chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chills, Hyperhidrosis
Clinical narrative: SHINGRIX Vial (10 PK) Kit. Several hours after the injection, I experienced severe (not life threatening obviously) adverse effects: No energy, sore muscles/joints, chills, fever (101 degrees), stomach ache, swelling/pain in left neck muscle, and a fevered injection site. These side effects continued throughout April 16 but subsided somewhat with ADVIL and BENADRYL. During the early morning of April 17, I broke out in a sweat when the fever subsided. The inject site experienced extreme redness, fever, and swelling. Except for the injection site, I felt well on April 17. During the night of April 17, I developed hives adjacent to the injection site which continues today.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Muscle swelling, Myalgia
Clinical narrative: SHINGRIX Vial (10 PK) Kit. Several hours after the injection, I experienced severe (not life threatening obviously) adverse effects: No energy, sore muscles/joints, chills, fever (101 degrees), stomach ache, swelling/pain in left neck muscle, and a fevered injection site. These side effects continued throughout April 16 but subsided somewhat with ADVIL and BENADRYL. During the early morning of April 17, I broke out in a sweat when the fever subsided. The inject site experienced extreme redness, fever, and swelling. Except for the injection site, I felt well on April 17. During the night of April 17, I developed hives adjacent to the injection site which continues today.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: SHINGRIX Vial (10 PK) Kit. Several hours after the injection, I experienced severe (not life threatening obviously) adverse effects: No energy, sore muscles/joints, chills, fever (101 degrees), stomach ache, swelling/pain in left neck muscle, and a fevered injection site. These side effects continued throughout April 16 but subsided somewhat with ADVIL and BENADRYL. During the early morning of April 17, I broke out in a sweat when the fever subsided. The inject site experienced extreme redness, fever, and swelling. Except for the injection site, I felt well on April 17. During the night of April 17, I developed hives adjacent to the injection site which continues today.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swellings (not at injection site), red, warm, itchy and sore.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Crying
Clinical narrative: After administration of last injection (PREVNAR in right thigh) patient had a vagal episode and briefly appeared not to be breathing. While rubbing sternum patient began crying. Doctor came in and listened to patient's heartbeat and stated that patient was fine.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Tdap was ordered (ADACEL); dtap was given (DAPTACEL).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Diarrhoea, Hyperaesthesia, Nausea, Pain
Clinical narrative: Patient returned to clinic on Friday 4/2/18. Patient states following injection she had temperature of 102 F for which she has been taking ADVIL and TYLENOL alternating every 4 hours. She stated she has pain in left arm since injection. Patient states last dose was 0400 of 400mg ADVIL (patient didn't eat with dose). Patient states she suffered a single emesis approx. 10 minutes prior to arrival at clinic. Continues to have nausea. Patient guarding left arm use states it is very sensitive to touch. UE girth: L 12" r 10.5". Hives from deltoid descending down arm 4" x3". Patient denies shortness of breath. Had a single loose bowel movement since Wed. morning. Patient denies blood in stool. Patient states that Tues at 2300 she developed body pain and symptoms. She is scheduled to travel out of the country.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Patient returned to clinic on Friday 4/2/18. Patient states following injection she had temperature of 102 F for which she has been taking ADVIL and TYLENOL alternating every 4 hours. She stated she has pain in left arm since injection. Patient states last dose was 0400 of 400mg ADVIL (patient didn't eat with dose). Patient states she suffered a single emesis approx. 10 minutes prior to arrival at clinic. Continues to have nausea. Patient guarding left arm use states it is very sensitive to touch. UE girth: L 12" r 10.5". Hives from deltoid descending down arm 4" x3". Patient denies shortness of breath. Had a single loose bowel movement since Wed. morning. Patient denies blood in stool. Patient states that Tues at 2300 she developed body pain and symptoms. She is scheduled to travel out of the country.
Age: 70.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with the first dose of VAQTA for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, 5 months to 5 and a half months after being vaccinated with the first dose of VAQTA, the patient received the second dose of the vaccine. No adverse effects were reported for the patient. This case is non-valid due to lack of patient identifiers. Follow up information has been received from the pharmacist on 15-APR-2018. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This report refers to a 71 year old male patient. The patient's concomitant medications included potassium chloride (KCL) as potassium supplement, irbesartan, atenolol and amlodipine for high blood pressure, and atorvastatin for high cholesterol. On an unspecified date in 2017, reported as "5 months to 5 and a half months before first vaccination", the patient received the first dose of VAQTA. On 13-JAN-2018, the patient received a second dose of VAQTA, lot # N005605, intramuscularly in the left side. It was not illness or pre-existing physician-diagnosed allergies, birth defect or medical conditions at time of vaccination. Additionally, the patient had not history of adverse event following prior vaccination.
Sex: M
Vaccine: PPV
Symptoms: Biopsy skin abnormal, Herpes zoster cutaneous disseminated, Periorbital oedema, Rash erythematous, Rash generalised
Clinical narrative: This literature marketed report has been received from the authors of the published literature article, refers to a 78 year old male patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route of administration, lot # and expiry date were not provided). On an unknown date, the patient presented with a diffuse pruritic rash 1 day after receiving polyvalent (23-valent)(manufacturer unknown). The rash had initially developed over his right arm but had spread to involve other parts of his body. Physical examination was significant for a diffuse erythematous, non-dermatomal papular rash on the scalp, face, chest, back, abdomen, groin, and bilateral upper and lower extremities. Fluid filled vesicles were not noted. A left periorbital edema was also noted. Biopsy revealed a small intraepidermal blister with degenerated keratinocytes showing multinucleation and chromatin margination, which were highlighted by Varicella-zoster virus (VZV) immunostain. Tissue culture was also positive for VZV, confirming the diagnosis of Disseminated Cutaneous Herpes Zoster. The outcome of the event was unknown. The authors considered the event of Disseminated Cutaneous Herpes Zoster to be related to pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown). Upon internal review the event of Disseminated Cutaneous Herpes Zoster was considered to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Rash papular, Rash pruritic, Varicella virus test positive
Clinical narrative: This literature marketed report has been received from the authors of the published literature article, refers to a 78 year old male patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route of administration, lot # and expiry date were not provided). On an unknown date, the patient presented with a diffuse pruritic rash 1 day after receiving polyvalent (23-valent)(manufacturer unknown). The rash had initially developed over his right arm but had spread to involve other parts of his body. Physical examination was significant for a diffuse erythematous, non-dermatomal papular rash on the scalp, face, chest, back, abdomen, groin, and bilateral upper and lower extremities. Fluid filled vesicles were not noted. A left periorbital edema was also noted. Biopsy revealed a small intraepidermal blister with degenerated keratinocytes showing multinucleation and chromatin margination, which were highlighted by Varicella-zoster virus (VZV) immunostain. Tissue culture was also positive for VZV, confirming the diagnosis of Disseminated Cutaneous Herpes Zoster. The outcome of the event was unknown. The authors considered the event of Disseminated Cutaneous Herpes Zoster to be related to pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown). Upon internal review the event of Disseminated Cutaneous Herpes Zoster was considered to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. On 16-APR-2018 around 08:00 am (central standard time), the patient was vaccinated with an expired dose of VAQTA injection 50/1.0 U/ml (dose and route of administration were not provided) (lot # L017757, expiration date: 08-APR-2018) for prophylaxis (expired product administered). There was no previous temperature excursion. No adverse effect was reported. There was no product quality complaint (PQC) reported.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 64 year and 10 month old male patient. Medical history, concurrent condition and concomitant medications were reported as none. On 11-APR-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On 12-APR-2018, at 4 am the following day, he woke up with severe pain at the injection site (10 out of 10 on the pain scale). There is no swelling or mark at the injection site, and he did not had fever. He has tried to treat the pain unsuccessfully with TYLENOL 325mg and hot compresses. He has made an appointment with a neurologist but has not had an appointment yet. The outcome of vaccination site pain was reported as not recovered/not resolved. Causality assessment was not provided. No product quality complaint was present.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as administrator) refers to a identifiable patient of unknown age. On 25-JAN-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 from lot N014946 expiry date 01-FEB-2019 for prophylaxis. No adverse effect reported. Temperature was reported as 52 degrees Fahrenheit. Time frame was reported as 4 hours. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1804USA008339.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as administrator) refers to a identifiable patient of unknown age. On 29-MAR-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 from lot N014946 expiry date 01-FEB-2019 for prophylaxis (Product storage error). No adverse effect reported. Temperature was reported as 52 degrees Fahrenheit. Time frame was reported as 4 hours. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1804USA008222.
Sex: F
Vaccine: PNC13
Symptoms: Blood culture positive, Cough, Dyspnoea, Intensive care, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself. This 75-year-old female patient of unknown race received PREVNAR 13 at single dose for immunization in Oct2015. Relevant medical history included breast cancer, diverticulitis, abdominal discomfort, she has a leaky valve in her heart which started about 5 years ago, pulmonary embolism, treated with Zpack and so the patient was fine. The patient experienced sepsis and multiple episodes of pneumonia from Jun2017. It was reported that in Jun2017 the patient experienced a small bout of pneumonia with outcome of recovered, in Nov2017 cough and short of breath and she did not know if they are symptom of cold, the patient was on the cruise ship and was treated in their ship hospital with antibiotics in IV form and inhaler. Then she was on the plane and there was a guy sitting next to her and he was really sick and coughing and hacking. She started with a cough and coughed a lot. She took a lot of Zinc and Vitamin C to try to cut it short. Then she got to the point, she needed to get some oxygen and went to emergency and sent her to ICU. She ended up in the hospital for 9 days. They knew that I would have IV antibiotics. After that she developed Steven Johnson Syndrome when she had the antibiotics. The last time she was in hospital after a trip and her daughter had to explain to them that she could get Steven Johnson syndrome again and no one in that hospital knew about this condition and her daughter was adamant about getting a doctor who knew how to take care of her. She did prednisone again and the doctor was wonderful. I also was sepsis. The outcome of the event pneumonia reported as recovered while the outcome of the event sepsis was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Sepsis, Stevens-Johnson syndrome
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself. This 75-year-old female patient of unknown race received PREVNAR 13 at single dose for immunization in Oct2015. Relevant medical history included breast cancer, diverticulitis, abdominal discomfort, she has a leaky valve in her heart which started about 5 years ago, pulmonary embolism, treated with Zpack and so the patient was fine. The patient experienced sepsis and multiple episodes of pneumonia from Jun2017. It was reported that in Jun2017 the patient experienced a small bout of pneumonia with outcome of recovered, in Nov2017 cough and short of breath and she did not know if they are symptom of cold, the patient was on the cruise ship and was treated in their ship hospital with antibiotics in IV form and inhaler. Then she was on the plane and there was a guy sitting next to her and he was really sick and coughing and hacking. She started with a cough and coughed a lot. She took a lot of Zinc and Vitamin C to try to cut it short. Then she got to the point, she needed to get some oxygen and went to emergency and sent her to ICU. She ended up in the hospital for 9 days. They knew that I would have IV antibiotics. After that she developed Steven Johnson Syndrome when she had the antibiotics. The last time she was in hospital after a trip and her daughter had to explain to them that she could get Steven Johnson syndrome again and no one in that hospital knew about this condition and her daughter was adamant about getting a doctor who knew how to take care of her. She did prednisone again and the doctor was wonderful. I also was sepsis. The outcome of the event pneumonia reported as recovered while the outcome of the event sepsis was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Stool analysis
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician. A 66 year-old Caucasian male patient of an unspecified ethnicity received the first dose of PREVNAR 13, (lot 539564, expiry date Sep2018) intramuscular in the right deltoid on 06Nov2017 at 0.5 ml single for immunization. Medical history included varicose vein diagnosed for a couple of years and unknown if ongoing, the patient was allergic to penicillin. There were no concomitant medications. The patient had previously taken for immunization influenza vaccine in Sep2017, pneumococcal vaccine polysacch 23v on 04Oct2016, diphtheria, TDAP, (lot C5212AA, expiry date 05Jun2019, NDC 49281-400-58P) intramuscular in the left deltoid on 04Aug2017. Since 11Nov2017 the patient's bowel movements and stools have changed from soft to runny and have not changed back. The patient was not recovered from the reported event. The reporter was asking what to do about the event. The patient saw the doctor due to the event on 16Apr2018. The doctor was having the patient's stool tested, no results were available at reporting time. Seriousness of event was not specified.
Sex: M
Vaccine: FLU4
Symptoms: Biopsy kidney abnormal, Blood albumin decreased, Complement factor normal, Creatinine urine increased, Glomerulonephritis minimal lesion
Clinical narrative: This case was reported in a literature article and described the occurrence of minimal change disease in a 80-year-old male patient who received FLULAVAL TETRA. Concurrent medical conditions included Waldenstrom's macroglobulinemia (in remission state). On an unknown date, the patient received FLULAVAL TETRA. On an unknown date, 8 days after receiving FLULAVAL TETRA, the patient experienced minimal change disease (serious criteria hospitalization and GSK medically significant), proteinuria (serious criteria hospitalization), leg edema (serious criteria hospitalization) and facial swelling (serious criteria hospitalization). The patient was treated with Ace Inhibitor and Statin (NOS). On an unknown date, the outcome of the minimal change disease, proteinuria, leg edema and facial swelling were unknown. The reporter considered the minimal change disease, proteinuria, leg edema and facial swelling to be related to FLULAVAL TETRA. Additional information was provided. This case was reported in a literature and described the occurrence of Minimal Change Disease in a 80 year old male who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). The patient had history of Waldenstrom's macroglobulinemia. The patient was following oncology for Waldenstrom's Macroglobulinemia and was considered in remission. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient received FLULAVAL TETRA (administration site and route unspecified, dosage unknown; Lot: 9335Z, NDC: 19515-912-41). The age of vaccination was not provided. On an unspecified date, 8 days after vaccination, the patient presented with abrupt onset facial swelling, leg oedema. Laboratory findings showed elevated creatinine compared to the baseline with heavy proteinuria. Urine protein: creatinine ratio (UPCR) was 10 with evaluation in the Hospital showing 24 hour urine protein to be 1226 gram. Albumin level was noticeably low at 1.5. Immunology testing was negative, complement levels were normal. Biopsy revealed minimal change disease with thin Basement Membrane. Fibrillary deposits on Electron microscopy noted and negative for congo stain. Tubules stained for both kappa and lambda with absence of monoclonality. This case has been considered serious due to hospitalisation. The patient was started on Angiotensin converting enzyme inhibitors and statin therapy. The outcome of the event was not reported. The authors commented "Few cases of Minimal Change Disease have been reported in the literature related to the influenza vaccination and Waldenstrom's macroglobulinemia. The abruptness of onset with temporal association of symptoms just days of vaccination lead us to conclude that Influenza vaccination was the culprit for Minimal Change Disease in this patient". The authors concluded "This case highlights a very rare complication related to the Influenza vaccination".
Sex: M
Vaccine: FLU4
Symptoms: Immunology test normal, Microscopy, Oedema peripheral, Protein urine present, Proteinuria
Clinical narrative: This case was reported in a literature article and described the occurrence of minimal change disease in a 80-year-old male patient who received FLULAVAL TETRA. Concurrent medical conditions included Waldenstrom's macroglobulinemia (in remission state). On an unknown date, the patient received FLULAVAL TETRA. On an unknown date, 8 days after receiving FLULAVAL TETRA, the patient experienced minimal change disease (serious criteria hospitalization and GSK medically significant), proteinuria (serious criteria hospitalization), leg edema (serious criteria hospitalization) and facial swelling (serious criteria hospitalization). The patient was treated with Ace Inhibitor and Statin (NOS). On an unknown date, the outcome of the minimal change disease, proteinuria, leg edema and facial swelling were unknown. The reporter considered the minimal change disease, proteinuria, leg edema and facial swelling to be related to FLULAVAL TETRA. Additional information was provided. This case was reported in a literature and described the occurrence of Minimal Change Disease in a 80 year old male who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). The patient had history of Waldenstrom's macroglobulinemia. The patient was following oncology for Waldenstrom's Macroglobulinemia and was considered in remission. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient received FLULAVAL TETRA (administration site and route unspecified, dosage unknown; Lot: 9335Z, NDC: 19515-912-41). The age of vaccination was not provided. On an unspecified date, 8 days after vaccination, the patient presented with abrupt onset facial swelling, leg oedema. Laboratory findings showed elevated creatinine compared to the baseline with heavy proteinuria. Urine protein: creatinine ratio (UPCR) was 10 with evaluation in the Hospital showing 24 hour urine protein to be 1226 gram. Albumin level was noticeably low at 1.5. Immunology testing was negative, complement levels were normal. Biopsy revealed minimal change disease with thin Basement Membrane. Fibrillary deposits on Electron microscopy noted and negative for congo stain. Tubules stained for both kappa and lambda with absence of monoclonality. This case has been considered serious due to hospitalisation. The patient was started on Angiotensin converting enzyme inhibitors and statin therapy. The outcome of the event was not reported. The authors commented "Few cases of Minimal Change Disease have been reported in the literature related to the influenza vaccination and Waldenstrom's macroglobulinemia. The abruptness of onset with temporal association of symptoms just days of vaccination lead us to conclude that Influenza vaccination was the culprit for Minimal Change Disease in this patient". The authors concluded "This case highlights a very rare complication related to the Influenza vaccination".
Sex: M
Vaccine: FLU4
Symptoms: Swelling face, Urine protein/creatinine ratio increased
Clinical narrative: This case was reported in a literature article and described the occurrence of minimal change disease in a 80-year-old male patient who received FLULAVAL TETRA. Concurrent medical conditions included Waldenstrom's macroglobulinemia (in remission state). On an unknown date, the patient received FLULAVAL TETRA. On an unknown date, 8 days after receiving FLULAVAL TETRA, the patient experienced minimal change disease (serious criteria hospitalization and GSK medically significant), proteinuria (serious criteria hospitalization), leg edema (serious criteria hospitalization) and facial swelling (serious criteria hospitalization). The patient was treated with Ace Inhibitor and Statin (NOS). On an unknown date, the outcome of the minimal change disease, proteinuria, leg edema and facial swelling were unknown. The reporter considered the minimal change disease, proteinuria, leg edema and facial swelling to be related to FLULAVAL TETRA. Additional information was provided. This case was reported in a literature and described the occurrence of Minimal Change Disease in a 80 year old male who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). The patient had history of Waldenstrom's macroglobulinemia. The patient was following oncology for Waldenstrom's Macroglobulinemia and was considered in remission. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient received FLULAVAL TETRA (administration site and route unspecified, dosage unknown; Lot: 9335Z, NDC: 19515-912-41). The age of vaccination was not provided. On an unspecified date, 8 days after vaccination, the patient presented with abrupt onset facial swelling, leg oedema. Laboratory findings showed elevated creatinine compared to the baseline with heavy proteinuria. Urine protein: creatinine ratio (UPCR) was 10 with evaluation in the Hospital showing 24 hour urine protein to be 1226 gram. Albumin level was noticeably low at 1.5. Immunology testing was negative, complement levels were normal. Biopsy revealed minimal change disease with thin Basement Membrane. Fibrillary deposits on Electron microscopy noted and negative for congo stain. Tubules stained for both kappa and lambda with absence of monoclonality. This case has been considered serious due to hospitalisation. The patient was started on Angiotensin converting enzyme inhibitors and statin therapy. The outcome of the event was not reported. The authors commented "Few cases of Minimal Change Disease have been reported in the literature related to the influenza vaccination and Waldenstrom's macroglobulinemia. The abruptness of onset with temporal association of symptoms just days of vaccination lead us to conclude that Influenza vaccination was the culprit for Minimal Change Disease in this patient". The authors concluded "This case highlights a very rare complication related to the Influenza vaccination".
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Large, red, warm, raised area size of grapefruit.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt has swelling, redness, clean fluid weeping at injection site. Also claims injection site is "hot".
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chest pain, Chills, Extensive swelling of vaccinated limb, Hyperhidrosis
Clinical narrative: Pt has swelling, redness, clean fluid weeping at injection site. Also claims injection site is "hot".
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site extravasation, Injection site pain, Myalgia, Pain in jaw
Clinical narrative: Pt has swelling, redness, clean fluid weeping at injection site. Also claims injection site is "hot".
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Erythema, Pain
Clinical narrative: Next day woke up with some redness, pain to area and chills. No fever or swelling. Read VIS to Pt and told him to ice area and watch temps. No further follow up has been needed since.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain, Pain
Clinical narrative: Within 2 hours I suddenly experienced severe pain on the muscle on my left arm around the injection site. It severely painful on movement requiring that muscle. It is painful at rest too. I woke up about 17 hours after the injection experiencing very uncomfortable throbbing over the same area. It is now almost 24 hours since the injection, and I am still at aboutthe samelevel of discomfort. I have tried icing, ibuprofen, PERCOCET, and ZANAFLEX with little-to-no improvement.
Age: 56.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Received pre-employment vaccines (Hepatitis B and MMR) in left arm. The patient discovered a dull ache that extended from shoulder to forearm. No swelling redness or weakness in affected side. Has successfully treated w/ prescribed pain medication and over the counter pain medication. Massage has also been effective. Has not sought medical treatment.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Cough, Dizziness, Headache, Myalgia
Clinical narrative: Fever (to 100.5), headache, cough, myalgia, dizziness.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever (to 100.5), headache, cough, myalgia, dizziness.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Painful site almost immediate. Headache, body aches, fatigue, 16 hours after injection.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Allergy test
Clinical narrative: Allergy status to serum and vaccine status on 2018-04-12.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, UNK
Symptoms: Meningism
Clinical narrative: Meningismus on 2018-04-11.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Dental caries
Clinical narrative: I have received numerous Anthrax vaccinations between 03/2002 and 03/2018. May have caused severe dental decay.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Whole body maculopapular rash with two days of fever up to 100.8.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypoaesthesia, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Patient experienced injection site pain immediately after the vaccine. She noted that 30 minutes after the vaccine she started noticing the area became warm and red. She stated this was expected as she had been counseled on it. The next day she started noticing tingling and numbing in the last three fingers of the immunized arm, which recurred 5-6 times throughout the day. The redness and warmth persisted. The patient also experienced flu-like sx 24-hours post the immunization (headache, fever, fatigue), which she reports lasted for 1-2 days. The redness and numbness persisted for 4 days following the immunization, but are noted to have improved as time passes. The patient has not noted a similar reaction in the past. She stated that the injection site pain had occurred for 1-2 days after receiving Tdap, but never with other immunizations.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Paraesthesia, Pyrexia
Clinical narrative: Patient experienced injection site pain immediately after the vaccine. She noted that 30 minutes after the vaccine she started noticing the area became warm and red. She stated this was expected as she had been counseled on it. The next day she started noticing tingling and numbing in the last three fingers of the immunized arm, which recurred 5-6 times throughout the day. The redness and warmth persisted. The patient also experienced flu-like sx 24-hours post the immunization (headache, fever, fatigue), which she reports lasted for 1-2 days. The redness and numbness persisted for 4 days following the immunization, but are noted to have improved as time passes. The patient has not noted a similar reaction in the past. She stated that the injection site pain had occurred for 1-2 days after receiving Tdap, but never with other immunizations.
Age: 57.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: Pain @ injection site. Nausea & vomiting about 5 hours after injection.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: Patient noticed on the night of the day she received the above mentioned two vaccines that her hands and feet were swollen, itchy, blotchy and painful.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site pain, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Patient presented to clinic two days after receiving vaccine reporting erythematous rash that is painful adjacent to the site where she received a PPSV 23 vaccination. She says the muscle "biceps" and her axilla feels sore and that the raised red rash developed within 24 hours of the immunization. It is not pruritic and does not seem to be spreading rather in fact seems to be improving. She has no mouth, tongue or lip swelling. She has no dyspnea or fevers. She is otherwise feeling fine. Right anterolateral arm with a 3.5 x 4" patch of erythematous confluent papules with raised edges. These do not feel fluctuant and they're minimally tender to palpation.  There is no significant warmth. She is able to move her arm at the elbow and shoulder without discomfort. She has no axillary lymphadenopathy.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Rash papular
Clinical narrative: Patient presented to clinic two days after receiving vaccine reporting erythematous rash that is painful adjacent to the site where she received a PPSV 23 vaccination. She says the muscle "biceps" and her axilla feels sore and that the raised red rash developed within 24 hours of the immunization. It is not pruritic and does not seem to be spreading rather in fact seems to be improving. She has no mouth, tongue or lip swelling. She has no dyspnea or fevers. She is otherwise feeling fine. Right anterolateral arm with a 3.5 x 4" patch of erythematous confluent papules with raised edges. These do not feel fluctuant and they're minimally tender to palpation.  There is no significant warmth. She is able to move her arm at the elbow and shoulder without discomfort. She has no axillary lymphadenopathy.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced swelling,pain,redness and heat from injection site distally to the elbow within 4hr of vaccination.Patient began taking diphenhydramine 50mg every 6hr as soon as symptoms developed and symptoms resolved within 72hr of onset.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Circumstance or information capable of leading to medication error, Erythema, Swelling
Clinical narrative: Two inch area of raised, red skin. Patient was not still during injection.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Weight bearing difficulty, X-ray
Clinical narrative: Pt says she has felt a lot pain in her arm so much that she can barely move it. She cannot lift or turn her arm. She also cannot pick up heavy items. She spoke with PCP and she was taken to the ER where x-rays were done. The pt said the ER gave her medication for the pain but she is still feeling the pain now. The member also said her PCP recommended medications she could take for pain.
Age: 26.0
Sex: M
Vaccine: MNQ, PNC13
Symptoms: Anxiety, Dizziness, Hyperhidrosis
Clinical narrative: Anxious, lightheaded, sweaty. Patient given water, cool cloth and sat for a few minutes. S/S resolved.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Had meningitis shot 4/17/18, started to have mild swelling and redness 1-2 hours later 4/18/18 reports the redness and swelling increased in size. Reported to PCP office on 4/19/18 on exam site noted to be red, swollen, warm to touch no pus/drainage, "rash", reported "itchy" patient tried calamine lotion and BENADRYL 4/18/18 at home. No fever, no chills reported. Skin was noted to have large circular area of erythema to left upper arm/deltoid measuring, 10 cm in diameter. Skin is tense but not painful to touch skin was relatively warm no open skin or drainage. No limitation to movement of the arm.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site warmth, Skin tightness, Swelling
Clinical narrative: Had meningitis shot 4/17/18, started to have mild swelling and redness 1-2 hours later 4/18/18 reports the redness and swelling increased in size. Reported to PCP office on 4/19/18 on exam site noted to be red, swollen, warm to touch no pus/drainage, "rash", reported "itchy" patient tried calamine lotion and BENADRYL 4/18/18 at home. No fever, no chills reported. Skin was noted to have large circular area of erythema to left upper arm/deltoid measuring, 10 cm in diameter. Skin is tense but not painful to touch skin was relatively warm no open skin or drainage. No limitation to movement of the arm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site swelling, Rash, Urticaria
Clinical narrative: Baby developing rash and hives on (R) cheek and some non-typical rash on the chest 15 minutes after given shots. Mild swelling in the injection site of varicella. Improved after given BENADRYL/Ibuprofen.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation. During 2013, a female patient, age unspecified, was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 12-MAY-2016 the patient was treated (by an unspecified health care professional) at an urgent care facility for blistering vesicular outbreaks that were diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: FLU4, HIBV, MMR, VARCEL
Symptoms: Blister, Pruritus, Pyrexia, Rhinorrhoea
Clinical narrative: Varicella positive symptoms include vesicles, fever, itching, rhinorrhea-onset first lesions 2 days ago 4/18/18.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Left upper arm swollen and red and warm. Erythema multiform and urticaria pruritus.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Left upper arm swollen and red and warm. Erythema multiform and urticaria pruritus.
Age: 55.0
Sex: M
Vaccine: MMR
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Skin rash and nausea, vomiting.
Age: 64.0
Sex: F
Vaccine: PER, TTOX
Symptoms: Injection site reaction, Musculoskeletal pain, Myositis, Nerve conduction studies normal, Pain
Clinical narrative: The day after having the vaccine my arm was hurting, figured it was just a side effect, but the pain kept getting worse and then I started getting shooting pain into my shoulder. On 2/20 I called my doctor's office, they told me to ice it and take TYLENOL. That did not help I called them again on 2/26. She had me come in and looked at the arm, there was no swelling or redness, she said to use SALONPAS Patches and gave me a prescription for Gabapentin. The pain just kept getting worse I called Doctor back on 3/7 was told to increase the gabapentin. Still no relief so on 3/27 I called doctor again and she recommended I see a neurologist. On 4/4/18 I had an appointment with a neurologist. She did many tests and wanted me to see a Physical Therapist. Saw staff at Physical therapy on 4/11/18, she did some tests and gave me some exercises to do. She said I had an inflamed muscle from where the tetanus vaccine was given. I did the exercises and saw her again on 4/17/18. She gave me more exercises and also did some therapy on my arm. When I left there I was in the most severe pain ever, and it is still going on till this day. Very severe pain in the muscle of my arm with sharp stabbing pains from shoulder into the arm.
Age: 64.0
Sex: F
Vaccine: PER, TTOX
Symptoms: Pain in extremity
Clinical narrative: The day after having the vaccine my arm was hurting, figured it was just a side effect, but the pain kept getting worse and then I started getting shooting pain into my shoulder. On 2/20 I called my doctor's office, they told me to ice it and take TYLENOL. That did not help I called them again on 2/26. She had me come in and looked at the arm, there was no swelling or redness, she said to use SALONPAS Patches and gave me a prescription for Gabapentin. The pain just kept getting worse I called Doctor back on 3/7 was told to increase the gabapentin. Still no relief so on 3/27 I called doctor again and she recommended I see a neurologist. On 4/4/18 I had an appointment with a neurologist. She did many tests and wanted me to see a Physical Therapist. Saw staff at Physical therapy on 4/11/18, she did some tests and gave me some exercises to do. She said I had an inflamed muscle from where the tetanus vaccine was given. I did the exercises and saw her again on 4/17/18. She gave me more exercises and also did some therapy on my arm. When I left there I was in the most severe pain ever, and it is still going on till this day. Very severe pain in the muscle of my arm with sharp stabbing pains from shoulder into the arm.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Cardiac monitoring, Cardiac monitoring abnormal, Consciousness fluctuating, Unresponsive to stimuli
Clinical narrative: After the vaccinations had been administered, the lady in the Immunizations department at the clinic who administered them, told me that if her fever went above 102 to take her in. By 6 pm that evening, I took her to the ER after rectally taking her temperature and it being 103.4. She was in and out of consciousness on our way and would not smile or react to me. They hooked her to a heart monitor machine and her HR reached as high as 212.
Age: 49.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Patient received previous MENVEO on 4/3/18. I spoke with patient on 4/20/18 by telephone and he denied any adverse reactions. Slight soreness in arm where he received the MENVEO and also a Hepatitis A vaccine.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Today patient presented to pharmacy with large red/pink area surrounding the injection site. Patient stated that it started with pain and then a bump and then the redness spread. The redness was from the shoulder down to the elbow. The site was warm to the touch. Got in touch with our clinical director and showed a picture of the reaction informed patient to go to urgent care. Patient has been icing and said is looking better and will wait before going to urgernt care.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne
Clinical narrative: Patient reported that a few days after getting the SHINGRIX vaccination she broke out in small comedone like pimples on her legs, stomach, and back.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Disabling headache, fever, chills, muscle aches, nausea, fatigue, arm pain for 16 hours. Fatigue during the next 6 hours.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Disabling headache, fever, chills, muscle aches, nausea, fatigue, arm pain for 16 hours. Fatigue during the next 6 hours.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Drug dispensed to wrong patient, Pain
Clinical narrative: 4/19/2018 Pt in office with younger sibling and parents for children's immunization clinic. Vaccines drawn for both pt and younger sibling. Pt to receive Hep A, younger sibling to receive PENTACEL and PCV13. Pt inadvertently give younger sibling vaccines. Parents made aware of error. Pt given Hep A vaccine. Pt tolerated without difficulty. Parents educated r/t vaccines and possible side effects encouraged appropriate follow up with provider if needed pt mom verbalize understanding. Pt alert, pink and taking when she left the clinic with her parents. 3/20/2018 call placed to pt parents spoke with pt Dad PHN advise call to follow up on pt. Pt Dad states pt doing ok today " she was in a lot of pain last night" Pt Dad states follow up appointment scheduled with pt PCP today at 1100.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Impaired work ability, Injection site erythema
Clinical narrative: Extreme shivering (2 hours); nausea/vomiting; weakness upon standing; muscle ache; severe headache (2 days); redness and swelling at vaccine site. Lost time at work.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Vaccination site swelling, Vomiting
Clinical narrative: Extreme shivering (2 hours); nausea/vomiting; weakness upon standing; muscle ache; severe headache (2 days); redness and swelling at vaccine site. Lost time at work.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: DONOR FELT FEVERISH AFTER INJECTION AND HAD CRAMPS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash/pruritus on extremities and torso-subsided after loratadine was given.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest X-ray normal, Cough, Croup infectious, Febrile convulsion, Pyrexia
Clinical narrative: Vaccine 4/16/18. Fever, croupy cough, and seizure (febrile seizure in pt with h/o seizures) on 4/17/18. Eval at ED.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Client came into the clinic on Wednesday, April 18, 2018 to have a healthcare professional take a look at his arm. He had some noticeable swelling, redness, and felt hot to the touch. Advised client and mother to apply a cold compress to the site several times a day, take ibuprofen/TYLENOL as needed, and RTC by Friday, April 20th in the AM. Client has not returned to clinic.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Pain, Poor quality sleep
Clinical narrative: Wakefulness, mild nausea, mild diarrhea, overall achiness, chills, shivering, fever.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Wakefulness, mild nausea, mild diarrhea, overall achiness, chills, shivering, fever.
Age: 64.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Chills, Erythema, Headache, Mobility decreased, Peripheral swelling
Clinical narrative: Could not move arm the next day, it was swollen, red, hot to the touch. Patient also had chills and headache.
Age: 64.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Skin warm
Clinical narrative: Could not move arm the next day, it was swollen, red, hot to the touch. Patient also had chills and headache.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV
Symptoms: Dermatitis diaper, Injection site erythema, Rash erythematous
Clinical narrative: She woke up this morning with a bright red diaper rash in her genitals. She also has a small red circle around one of her shot injection sites.