chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Extremely intense headache for 24 hours.  Headache not a sufficient term for the pain, really.  Treated with Tylenol.  Also, injection site had red blotches, swelled up, and very tender to the touch.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Nervousness, Pyrexia
Clinical narrative: During the initial 24 hours following the injection, patient noticed fever of 101F and felt "shaky". Three days later patient noticed rash and pain around the injection site. Went to see PCP and was given course of corticosteroid treatment.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Blood bilirubin increased, C-reactive protein normal, Complement factor C4, Granulocyte count increased
Clinical narrative: in days immediately following vaccine, patient reports mild headache, mild pharyngitis, and myalgias. these symptoms resolved with no symptoms for several days, followed by onset of urticarial 9-10 following vaccination. urticarial lesions lasted for 5d, on the 5th day, he had facial angioedema in association with urticaria, prompting ED visit. the patient continues to have urticaria on 24October19.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Myalgia, Pharyngitis, Red blood cell sedimentation rate normal, Urticaria
Clinical narrative: in days immediately following vaccine, patient reports mild headache, mild pharyngitis, and myalgias. these symptoms resolved with no symptoms for several days, followed by onset of urticarial 9-10 following vaccination. urticarial lesions lasted for 5d, on the 5th day, he had facial angioedema in association with urticaria, prompting ED visit. the patient continues to have urticaria on 24October19.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: White blood cell count increased
Clinical narrative: in days immediately following vaccine, patient reports mild headache, mild pharyngitis, and myalgias. these symptoms resolved with no symptoms for several days, followed by onset of urticarial 9-10 following vaccination. urticarial lesions lasted for 5d, on the 5th day, he had facial angioedema in association with urticaria, prompting ED visit. the patient continues to have urticaria on 24October19.
Age: 72.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site bruising
Clinical narrative: Patient reported to pharmacy on 10/24/2019, that she develop bruise in left shoulder area approx. 1.5 in in diameter
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient recevied pnuemovax in right arm this morning; came back early this evening and arm was somewhat warm to the touch and swollen
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported swelling, redness and warm to touch arm below the injection site on the inside of the arm from armpit down to elbow.
Age: 57.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Vaccination site induration
Clinical narrative: Onset of 4 in. x 3 in. diameter red indurated itchy area around vaccine site in right arm at ~ 12 noon on 10/1/19 then by 10/1/19 9pm whole back of upper right arm red, swollen and itchy.  On 10/2/19 morning redness had extended to below right elbow and at 3pm on 10/2/19 patient went to Urgent Care as she was leaving on vacation the next day.  Urgent Care provided Prednisone tapering dose pack for the next week & Clindamycin antibiotic just in case became infected while on vacation (patient did not use);  patient used OTC Benadryl spray to help with itching. 10/3/19 redness & induration much less and by 10/7/19 all symptoms resolved and no sequellae.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure like phenomena
Clinical narrative: What the mother thought was going to be a fainting episode, it actually turned into what looked like a seizure which lasted about 15 seconds.
Age: 42.0
Sex: F
Vaccine: FLUC4, HEPAB, TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: The patient called the pharmacy on 10/24/19 stating that the day after the  3 vaccines she had a 3cm diameter red spot on both arms which was warm to the touch. She said this resolved by 10/23/19 and all that remained on each arm was a small nodule 4-5 fingers down from the top of the shoulder which were symptom-less.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Pt reports numbness in hand following vaccination.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: patient had severe swelling in the arm.  had some pain in arm day after shot.  about 4-5 days later, developing swelling around the muscle
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: patient states injection site was puffy and warm the morning after immunization, then became red later on in the day.  by about 5pm patient reported redness had extended down her left arm close to the elbow with a red line around it. patient states she felt a little lightheaded and that injection site was painful.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Pain in extremity
Clinical narrative: arm sore, extremely red on the arm, patient not feeling well
Age: 91.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Lymphadenitis, Pyrexia
Clinical narrative: patient said her second injection was painful. Then,  that night her arm is swollen all the way down to her armpit and her breast and she ran fever. She contacted the pharmacy 2 days after her shot and she said she is still running a fever and her swellings are still present. She went to see a doctor today and awaiting her test results
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Hyperhidrosis, Loss of consciousness, Seizure
Clinical narrative: After giving vaccines, patient appeared tired and laid back in chair and passed out, then patient started seizing for less than a minute. Patient began talking to us that she's okay and then several seconds later it occurred again. Afterwards, she needed time to rest and she was sweating. Patient became okay after taking rest and drinking water. She was also accompanied by her husband/boyfriend.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Hyperhidrosis, Influenza, Malaise, Nausea
Clinical narrative: I had mild flu symptoms after the first shot. I was down for a couple days.  The second shot was way worse.  I am on day 6 and still have a lot of pain in my upper arm. I was absolutely down for three days with flu like symptoms, fever, bodyaches, severe sweating, increased heart rate and nausea. Tylenol and Advil did not help at all. I was just incredibly sick for over three days. Better today, but my upper arm is still hot to the touch and quite sore.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: I had mild flu symptoms after the first shot. I was down for a couple days.  The second shot was way worse.  I am on day 6 and still have a lot of pain in my upper arm. I was absolutely down for three days with flu like symptoms, fever, bodyaches, severe sweating, increased heart rate and nausea. Tylenol and Advil did not help at all. I was just incredibly sick for over three days. Better today, but my upper arm is still hot to the touch and quite sore.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Eructation, Malaise, Nausea, Pyrexia
Clinical narrative: fever, nausea, malaise, belching, weak
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nasopharyngitis
Clinical narrative: significant fatigue, soreness at the injection site, mild cold-like symptoms
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed Shingles on 10/12/19, confirmed by md
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Fatigue, Immediate post-injection reaction, Myalgia
Clinical narrative: Extreme soreness in left arm immediately after injection then slight fever/chills around 8:00p.m. day of injection.  Chills became severe around 8:30 p.m. and lasted approximately 1 1/2 hours--uncontrollable shaking involved  then subsided somewhat during the night.  Also vomited. Temp 102.4.   Took 2 Tylenol 500 mg each.  Slight fever, muscle soreness, tiredness, weakness persisted through next day.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia, Tremor, Vomiting
Clinical narrative: Extreme soreness in left arm immediately after injection then slight fever/chills around 8:00p.m. day of injection.  Chills became severe around 8:30 p.m. and lasted approximately 1 1/2 hours--uncontrollable shaking involved  then subsided somewhat during the night.  Also vomited. Temp 102.4.   Took 2 Tylenol 500 mg each.  Slight fever, muscle soreness, tiredness, weakness persisted through next day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Pain
Clinical narrative: 3 days after vaccine was administered , I developed debilitating pain on my lower back , right side. Extremely  Painful sitting down and rising from a seated position   His has been goin on for 2 days. I went to doctor today who prescribed  and striped pack.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Fatigue, Hallucination, visual, Headache
Clinical narrative: Symptoms began as follows: throat tightness, chest tightness, rapid heartbeat, body aches, fatigue, headache, extreme chills, vomiting, vision changes, (red & white flashes) hallucinations (things crawling on walls, a jet engine in bedroom door),
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Pain, Photopsia, Throat tightness, Visual impairment
Clinical narrative: Symptoms began as follows: throat tightness, chest tightness, rapid heartbeat, body aches, fatigue, headache, extreme chills, vomiting, vision changes, (red & white flashes) hallucinations (things crawling on walls, a jet engine in bedroom door),
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Symptoms began as follows: throat tightness, chest tightness, rapid heartbeat, body aches, fatigue, headache, extreme chills, vomiting, vision changes, (red & white flashes) hallucinations (things crawling on walls, a jet engine in bedroom door),
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Differential white blood cell count, Full blood count, Lymph node palpable, Swelling
Clinical narrative: Left Supraclavicular swelling and palpable Lymph node
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood creatinine normal, Cellulitis, Chills, Computerised tomogram thorax normal
Clinical narrative: 09/25/19 The patient is a 67-year-old female with known history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, depression, deep venous thrombosis, who admitted on September 24, 2019, for severe pain and swelling to the left arm extending to the left shoulder following a Pneumovax intramuscular injection to the left shoulder. The patient also started having fever with associated chills, dizziness and generalized weakness. She also had complained of some nausea. She had been unable to move her left shoulder and noted some area of redness on the left upper arm. The patient called the EMS and was brought to ER and was found to be hypotensive and febrile. T-max is at 102.9. Admission white cell count was elevated at 16 and is now down to 11.4. The patient has multiple antibiotic allergies and was started on Rocephin and Zithromax and on some ibuprofen and states that she is now feeling about 50% improved. The patient was wanting to be transferred to another hospital, however, there is no bed available. Nares screen for MRSA has come back negative. Creatinine is at 0.58. Procalcitonin is at 0.22. Troponins were negative. CT angiogram of the chest did not reveal any underlying pulmonary embolus or aortic dissection. An MRI of the left arm and shoulder has been ordered and remains pending. The patient denies any chest pain, palpitations, or shortness of breath. She denies any vomiting, abdominal pain, or diarrhea. The patient could have another severe drug reaction similar to what happened to her in 2008 when she was admitted to Hospital for infected left TKA. She hadanaphylactic shock and generalized pustular rash due to daptomycin. 10/01/2019 Patient received a Pneumovax 23 vaccine on September 23. As the day progressed, she developed severe pain and swelling in her left arm at the injection site extending up to her left shoulder. She also had fever and chills, dizziness and weakness with a MAXIMUM TEMPERATURE of 102.9. She was brought to the emergency room when she was found to be hypotensive as well as febrile. She was treated for cellulitis with azithromycin, Rocephin, and clindamycin given her multiple antibiotic allergies. MRI of the shoulder revealed diffuse myofascial edema and mild Intramuscular edema within the deltoid consistent with nonspecific myositis and fasciitis. Her clinical presentation was therefore felt to be more consistent with an adverse reaction to the vaccine. She was given Solu-Medrol and started on a prednisone taper. She is currently on 40 mg of prednisone daily for 3 days, and will decrease by 10 mg every 3 days, finishing with 5 mg daily for 4 days. She also was given prescriptions for Cefdinir 300 mg b.i.d. for an additional 7 days and clindamycin 300 mg every 6 hours for an additional 7 days. Erythema has essentially resolved. She does note that her tongue is sore now. Her appetite is somewhat low, but food doesn't taste quite right.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Dizziness, Fasciitis, Glossodynia, Hypotension
Clinical narrative: 09/25/19 The patient is a 67-year-old female with known history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, depression, deep venous thrombosis, who admitted on September 24, 2019, for severe pain and swelling to the left arm extending to the left shoulder following a Pneumovax intramuscular injection to the left shoulder. The patient also started having fever with associated chills, dizziness and generalized weakness. She also had complained of some nausea. She had been unable to move her left shoulder and noted some area of redness on the left upper arm. The patient called the EMS and was brought to ER and was found to be hypotensive and febrile. T-max is at 102.9. Admission white cell count was elevated at 16 and is now down to 11.4. The patient has multiple antibiotic allergies and was started on Rocephin and Zithromax and on some ibuprofen and states that she is now feeling about 50% improved. The patient was wanting to be transferred to another hospital, however, there is no bed available. Nares screen for MRSA has come back negative. Creatinine is at 0.58. Procalcitonin is at 0.22. Troponins were negative. CT angiogram of the chest did not reveal any underlying pulmonary embolus or aortic dissection. An MRI of the left arm and shoulder has been ordered and remains pending. The patient denies any chest pain, palpitations, or shortness of breath. She denies any vomiting, abdominal pain, or diarrhea. The patient could have another severe drug reaction similar to what happened to her in 2008 when she was admitted to Hospital for infected left TKA. She hadanaphylactic shock and generalized pustular rash due to daptomycin. 10/01/2019 Patient received a Pneumovax 23 vaccine on September 23. As the day progressed, she developed severe pain and swelling in her left arm at the injection site extending up to her left shoulder. She also had fever and chills, dizziness and weakness with a MAXIMUM TEMPERATURE of 102.9. She was brought to the emergency room when she was found to be hypotensive as well as febrile. She was treated for cellulitis with azithromycin, Rocephin, and clindamycin given her multiple antibiotic allergies. MRI of the shoulder revealed diffuse myofascial edema and mild Intramuscular edema within the deltoid consistent with nonspecific myositis and fasciitis. Her clinical presentation was therefore felt to be more consistent with an adverse reaction to the vaccine. She was given Solu-Medrol and started on a prednisone taper. She is currently on 40 mg of prednisone daily for 3 days, and will decrease by 10 mg every 3 days, finishing with 5 mg daily for 4 days. She also was given prescriptions for Cefdinir 300 mg b.i.d. for an additional 7 days and clindamycin 300 mg every 6 hours for an additional 7 days. Erythema has essentially resolved. She does note that her tongue is sore now. Her appetite is somewhat low, but food doesn't taste quite right.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Magnetic resonance imaging abnormal
Clinical narrative: 09/25/19 The patient is a 67-year-old female with known history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, depression, deep venous thrombosis, who admitted on September 24, 2019, for severe pain and swelling to the left arm extending to the left shoulder following a Pneumovax intramuscular injection to the left shoulder. The patient also started having fever with associated chills, dizziness and generalized weakness. She also had complained of some nausea. She had been unable to move her left shoulder and noted some area of redness on the left upper arm. The patient called the EMS and was brought to ER and was found to be hypotensive and febrile. T-max is at 102.9. Admission white cell count was elevated at 16 and is now down to 11.4. The patient has multiple antibiotic allergies and was started on Rocephin and Zithromax and on some ibuprofen and states that she is now feeling about 50% improved. The patient was wanting to be transferred to another hospital, however, there is no bed available. Nares screen for MRSA has come back negative. Creatinine is at 0.58. Procalcitonin is at 0.22. Troponins were negative. CT angiogram of the chest did not reveal any underlying pulmonary embolus or aortic dissection. An MRI of the left arm and shoulder has been ordered and remains pending. The patient denies any chest pain, palpitations, or shortness of breath. She denies any vomiting, abdominal pain, or diarrhea. The patient could have another severe drug reaction similar to what happened to her in 2008 when she was admitted to Hospital for infected left TKA. She hadanaphylactic shock and generalized pustular rash due to daptomycin. 10/01/2019 Patient received a Pneumovax 23 vaccine on September 23. As the day progressed, she developed severe pain and swelling in her left arm at the injection site extending up to her left shoulder. She also had fever and chills, dizziness and weakness with a MAXIMUM TEMPERATURE of 102.9. She was brought to the emergency room when she was found to be hypotensive as well as febrile. She was treated for cellulitis with azithromycin, Rocephin, and clindamycin given her multiple antibiotic allergies. MRI of the shoulder revealed diffuse myofascial edema and mild Intramuscular edema within the deltoid consistent with nonspecific myositis and fasciitis. Her clinical presentation was therefore felt to be more consistent with an adverse reaction to the vaccine. She was given Solu-Medrol and started on a prednisone taper. She is currently on 40 mg of prednisone daily for 3 days, and will decrease by 10 mg every 3 days, finishing with 5 mg daily for 4 days. She also was given prescriptions for Cefdinir 300 mg b.i.d. for an additional 7 days and clindamycin 300 mg every 6 hours for an additional 7 days. Erythema has essentially resolved. She does note that her tongue is sore now. Her appetite is somewhat low, but food doesn't taste quite right.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Muscle oedema, Myositis, Nausea, Procalcitonin increased, Pyrexia
Clinical narrative: 09/25/19 The patient is a 67-year-old female with known history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, depression, deep venous thrombosis, who admitted on September 24, 2019, for severe pain and swelling to the left arm extending to the left shoulder following a Pneumovax intramuscular injection to the left shoulder. The patient also started having fever with associated chills, dizziness and generalized weakness. She also had complained of some nausea. She had been unable to move her left shoulder and noted some area of redness on the left upper arm. The patient called the EMS and was brought to ER and was found to be hypotensive and febrile. T-max is at 102.9. Admission white cell count was elevated at 16 and is now down to 11.4. The patient has multiple antibiotic allergies and was started on Rocephin and Zithromax and on some ibuprofen and states that she is now feeling about 50% improved. The patient was wanting to be transferred to another hospital, however, there is no bed available. Nares screen for MRSA has come back negative. Creatinine is at 0.58. Procalcitonin is at 0.22. Troponins were negative. CT angiogram of the chest did not reveal any underlying pulmonary embolus or aortic dissection. An MRI of the left arm and shoulder has been ordered and remains pending. The patient denies any chest pain, palpitations, or shortness of breath. She denies any vomiting, abdominal pain, or diarrhea. The patient could have another severe drug reaction similar to what happened to her in 2008 when she was admitted to Hospital for infected left TKA. She hadanaphylactic shock and generalized pustular rash due to daptomycin. 10/01/2019 Patient received a Pneumovax 23 vaccine on September 23. As the day progressed, she developed severe pain and swelling in her left arm at the injection site extending up to her left shoulder. She also had fever and chills, dizziness and weakness with a MAXIMUM TEMPERATURE of 102.9. She was brought to the emergency room when she was found to be hypotensive as well as febrile. She was treated for cellulitis with azithromycin, Rocephin, and clindamycin given her multiple antibiotic allergies. MRI of the shoulder revealed diffuse myofascial edema and mild Intramuscular edema within the deltoid consistent with nonspecific myositis and fasciitis. Her clinical presentation was therefore felt to be more consistent with an adverse reaction to the vaccine. She was given Solu-Medrol and started on a prednisone taper. She is currently on 40 mg of prednisone daily for 3 days, and will decrease by 10 mg every 3 days, finishing with 5 mg daily for 4 days. She also was given prescriptions for Cefdinir 300 mg b.i.d. for an additional 7 days and clindamycin 300 mg every 6 hours for an additional 7 days. Erythema has essentially resolved. She does note that her tongue is sore now. Her appetite is somewhat low, but food doesn't taste quite right.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Staphylococcus test negative, Taste disorder, Troponin normal, Vaccination complication, White blood cell count increased
Clinical narrative: 09/25/19 The patient is a 67-year-old female with known history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, depression, deep venous thrombosis, who admitted on September 24, 2019, for severe pain and swelling to the left arm extending to the left shoulder following a Pneumovax intramuscular injection to the left shoulder. The patient also started having fever with associated chills, dizziness and generalized weakness. She also had complained of some nausea. She had been unable to move her left shoulder and noted some area of redness on the left upper arm. The patient called the EMS and was brought to ER and was found to be hypotensive and febrile. T-max is at 102.9. Admission white cell count was elevated at 16 and is now down to 11.4. The patient has multiple antibiotic allergies and was started on Rocephin and Zithromax and on some ibuprofen and states that she is now feeling about 50% improved. The patient was wanting to be transferred to another hospital, however, there is no bed available. Nares screen for MRSA has come back negative. Creatinine is at 0.58. Procalcitonin is at 0.22. Troponins were negative. CT angiogram of the chest did not reveal any underlying pulmonary embolus or aortic dissection. An MRI of the left arm and shoulder has been ordered and remains pending. The patient denies any chest pain, palpitations, or shortness of breath. She denies any vomiting, abdominal pain, or diarrhea. The patient could have another severe drug reaction similar to what happened to her in 2008 when she was admitted to Hospital for infected left TKA. She hadanaphylactic shock and generalized pustular rash due to daptomycin. 10/01/2019 Patient received a Pneumovax 23 vaccine on September 23. As the day progressed, she developed severe pain and swelling in her left arm at the injection site extending up to her left shoulder. She also had fever and chills, dizziness and weakness with a MAXIMUM TEMPERATURE of 102.9. She was brought to the emergency room when she was found to be hypotensive as well as febrile. She was treated for cellulitis with azithromycin, Rocephin, and clindamycin given her multiple antibiotic allergies. MRI of the shoulder revealed diffuse myofascial edema and mild Intramuscular edema within the deltoid consistent with nonspecific myositis and fasciitis. Her clinical presentation was therefore felt to be more consistent with an adverse reaction to the vaccine. She was given Solu-Medrol and started on a prednisone taper. She is currently on 40 mg of prednisone daily for 3 days, and will decrease by 10 mg every 3 days, finishing with 5 mg daily for 4 days. She also was given prescriptions for Cefdinir 300 mg b.i.d. for an additional 7 days and clindamycin 300 mg every 6 hours for an additional 7 days. Erythema has essentially resolved. She does note that her tongue is sore now. Her appetite is somewhat low, but food doesn't taste quite right.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Seizure
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted when exiting exam room after getting HPV to go wait in waiting room for 15 minute monitoring-.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Pt experienced severe pain in upper and lower extremities. Parents treated with alternating Tylenol and Ibuprofen. Pt was out of school for 3 days. Pain eventually resolved. Per parents pt. also had the same reaction to the flu vaccine in October 2018. Pt experienced pain in upper and lower extremities. Each occurrence had taken 1 to 2 weeks for the pain to subside. Flu vaccine in 2018 was given at Pharmacy.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Axillary pain, Breast pain, Erythema, Injection site erythema, Pain in extremity
Clinical narrative: Shot given around 1130-12 AM - that afternoon, pain, redness swelling moving around to armpit and (R) breast. Pain down arm to the wrist. Next day redness, moved down around bicep area - saw nurse practitioner at her job 9/26 - prescribed cephalexin. 9/30/19 much better.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: Shot given around 1130-12 AM - that afternoon, pain, redness swelling moving around to armpit and (R) breast. Pain down arm to the wrist. Next day redness, moved down around bicep area - saw nurse practitioner at her job 9/26 - prescribed cephalexin. 9/30/19 much better.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Pruritus, Urticaria
Clinical narrative: 1 hr after immunization with flu, arms broke out in hives, itchy, had diarrhea. Didn't take anything for it. By the end of the day all went away.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Swelling
Clinical narrative: Shoulder pain + swelling.
Age: 27.0
Sex: U
Vaccine: FLU4
Symptoms: Blood pressure systolic increased, Fatigue, Pain, Pyrexia, Tachycardia
Clinical narrative: Given vaccine at work site, Nsg unit reports 2AM - tachycardic rate 130, BP increase systolic 150 drank water, sat 1 hr sx resolved. Next day. Fever 101-103 through Monday 10/21 body aches/fatigue 10/22/19 sx resolved.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3
Symptoms: Deafness
Clinical narrative: Total Loss of hearing  ER - unable to determine cause.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3
Symptoms: Audiogram abnormal, Blood test, Chest X-ray, Deafness bilateral, Magnetic resonance imaging
Clinical narrative: Total Loss of hearing  ER - unable to determine cause.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3
Symptoms: Urine analysis
Clinical narrative: Total Loss of hearing  ER - unable to determine cause.
Age: 43.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: Was given vaccine 10/28/19 subcutaneous right posterior arm. 10/22/10 developed area that was golf ball size diameter that was red, warm, and tender. Was seen at urgent care + placed on antibiotic for cellulitis.
Age: 82.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Nausea, Somnolence, Vomiting
Clinical narrative: extreme muscle ache, sleepiness, nausea, vomiting
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysstasia, Headache, Muscle disorder
Clinical narrative: Shopped in store for approx.-15 minutes, the muscles in my back felt like they couldn't work. I wasn't able to stand upright for approx. 2 min. I got the chills and a headache. This lasted for 48 hours.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dizziness, Hypertension, Oral herpes, Syncope
Clinical narrative: (injection administered intramuscularly in upper left arm) Left side of lower lip affected with Herpes breakout - grew to size of quarter - down on face w/blisters, etc. (Residue still remains) 1 1/2 hrs after vac. had episode of extremely Hi B/P - lite headed, faint.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Pruritus, Reaction to previous exposure to any vaccine
Clinical narrative: M.D. - FOR 10 YRS administered Non-PRESERVative vaccine (FLu) BECAUSE OF Previous problem (#23) SHE DIED 8/2019. PHARmaCisT insisted NO preservative AnD DiD NOT TELL me about ADJuvAnT in FluAD. I started severE JoinT PaiN by 9/29/20 - Similar to Osteoarthritis. Continued for 3 weeks. TreateD with X-StrenGTH TYLENOL.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Oral herpes, Pyrexia
Clinical narrative: Patient received vaccine @ approximately 2pm 10/22/19. Developed subjective fever approximately 5pm. Noticed fever blister on lower lip that evening + worsened the next day. Sought treatment 10/24/19
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site swelling, Throat irritation, Urticaria, Vomiting
Clinical narrative: -swelling down to elbow in left arm - hives -scratchy/irritated throat - vomiting
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: 24 hrs after immunization, the patient developed redness, pain and edema below injection site -over the next few hours, pain and swelling moved into her left fore-arm.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: pt has rash and red blotches going down her arm but went away in a week
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient used Benadryl once, swelling went down after 2 days
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Swelling
Clinical narrative: Patient used Benadryl once, swelling went down after 2 days
Age: 73.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Erythema, Infection, Influenza, Laboratory test, Ultrasound scan
Clinical narrative: Pt wife said that she took her husband to the hospital and they found out that the site where he got the vaccines was infected. She said that he had a lot of fluid retention
Age: 73.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Fluid retention, Vaccination site infection
Clinical narrative: Pt wife said that she took her husband to the hospital and they found out that the site where he got the vaccines was infected. She said that he had a lot of fluid retention
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza like illness, Oropharyngeal pain, Pain
Clinical narrative: Soreness and sore throat that had led to more flu like symptoms.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Headache, Lethargy, Skin warm, Swelling
Clinical narrative: Within 24 hours red, swollen, tender, hot to the touch, headaches, lethargy,
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: Within 24 hours red, swollen, tender, hot to the touch, headaches, lethargy,
Sex: F
Vaccine: PPV
Symptoms: Back pain, Condition aggravated
Clinical narrative: lower back muscles exhibit "more pain than usual"  when going from a sitting to standing position and vice versa after receipt of the vaccine; This spontaneous report was received from a consumer referring to herself as a 69 years old female patient. The patient's concurrent condition included drug reaction/allergy to unspecified antibiotic, and lower back muscles pain. Her medical history included pneumonia. Concomitant medication was not reported.  On an unspecified date in July 2019, unspecified lab diagnostics/studies were performed (results not reported). On 04-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, lot number and expiration date were nor reported; route of administration reported as injection) for prophylaxis.         On an unspecified date in September 2019 (reported as after receiving the vaccine), the patient's lower back muscles exhibited more pain than usual when going from a sitting to standing position and vice versa (back pain). No treatment was given for this event and the patient did not seek medical attention. At the reporting time, the patient had not recovered from back pain. The reporter stated that she was not sure if the event was related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or not.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported.; a dose of PNEUMOV AX 23 was "administered one year after a previous dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a 60 year old patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On approximately October 2018 (reported as "one year after a previous dose of PNEUMOVAX 23"), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, frequency, route, lot number and expiration date were not provided), for prophylaxis. On 16-OCT-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S002582 with an expiration date in 10-AUG-2020), (strength, dose, frequency and route), for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Fatigue, Immunology test, Peripheral swelling, Rash
Clinical narrative: patient experienced left arm swelling; fatigue; rash on body/chicken pox rash; This spontaneous report was received from a physician refers to a 55-year-old adult female patient. The patient had no pertinent medical history and drug reactions/allergies. The patient was not taking any concomitant medications.  On 03-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, lot# and expiry date were unknown) for prophylaxis (also reported as "requirement for work"). On 15-JUN-2019, the patient started to have adverse effects and experienced left arm swelling (peripheral swelling), fatigue, rash on body/chicken pox rash (varicella). On an unknown date in 2019, the patient sought medical attention and was hospitalized for an unspecified amount of time. The patient was treated with acyclovir for the events. On an unknown date, the patient underwent immune system check and blood work and the results were not reported. The patient had no overdose or cancer. No product quality complaint was reported. The outcome of peripheral swelling and fatigue was reported as not recovered. The outcome of varicella was reported as recovered. Causality assessment was not reported.  The reporter considered the events of left arm swelling, fatigue, rash on body/chicken pox rash to be disabling.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: patient experienced left arm swelling; fatigue; rash on body/chicken pox rash; This spontaneous report was received from a physician refers to a 55-year-old adult female patient. The patient had no pertinent medical history and drug reactions/allergies. The patient was not taking any concomitant medications.  On 03-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, lot# and expiry date were unknown) for prophylaxis (also reported as "requirement for work"). On 15-JUN-2019, the patient started to have adverse effects and experienced left arm swelling (peripheral swelling), fatigue, rash on body/chicken pox rash (varicella). On an unknown date in 2019, the patient sought medical attention and was hospitalized for an unspecified amount of time. The patient was treated with acyclovir for the events. On an unknown date, the patient underwent immune system check and blood work and the results were not reported. The patient had no overdose or cancer. No product quality complaint was reported. The outcome of peripheral swelling and fatigue was reported as not recovered. The outcome of varicella was reported as recovered. Causality assessment was not reported.  The reporter considered the events of left arm swelling, fatigue, rash on body/chicken pox rash to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at physician office for herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient was vaccinated with an improperly stored M-M-R II; This spontaneous report was received from a medical assistant, regarding a 6 year old male patient. The patient's illness at the time of vaccination were reported as none. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis A virus vaccine (unspecified) and "FW".  On 19-SEP-2019, the patient was vaccinated with the first dose of an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly (IM), (dose and location of administration were not reported) (lot # R028382, expiration date 10-MAR-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The temperature was exposed to a temperature of 13.13 degree Celsius since 23-MAY-2019 to 02-OCT-2019 as recorded by a digital data logger was involved. There were no previous temperature excursions, however, on an unknown date the vaccine had a temperature excursion with a highest temperature above 9 degree Celsius (58.96 degree Celsius) for 8299 and 45 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012352: US-009507513-1910USA012351: US-009507513-1910USA012357: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012359: US-009507513-1910USA007637: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012360: US-009507513-1910USA012358: US-009507513-1910USA012356: US-009507513-1910USA012981: US-009507513-1910USA012350:
Age: 1.67
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient was vaccinated with an improperly stored VARIVAX; This spontaneous report was received from a medical assistant, regarding a 20 month old male patient. The patient's illness at the time of vaccination were reported as none. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included pneumococcal 13v conj vaccine (CRM197) and Hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL).  On 02-OCT-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S000133, expiration date 02-JAN-2021), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 13.28 degree Celsius from 30-MAY-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012360: US-009507513-1910USA012981: US-009507513-1910USA012356: US-009507513-1910USA012355: US-009507513-1910USA012357: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012358:
Age: 8.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect reported; an 8 year old male patient was inadvertently administered one dose of GARDASIL 9; This spontaneous report was received from a physician, referring to a 8 year old male patient. The patient's pertinent medical history, concomitant medications, concurrent conditions, previous drug reactions and allergies were not reported.  On 19-AUG-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly for prophylaxis (strength, dose number, anatomical injection site, lot number and expiration date were not reported) (product administered to patient of inappropriate age). No adverse events were reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Death, Vaccination complication
Clinical narrative: After three years of suffering, 19 Year old girl dies from GARDASTL vaccine injury; This spontaneous report was received from a consumer via a company representative through an online article referring to a 19 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On an unknown date the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dosage detail, route, strength, lot # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (it was unclear which the two products was involved). On an unknown date (reported as after three years of suffering), the patient died from vaccine injury.  It was unknown if an autopsy was performed. The reporter considered the event to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).; Reported Cause(s) of Death: vaccine injury
Sex: M
Vaccine: HPV9
Symptoms: Haemorrhage, Product administered at inappropriate site
Clinical narrative: blood coming out in spurts; mistakes include wrong location, not deep enough; Information has been received from a male patient of unknown age, referring to himself. The patient's concomitant medication, concurrent condition, pertinent medical history and drug reactions/allergies were unknown.  In approximately March 2019 (reported as about 7 months ago), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (route, dose, frequency, lot# and expiration date unknown) for prophylaxis. In 2019, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). In approximately September 2019 (reported as about a month ago), the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  An unspecified pharmacy had made "mistakes in administering his three doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)". The patient mentioned the mistakes included "wrong location, not deep enough, and blood coming out in spurts" (start date in approximately March 2019). The outcome of blood coming out in spurts was unknown. The causality between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and blood coming out in spurts was unknown.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse eilects; a patient received an expired dose of PNEUMOVAX; Information has been received from a pharmacy student, referring to a patient of unknown age and gender. The patient's historical and concurrent conditions were unknown. Concomitant medication was not provided.  On 22-OCT-2019, the patient was vaccine with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# R000692, expiration date 09-SEP-2019, strength and dose were unknown) vaccine for prophylaxis, which was expired (expired vaccine used). No known adverse effects were reported.