chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume normal
Clinical narrative: He started to complain that his legs hurt. He received the vaccine in his arms He was very fatigued and laid down at home. Mom was concerned that he was more tired than normal. He started shaking and mom stated he had a temp of 100.4F. He then continued to be very fatigued. According to mom he seemed to be very limp. His heart started racing and he started breathing very fast. Mom became concerned and started to take him to the Emergency Room. On the way to the Emergency Room, mom called 911 because she was concerned that he was starting to lose consciousness. On arrival to the ED, EMS reported that he was tachycardic and complaining of abdominal pain and headache. It is noted in the ED note that he had been taking FLOVENT for a cough he had for 3 weeks. Parents told the ED doctors that he had a cough and congestion for the past 1 week prior to the vaccine. His vitals in the ED were Temp 100.9F, HR 150, RR 20 BP 110/61. He was given a NS bolus, albuterol nebulizer and acetaminophen. He was well appearing to the ED physicians and was dx with a viral URI. He did have lab work done at the parental request: Hematology LATEST RESULTS HISTORICAL RESULTS: WBC 01/14/17 14:38  12.2 12/27/16  10.4 RBC  01/14/17 14:38 5.17 High 12/27/16 5.12  High HGB  01/14/17 14:38  12.8   12/27/16  12.6 HCT 01/14/17 14:38  39.1 12/27/16  38.7 MCV  01/14/17 14:38 76 12/27/16 76 MCH  01/14/17 14:38  24.8  12/27/16  24.6 MCHC  01/14/17 14:38 32.7 12/27/16  32.6 Platelet  01/14/17 14:38  275  12/27/16  301 MPV  01/14/17 14:38  8.6 Low  12/27/16  9.2 RDW-SD  01/14/17 14:38 38.3  12/27/16 37.0 RDW-CV  01/14/17 14:38  13.7   12/27/16  13.4 Abs Neut Ct  01/14/17 14:38   9.55  High   12/27/16  5.10 Abs Immature Gran Ct  01/14/17 14:38  0.03   12/27/16  0.02 Abs Lymph Ct  01/14/17 14:38   1.43  Low   12/27/16  3.98 Abs Mono Ct  01/14/17 14:38  1.11 High 12/27/16  1.04  High Abs Eos  01/14/17 14:38  0.03 12/27/16  0.23 Abs Baso Ct  01/14/17 14:38  0.02 12/27/16  0.05 Mature Neutrophils  01/14/17 14:38  78   12/27/16  49 Immature Gran  01/14/17 14:38  0.2 12/27/16  0.2 Lymphocytes - Normal  01/14/17 14:38  12 12/27/16  38 Monocyte  01/14/17 14:38  9  12/27/16 10 Eosinophil  01/14/17 14:38  0  12/27/16  2 Basophils  01/14/17 14:38 0 12/27/16  0 Sed Rate  01/14/17 14:38  11  High Electrolytes  LATEST RESULTS BUN  01/14/17 14:38 12 Creatinine  01/14/17 14:38 0.30 Low Sodium  01/14/17 14:38  135  Low  Potassium  01/14/17 14 He was discharged to home. He followed up in our office 2 days later and was doing well. He continued to have cough.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Monocyte count increased, Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage decreased, Pain in extremity
Clinical narrative: He started to complain that his legs hurt. He received the vaccine in his arms He was very fatigued and laid down at home. Mom was concerned that he was more tired than normal. He started shaking and mom stated he had a temp of 100.4F. He then continued to be very fatigued. According to mom he seemed to be very limp. His heart started racing and he started breathing very fast. Mom became concerned and started to take him to the Emergency Room. On the way to the Emergency Room, mom called 911 because she was concerned that he was starting to lose consciousness. On arrival to the ED, EMS reported that he was tachycardic and complaining of abdominal pain and headache. It is noted in the ED note that he had been taking FLOVENT for a cough he had for 3 weeks. Parents told the ED doctors that he had a cough and congestion for the past 1 week prior to the vaccine. His vitals in the ED were Temp 100.9F, HR 150, RR 20 BP 110/61. He was given a NS bolus, albuterol nebulizer and acetaminophen. He was well appearing to the ED physicians and was dx with a viral URI. He did have lab work done at the parental request: Hematology LATEST RESULTS HISTORICAL RESULTS: WBC 01/14/17 14:38  12.2 12/27/16  10.4 RBC  01/14/17 14:38 5.17 High 12/27/16 5.12  High HGB  01/14/17 14:38  12.8   12/27/16  12.6 HCT 01/14/17 14:38  39.1 12/27/16  38.7 MCV  01/14/17 14:38 76 12/27/16 76 MCH  01/14/17 14:38  24.8  12/27/16  24.6 MCHC  01/14/17 14:38 32.7 12/27/16  32.6 Platelet  01/14/17 14:38  275  12/27/16  301 MPV  01/14/17 14:38  8.6 Low  12/27/16  9.2 RDW-SD  01/14/17 14:38 38.3  12/27/16 37.0 RDW-CV  01/14/17 14:38  13.7   12/27/16  13.4 Abs Neut Ct  01/14/17 14:38   9.55  High   12/27/16  5.10 Abs Immature Gran Ct  01/14/17 14:38  0.03   12/27/16  0.02 Abs Lymph Ct  01/14/17 14:38   1.43  Low   12/27/16  3.98 Abs Mono Ct  01/14/17 14:38  1.11 High 12/27/16  1.04  High Abs Eos  01/14/17 14:38  0.03 12/27/16  0.23 Abs Baso Ct  01/14/17 14:38  0.02 12/27/16  0.05 Mature Neutrophils  01/14/17 14:38  78   12/27/16  49 Immature Gran  01/14/17 14:38  0.2 12/27/16  0.2 Lymphocytes - Normal  01/14/17 14:38  12 12/27/16  38 Monocyte  01/14/17 14:38  9  12/27/16 10 Eosinophil  01/14/17 14:38  0  12/27/16  2 Basophils  01/14/17 14:38 0 12/27/16  0 Sed Rate  01/14/17 14:38  11  High Electrolytes  LATEST RESULTS BUN  01/14/17 14:38 12 Creatinine  01/14/17 14:38 0.30 Low Sodium  01/14/17 14:38  135  Low  Potassium  01/14/17 14 He was discharged to home. He followed up in our office 2 days later and was doing well. He continued to have cough.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Palpitations, Platelet count normal, Red blood cell count normal, Red blood cell sedimentation rate increased, Red cell distribution width normal
Clinical narrative: He started to complain that his legs hurt. He received the vaccine in his arms He was very fatigued and laid down at home. Mom was concerned that he was more tired than normal. He started shaking and mom stated he had a temp of 100.4F. He then continued to be very fatigued. According to mom he seemed to be very limp. His heart started racing and he started breathing very fast. Mom became concerned and started to take him to the Emergency Room. On the way to the Emergency Room, mom called 911 because she was concerned that he was starting to lose consciousness. On arrival to the ED, EMS reported that he was tachycardic and complaining of abdominal pain and headache. It is noted in the ED note that he had been taking FLOVENT for a cough he had for 3 weeks. Parents told the ED doctors that he had a cough and congestion for the past 1 week prior to the vaccine. His vitals in the ED were Temp 100.9F, HR 150, RR 20 BP 110/61. He was given a NS bolus, albuterol nebulizer and acetaminophen. He was well appearing to the ED physicians and was dx with a viral URI. He did have lab work done at the parental request: Hematology LATEST RESULTS HISTORICAL RESULTS: WBC 01/14/17 14:38  12.2 12/27/16  10.4 RBC  01/14/17 14:38 5.17 High 12/27/16 5.12  High HGB  01/14/17 14:38  12.8   12/27/16  12.6 HCT 01/14/17 14:38  39.1 12/27/16  38.7 MCV  01/14/17 14:38 76 12/27/16 76 MCH  01/14/17 14:38  24.8  12/27/16  24.6 MCHC  01/14/17 14:38 32.7 12/27/16  32.6 Platelet  01/14/17 14:38  275  12/27/16  301 MPV  01/14/17 14:38  8.6 Low  12/27/16  9.2 RDW-SD  01/14/17 14:38 38.3  12/27/16 37.0 RDW-CV  01/14/17 14:38  13.7   12/27/16  13.4 Abs Neut Ct  01/14/17 14:38   9.55  High   12/27/16  5.10 Abs Immature Gran Ct  01/14/17 14:38  0.03   12/27/16  0.02 Abs Lymph Ct  01/14/17 14:38   1.43  Low   12/27/16  3.98 Abs Mono Ct  01/14/17 14:38  1.11 High 12/27/16  1.04  High Abs Eos  01/14/17 14:38  0.03 12/27/16  0.23 Abs Baso Ct  01/14/17 14:38  0.02 12/27/16  0.05 Mature Neutrophils  01/14/17 14:38  78   12/27/16  49 Immature Gran  01/14/17 14:38  0.2 12/27/16  0.2 Lymphocytes - Normal  01/14/17 14:38  12 12/27/16  38 Monocyte  01/14/17 14:38  9  12/27/16 10 Eosinophil  01/14/17 14:38  0  12/27/16  2 Basophils  01/14/17 14:38 0 12/27/16  0 Sed Rate  01/14/17 14:38  11  High Electrolytes  LATEST RESULTS BUN  01/14/17 14:38 12 Creatinine  01/14/17 14:38 0.30 Low Sodium  01/14/17 14:38  135  Low  Potassium  01/14/17 14 He was discharged to home. He followed up in our office 2 days later and was doing well. He continued to have cough.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Respiratory rate increased, Respiratory tract congestion, Tachycardia, Tremor, Viral upper respiratory tract infection
Clinical narrative: He started to complain that his legs hurt. He received the vaccine in his arms He was very fatigued and laid down at home. Mom was concerned that he was more tired than normal. He started shaking and mom stated he had a temp of 100.4F. He then continued to be very fatigued. According to mom he seemed to be very limp. His heart started racing and he started breathing very fast. Mom became concerned and started to take him to the Emergency Room. On the way to the Emergency Room, mom called 911 because she was concerned that he was starting to lose consciousness. On arrival to the ED, EMS reported that he was tachycardic and complaining of abdominal pain and headache. It is noted in the ED note that he had been taking FLOVENT for a cough he had for 3 weeks. Parents told the ED doctors that he had a cough and congestion for the past 1 week prior to the vaccine. His vitals in the ED were Temp 100.9F, HR 150, RR 20 BP 110/61. He was given a NS bolus, albuterol nebulizer and acetaminophen. He was well appearing to the ED physicians and was dx with a viral URI. He did have lab work done at the parental request: Hematology LATEST RESULTS HISTORICAL RESULTS: WBC 01/14/17 14:38  12.2 12/27/16  10.4 RBC  01/14/17 14:38 5.17 High 12/27/16 5.12  High HGB  01/14/17 14:38  12.8   12/27/16  12.6 HCT 01/14/17 14:38  39.1 12/27/16  38.7 MCV  01/14/17 14:38 76 12/27/16 76 MCH  01/14/17 14:38  24.8  12/27/16  24.6 MCHC  01/14/17 14:38 32.7 12/27/16  32.6 Platelet  01/14/17 14:38  275  12/27/16  301 MPV  01/14/17 14:38  8.6 Low  12/27/16  9.2 RDW-SD  01/14/17 14:38 38.3  12/27/16 37.0 RDW-CV  01/14/17 14:38  13.7   12/27/16  13.4 Abs Neut Ct  01/14/17 14:38   9.55  High   12/27/16  5.10 Abs Immature Gran Ct  01/14/17 14:38  0.03   12/27/16  0.02 Abs Lymph Ct  01/14/17 14:38   1.43  Low   12/27/16  3.98 Abs Mono Ct  01/14/17 14:38  1.11 High 12/27/16  1.04  High Abs Eos  01/14/17 14:38  0.03 12/27/16  0.23 Abs Baso Ct  01/14/17 14:38  0.02 12/27/16  0.05 Mature Neutrophils  01/14/17 14:38  78   12/27/16  49 Immature Gran  01/14/17 14:38  0.2 12/27/16  0.2 Lymphocytes - Normal  01/14/17 14:38  12 12/27/16  38 Monocyte  01/14/17 14:38  9  12/27/16 10 Eosinophil  01/14/17 14:38  0  12/27/16  2 Basophils  01/14/17 14:38 0 12/27/16  0 Sed Rate  01/14/17 14:38  11  High Electrolytes  LATEST RESULTS BUN  01/14/17 14:38 12 Creatinine  01/14/17 14:38 0.30 Low Sodium  01/14/17 14:38  135  Low  Potassium  01/14/17 14 He was discharged to home. He followed up in our office 2 days later and was doing well. He continued to have cough.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: He started to complain that his legs hurt. He received the vaccine in his arms He was very fatigued and laid down at home. Mom was concerned that he was more tired than normal. He started shaking and mom stated he had a temp of 100.4F. He then continued to be very fatigued. According to mom he seemed to be very limp. His heart started racing and he started breathing very fast. Mom became concerned and started to take him to the Emergency Room. On the way to the Emergency Room, mom called 911 because she was concerned that he was starting to lose consciousness. On arrival to the ED, EMS reported that he was tachycardic and complaining of abdominal pain and headache. It is noted in the ED note that he had been taking FLOVENT for a cough he had for 3 weeks. Parents told the ED doctors that he had a cough and congestion for the past 1 week prior to the vaccine. His vitals in the ED were Temp 100.9F, HR 150, RR 20 BP 110/61. He was given a NS bolus, albuterol nebulizer and acetaminophen. He was well appearing to the ED physicians and was dx with a viral URI. He did have lab work done at the parental request: Hematology LATEST RESULTS HISTORICAL RESULTS: WBC 01/14/17 14:38  12.2 12/27/16  10.4 RBC  01/14/17 14:38 5.17 High 12/27/16 5.12  High HGB  01/14/17 14:38  12.8   12/27/16  12.6 HCT 01/14/17 14:38  39.1 12/27/16  38.7 MCV  01/14/17 14:38 76 12/27/16 76 MCH  01/14/17 14:38  24.8  12/27/16  24.6 MCHC  01/14/17 14:38 32.7 12/27/16  32.6 Platelet  01/14/17 14:38  275  12/27/16  301 MPV  01/14/17 14:38  8.6 Low  12/27/16  9.2 RDW-SD  01/14/17 14:38 38.3  12/27/16 37.0 RDW-CV  01/14/17 14:38  13.7   12/27/16  13.4 Abs Neut Ct  01/14/17 14:38   9.55  High   12/27/16  5.10 Abs Immature Gran Ct  01/14/17 14:38  0.03   12/27/16  0.02 Abs Lymph Ct  01/14/17 14:38   1.43  Low   12/27/16  3.98 Abs Mono Ct  01/14/17 14:38  1.11 High 12/27/16  1.04  High Abs Eos  01/14/17 14:38  0.03 12/27/16  0.23 Abs Baso Ct  01/14/17 14:38  0.02 12/27/16  0.05 Mature Neutrophils  01/14/17 14:38  78   12/27/16  49 Immature Gran  01/14/17 14:38  0.2 12/27/16  0.2 Lymphocytes - Normal  01/14/17 14:38  12 12/27/16  38 Monocyte  01/14/17 14:38  9  12/27/16 10 Eosinophil  01/14/17 14:38  0  12/27/16  2 Basophils  01/14/17 14:38 0 12/27/16  0 Sed Rate  01/14/17 14:38  11  High Electrolytes  LATEST RESULTS BUN  01/14/17 14:38 12 Creatinine  01/14/17 14:38 0.30 Low Sodium  01/14/17 14:38  135  Low  Potassium  01/14/17 14 He was discharged to home. He followed up in our office 2 days later and was doing well. He continued to have cough.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Abdominal pain upper, Altered state of consciousness, Cardiac disorder, Dizziness, Headache
Clinical narrative: Felt nauseated, dizzy, severe headache, severe stomach ache, fever. Since that time patient developed lupus and problems with her heart.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Heart rate increased, Nausea, Pyrexia, Systemic lupus erythematosus
Clinical narrative: Felt nauseated, dizzy, severe headache, severe stomach ache, fever. Since that time patient developed lupus and problems with her heart.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea on 7/29/16, 15 days after tetanus vaccine was given.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bowel movement irregularity, Constipation, Depressed level of consciousness, Hyporesponsive to stimuli, Injection site pain
Clinical narrative: Severe pain at any movement of leg shot was administered in for about 24 hrs. Not as responsive/alert as normal, almost as in a daze for about 12hrs. No BM for 6 days, then irregularity for 2 weeks.
Age: 38.0
Sex: F
Vaccine: HEP, HEPA, PPV, TDAP
Symptoms: Abdominal pain upper, Bile duct stone, Cellulitis, Delusion, Headache
Clinical narrative: I received a vaccination at my job which I thought was a series of flu shots but ended up being hep A, Hep B, flu, pneumonia and booster. The very next day I had to go to the hospital because I had severe headache, delusional, fever of 103 and a serious infection on my arm called cellulitis. The antibiotics they gave me did not work so I had to go back to the hospital the next day. They prescribed me stronger antibiotics which finally did work but that night I had severe stomach pain. So I went to the hospital again. The doctor told me I had a bile duct stone which can be caused by infection and trauma. I had to get surgery and stay in the hospital for 2 more days. I ended up missing a week from work amongst other problems. I have reoccuring headaches that I never had before. Now I'm receiving thousands of dollars of hospital bills. I talk to my store manager and the people from the pharmacy and they dont want to help me and I dont know what to do.
Age: 38.0
Sex: F
Vaccine: HEP, HEPA, PPV, TDAP
Symptoms: Impaired work ability, Pyrexia, Surgery
Clinical narrative: I received a vaccination at my job which I thought was a series of flu shots but ended up being hep A, Hep B, flu, pneumonia and booster. The very next day I had to go to the hospital because I had severe headache, delusional, fever of 103 and a serious infection on my arm called cellulitis. The antibiotics they gave me did not work so I had to go back to the hospital the next day. They prescribed me stronger antibiotics which finally did work but that night I had severe stomach pain. So I went to the hospital again. The doctor told me I had a bile duct stone which can be caused by infection and trauma. I had to get surgery and stay in the hospital for 2 more days. I ended up missing a week from work amongst other problems. I have reoccuring headaches that I never had before. Now I'm receiving thousands of dollars of hospital bills. I talk to my store manager and the people from the pharmacy and they dont want to help me and I dont know what to do.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Crying, Dysphagia, Dyspnoea, Haemorrhage
Clinical narrative: Swelling, pain, bleeding, Hives on neck Left arm chest at 3:00PM.  Difficulty swallowing and hard to catch breath by 5:00 PM. Took Benadryl and Tylenol went to bed at 5:10 PM. Woke up 9 PM crying in pain. Took Advil and more Benadryl, laid in bed in pain. 12 AM took Tylenol and more Benadryl for pain and swelling in my arm and armpit and lymph nodes in neck, left cheek and armpit  hot to the touch and very painful. 01/14/2017 returned to Clinic and showed the nurse who said she would report it and wrote a note saying to never receive the FLUZONE flu shot again.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling, pain, bleeding, Hives on neck Left arm chest at 3:00PM.  Difficulty swallowing and hard to catch breath by 5:00 PM. Took Benadryl and Tylenol went to bed at 5:10 PM. Woke up 9 PM crying in pain. Took Advil and more Benadryl, laid in bed in pain. 12 AM took Tylenol and more Benadryl for pain and swelling in my arm and armpit and lymph nodes in neck, left cheek and armpit  hot to the touch and very painful. 01/14/2017 returned to Clinic and showed the nurse who said she would report it and wrote a note saying to never receive the FLUZONE flu shot again.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Urticaria
Clinical narrative: Swelling, pain, bleeding, Hives on neck Left arm chest at 3:00PM.  Difficulty swallowing and hard to catch breath by 5:00 PM. Took Benadryl and Tylenol went to bed at 5:10 PM. Woke up 9 PM crying in pain. Took Advil and more Benadryl, laid in bed in pain. 12 AM took Tylenol and more Benadryl for pain and swelling in my arm and armpit and lymph nodes in neck, left cheek and armpit  hot to the touch and very painful. 01/14/2017 returned to Clinic and showed the nurse who said she would report it and wrote a note saying to never receive the FLUZONE flu shot again.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Autoimmune disorder, Cold type haemolytic anaemia, Feeling abnormal, Nasopharyngitis, Skin discolouration
Clinical narrative: Felt that she was getting a cold but had no fever, just didn't feel right. By 12/21/2016 she was taken emergently to ER with blackened hands and feet, an AUTO IMMUNE REACTION called cold agglutinin. She was diagnosed at facility, and she was previously healthy and independent and something triggered this autoimmune response, perhaps the vaccine.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin abrasion, Skin warm, Swelling
Clinical narrative: Redness swelling, removal of bandages caused abrasion to adhesive side ,soaness tenderness and heat.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Redness swelling, removal of bandages caused abrasion to adhesive side ,soaness tenderness and heat.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RVX
Symptoms: Abnormal behaviour, Asthenia, Fatigue, Pyrexia
Clinical narrative: After the 4 months regular vaccines, my child had fever, feeling tired and we noticed that the baby did not response the same way as before. She lost the strength in her hands and foot, she did make any sounds any before. We decided to take her to the doctor and advised the situation. Dr. send her to neurologist for check up. Awaiting to appointment.
Age: 1.33
Sex: M
Vaccine: FLU4, HIBV, MMR, VARCEL
Symptoms: Dyskinesia, Pyrexia
Clinical narrative: Patient with fever of 104.5 and a couple episodes of jerking after vaccines. Spoke with Dr. and she advised give alternating doses of APAP and Ibuprofen to control fever.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Swelling, Vomiting
Clinical narrative: Patient reported swelling, pain, nausea and vomiting. Patient attended hospital following day. Rx for Ibuprofen, ZOFRAN.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received Tdap (L) deltoid which swelled within 3 hours, became red and hot. Administration 1/11/17. Swelling, tenderness persists as of 1/16/17 at follow eval.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan
Clinical narrative: Received Tdap (L) deltoid which swelled within 3 hours, became red and hot. Administration 1/11/17. Swelling, tenderness persists as of 1/16/17 at follow eval.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: Muscle disorder, Muscular weakness, Pain
Clinical narrative: Pain, muscles freezing, locks up when stretching (certain movement), muscle weakness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Haematoma, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema (R) deltoid area, Left arm hematoma in resolution. Given KEFLEX x 10 days on 12/23/16. Seen for follow up on 1/16/17. Resolved swelling, erythema and hematoma.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Injection site pain
Clinical narrative: Left shoulder pain-SIRVA. Referred to ortho.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Blood folate decreased, Blood iron decreased, Body temperature increased, Cellulitis, Dysphonia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received pneumococcal PREVNAR 13, via an unspecified route of administration on 20Apr2016 14:16 at 0.5ml, single for immunisation in left arm, and ZOSTER VACCINE in left arm for immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID. The patient previously took smallpox vaccine and experienced cow pox. The patient received both in her left arm. She thought that the nurse who administered it hit a nerve or the bone. Within 2 days she developed cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature have gone away, but the swelling and red-purple comes back anytime her body is under duress or she exerts herself doing something really physical, but the recurrences have lessened with the colder weather. Starting around Aug2016 she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat, that is not sore.  She has had multiple tests done and had her pulmonary function tested and nothing was detected as being wrong.  She also had blood work done in Dec2016 and it was discovered that she has developed vitamin deficiencies in vitamin B12, vitamin D, iron and folic acid. Outcome of the events cellulitis, temperature elevation was recovered; swelling, red-purple hue were recovering; outcome of the events  breathlessness, hoarse throat, vitamin B12 deficiency, vitamin D deficiency, iron deficiency, folic acid deficiency was not recovered. Outcome of fatigue was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Dyspnoea, Erythema, Fatigue, Folate deficiency, Injection site injury
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received pneumococcal PREVNAR 13, via an unspecified route of administration on 20Apr2016 14:16 at 0.5ml, single for immunisation in left arm, and ZOSTER VACCINE in left arm for immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID. The patient previously took smallpox vaccine and experienced cow pox. The patient received both in her left arm. She thought that the nurse who administered it hit a nerve or the bone. Within 2 days she developed cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature have gone away, but the swelling and red-purple comes back anytime her body is under duress or she exerts herself doing something really physical, but the recurrences have lessened with the colder weather. Starting around Aug2016 she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat, that is not sore.  She has had multiple tests done and had her pulmonary function tested and nothing was detected as being wrong.  She also had blood work done in Dec2016 and it was discovered that she has developed vitamin deficiencies in vitamin B12, vitamin D, iron and folic acid. Outcome of the events cellulitis, temperature elevation was recovered; swelling, red-purple hue were recovering; outcome of the events  breathlessness, hoarse throat, vitamin B12 deficiency, vitamin D deficiency, iron deficiency, folic acid deficiency was not recovered. Outcome of fatigue was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site swelling, Iron deficiency, Laboratory test normal, Local swelling, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received pneumococcal PREVNAR 13, via an unspecified route of administration on 20Apr2016 14:16 at 0.5ml, single for immunisation in left arm, and ZOSTER VACCINE in left arm for immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID. The patient previously took smallpox vaccine and experienced cow pox. The patient received both in her left arm. She thought that the nurse who administered it hit a nerve or the bone. Within 2 days she developed cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature have gone away, but the swelling and red-purple comes back anytime her body is under duress or she exerts herself doing something really physical, but the recurrences have lessened with the colder weather. Starting around Aug2016 she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat, that is not sore.  She has had multiple tests done and had her pulmonary function tested and nothing was detected as being wrong.  She also had blood work done in Dec2016 and it was discovered that she has developed vitamin deficiencies in vitamin B12, vitamin D, iron and folic acid. Outcome of the events cellulitis, temperature elevation was recovered; swelling, red-purple hue were recovering; outcome of the events  breathlessness, hoarse throat, vitamin B12 deficiency, vitamin D deficiency, iron deficiency, folic acid deficiency was not recovered. Outcome of fatigue was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Pulmonary function test normal, Skin discolouration, Vitamin B12 decreased, Vitamin B12 deficiency, Vitamin D decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received pneumococcal PREVNAR 13, via an unspecified route of administration on 20Apr2016 14:16 at 0.5ml, single for immunisation in left arm, and ZOSTER VACCINE in left arm for immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID. The patient previously took smallpox vaccine and experienced cow pox. The patient received both in her left arm. She thought that the nurse who administered it hit a nerve or the bone. Within 2 days she developed cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature have gone away, but the swelling and red-purple comes back anytime her body is under duress or she exerts herself doing something really physical, but the recurrences have lessened with the colder weather. Starting around Aug2016 she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat, that is not sore.  She has had multiple tests done and had her pulmonary function tested and nothing was detected as being wrong.  She also had blood work done in Dec2016 and it was discovered that she has developed vitamin deficiencies in vitamin B12, vitamin D, iron and folic acid. Outcome of the events cellulitis, temperature elevation was recovered; swelling, red-purple hue were recovering; outcome of the events  breathlessness, hoarse throat, vitamin B12 deficiency, vitamin D deficiency, iron deficiency, folic acid deficiency was not recovered. Outcome of fatigue was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Vitamin D deficiency
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received pneumococcal PREVNAR 13, via an unspecified route of administration on 20Apr2016 14:16 at 0.5ml, single for immunisation in left arm, and ZOSTER VACCINE in left arm for immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID. The patient previously took smallpox vaccine and experienced cow pox. The patient received both in her left arm. She thought that the nurse who administered it hit a nerve or the bone. Within 2 days she developed cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature have gone away, but the swelling and red-purple comes back anytime her body is under duress or she exerts herself doing something really physical, but the recurrences have lessened with the colder weather. Starting around Aug2016 she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat, that is not sore.  She has had multiple tests done and had her pulmonary function tested and nothing was detected as being wrong.  She also had blood work done in Dec2016 and it was discovered that she has developed vitamin deficiencies in vitamin B12, vitamin D, iron and folic acid. Outcome of the events cellulitis, temperature elevation was recovered; swelling, red-purple hue were recovering; outcome of the events  breathlessness, hoarse throat, vitamin B12 deficiency, vitamin D deficiency, iron deficiency, folic acid deficiency was not recovered. Outcome of fatigue was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Dyspnoea, Fatigue, Folate deficiency, Iron deficiency, Laboratory test normal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received pneumococcal PREVNAR 13, via an unspecified route of administration on 20Apr2016 14:16 at 0.5ml, single for immunisation in left arm, and ZOSTER VACCINE in left arm for immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID. The patient previously took smallpox vaccine and experienced cow pox. The patient received both in her left arm. She thought that the nurse who administered it hit a nerve or the bone. Within 2 days she developed cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature have gone away, but the swelling and red-purple comes back anytime her body is under duress or she exerts herself doing something really physical, but the recurrences have lessened with the colder weather. Starting around Aug2016 she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat, that is not sore.  She has had multiple tests done and had her pulmonary function tested and nothing was detected as being wrong.  She also had blood work done in Dec2016 and it was discovered that she has developed vitamin deficiencies in vitamin B12, vitamin D, iron and folic acid. Outcome of the events cellulitis, temperature elevation was recovered; swelling, red-purple hue were recovering; outcome of the events  breathlessness, hoarse throat, vitamin B12 deficiency, vitamin D deficiency, iron deficiency, folic acid deficiency was not recovered. Outcome of fatigue was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Local swelling, Peripheral swelling, Pulmonary function test normal, Skin discolouration, Vitamin B12 decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received pneumococcal PREVNAR 13, via an unspecified route of administration on 20Apr2016 14:16 at 0.5ml, single for immunisation in left arm, and ZOSTER VACCINE in left arm for immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID. The patient previously took smallpox vaccine and experienced cow pox. The patient received both in her left arm. She thought that the nurse who administered it hit a nerve or the bone. Within 2 days she developed cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature have gone away, but the swelling and red-purple comes back anytime her body is under duress or she exerts herself doing something really physical, but the recurrences have lessened with the colder weather. Starting around Aug2016 she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat, that is not sore.  She has had multiple tests done and had her pulmonary function tested and nothing was detected as being wrong.  She also had blood work done in Dec2016 and it was discovered that she has developed vitamin deficiencies in vitamin B12, vitamin D, iron and folic acid. Outcome of the events cellulitis, temperature elevation was recovered; swelling, red-purple hue were recovering; outcome of the events  breathlessness, hoarse throat, vitamin B12 deficiency, vitamin D deficiency, iron deficiency, folic acid deficiency was not recovered. Outcome of fatigue was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Vitamin B12 deficiency, Vitamin D decreased, Vitamin D deficiency
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received pneumococcal PREVNAR 13, via an unspecified route of administration on 20Apr2016 14:16 at 0.5ml, single for immunisation in left arm, and ZOSTER VACCINE in left arm for immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID. The patient previously took smallpox vaccine and experienced cow pox. The patient received both in her left arm. She thought that the nurse who administered it hit a nerve or the bone. Within 2 days she developed cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature have gone away, but the swelling and red-purple comes back anytime her body is under duress or she exerts herself doing something really physical, but the recurrences have lessened with the colder weather. Starting around Aug2016 she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat, that is not sore.  She has had multiple tests done and had her pulmonary function tested and nothing was detected as being wrong.  She also had blood work done in Dec2016 and it was discovered that she has developed vitamin deficiencies in vitamin B12, vitamin D, iron and folic acid. Outcome of the events cellulitis, temperature elevation was recovered; swelling, red-purple hue were recovering; outcome of the events  breathlessness, hoarse throat, vitamin B12 deficiency, vitamin D deficiency, iron deficiency, folic acid deficiency was not recovered. Outcome of fatigue was unknown.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Acoustic stimulation tests, Deafness unilateral, Ear pain, Nuclear magnetic resonance imaging brain, Vertigo
Clinical narrative: Patient work with bilateral ear pain 3/10 and no hearing out of left ear.  Patient also had vertigo.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Headache, Pyrexia
Clinical narrative: Fever, headache during night. Then, it subsided until 12/25 night and it hit me like a semi truck: horrible headache, fever, cough. It lasted for 3 days. The worst part was that family visited for Christmas, so my husband and 7 others came down with it within 72 hours.
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Seizure
Clinical narrative: Very bad seizure. Multiple that evening. My son has had nocturnal seizures ever since the first.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site mass, Injection site rash, Pyrexia
Clinical narrative: Hard lump, fever, rash at injection site for 6 days. Achy joints throughout body for 7+ days. Mother who is immune suppressed (RA medication) became severely ill after contact and touching injection site.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse refers to a 26 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were reported as "none". The patient became pregnant with last menstrual period (LMP) of 14-JUL-2016 and estimated date of delivery (EDD) of 20-APR-2017, based on the date of the report. The pregnancy outcome was pending and the fetal outcome was unknown. On 22-DEC-2016, at 23 weeks of pregnancy, the patient was vaccinated inadvertently with the third dose of GARDASIL 9, intramuscularly (strength, dose, lot number and expiration date were not provided) for prophylaxis. Initial exposure to GARDASIL 9 was unknown as well as the date of the second dose. It was reported that the patient sought medical attention but no adverse events were reported. It was reported that the patient did not receive a treatment and labs were not performed. There was no product quality complaint (PQC) involved. At the time of reporting, the outcome of exposure during pregnancy was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 20-DEC-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # L008053, expiration date 30-NOV-2016) (dose not reported) orally for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a unknown number of patients of unknown age and gender. The patients' medical histories, concomitant medications and drug histories were all unknown. On 21-NOV-2016, temperature excursion connected with suspect vaccines occurred (duration was not reported) and on unknown dates in 2016, the patients were vaccinated with a doses of improperly stored ROTATEQ taken orally, lot # M019706, expiration date 24-OCT-2017 (dose and frequency was not reported). The reporting nurse stated that none of the patients reported adverse events or symptoms after receiving their vaccination. The patients' laboratory data was unknown. As of 28-DEC-2016, it was unknown if the patients would continue the therapy with ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014979: US-009507513-1612USA015005:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates the patient were vaccinated with GARDASIL 9 (lot #: M016193, Expiry date: 24-APR-2018) which was improperly stored (Data logger used; Temperature/Time Frame: 50F for 3 hours). There were no prior excursions. No adverse effects were reported.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extra dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported) . On an unknown date, the patient's arm became red. On an unknown date, reported as "6 months apart", the patient received the second dose of ZOSTAVAX injection (dose, route of administration, lot# and expiry date were not reported). On an unknown date, after the second dose of vaccination, the patient reported that "her arm got more red".  The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PATIENT CAME TO PHARMACY COMPLAINING WITH PAIN AND SWALLOWING IN THE RIGHT ARM WHERE SHE RECEIVED BOOSTRIX VACCINE.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: 2 minutes after receiving HPV 9 vaccination patient had a brief episode of syncope.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring an unspecified patient. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 23-DEC-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # M029681, expiration date: 22-JAN-2018; dose was unknown) intramuscularly for prophylaxis. The temperature for the vaccine stored was 49 Fahrenheit degree with 87 hours time frame. Previous temperature excursion was reported as exposure to 49 Fahrenheit for 63 hours, Data logger was not involved. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 27-DEC-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection (HSA; lot # M000768 expiration date: 05-JAN-2018; dose and route of administration were not provided). Administered dose of vaccine was exposed to the temperature excursion of 9.4 degrees Celsius for 1 hour and 30 minutes on an unspecified date. A digital data logger was involved. There were no previous excursions reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to four patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored of ZOSTAVAX (19400 PFU) lot # reported as M035696 , expiration date 07-NOV-2017 (dose, dose number  and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of >5F - <46F degrees Fahrenheit the most prolonged duration between 5F and 14F  degrees Fahrenheit was 78 hours and the lowest was 4hours, and most prolonged duration between 14F and  46F  degrees Fahrenheit was 24.5 hours and the lowest was 4hours. Data logger was involved. There were no previous excursions reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA006211:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 31-AUG-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M012987 with expiration date 12-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 31-AUG-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M012987 with expiration date 12-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245: