscle weakness; Information has been received regarding a case in litigation from a lawyer, a male patient (pt) of unknown age, and his spouse. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication.  On or about 03-SEP-2013, the pt was administered the zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported).   On unknown dates (reported as "shortly after"), the pt was diagnosed with chronic Inflammatory demyelinating polyneuropathy(CIDP), myopathy, thrombocytopenia, hearing loss (deafness), syncope, and muscle weakness, that resulted in extensive medical treatment (unspecified). It was stated that the symptoms have resulted in serious, progressive, severe, permanent personal and incurable injuries/physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and that these injuries have resulted in extensive medical treatment and have severely and negatively affected the pt's quality of life, as well as, well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt also claimed loss of consortium., loss of services and economic losses (medical expenses; the loss of accumulations). The outcome of the events was not recovered.  The reporter considered all aforementioned events disabling and to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events chronic inflammatory demyelinating polyradiculoneuropathy, syncope, deafness and thrombocytopenia to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: The patient was immunized against measles, mumps and rubella as a child, and received the MMR II in both 2014 (exact date unknown) and 11DEC2019, and has documented evidence of vaccine administration for both doses.; This spontaneous report was received from a pharmacist, referring to a 40-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   The patient stated that, when he/she was a child was immunized (prophylaxis) against measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), in 2014 the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), on 11-DEC-2020 the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number R022423, which has been verified to be valid, expiration date reported and validated as 06-AUG-2020) (extra dose administered), the patient has documented evidence of vaccine administration for both doses.
Age: 1.08
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: have not reported any specific side effects; Patient receiving overdose of varicella component; Patient receiving overdose of varicella component; This spontaneous report was received from a Licensed Practical Nurse referring to a 13-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.  On 04-DEC-2020, the patient was vaccinated with the first dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# T021301 with an expiration date on 19-DEC-2021) concomitantly with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot# S033540, with an expiration date on 22-OCT-2021) for prophylaxis by mistake, reconstituted with sterile diluent (inappropriate schedule of product administration).  Strength, dose, anatomical location, and route of administration were not reported for both vaccines.    The nurse reported its concern about the patient's overdose of varicella components. However, the patient's parents had no reported any specific side effects as of yet.